Annual Comprehensive List of Guidance Documents at the Food and Drug Administration, 824-913 [05-155]

Download as PDF 824 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices • ‘‘E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs’’ (69 FR 55163; Docket No. 2004D–0377) provides recommendations to sponsors concerning clinical studies to assess the potential of a new drug to cause cardiac arrhythmias, focusing on the assessment of changes in the QT/QTc interval on the electrocardiogram as a predictor of risk. • ‘‘S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals’’ (69 FR 55164; Docket No. 2004D–0378) describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization and includes information concerning nonclinical assays and an integrated risk assessment. Interested persons were given until December 13, 2004, to submit comments on the draft guidances. On December 13, 2004, FDA received letters from Wyeth Pharmaceuticals requesting that the agency extend the comment periods for the draft guidances. In response to these requests, FDA has decided to reopen the comment period on the draft guidances until February 18, 2005, to allow the public more time to review and comment on the contents. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidances on or before February 18, 2005. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Identify comments with the corresponding docket number of the draft guidance as follows: Docket No. 2004D–0377 ‘‘E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs’’ and Docket No. 2004D–0378 ‘‘S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals.’’ The draft guidances and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m. Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the draft guidance documents at https://www.fda.gov/ VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 ohrms/dockets/default.htm, https:// www.fda.gov/cder/guidance/index.htm, or https://www.fda.gov/cber/ publications.htm. Dated: December 28, 2004. William K. Hubbard, Associate Commissioner for Policy and Planning. [FR Doc. 05–110 Filed 1–4–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1998N–0046] Annual Comprehensive List of Guidance Documents at the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing its annual comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA’s good guidance practices (GGPs) regulations. It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past year. DATES: We welcome general comments on this list and on agency guidance documents at any time. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. We have provided information in the tables in the SUPPLEMENTARY INFORMATION section of this document on where to obtain a single copy of any of the guidance documents listed. FOR FURTHER INFORMATION CONTACT: Regarding GGPs: Lisa Helmanis, Office of Policy (HF–26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–3480. SUPPLEMENTARY INFORMATION: I. Background FDA’s GGPs were published in the Federal Register of September 19, 2000 (65 FR 56468), and became effective October 19, 2000. GGPs are intended to ensure involvement of the public in the development of guidance documents, PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 and to enhance understanding of the availability, nature, and legal effect of such guidance (§ 10.115 (21 CFR 10.115)). In § 10.115(n)(2), FDA stated that it intended to publish an annual comprehensive list of guidance documents. The list in this document updates a comprehensive list that published October 24, 2001 (66 FR 53836). The following comprehensive list identifies all guidances that have been issued and are in use, and all draft guidances that have been distributed for comment and not for implementation. Any guidances that have been withdrawn since the last publication of this comprehensive list are also identified. These withdrawn guidances include some final and draft guidances that had been withdrawn prior to the date of publication of this list, and some that are being withdrawn as of this date. In accordance with the agency’s general policy on guidances, you may comment on this list and on any FDA guidance document at any time. Please note that although we have stated that the ‘‘Guidance for Industry on Qualified Health Claims in Labeling of Conventional Foods and Dietary Supplements’’ (December 2002) has been ‘‘replaced’’ by subsequent guidance, the agency has not abandoned the position in the 2002 guidance regarding reasonable consumer standard. We have organized the documents by the issuing center or office within FDA, and have identified the pertinent intended users or regulatory activities. The dates in the list refer to the date we issued the guidances or, where applicable, the last date we revised a document. Because each issuing center or office maintains its own database, there are slight variations in the way in which they provide information in the tables in this document. The following most frequently used Internet sites for agency guidances are provided for future reference: • Center for Biologics Evaluation and Research (CBER): https://www.fda.gov/ cber/guidelines.htm • Center for Drug Evaluation and Research (CDER): https://www.fda.gov/ cder/guidance/index.htm • Center for Devices and Radiological Health (CDRH): https://www.fda.gov/ cdrh/guidance.html • Center for Food Safety and Applied Nutrition (CFSAN): https:// www.cfsan.fda.gov/dms/guidance.html • Center for Veterinary Medicine (CVM): https://www.fda.gov/cvm/ guidance/published.htm • Office of Regulatory Affairs (ORA) and Office of the Commissioner: http:/ E:\FR\FM\05JAN1.SGM 05JAN1 825 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices /www.fda.gov/opacom/morechoices/ industry/guidance.htm GUIDANCE DOCUMENTS ISSUED BY CBER Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Guidelines for Immunization of Source Plasma (Human) Donors With Blood Substances June 1980 FDA regulated industry Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448, 1– 800–835–4709 or 301–827–1800 https://www.fda.gov/ cber/guidelines.htm Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes) January 28, 1981 Ditto (Do) Do. https://www.fda.gov/ cber/memo.htm Interferon Test Procedures: Draft Points to Consider (PTC) in the Production and Testing of Interferon Intended for Investigational Use in Humans July 28, 1983 Do. Do. https://www.fda.gov/ cber/guidelines.htm Deferral of Blood Donors Who Have Received the Drug Accutane (isotretinoin/Roche; 13-cis-retinoic acid) February 28, 1984 Do. Do. https://www.fda.gov/ cber/memo.htm Equivalent Methods for Compatibility Testing December 14, 1984 Do. Do. Do. Plasma Derived From Therapeutic Plasma Exchange December 14, 1984 Do. Do. Do. Draft PTC in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology April 10, 1985 Do. Do. https://www.fda.gov/ cber/guidelines.htm Reduction of the Maximum Platelet Storage Period to 5 Days in an Approved Container June 2, 1986 Do. Do. https://www.fda.gov/ cber/memo.htm To In Vitro Diagnostic Reagent Manufacturers: Guidance on the Labeling of Human Blood Derived In Vitro Diagnostic Devices in Regard to Labeling for HTLV–III/LAV Antibody Testing December 6, 1986 Do. Do. Do. Guideline on General Principles of Process Validation May 1987 Do. Do. https://www.fda.gov/ cber/guidelines/htm Deferral of Donors Who Have Received Human Pituitary-Derived Growth Hormone November 25, 1987 Do. Do. https://www.fda.gov/ cber/memo.htm Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices December 1987 Do. Do. https://www.fda.gov/ cber/guidelines.htm Recommendations for the Management of Donors and Units That Are Initially Reactive for Hepatitis B Surface Antigen (HbsAg) December 2, 1987 Do. Do. https://www.fda.gov/ cber/memo.htm Extension of Dating Period for Storage of Red Blood Cells, Frozen December 4, 1987 Do. Do. Do. To Licensed In Vitro Diagnostic Manufacturers: Handling of Human Blood Source Materials December 23, 1987 Do. Do. Do. Recommendations for Implementation of Computerization in Blood Establishments April 6, 1988 Do. Do. Do. Control of Unsuitable Blood and Blood Components April 6, 1988 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 826 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Discontinuance of Prelicensing Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines July 7, 1988 Do. Do. Do. Physician Substitutes August 15, 1988 Do. Do. Do. To Licensed Manufacturers of Blood Grouping Reagents: Criteria for Exemption of Lot Release August 26, 1988 Do. Do. Do. Revised Guideline for the Collection of Platelets, Pheresis October 7, 1988 Do. Do. Do. To Manufacturers of HTLV–I Antibody Test Kits: Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV–I) Release Panel I October 18, 1988 Do. Do. Do. HTLV–1 Antibody Testing November 29, 1988 Do. Do. Do. Use of Recombigen HIV–1 LA Test February 1, 1989 Do. Do. Do. Guidance for Autologous Blood and Blood Components March 15, 1989 Do. Do. Do. Use of Recombigen HIV–1 Latex Agglutination (LA) Test August 1, 1989 Do. Do. Do. Draft PTC in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus, Type 1 August 8, 1989 Do. Do. https://www.fda.gov/ cber/guidelines.htm PTC in the Collection, Processing, and Testing of Ex Vivo Activated Mononuclear Leukocytes for Administration to Humans August 22, 1989 Do. Do. Do. Requirements for Computerization of Blood Establishments September 8, 1989 Do. Do. https://www.fda.gov/ cber/memo.htm Abbott Laboratories’ HIVAG–1 Test for HIV–1 Antigen(s) Not Recommended for Use as a Donor Screen October 4, 1989 Do. Do. Do. Guideline for Collection of Blood or Blood Products From Donors With Positive Tests for Infectious Disease Markers (‘‘High Risk’’ Donors) October 26, 1989 Do. Do. Do. Guideline for the Determination of Residual Moisture in Dried Biological Products January 1990 Do. Do. https://www.fda.gov/ cber/guidelines.htm Autologous Blood Collection and Processing Procedures February 12, 1990 Do. Do. https://www.fda.gov/ cber/memo.htm Use of Genetic Systems HIV–2 EIA June 21, 1990 Do. Do. Do. FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica March 15, 1991 Do. Do. Do. Revision to October 26, 1989, Guideline for Collection of Blood or Blood Products From Donors With Positive Tests for Infectious Disease Markers (‘‘High Risk’’ Donors) April 17, 1991 Do. Do. Do. Deficiencies Relating to the Manufacture of Blood and Blood Components March 20, 1991 Do. Do. Do. Responsibilities of Blood Establishments Related to Errors and Accidents in the Manufacture of Blood and Blood Components March 20, 1991 Do. Do. Do. FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc) September 10, 1991 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 827 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Disposition of Blood Products Intended for Autologous Use That Test Repeatedly Reactive for Anti-HCV September 11, 1991 Do. Do. Do. Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing December 12, 1991 Do. Do. Do. Supplement to the PTC in the Production and Testing of New Drugs and Biologics Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability April 6, 1992 Do. Do. https://www.fda.gov/ cber/guidelines.htm Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products April 23, 1992 Do. Do. https://www.fda.gov/ cber/memo.htm Use of Fluorognost HIV–1 Immunofluorescent Assay (IFA) April 23, 1992 Do. Do. Do. Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma, and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) April 23, 1992 Do. Do. Do. Exemptions to Permit Persons With a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma: Alternative Procedures, 21 CFR 640.120 April 23, 1992 Do. Do. Do. Changes in Equipment for Processing Blood Donor Samples July 21, 1992 Do. Do. Do. Nomenclature for Monoclonal Blood Grouping Reagents September 28, 1992 Do. Do. Do. Volume Limits for Automated Collection of Source Plasma November 4, 1992 Do. Do. Do. FDA’s Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed Biologics November 25, 1992 Do. Do. https://www.fda.gov/ cber/guidelines.htm Revision of October 7, 1988, Memo Concerning Red Blood Cell Immunization Programs December 16, 1992 Do. Do. https://www.fda.gov/ cber/memo.htm Draft PTC in the Characterization of Cell Lines Used to Produce Biologicals July 12, 1993 Do. Do. https://www.fda.gov/ cber/guidelines.htm Guidance on Alternatives to Lot Release for Licensed Biological Products July 20, 1993 Do. Do. Do. Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products July 22, 1993 Do. Do. https://www.fda.gov/ cber/memo.htm Deferral of Blood and Plasma Donors Based on Medications July 28, 1993 Do. Do. Do. Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma, and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) August 5, 1993 Do. Do. Do. Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor Notification August 19, 1993 Do. Do. Do. Draft Guideline for the Validation of Blood Establishment Computer Systems September 28, 1993 Do. Do. https://www.fda.gov/ cber/guidelines.htm Guidance Regarding Post Donation Information Reports December 10, 1993 Do. Do. https://www.fda.gov/ cber/memo.htm VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 828 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis December 22, 1993 Do. Do. Do. Recommendations for the Invalidation of Test Results When Using Licensed Viral Marker Assays to Screen Donors January 3, 1994 Do. Do. Do. Recommendations for Deferral of Donors for Malaria Risk July 26, 1994 Do. Do. Do. Office of Establishment Licensing and Product Surveillance (OELPS), Advertising and Promotional Labeling Staff, Procedural Guidance Document (Draft) August 1994 Do. Do. https://www.fda.gov/ cber/guidelines.htm Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances November 1994 Do. Do. Do. Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems December 20, 1994 Do. Do. https://www.fda.gov/ cber/memo.htm Timeframe for Licensing Irradiated Blood Products February 3, 1995 Do. Do. Do. Revision of August 27, 1982, FDA Memo: Requirements for Infrequent Plasmapheresis Donors March 10, 1995 Do. Do. Do. To All Licensed Establishments Performing Red Blood Cell Immunizations: Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors March 14, 1995 Do. Do. Do. Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes, and Source Plasma June 8, 1995 Do. Do. Do. Guideline for Quality Assurance in Blood Establishments July 11, 1995 Do. Do. https://www.fda.gov/ cber/guidelines.htm FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products July 11, 1995 Do. Do. Do. Recommendations for Labeling and Use of Units of Whole Blood, Blood Components, Source Plasma, Recovered Plasma, or Source Leukocytes Obtained From Donors With Elevated Levels of Alanine Aminotransferase (ALT) August 8, 1995 Do. Do. https://www.fda.gov/ cber/memo.htm Recommendations for Donor Screening With a Licensed Test for HIV–1 Antigen August 8, 1995 Do. Do. Do. PTC in the Manufacture and Testing of Therapeutic Products for Human Use Derived From Transgenic Animals 1995 Do. Do. https://www.fda.gov/ cber/guidelines.htm Draft Reviewers’ Guide: Informed Consent for Plasmapheresis/Immunization October 1, 1995 FDA personnel Do. Do. Draft Reviewers’ Guide: Disease Associated Antibody Collection Program October 1, 1995 Do. Do. Do. Draft Document Concerning the Regulation of Placental/ Umbilical Cord Blood Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products December 1995 Do. Do. https://www.fda.gov/ cber/memo.htm VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 829 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis December 4, 1995 FDA regulated industry Do. Do. Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products February 1996 Do. Do. Do. International Conference on Harmonisation (ICH) Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products February 23, 1996 Do. Do. https://www.fda.gov/ cber/guidelines.htm ICH Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals March 1, 1996 Do. Do. Do. Additional Recommendations for Donor Screening With a Licensed Test for HIV–1 Antigen March 14, 1996 Do. Do. https://www.fda.gov/ cber/memo.htm FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products April 1996 Do. Do. https://www.fda.gov/ cber/guidelines.htm Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma, and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) May 16, 1996 Do. Do. https://www.fda.gov/ cber/memo.htm Guidance for Industry—The Content and Format for Pediatric Use Supplements May 1996 Do. Do. https://www.fda.gov/ cber/guidelines.htm Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair or Reconstruction May 1996 Do. Do. Do. Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products May 29, 1996 Do. Do. https://www.fda.gov/ cber/memo.htm ICH Final Guidelines on Stablity Testing of Biotechnological/Biological Products July 10, 1996 Do. Do. https://www.fda.gov/ cber/guidelines.htm Recommendations for the Quarantine and Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human TLymphotropic Virus Type I (HTLV–I) July 19, 1996 Do. Do. https://www.fda.gov/ cber/memo.htm Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use August 1996 Do. Do. https://www.fda.gov/ cber/guidelines.htm Interim Recommendations for Deferral of Donors at Increased Risk for HIV–1 Group O Infection December 11, 1996 Do. Do. https://www.fda.gov/ cber/memo.htm PTC on Plasmid DNA Vaccines for Preventive Infectious Disease Indications December 1996 Do. Do. https://www.fda.gov/ cber/guidelines.htm Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products January 1997 Do. Do. Do. Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software January 13, 1997 FDA personnel Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 830 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address PTC in the Manufacture and Testing of Monoclonal Antibody Products for Human Use February 28, 1997 FDA regulated industry Do. Do. Proposed Approach to Regulation of Cellular and Tissue-Based Products February 28, 1997 Do. Do. Do. Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing, and Clinical Studies April 1997 Do. Do. Do. ICH Guidelines for the Photostability Testing of New Drug Substances and Products May 16, 1997 Do. Do. Do. Guidance for Industry: Changes to an Approved Application: Biological Products July 1997 Do. Do. Do. Guidance for Industry: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products July 1997 Do. Do. Do. Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation July 1997 Do. Do. Do. Guidance for Industry: Donor Screening for Antibodies to HTLV–II August 1997 Do. Do. Do. Guidance for Industry: Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report August 1997 Do. Do. Do. Guidance for Industry: The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use September 1997 Do. Do. Do. Guidance for FDA and Industry: Direct Final Rule Procedures November 21, 1997 FDA personnel and regulated industry Do. Do. Draft Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) December 1997 FDA regulated industry Do. Do. Guidance for Industry: Industry-Supported Scientific and Educational Activities November 1997 Do. Do. Do. Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products January 1998 Do. Do. Do. Draft Guidance for Industry: Container and Closure Integrity Testing In Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products January 28, 1998 Do. Do. Do. Draft Guidance for Industry: Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients March 1998 Do. Do. Do. Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy March 1998 Do. Do. Do. Draft Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to CBER May 1998 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 831 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Guidance for Industry: Classifying Resubmissions in Response to Action Letters May 14, 1998 Do. Do. Do. Guidance for Industry: Pharmacokinetics in Patients With Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing and Labeling May 1998 Do. Do. Do. Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements May 15, 1998 Do. Do. Do. Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products May 1998 Do. Do. Do. Draft Guidance for Industry: Stability Testing of Drug Substances and Drug Products June 1998 Do. Do. Do. Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing June 1998 Do. Do. Do. ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data June 10, 1998 Do. Do. Do. Draft Guidance for Industry: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 June 12, 1998 Do. Do. Do. Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements July 1998 Do. Do. Do. Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications July 1998 Do. Do. Do. Draft Guidance for Industry: Submitting Debarment Certification Statements September 1998 Do. Do. Do. Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS–1) September 1998 Do. Do. Do. Guidance for Industry: Fast Track Drug Development Programs—Designation, Development, and Application Review July 2004 Do. Do. Do. ICH Guidance on Statistical Principles for Clinical Trials September 16, 1998 Do. Do. Do. ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products September 21, 1998 Do. Do. Do. ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin September 24, 1998 Do. Do. Do. Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products November 1998 Do. Do. Do. Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products December 1998 Do. Do. Do. Draft Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling January 1999 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 832 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Guidance for Industry: Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Vaccine or Related Product January 1999 Do. Do. Do. Guidance on Amended Procedures for Advisory Panel Meetings January 26, 1999 Do. Do. Do. Draft Guidance for Industry; Providing Regulatory Submissions in Electronic Format—General Considerations October 2003 Do. Do. https://www.fda.gov/ cber/esub/ esubguid.htm Guidance for Industry: Population Pharmacokinetics February 1999 Do. Do. https://www.fda.gov/ cber/guidelines.htm Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) February 1999 Do. Do. Do. Guidance for Industry: For the Submission of Chemistry, Manufacturing, and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma, or Serum-Derived Products February 1999 Do. Do. Do. Draft Guidance for Industry: Accelerated Approval Products—Submission of Promotional Materials March 1999 Do. Do. Do. Guidance for Industry: Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product March 1999 Do. Do. Do. Guidance for Industry: Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans April 1999 Do. Do. Do. Guidance for Industry on the Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test April 1999 Do. Do. Do. Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the Form FDA 356h ‘‘Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use’’ May 1999 Do. Do. Do. Draft Guidance for Industry for Platelet Testing and Evaluation of Platelet Substitute Products May 1999 Do. Do. Do. Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use May 1999 Do. Do. Do. Draft Reviewer Guidance: Evaluation of Human Pregnancy Outcome Data June 1999 FDA personnel Do. Do. Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections From Donors With Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV) June 1999 FDA regulated industry Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 833 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) June 25, 1999 Do. Do. Do. Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) July 1999 Do. Do. Do. Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations July 1999 Do. Do. Do. Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics August 1999 Do. Do. Do. Guidance for Industry: Consumer-Directed Broadcast Advertisements August 1999 Do. Do. Do. Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products August 1999 Do. Do. Do. Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications August 1999 Do. Do. Do. ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products August 18, 1999 Do. Do. Do. Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act September 1999 Do. Do. Do. Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format—Biologics Marketing Applications (Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA), and New Drug Application (NDA)); revised November 1999 Do. Do. Do. Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies—Study Design, Data Analysis, and Recommendations for Dosing and Labeling November 1999 Do. Do. Do. ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use; M4: Common Technical Document November 8, 1999 Do. Do. Do. Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2 December 1999 Do. Do. Do. Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol November 2000 FDA personnel Do. Do. Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products February 2000 FDA regulated industry Do. Do. Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level February 2000 Do. Do. Do. Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing February 2000 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 834 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Draft Guidance for Industry: Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics May 2000 Do. Do. Do. Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components June 2000 Do. Do. Do. Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria June 2000 Do. Do. Do. Draft Guidance for Industry: Pediatric Oncology Studies in Response to a Written Request June 2000 Do. Do. Do. Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use With Cadaveric Blood Specimens June 2000 Do. Do. Do. Draft Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment June 2000 Do. Do. Do. Draft Guidance for Industry: Analytical Procedures and Methods Validation—Chemistry, Manufacturing, and Controls Documentation August 2000 Do. Do. Do. Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications August 2000 Do. Do. Do. Guidance for Industry: Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including WellCharacterized, Therapeutic, Biotechnology-Derived Products October 2000 Do. Do. Do. Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Followup of Patients in Clinical Trials Using Retroviral Vectors October 2000 Do. Do. Do. Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds October 2000 Do. Do. Do. Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts November 2000 Do. Do. Do. Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices November 2000 Do. Do. Do. Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) November 2000 Do. Do. Do. ICH Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric Population December 2000 Do. Do. Do. Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees December 2000 Do. Do. Do. ICH Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances December 29, 2000 Do. Do. Do. PHS Guideline on Infectious Disease Issues in Xenotransplantation January 19, 2001 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 835 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion January 2001 Do. Do. Do. Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods January 2001 Do. Do. Do. Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Prescription Drug Advertising and Promotional Labeling January 2001 Do. Do. Do. Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods— Technical Correction February 2001 Do. Do. Do. Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research February 2001 Do. Do. Do. Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines March 2001 Do. Do. Do. Guidance for Industry: Acceptance of Foreign Clinical Studies March 2001 Do. Do. Do. Guidance for Industry: Financial Disclosure by Clinical Investigators March 2001 Do. Do. Do. Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing March 2001 Do. Do. Do. Draft Guidance for Industry: Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 April 2001 Do. Do. Do. Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety Reports May 2001 Do. Do. Do. Guidance for Industry: E10 Choice of Control Group and Related Issues in Clinical Trials May 2001 Do. Do. Do. Draft Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information May 2001 Do. Do. Do. Draft Guidance for Industry: Clinical Studies Section of Labeling for Prescription Drugs and Biologics—Content and Format July 2001 Do. Do. Do. Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From an Outside Supplier July 2001 Do. Do. Do. Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors July 2001 Do. Do. Do. ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals July 2001 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 836 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components July 2001 Do. Do. Do. Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices) July 2001 Do. Do. Do. Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers July 2001 Do. Do. Do. Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture July 2001 Do. Do. Do. Draft Guidance for FDA Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments August 2001 Do. Do. Do. Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other Than Blood and Blood Components August 2001 Do. Do. Do. Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments August 2001 Do. Do. Do. Guidance for Industry: Variances for Blood Collection From Individuals With Hereditary Hemochromatosis August 2001 Do. Do. Do. Draft Guidance for Industry: Submitting Type V Drug Master Files to the CBER August 2001 Do. Do. Do. Draft Guidance for Industry: Premarket Notifications (510(k)s) for In Vitro HIV Drug Resistance Genotype Assays: Special Controls August 2001 Do. Do. Do. Draft Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format—General Considerations August 2001 Do. Do. Do. ICH Guidance: Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients August 2001 Do. Do. Do. ICH Guidance on M4 Common Technical Document August 2001 Do. Do. Do. Guidance for Industry: Cancer Drug and Biological Products—Clinical Data in Marketing Applications October 2001 Do. Do. Do. Guidance for Industry: Content and Format of Geriatric Labeling October 2001 Do. Do. Do. Guidance for Industry: Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax October 2001 Do. Do. Do. Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees November 2001 Do. Do. Do. Guidance for Industry: Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act November 2001 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 837 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products January 2002 Do. Do. Do. Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff January 2002 Do. Do. Do. Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products From Xenotransplantation Product Recipients and Their Intimate Contacts February 2002 Do. Do. Do. Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation March 2002 Do. Do. Do. Guidance for Industry; Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions March 2002 Do. Do. https://www.fda.gov/ cber/gdlns/ clintrial031802.pdf Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format—Investigational New Drug Applications (INDs) March 2002 Do. Do. https://www.fda.gov/ cber/guidelines.htm Guidance for Industry: E2BM Data Elements for Transmission of Individual Case Safety Reports April 2002 Do. Do. Do. Draft Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and Source Plasma Donations April 2002 Do. Do. Do. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation May 1999 Do. Do. Do. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Questions and Answers May 2002 Do. Do. Do. Draft Guidelines for Ensuring the Quality of Information Disseminated to the Public (HHS Guideline) May 2002 Do. Do. Do. Guidance for Industry: Special Protocol Assessment May 2002 Do. Do. Do. Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of CreutzfeldtJakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) June 2002 Do. Do. Do. Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records August 2002 Do. Do. Do. Guidance for Industry: Establishing Pregnancy Exposure Registries August 2002 Do. Do. Do. Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals September 2002 Do. Do. Do. Draft Guidance for Industry: Nonclinical Studies for Development of Pharmaceutical Excipients September 2002 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 838 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry October 2002 Do. Do. Do. Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Human Dura Mater December 18, 2003 Do. Do. https://www.fda.gov/ cber/gdlns/ humduramat.pdf Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients December 2002 Do. Do. https://www.fda.gov/ cber/guidelines.htm Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers December 2002 Do. Do. Do. ICH Guidance for Industry; Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products January 2003 Do. Do. Do. Draft Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials January 2003 Do. Do. Do. Draft Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls Information January 2003 Do. Do. Do. ICH Guidance for Industry: M4 CTD—Safety: Questions and Answers February 2003 Do. Do. Do. Guidance for Industry and FDA Staff: Quality System Information for Certain Premarket Application Reviews February 2003 Do. Do. Do. ICH Guidance for Industry: Q3A Impurities in New Drug Substances February 2003 Do. Do. Do. Draft Guidance for Industry; Comparability Protocols— Chemistry, Manufacturing, and Controls Information February 2003 Do. Do. Do. Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products; Guidance for Industry and FDA February 25, 2003 Do. Do. https://www.fda.gov/ cber/dap/ devpubs.htm Guidance for Industry and FDA: FY 2003 MDUFMA Small Business Qualification Worksheet and Certification March 2003 Do. Do. https://www.fda.gov/ cber/guidelines.htm ICH Guidance for Industry: M2 eCTD: Electronic Common Technical Document Specification April 2003 Do. Do. Do. Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans April 2003 Do. Do. Do. Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS April 2003 Do. Do. Do. Guidance for Industry, FDA Staff, and Third Parties; Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria October 4, 2004 Do. Do. https://www.fda.gov/ cber/dap/ devpubs.htm VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 839 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Guidance for Industry: Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory Applications April 2003 Do. Do. https://www.fda.gov/ cber/guidelines.htm Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection May 2003 Do. Do. Do. Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling May 2003 Do. Do. Do. Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002—Identification of Manufacturer of Medical Devices June 2003 Do. Do. Do. Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective Collaborations June 2003 Do. Do. Do. Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Postmarketing Periodic Adverse Drug Experience Reports June 2003 Do. Do. Do. Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis June 2003 Do. Do. Do. Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices July 2003 Do. Do. Do. Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires July 2003 Do. Do. Do. Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices July 2003 Do. Do. Do. Draft Guidance for Review Staff and Industry: Good Review Management Principles for PDUFA Products July 2003 Do. Do. Do. Compliance Program Guidance Manual (drugs and biologics) Dates vary—Individual issue dates Do. Do. https://www.fda.gov/ cber/cpg/cpg.htm ICH Guidance for Industry: Q3C—Tables and List November 2003 Do. Do. https://www.fda.gov/ cber/guidelines.htm ICH Guidance for Industry: Q3B(R) Impurities in New Drug Products November 2003 Do. Do. Do. ICH Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products November 2003 Do. Do. Do. Draft Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma November 1999 Do. N/A Draft Document Concerning the Regulation of Placental/ Umbilical Cord Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products December 1995 Do. Do. WITHDRAWN GUIDANCES VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 840 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CBER—Continued Name of Document Intended User or Regulatory Activity Date of Issuance How to Obtain a Copy of the Document Mailing Address Internet Address Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing into Injectable Products February 1996 Do. Do. Draft Advertising and Promotional Labeling Staff Procedural Guidance August 1994 Do. Do. Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Validation August 2001 Do. Do. Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Glossary of Terms August 2001 Do. Do. Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Time Stamps February 2002 Do. Do. Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records July 2002 Do. Do. GUIDANCE DOCUMENTS ISSUED BY CDER Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling January 12, 1998 Advertising Division of Drug Information (HFD– 200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301– 827–4573 https://www.fda.gov/ cder/guidance/ index.htm Consumer-Directed Broadcast Advertisements August 9, 1999 Do. Do. Do. Industry-Supported Scientific and Educational Activities December 3, 1997 Do. Do. Do. Accelerated Approval Products—Submission of Promotional Materials March 26, 1999 Advertising draft Do. Do. Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements February 10, 2004 Do. Do. Do. ‘‘Help-Seeking’’ and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms February 10, 2004 Do. Do. Do. Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling March 12, 1999 Do. Do. Do. Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) January 5, 1998 Do. Do. Do. Bioanalytical Method Validation May 23, 2001 Biopharmaceutics Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 841 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations March 19, 2003 Do. Do. Do. Cholestyramine Powder In Vitro Bioequivalence July 15, 1993 Do. Do. Do. Clozapine Tablets In Vivo Bioequivalence and In Vitro Dissolution Testing November 15, 1996 Do. Do. Do. Corticosteroids, Dermatologic (topical) In Vivo June 2, 1995 Do. Do. Do. Dissolution Testing of Immediate Release Solid Oral Dosage Forms August 25, 1997 Do. Do. Do. Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations September 26, 1997 Do. Do. Do. Food-Effect Bioavailability and Fed Bioequivalence Studies December 2002 Do. Do. Do. Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro June 27, 1989 Do. Do. Do. Phenytoin/Phenytion Sodium (capsules, tablets, suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing March 4, 1994 Do. Do. Do. Statistical Approaches to Establishing Bioequivalence February 2, 2001 Do. Do. Do. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System August 31, 2000 Do. Do. Do. Antifungal (topical) February 24, 1990 Biopharmaceutics draft Do. N/A Antifungal (vaginal) February 24, 1990 Do. Do. Do. Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action April 2003 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing December 2003 Do. Do. Do. Conjugated Estrogens, USP–LC–MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence March 2000 Do. Do. Do. BACPAC I: Intermediates in Drug Substance Synthesis: Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation February 16, 2001 Chemistry Do. https://www.fda.gov/ cder/guidance/ index.htm Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products July 24, 1997 Do. Do. Do. Changes to an Approved NDA or ANDA April 2004 Do. Do. Do. Changes to an Approved NDA or ANDA: Questions and Answers January 22, 2001 Do. Do. Do. Container Closure Systems for Packaging Human Drugs and Biologics May 1999 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 842 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products April 1996 Do. Do. Do. Development of New Stereoisomeric Drugs May 1, 1992 Do. Do. Do. Drug Master Files September 1, 1989 Do. Do. Do. Drug Master Files for Bulk Antibiotic Drug Substances November 29, 1999 Do. Do. Do. Environmental Assessment of Human Drug and Biologics Applications July 27, 1998 Do. Do. Do. Format and Content for the CMC Section of an Annual Report September 1, 1994 Do. Do. Do. Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application February 1, 1987 Do. Do. Do. Format and Content of the Microbiology Section of an Application February 1, 1987 Do. Do. Do. IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information May 25, 2001 Do. Do. Do. INDs for Phase 2 and 3 Studies; Chemistry, Manufacturing, and Controls Information May 20, 2003 Do. Do. Do. Monoclonal Antibodies Used as Reagents in Drug Manufacturing March 29, 2001 Do. Do. Do. Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products—Chemistry, Manufacturing, and Controls Documentation July 5, 2002 Do. Do. Do. NDAs: Impurities in Drug Substances February 25, 2000 Do. Do. Do. PAC–ALTS: Postapproval Changes—Analytical Testing Laboratory Sites April 28, 1998 Do. Do. Do. Reviewer Guidance: Validation of Chromatographic Methods November 1994 Do. Do. Do. Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products November 1, 1994 Do. Do. Do. Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances November 1994 Do. Do. Do. Submitting Documentation for the Manufacturing of, and Controls for, Drug Products February 1, 1987 Do. Do. Do. Submitting Documentation for the Stability of Human Drugs and Biologics February 1, 1987 Do. Do. Do. Submitting Samples and Analytical Data for Methods Validation February 1987 Do. Do. Do. Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Products February 1, 1987 Do. Do. N/A Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances February 1987 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 843 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address SUPAC IR—Immediate-Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation November 1995 Do. Do. Do. SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum January 1999 Do. Do. Do. SUPAC–IR Questions and Answers About SUPAC–IR Guidance February 18, 1997 Do. Do. Do. SUPAC–MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation October 6, 1997 Do. Do. Do. SUPAC–SS—Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation May 1997 Do. Do. Do. The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) December 20, 2000 Do. Do. Do. Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation August 30, 2000 Chemistry draft Do. Do. Botanical Drug Products June 9, 2004 Do. Do. Do. Comparability Protocols—Chemistry, Manufacturing, and Controls Information February 25, 2003 Do. Do. Do. Drug Product: Chemistry, Manufacturing, and Controls Information January 28, 2003 Do. Do. Do. Drug Substance: Chemistry, Manufacturing, and Controls Information January 7, 2004 Do. Do. Do. Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals September 2002 Do. Do. Do. Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations July 1999 Do. Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation August 2002 Do. Do. Do. Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation November 19, 1998 Do. Do. Do. Stability Testing of Drug Substances and Drug Products June 8, 1998 Do. Do. Do. Submitting Supporting Chemistry Documentation in Radiopharmaceutical Drug Applications November 1, 1991 Do. Do. N/A SUPAC–SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum January 5, 1999 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 Do. E:\FR\FM\05JAN1.SGM 05JAN1 844 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Antiretroviral Drugs Using Plasma HIV RNA Measurements—Clinical Considerations for Accelerated and Traditional Approval October 2002 Clinical antimicrobial Do. Do. Clinical Development and Labeling of Anti-Infective Drug Products October 26, 1992 Do. Do. Do. Clinical Evaluation of Anti-Infective Drugs (Systemic) September 1, 1977 Do. Do. Do. Preclinical Development of Antiviral Drugs November 1990 Do. Do. Do. Acute Bacterial Exacerbation of Chronic Bronchitis; Developing Antimicrobial Drugs for Treatment July 22, 1998 Clinical antimicrobial draft Do. Do. Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Acute Bacterial Sinusitis; Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Acute Otitis Media; Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Catheter-Related Bloodstream Infections—Developing Antimicrobial Drugs for Treatment October 18, 1999 Do. Do. Do. Community Acquired Pneumonia; Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Complicated Urinary Tract Infections and Pylonephritis—Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Developing Antimicrobial Drugs—General Considerations for Clinical Trials July 22, 1998 Do. Do. Do. Developing Drugs to Treat Inhalational Anthrax (PostExposure) March 18, 2002 Do. Do. Do. Empiric Therapy of Febrile Neutropenia—Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products February 1997 Do. Do. Do. Lyme Disease—Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Nosocomial Pneumonia—Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Secondary Bacterial Infections of Acute Bronchitis— Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Streptococcal Pharyngitis and Tonsillitis—Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Uncomplicated and Complicated Skin and Skin Structure Infections—Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 845 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Uncomplicated Gonorrhea—Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Uncomplicated Urinary Tract Infections—Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Vaccinia Virus—Developing Drugs to Mitigate Complications From Smallpox Vaccination March 2004 Do. Do. Do. Vuvlovaginal Candidiasis—Developing Antimicrobial Drugs for Treatment July 22, 1998 Do. Do. Do. Acceptance of Foreign Clinical Studies March 2001 Clinical medical Do. Do. Calcium DTPA and Zinc DTPA Drug Products—Submitting a New Drug Application August 2004 Do. Do. Do. Cancer Drug and Biological Products—Clinical Data in Marketing Applications October 2001 Do. Do. Do. Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) February 1999 Do. Do. Do. Clinical Development Programs for MDI and DPI Drug Products September 19, 1994 Do. Do. Do. Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and children) April 1988 Do. Do. Do. Clinical Evaluation of Antianxiety Drugs September 1, 1977 Do. Do. Do. Clinical Evaluation of Antidepressant Drugs September 1, 1977 Do. Do. Do. Clinical Evaluation of Antiepileptic Drugs (adults and children) January 1, 1981 Do. Do. Do. Clinical Evaluation of General Anesthetics May 1, 1982 Do. Do. Do. Clinical Evaluation of Hypnotic Drugs September 1, 1977 Do. Do. Do. Clinical Evaluation of Local Anesthetics May 1982 Do. Do. Do. Clinical Evaluation of Psychoactive Drugs in Infants and Children July 1979 Do. Do. Do. Content and Format for Pediatric Use Supplements May 1996 Do. Do. Do. Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products November 1995 Do. Do. Do. Establishing Pregnancy Exposure Registries August 2002 Do. Do. Do. FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products February 2, 1999 Do. Do. Do. FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer January 1991 Do. Do. Do. Format and Content of the Clinical and Statistical Sections of an Application July 1, 1988 Do. Do. Do. Format and Content of the Summary for New Drug and Antibiotic Applications February 1, 1987 Do. Do. Do. Formatting, Assembling and Submitting New Drug and Antiobiotic Applications February 1, 1987 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 846 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address General Considerations for the Clinical Evaluation of Drugs December 1, 1978 Do. Do. Do. General Considerations for the Clinical Evaluation of Drugs in Infants and Children September 1, 1977 Do. Do. Do. Guidance for the Development of Vaginal Contraceptive Drugs (NDA) April 1995 Do. Do. Do. IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer January 15, 2004 Do. Do. Do. Integration of Dose-Counting Mechanisms Into MDI Drug Products March 2003 Do. Do. Do. Levothyroxine Sodium Tablets—In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing March 8, 2001 Do. Do. Do. Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancer April 19, 1988 Do. Do. Do. Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer April 1988 Do. Do. Do. Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report August 27, 1997 Do. Do. Do. Postmarketing Reporting of Adverse Drug Experiences March 1, 1992 Do. Do. Do. Preclinical Development of Immunomodulatory Drugs for Treatment of HIV Infection and Associated Disorders September 1992 Do. Do. Do. Preparation of Investigational New Drug Products (Human and Animal) November 1, 1992 Do. Do. Do. Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products May 1998 Do. Do. Do. Prussian Blue Drug Products—Submitting a New Drug Application February 4, 2003 Do. Do. Do. Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs July 22, 1993 Do. Do. Do. Study of Drugs Likely to be Used in the Elderly November 1, 1989 Do. Do. Do. Submission of Abbreviated Reports and Synopses in Support of Marketing Applications September 13, 1999 Do. Do. Do. Abuse Liability Assessment July 1, 1990 Clinical medical draft Do. N/A Allergic Rhinitis: Clinical Development Programs for Drug Products June 21, 2000 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm Available Therapy July 22, 2004 Do. Do. Do. Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment June 28, 2000 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 847 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) July 1999 Do. Do. Do. Clinical Evaluation of Anti-Anginal Drugs January 1, 1989 Do. Do. N/A Clinical Evaluation of Anti-Arrhythmic Drugs July 1, 1985 Do. Do. Do. Clinical Evaluation of Antihypertensive Drugs May 1, 1988 Do. Do. Do. Clinical Evaluation of Drugs for the Treatment of Congestive Heart Failure December 1, 1987 Do. Do. Do. Clinical Evaluation of Lipid-Altering Agents in Adults and Children September 1990 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm Clinical Evaluation of Weight-Control Drugs September 24, 1996 Do. Do. Do. Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees November 2001 Do. Do. Do. Collection of Race and Ethnicity Data in Clinical Trials for FDA-Regulated Products January 30, 2003 Do. Do. Do. Developing Medical Imaging Drug and Biological Products—2nd draft May 19, 2003 Do. Do. Do. Development and Evaluation of Drugs for the Treatment of Psychoactive Substance Use Disorders February 12, 1992 Do. Do. N/A Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis May 2000 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals September 2002 Do. Do. Do. Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms—Recommendations for Clinical Evaluation January 2003 Do. Do. Do. Evaluation of Human Pregnancy Outcome Data June 1999 Do. Do. Do. Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth in Children November 6, 2001 Do. Do. Do. Exercise-Induced Bronchospasm (EIB)—Development of Drugs to Prevent EIB February 20, 2002 Do. Do. Do. Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment May 19, 2000 Do. Do. Do. Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research March 2000 Do. Do. Do. Inhalation Drug Products Packaged in Semipermeable Container Closure Systems July 26, 2002 Do. Do. Do. OTC Treatment of Herpes Labialis with Antiviral Agents March 8, 2000 Do. Do. Do. Pediatric Oncology Studies in Response to a Written Request June 21, 2000 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 848 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis April 1, 1994 Do. Do. Do. Preparation of IND Applications for New Drugs Intended for the Treatment of HIV-Infected Individuals September 1, 1991 Do. Do. N/A Recommendations for Complying With the Pediatric Rule November 2000 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro April 7, 1997 Clinical pharmacology Do. Do. Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory Applications April 2003 Do. Do. Do. Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application February 1, 1987 Do. Do. Do. In Vivo Metabolism/Drug Interaction Studies—Study Design, Data Analysis, and Recommendations for Dosing and Labeling November 24, 1999 Do. Do. Do. Pharmacokinetics in Patients With Impaired Hepatic Function; Study Design, Data Analysis, and Impact on Dosing and Labeling May 30, 2003 Do. Do. Do. Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing and Labeling May 1998 Do. Do. Do. Population Pharmacokinetics February 10, 1999 Do. Do. Do. General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products November 30, 1998 Clinical pharmacology draft Do. Do. A Review of FDA’s Implementation of the Drug Export Amendments of 1986 May 1990 Compliance Do. Do. Compressed Medical Gases February 1989 Do. Do. Do. Computerized Systems Used in Clinical Trials April 1999 Do. Do. Do. Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron June 27, 1997 Do. Do. Do. General Principles of Process Validation May 1987 Do. Do. Do. Good Laboratory Practice Regulations Questions and Answers June 1981 Do. Do. Do. Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities—FDA Public Health Advisory March 2001 Do. Do. Do. Guideline for Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices December 1987 Do. Do. Do. Monitoring of Clinical Investigations January 1988 Do. Do. Do. Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment May 1984 Do. Do. Do. Pharmacy Compounding: Compliance Policy Guide May 2002 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 849 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Possible Dioxin/PCB Contamination of Drug and Biological Products August 23, 1999 Do. Do. Do. Sterile Drug Products Produced by Aseptic Processing June 1987 Do. Do. Do. Street Drug Alternatives March 2000 Do. Do. Do. Current Good Manufacturing Practices for Medical Gases May 6, 2003 Compliance draft Do. Do. Good Manufacturing Practice for Positron Emission Tomography Drug Products April 1, 2002 Do. Do. Do. Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research May 12, 2000 Do. Do. Do. Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production September 30, 1998 Do. Do. Do. Manufacture, Processing, or Holding of Active Pharmaceutical Ingredients April 17, 1998 Do. Do. Do. Marketed Unapproved Drugs—Compliance Policy Guide October 2003 Do. Prescription Drug Marketing Act Regulations for Donation of Prescription Drug Samples to Free Clinics June 27, 2002 Do. Do. Do. Repackaging of Solid Oral Dosage Form Drug Products February 1, 1992 Do. Do. N/A Part 11, Electronic Records; Electronic Signatures— Scope and Application August 2003 Current good manufacturing practices (CGMPs) Do. https://www.fda.gov/ cder/guidance/ index.htm Comparability Protocols—Protein Drug Products and Biological Products—Chemistry, Manufacturing, and Controls Information September 2003 CGMPs draft Do. Do. Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practices August 2003 Do. Do. Do. Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment November 7, 2003 Do. Do. Do. Process Analytical Technology—A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance October 4, 2004 Do. Do. Do. Sterile Drug Products Produced by Aseptic Processing October 4, 2004 Do. Do. Do. Providing Electronic Submissions in Electronic Format—ANDAs June 27, 2002 Electronic submissions Do. Do. Regulatory Submissions in Electronic Format; General Considerations January 28, 1999 Do. Do. Do. Regulatory Submissions in Electronic Format; New Drug Applications January 28, 1999 Do. Do. Do. Providing Regulatory Submissions in Electronic Format—Annual Reports for NDAs and ANDAs August 2003 Electronic submissions draft Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 Do. E:\FR\FM\05JAN1.SGM 05JAN1 850 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Providing Regulatory Submissions in Electronic Format—Content of Labeling February 2004 Do. Do. Do. Providing Regulatory Submissions in Electronic Format—General Considerations October 22, 2003 Do. Do. Do. Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions August 29, 2003 Do. Do. Do. Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety Reports May 4, 2001 Do. Do. Do. Providing Regulatory Submissions in Electronic Format—Postmarketing Periodic Adverse Drug Experience Reports June 2003 Do. Do. Do. Providing Regulatory Submissions in Electronic Format, Prescription Drug Advertising and Promotional Labeling January 31, 2001 Do. Do. Do. 180-Day Exclusivity When Multiple Abbreviated New Drug Applications Are Submitted on the Same Day July 2003 Generics Do. Alternate Source of Active Pharmaceutical Ingredients in Pending ANDAs December 12, 2000 Do. Do. Do. ANDAs: Impurities in Drug Substances November 1999 Do. Do. Do. Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act March 2000 Do. Do. Do. Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability studies conducted in the past August 1995 Do. Do. Do. Letter describing efforts by the CDER & the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new & abbreviated drug approval process in order to reduce duplication or redundancy in the process October 1994 Do. Do. Do. Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy April 1994 Do. Do. Do. Letter on the provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters July 1992 Do. Do. Do. Letter on the provision of new procedures and policies affecting the generic drug review process March 1989 Do. Do. Do. Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions November 1991 Do. Do. Do. Letter on the response to 12/20/84 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act March 1985 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 851 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuseto-file incomplete submissions as required by the new law January 1993 Do. Do. Do. Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria, and bioequivalence requirements August 1993 Do. Do. Do. Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications December 2001 Do. Do. Do. Organization of an ANDA March 2, 1999 Do. Do. Do. Revising ANDA Labeling Following Revision of the RLD Labeling May 2000 Do. Do. Do. Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products February 3, 2000 Do. Do. Do. Variations in Drug Products that May Be Included in a Single ANDA December 1998 Do. Do. Do. ANDAs: Impurities in Drug Products January 5, 1999 Generics draft Do. Do. Handling and Retention of Bioavailability and Bioequivalence Testing Samples May 26, 2004 Do. Do. Do. Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (revised) August 7, 2002 Do. Do. Do. Pharmacology/Toxicology Review Format May 2001 Good review practices (GRP) Do. Do. Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review November 22, 1996 GRP draft Do. Do. Good Review Management Principles for Prescription Drug User Fee Act Products July 28, 2003 Do. Do. Do. E10—Choice of Control Group and Related Issues in Clinical Trials May 14, 2001 ICH, efficacy Do. Do. E11—Clinical Investigation of Medicinal Products in the Pediatric Population December 15, 2000 Do. Do. Do. E1A—The Extent of Population Exposure to Assess Clinical Safety: for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions March 1995 Do. Do. Do. E2A—Clinical Safety Data Management: Definitions and Standards for Expedited Reporting March 1995 Do. Do. Do. E2B—Data Elements for Transmission of Individual Case Safety Reports January 15, 1998 Do. Do. Do. E2BM—Data Elements for Transmission of Individual Case Safety Reports (revised) April 3, 2002 Do. Do. Do. E2BM—Data Elements for Transmission of Individual Case Safety Reports—Questions and Answers May 2004 Do. Do. Do. E2C—Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs May 19, 1997 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 852 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address E2C Addendum—Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs February 5, 2004 Do. Do. Do. E3—Structure and Content of Clinical Study Reports July 1996 Do. Do. Do. E4—Dose-Response Information to Support Drug Registration November 1994 Do. Do. Do. E5—Ethnic Factors in the Acceptability of Foreign Clinical Data June 1998 Do. Do. Do. E6—Good Clinical Practice: Consolidated Guideline May 9, 1997 Do. Do. Do. E7—Studies in Support of Special Populations: Geriatrics August 1994 Do. Do. Do. E8—General Considerations for Clinical Trials December 24, 1997 Do. Do. Do. E9—Statistical Principles for Clinical Trials September 1998 Do. Do. Do. M2 eCTD: Electronic Common Technical Document Specification April 2, 2003 ICH, joint safety/ efficacy (multidisciplinary) Do. Do. M3—Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals November 25, 1997 Do. Do. Do. M4—Organization of the CTD August 2004 Do. Do. Do. M4—The CTD—Efficacy Questions and Answers May 2004 Do. Do. Do. M4—The CTD—General Questions and Answers May 2004 Do. Do. Do. M4—The CTD—Safety Questions and Answers February 4, 2003 Do. Do. Do. Q1A(R2)—Stability Testing of New Drug Substances and Products November 21, 2003 ICH, quality Do. Do. Q1B—Photostability Testing of New Drug Substances and Products November 1996 Do. Do. Do. Q1C—Stability Testing for New Dosage Forms May 9, 1997 Do. Do. Do. Q1D—Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products January 16, 2003 Do. Do. Do. Q1F—Stability Data Package for the Registration in Climatic Zones III and IV June 2004 Do. Do. Do. Q2A—Text on Validation of Analytical Procedures March 1995 Do. Do. Do. Q2B—Validation of Analytical Procedures: Methodology May 19, 1997 Do. Do. Do. Q3A—Impurities in New Drug Substances February 2003 Do. Do. Do. Q3B(R)—Impurities in Drug Products November 14, 2003 Do. Do. Do. Q3C—Impurities: Residual Solvents December 24, 1997 Do. Do. Do. Q3C—Tables and List (revised recommendations for N-Methylpyrrolidone and Tetrahydrofuran) November 2003 Do. Do. Do. Q5A—Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin September 24, 1998 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 853 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Q5B—Quality of Biotechnology Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products February 1996 Do. Do. Do. Q5C—Quality of Biotechnological Products: Stability Testing of Biotechnology/Biological Products July 1996 Do. Do. Do. Q5D—Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products September 21, 1998 Do. Do. Do. Q6A—Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances December 29, 2000 Do. Do. Do. Q6B—Test Procedures and Acceptance Criteria for Biotechnological/Biological Products August 18, 1999 Do. Do. Do. Q7A—Good Manufacturing Practice for Active Pharmaceutical Ingredients August 2001 Do. Do. Do. S1A—The Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals March 1996 ICH, safety Do. Do. S1B—Testing for Carcinogenicity of Pharmaceuticals July 1997 Do. Do. Do. S1C—Dose Selection for Carcinogenicity Studies of Pharmaceuticals March 1995 Do. Do. Do. S1C(R)—Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes December 4, 1997 Do. Do. Do. S2A—Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals April 1996 Do. Do. Do. S2B—Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals November 21, 1997 Do. Do. Do. S3A—Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies March 1995 Do. Do. Do. S3B—Pharmacokinetics: Repeated Dose Tissue Distribution Studies March 1995 Do. Do. Do. S4A—Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) June 25, 1999 Do. Do. Do. S5A—Detection of Toxicity to Reproduction for Medicinal Products September 22, 1994 Do. Do. Do. S5B—Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility April 1996 Do. Do. Do. S6—Preclinical Safety Evaluation of BiotechnologyDerived Pharmaceuticals November 18, 1997 Do. Do. Do. S7A—Safety Pharmacology Studies for Human Pharmaceuticals July 13, 2001 Do. Do. Do. E2D—Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting July 2003 ICH draft, efficacy Do. Do. E12A—Principles for Clinical Evaluation of New Antihypertensive Drugs August 9, 2000 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 854 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address M4—Common Technical Document—Quality: Questions and Answers/Location Issues December 30, 2002 ICH draft, joint safety/efficacy (multidisciplinary) Do. Do. Submitting Marketing Appilcations According to the ICH–CTD Format—General Considerations September 5, 2001 Do. Do. Do. Q1E—Evaluation of Stability Data June 14, 2002 ICH draft, quality Do. Do. S7B—The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals June 2004 ICH draft, safety Do. Do. Content and Format of INDs for Phase 1 Studies of Drugs; Including Well-Characterized, Therapeutic, Biotechnology-Derived Products November 1995 IND Do. Do. A Revision in Sample Collection Under the Compliance Program Pertaining to Preapproval Inspections July 15, 1996 Industry letters Do. N/A Continuation of a series of letters communicating interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program March 2, 1998 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm Fifth of a series of letters providing informal notice about the Act, discussing the statutory mechanism by which ANDA applicants may make modifications in approved drugs where clinical data is required April 1987 Do. Do. Do. Fourth of a series of letters providing informal notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I October 1986 Do. Do. Do. Implementation of the Drug Price Competition and Patent Term Restoration Act. Preliminary Guidance October 1984 Do. Do. Do. Implementation Plan USP injection nomenclature October 1995 Do. Do. Do. Instructions for Filing Supplements Under the Provisions of SUPAC–IR April 11, 1996 Do. Do. N/A Seventh of a series of letters about the Act providing guidance on the ‘‘180-day exclusivity’’ provision of section 505(j)(4)(B)(iv) of the FD&C Act July 1988 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm Sixth of a series of informal notice letters about the Act discussing 3- and 5-year exclusivity provisions of sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act April 1988 Do. Do. Do. Streamlining Initiatives December 24, 1996 Do. Do. N/A Supplement to 10/11/84 letter about policies, procedures and implementation of the Act (Q & A format) November 1984 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm Third of a series of letters regarding the implementation of the Act May 1985 Do. Do. Do. Year 2000 Letter from Dr. Janet Woodcock October 19, 1998 Do. Do. Do. Barbiturate, Single Entity-Class Labeling March 1, 1981 Labeling Do. N/A VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 855 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Content and Format for Geriatric Labeling October 5, 2001 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm Hypoglycemic Oral Agents April 1, 1984 Do. Do. N/A Labeling Over-the-Counter Human Drug Products; Updating Labeling in Reference Listed Drugs and Abbreviated New Drug Applications October 18, 2002 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm Local Anesthetics—Class Labeling September 1, 1982 Do. Do. N/A Clinical Studies Section of Labeling for Prescription Drugs and Biologics—Content and Format July 9, 2001 Labeling draft Do. https://www.fda.gov/ cder/guidance/ index.htm Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics March 5, 2004 Do. Do. Do. Labeling for Combined Oral Contraceptives March 2004 Do. Do. Do. Labeling for Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms—Prescribing Information for Health Care Providers and Patient Labeling February 2004 Do. Do. Do. OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) June 1998 Do. Do. Do. Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications October 26, 2000 Do. Do. Do. Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16) May 1984 OTC Do. Do. General Guidelines for OTC Combination Products September 1978 Do. Do. Do. Labeling OTC Human Drug Products Using a Column Format December 19, 2000 Do. Do. Do. Upgrading Category III Antiperspirants to Category I (43 FR 46728–46731) October 1978 Do. Do. Do. Labeling OTC Human Drug Products—Submitting Requests for Exemptions and Deferrals December 19, 2000 OTC draft Do. Do. Labeling OTC Human Drug Products Updating Labeling in ANDAs February 2001 Do. Do. Do. OTC Actual Use Studies July 22, 1994 Do. Do. N/A OTC Nicotine Substitutes March 1, 1994 Do. Do. Do. Time and Extent Applications February 10, 2004 Do. Do. https://www.fda.gov/ cder/guidance/ index.htm Carcinogenicity Study Protocol Submissions May 2002 Pharmacology/ Toxicology Do. Do. Format and Content of the Nonclinical Pharmacology/ Toxicology Section of an Application February 1987 Do. Do. Do. Immunotoxicology Evaluation of Investigational New Drugs October 2002 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 856 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives October 1996 Do. Do. Do. Photosafety Testing May 7, 2003 Do. Do. Do. Reference Guide for the Nonclinical Toxicity Studies of Antiviral Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease: Evaluation of Drug Toxicity Prior to Phase I Clinical Studies February 1989 Do. Do. Do. Single Dose Acute Toxicity Testing for Pharmaceuticals August 1996 Do. Do. Do. Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers January 16, 2003 Pharmacology/ Toxicology draft Do. Do. Integration of Study Results to Access Concerns About Human Reproductive and Developmental Toxicities November 13, 2001 Do. Do. Do. Nonclinical Safety Evaluation of Pediatric Drug Products February 2003 Do. Do. Do. Nonclinical Studies for Development of Pharmaceutical Excipients October 2, 2002 Do. Do. Do. Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals May 8, 2001 Do. Do. Do. 180-Day Generic Drug Exclusivity Under the HatchWaxman Amendments to the Federal Food, Drug, and Cosmetic Act June 1998 Procedural Do. Do. Continuous Marketing Applications: Pilot 1—Reviewable Units for Fast Track Products Under the PDUFA October 2003 Do. Do. Do. Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Drug Development of Fast Track Products Under the PDUFA October 2003 Do. Do. Do. Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act March 27, 2000 Do. Do. Do. Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000 November 30, 1999 Do. Do. Do. Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate—Labeling Enforcement Policy June 3, 2003 Do. Do. Do. Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act November 23, 1998 Do. Do. Do. Fast Track Drug Development Programs—Designation, Development, and Application Review July 2004 Do. Do. Do. Financial Disclosure by Clinical Investigators March 2001 Do. Do. Do. Formal Dispute Resolution: Appeals Above the Division Level February 2000 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 857 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Formal Meetings With Sponsors and Applicants For PDUFA Products February 2003 Do. Do. Do. Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997—Advisory Committees November 2, 1998 Do. Do. Do. Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements July 21, 1998 Do. Do. Do. Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions January 27, 2004 Do. Do. Do. Potassium Iodide in Radiation Emergencies—Questions and Answers December 23, 2002 Do. Do. Do. Potassium Iodide Tablets for Shelf Life Extension for Federal Agencies and State and Local Governments March 8, 2004 Do. Do. Do. Levothyroxine Sodium Products Enforcement of August 14, 2001, Compliance Date and Submission of New Applications July 13, 2001 Do. Do. Do. National Uniformity for Nonprescription Drugs—Ingredient Listing for OTC Drugs April 9, 1998 Do. Do. Do. Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies December 11, 2001 Do. Do. Do. Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (revised) September 1999 Do. Do. Do. Refusal to File July 12, 1993 Do. Do. Do. Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act May 1998 Do. Do. Do. Special Protocol Assessment May 17, 2002 Do. Do. Do. Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements May 15, 1998 Do. Do. Do. Guidance for FDA Staff: The Leveraging Handbook; an Agency Resource for Effective Collaborations June 19, 2003 Do. Do. Do. Women and Minorities Guidance Requirements July 20, 1998 Do. Do. Do. Applications Covered by Section 505(b)(2) October 1999 Procedural draft Do. Do. Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees November 2001 Do. Do. Do. PET Drug Applications—Content and Format for NDAs and ANDAs March 2000 Do. Do. Do. Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by CDER, Beginning January 1, 2000 December 22, 1999 Do. Do. Do. Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees February 14, 2002 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 858 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution April 2001 Do. Do. Do. Good Review Management Principles for PDUFA Products July 28, 2003 Do. Do. Do. Independent Consultants for Biotechnology Clinical Trial Protocols May 7, 2003 Do. Do. Do. Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions January 27, 2004 Do. Do. Do. Pharmacogenomic Data Submissions January 27, 2004 Do. Do. Do. Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines March 12, 2001 Do. Do. Do. Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 April 4, 2001 Do. Do. Do. Submitting Debarment Certification Statements October 2, 1998 Do. Do. Do. Submitting Marketing Applications According to the ICH/CTD Format—General Considerations September 5, 2001 Do. Do. Do. The Use of Clinical Holds Following Clinical Investigator Misconduct April 2002 Do. Do. Do. Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation—Small Entity Compliance Guide November 7, 2001 Small entity compliance guides Do. Do. Applicability of User Fees to (1) Applications Withdrawn Before Filing, or (2) Applications the Agency Has Refused to File and That Are Resubmitted or Filed Over Protest (Attachment F) July 12, 1993 User fee Do. Do. Application, Product, and Establishment Fees: Common Issues and Their Resolution (revised) (attachment D) (I) December 16, 1994 Do. Do. Do. Classifying Resubmissions in Response to Action Letters May 14, 1998 Do. Do. Do. Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act June 1999 Do. Do. Do. Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act November 21, 2001 Do. Do. Do. Submitting and Reviewing Complete Responses to Clinical Holds (revised) October 26, 2000 Do. Do. Do. Document for Waivers of and Reductions in User Fees (attachment G) July 16, 1993 User fees draft Do. Do. Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees December 2000 Do. Do. Do. In Vivo Bioequivalence Studies on Population and Individual Bioequivalence Studies December 30, 1987 Do. Do. Clinical Evaluation of Antacid Drugs April 1, 1978 N/A N/A Clinical Evaluation of Antidiarrheal Drugs September 1, 1977 Do. Do. WITHDRAWALS VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 859 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document Date of Issuance How to Obtain a Copy of the Document Intended User or Regulatory Activity Mailing Address Internet Address Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs September 1, 1977 Do. Do. Clinical Evaluation of Laxative Drugs April 1, 1978 Do. Do. Clinical Evaluation of Radiopharmaceutical Drugs October 1, 1981 Do. Do. FDA Requirements for Approval of Drugs to Treat Superficial Bladder Cancer June 20, 1989 Do. Do. ANDAs: Blend Uniformity Analysis August 27, 1999 Do. Do. Topical Dermatological Drug Products NDAs and ANDAs—In Vivo Bioavailability, Bioequivalence, In Vitro Release, and Associated Studies June 18, 1998 Do. Do. Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women March 1, 1995 Do. Do. Noncontraceptive Estrogen Drug Products—Prescribing Information for Healthcare Providers and Patient Labeling September 27, 1999 Do. Do. Chlordiazepoxide Hydrochloride Capsules January 1, 1988 Do. Do. Clorazepate Dipotassium Capsules/Tablets March 1, 1993 Do. Do. Cyproheptadine Hydrochloride Tablets/Syrup December 1, 1986 Do. Do. Dipivefrin Hydrochloride Ophthalmic Solution, 0.1% November 2, 1998 Do. Do. Ergoloid Mesylate Tablets January 1, 1988 Do. Do. Hydroxyzine Hydrochloride Injection December 1, 1989 Do. Do. Isoetharine Inhalation Solution March 1, 1989 Do. Do. Meclofenamate Sodium Capsules July 1, 1992 Do. Do. Naphazoline Hydrochloride Ophthalmic Solution March 1, 1989 Do. Do. Niacin Tablets July 1, 1992 Do. Do. Phendimetrazine Tartrate Capsules/Tablets and Extended-Release Capsules February 1, 1991 Do. Do. Phentermine Hydrochloride Capsules/Tablets August 1, 1988 Do. Do. Promethazine Hydrochloride Tablets March 1, 1990 Do. Do. Propantheline Bromide Tablets August 1, 1988 Do. Do. Pyridoxine Hydrochloride Injection June 1, 1984 Do. Do. Quinidine Sulfate Capsules USP October 1, 1995 Do. Do. Sulfamethoxazole and Phenazopyridine Hydrochloride Tablets February 1, 1992 Do. Do. Theophylline Immediate Release Oral Dosage Forms February 1, 1995 Do. Do. Thiamine Hydrochloride Injection February 1, 1988 Do. Do. Vitamin A Capsules February 1, 1992 Do. Do. Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records November 12, 2002 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 860 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDER—Continued Name of Document How to Obtain a Copy of the Document Intended User or Regulatory Activity Date of Issuance Mailing Address Internet Address Clinical Evaluation of Analgesic Drugs December 1, 1992 Do. Do. Using FDA-Approved Patient Labeling in ConsumerDirected Print Advertisements April 23, 2001 Do. Do. GUIDANCE DOCUMENTS ISSUED BY CDRH Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Guidance for Industry, FDA Staff, and Third Parties; Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria October 4, 2004 FDA, regulated industry, and third parties Division of Small Manufacturers, International and Consumer Assistance, 1–800–638–2041 or 301–443–6597; or Factson-Demand,1 301–827– 0111; or Internet at http:/ /www.fda.gov/cdrh/ guidance.html Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry, and Third Parties February 2, 2001 Do. Do. Mutual Recognition Agreement Between the European Union and the United States of America: Confidence Building Programme: Overview and Procedure; Medical Device Annex, Version 7, June 29, 2000; Draft June 29, 2000 FDA and regulated industry Do. Draft Guidance for Industry and FDA; Medical Glove Guidance Manual July 30, 1999 Do. Do. Guidance for Industry and FDA; Regulation of Medical Devices; Background Information for International Officials (entire document available on disk) April 14, 1999 Do. Do. Guidance for Staff, Industry, and Third Parties; Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA) January 6, 1999 Do. Do. Medical Device Appeals and Complaints: Guidance on Dispute Resolution February 1998 Do. Do. Overview of FDA Modernization Act of 1997 Medical Device Provisions February 19, 1998 Do. Do. Medical Device Reporting for Manufacturers March 1997 Do. Do. In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions (FDA 97–4224) January 1997 Do. Do. Medical Device Quality Systems Manual: A Small Entity Compliance Guide April 14, 1999 Do. Do. Comparison Chart: 1996 Quality System Regulation vs. 1978 Good Manufacturing Practices Regulation vs. ANSI/ISO/ASQC Q9001–1994 and ISO/DIS 13485:1996 November 29, 1996 Do. Do. Premarket Notification: 510(k)—Regulatory Requirements for Medical Devices (FDA 95–4158) August 1995 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 861 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Labeling—Regulatory Requirements for Medical Devices September 1, 1989 Do. Do. Impact Resistant Lenses: Questions and Answers (FDA 87–4002) September 1987 Do. Do. CDRH Manual for the GGP Regulations; Final Guidance for FDA Staff February 9, 2001 FDA Do. Human Factors Principles for Medical Device Labeling September 1, 1993 FDA, regulated industry Do. Human Factors PTC for IDE Devices January 17, 1997 Do. Do. Write It Right August 1993 Do. Do. Do It By Design—An Introduction to Human Factors in Medical Devices December 1996 Do. Do. Guidance for Industry and FDA Premarket and Design Control Reviewers; Medical Device Use— Safety: Incorporating Human Factors Engineering into Risk Management July 18, 2000 Do. Do. Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers April 19, 2001 Do. Do. Medical Device Reporting for User Facilities April 1996 FDA and user facilities Do. Frequently-Asked Questions About the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Final Guidance for Industry and FDA Staff July 6, 2001 FDA, regulated industry, third party, and hospital reprocessors Do. Frequently-Asked Questions About the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions July 16, 2003 Do. Do. Continuing Education Credit for Reading/Writing Articles/Papers and Presenting Courses/Lectures (incorporated into the Policy Guidance Help System (PGHS)) March 17, 1998 FDA, accreditation bodies, and mammography facilities Do. Guidance for Submission of Request for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Acts, 42 U.S.C. 263(b)/4/8, 1998 (incorporated into PGHS) March 26, 1998 Do. Do. Guidance for Review of Requests for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. 263(b)/4/8, 1998 (incorporated into PGHS) March 26, 1998 Do. Do. Policy and Standard Operating Procedures When Mammography Facilities in States That Have Accreditation Bodies Intend to Change Accreditation Bodies (incorporated into PGHS) April 15, 1998 Do. Do. Guidance for Industry; Requalification for Interpreting Physician’s Continuing Experience Requirement (incorporated into PGHS) May 28, 1998 Do. Do. Guidance; The Mammography Quality Standards Act Final Regulations; Document #1 (incorporated into PGHS) March 19, 1999 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 862 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Compliance Guidance; The Mammography Quality Standards Act Final Regulations Motion of TubeImage Receptor Assembly (incorporated into PGHS) March 23, 1999 Do. Do. Guidance for Request and Issuance of Interim Notice Letters for Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. Section 263(b) (incorporated into PGHS) May 4, 1999 Do. Do. Compliance Guidance; The Mammography Quality Standards Act Final Regulations Quality Assurance Documentation (incorporated into PGHS) December 7, 1999 Do. Do. Compliance Guidance; The Mammography Quality Standards Act Final Regulations; Document #2 (incorporated into PGHS) February 25, 2000 Do. Do. The Mammography Quality Standards Act Final Regulations Modifications to the Policy Guidance Help System #1; Guidance for Industry and FDA (incorporated into PGHS) July 5, 2000 Do. Do. Compliance Guidance; The Mammography Quality Standards Act Final Regulations; Document #3 (incorporated into PGHS) July 18, 2000 Do. Do. Compliance Guidance; Mammography Facility Survey, Equipment Evaluation, and Medical Physicist Qualification Requirements Under MQSA; Final (incorporated into PGHS) November 6, 2000 Do. Do. The Mammography Quality Standards Act Final Regulations; Modifications and Additions to Policy Guidance Help System #2; Final Guidance for Industry and FDA (incorporated into PGHS) January 24, 2001 Do. Do. The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #4; Guidance for Industry and FDA (incorporated into PGHS) May 23, 2001 Do. Do. The Mammography Quality Standards Act Final Regulations Modifications to the Policy Guidance Help System Due to the September 11, 2002, Terrorist Attacks; Final Guidance for Industry and FDA (incorporated into PGHS) October 5, 2001 Do. Do. The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #3; Guidance for Industry and FDA (incorporated into PGHS) November 5, 2001 Do. Do. Compliance Guidance; The Mammography Quality Standards Act Final Regulations—Preparing for MQSA Inspections (incorporated into PGHS) November 5, 2001 Do. Do. The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #4; Guidance for Industry and FDA (incorporated into PGHS) March 25, 2002 Do. Do. The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #5; Guidance for Industry and FDA (incorporated into PGHS) July 8, 2002 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 863 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #7; Guidance for Industry and FDA (incorporated into PGHS) January 28, 2003 Do. Do. The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #6 (incorporated into PGHS) August 19, 2003 Do. Do. Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations to State and Local Agencies August 13, 1998 FDA, State and local agencies Do. FY 2004 MDUFMA Small Business Qualification Worksheet and Certification; Guidance for Industry and FDA August 1, 2003 Office of Device Evaluation Do. Premarket Assessment of Pediatric Medical Devices; Draft Guidance for Industry and FDA Staff July 24, 2003 Do. Do. Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA Staff June 3, 2003 Do. Do. Premarket Approval Application Filing Review; Guidance for Industry and FDA Staff May 1, 2003 Do. Do. Guidance for Industry and FDA; FY 2003 MDUFMA Small Business Qualification Worksheet and Certification March 27, 2003 Do. Do. Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products February 21, 2003 Do. Do. Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff December 3, 2002 Do. Do. The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry October 4, 2002 Do. Do. Medical Devices Made With Polyvinylchloride (PVC) Using the Plasticizer di-(2-Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA September 6, 2002 Do. Do. Updated 510(k) Sterility Review Guidance K90–1; Final Guidance for Industry and FDA August 30, 2002 Do. Do. Availability of Information Given to Advisory Committee Members in Connection With CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff July 18, 2001 Do. Do. Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers; Final Guidance for Industry July 12, 2001 Do. Do. Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff May 29, 2001 Do. Do. Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff February 28, 2001 Do. Do. Office of Device Evaluation VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 864 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Deciding When To Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry November 30, 2000 Do. Do. Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 August 9, 2000 Do. Do. Guidance on Amended Procedures for Advisory Panel Meetings; Final July 22, 2000 Do. Do. Guidance on the Use of Standards in Substantial Equivalence Determinations; Final March 12, 2000 Do. Do. Guidance for Off-the-Shelf Software Use in Medical Devices; Final September 9, 1999 Do. Do. Draft Guidance on Evidence Models for the Least Burdensome Means to Market September 1, 1999 Do. Do. Medical Devices Containing Materials Derived from Animal Sources (Except In Vitro Diagnostic Devices); Final Guidance for FDA Reviewers and Industry November 16, 1998 Do. Do. Guidance for the Medical Device Industry on PMA Shell Development and Modular Review; Final November 6, 1998 Do. Do. Guidance for Industry; General/Specific Intended Use; Final November 4, 1998 Do. Do. Frequently Asked Questions on the New 510(k) Paradigm; Final October 22, 1998 Do. Do. Modifications to Devices Subject to Premarket Approval—The PMA Supplement Decision Making Process; Draft August 6, 1998 Do. Do. Guidance for Industry; Contents of a Product Development Protocol; Draft July 27, 1998 Do. Do. New Model Medical Device Development Process; Final July 21, 1998 Do. Do. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Final May 29, 1998 Do. Do. Guidance to Industry Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; Final May 20, 1998 Do. Do. A New 510(k) Paradigm—Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications March 20, 1998 Do. Do. PMA/510(k) Expedited Review; Guidance for Industry and CDRH Staff; Final March 20, 1998 Do. Do. PMA/510(k) Expedited Review G94–4 (blue book memo) March 20, 1998 Do. Do. 30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes; Guidance for Industry and CDRH (Docket No. 98D– 0080); Final February 19, 1998 Do. Do. Guidance on PMA Interactive Procedures for Day100 Meetings and Subsequent Deficiencies—for Use by CDRH and Industry; Final February 19, 1998 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 865 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document New section 513(f)(2)—Evaluation of Automatic Class III Designation; Guidance for Industry and CDRH Staff; Final February 19, 1998 Do. Do. Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff; Final February 19, 1998 Do. Do. Guidance on IDE Policies and Procedures; Final January 20, 1998 Do. Do. Distribution and Public Availability of PMA Summary of Safety and Effectiveness Data Packages October 10, 1997 Do. Do. Kit Certification for 510(k)s July 1, 1997 Do. Do. Convenience Kits Interim Regulatory Guidance May 20, 1997 Do. Do. Real-Time Review Program for Premarket Aproval Application (PMA) Supplements April 22, 1997 Do. Do. Deciding When to Submit a 510(k) for a Change to an Existing Device (K97–1) January 10, 1997 Do. Do. Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities September 3, 1996 Do. Do. Memorandum of Understanding Regarding Patient Labeling Review (blue book memo #G96–3) August 9, 1996 Do. Do. Continued Access to Investigational Devices During PMA Preparation and Review (blue book memo #D96–1) July 15, 1996 Do. Do. Document Review by the Office of the Chief Counsel (blue book memo G96–1) June 6, 1996 Do. Do. Format for IDE Progress Reports June 1, 1996 Do. Do. Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance April 1, 1996 Do. Do. 510(k) Quality Review Program (blue book memo) March 29, 1996 Do. Do. Suggested Content for Original IDE Application Cover Letter February 27, 1996 Do. Do. Indications for Use Statement January 2, 1996 Do. Do. Letter—Vascular Graft Industry (Philip Phillips) November 22, 1995 Do. Do. Cover Letter: 510(k) Requirements During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (blue book memo #K95–1) November 21, 1995 Do. Do. Color Additives for Medical Devices (Snesko) November 15, 1995 Do. Do. #D95–2, Attachment A (Interagency Agreement between FDA and HCFA) September 15, 1995 Do. Do. #D95–2, Attachment B (Criteria for Categorization of Investigational Devices (HCFA)) September 15, 1995 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 866 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document HCFA Reimbursement Categorization Determinations for FDA-Approved IDEs September 15, 1995 Do. Do. Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Attachment A Interagency Agreement, Attachment B Criteria for Catergorization of Investigational Devices, and Attachment C—List (blue book memo #D95–2) September 15, 1995 Do. Do. Goals and Initiatives for the IDE Program (blue book memo #D95–1) July 12, 1995 Do. Do. Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and Solutions June 13, 1995 Do. Do. Use of International Standard ISO–10993, ‘‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing’’ (replaces #G87–1 #8294) (blue book memo) May 1, 1995 Do. Do. Premarket Approval Application (PMA) Closure (blue book memo #P94–2) July 8, 1994 Do. Do. 510(k) Sign-Off Procedures (blue book memo #K94– 2) June 3, 1994 Do. Do. Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer from Susan Alpert, Ph.D., M.D. May 26, 1994 Do. Do. 510(k) Refuse to Accept Procedures (blue book memo #K94–1) May 20, 1994 Do. Do. IDE Refuse to Accept Procedures (blue book memo #D94–1) May 20, 1994 Do. Do. PMA/510(k) Triage Review Procedures (blue book memo #G94–1) May 20, 1994 Do. Do. Preamendments Class III Strategy April 19, 1994 Do. Do. Premarket Notification (510(k)) Status Request Form March 7, 1994 Do. Do. Documentation and Resolution of Differences of Opinion on Product Evaluations (blue book memo #G93–1) December 23, 1993 Do. Do. 510(k) Additional Information Procedures (blue book memo #K93–1) July 23, 1993 Do. Do. CDRH’s Investigational Device Exemption (IDE) Refuse to Accept Policy June 30, 1993 Do. Do. CDRH’s Premarket Notification (510(k)) Refuse to Accept Policy (updated checklist March 14, 1995) June 30, 1993 Do. Do. Proposal for Establishing Mechanisms for Setting Review Priorities Using Risk Assesment and Allocating Review Resources June 30, 1993 Do. Do. Classified Convenience Kits April 30, 1993 Do. Do. Telephone Communications Between ODE Staff and Manufacturers (blue book memo #I93–1) January 29, 1993 Do. Do. Preamendment Class III Devices March 11, 1992 Do. Do. Nondisclosure of Financially Sensitive Information (blue book memo #I92–1) March 5, 1992 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 867 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Document Review Processing (blue book memo #I91–1) February 12, 1992 Do. Do. 4-of-a-Kind PMAs October 1, 1991 Do. Do. Review of 510(k)s for Computer Controlled Medical Devices (blue book memo #K91–1) August 29, 1991 Do. Do. Review of Final Draft Medical Device Labeling (blue book memo #P91–4) August 29, 1991 Do. Do. Integrity of Data and Information Submitted to ODE (blue book memo #I91–2) May 29, 1991 Do. Do. Clinical Utility and Premarket Approval (blue book memo #P91–1) May 3, 1991 Do. Do. Panel Review of Premarket Approval Applications (blue book memo #P91–2) May 3, 1991 Do. Do. PMA Compliance Program (blue book memo #P91– 3) May 3, 1991 Do. Do. Shelf Life of Medical Devices April 1, 1991 Do. Do. Device Labeling Guidance (blue book memo #G91– 1) March 8, 1991 Do. Do. Review and Approval of PMAs of Licensees (blue book memo #P86–4) October 22, 1990 Do. Do. Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices (blue book memo #G90–2) October 19, 1990 Do. Do. Consolidated Review of Submissions for Lasers and Accessories (blue book memo #G90–1) October 19, 1990 Do. Do. Assignment of Review Documents (blue book memo #I90–2) August 24, 1990 Do. Do. PMA Supplements: ODEs Letter to Manufacturers; Identifies Situations Which May Require the Submission of a PMA Supplement (When PMA Supplements Are Required) (blue book memo #P90– 1) April 24, 1990 Do. Do. Policy Development and Review Procedures (blue book memo #I90–1) February 15, 1990 Do. Do. Substantial Equivalence (SE) Decision Making Documentation Attached: ‘‘SE’’ Decision Making Process (detailed); i.e., The Decision Making Tree January 1, 1990 Do. Do. Threshold Assessment of the Impact of Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976 January 1, 1990 Do. Do. Meetings with the Regulated Industry (blue book memo #I89–3) November 20, 1989 Do. Do. FDA Policy for The Regulation of Computer Products; Draft November 13, 1989 Do. Do. Toxicology Risk Assessment Committee (blue book memo #G89–1) August 9, 1989 Do. Do. Review of IDEs for Feasibility Studies (blue book memo #D89–1) May 17, 1989 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 868 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Premarket Notification—Consistency of Reviews (blue book memo #K89–1) February 28, 1989 Do. Do. Review of Laser Submissions (blue book memo #G88–1) April 15, 1988 Do. Do. PMA Review Schedules (P87–1); replaced by P94–2 March 31, 1988 Do. Do. Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin Test December 1, 1987 Do. Do. Necessary Information for Diagnostic Ultrasound 510(k); Draft November 24, 1987 Do. Do. Limulus Amebocute Lysate; Reduction of Samples for Testing October 23, 1987 Do. Do. ODE Executive Secretary Guidance Manual G87–3 August 7, 1987 Do. Do. Guideline on Sterile Drug Products Produced by Aseptic Processing June 1, 1987 Do. Do. Master Files Part III; Guidance on Scientific and Technical Information June 1, 1987 Do. Do. ODE Regulatory Information for the Office of Compliance—Information Sharing Procedures (blue book memo #G87–2) May 15, 1987 Do. Do. Guideline on General Principles of Process Validation May 1, 1987 Do. Do. Industry Representatives on Scientific Panel March 27, 1987 Do. Do. Panel Review of ‘‘Me-Too’’ Devices (blue book memo #P86–6) July 1, 1986 Do. Do. Guidance on CDRH’s Premarket Notification Review Program (blue book memo #K86–3) June 30, 1986 Do. Do. Panel Report and Recommendations on PMA Approvals (blue book memo #P86–5) April 18, 1986 Do. Do. Criteria for Panel Review of PMA Supplements (blue book memo #P86–3) January 30, 1986 Do. Do. PMAs—Early Review and Preparation of Summaries of Safety and Effectiveness (blue book memo #P86–1) January 27, 1986 Do. Do. PTC in the Characterization of Cell Lines Used to Produce Biological Products June 1, 1984 Do. Do. Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices December 1, 1983 Do. Do. Methods for Conducting Recall Effectiveness Checks June 16, 1978 Do. Do. Guidance for Submitting Reclassification Petition 1997 Do. Do. Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; Draft February 8, 2000 Do. Do. Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA July 17, 2002 Do. Do. Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA December 13, 2002 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 869 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA October 5, 2001 Do. Do. Heated Humidifier Review Guidance August 30, 1991 Do. Do. Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA April 22, 2003 Do. Do. Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA November 12, 2002 Do. Do. Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices; Draft Guidance for Industry and FDA Reviewers August 14, 2002 Do. Do. Class II Special Controls Guidance Document: RootForm Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDA May 14, 2002 Do. Do. Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Draft Guidance for Industry and FDA February 20, 2002 Do. Do. Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants; Final April 21, 1999 Do. Do. Guidance for the Preparation of Premarket Notifications for Dental Composites November 27, 1998 Do. Do. Dental Cements—Premarket Notification; Final August 18, 1998 Do. Do. Dental Impression Materials—Premarket Notification; Final August 17, 1998 Do. Do. OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; Final August 17, 1998 Do. Do. Draft Guidance Document for the Preparation of Premarket Notification 510(k)s for Dental Alloys March 3, 1997 Do. Do. Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants December 9, 1996 Do. Do. Guidance Document on Dental Handpieces July 1, 1995 Do. Do. Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application for an Endosseous Implant for Prosthetic Attachment May 16, 1989 Do. Do. Supplementary Guidance on Premarket Notifications for Medical Devices With Sharps Injury Prevention Features; Guidance for Industry and FDA December 31, 2002 Do. Do. Guidance on Premarket Notifications for Intravascular Administration Sets October 12, 2000 Do. Do. Neonatal and Neonatal Transport Incubators—Premarket Notifications; Final September 18, 1998 Do. Do. Guidance on the Content of Premarket Notification (510(k)) Submissions for Protective Restraints December 1, 1995 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 870 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Name of Document Date of Issuance Guidance on Premarket Notification (510(k)) Submissions for Short-Term and Long-Term Intravascular Catheters March 16, 1995 Do. Do. Guidance on the Content of Premarket Notification (510(k)) Submissions for Hypodermic Single Lumen Needles April 1, 1993 Do. Do. Guidance on the Content of Premarket Notification (510(k)) Submissions for Piston Syringes April 1, 1993 Do. Do. Guidance on the Content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers March 1, 1993 Do. Do. Guidance on the Content of Premarket Notification (510(k)) Submissions for External Infusion Pumps March 1, 1993 Do. Do. Guidance on 510(k) Submissions for Implanted Infusion Ports October 1, 1990 Do. Do. Surgical Masks—Premarket Notification (510(k)) Submissions; Draft Guidance May 15, 2003 Do. Do. Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA August 30, 2002 Do. Do. Premarket Notification (510(k)) Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA March 7, 2002 Do. Do. Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff February 7, 2002 Do. Do. Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff June 1, 2001 Do. Do. Premarket Notifications (510(k)) for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers May 21, 2001 Do. Do. Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA March 2, 2001 Do. Do. Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants and High Level Disinfectants; Final January 3, 2000 Do. Do. Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for Medical Gloves; Draft November 16, 1999 Do. Do. Premarket Notification (510(k)) Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products; Final January 13, 1999 Do. Do. CDRH Regulatory Guidance for Washers and Washer-Disinfectors Intended for Use in Processing Reusable Medical Devices June 2, 1998 Do. Do. Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (addendum to 944) July 28, 1997 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00094 Fmt 4703 Intended User or Regulatory Activity Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 How to Obtain a Copy of the Document Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 871 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Addendum to Guidance on Premarket Notification (510(k)) Submissions for Sterilizers Intended for Use in Health Care Facilities September 19, 1995 Do. Do. Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Sharps Containers October 1, 1993 Do. Do. Guidance on Premarket Notification (510(k)) Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities August 1, 1993 Do. Do. Guidance on Premarket Notification (510(k)) Submissions for Surgical Gowns and Surgical Drapes August 1, 1993 Do. Do. Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities March 1, 1993 Do. Do. Battery Guidance January 1, 1994 Do. Do. Policy for Expiration Dating (DCRND RB92–G) October 30, 1992 Do. Do. Balloon Valvuloplasty Guidance for the Submission of an IDE Application and a PMA Application January 1, 1989 Do. Do. Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry July 1, 2002 Do. Do. Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers November 8, 2000 Do. Do. Recommended Clinical Study Design for Ventricular Tachycardia Ablation May 7, 1999 Do. Do. Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1; Final November 19, 1998 Do. Do. Non-Invasive Blood Pressure (NIBP) Monitor Guidance March 10, 1997 Do. Do. Electrocardiograph (ECG) Electrode February 11, 1997 Do. Do. Electrocardiograph (ECG) Lead Switching Adapter February 11, 1997 Do. Do. Electrocardiograph (ECG) Surface Electrode Tester February 11, 1997 Do. Do. Draft Version Cardiac Ablation Preliminary Guidance (Data To Be Submitted to the FDA in Support Investigation Device Exemption Application) March 1, 1995 Do. Do. Draft Version Electrode Recording Catheter Preliminary Guidance (Data To Be Submitted to the FDA in Support of Premarket Notifications) March 1, 1995 Do. Do. Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff January 31, 2001 Do. Do. Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDA November 29, 2000 Do. Do. Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDA November 29, 2000 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 872 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff November 13, 2000 Do. Do. Draft Replacement Heart Valve Guidance October 14, 1994 Do. Do. Draft Guidance; Human Heart Valve Allografts June 21, 1991 Do. Do. Guidance for the Preparation of the Annual Report to the PMA Approved Heart Valve Prostheses April 1, 1990 Do. Do. Draft Intravascular Brachytherapy—Guidance for Data To Be Submitted to FDA in Support of Investigational Device Exemption (IDE) Applications May 24, 1996 Do. Do. Draft Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents May 1, 1995 Do. Do. Draft Percutaneous Transluminal Coronary Angioplasty Package Insert Template February 7, 1995 Do. Do. Coronary and Cerebrovascular Guidewire Guidance January 1, 1995 Do. Do. Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions November 1, 2000 Do. Do. Draft Guidance for Implantable CardioverterDefibrillators June 19, 1996 Do. Do. Implantable Pacemaker Testing Guidance January 12, 1990 Do. Do. Guidance Document for Vascular Prostheses 510(k) Submissions November 1, 2000 Do. Do. Guidance for Cardiovascular Intravascular Filter 510(k) Submissions; Final November 26, 1999 Do. Do. Carotid Stent—Suggestions for Content of Submissions to FDA in Support of Investigational Devices Exemption (IDE) Applications October 26, 1996 Do. Do. Draft Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses August 1, 1993 Do. Do. Guidance Document for Powered Suction Pump 510(k)s September 30, 1998 Do. Do. Guidance Document for Surgical Lamp 510(k)s; Final July 13, 1998 Do. Do. Electroencephalograph Devices Draft Guidance for 510(k) Content November 3, 1997 Do. Do. Guidelines for Reviewing Premarket Notifications That Claim Substantial Equivalence to Evoked Response Stimulators February 1, 1997 Do. Do. Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Electromyograph Needle Electrodes July 26, 1995 Do. Do. Guidance on the Content and Organization of a Premarket Notification for a Medical Laser June 1, 1995 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 873 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Draft 510(k) Guideline for General Surgical Electrosurgical Devices May 10, 1995 Do. Do. Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices August 30, 1994 Do. Do. Galvanic Skin Response Measurement Devices; Draft Guidance for 510(k) Content August 23, 1994 Do. Do. Draft Version 1; Biofeedback Devices; Draft Guidance for 510(k) Content August 1, 1994 Do. Do. Draft Version Cranial Perforator Guidance July 13, 1994 Do. Do. Draft Version Neuro Endoscope Guidance July 7, 1994 Do. Do. Draft Premarket Notification Review Guidance for Evoked Response Somatosensory Stimulators June 1, 1994 Do. Do. Draft Guidance for Arthroscope and Accessory 510(k)s May 1, 1994 Do. Do. Class II Special Controls Guidance Document; Knee Joint Patellofemorotibial and Femorotibial Metal/ Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA January 16, 2003 Do. Do. Class II Special Controls Guidance Document; Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA July 17, 2002 Do. Do. Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis April 30, 2002 Do. Do. Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semiconstrained Porous-Coated Uncemented Prosthesis October 31, 2000 Do. Do. Guidance for Spinal System 510(k)s September 27, 2000 Do. Do. Guidance Document for the Preparation of IDEs for Spinal Systems January 13, 2000 Do. Do. Guidance Document for Industry and CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; Draft March 18, 1998 Do. Do. Draft Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices—The Basic Elements July 16, 1997 Do. Do. ORDB 510(k) Sterility Review Guidance July 3, 1997 Do. Do. Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants February 21, 1997 Do. Do. Reviewers Guidance Checklist for Intramedullary Rods February 21, 1997 Do. Do. Reviewers Guidance Checklist for Orthopedic External Fixation Devices February 21, 1997 Do. Do. 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants February 20, 1997 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 874 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Guidance Document for Testing Biodegradable Polymer Implant Devices April 20, 1996 Do. Do. Guidance Document for Testing Bone Anchor Devices April 20, 1996 Do. Do. Draft Guidance Document for Femoral Stem Prostheses August 1, 1995 Do. Do. Draft Guidance Document for Testing Acetabular Cup Prostheses May 1, 1995 Do. Do. Guidance Document for Testing Non-Articulating, ‘‘Mechanically Locked,’’ Modular Implant Components May 1, 1995 Do. Do. Draft Data Requirements for Ultrahigh Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic Devices March 28, 1995 Do. Do. Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip Systems January 10, 1995 Do. Do. Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone or Bone Cement April 28, 1994 Do. Do. Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semiconstrained Total Knee Prostheses April 1, 1993 Do. Do. Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prothetic Knee Ligament Devices February 18, 1993 Do. Do. Class II Special Controls Guidance Document; Surgical Sutures; Guidance for Industry and FDA June 3, 2003 Do. Do. Guidance for Saline, Silicone Gel, and Alternative Breast Implants; Guidance for Industry and FDA February 11, 2003 Do. Do. Class II Special Controls Guidance Document; Human Dura Mater; Draft Guidance for Industry and FDA October 22, 2002 Do. Do. Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry June 18, 2002 Do. Do. Guidance Document for Dura Substitute Devices; Final Guidance for Industry November 9, 2000 Do. Do. Guidance for Neurological Embolization Devices November 1, 2000 Do. Do. Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater; Final October 14, 1999 Do. Do. Guidance for Dermabrasion Devices; Final March 2, 1999 Do. Do. Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final March 2, 1999 Do. Do. Guidance for Content of Premarket Notifications for Esophageal and Tracheal Prostheses; Final April 28, 1998 Do. Do. Guidance for Testing MR Interaction With Aneurysm Clips May 22, 1996 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 875 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Draft Guidance for the Preparation of IDE Submission for Interactive Wound and Burn Dressing April 4, 1995 Do. Do. Draft Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing March 31, 1995 Do. Do. Draft Version; Guidance on Biocompatibility Requirements for Long Term Neurological Implants: Part 3—Implant Model September 12, 1994 Do. Do. Protocol for Dermal Toxicity Testing for Devices in Contact With Skin; Draft January 1, 1985 Do. Do. Class II Special Controls Guidance Document; Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA June 2, 2003 Do. Do. Guidance Document for Powered Muscle Stimulator 510(k)s; Final June 9, 1999 Do. Do. Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators July 26, 1995 Do. Do. Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Beds July 26, 1995 Do. Do. Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Communications Systems (Powered and Nonpowered) and Powered Environmental Control Systems July 26, 1995 Do. Do. Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Exercise Equipment July 26, 1995 Do. Do. Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Heating and Cooling Devices July 26, 1995 Do. Do. Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Immersion Hydrobaths July 26, 1995 Do. Do. Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Powered Tables and Multifunctional Physical Therapy Tables July 26, 1995 Do. Do. Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Submerged (Underwater) Exercise Equipment July 26, 1995 Do. Do. Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles July 26, 1995 Do. Do. Guide for TENS 510(k) Content; Draft August 1, 1994 Do. Do. Draft Version Guidance for Clinical Data To Be Submitted for Premarket Approval Application for Cranial Electrotherapy Stimulators August 20, 1992 Do. Do. Draft Guidance for Cortical Electrode 510(k) Content August 10, 1992 Do. Do. Guidance for Studies for Pain Therapy Devices— General Consideration in the Design of Clinical Studies for Pain-Alleviating Devices May 12, 1988 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 876 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Accountability Analysis for Clinical Studies for Ophthalmic Devices; Draft August 4, 1999 Do. Do. Guidance Document for Nonprescription Sunglasses; Final October 9, 1998 Do. Do. Ophthalmoscope Guidance July 8, 1998 Do. Do. Retinoscope Guidance; Final July 8, 1998 Do. Do. Slit Lamp Guidance; Final July 8, 1998 Do. Do. Discussion Points for Expansion of the ‘‘Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers;’’ Draft Document September 5, 1997 Do. Do. Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k)) January 31, 1997 Do. Do. Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket Notification (510(k)) January 31, 1997 Do. Do. Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers (excimer) October 10, 1996 Do. Do. Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final March 12, 2000 Do. Do. Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification; Final January 14, 1998 Do. Do. Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Children Ages 2 through 17 Years May 1, 1990 Do. Do. Guideline for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Adults at Least 18 Years of Age May 1, 1990 Do. Do. Refractive Implants: Guidance for Investigational Device Exemptions (IDE) and Premarket Approval (PMA) Applications; Draft August 1, 2000 Do. Do. Intraocular Lens Guidance Document; Draft October 14, 1999 Do. Do. Guidance on 510(k) Submissions for Keratoprostheses; Final March 3, 1999 Do. Do. Aqueous Shunts—510(k) Submissions; Final November 16, 1998 Do. Do. FDA Guidelines for Multifocal Intraocular Lens IDE Studies and PMAs May 29, 1997 Do. Do. Important Information About Rophae Intraocular Lenses August 20, 1992 Do. Do. Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses; Final April 10, 2000 Do. Do. Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Final August 11, 1998 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 877 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Premarket Notification 510(k) Guidance for Contact Lens Care Products May 1, 1997 Do. Do. Premarket Notification (510(k)) Guidance Document for Class II Daily Wear Contact Lenses June 28, 1994 Do. Do. New FDA Recommendations and Results of Contact Lens Study (7-day letter) May 30, 1989 Do. Do. Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA November 28, 2001 Do. Do. Class II Special Controls Guidance Document; Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers May 16, 2001 Do. Do. Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers January 16, 2001 Do. Do. Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems; Final August 7, 1998 Do. Do. Guidance for the Content of Premarket Notification for Conventional and High Permeability Hemodialyzers; Final August 7, 1998 Do. Do. Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; Final February 5, 1998 Do. Do. Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis May 30, 1997 Do. Do. Draft Guidance for Hemodialyzer Reuse Labeling October 6, 1995 Do. Do. Class II Special Controls Guidance Document; Breast Lesion Documentation System; Guidance for Industry and FDA Staff July 28, 2003 Do. Do. Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers March 9, 2001 Do. Do. Class II Special Controls Guidance Document for Clitoral Engorgement Devices July 3, 2000 Do. Do. Draft Guidance for Industry; Electro-optical Sensors for the In Vivo Detection of Cervical Cancer and Its Precursors: Submission Guidance for an IDE/ PMA August 25, 1999 Do. Do. Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures; Draft September 10, 1998 Do. Do. Latex Condoms for Men—Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions July 23, 1998 Do. Do. Uniform Contraceptive Labeling; Final July 23, 1998 Do. Do. Intrapartum Continuous Monitors for Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft Document June 14, 1997 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 878 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Letter to Manufacturers of Prescription Home Monitors for Nonstress Tests September 6, 1996 Do. Do. Letter to Manufacturers of Falloposcopes September 5, 1996 Do. Do. Thermal Endometrial Ablation Devices (Submission Guidance for an IDE) March 14, 1996 Do. Do. Hysteroscopes and Gynecology Laparoscopes (Submission Guidance for a 510(k)) March 7, 1996 Do. Do. Hysteroscopes and Laparoscopic Insufflators (Submission Guidance for a 510(k)) August 1, 1995 Do. Do. Testing Guidance for Male Condoms Made From New Material (Nonlatex) June 29, 1995 Do. Do. Draft Guidance for the Content of Premarket Notifications for Menstrual Tampons May 25, 1995 Do. Do. Information for a Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch; Draft April 13, 1994 Do. Do. Premarket Testing Guidelines for Falloposcopes November 20, 1992 Do. Do. Draft Guidance for the Content of Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical Excisions July 29, 1991 Do. Do. Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases April 4, 1990 Do. Do. Guidance (‘‘Guidelines’’) for Evaluation of Hysteroscopic Sterilization Devices May 10, 1978 Do. Do. Guidance (‘‘Guidelines’’) for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories) May 1, 1978 Do. Do. Guidance (‘‘Guidelines’’) for Evaluation of Tubal Occlusion Devices November 22, 1977 Do. Do. Guidance (‘‘Guidelines’’) for Evaluation of Fetal Clip Electrode March 8, 1977 Do. Do. Guidelines for Evaluation of Nondrug IUDs September 28, 1976 Do. Do. Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices; Guidance for Industry and FDA Staff July 14, 2003 Do. Do. Bone Sonometer PMA Applications; Final Guidance for Industry and FDA June 21, 2001 Do. Do. Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA February 16, 2001 Do. Do. Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources August 2, 2000 Do. Do. Guidance for the Submission of Premarket Notifications for Medical Image Management Devices July 27, 2000 Do. Do. Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices; Final August 6, 1999 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 879 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Final December 3, 1998 Do. Do. Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; Final November 20, 1998 Do. Do. Harmonic Imaging With/Without Contrast—Premarket Notification; Final November 16, 1998 Do. Do. Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Final November 14, 1998 Do. Do. Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers September 30, 1997 Do. Do. Letter: Notice to Manufacturers of Bone Mineral Densitometers September 25, 1997 Do. Do. Simplified 510(k) Procedures for Certain Radiology Devices: 12/21/93 letter from L. Yin, ODE/ DRAERD, to NEMA December 21, 1993 Do. Do. Draft Guidance for Review of Bone Densitometer 510(k) Submissions November 9, 1992 Do. Do. Reviewer Guidance for Automatic X-Ray Film Processor 510(k) February 1, 1990 Do. Do. Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi August 9, 2000 Do. Do. Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; Final January 16, 2000 Do. Do. Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; Final November 30, 1998 Do. Do. CDRH Interim Regulatory Policy for External Penile Rigidity Devices September 10, 1997 Do. Do. Draft Guidance for Preclinical and Clinical Investigations of Urethral Bulking Agents Used in the Treatment of Urinary Incontinence November 29, 1995 Do. Do. Draft Guidance for the Clinical Investigation of Urethral Stents November 2, 1995 Do. Do. Draft 510(k) Checklist for Endoscopic Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and Urology August 16, 1995 Do. Do. Draft 510(k) Checklist for Urological Irrigation System and Tubing Set August 1, 1995 Do. Do. Draft 510(k) Checklist for Endoscopic Light Sources Used in Gastroenterology and Urology June 22, 1995 Do. Do. Draft 510(k) Checklist for Non-Implanted Electrical Stimulators Used for the Treatment of Urinary Incontinence June 6, 1995 Do. Do. Draft Guidance for Preparation of PMA Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter) May 1, 1995 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 880 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Name of Document Date of Issuance Draft Guidance for the Content of Premarket Notifications for Endoscopes Used in Gastroenterology and Urology March 17, 1995 Do. Do. Draft 510(k) Checklist for Condom Catheters February 23, 1995 Do. Do. Draft Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) November 11, 1994 Do. Do. Checklist for Mechanical Lithotripters and Stone Dislodgers Used in Gastroenterology and Urology November 1, 1994 Do. Do. 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments September 19, 1994 Do. Do. Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters September 12, 1994 Do. Do. Guidance for the Content of Premarket Notifications for Urodynamic/Uroflowmetry Systems July 29, 1994 Do. Do. Guidance for the Content of Premarket Notifications for Urine Drainage Bags June 7, 1994 Do. Do. Draft Guidance Outline—PTC for Clinical Studies for Vasovasostomy Devices November 30, 1993 Do. Do. Draft Guidance for Preparation of PMA Applications for Penile Inflatable Implants March 16, 1993 Do. Do. Draft Guidance for Preparation of PMA Applications for Testicular Prostheses March 16, 1993 Do. Do. Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology February 10, 1993 Do. Do. Guidance for the Content of Premarket Notifications for Ureteral Stents February 10, 1993 Do. Do. Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Cathethers January 24, 1992 Do. Do. Draft of Suggested Information for Reporting Extracorporeal Shock Wave Lithotripsy Device Shock Wave Measurements January 18, 1991 Do. Do. Draft Guidance to Firms on Biliary Lithotripsy Studies August 2, 1990 Do. Do. Intended User or Regulatory Activity How to Obtain a Copy of the Document Office of In Vitro Diagnostic Device Evaluation and Safety Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry February 26, 2003 Do. Do. Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft PTC Regarding Labeling and Premarket Submissions October 1, 1988 Do. Do. Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated Analyzers June 10, 1996 Do. Do. Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff December 3, 2002 Do. Do. Guidance for Administrative Procedures for CLIA Categorization August 14, 2000 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 881 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA March 1, 2001 Do. Do. Guidance for Industry; Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final February 22, 1999 Do. Do. Guidance on Labeling for Laboratory Tests; Draft June 24, 1999 Do. Do. Letter to IVD Manufacturers on Streamlined PMA; Final December 22, 1997 Do. Do. PTC for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance September 26, 1994 Do. Do. PTC for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices (cover letter dated March 14, 1996) February 1, 1996 Do. Do. PTC Guidance Document on Assayed and Unassayed Quality Control Material; Draft February 3, 1999 Do. Do. Premarket Approval Application Filing Review; Guidance for Industry and FDA Staff May 1, 2003 Do. Do. Breath Nitric Oxide Test System; Class II Special Controls Guidance Document July 7, 2003 Do. Do. Class II Special Control Guidance Document for BType Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers November 30, 2000 Do. Do. Class II Special Controls Guidance Document; Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA September 16, 2002 Do. Do. Draft Guidance for Prescription Use of Drugs of Abuse Assays Premarket Notifications November 14, 2000 Do. Do. Draft Guidance on the Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing December 21, 1999 Do. Do. Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians’ Office Laboratory, and Home Use July 14, 1995 Do. Do. Guidance for Industry In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System; Final July 6, 1998 Do. Do. Guidance for Industry In Vitro Diagnostic Chloride Test System; Final July 6, 1998 Do. Do. Guidance for Industry In Vitro Diagnostic Creatinine Test System; Final July 2, 1998 Do. Do. Guidance for Industry In Vitro Diagnostic Glucose Test System; Final July 6, 1998 Do. Do. Guidance for Industry In Vitro Diagnostic Potassium Test System; Final July 6, 1998 Do. Do. Guidance for Industry In Vitro Diagnostic Sodium Test System; Final July 6, 1998 Do. Do. Guidance for Industry In Vitro Diagnostic Urea Nitrogen Test System; Final July 6, 1998 Do. Do. Guidance for Industry; In Vitro Diagnostic C-Reactive Protein Immunological Test System July 20, 1998 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00105 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 882 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s July 22, 2000 Do. Do. Guidance for Over-the-Counter (OTC) Ovulation Predictor 510(k)s July 22, 2000 Do. Do. Over-the-Counter (OTC) Screening Tests for Drugs of Abuse; Guidance for Premarket Notifications November 14, 2000 Do. Do. PTC for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate Nursery February 20, 1996 Do. Do. Review Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies August 31, 1995 Do. Do. Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology February 14, 1996 Do. Do. Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs) November 6, 1996 Do. Do. 510(k) Submissions for Coagulation Instruments; Guidance for Industry and FDA Staff June 19, 2003 Do. Do. Class II Special Control Guidance Document for Anti-Saccharomyces cerevisia (S. cerevisiae) Antibody (ASCA) Premarket Notifications August 23, 2000 Do. Do. Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA December 4, 2001 Do. Do. Document for Special Controls for Erythropoietin Assay Premarket Notifications (510(k)s); Final April 28, 1999 Do. Do. Draft Guidance Document for 510(k) Submission of Fecal Occult Blood Tests July 29, 1992 Do. Do. Draft Guidance Document for 510(k) Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs September 30, 1991 Do. Do. Draft Guidance Document for 510(k) Submission of Immunoglobulins A, G, M, D and E Immunoglobulin System In Vitro Devices September 1, 1992 Do. Do. Draft Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs Using Monoclonal Antibodies September 26, 1991 Do. Do. Draft; Premarketing Approval Review Criteria for Premarket Approval of Estrogen (ER) or Progesterone (PGR) Receptors In Vitro Diagnostic Devices Using Steroid Hormone Binding (SBA) with Dextran-Coated Charcoal (DCC) Separation, Histochemical Receptor Bind September 10, 1992 Do. Do. Guidance Document for the Submission of Tumor Associated Antigen Premarket Notification (510(k)) to FDA September 19, 1996 Do. Do. Guidance for Submission of Immunohistochemistry Applications to the FDA; Final June 3, 1998 Do. Do. In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Final April 27, 1999 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 883 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Multiplex Tests for Heritable DNA Markers, Mutations, and Expression Patterns; Draft Guidance for Industry and FDA Reviewers February 27, 2003 Do. Do. PTC for Cervical Cytology Devices July 25, 1994 Do. Do. PTC for Hematology Quality Control Materials September 30, 1997 Do. Do. Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final Guidance for Industry and FDA August 22, 2001 Do. Do. Review Criteria for Assessment of Alpha-Fetoprotein (AFP) In Vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies July 15, 1994 Do. Do. Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers July 15, 1991 Do. Do. Review Criteria for Assessment of Rheumatoid Factor (RF) In Vitro Diagnostic Devices Using Enzyme-Linked Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate Nephelometry February 21, 1997 Do. Do. Review Criteria for Blood Culture Systems August 12, 1991 Do. Do. Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Do Antibodies to Viral Agents August 1, 1992 Do. Do. Review Criteria for In Vitro Diagnostic Devices for the Assessment of Thyroid Autoantibodies Using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA) February 1, 1994 Do. Do. Review Criteria for In Vitro Diagnostic Devices That Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic) February 15, 1996 Do. Do. Review Criteria for the Assessment of Anti-Nuclear Antibodies (ANA) In Vitro Diagnostic Devices Using Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD), and Enzyme Linked Immunosorbant Assay (ELISA) September 1, 1992 Do. Do. Class II Special Controls Guidance Document; Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA February 5, 2003 Do. Do. Draft Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms June 14, 1993 Do. Do. Premarket Approval Applications for In Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses (HCV): Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection, Hepatitis C, or Other HCV-Associated Disease; Draft Guidance for Industry and FDA April 27, 2001 Do. Do. Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs October 30, 1996 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 884 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical Specimens January 1, 1992 Do. Do. Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. (Tuberculosis (TB)) July 6, 1993 Do. Do. Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pylori September 17, 1992 Do. Do. Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated Diseases May 31, 1990 Do. Do. Review Criteria for Devices Intended for the Detection of Hepatitis B ‘e’ Antigen and Antibody to HBe December 30, 1991 Do. Do. Review Criteria for Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 May 15, 1992 Do. Do. PMA Review Statistical Checklist (no date available) Do. Do. Statistical Aspects of Submissions to FDA: A Medical Device Perspective (also includes as appendix the article ‘‘Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions’’) June 1, 1984 Do. Do. Statistical Guidance for Clinical Trials of Nondiagnostic Medical Devices January 1, 1996 Do. Do. MDR Guidance Document: Remedial Action Exemption; Final September 26, 2001 Industry and FDA Do. Guidance on Adverse Event Reporting for Hospitals That Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use April 24, 2001 Industry Do. MDR Guidance Document No. 1—IOL—E1996004; Final August 7, 1996 Do. Do. Common Problems: Baseline Reports and Medwatch Form 3500A January 1, 1997 Do. Do. Medical Device Reporting: An Overview; Final April 1, 1996 Do. Do. Instructions for Completing FDA Form 3500A With Coding Manual for Form 3500A (MEDWATCH) (MDR); Final December 15, 1995 Do. Do. MEDWATCH FDA Form 3500A for Use by User Facilities, Distributors and Manufacturers for Mandatory Reporting (MDR); Final June 1, 1993 Industry and user facilities Do. Variance from Manufacturer Report Number Format (MDR letter); Final July 16, 1996 Industry Do. Instructions for Completing Form 3417: Medical Device Reporting Baseline Report (MDR); Final March 31, 1997 Do. Do. Medical Device Reporting—Alternative Summary Reporting (ASR) Program; Guidance for Industry October 19, 2000 Do. Do. Addendum to the Instructions for Completing FDA Form 3500A With Coding Manual (MEDWATCH) (MDR); Final June 9, 1999 Do. Do. Office of Surveillance and Biometrics VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 885 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Needlesticks—Medical Device Reporting Guidance November 12, 2002 Industry and user facilities Do. Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads) June 9, 1993 Industry and FDA reviewers Do. Guidance on Criteria and Approaches for Postmarket Surveillance November 2, 1998 Do. Do. Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies (FDAMA); Final February 19, 1998 FDA reviewers Do. Guidance on Procedures for Review of Postmarket Surveillance Submissions (FDAMA); Final February 19, 1998 Do. Do. Guidance for Industry and FDA Staff; SMDA to FDAMA: Guidance on FDA’s Transition Plan for Existing Postmarket Surveillance Protocols (FDAMA); Final November 2, 1998 Industry and FDA reviewers Do. Amendment to Guidance on Discretionary Postmarket Surveillance on Pacemaker Leads; Final March 30, 1994 Do. Do. Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket February 2, 2000 Do. Do. Commercial Distribution/Exhibit Letter March 11, 1992 Do. Do. FDA Guide for Validation of Biological Indicator Incubation Time January 1, 1986 Do. Do. Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88– 8264) March 1, 1988 Do. Do. General Principles of Software Validation; Draft Guidance January 11, 2002 Do. Do. Guidance on Medical Device Tracking (FDAMA); Guidance for Industry and FDA Staff May 23, 2003 Do. Do. Compliance Program Guidance Manual: Inspection of Medical Devices; Draft February 7, 2001 Do. Do. Procedures for Laboratory Compliance Testing of Television Revivers—Part of TV Packet May 1, 1986 Do. Do. Guidance on Quality System Regulation Information for Various Premarket Submissions; Draft February 3, 2003 Do. Do. Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves; Guidance for Industry July 26, 2000 Do. Do. Manufacturers/Assemblers of Diagnostic X-Ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) October 13, 1993 Do. Do. Guidance for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components January 1, 1982 Do. Do. Office of Compliance VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 886 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Name of Document Date of Issuance Exemption From Reporting and Recordkeeping Requirements for Certain Sunlamp Product Manufacturers September 16, 1981 Do. Do. Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi) May 17, 1993 Do. Do. Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89–8221) March 1, 1989 Do. Do. CPG 7133.19: Retention of Microwave Oven Test Record/Cover Letter: August 24, 1981; Retention of Records Required by 21 CFR 1002 March 1, 1995 Do. Do. A Guidance for the Submission of Abbreviated Radiation Safety Reports on Cephalometric X-Ray Devices: Defined as Dental Units With an Attachment for Mandible Work That Holds a Cassette and Beam Limiting Device March 1, 1996 Do. Do. A Guide for the Submission of an Abbreviated Radiation Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use March 1, 1996 Do. Do. A Guide for the Submission of Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammography X-Ray Systems March 1, 1996 Do. Do. Compliance Program Guidance Manual; Field Compliance Testing of Diagnostic (Medical) X-Ray Equipment; Guidance for FDA Staff March 15, 2000 Do. Do. Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final Guidance for Industry and FDA April 2, 2001 Do. Do. Guide for Submission of Information on Accelerators Intended to Emit X-Radiation Required Pursuant to 21 CFR 1002.10 April 1, 1971 Do. Do. Abbreviated Report on Radiation Safety for Microwave Products (Other Than Microwave Ovens)— e.g., Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems August 1, 1995 Do. Do. Guide for Preparing Reports on Radiation Safety of Microwave Ovens March 1, 1985 Do. Do. Reporting Guide for Laser Light Shows and Displays (21 CFR 1002) (FDA 88–8140) September 1, 1995 Do. Do. Guide for Filing Annual Reports for X-Ray Components and Systems July 1, 1980 Do. Do. Reporting and Compliance Guide for Television Products Including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information, and Guidance October 1, 1995 Do. Do. Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (replaces FDA 82–8127) September 1, 1995 Do. Do. Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use September 1, 1996 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00110 Fmt 4703 Intended User or Regulatory Activity Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 How to Obtain a Copy of the Document Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 887 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Letter to Manufacturers and Importers of Microwave Ovens: Information Requirements for Cookbooks and User and Service Manuals October 31, 1988 Do. Do. Abbreviated Report on Radiation Safety of Nonmedical Ultrasonic Products August 1, 1995 Do. Do. Guide for Preparing Product Reports for Medical Ultrasound Products September 1, 1996 Do. Do. Letter to Manufacturers, Distributors, and Importers of Condom Products February 23, 1994 Do. Do. Letter to Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt) February 13, 1989 Do. Do. Letter to Condom Manufacturers and Distributors April 5, 1994 Do. Do. Letter to Manufacturers/Repackers Using Cotton April 22, 1994 Do. Do. Guide for Preparing Product Reports for Lasers and Products Containing Lasers September 1, 1995 Do. Do. Compliance Guide for Laser Products (FDA 86– 8260) September 1, 1985 Do. Do. Condoms: Inspection and Sampling at Domestic Manufacturers and of All Repackers; Sampling From All Importers (Damaska memo to field on April 8, 1987) April 8, 1987 Do. Do. Dental Hand Piece Sterilization (dear doctor letter) September 28, 1992 Do. Do. Latex Labeling Letter (Johnson) March 18, 1993 Do. Do. Pesticide Regulation Notice 94–4: Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides With Medical Device Use Claims Under the Memorandum of Understanding Between EPA and FDA June 30, 1994 Do. Do. Letter to Industry, Powered Wheelchair Manufacturers, from RM Johnson May 10, 1993 Do. Do. Hazards of Volume Ventilators and Heated Humidifiers September 15, 1993 Do. Do. Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care Professionals February 3, 1994 Do. Do. Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol: Proposed Maximum Residue Limits and Maximum Levels of Exposure June 23, 1978 Do. Do. Letter to Manufacturers and Users of Lasers for Refractive Surgery (excimer) October 10, 1996 Do. Do. Shielded Trocars and Needles Used for Abdominal Access During Laparoscopy August 23, 1996 Do. Do. Surveillance and Detention Without Physical Examination of Condoms; Draft Guidance for Industry August 14, 2000 Do. Do. All U.S. Condom Manufacturers, Importers, and Repackagers April 7, 1987 Do. Do. Manufacturers and Initial Distributors of Hemodialyzers May 23, 1996 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00111 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 888 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Laser Light Show Safety—Who’s Responsible? (FDA 86–8262) May 1, 1986 Do. Do. Suggested State Regulations for Control of Radiation; Volume II; Nonionizing Radiation—Lasers (FDA Pub. No. 83–8220) January 1, 1982 Do. Do. Letter to All Foreign Manufacturers and Importers of Electronic Products For Which Applicable FDA Performance Standards Exist May 28, 1981 Do. Do. Guide for Submission of Information on Industrial XRay Equipment Required Pursuant to 21 CFR 1002.10 March 1, 1973 Do. Do. Guide for Submission of Information on Analytical XRay Equipment Required Pursuant to 21 CFR 1002.10 April 30, 1974 Do. Do. Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 February 1, 1975 Do. Do. Guide for Preparing Annual Reports in Radiation Safety Testing of Electronic Products (General) October 1, 1987 Do. Do. Computerized Devices/Processes Guidance—Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes May 1, 1992 Do. Do. Guide for Preparing Product Reports for Ultrasonic Therapy Products (Physical Therapy Only) August 1, 1996 Do. Do. Guide for Submission of Information on Industrial Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81–8137) November 1, 1980 Do. Do. Guide for Preparing Annual Reports for Ultrasonic Therapy Products September 1, 1996 Do. Do. Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (replaces FDA 82–8127) September 1, 1995 Do. Do. Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor (replaces FDA 82–8127) September 1, 1995 Do. Do. Quality Control Guide for Sunlamp Products (FDA 88–8234) September 1, 1984 Do. Do. Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems December 1, 1985 Do. Do. Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21 CFR 1002) September 1, 1995 Do. Do. Letter: Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products June 25, 1985 Do. Do. Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR 1002) September 1, 1995 Do. Do. Quality Control Practices for Compliance With the Federal Mercury Vapor Lamp Performance Standard May 1, 1980 Do. Do. Keeping Up With the Microwave Revolution (FDA Publication No. 91–4160) March 1, 1990 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00112 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 889 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Quality Assurance Guidelines for Hemodialysis Devices February 1, 1991 Do. Do. Letter to Manufacturers and Importers of Microwave Ovens—Open Door Operation of Microwave Ovens as a Result of Oven Miswiring March 28, 1980 Do. Do. Reporting of New Model Numbers to Existing Model Families June 14, 1983 Do. Do. Import: Radiation-Producing Electronic Products (FDA 89–8008) November 1, 1988 Do. Do. Unsafe Patient Lead Wires and Cables September 3, 1993 Do. Do. Application of a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (form FDA 3147) July 1, 1998 Do. Do. Letter to Trade Association: Reuse of Single-Use or Disposable Medical Devices December 27, 1995 Do. Do. Design Control Guidance for Medical Device Manufacturers March 11, 1997 Do. Do. Keeping Medical Devices Safe from Electromagnetic Interference July 1, 1995 Do. Do. Safety of Electrically Powered Products: Letter to Medical Devices and Electronic Products Manufacturers from Lilliam Gill and BHB Correction Memo September 18, 1996 Do. Do. Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; Guidance for Industry and for FDA Staff August 14, 2000 Do. Do. Labeling for Electronic Anti-theft Systems; Final Guidance for Industry August 15, 2000 Do. Do. Wireless Medical Telemetry Risks and Recommendations; Final Guidance for Industry September 27, 2000 Do. Do. Policy on Warning Label Required on Sunlamp Products June 25, 1985 Do. Do. Policy on Lamp Compatibility (Sunlamps) September 2, 1986 Do. Do. Guidance on Frequently Asked Questions on Recognition of Consensus Standards (FDAMA) December 21, 1998 Do. Do. Guidance on the Recognition and Use of Consensus Standards; appendix A (FDAMA) February 19, 1998 Do. Do. CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for Recognition August 6, 1999 Do. Do. Guidance for Industry and FDA Reviewers: Guidance on Immunotoxicity Testing May 6, 1999 Do. Do. September 6, 2002 N/A N/A Office of Science and Technology WITHDRAWN GUIDANCES Medical Devices Made With Polyvinylchloride (PVC) Using the Plasticizer di-(2-Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00113 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 890 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Draft Guidance on Evidence Models for the Least Burdensome Means to Market September 1, 1999 Do. Do. Modifications to Devices Subject to Premarket Approval—The PMA Supplement Decision Making Process; Draft August 6, 1998 Do. Do. Guidance for Industry; Contents of a Product Development Protocol; Draft July 27, 1998 Do. Do. New Model Medical Device Development Process; Final July 21, 1998 Do. Do. Document Review by the Office of the Chief Counsel (blue book memo G96–1) June 6, 1999 Do. Do. Letter: Vascular Graft Industry (Philip Phillips) November 22, 1995 Do. Do. Color Additives for Medical Devices (Snesko) November 15, 1995 Do. Do. PMA/510(k) Triage Review Procedures (blue book memo #G94–1) May 20, 1994 Do. Do. Proposal for Establishing Mechanisms for Setting Review Priorities Using Risk Assessment and Allocating Review Resources June 30, 1993 Do. Do. 4-of-a-Kind PMAs October 1, 1999 Do. Do. Review of 510(k)s for Computer Controlled Medical Devices (blue book memo #K91–1) August 29, 1991 Do. Do. Review of Final Draft Medical Device Labeling (blue book memo #P91–4) August 29, 1991 Do. Do. Clinical Utility and Premarket Approval (blue book memo #P91–1) May 3, 1991 Do. Do. Review and Approval of PMAs of Licensees (blue book memo #P86–4) October 22, 1990 Do. Do. PMA Supplements: ODEs Letter to Manufacturers; Identifies Situation Which May Require the Submission of a PMA Supplement (blue book memo #P90–1) April 24, 1990 Do. Do. FDA Policy for the Regulation of Computer Products; Draft November 13, 1989 Do. Do. PMA Review Schedules (P87–1) (replaced by P94– 2) March 31, 1988 Do. Do. Necessary Information for Diagnostic Ultrasound 510(k); Draft November 24, 1987 Do. Do. Guideline on Sterile Drug Products Produced by Aseptic Processing June 1, 1987 Do. Do. ODE Regulatory Information for the Office of Compliance; Information Sharing Procedures (blue book memo #G87–2) May 15, 1987 Do. Do. Panel Review of ‘‘Me-Too’’ Devices (blue book memo #P86–6) July 1, 1986 Do. Do. Criteria for Panel Review of PMA Supplements (blue book memo #P86–3) January 30, 1986 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00114 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 891 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document PMAs-Early Review and Preparation of Summaries of Safety and Effectiveness (blue book memo #P86–1) January 27, 1986 Do. Do. Draft Guidance for the Preparation of Premarket Notification 510(k)s for Dental Alloys March 3, 1997 Do. Do. Premarket Guidance; Reprocessing and Reuse of Single-Use Devices; Draft June 1, 2001 Do. Do. Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for Medical Gloves; Draft November 16, 1999 Do. Do. Draft Version Cardiac Ablation Preliminary Guidance (Data To Be Submitted to the FDA in Support Investigation Device Exemption Application) March 1, 1995 Do. Do. Draft Version Electrode Recording Catheter Preliminary Guidance (Data To Be Submitted to the FDA in Support of Premarket Notifications) March 1, 1995 Do. Do. Draft Replacement Heart Valve Guidance October 14, 1994 Do. Do. Draft Guidance on Human Heart Valve Allografts June 21, 1991 Do. Do. Draft Intravascular Brachytherapy—Guidance for Data To Be Submitted to FDA in Support of Investigational Device Exemption (IDE) Applications May 24, 1996 Do. Do. Draft Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents May 1, 1995 Do. Do. Draft Percutaneous Transluminal Coronary Angioplasty Package Insert Template February 7, 1995 Do. Do. Draft Guidance for Implantable CardioverterDefibrillators June 19, 1996 Do. Do. Draft Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses August 1, 1993 Do. Do. Electroencephalograph Devices Draft Guidance for 510(k) Content November 3, 1997 Do. Do. Draft 510(k) Guideline for General Surgical Electrosurgical Devices May 10, 1995 Do. Do. Galvanic Skin Response Measurement Devices; Draft Guidance for 510(k) Content August 23, 1994 Do. Do. Draft Version 1; Biofeedback Devices; Draft Guidance for 510(k) Content August 1, 1994 Do. Do. Draft Version Cranial Perforator Guidance July 13, 1994 Do. Do. Draft Version Neuro Endoscope Guidance July 7, 1994 Do. Do. Draft Premarket Notification Review Guidance for Evoked Response Somatosensory Stimulators June 1, 1994 Do. Do. Draft Guidance for Arthroscope and Accessory 510(k)s May 1, 1994 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00115 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 892 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Name of Document Date of Issuance Guidance Document for Industry and CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; Draft March 18, 1998 Do. Do. Draft Guidance for Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices: The Basic Elements July 16, 1997 Do. Do. Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submission for Orthopedic and Dental Endosseous Implants February 21, 1997 Do. Do. Draft Guidance Document for Femoral Stem Prostheses August 1, 1995 Do. Do. Draft Guidance Document for Testing Acetabular Cup Prostheses May 1, 1995 Do. Do. Draft Data Requirements for Ultrahigh Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic Devices March 23, 1995 Do. Do. Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semiconstrained Total Knee Prostheses April 1, 1993 Do. Do. Draft Guidance for the Preparation of IDE Submission for Interactive Wound and Burn Dressing April 4, 1995 Do. Do. Draft Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing March 31, 1995 Do. Do. Draft Version; Guidance on Biocompatibility Requirements for Long Term Neurological Implants: Part 3—Implant Model September 12, 1994 Do. Do. Protocol for Dermal Toxicity Testing for Devices in Contact with Skin; Draft January 1, 1985 Do. Do. Guide for TENS 510(k) Content; Draft August 1, 1994 Do. Do. Draft Version Guidance for Clinical Data To Be Submitted for Premarket Approval Application for Cranial Electrotherapy Stimulators August 20, 1992 Do. Do. Draft Guidance for Cortical Electrode 510(k) Content August 10, 1999 Do. Do. Accountability Analysis for Clinical Studies for Ophthalmic Devices; Draft August 4, 1999 Do. Do. Refractive Implants: Guidance for Investigational Device Exemptions (IDE) and Premarket Approval (PMA) Applications; Draft August 1, 2000 Do. Do. Intraocular Lens Guidance Document; Draft October 14, 1999 Do. Do. Draft Guidance for Hemodialyzer Reuse Labeling October 6, 1995 Do. Do. Draft Guidance for Industry: Electro-Optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors; Submission Guidance for an IDE/PMA August 25, 1999 Do. Do. Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures; Draft September 10, 1988 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00116 Fmt 4703 Intended User or Regulatory Activity Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 How to Obtain a Copy of the Document Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 893 GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Name of Document Date of Issuance Intrapartum Continuous Monitors for Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft Document June 14, 1997 Do. Do. Draft Guidance for the Content of Premarket Notifications for Menstrual Tampons May 25, 1995 Do. Do. Information for a Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch; Draft April 13, 1994 Do. Do. Premarket Testing Guidelines for Falloscopes November 20, 1992 Do. Do. Draft Guidance for the Content of Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical Excisions July 29, 1991 Do. Do. Draft Guidance for Review of Bone Densitometer 510(k) Submissions November 9, 1992 Do. Do. Draft Guidance for Preclinical and Clinical Investigations of Urethral Bulking Agents Used in the Treatment of Urinary Incontinence November 29, 1995 Do. Do. Draft Guidance for Clinical Investigation of Urethral Stents November 2, 1995 Do. Do. Draft 510(k) Checklist for Endoscopic Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and Urology August 16, 1995 Do. Do. Draft 510(k) Checklist for Urological Irrigation System and Tubing Set August 1, 1995 Do. Do. Draft 510(k) Checklist for Endoscopic Light Sources Used in Gastroenterology and Urology June 22, 1995 Do. Do. Draft 510(k) Checklist for Non-Implanted Electrical Stimulators Used for the Treatment of Urinary Incontinence June 6, 1995 Do. Do. Draft Guidance for Preparation of PMA Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter) May 1, 1995 Do. Do. Draft Guidance for the Content of Premarket Notifications for Endoscopes Used in Gastroenterology and Urology March 17, 1995 Do. Do. Draft 510(k) Checklist for Condom Catheters February 23, 1995 Do. Do. Draft Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) November 11, 1994 Do. Do. Draft Guidance Outline; PTC for Clinical Studies for Vasovasostomy Devices November 30, 1993 Do. Do. Draft Guidance for Preparation of PMA Applications for Penile Inflatable Implants March 16, 1993 Do. Do. Draft Guidance for Preparation of PMA Applications for Testicular Prostheses March 16, 1993 Do. Do. Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters January 24, 1992 Do. Do. Draft of Suggested Information for Reporting Extracorporeal Shock Wave Lithotripsy Device Shock Wave Measurements January 18, 1991 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00117 Fmt 4703 Intended User or Regulatory Activity Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 How to Obtain a Copy of the Document 894 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CDRH—Continued Name of Document Date of Issuance Draft Guidance to Firms on Biliary Lithotripsy Studies August 2, 1990 Do. Do. Statistical Aspects of Submissions to FDA: A Medical Device Perspective (also includes as appendix the article ‘‘Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions’’) June 1, 1984 Do. Do. Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads) June 9, 1993 Do. Do. Amendment to Guidance on Discretionary Postmarket Surveillance on Pacemaker Leads; Final March 30, 1994 Do. Do. Premarketing Approval Review Criteria for Premarket Approval of Estrogen (ER) or Progesterone (PGR) Receptors In Vitro Diagnostic Devices Using Steroid Hormone Binding (SBA) With Dextran-Coated Charcoal (DCC) Separation, Histochemical Receptor Bind; Draft September 10, 1992 Do. Do. Premarket Approval Applications for In Vitro diagnostic Devices Pertaining to Hepatitis C Viruses (HCV): Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection, Hepatitis C, Other HCV-Associated Disease; Draft Guidance for Industry and FDA April 27, 2001 Do. Do. Premarket Approval (PMA) Manual January 1998 Do. Do. SMDA Changes—PMA Manual Insert April 17, 1992 Do. Do. Investigational Device Exemptions (IDE) Manual (FDA 96–4159) June 1, 1996 Do. Do. 510(k) Manual—Premarket Notification: 510(k)— Regulatory Requirements for Medical Devices August 1, 1995 Do. Do. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Beds July 26, 1995 Do. Do. 1See How to Obtain a Copy of the Document Intended User or Regulatory Activity Internet address for Facts-on-Demand number. GUIDANCE DOCUMENTS ISSUED BY CFSAN Date of Issuance Intended User or Regulatory Activity Compliance Policy Guides Manual August 2000; updated in April 2001 General publications https://www.cfsan.fda.gov/ guidance.html Compliance Programs Guidance Manual March 1995 Do. Do. FDA Recall Policy 2002 Do. Do. Guidance for FDA Staff; The Leveraging Handbook; An Agency Resource for Effective Collaborations 2003 Do. Do. Guidance for Small Businesses; Submission of Comments for CFSAN Rulemaking 2002 Do. Do. Investigations Operations Manual May 1996 Do. Do. Regulatory Procedures Manual August 1997 Do. Do. Name of Document VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00118 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 How to Obtain a Copy of the Document Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 895 GUIDANCE DOCUMENTS ISSUED BY CFSAN—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Draft Guidance: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, For Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency July 2003 Chemical and pesticide contaminants publications Do. Channels of Trade Policy for Commodities With Vinclozolin Residues June 2002 Do. Do. FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments for Cry9C Protein Residues January 2001 Do. Do. Channels of Trade Policy for Commodities With Methyl Parathion Residues December 2000 Do. Do. Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed 2000 Do. Do. Pesticides Analytical Manual 1999 Do. Do. FDA Advisory for Deoxynivanol (DON) in Finished Wheat Products Intended for Human Consumption and in Grain and Grain By-Products for Animal Feed September 1993 Do. Do. FDA’s Cosmetic Labeling Manual October 1991 Cosmetic publications Do. Draft Guidance: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients December 2, 2002 Do. Do. Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements July 10, 2003 Dietary supplements publications Do. Interim Evidence-Based Ranking System for Scientific Data July 10, 2003 Do. Do. Structure/Function Claims: Small Entity Compliance Guide January 9, 2002 Do. Do. Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance Guide January 1999 Do. Do. Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements December 1999 Do. Do. Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body July 1998 Do. Do. Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide October 17, 2003 Do. Do. Providing Regulatory Submissions in Electronic Format; General Considerations July 2001 Food and color additives publications Do. Providing Food and Color Additive Petitions in Electronic Format July 2001 Do. Do. Electronic Submission Forms July 2001 Do. Do. FDA’s Policy for Foods Developed by Biotechnology 1995 Do. Do. Partial List of Enzyme Preparations That Are Used in Foods 2001 Do. Do. Partial List of Microorganisms and Microbial-Derived Ingredients That Are Used in Food 2001 Do. Do. Use of Antibiotic Resistance Marker Genes in Transgenic Plants September 1998 Do. Do. Enzyme Preparations: Chemistry Recommendations for Food Additive and GRAS Affirmation Petitions January 1993 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00119 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 896 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CFSAN—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Guidance for Submitting Requests Under 21 CFR 170.39; Threshold of Regulation for Substances Used in Food Contact Articles 1996 Do. Do. PTC for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations December 1992 Do. Do. How to Submit a GRAS Notice April 17, 1997 Do. Do. Recommendations for Submission of Chemical and Technological Data for Direct Food Additive and GRAS Food Ingredient Petitions May 1993 Do. Do. Statement of Policy; Foods Derived from New Plant Varieties; Notice May 1992 Do. Do. Guidelines for the Preparation of Petition Submissions 1996 Do. Do. Guidelines for Approval of Color Additives in Contact Lenses Intended as Colors 1996 Do. Do. FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drug, or Cosmetic Use January 1997 Do. Do. Estimating Exposure to Direct Food Additive and Chemical Contaminants in the Diet September 1995 Do. Do. Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food (also known as redbook I) 1982 Do. Do. Toxicological Principles for the Safety of Food Ingredients (redbook 2000) April 2004 Do. Do. Draft Guidance; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN September 17, 2003 Do. Do. Environmental Assessment Technical Handbook March 1987 Do. Do. Toxicological Testing of Food Additives 1983 Do. Do. Guidance on Consultation Procedures Foods Derived From New Plant Varieties October 1997 Do. Do. Bovine Spongiform Encephalopathy (BSE) in Products for Human Use 1997 Do. Do. Food Additive Petition Expedited Review; Guidance for Industry and CFSAN January 1999 Do. Do. Antimicrobial Food Additives Guidance July 1999 Do. Do. Preparation of Premarket Notifications for Food Contact Substances (Food Contact Notifications (FCN)): Administrative Recommendations May 2002 Do. Do. Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations April 2002 Do. Do. Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations April 2002 Do. Do. A Food Labeling Guide May 1997 Food labeling publications Do. Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims; Small Entity Compliance Guide August 20, 2003 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00120 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 897 GUIDANCE DOCUMENTS ISSUED BY CFSAN—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements December 18, 2002 Do. Do. Draft Guidance; Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering January 2001 Do. Do. Small Business Food Labeling Exemption June 1996 Do. Do. Food Labeling: Questions and Answers (volume I) August 1994 Do. Do. Food Labeling: Questions and Answers (volume II) February 1996 Do. Do. Fair Packaging and Labeling Act Manual June 1978 Do. Do. Implementation of Section 10809 of the Farm Security and Investment Act of 2002, Public Law No. 107–171, § 10809 (2002), Regarding the Petition Process to Request Approval of Labeling for Foods That Have Been Treated by Irradiation 2002 Do. Do. FDA Nutrition Labeling Manual—A Guide for Developing and Using Databases March 1998 Do. Do. Guidelines for Determining Metric Equivalents of Household Measures October 1, 1993 Do. Do. Food Labeling—Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution; Small Entity Compliance Guide July 2001 Do. Do. Exemptions From the Warning Label Requirement for Juice— Recommendations for Effectively Achieving a 5-Log Pathogen Reduction October 7, 2002 Do. Do. Food Labeling—Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance Guide July 2001 Do. Do. Bacteriological Analytical Manual (7th ed.) 1992 Food processing publicatons Do. Bacteriological Analytical Manual Online 2001 Do. Do. Questions and Answers Regarding Registration of Food Facilities (4th ed.) August 6, 2004 Food and cosmetic security publications Do. Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance December 17, 2003 Do. Do. Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance December 17, 2003 Do. Do. What You Need to Know About Registration of Food Facilities November 25, 2003 Do. Do. What You Need to Know About Prior Notice of Imported Food Shipments November 25, 2003 Do. Do. Necessity of the Use of Food Product Categories in Registration of Food Facilities July 17, 2003 Do. Do. Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations, and Fluid Milk Processors: Food Security Preventive Measures Guidance July 11, 2003 Do. Do. Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance March 21, 2003 Do. Do. Importers and Filers: Food Security Preventive Measures Guidance March 21, 2003 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00121 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 898 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CFSAN—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Compliance Policy Guide; Guidance for FDA Staff on Registration of Food Facilities 2003 Do. Do. Compliance Policy Guide; Guidance for FDA Staff on Prior Notice of Imported Foods 2003 Do. Do. Prior Notice of Imported Food Questions and Answers (2nd ed.) May 2004 Imports and exports publications Do. Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged With Prior Notice Indicators August 2004 Do. Do. Guidance for Industry and FDA; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile May 23, 2003 Do. Do. FDA Food Importer’s Guide for Low-Acid Canned and Acidified Foods 1985 Do. Do. Guidance for Industry; FDA Export Certificates 2002 Do. Do. Draft Guidance; Regulatory Procedures Manual, chapter 9, subchapter: Guidance Concerning Recommending Customs’ Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned November 5, 2002 Do. Do. Guidelines Concerning Notification and Testing of Infant Formula 1985 Infant formula publications Do. Guidelines for Evaluation of the Safety and Suitability of New Infant Formulas for Feeding Preterm Infants 1988 Do. Do. Clinical Testing of Infant Formulas With Respect to Nutritional Suitability for Term Infants 1988 Do. Do. Guidelines for Evaluation of the Safety and Suitability of Infant Formulas for Feeding Infants With Allergic Diseases 1990 Do. Do. Guidelines for the Clinical Evaluation of New Products Used in the Dietary Management of Infants, Children, and Pregnant Women With Metabolic Disorders 1987 Do. Do. The Juice HACCP Regulation: Questions and Answers September 4, 2003 Juice publications Do. Standardized Training Curriculum for Application of HACCP Principles to Juice Processing June 2003 Do. Do. Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices April 24, 2002 Do. Do. Juice HACCP Small Entity Compliance Guide April 4, 2003 Do. Do. Draft Guidance; Juice HACCP Hazards and Control Guidance (1st ed.) March 3, 2004 Do. Do. Apple Juice, Apple Juice Concentrates, and Apple Juice Products—Adulteration With Patulin October 2001 Do. Do. The Juice HACCP Regulation: Questions and Answers August 31, 2001 Do. Do. FDA Food Importer’s Guide for Low-Acid Canned and Acidified Foods 1985 Low-acid and acidified foods publications Do. Grade ‘‘A’’ Pasteurized Milk Ordinance (2001 revision) May 15, 2002 Milk sanitation publications Do. Importation of PMO Defined Dairy Products (M–I–00–4) April 11, 2000 Do. Do. Evaluation of Milk Laboratories 1995 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00122 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 899 GUIDANCE DOCUMENTS ISSUED BY CFSAN—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Methods of Making Sanitation Ratings of Milk Supplies 1999 Do. Do. Procedures Governing the Cooperative State-Public Health Service/FDA Program for Certification of Interstate Milk Shippers 1999 Do. Do. Frozen Dessert Processing Guidelines 1989 Do. Do. Dry Milk Ordinance 1995 Do. Do. Pasteurized Milk Ordinance 1999 Do. Do. Fumonisin Levels in Human Foods and Animal Feeds November 9, 2001 Natural toxins publications Do. List of Products for Each Product Category October 8, 1992 Nutrition and food science publications Do. Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers June 10, 1996 Do. Do. Guidance on Labeling of Foods That Need Refrigeration by Consumers February 24, 1997 Do. Do. Interim Guidance on the Voluntary Labeling of Milk and Milk Products That Have Not Been Treated With Recombinant Bovine Somatropin February 10, 1994 Do. Do. Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables October 26, 1998 Produce publications Do. Reducing Microbial Food Safety Hazards for Sprouted Seeds October 1999 Do. Do. Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production October 1999 Do. Do. Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance December 17, 2003 Retail food protection publications Do. Foods—Adulteration Involving Hard or Sharp Foreign Objects February 1999 Sanitation publications Do. Defect Action Levels (DALs) May 1998 Do. Do. Action Levels for Poisonous or Deleterious Substances in Human Food and Feed 2000 Do. Do. Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products July 2001 Seafood publications Do. Seafood HACCP Transition Policy December 1999 Do. Do. Seafood List 1993 Do. Do. Fish and Fisheries Products Hazards and Control Guide (3rd ed.) 2001 Do. Do. HACCP Regulation for Fish and Fishery Products: Questions and Answers 1998 Do. Do. Implementation of Section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)) Regarding the Use of the Term ‘‘Catfish’’ December 2002 Do. Do. Letter to Various Seafood Trade Associations Regarding the Labeling of Catfish February 28, 2003 Do. Do. WITHDRAWN GUIDANCES VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00123 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 900 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CFSAN—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds, Draft (replaced by Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds; Final (November 2001) June 2000 N/A N/A Guidance for Industry Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements (replaced by Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements and Interim Evidence-Based Ranking System for Scientific Data (July 2003)) December 2002 Do. Do. Guidance for Industry Preparation of Premarket Notifications for Food Contact Substances: Administrative; Draft (replaced by Guidance for Industry Preparation of Premarket Notifications for Food Contact Substances: Administrative; Final (May 2002)) June 2000 Do. Do. Guidance for Industry Preparation of Premarket Notifications for Food Contact Substances: Chemistry Recommendations, Draft (replaced by Guidance for Industry Preparation of Food Contact Notifications for Food Contact Substances: Chemistry Recommendations; Final (April 2002)) May 2000 Do. Do. Recommendations for Chemistry Data for Indirect Food Additive Petitions (replaced by Guidance for Industry Preparation of Food Contact Notifications for Food Contact Substances: Chemistry Recommendations; Final (April 2002)) June 1995 Do. Do. Guidance for Industry Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations (replaced by Guidance for Industry Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations; Final (April 2002)) September 1999 Do. Do. Iron-Containing Supplements and Drugs: Label Warning and Unit Dose Packaging Small Entity Compliance Guide (replaced by Guidance for Industry; Iron-Containing Supplements and Drugs: Label Warning Statements; Small Entity Compliance Guide (October 2003)) November 1997 Do. Do. Guidance for Industry Channels of Trade Policy for Commodities With Vinclozolin Residues; Draft (replaced by Guidance for Industry Channels of Trade Policy for Commodities With Vinclozolin Residues; Final (June 2002)) July 2001 Do. Do. Guidance for Industry Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products; Draft (replaced by Guidance for Industry Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products; Final (July 2001)) November 2000 Do. Do. Guidance Document for Arsenic 1993 Do. Do. Guidance Document for Cadmium 1993 Do. Do. Guidance Document for Chromium 1993 Do. Do. Guidance Document for Lead 1993 Do. Do. Guidance Document for Nickel 1993 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00124 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 901 GUIDANCE DOCUMENTS ISSUED BY CVM Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document #159 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (VICH GL36) November 12, 2003 FDA personnel and regulated industry Internet via https:// www.fda.gov/cvm/guidance/published.htm, or Communications Staff (HFV–12), FDA/CVM, 7519 Standish Pl., Rockville, MD, 301–827–3800, FAX: 301–827–4065 #158 Use of Material From Deer and Elk in Animal Feed; Final September 15, 2003 Regulated industry Do. #156 Comparability Protocols; Chemistry, Manufacturing, and Controls Information; Draft February 2003 Do. Do. #153 Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals; Draft September 2002 Do. Do. #152 Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern October 23, 2003 Do. Do. #151 FDA Export Certificates July 2004 Do. Do. #150 Status of Clove Oil and Eugenol for Anesthesia of Fish June 11, 2002 Do. Do. #149 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing (VICH GL33) May 18, 2004 Do. Do. #148 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing (VICH GL32); Final Guidance March 19, 2004 Do. Do. #147 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food; Repeat Dose (90-day) Toxicity Testing (VICH GL31) November 12, 2003 Do. Do. #145 Bioanalytical Method Validation May 2001 Do. Do. #144 Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-producing Animals with Respect to Antimicrobial Resistance (VICH GL27); Final Guidance April 27, 2004 Do. Do. #143 Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms (VICH GL30); Draft Guidance February 1, 2002 Do. Do. #142 Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) (VICH GL29); Draft Guidance December 12, 2001 Do. Do. #141 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing (VICH GL28); Final Guidance May 24, 2004 Do. Do. #132 The Administrative New Animal Drug Application Process; Draft November 6, 2002 Do. Do. #126 BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation February 2001 Do. Do. #124 Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft January 2001 Do. Do. #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores November 9, 2004 Do. Do. Name of Document VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00125 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 902 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CVM—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document #121 Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims March 6, 2001 Do. Do. # 120 Veterinary Feed Directive Regulation March 1, 2001 Do. Do. # 119 How CVM Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug; Final Guidance August 29, 2002 Do. Do. #118 Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues; Final Guidance May 1, 2003 Do. Do. #117 Pharmacovigilance of Veterinary Medical Products: Management of Adverse Event Reports (AERs) (VICH GL24); Draft Guidance December 12, 2000 Do. Do. #116 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (VICH GL23); Final Guidance January 3, 2002 Do. Do. #115 Safety Studies for Veterinary Drug Residues in Human Food; Reproduction Toxicity Testing (VICH GL22); Final Guidance January 3, 2002 Do. Do. #114 Effectiveness of Anthelmintics: Specific Recommendations for Poultry-Gallus Gallus (VICH GL21); Final Guidance June 19, 2002 Do. Do. #113 Effectiveness of Anthelmintics: Specific Recommendations for Feline (VICH GL20); Final Guidance June 19, 2002 Do. Do. #112 Fumonisin Levels in Human Foods and Animal Feeds; Final Guidance November 9, 2001 Do. Do. #111 Effectiveness of Anthelmintics: Specific Recommendations for Canine (VICH GL19); Final Guidance June 27, 2002 Do. Do. #110 Effectiveness of Anthelmintics: Specific Recommendations for Porcine (VICH GL16); Final Guidance June 27, 2002 Do. Do. #109 Effectiveness of Anthelmintics: Specific Recommendations for Equine (VICH GL15); Final Guidance June 27, 2002 Do. Do. #108 How to Submit Information in Electronic Format by E-mail May 21, 2004 Do. Do. #107 How to Submit a Protocol in Electronic Format by E-mail May 21, 2004 Do. Do. #106 The Use of Published Literature in Support of New Animal Drug Approval August 31, 2000 Do. Do. #105 Computerized Systems Used in Clinical Trials September 2004 Do. Do. #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports for Submission to the Division of Therapeutic Drugs for Nonfood Animals July 10, 2001 Do. Do. #103 Possible Dioxin/PCB Contamination of Drug and Biological Products August 1999 Do. Do. #102 Manufacture and Distribution of Unapproved Piperazine Products; Revised August 27, 1999 Do. Do. #100 Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (VICH GL18); Final Guidance May 15, 2001 Do. Do. #99 Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products (VICH GL17); Final Guidance March 26, 2001 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00126 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 903 GUIDANCE DOCUMENTS ISSUED BY CVM—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document #98 Dioxin in Anticaking Agents Used in Animal Feed and Feed Ingredients; Revised April 14, 2000 Do. Do. #97 Effectiveness of Anthelmintics: Specific Recommendations for Caprine (VICH GL14); Final Guidance March 26, 2001 Do. Do. #96 Effectiveness of Anthelmintics: Specific Recommendations for Ovine (VICH GL13); Final Guidance March 26, 2001 Do. Do. #95 Efficacy of Anthelmintics: Specific Recommendations for Bovines; (VICH GL12); Final Guidance March 26, 2001 Do. Do. #93 Impurities in New Veterinary Medical Products (VICH GL11) May 1, 2000 Do. Do. #92 Impurities in New Veterinary Drug Substances (VICH GL10) May 1, 2000 Do. Do. #91 Stability Testing for Medicated Premixes (VICH GL8); Final Guidance March 2000 Do. Do. #90 Effectiveness of Anthelmintics: General Recommendations (VICH GL7); Final Guidance (replaces March 26, 2001) October 11, 2001 Do. Do. #89 Environmental Impact Assessments (EIAs) for Veterinary Medicinal Products (VMPs)—Phase I (VICH GL6); Final Guidance March 7, 2001 Do. Do. #88 How to Submit a Request for a Meeting or Teleconference in Electronic Format by E-mail May 21, 2004 Do. Do. #87 How to Submit a Notice of Intent to Slaughter for Human Food Purposes in Electronic Format by E-mail May 21, 2004 Do. Do. #86 How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format by E-mail May 21, 2004 Do. Do. #85 Good Clinical Practice (VICH GL9); Final Guidance May 9, 2001 Do. Do. #84 Product Name Placement, Size and Prominence in Advertising and Promotional Labeling; Draft Guidance January 1999 Do. Do. #83 Chemistry, Manufacturing, and Controls Changes to an Approved NADA or ANADA; Draft Guidance June 1999 Do. Do. #82 Development of Supplemental Applications for Approved New Animal Drugs; Final Guidance October 28, 2002 Do. Do. #80 Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds November 21, 2002 Do. Do. #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM; Draft Guidance May 16, 2003 Do. Do. #78 Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals December 13, 1999 Do. Do. #76 Questions and Answers: BSE Feed Regulation July 1998 Do. Do. #75 Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products; Final Guidance September 1999 Do. Do. #74 Stability Testing of New Veterinary Dosage Forms (VICH GL4); Final Guidance September 1999 Do. Do. #73 Stability Testing of New Veterinary Drug Substances and Medicinal Products (VICH GL3); Final Guidance September 1999 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00127 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 904 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CVM—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document #72 GMPs for Medicated Feed Manufacturers Not Required to Register and Be Licensed With FDA May 1998 Do. Do. #70 Para Alimentadores de Animales Rumiantes Sin Operaciones de Mezclado de Alimentos en la Granja February 1998 Do. Do. #70 Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations February 1998 Do. Do. #69 Para Alimentadores de Animales Rumiantes Con Operaciones de Mezclado de Alimentos en la Granja February 1998 Do. Do. #69 Small Entities Compliance Guide for Feeders of Ruminant Animals With On-Farm Feed Mixing Operations February 1998 Do. Do. ´ #68 Para Mezcladores de ProteInas, Fabricantes de Alimentos para Animales y Distribuidores February 1999 Do. Do. #68 Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors February 1998 Do. Do. #67 Para Extractores de Grasa por Fusion February 1998 Do. Do. #67 Small Entities Compliance Guide for Renderers February 1998 Do. Do. #65 Industry-Supported Scientific and Educational Activities November 1997 Do. Do. #64 Validation of Analytical Procedures: Methodology; Final Guidance July 1999 Do. Do. #63 Validation of Analytical Procedures: Definition and Terminology July 1999 Do. Do. #62 Consumer-Directed Broadcast Advertisements; Final Guidance August 1999 Do. Do. #61 FDA Approval of New Animal Drugs for Minor Uses and for Minor Species April 1999 Do. Do. #59 How to Submit a Notice of Claimed Investigational Exemption in Electronic Format by E-mail May 21, 2004 Do. Do. #57 Guidance for Industry for the Preparation and Submission of Veterinary Master Files 1995 Do. Do. #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials July 10, 2001 Do. Do. #55 Supportive Data for Cat Food Labels Bearing ‘‘Reduces Urinary pH’’ Claims: Guideline in Protocol Development June 1994 Do. Do. #54 Draft Guideline for Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds (see final guidance #80) June 22, 1994 Do. Do. #53 Guideline for the Evaluation of the Utility of Food Additives in Diets Fed to Aquatic Animals May 1994 Do. Do. #52 Assessment of the Effects of Antimicrobial Drug Residues From Food of Animal Origin on the Human Intestinal Flora February 18, 2004 Do. Do. #50 Draft Guideline for Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products February 1, 1993 Do. Do. #49 Guidance Document for Target Animal Safety and Drug Effectiveness Studies for Antimicrobial Bovine Mastitis Products (Lactating and Nonlactating Cow Products) April 4, 1996 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00128 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 905 GUIDANCE DOCUMENTS ISSUED BY CVM—Continued Name of Document Date of Issuance Intended User or Regulatory Activity How to Obtain a Copy of the Document #48 Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products November 1994 Do. Do. #45 Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle August 1993 Do. Do. #43 Guidance on Generic Animal Drug Products Containing Fermentation-Derived Drug Substances October 1995 Do. Do. #42 Animal Drug Manufacturing Guidelines 1994 Do. Do. #41 Draft Guideline for Formatting, Assembling, and Submitting New Animal Drug Applications June 1992 Do. Do. #40 Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in Poultry April 1992 Do. Do. #38 Guideline for Effectiveness Evaluation of Topical/OTIC Animal Drugs August 21, 1984 Do. Do. #37 Guidelines for Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feeds for Pigmentation March 1984 Do. Do. #36 Guideline for Efficacy Evaluation of Canine/Feline Anthelmintics July 18, 1985 Do. Do. #35 Bioequivalence Guideline Revised October 9, 2002 Do. Do. #33 Target Animal Safety Guidelines for New Animal Drugs June 1989 Do. Do. #31 Guidelines for the Evaluation of Bovine Anthelmintics July 1981 Do. Do. #29 Guidelines for the Effectiveness Evaluation of Swine Anthelmintics September 30, 1980 Do. Do. #28 Animal Drug Applications Expedited Review Guideline (see Policy and Procedures Guide 1240.3135) December 3, 1997 Do. Do. #27 New Animal Drug Determination (see Policy and Procedures Guide 1240.3500) July 1989 Do. Do. #24 Guideline for Drug Combinations for Use in Animals October 1983 Do. Do. #23 Medicated Free-Choice Feeds-Manufacturing Controls July 1, 1985 Do. Do. Do. Do. #22 Labeling of Arecoline Base Drugs Intended for Animal Use #21 Nutritional Ingredients in Animal Drugs and Feeds (see Policy and Procedures Guide 1240.3420) March 1993 Do. Do. #16 Freedom of Information Summary Guidelines May 10, 1985 Do. Do. #13 Guidelines for Evaluation and Effectiveness of New Animal Drugs for Use in Free-Choice Feeds (revision of The Cattle Medicated Block Guideline) January 1985 Do. Do. #10 Amendment of Section II(G)(1)(b)(4) of the Preclearance Guidelines October 1975 Do. Do. #9 Preclearance Guidelines for Production Drugs Withdrawn pending revisions Do. Do. #6 Guideline for Submitting NADAs for Generic Drugs Reviewed by NAS/NRC October 20, 1971; revised March 19, 1976 Do. Do. #5 Drug Stability Guidelines December 1, 1990 Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00129 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 906 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY CVM—Continued Name of Document Intended User or Regulatory Activity Date of Issuance #3 General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals (revised) (see guidance #118 for update to Section V.B.1) How to Obtain a Copy of the Document July 1994 Do. Do. #58 Guidance for Industry; Good Target Animal Study Practices: Clinical Investigators and Monitors May 1997 N/A N/A #155 Guidance for Industry; 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records March 1997/February 2003 Do. Do. #154 Draft Guidance for Industry on Part 11; Electronic Records, Electronic Signatures—Scope and Application March 1997/February 2003 Do. Do. #77 Interpretation of On-Farm Feed Manufacturing and Mixing Operations September 1998/June 2003 Do. Do. #66 Professional Flexible Labeling of Antimicrobial Drugs August 1998/January 2002 December 2004 Do. Do. Do. Do. #19 Antibacterial Drugs in Animal Feeds: Animal Health Safety Criteria December 2004 Do. Do. #18 Antibacterial Drugs in Animal Feeds: Human Health Safety Criteria December 2004 Do. Do. #15 Guideline for Reporting the Details of Clinical Trials Using an Investigational New Animal Drug in Non-Food Producing Animals February 1977/December 2004 Do. Do. #14 Guideline for Reporting the Details of Clinical Trials Using an Investigational New Animal Drug in Food-Producing Animals December 2004 Do. Do. #4 Guideline for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle December 2004 Do. Do. #2 Anthelmintics December 2004 Do. Do. WITHDRAWN DOCUMENTS #20 Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness Criteria GUIDANCE DOCUMENTS ISSUED BY THE OFFICE OF THE COMMISSIONER AND THE OFFICE OF POLICY Intended User or Regulatory Activity Name of Document Date of Issuance FDA Information Sheets for Institutional Review Boards and Clinical Investigators September 1998 Regulated industry Internet via https://www.fda.gov/oc/ohrt/irbs/default.htm or Good Clinical Practice Programs (HF–34), Food and Drug Administration, 5600 Fishers Lane, rm. 9C–24, Rockville, MD 20857, 301–827–3340, https://www.fda.gov/oc/ gcp/guidance.html Guidance for Industry; Computerized Systems Used in Clinical Trials April 1999 Do. Internet via https://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.pdf or Good Clinical Practice Programs (HF–34), Food and Drug Administration, 5600 Fishers Lane, rm. 9C– 24, Rockville, MD 20857, 301–827–3340, https://www.fda.gov/oc/gcp/guidance.htm Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exceptions From Informed Consent Requirements for Emergency Research March 30, 2000 Do. Internet via https://www.fda.gov/ora/compliance_ref/bimo/err_guide.htm or Good Clinical Practice Programs (HF–34), Food and Drug Administration, 5600 Fishers Lane, rm. 9C– 24, Rockville, MD 20857, 301–827–3340 VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00130 Fmt 4703 Sfmt 4703 How to Obtain a Copy of the Document E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 907 GUIDANCE DOCUMENTS ISSUED BY THE OFFICE OF THE COMMISSIONER AND THE OFFICE OF POLICY—Continued Intended User or Regulatory Activity Date of Issuance Name of Document How to Obtain a Copy of the Document Draft Guidance for Industry on Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 February 1998 Do. Internet via https://www.fda.gov/opacom/ fedregister/frexport.html Guidance for FDA and Industry: Direct Final Rule Procedures November 21, 1997 FDA personnel Internet via https://www.fda.gov/opacom/ morechoices/industry/guidance.htm, or Office of Policy, 301–827–3360 International Harmonization; Policy on Standards October 11, 1995 Regulated industry and FDA personnel 60 FR 53078, October 11, 1995; or Office of International Programs, 301–827–4480 GUIDANCE DOCUMENTS ISSUED BY ORA Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Compliance Policy Guides Manual (replaces Compliance Policy Guide—January 1996) Updated December 12, 2003 FDA staff National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 https://www.fda.gov/ora/cpgm Compliance Policy Guide, Section 615.115: Extra-Label Use of Medicated Feeds for Minor Species April 2001 Do. Division of Compliance Policy (HFC–230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–0420 https://www.fda.gov/ora/ compliance_ref/revisions.htm Compliance Policy Guide, Section 608.400: Compounding of Drugs for Use in Animals July 2003 Do. Do. Do. Compliance Policy Guide, Section 555.600: Filth From Insects, Rodents, and Other Pests in Foods November 14, 2002 Do. Do. Do. Compliance Policy Guide, Section 460.200: Pharmacy Compounding May 29, 2002 Do. Do. Do. Compliance Policy Guide, Section 575.100: Pesticide Residues in Food and Feed— Enforcement Criteria (CPG 7141.01) (revised) May 16, 2002 Do. Do. Do. Compliance Policy Guide, Section 230.150: Blood Donor Classification Statement, Paid or Volunteer Donor May 7, 2002 Do. Do. Do. Compliance Policy Guide, Section 510.150: Apple Juice, Apple Juice Concentrates, and Apple Juice Products—Adulteration With Patulin October 2001 Do. Do. Do. Compliance Policy Guide, Section 555.250: Statement of Policy for Labeling and Preventing Cross-Contact of Common Food Allergens April 2001 Do. Do. Do. Compliance Policy Guide, Section 220.100: Interstate Shipment of Biological Products for Use in Medical Emergencies Reformatted March 2001 Do. Do. https://www.fda.gov/ora/ compliance_ref/cpg/ VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00131 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 908 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY ORA—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Compliance Policy Guide, Section 270.100: Final Container Labels—Allergenic Extracts Containing Glycerin; Reporting Changes Reformatted March 2001 Do. Do. Do. Compliance Policy Guide, Section 230.150: Blood Donor Incentives; Draft December 2000 Do. Do. Do. Compliance Policy Guide, Section 7150.09: Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities July 1991 FDA staff and regulated industry Do. https://www.fda.gov/ora/ compliance_ref/cpg/cpggenl/ cpg120100.html Glossary of Computerized System and Software Development Terminology August 1995 Do. National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96– 127352) https://www.fda.gov/ora/inspect_ref/ igs/gloss.html Guidelines for Entry Review of RadiationEmitting Electronic Devices March 12, 1999 FDA staff Division of Import Operations and Policy (HFC–170), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594–1218 N/A Laboratory Procedures Manual June 1994 Do. Division of Field Science (HFC–141), Food and Drug Administration, 5600 Fishers Lane, rm. 12–41, Rockville, MD 20857 https://www.fda.gov/ora/science_ref/ Laboratory Procedures Manual; ch. 10: Method Validation Samples May 1999 Do. Do. Do. Memorandum: ORA Investigational Strategy on Gamma-Butyrolactone (GBL) and Related Products May 15, 2000 Do. Division of Field Investigations, Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 N/A IOM: Investigations Operations Manual March 2004 Do. National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB2001– 913399) https://www.fda.gov/ora/inspect_ref/ Regulatory Procedures Manual March 2004 Do. Do (NTIS Order No. PB97–196182) https://www.fda.gov/ora/ compliance_ref/rpm/default.htm Regulatory Procedures Manual; ch. 5–7–10: Civil Money Penalty Reduction Policy for Small Entities March 2004 Do. Division of Compliance Policy (HFC–230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–0420 Do. Regulatory Procedures Manual; ch. 10–9: Application Integrity Policy March 2004 Do. Do. Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00132 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 909 GUIDANCE DOCUMENTS ISSUED BY ORA—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Regulatory Procedures Manual; ch. 9: Import Operations/Actions September 2002 Do. Do. Do. Regulatory Procedures Manual; ch. 6–1: Seizure March 2004 Do. Do. Do. Regulatory Procedures Manual; ch. 6–6: Civil Penalties—Electronic Product Radiation Control March 2004 Do. Do. Do. Regulatory Procedures Manual; ch. 4–1: Warning Letters March 2004 Do. Do. https://www.fda.gov/ora/ compliance_ref/rpm_new2/ ch4.html Guide to Inspections of Bulk Pharmaceutical Chemicals May 1994 Do. National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96– 127154) https://www.fda.gov/ora/inspect_ref/ igs/iglist.html Guide to Inspections of Pharmaceutical Quality Control Laboratories July 1993 Do. Do (NTIS Order No. PB96–127279) Do. Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories July 1993 Do. Do (NTIS Order No. PB96–127287) Do. Guide to Inspections of Validation of Cleaning Processes July 1993 Do. Do (NTIS Order No. PB96–127246) Do. Guide to Inspections of Lyophilization of Parenterals July 1993 Do. Do (NTIS Order No. PB96–127253) Do. Guide to Inspections of High Purity Water Systems July 1993 Do. Do (NTIS Order No. PB96–127261) Do. Guide to Inspections of Dosage Form Drug Manufacturers—CGMPs October 1993 Do. Do (NTIS Order No. PB96–127212) Do. Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation January 1994 Do. Do (NTIS Order No. PB96–127345) Do. Guide to Inspections of Topical Drug Products July 1994 Do. Do (NTIS Order No. PB96–127394) Do. Guide to Inspections of Sterile Drug Substance Manufacturers July 1994 Do. Do (NTIS Order No. PB96–127295) Do. Guide to Inspections of Oral Solutions and Suspensions August 1994 Do. Do (NTIS Order No. PB96–127147) Do. Guide to Nutritional Labeling and Education Act (NLEA) Requirements February 1995 Do. Do (NTIS Order No. PB96–127378) Do. Guide to Inspections of Interstate Carriers and Support Facilities April 1995 Do. Do (NTIS Order No. PB96–127386) Do. Guide to Inspections of Dairy Product Manufacturers April 1995 Do. Do (NTIS Order No. PB96–127329) Do. Guide to Inspections of Manufacturers of Miscellaneous Foods—vol. 1 May 1995 Do. Do (NTIS Order No. PB97–127220) Do. Guide to Inspections of Manufacturers of Miscellaneous Food Products—vol. 2 September 1996 Do. Do (NTIS Order No. PB97–196133) Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00133 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 910 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY ORA—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Guide to Inspections of Cosmetic Product Manufacturers February 1995 Do. Do (NTIS Order No. PB96–127238) Do. Guide to Inspections of Low Acid Canned Food Manufacturers, Part 1—Administrative Procedures/Scheduled Processes November 1996 Do. Do (NTIS Order No. PB97–196141) Do. Guide to Inspections of Low Acid Canned Food Manufacturers, Part 2—Manufacturing Processes/Procedures April 1997 Do. Do (NTIS Order No. PB97–196158) Do. Guide to Inspections of Low Acid Canned Food Manufacturers, Part 3—Container/ Closures November 1998 FDA staff Do (NTIS Order No. PB00–133795) N/A Guide to Inspections of Blood Banks September 1994 Do. Do (NTIS Order No. PB96–127303) https://www.fda.gov/ora/inspect_ref/ igs/iglist.html Guide to Inspections of Source Plasma Establishments Revised April 2001 Do. N/A Do. Guide to Inspections of Infectious Disease Marker Testing Facilities October 1996 Do. National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96– 199476) Do. Biotechnology Inspection Guide Reference Materials and Training Aids November 1991 Do. Do (NTIS Order No. PB96–127402) Do. Guide to Inspection of Computerized Systems in Drug Processing February 1983 Do. Do (NTIS Order No. PB96–127337) Do. Guide to Inspections of Foreign Medical Device Manufacturers September 1995 Do. Do (NTIS Order No. PB96–127311) Do. Guide to Inspections of Foreign Pharmaceutical Manufacturers May 1996 Do. Do (NTIS Order No. PB96–199468) Do. Guide to Inspections of Medical Device Manufacturers December 1997 Do. Do (NTIS Order No. PB 98–127145 ) Do. Mammography Quality Standards Act (MQSA) Auditor’s Guide January 1998 Do. Do (NTIS Order No. PB98–127178) Do. Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems December 1997 Do. Do (NTIS Order No. PB98–127152) Do. Guide to Inspections of Acidified Food Manufacturers May 1998 Do. N/A Do. Guide to Inspection of Aseptic Processing and Packaging for the Food Industry February 2001 Do. Division of Field Investigations, Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 N/A Guide to Inspections of Grain Product Manufacturers July 2003 Do. Do (NTIS Order No. PB98–137128) Do. Guide to Bioresearch Monitoring Inspections of In Vitro Diagnostic Devices February 1998 Do. Do (NTIS Order No. PB98–137151) Do. Guide to Inspections of Viral Clearance Processes for Plasma Derivatives March 1998 Do. Do (NTIS Order No. PB– 98137144) Do. VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00134 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 911 GUIDANCE DOCUMENTS ISSUED BY ORA—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Guide to Traceback of Fresh Fruits and Vegetables Implicated in Epidemiological Investigations April 2001 Do. N/A Do. Guide to Inspections of Computerized Systems in the Food Processing Industry August 1998 Do. National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB98– 137136) Do. Guide to International Inspections and Travel (revision) (formerly FDA/ORA International Inspection Manual and Travel Guide) November 2002 Do. N/A https://www.fda.gov/ora/inspect_ref/ giit/ default.htm Guide to Inspections of Quality Systems August 1999 Do. N/A https://www.fda.gov/ora/inspect_ref/ igs/qsit/QSITGUIDE.PDF Guide to Inspection of Firms Producing Food Products Susceptible to Contamination With Allergenic Ingredients August 2001 Do. N/A https://www.fda.gov/ora/inspect_ref/ igs/iglist.html Computerized Systems Used in Clinical Trials April 1999 Do. N/A https://www.fda.gov/ora/ compliance_ref/bimo/ Compliance Program 7348.001: Bioresearch Monitoring, Human Drugs, In Vivo Bioequivalence October 1, 1999 Do. Division of Compliance Policy (HFC–230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–0420 Do. Guide for Detecting Fraud in Bioresearch Monitoring Inspections April 2003 Do. Division of Freedom of Information (HFI–35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 N/A Good Laboratory Practice Program 7348.808A (Nonclinical Laboratories); EPA Data Audit Inspections October 1, 2000 Do. Division of Compliance Policy (HFC–230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–0420 https://www.fda.gov/ora/ compliance_ref/bimo/ Guideline for the Monitoring of Clinical Investigations January 1988 FDA regulated industry Do. Do. Small Business Guide to FDA Revised March 31, 2004 Do. Federal-State Relations (HFC–150), Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–2905 https://www.fda.gov/ora/fed_state/ small_business/sb_guide/default.htm Compliance Program 7348.808; Bioresearch Monitoring, Good Laboratory Practice (Nonclinical Laboratories) Revised February 21, 2001 FDA staff Division of Compliance Policy (HFC–230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–0420 https://www.fda.gov/ora/ compliance_ref/bimo/ VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00135 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 912 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices GUIDANCE DOCUMENTS ISSUED BY ORA—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Compliance Program 7348.809; Bioresearch Monitoring; Institutional Review Board October 1, 1994 Do. Do. Do. Compliance Program 7348.811; Bioresearch Monitoring, Clinical Investigators October 1, 1997 Do. Do. Do. Good Laboratory Practice Regulations; Management Briefings; Post Conference Report August 1979 Do. Do. Do. Good Laboratory Practices; Questions and Answers June 1981 Do. Do. Do. Guidance for FDA Staff on Sampling or Detention Without Physical Examination of Decorative Contact Lenses (Import Alert #86–10) April 4, 2003 FDA staff N/A https://www.fda.gov/ohrms/dockets/ 98fr/03-8315.pdf Compliance Policy Guide; Section 345.100: Male Condom Defects (CPG 7124.21); Draft March 29, 2002 FDA staff and industry Division of Compliance Policy (HFC–230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–0420 https://www.fda.gov/ora/ compliance_ref/cpg/ PTC for Internal Reviews and Corrective Action Operating Plans June 1991 Do. N/A https://www.fda.gov/ora/ compliance_ref/aip_points.html Compliance Policy Guide—Section 305.100: Acupuncture Devices and Accessories (CPG 7124.11) June 15, 1976 FDA staff and industry N/A Compliance Policy Guide—Section 396.100: Applicability of the Sunlamp Performance Standard to UVA Tanning Products (CPG 7133.16) October 1, 1980 Do. Do. Compliance Policy Guide—Section 391.100: Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps (CPG 7133.13) October 1, 1980 Do. Do. Compliance Policy Guide—Section 315.200: Status of Dental Supplies Such As Denture Cleaners, Adhesives, Cushions, and Repair Materials as a Device or Cosmetic (CPG 7124.05) April 26, 1976 Do. Do. Compliance Policy Guide—Section 398.475: Minimum X-Ray Field Size for Spot-Film Operation of Fluoroscopic Systems With Fixed SID and Without Stepless Adjustment of the Field Size (CPG 7133.17) October 1, 1980 Do. Do. Medical Device Warning Letter Pilot Termination March 8, 1999 Do. Do. Compliance Policy Guide—Section 160.850: Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (CPG 7153.17) May 13, 1999 Do. Do. Draft Guidance—21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records August 2002 Do. Do. WITHDRAWALS VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 PO 00000 Frm 00136 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1 Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices 913 GUIDANCE DOCUMENTS ISSUED BY ORA—Continued Date of Issuance Name of Document Intended User or Regulatory Activity How to Obtain a Copy of the Document Mailing Address Internet Address Draft Guidance—21 CFR Part 11; Electronic Records; Electronic Signatures Validation August 2001 Do. Do. Draft Guidance—21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms August 2001 Do. Do. Draft Guidance—21 CFR Part 11; Electronic Records; Electronic Signatures, Time Stamps February 2002 Do. Do. Draft Guidance—21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records July 2002 Do. Do. Compliance Policy Guide—Section 300.700: Direct Reference Authority for Class III Medical Devices Without a Premarket Notification (510(k)) or an Approved Premarket Approval Application (PMA) (CPG 7124.30) February 26, 1991 Do. Do. Compliance Policy Guide—Section 405.100: Prescriptions Prepared From Certified Antibiotics (CPG 7122.01) October 1, 1980 Do. Do. Compliance Policy Guide—Section 405.200: Export of Uncertified Antibiotics (CPG 7122.02) October 1, 1980 Do. Do. Compliance Policy Guide—Section 405.210: Returned Antibiotics Exported Under 801(d) of the Act (CPG 7122.03) July 1, 1981 Do. Do. Draft Compliance Policy Guide—Distributor Medical Device Reporting August 28, 1997 Do. Do. Dated: December 22, 2004. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–155 Filed 1–4–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N–0479] Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is extending to February 23, 2005, the comment period for the notice that appeared in the VerDate jul<14>2003 17:49 Jan 04, 2005 Jkt 205001 Federal Register of November 24, 2004 (69 FR 68384). In the notice, FDA requested comments on a draft risk assessment of the potential impact that food-animal use of streptogramin antimicrobials has on the resistance to chemically similar streptogramins used to treat human enterococcal infections. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: Submit written and electronic comments by February 23, 2005. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Barry Hooberman, Center for Veterinary Medicine (HFV–102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–8557, email: bhooberm@cvm.fda.gov. PO 00000 Frm 00137 Fmt 4703 Sfmt 4703 SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of November 24, 2004 (69 FR 68384), FDA published a notice with a 60-day comment period to request comments on a draft risk assessment of the potential impact that food-animal use of streptogramin antimicrobials has on the resistance to chemically similar streptogramins used to treat human enterococcal infections. The veterinary drug of interest in this risk assessment is the streptogramin, virginiamycin, a drug approved for use in chicken, turkey, swine, and cattle feed. FDA will consider information received during the comment period in its preparation of a final risk assessment. The agency has received a request for a 60-day extension of the comment period for the notice. This request conveyed concern that the current 60day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the notice. E:\FR\FM\05JAN1.SGM 05JAN1

