Withdrawal of Draft Guidance Documents Published Before December 31, 2013, 26059-26061 [2015-10477]

Download as PDF Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Mehul Mehta, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–1573. SUPPLEMENTARY INFORMATION: tkelley on DSK3SPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Waiver of In Vivo Bioavailability and Bioequivalence Studies for ImmediateRelease Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.’’ This guidance provides recommendations for sponsors and applicants who wish to request a waiver of in vivo BA and/or BE studies for IR solid oral dosage forms. These waivers are intended to apply to: (1) Subsequent in vivo BA or BE studies of formulations after the initial establishment of the in vivo BA of IR dosage forms during the IND period and (2) in vivo BE studies of IR dosage forms in ANDAs. Regulations at 21 CFR part 320 address the requirements for BA and BE data for approval of drug applications and supplemental applications. Provision for waivers of in vivo BA/BE studies (biowaivers) under certain conditions is provided at § 320.22. This guidance updates the guidance for industry on ‘‘Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System,’’ published in August 2000, and explains when biowaivers can be requested for IR solid oral dosage forms based on an approach termed the Biopharmaceutics Classification System (BCS). This guidance includes biowaiver extension to BCS class 3 drug products and additional modifications, such as criteria for high permeability and high solubility. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current thinking on waiver of in vivo bioavailability and bioequivalence studies for immediaterelease solid oral dosage forms based on a BCS. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the VerDate Sep<11>2014 18:43 May 05, 2015 Jkt 235001 requirements of the applicable statutes and regulations. II. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 314, including §§ 314.50 and 314.94, have been approved under OMB control number 0910–0001. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: April 29, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–10479 Filed 5–5–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–1419] Withdrawal of Draft Guidance Documents Published Before December 31, 2013 AGENCY: Food and Drug Administration, Notice. The Food and Drug Administration (FDA) is announcing the withdrawal of 47 draft guidance documents that published before December 31, 2013, and have never been finalized. FDA is taking this action to improve the efficiency and transparency of the guidance development process. SUMMARY: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), if you wish to submit comments on a specific withdrawal action in this notice, submit either electronic or written comments by June 5, 2015. ADDRESSES: You may submit comments by any of the following methods: DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Docket No. FDA– 2015–N–1419 for this action. All comments received may be posted without change to https:// www.regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov and insert the docket number(s), found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lisa M. Helmanis, Regulations Policy and Management Staff, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3326, Silver Spring, MD 20993–0002, 301–796–9135, email: Lisa.Helmanis.@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background HHS. ACTION: 26059 In September 2000, FDA codified its good guidance practices (GGPs). GGPs are FDA’s policies and procedures for the development, issuance, and use of guidance documents. Level I guidance documents set forth initial interpretations of statutory or regulatory requirements, explain changes in interpretation of policies, or discuss complex scientific issues or highly controversial issues. The GGPs, generally, require that such guidances be issued in draft for public comment before they are finalized. FDA’s guidance documents do not create E:\FR\FM\06MYN1.SGM 06MYN1 26060 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices legally enforceable rights or responsibilities and do not legally bind the public or FDA. A key component of the GGPs is ensuring transparency during guidance development and issuance. In 2011, as part of the Agency’s Transparency Initiative, FDA reviewed and set forth best practices for facilitating early stakeholder input, efficiency, and transparency in the Agency’s processes, including GGPs. In recent years, FDA’s guidance workload has increased due to requests from the public for guidance to clarify specific issues and statutorily mandated guidances. Many of these draft guidances were not finalized most often because of higher priorities and resource issues. However, over the years, because of new information, scientific developments, and emerging technologies, a number of draft guidances have become outdated and therefore, should be withdrawn. II. Withdrawal of Guidances FDA is withdrawing the following 47 guidance documents. Draft guidance Docket No. tkelley on DSK3SPTVN1PROD with NOTICES 1. Draft Guidance for Industry: Platelet Testing and Evaluation of Platelet Substitute Products ....... 