Agencies

[Federal Register Volume 70, Number 3 (Wednesday, January 5, 2005)]
[Notices]
[Pages 824-913]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-155]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998N-0046]


Annual Comprehensive List of Guidance Documents at the Food and 
Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing its 
annual comprehensive list of all guidance documents currently in use at 
the agency. This list is being published under FDA's good guidance 
practices (GGPs) regulations. It is intended to inform the public of 
the existence and availability of all of our current guidance 
documents. It also provides information on guidance documents that have 
been added or withdrawn in the past year.

DATES: We welcome general comments on this list and on agency guidance 
documents at any time.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.fda.gov/dockets/ecomments. We have provided information in the 
tables in the SUPPLEMENTARY INFORMATION section of this document on 
where to obtain a single copy of any of the guidance documents listed.

FOR FURTHER INFORMATION CONTACT: Regarding GGPs: Lisa Helmanis, Office 
of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3480.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's GGPs were published in the Federal Register of September 19, 
2000 (65 FR 56468), and became effective October 19, 2000. GGPs are 
intended to ensure involvement of the public in the development of 
guidance documents, and to enhance understanding of the availability, 
nature, and legal effect of such guidance (Sec.  10.115 (21 CFR 
10.115)). In Sec.  10.115(n)(2), FDA stated that it intended to publish 
an annual comprehensive list of guidance documents. The list in this 
document updates a comprehensive list that published October 24, 2001 
(66 FR 53836).
    The following comprehensive list identifies all guidances that have 
been issued and are in use, and all draft guidances that have been 
distributed for comment and not for implementation. Any guidances that 
have been withdrawn since the last publication of this comprehensive 
list are also identified. These withdrawn guidances include some final 
and draft guidances that had been withdrawn prior to the date of 
publication of this list, and some that are being withdrawn as of this 
date. In accordance with the agency's general policy on guidances, you 
may comment on this list and on any FDA guidance document at any time. 
Please note that although we have stated that the ``Guidance for 
Industry on Qualified Health Claims in Labeling of Conventional Foods 
and Dietary Supplements'' (December 2002) has been ``replaced'' by 
subsequent guidance, the agency has not abandoned the position in the 
2002 guidance regarding reasonable consumer standard.
    We have organized the documents by the issuing center or office 
within FDA, and have identified the pertinent intended users or 
regulatory activities. The dates in the list refer to the date we 
issued the guidances or, where applicable, the last date we revised a 
document. Because each issuing center or office maintains its own 
database, there are slight variations in the way in which they provide 
information in the tables in this document.
    The following most frequently used Internet sites for agency 
guidances are provided for future reference:
     Center for Biologics Evaluation and Research (CBER): 
https://www.fda.gov/cber/guidelines.htm
     Center for Drug Evaluation and Research (CDER): https://
www.fda.gov/cder/guidance/index.htm
     Center for Devices and Radiological Health (CDRH): https://
www.fda.gov/cdrh/guidance.html
     Center for Food Safety and Applied Nutrition (CFSAN): 
https://www.cfsan.fda.gov/dms/guidance.html
     Center for Veterinary Medicine (CVM): https://www.fda.gov/
cvm/guidance/published.htm
     Office of Regulatory Affairs (ORA) and Office of the 
Commissioner: http:/

[[Page 825]]

/www.fda.gov/opacom/morechoices/industry/guidance.htm

                    Guidance Documents Issued by CBER
------------------------------------------------------------------------
                                                   How to Obtain a Copy
                                       Intended       of the Document
     Name of Document        Date of    User or  -----------------------
                            Issuance  Regulatory    Mailing    Internet
                                        Activity    Address     Address
------------------------------------------------------------------------
Guidelines for              June      FDA         Office of   https://
 Immunization of Source      1980      regulated   Communica   www.fda.g
 Plasma (Human) Donors                 industry    tion,       ov/cber/
 With Blood Substances                             Training,   guideline
                                                   and         s.htm
                                                   Manufactu
                                                   rers
                                                   Assistanc
                                                   e (HFM-
                                                   40),
                                                   Center
                                                   for
                                                   Biologics
                                                   Evaluatio
                                                   n and
                                                   Research,
                                                   Food and
                                                   Drug
                                                   Administr
                                                   ation,
                                                   1401
                                                   Rockville
                                                   Pike,
                                                   Rockville
                                                   , MD
                                                   20852-144
                                                   8, 1-800-
                                                   835-4709
                                                   or 301-
                                                   827-1800
------------------------------------------------------------------------
Collection of Human         January   Ditto (Do)  Do.         https://
 Leukocytes for Further      28,                               www.fda.g
 Manufacturing (Source       1981                              ov/cber/
 Leukocytes)                                                   memo.htm
------------------------------------------------------------------------
Interferon Test             July 28,  Do.         Do.         https://
 Procedures: Draft Points    1983                              www.fda.g
 to Consider (PTC) in the                                      ov/cber/
 Production and Testing of                                     guideline
 Interferon Intended for                                       s.htm
 Investigational Use in
 Humans
------------------------------------------------------------------------
Deferral of Blood Donors    February  Do.         Do.         https://
 Who Have Received the       28,                               www.fda.g
 Drug Accutane               1984                              ov/cber/
 (isotretinoin/Roche; 13-                                      memo.htm
 cis-retinoic acid)
------------------------------------------------------------------------
Equivalent Methods for      December  Do.         Do.         Do.
 Compatibility Testing       14,
                             1984
------------------------------------------------------------------------
Plasma Derived From         December  Do.         Do.         Do.
 Therapeutic Plasma          14,
 Exchange                    1984
------------------------------------------------------------------------
Draft PTC in the            April     Do.         Do.         https://
 Production and Testing of   10,                               www.fda.g
 New Drugs and Biologicals   1985                              ov/cber/
 Produced by Recombinant                                       guideline
 DNA Technology                                                s.htm
------------------------------------------------------------------------
Reduction of the Maximum    June 2,   Do.         Do.         https://
 Platelet Storage Period     1986                              www.fda.g
 to 5 Days in an Approved                                      ov/cber/
 Container                                                     memo.htm
------------------------------------------------------------------------
To In Vitro Diagnostic      December  Do.         Do.         Do.
 Reagent Manufacturers:      6, 1986
 Guidance on the Labeling
 of Human Blood Derived In
 Vitro Diagnostic Devices
 in Regard to Labeling for
 HTLV-III/LAV Antibody
 Testing
------------------------------------------------------------------------
Guideline on General        May 1987  Do.         Do.         https://
 Principles of Process                                         www.fda.g
 Validation                                                    ov/cber/
                                                               guideline
                                                               s/htm
------------------------------------------------------------------------
Deferral of Donors Who      November  Do.         Do.         https://
 Have Received Human         25,                               www.fda.g
 Pituitary-Derived Growth    1987                              ov/cber/
 Hormone                                                       memo.htm
------------------------------------------------------------------------
Guideline on Validation of  December  Do.         Do.         https://
 the Limulus Amebocyte       1987                              www.fda.g
 Lysate Test as an End-                                        ov/cber/
 Product Endotoxin Test                                        guideline
 for Human and Animal                                          s.htm
 Parenteral Drugs,
 Biological Products, and
 Medical Devices
------------------------------------------------------------------------
Recommendations for the     December  Do.         Do.         https://
 Management of Donors and    2, 1987                           www.fda.g
 Units That Are Initially                                      ov/cber/
 Reactive for Hepatitis B                                      memo.htm
 Surface Antigen (HbsAg)
------------------------------------------------------------------------
Extension of Dating Period  December  Do.         Do.         Do.
 for Storage of Red Blood    4, 1987
 Cells, Frozen
------------------------------------------------------------------------
To Licensed In Vitro        December  Do.         Do.         Do.
 Diagnostic Manufacturers:   23,
 Handling of Human Blood     1987
 Source Materials
------------------------------------------------------------------------
Recommendations for         April 6,  Do.         Do.         Do.
 Implementation of           1988
 Computerization in Blood
 Establishments
------------------------------------------------------------------------
Control of Unsuitable       April 6,  Do.         Do.         Do.
 Blood and Blood             1988
 Components
------------------------------------------------------------------------

[[Page 826]]

 
Discontinuance of           July 7,   Do.         Do.         Do.
 Prelicensing Inspection     1988
 for Immunization Using
 Licensed Tetanus Toxoid
 and Hepatitis B and
 Rabies Vaccines
------------------------------------------------------------------------
Physician Substitutes       August    Do.         Do.         Do.
                             15,
                             1988
------------------------------------------------------------------------
To Licensed Manufacturers   August    Do.         Do.         Do.
 of Blood Grouping           26,
 Reagents: Criteria for      1988
 Exemption of Lot Release
------------------------------------------------------------------------
Revised Guideline for the   October   Do.         Do.         Do.
 Collection of Platelets,    7, 1988
 Pheresis
------------------------------------------------------------------------
To Manufacturers of HTLV-I  October   Do.         Do.         Do.
 Antibody Test Kits:         18,
 Antibody to Human T-Cell    1988
 Lymphotropic Virus, Type
 I (HTLV-I) Release Panel
 I
------------------------------------------------------------------------
HTLV-1 Antibody Testing     November  Do.         Do.         Do.
                             29,
                             1988
------------------------------------------------------------------------
Use of Recombigen HIV-1 LA  February  Do.         Do.         Do.
 Test                        1, 1989
------------------------------------------------------------------------
Guidance for Autologous     March     Do.         Do.         Do.
 Blood and Blood             15,
 Components                  1989
------------------------------------------------------------------------
Use of Recombigen HIV-1     August    Do.         Do.         Do.
 Latex Agglutination (LA)    1, 1989
 Test
------------------------------------------------------------------------
Draft PTC in the            August    Do.         Do.         https://
 Manufacture and Clinical    8, 1989                           www.fda.g
 Evaluation of In Vitro                                        ov/cber/
 Tests to Detect                                               guideline
 Antibodies to the Human                                       s.htm
 Immunodeficiency Virus,
 Type 1
------------------------------------------------------------------------
PTC in the Collection,      August    Do.         Do.         Do.
 Processing, and Testing     22,
 of Ex Vivo Activated        1989
 Mononuclear Leukocytes
 for Administration to
 Humans
------------------------------------------------------------------------
Requirements for            Septembe  Do.         Do.         https://
 Computerization of Blood    r 8,                              www.fda.g
 Establishments              1989                              ov/cber/
                                                               memo.htm
------------------------------------------------------------------------
Abbott Laboratories' HIVAG- October   Do.         Do.         Do.
 1 Test for HIV-1            4, 1989
 Antigen(s) Not
 Recommended for Use as a
 Donor Screen
------------------------------------------------------------------------
Guideline for Collection    October   Do.         Do.         Do.
 of Blood or Blood           26,
 Products From Donors With   1989
 Positive Tests for
 Infectious Disease
 Markers (``High Risk''
 Donors)
------------------------------------------------------------------------
Guideline for the           January   Do.         Do.         https://
 Determination of Residual   1990                              www.fda.g
 Moisture in Dried                                             ov/cber/
 Biological Products                                           guideline
                                                               s.htm
------------------------------------------------------------------------
Autologous Blood            February  Do.         Do.         https://
 Collection and Processing   12,                               www.fda.g
 Procedures                  1990                              ov/cber/
                                                               memo.htm
------------------------------------------------------------------------
Use of Genetic Systems HIV- June 21,  Do.         Do.         Do.
 2 EIA                       1990
------------------------------------------------------------------------
FDA Request for             March     Do.         Do.         Do.
 Information on Blood        15,
 Storage Patterns and Red    1991
 Cell Contamination by
 Yersinia Enterocolitica
------------------------------------------------------------------------
Revision to October 26,     April     Do.         Do.         Do.
 1989, Guideline for         17,
 Collection of Blood or      1991
 Blood Products From
 Donors With Positive
 Tests for Infectious
 Disease Markers (``High
 Risk'' Donors)
------------------------------------------------------------------------
Deficiencies Relating to    March     Do.         Do.         Do.
 the Manufacture of Blood    20,
 and Blood Components        1991
------------------------------------------------------------------------
Responsibilities of Blood   March     Do.         Do.         Do.
 Establishments Related to   20,
 Errors and Accidents in     1991
 the Manufacture of Blood
 and Blood Components
------------------------------------------------------------------------
FDA Recommendations         Septembe  Do.         Do.         Do.
 Concerning Testing for      r 10,
 Antibody to Hepatitis B     1991
 Core Antigen (Anti-HBc)
------------------------------------------------------------------------

[[Page 827]]

 
Disposition of Blood        Septembe  Do.         Do.         Do.
 Products Intended for       r 11,
 Autologous Use That Test    1991
 Repeatedly Reactive for
 Anti-HCV
------------------------------------------------------------------------
Clarification of FDA        December  Do.         Do.         Do.
 Recommendations for Donor   12,
 Deferral and Product        1991
 Distribution Based on the
 Results of Syphilis
 Testing
------------------------------------------------------------------------
Supplement to the PTC in    April 6,  Do.         Do.         https://
 the Production and          1992                              www.fda.g
 Testing of New Drugs and                                      ov/cber/
 Biologics Produced by                                         guideline
 Recombinant DNA                                               s.htm
 Technology: Nucleic Acid
 Characterization and
 Genetic Stability
------------------------------------------------------------------------
Revised Recommendations     April     Do.         Do.         https://
 for the Prevention of       23,                               www.fda.g
 Human Immunodeficiency      1992                              ov/cber/
 Virus (HIV) Transmission                                      memo.htm
 by Blood and Blood
 Products
------------------------------------------------------------------------
Use of Fluorognost HIV-1    April     Do.         Do.         Do.
 Immunofluorescent Assay     23,
 (IFA)                       1992
------------------------------------------------------------------------
Revised Recommendations     April     Do.         Do.         Do.
 for Testing Whole Blood,    23,
 Blood Components, Source    1992
 Plasma, and Source
 Leukocytes for Antibody
 to Hepatitis C Virus
 Encoded Antigen (Anti-
 HCV)
------------------------------------------------------------------------
Exemptions to Permit        April     Do.         Do.         Do.
 Persons With a History of   23,
 Viral Hepatitis Before      1992
 the Age of Eleven Years
 to Serve as Donors of
 Whole Blood and Plasma:
 Alternative Procedures,
 21 CFR 640.120
------------------------------------------------------------------------
Changes in Equipment for    July 21,  Do.         Do.         Do.
 Processing Blood Donor      1992
 Samples
------------------------------------------------------------------------
Nomenclature for            Septembe  Do.         Do.         Do.
 Monoclonal Blood Grouping   r 28,
 Reagents                    1992
------------------------------------------------------------------------
Volume Limits for           November  Do.         Do.         Do.
 Automated Collection of     4, 1992
 Source Plasma
------------------------------------------------------------------------
FDA's Policy Statement      November  Do.         Do.         https://
 Concerning Cooperative      25,                               www.fda.g
 Manufacturing               1992                              ov/cber/
 Arrangements for Licensed                                     guideline
 Biologics                                                     s.htm
------------------------------------------------------------------------
Revision of October 7,      December  Do.         Do.         https://
 1988, Memo Concerning Red   16,                               www.fda.g
 Blood Cell Immunization     1992                              ov/cber/
 Programs                                                      memo.htm
------------------------------------------------------------------------
Draft PTC in the            July 12,  Do.         Do.         https://
 Characterization of Cell    1993                              www.fda.g
 Lines Used to Produce                                         ov/cber/
 Biologicals                                                   guideline
                                                               s.htm
------------------------------------------------------------------------
Guidance on Alternatives    July 20,  Do.         Do.         Do.
 to Lot Release for          1993
 Licensed Biological
 Products
------------------------------------------------------------------------
Recommendations Regarding   July 22,  Do.         Do.         https://
 License Amendments and      1993                              www.fda.g
 Procedures for Gamma                                          ov/cber/
 Irradiation of Blood                                          memo.htm
 Products
------------------------------------------------------------------------
Deferral of Blood and       July 28,  Do.         Do.         Do.
 Plasma Donors Based on      1993
 Medications
------------------------------------------------------------------------
Revised Recommendations     August    Do.         Do.         Do.
 for Testing Whole Blood,    5, 1993
 Blood Components, Source
 Plasma, and Source
 Leukocytes for Antibody
 to Hepatitis C Virus
 Encoded Antigen (Anti-
 HCV)
------------------------------------------------------------------------
Clarification of the Use    August    Do.         Do.         Do.
 of Unlicensed Anti-HCV      19,
 Supplemental Test Results   1993
 in Regard to Donor
 Notification
------------------------------------------------------------------------
Draft Guideline for the     Septembe  Do.         Do.         https://
 Validation of Blood         r 28,                             www.fda.g
 Establishment Computer      1993                              ov/cber/
 Systems                                                       guideline
                                                               s.htm
------------------------------------------------------------------------
Guidance Regarding Post     December  Do.         Do.         https://
 Donation Information        10,                               www.fda.g
 Reports                     1993                              ov/cber/
                                                               memo.htm
------------------------------------------------------------------------

[[Page 828]]

 
Donor Suitability Related   December  Do.         Do.         Do.
 to Laboratory Testing for   22,
 Viral Hepatitis and a       1993
 History of Viral
 Hepatitis
------------------------------------------------------------------------
Recommendations for the     January   Do.         Do.         Do.
 Invalidation of Test        3, 1994
 Results When Using
 Licensed Viral Marker
 Assays to Screen Donors
------------------------------------------------------------------------
Recommendations for         July 26,  Do.         Do.         Do.
 Deferral of Donors for      1994
 Malaria Risk
------------------------------------------------------------------------
Office of Establishment     August    Do.         Do.         https://
 Licensing and Product       1994                              www.fda.g
 Surveillance (OELPS),                                         ov/cber/
 Advertising and                                               guideline
 Promotional Labeling                                          s.htm
 Staff, Procedural
 Guidance Document (Draft)
------------------------------------------------------------------------
Guidance for Industry for   November  Do.         Do.         Do.
 the Submission of           1994
 Chemistry, Manufacturing,
 and Controls Information
 for Synthetic Peptide
 Substances
------------------------------------------------------------------------
Recommendations to Users    December  Do.         Do.         https://
 of Medical Devices That     20,                               www.fda.g
 Test for Infectious         1994                              ov/cber/
 Disease Markers by Enzyme                                     memo.htm
 Immunoassay (EIA) Test
 Systems
------------------------------------------------------------------------
Timeframe for Licensing     February  Do.         Do.         Do.
 Irradiated Blood Products   3, 1995
------------------------------------------------------------------------
Revision of August 27,      March     Do.         Do.         Do.
 1982, FDA Memo:             10,
 Requirements for            1995
 Infrequent Plasmapheresis
 Donors
------------------------------------------------------------------------
To All Licensed             March     Do.         Do.         Do.
 Establishments Performing   14,
 Red Blood Cell              1995
 Immunizations: Revised
 Recommendations for Red
 Blood Cell Immunization
 Programs for Source
 Plasma Donors
------------------------------------------------------------------------
Recommendations for the     June 8,   Do.         Do.         Do.
 Deferral of Current and     1995
 Recent Inmates of
 Correctional Institutions
 as Donors of Whole Blood,
 Blood Components, Source
 Leukocytes, and Source
 Plasma
------------------------------------------------------------------------
Guideline for Quality       July 11,  Do.         Do.         https://
 Assurance in Blood          1995                              www.fda.g
 Establishments                                                ov/cber/
                                                               guideline
                                                               s.htm
------------------------------------------------------------------------
FDA Guidance Document       July 11,  Do.         Do.         Do.
 Concerning Use of Pilot     1995
 Manufacturing Facilities
 for the Development and
 Manufacture of Biological
 Products
------------------------------------------------------------------------
Recommendations for         August    Do.         Do.         https://
 Labeling and Use of Units   8, 1995                           www.fda.g
 of Whole Blood, Blood                                         ov/cber/
 Components, Source                                            memo.htm
 Plasma, Recovered Plasma,
 or Source Leukocytes
 Obtained From Donors With
 Elevated Levels of
 Alanine Aminotransferase
 (ALT)
------------------------------------------------------------------------
Recommendations for Donor   August    Do.         Do.         Do.
 Screening With a Licensed   8, 1995
 Test for HIV-1 Antigen
------------------------------------------------------------------------
PTC in the Manufacture and  1995      Do.         Do.         https://
 Testing of Therapeutic                                        www.fda.g
 Products for Human Use                                        ov/cber/
 Derived From Transgenic                                       guideline
 Animals                                                       s.htm
------------------------------------------------------------------------
Draft Reviewers' Guide:     October   FDA         Do.         Do.
 Informed Consent for        1, 1995   personnel
 Plasmapheresis/
 Immunization
------------------------------------------------------------------------
Draft Reviewers' Guide:     October   Do.         Do.         Do.
 Disease Associated          1, 1995
 Antibody Collection
 Program
------------------------------------------------------------------------
Draft Document Concerning   December  Do.         Do.         https://
 the Regulation of           1995                              www.fda.g
 Placental/Umbilical Cord                                      ov/cber/
 Blood Stem Cell Products                                      memo.htm
 Intended for
 Transplantation or
 Further Manufacturing
 Into Injectable Products
------------------------------------------------------------------------

[[Page 829]]

 
Donor Deferral Due to Red   December  FDA         Do.         Do.
 Blood Cell Loss During      4, 1995   regulated
 Collection of Source                  industry
 Plasma by Automated
 Plasmapheresis
------------------------------------------------------------------------
Draft Document Concerning   February  Do.         Do.         Do.
 the Regulation of           1996
 Peripheral Blood
 Hematopoietic Stem Cell
 Products Intended for
 Transplantation or
 Further Manufacturing
 Into Injectable Products
------------------------------------------------------------------------
International Conference    February  Do.         Do.         https://
 on Harmonisation (ICH)      23,                               www.fda.g
 Final Guideline on          1996                              ov/cber/
 Quality of                                                    guideline
 Biotechnological                                              s.htm
 Products: Analysis of the
 Expression Construct in
 Cells Used for Production
 of r-DNA Derived Protein
 Products
------------------------------------------------------------------------
ICH Final Guideline on the  March 1,  Do.         Do.         Do.
 Need for Long-Term Rodent   1996
 Carcinogenicity Studies
 of Pharmaceuticals
------------------------------------------------------------------------
Additional Recommendations  March     Do.         Do.         https://
 for Donor Screening With    14,                               www.fda.g
 a Licensed Test for HIV-1   1996                              ov/cber/
 Antigen                                                       memo.htm
------------------------------------------------------------------------
FDA Guidance Concerning     April     Do.         Do.         https://
 Demonstration of            1996                              www.fda.g
 Comparability of Human                                        ov/cber/
 Biological Products,                                          guideline
 Including Therapeutic                                         s.htm
 Biotechnology-Derived
 Products
------------------------------------------------------------------------
Additional Recommendations  May 16,   Do.         Do.         https://
 for Testing Whole Blood,    1996                              www.fda.g
 Blood Components, Source                                      ov/cber/
 Plasma, and Source                                            memo.htm
 Leukocytes for Antibody
 to Hepatitis C Virus
 Encoded Antigen (Anti-
 HCV)
------------------------------------------------------------------------
Guidance for Industry--The  May 1996  Do.         Do.         https://
 Content and Format for                                        www.fda.g
 Pediatric Use Supplements                                     ov/cber/
                                                               guideline
                                                               s.htm
------------------------------------------------------------------------
Guidance on Applications    May 1996  Do.         Do.         Do.
 for Products Comprised of
 Living Autologous Cells
 Manipulated Ex Vivo and
 Intended for Structural
 Repair or Reconstruction
------------------------------------------------------------------------
Recommendations and         May 29,   Do.         Do.         https://
 Licensure Requirements      1996                              www.fda.g
 for Leukocyte-Reduced                                         ov/cber/
 Blood Products                                                memo.htm
------------------------------------------------------------------------
ICH Final Guidelines on     July 10,  Do.         Do.         https://
 Stablity Testing of         1996                              www.fda.g
 Biotechnological/                                             ov/cber/
 Biological Products                                           guideline
                                                               s.htm
------------------------------------------------------------------------
Recommendations for the     July 19,  Do.         Do.         https://
 Quarantine and              1996                              www.fda.g
 Disposition of Units From                                     ov/cber/
 Prior Collections From                                        memo.htm
 Donors With Repeatedly
 Reactive Screening Tests
 for Hepatitis B Virus
 (HBV), Hepatitis C Virus
 (HCV), and Human T-
 Lymphotropic Virus Type I
 (HTLV-I)
------------------------------------------------------------------------
Guidance for Industry for   August    Do.         Do.         https://
 the Submission of           1996                              www.fda.g
 Chemistry, Manufacturing,                                     ov/cber/
 and Controls Information                                      guideline
 for a Therapeutic                                             s.htm
 Recombinant DNA-Derived
 Product or a Monoclonal
 Antibody Product for In
 Vivo Use
------------------------------------------------------------------------
Interim Recommendations     December  Do.         Do.         https://
 for Deferral of Donors at   11,                               www.fda.g
 Increased Risk for HIV-1    1996                              ov/cber/
 Group O Infection                                             memo.htm
------------------------------------------------------------------------
PTC on Plasmid DNA          December  Do.         Do.         https://
 Vaccines for Preventive     1996                              www.fda.g
 Infectious Disease                                            ov/cber/
 Indications                                                   guideline
                                                               s.htm
------------------------------------------------------------------------
Guidance for the            January   Do.         Do.         Do.
 Submission of Chemistry,    1997
 Manufacturing, and
 Controls Information and
 Establishment Description
 for Autologous Somatic
 Cell Therapy Products
------------------------------------------------------------------------
Reviewer Guidance for a     January   FDA         Do.         Do.
 Premarket Notification      13,       personnel
 Submission for Blood        1997
 Establishment Computer
 Software
------------------------------------------------------------------------

[[Page 830]]

 
PTC in the Manufacture and  February  FDA         Do.         Do.
 Testing of Monoclonal       28,       regulated
 Antibody Products for       1997      industry
 Human Use
------------------------------------------------------------------------
Proposed Approach to        February  Do.         Do.         Do.
 Regulation of Cellular      28,
 and Tissue-Based Products   1997
------------------------------------------------------------------------
Guidance for Industry for   April     Do.         Do.         Do.
 the Evaluation of           1997
 Combination Vaccines for
 Preventable Diseases:
 Production, Testing, and
 Clinical Studies
------------------------------------------------------------------------
ICH Guidelines for the      May 16,   Do.         Do.         Do.
 Photostability Testing of   1997
 New Drug Substances and
 Products
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Changes to an Approved      1997
 Application: Biological
 Products
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Changes to an Approved      1997
 Application for Specified
 Biotechnology and
 Specified Synthetic
 Biological Products
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Screening and Testing of    1997
 Donors of Human Tissue
 Intended for
 Transplantation
------------------------------------------------------------------------
Guidance for Industry:      August    Do.         Do.         Do.
 Donor Screening for         1997
 Antibodies to HTLV-II
------------------------------------------------------------------------
Guidance for Industry:      August    Do.         Do.         Do.
 Postmarketing Adverse       1997
 Experience Reporting for
 Human Drug and Licensed
 Biological Products:
 Clarification of What to
 Report
------------------------------------------------------------------------
Guidance for Industry: The  Septembe  Do.         Do.         Do.
 Sourcing and Processing     r 1997
 of Gelatin to Reduce the
 Potential Risk Posed by
 Bovine Spongiform
 Encephalopathy (BSE) in
 FDA-Regulated Products
 for Human Use
------------------------------------------------------------------------
Guidance for FDA and        November  FDA         Do.         Do.
 Industry: Direct Final      21,       personnel
 Rule Procedures             1997      and
                                       regulated
                                       industry
------------------------------------------------------------------------
Draft Guidance for          December  FDA         Do.         Do.
 Industry: Promoting         1997      regulated
 Medical Products in a                 industry
 Changing Healthcare
 Environment; I. Medical
 Product Promotion by
 Healthcare Organizations
 or Pharmacy Benefits
 Management Companies
 (PBMs)
------------------------------------------------------------------------
Guidance for Industry:      November  Do.         Do.         Do.
 Industry-Supported          1997
 Scientific and
 Educational Activities
------------------------------------------------------------------------
Guidance for Industry:      January   Do.         Do.         Do.
 Year 2000 Date Change for   1998
 Computer Systems and
 Software Applications
 Used in the Manufacture
 of Blood Products
------------------------------------------------------------------------
Draft Guidance for          January   Do.         Do.         Do.
 Industry: Container and     28,
 Closure Integrity Testing   1998
 In Lieu of Sterility
 Testing as a Component of
 the Stability Protocol
 for Sterile Products
------------------------------------------------------------------------
Draft Guidance for          March     Do.         Do.         Do.
 Industry: Manufacturing,    1998
 Processing, or Holding
 Active Pharmaceutical
 Ingredients
------------------------------------------------------------------------
Guidance for Industry:      March     Do.         Do.         Do.
 Guidance for Human          1998
 Somatic Cell Therapy and
 Gene Therapy
------------------------------------------------------------------------
Draft Guidance for          May 1998  Do.         Do.         Do.
 Industry: Instructions
 for Submitting Electronic
 Lot Release Protocols to
 CBER
------------------------------------------------------------------------

[[Page 831]]

 
Guidance for Industry:      May 14,   Do.         Do.         Do.
 Classifying Resubmissions   1998
 in Response to Action
 Letters
------------------------------------------------------------------------
Guidance for Industry:      May 1998  Do.         Do.         Do.
 Pharmacokinetics in
 Patients With Impaired
 Renal Function--Study
 Design, Data Analysis,
 and Impact on Dosing and
 Labeling
------------------------------------------------------------------------
Guidance for Industry:      May 15,   Do.         Do.         Do.
 Standards for the Prompt    1998
 Review of Efficacy
 Supplements, Including
 Priority Efficacy
 Supplements
------------------------------------------------------------------------
Guidance for Industry:      May 1998  Do.         Do.         Do.
 Providing Clinical
 Evidence of Effectiveness
 for Human Drugs and
 Biological Products
------------------------------------------------------------------------
Draft Guidance for          June      Do.         Do.         Do.
 Industry: Stability         1998
 Testing of Drug
 Substances and Drug
 Products
------------------------------------------------------------------------
Guidance for Industry:      June      Do.         Do.         Do.
 Errors and Accidents        1998
 Regarding Saline Dilution
 of Samples Used for Viral
 Marker Testing
------------------------------------------------------------------------
ICH Guidance on Ethnic      June 10,  Do.         Do.         Do.
 Factors in the              1998
 Acceptability of Foreign
 Clinical Data
------------------------------------------------------------------------
Draft Guidance for          June 12,  Do.         Do.         Do.
 Industry: Exports and       1998
 Imports Under the FDA
 Export Reform and
 Enhancement Act of 1996
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Implementation of Section   1998
 126 of the Food and Drug
 Administration
 Modernization Act of
 1997--Elimination of
 Certain Labeling
 Requirements
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Environmental Assessment    1998
 of Human Drug and
 Biologics Applications
------------------------------------------------------------------------
Draft Guidance for          Septembe  Do.         Do.         Do.
 Industry: Submitting        r 1998
 Debarment Certification
 Statements
------------------------------------------------------------------------
Guidance for Industry: How  Septembe  Do.         Do.         Do.
 to Complete the Vaccine     r 1998
 Adverse Event Reporting
 System Form (VAERS-1)
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 Fast Track Drug             2004
 Development Programs--
 Designation, Development,
 and Application Review
------------------------------------------------------------------------
ICH Guidance on             Septembe  Do.         Do.         Do.
 Statistical Principles      r 16,
 for Clinical Trials         1998
------------------------------------------------------------------------
ICH Guidance on Quality of  Septembe  Do.         Do.         Do.
 Biotechnological/           r 21,
 Biological Products:        1998
 Derivation and
 Characterization of Cell
 Substrates Used for
 Production of
 Biotechnological/
 Biological Products
------------------------------------------------------------------------
ICH Guidance on Viral       Septembe  Do.         Do.         Do.
 Safety Evaluation of        r 24,
 Biotechnology Products      1998
 Derived From Cell Lines
 of Human or Animal Origin
------------------------------------------------------------------------
Draft Guidance for          November  Do.         Do.         Do.
 Industry: General           1998
 Considerations for
 Pediatric Pharmacokinetic
 Studies for Drugs and
 Biological Products
------------------------------------------------------------------------
Guidance for Industry: FDA  December  Do.         Do.         Do.
 Approval of New Cancer      1998
 Treatment Uses for
 Marketed Drug and
 Biological Products
------------------------------------------------------------------------
Draft Guidance for          January   Do.         Do.         Do.
 Industry: Product Name      1999
 Placement, Size, and
 Prominence in Advertising
 and Promotional Labeling
------------------------------------------------------------------------

[[Page 832]]

 
Guidance for Industry:      January   Do.         Do.         Do.
 Content and Format of       1999
 Chemistry, Manufacturing,
 and Controls Information
 and Establishment
 Description Information
 for a Vaccine or Related
 Product
------------------------------------------------------------------------
Guidance on Amended         January   Do.         Do.         Do.
 Procedures for Advisory     26,
 Panel Meetings              1999
------------------------------------------------------------------------
Draft Guidance for          October   Do.         Do.         https://
 Industry; Providing         2003                              www.fda.g
 Regulatory Submissions in                                     ov/cber/
 Electronic Format--                                           esub/
 General Considerations                                        esubguid.
                                                               htm
------------------------------------------------------------------------
Guidance for Industry:      February  Do.         Do.         https://
 Population                  1999                              www.fda.g
 Pharmacokinetics                                              ov/cber/
                                                               guideline
                                                               s.htm
------------------------------------------------------------------------
Guidance for Industry:      February  Do.         Do.         Do.
 Clinical Development        1999
 Programs for Drugs,
 Devices, and Biological
 Products for the
 Treatment of Rheumatoid
 Arthritis (RA)
------------------------------------------------------------------------
Guidance for Industry: For  February  Do.         Do.         Do.
 the Submission of           1999
 Chemistry, Manufacturing,
 and Controls and
 Establishment Description
 Information for Human
 Plasma-Derived Biological
 Products, Animal Plasma,
 or Serum-Derived Products
------------------------------------------------------------------------
Draft Guidance for          March     Do.         Do.         Do.
 Industry: Accelerated       1999
 Approval Products--
 Submission of Promotional
 Materials
------------------------------------------------------------------------
Guidance for Industry:      March     Do.         Do.         Do.
 Content and Format of       1999
 Chemistry, Manufacturing,
 and Controls Information
 and Establishment
 Description Information
 for a Biological In Vitro
 Diagnostic Product
------------------------------------------------------------------------
Guidance for Industry:      April     Do.         Do.         Do.
 Public Health Issues        1999
 Posed by the Use of
 Nonhuman Primate
 Xenografts in Humans
------------------------------------------------------------------------
Guidance for Industry on    April     Do.         Do.         Do.
 the Content and Format of   1999
 Chemistry, Manufacturing,
 and Controls Information
 and Establishment
 Description Information
 for an Allergenic Extract
 or Allergen Patch Test
------------------------------------------------------------------------
Guidance for Industry for   May 1999  Do.         Do.         Do.
 the Submission of
 Chemistry, Manufacturing,
 and Controls and
 Establishment Description
 Information for Human
 Blood and Blood
 Components Intended for
 Transfusion or for
 Further Manufacture and
 for the Completion of the
 Form FDA 356h
 ``Application to Market a
 New Drug, Biologic, or an
 Antibiotic Drug for Human
 Use''
------------------------------------------------------------------------
Draft Guidance for          May 1999  Do.         Do.         Do.
 Industry for Platelet
 Testing and Evaluation of
 Platelet Substitute
 Products
------------------------------------------------------------------------
Guidance for Industry:      May 1999  Do.         Do.         Do.
 Efficacy Studies to
 Support Marketing of
 Fibrin Sealant Products
 Manufactured for
 Commercial Use
------------------------------------------------------------------------
Draft Reviewer Guidance:    June      FDA         Do.         Do.
 Evaluation of Human         1999      personnel
 Pregnancy Outcome Data
------------------------------------------------------------------------
Draft Guidance for          June      FDA         Do.         Do.
 Industry: Current Good      1999      regulated
 Manufacturing Practice                industry
 for Blood and Blood
 Components: (1)
 Quarantine and
 Disposition of Prior
 Collections From Donors
 With Repeatedly Reactive
 Screening Tests for
 Hepatitis C Virus (HCV);
 (2) Supplemental Testing,
 and the Notification of
 Consignees and
 Transfusion Recipients of
 Donor Test Results for
 Antibody to HCV (Anti-
 HCV)
------------------------------------------------------------------------

[[Page 833]]

 
ICH Guidance on the         June 25,  Do.         Do.         Do.
 Duration of Chronic         1999
 Toxicity Testing in
 Animals (Rodent and
 Nonrodent Toxicity
 Testing)
------------------------------------------------------------------------
Draft Guidance for          July      Do.         Do.         Do.
 Industry: Clinical          1999
 Development Programs for
 Drugs, Devices, and
 Biological Products
 Intended for the
 Treatment of
 Osteoarthritis (OA)
------------------------------------------------------------------------
Draft Guidance for          July      Do.         Do.         Do.
 Industry: Interpreting      1999
 Sameness of Monoclonal
 Antibody Products Under
 the Orphan Drug
 Regulations
------------------------------------------------------------------------
Draft Guidance for          August    Do.         Do.         Do.
 Industry: Cooperative       1999
 Manufacturing
 Arrangements for Licensed
 Biologics
------------------------------------------------------------------------
Guidance for Industry:      August    Do.         Do.         Do.
 Consumer-Directed           1999
 Broadcast Advertisements
------------------------------------------------------------------------
Guidance for Industry:      August    Do.         Do.         Do.
 Possible Dioxin/PCB         1999
 Contamination of Drug and
 Biological Products
------------------------------------------------------------------------
Guidance for Industry:      August    Do.         Do.         Do.
 Submission of Abbreviated   1999
 Reports and Synopses in
 Support of Marketing
 Applications
------------------------------------------------------------------------
ICH Guidance on             August    Do.         Do.         Do.
 Specifications: Test        18,
 Procedures and Acceptance   1999
 Criteria for
 Biotechnological/
 Biological Products
------------------------------------------------------------------------
Guidance for Industry:      Septembe  Do.         Do.         Do.
 Qualifying for Pediatric    r 1999
 Exclusivity Under Section
 505A of the Federal Food,
 Drug, and Cosmetic Act
------------------------------------------------------------------------
Guidance for Industry:      November  Do.         Do.         Do.
 Providing Regulatory        1999
 Submissions to CBER in
 Electronic Format--
 Biologics Marketing
 Applications (Biologics
 License Application
 (BLA), Product License
 Application (PLA)/
 Establishment License
 Application (ELA), and
 New Drug Application
 (NDA)); revised
------------------------------------------------------------------------
Guidance for Industry: In   November  Do.         Do.         Do.
 Vivo Drug Metabolism/Drug   1999
 Interaction Studies--
 Study Design, Data
 Analysis, and
 Recommendations for
 Dosing and Labeling
------------------------------------------------------------------------
ICH of Technical            November  Do.         Do.         Do.
 Requirements for            8, 1999
 Registration of
 Pharmaceuticals for Human
 Use; M4: Common Technical
 Document
------------------------------------------------------------------------
Guidance for Industry: In   December  Do.         Do.         Do.
 the Manufacture and         1999
 Clinical Evaluation of In
 Vitro Tests to Detect
 Nucleic Acid Sequences of
 Human Immunodeficiency
 Viruses Types 1 and 2
------------------------------------------------------------------------
Guidance for Reviewers:     November  FDA         Do.         Do.
 Potency Limits for          2000      personnel
 Standardized Dust Mite
 and Grass Allergen
 Vaccines: A Revised
 Protocol
------------------------------------------------------------------------
Guidance for Industry:      February  FDA         Do.         Do.
 Formal Meetings With        2000      regulated
 Sponsors and Applicants               industry
 for PDUFA Products
------------------------------------------------------------------------
Guidance for Industry:      February  Do.         Do.         Do.
 Formal Dispute              2000
 Resolution: Appeals Above
 the Division Level
------------------------------------------------------------------------
Guidance for Industry:      February  Do.         Do.         Do.
 Gamma Irradiation of        2000
 Blood and Blood
 Components: A Pilot
 Program for Licensing
------------------------------------------------------------------------

[[Page 834]]

 
Draft Guidance for          May 2000  Do.         Do.         Do.
 Industry: Content and
 Format of the Adverse
 Reactions Section of
 Labeling for Human
 Prescription Drugs and
 Biologics
------------------------------------------------------------------------
Guidance for Industry:      June      Do.         Do.         Do.
 Recognition and Use of a    2000
 Standard for the Uniform
 Labeling of Blood and
 Blood Components
------------------------------------------------------------------------
Draft Guidance for          June      Do.         Do.         Do.
 Industry: Recommendations   2000
 for Donor Questioning
 Regarding Possible
 Exposure to Malaria
------------------------------------------------------------------------
Draft Guidance for          June      Do.         Do.         Do.
 Industry: Pediatric         2000
 Oncology Studies in
 Response to a Written
 Request
------------------------------------------------------------------------
Guidance for Industry:      June      Do.         Do.         Do.
 Availability of Licensed    2000
 Donor Screening Tests
 Labeled for Use With
 Cadaveric Blood Specimens
------------------------------------------------------------------------
Draft Guidance for          June      Do.         Do.         Do.
 Industry: Chronic           2000
 Cutaneous Ulcer and Burn
 Wounds--Developing
 Products for Treatment
------------------------------------------------------------------------
Draft Guidance for          August    Do.         Do.         Do.
 Industry: Analytical        2000
 Procedures and Methods
 Validation--Chemistry,
 Manufacturing, and
 Controls Documentation
------------------------------------------------------------------------
Draft Guidance for          August    Do.         Do.         Do.
 Industry: Considerations    2000
 for Reproductive Toxicity
 Studies for Preventive
 Vaccines for Infectious
 Disease Indications
------------------------------------------------------------------------
Guidance for Industry: Q &  October   Do.         Do.         Do.
 A Content and Format of     2000
 INDs for Phase 1 Studies
 of Drugs, Including Well-
 Characterized,
 Therapeutic,
 Biotechnology-Derived
 Products
------------------------------------------------------------------------
Guidance for Industry:      October   Do.         Do.         Do.
 Supplemental Guidance on    2000
 Testing for Replication
 Competent Retrovirus in
 Retroviral Vector Based
 Gene Therapy Products and
 During Followup of
 Patients in Clinical
 Trials Using Retroviral
 Vectors
------------------------------------------------------------------------
Guidance for Industry:      October   Do.         Do.         Do.
 Submitting and Reviewing    2000
 Complete Responses to
 Clinical Holds
------------------------------------------------------------------------
Guidance for Industry:      November  Do.         Do.         Do.
 Testing Limits in           2000
 Stability Protocols for
 Standardized Grass Pollen
 Extracts
------------------------------------------------------------------------
Guidance for Industry: Use  November  Do.         Do.         Do.
 of Sterile Connecting       2000
 Devices in Blood Bank
 Practices
------------------------------------------------------------------------
Draft Guidance for          November  Do.         Do.         Do.
 Industry: Recommendations   2000
 for Complying With the
 Pediatric Rule (21 CFR
 314.55(a) and 601.27(a))
------------------------------------------------------------------------
ICH Guidance for Industry:  December  Do.         Do.         Do.
 E11 Clinical                2000
 Investigation of
 Medicinal Products in the
 Pediatric Population
------------------------------------------------------------------------
Guidance for Industry:      December  Do.         Do.         Do.
 Submitting Separate         2000
 Marketing Applications
 and Clinical Data for
 Purposes of Assessing
 User Fees
------------------------------------------------------------------------
ICH Guidance on Q6A         December  Do.         Do.         Do.
 Specifications: Test        29,
 Procedures and Acceptance   2000
 Criteria for New Drug
 Substances and New Drug
 Products: Chemical
 Substances
------------------------------------------------------------------------
PHS Guideline on            January   Do.         Do.         Do.
 Infectious Disease Issues   19,
 in Xenotransplantation      2001
------------------------------------------------------------------------

[[Page 835]]

 
Draft Guidance for          January   Do.         Do.         Do.
 Industry: Pre-Storage       2001
 Leukocyte Reduction of
 Whole Blood and Blood
 Components Intended for
 Transfusion
------------------------------------------------------------------------
Guidance for Industry:      January   Do.         Do.         Do.
 Recommendations for         2001
 Collecting Red Blood
 Cells by Automated
 Apheresis Methods
------------------------------------------------------------------------
Draft Guidance for          January   Do.         Do.         Do.
 Industry: Providing         2001
 Regulatory Submissions in
 Electronic Format--
 Prescription Drug
 Advertising and
 Promotional Labeling
------------------------------------------------------------------------
Guidance for Industry:      February  Do.         Do.         Do.
 Recommendations for         2001
 Collecting Red Blood
 Cells by Automated
 Apheresis Methods--
 Technical Correction
------------------------------------------------------------------------
Draft Guidance for          February  Do.         Do.         Do.
 Industry: Disclosing        2001
 Information Provided to
 Advisory Committees in
 Connection With Open
 Advisory Committee
 Meetings Related to the
 Testing or Approval of
 Biologic Products and
 Convened by the Center
 for Biologics Evaluation
 and Research
------------------------------------------------------------------------
Draft Guidance for          March     Do.         Do.         Do.
 Industry: Postmarketing     2001
 Safety Reporting for
 Human Drug and Biological
 Products Including
 Vaccines
------------------------------------------------------------------------
Guidance for Industry:      March     Do.         Do.         Do.
 Acceptance of Foreign       2001
 Clinical Studies
------------------------------------------------------------------------
Guidance for Industry:      March     Do.         Do.         Do.
 Financial Disclosure by     2001
 Clinical Investigators
------------------------------------------------------------------------
Guidance for Industry:      March     Do.         Do.         Do.
 Monoclonal Antibodies       2001
 Used as Reagents in Drug
 Manufacturing
------------------------------------------------------------------------
Draft Guidance for          April     Do.         Do.         Do.
 Industry: Reports on the    2001
 Status of Postmarketing
 Studies--Implementation
 of Section 130 of the
 Food and Drug
 Administration
 Modernization Act of 1997
------------------------------------------------------------------------
Draft Guidance for          May 2001  Do.         Do.         Do.
 Industry: Providing
 Regulatory Submissions in
 Electronic Format--
 Postmarketing Expedited
 Safety Reports
------------------------------------------------------------------------
Guidance for Industry: E10  May 2001  Do.         Do.         Do.
 Choice of Control Group
 and Related Issues in
 Clinical Trials
------------------------------------------------------------------------
Draft Guidance for          May 2001  Do.         Do.         Do.
 Industry: IND Meetings
 for Human Drugs and
 Biologics; Chemistry,
 Manufacturing, and
 Controls Information
------------------------------------------------------------------------
Draft Guidance for          July      Do.         Do.         Do.
 Industry: Clinical          2001
 Studies Section of
 Labeling for Prescription
 Drugs and Biologics--
 Content and Format
------------------------------------------------------------------------
Guidance for Industry:      July      Do.         Do.         Do.
 CBER Pilot Licensing        2001
 Program for Immunization
 of Source Plasma Donors
 Using Immunogen Red Blood
 Cells Obtained From an
 Outside Supplier
---------------------------------------------

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