2. 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. 3. Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes. 4. Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products. 5. Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). 6. Accelerated Approval Products—Submission of Promotional Materials ......................................... 7. Providing Regulatory Submissions in Electronic Format—Prescription Drug Advertising and Promotional Labeling. 8. Comparability Protocols—Protein Drug Products and Biological Products—Chemistry, Manufacturing, and Controls Information. 9. Providing Regulatory Submissions in Electronic Format—General Considerations ....................... 10. ‘‘Help-Seeking’’ and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms. 11. Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage. 12. Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices: Draft Points to Consider Regarding Labeling and Premarket Submissions. 13. 510(k) Submission of Lymphocyte Immunophenotyping IVDs Using Monoclonal Antibodies ..... 14. 510(k) Submission of Immunoglobulins A, G, M, D, and E Immunoglobulin System In Vitro Devices. 15. Draft Guidance for Preparation of PMA Applications for Testicular Prostheses .......................... 16. Emergency Resuscitator Guidance ............................................................................................... 17. 510(k) Submission Requirements for Peak Flow Meters .............................................................. 18. Reviewer Guidance on Face Masks and Shield for CPR ............................................................. 19. Reviewer Guidance for Ventilators ................................................................................................ 20. Testing MR Interaction with Aneurysm Clips ................................................................................ 21. A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems .............. 22. Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology. 23. Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages (P97–1). 24. Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests 25. Class II Special Controls Guidance Document: Tinnitus Masker Devices ................................... 26. Class II Special Controls Guidance Document: Absorbable Hemostatic Device ......................... 27. Class II Special Controls Guidance Document: Tissue Expander ................................................ 28. Heart Valves: Investigational Device Exemption and Premarket Approval Applications .............. 29. Class II Special Controls Guidance Document: Electroconductive Media ................................... 30. Class II Special Controls Guidance Document: Cutaneous Electrode ......................................... 31. Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief. 32. Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain Relief. 33. Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes. 34. Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes. 35. Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation .. 36. Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Rehabilitation. 37. Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning. 38. Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning. 39. Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use. VerDate Sep<11>2014 18:43 May 05, 2015 Jkt 235001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Publication date FDA–1998–D–0680 FDA–1999–D–0045 5/20/1999 2/11/2002 FDA–2004–D–0420 10/28/2004 FDA–2008–D–0055 2/11/2008 FDA–2009–D–0137 3/26/2009 FDA–1999–D–0752 FDA–2001–D–0169 3/26/1999 1/1/2001 FDA–2003–D–0355 9/5/2003 FDA–2003–D–0429 FDA–2004–D–0500 10/1/2003 1/26/2004 FDA–2012–D–0140 2/21/2012 FDA–1998–N–0050 10/5/1988 FDA–1998–N–0050 FDA–2013–N–0046 FDA–1998–N–0050 9/26/1991 FDA–1998–N–0050 FDA–1998–N–0050 FDA–1998–N–0050 FDA–1998–N–0050 FDA–1998–N–0050 FDA–1998–N–0050 FDA–1997–D–0423 FDA–2006–P–0022– 0003 FDA–1998–N–0050– 0002 FDA–2003–D–0373 FDA–2005–D–0085 FDA–2006–D–0356 FDA–2008–D–0603 FDA–2009–D–0559 FDA–2009–D–0495 FDA–2009–D–0495 FDA–2009–D–0495 3/16/1993 4/14/1993 1/3/1994 3/16/1994 7/1/1995 5/22/1996 2/7/1997 2/28/1997 9/1/1992 10/10/1997 12/2/2003 11/8/2005 10/31/2006 12/22/2008 1/20/2010 4/5/2010 4/5/2010 4/5/2010 FDA–2009–D–0495 4/5/2010 FDA–2009–D–0495 4/5/2010 FDA–2009–D–0495 4/5/2010 FDA–2009–D–0495 FDA–2009–D–0495 4/5/2010 4/5/2010 FDA–2009–D–0495 4/5/2010 FDA–2009–D–0495 4/5/2010 FDA–2009–D–0495 4/5/2010 E:\FR\FM\06MYN1.SGM 06MYN1 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices Draft guidance Docket No. 40. Recommended Warning for Surgeon’s Gloves and Patient Examination Gloves ........................ 41. Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection. 42. Use of Antibiotic Resistance Marker Genes in Transgenic Plants ............................................... 43. Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals. 44. Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act. 45. Guidance for Industry: Regulatory Procedures Manual—Chapter 9, Subchapter: Guidance Concerning Recommending Customs’ Seizure and Destruction of Imported Human and Animal Food That has Not Been Reconditioned; Draft Guidance. 46. Submission of Laboratory Packages By Accredited Laboratories ................................................ 47. Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings ................ Dated: April 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–10477 Filed 5–5–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–1376] Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices.’’ This draft guidance is being issued to explain the circumstances in which it may be appropriate to leverage existing clinical data to support pediatric device indications in premarket approval applications (PMAs) and humanitarian device exemptions (HDEs). The draft guidance also describes the approach that FDA would use to determine whether extrapolation is appropriate in medical devices, and the factors that would be considered within a statistical model for extrapolation. Extrapolation may be appropriate when the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients and the adult data are of high quality for borrowing. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:43 May 05, 2015 Jkt 235001 guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 4, 2015. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jacqueline Francis, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993–0002, 301–796–6405; or Stephen Ripley, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background Section 520(m)(6)(E)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j) defines pediatric device patients as persons aged 21 or younger at the time of their diagnosis or PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 26061 Publication date FDA–2011–D–0030 FDA–2011–D–0102 2/7/2011 5/18/2011 FDA–1998–N–0050 FDA–2002–D–0135 9/4/1998 9/11/2002 FDA–2009–D–0563 11/27/2009 FDA–1998–N–0050 11/5/2002 FDA–2008–D–0510 FDA–2008–D–0417 1/2009 8/1/2008 treatment (i.e., from birth through the 21st year of life, up to but not including the 22d birthday). Pediatric subpopulations are defined in section 520(m)(6)(E)(ii) (and adopted by reference in section 515A(c) of the FD&C Act (21 U.S.C. 360e)) to be neonates, infants, children, and adolescents. In an attempt to promote pediatric medical device development, CDRH published a final guidance document in 2004 entitled ‘‘Premarket Assessment of Pediatric Medical Devices’’ (Ref. 1). This 2004 document indicates that data can be extrapolated to support effectiveness and, on a limited basis, safety for premarket approval applications (PMAs) when consistent with scientific principles. Congress was aware of this 2004 document when it passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Title III of FDAAA is the Pediatric Medical Device Safety and Improvement Act (PMDSIA). The FDAAA specifically authorized the use of adult data to demonstrate pediatric effectiveness. While safety exploration is not discussed in PMDSIA, FDA believes that there are specific cases where it will be appropriate to consider extrapolation of existing clinical safety data to support or enhance evidence for pediatric indications. FDA seeks comment on the appropriateness of extrapolating from adult clinical data to support medical device safety in pediatric patients. FDA aims to increase the availability of safe and effective pediatric devices while ensuring that the approval of these devices is based on valid scientific evidence. Extrapolation of adult data for pediatric use may benefit pediatric patients by making it possible for devices to be approved for pediatricspecific indications and labeling, even when there is little or no existing pediatric data. Extrapolation facilitates the use of available relevant data by making optimal use of what is already known about device effects in other E:\FR\FM\06MYN1.SGM 06MYN1

Agencies

[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Pages 26059-26061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10477]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1419]

Withdrawal of Draft Guidance Documents Published Before December
31, 2013

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of 47 draft guidance documents that published before
December 31, 2013, and have never been finalized. FDA is taking this
action to improve the efficiency and transparency of the guidance
development process.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), if you wish to submit comments on a specific withdrawal
action in this notice, submit either electronic or written comments by
June 5, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Docket No.
FDA-2015-N-1419 for this action. All comments received may be posted
without change to https://www.regulations.gov, including any personal
information provided.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Lisa M. Helmanis, Regulations Policy
and Management Staff, Office of the Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3326, Silver
Spring, MD 20993-0002, 301-796-9135, email: Lisa.Helmanis.@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In September 2000, FDA codified its good guidance practices (GGPs).
GGPs are FDA's policies and procedures for the development, issuance,
and use of guidance documents. Level I guidance documents set forth
initial interpretations of statutory or regulatory requirements,
explain changes in interpretation of policies, or discuss complex
scientific issues or highly controversial issues. The GGPs, generally,
require that such guidances be issued in draft for public comment
before they are finalized. FDA's guidance documents do not create

[[Page 26060]]

legally enforceable rights or responsibilities and do not legally bind
the public or FDA.
A key component of the GGPs is ensuring transparency during
guidance development and issuance. In 2011, as part of the Agency's
Transparency Initiative, FDA reviewed and set forth best practices for
facilitating early stakeholder input, efficiency, and transparency in
the Agency's processes, including GGPs.
In recent years, FDA's guidance workload has increased due to
requests from the public for guidance to clarify specific issues and
statutorily mandated guidances. Many of these draft guidances were not
finalized most often because of higher priorities and resource issues.
However, over the years, because of new information, scientific
developments, and emerging technologies, a number of draft guidances
have become outdated and therefore, should be withdrawn.

II. Withdrawal of Guidances

FDA is withdrawing the following 47 guidance documents.

----------------------------------------------------------------------------------------------------------------
Draft guidance Docket No. Publication date
----------------------------------------------------------------------------------------------------------------
1. Draft Guidance for Industry: Platelet FDA-1998-D-0680 5/20/1999
Testing and Evaluation of Platelet Substitute
Products.
2. Draft Guidance for Industry: Precautionary FDA-1999-D-0045 2/11/2002
Measures to Reduce the Possible Risk of
Transmission of Zoonoses by Blood and Blood
Products from Xenotransplantation Product
Recipients and Their Intimate Contacts.
3. Draft Guidance for Industry: Criteria for FDA-2004-D-0420 10/28/2004
Safety and Efficacy Evaluation of Oxygen
Therapeutics as Red Blood Cell Substitutes.
4. Draft Guidance for Industry: Validation of FDA-2008-D-0055 2/11/2008
Growth-Based Rapid Microbiological Methods
for Sterility Testing of Cellular and Gene
Therapy Products.
5. Draft Guidance for Industry: Use of FDA-2009-D-0137 3/26/2009
Serological Tests to Reduce the Risk of
Transmission of Trypanosoma cruzi Infection
in Whole Blood and Blood Components for
Transfusion and Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps).
6. Accelerated Approval Products--Submission FDA-1999-D-0752 3/26/1999
of Promotional Materials.
7. Providing Regulatory Submissions in FDA-2001-D-0169 1/1/2001
Electronic Format--Prescription Drug
Advertising and Promotional Labeling.
8. Comparability Protocols--Protein Drug FDA-2003-D-0355 9/5/2003
Products and Biological Products--Chemistry,
Manufacturing, and Controls Information.
9. Providing Regulatory Submissions in FDA-2003-D-0429 10/1/2003
Electronic Format--General Considerations.
10. ``Help-Seeking'' and Other Disease FDA-2004-D-0500 1/26/2004
Awareness Communications by or on Behalf of
Drug and Device Firms.
11. Notification to FDA of Issues that May FDA-2012-D-0140 2/21/2012
Result in a Prescription Drug or Biological
Product Shortage.
12. Assessing the Safety and Effectiveness of FDA-1998-N-0050 10/5/1988
Home-Use In Vitro Diagnostic Devices: Draft
Points to Consider Regarding Labeling and
Premarket Submissions.
13. 510(k) Submission of Lymphocyte FDA-1998-N-0050 9/26/1991
Immunophenotyping IVDs Using Monoclonal FDA-2013-N-0046
Antibodies.
14. 510(k) Submission of Immunoglobulins A, G, FDA-1998-N-0050 9/1/1992
M, D, and E Immunoglobulin System In Vitro
Devices.
15. Draft Guidance for Preparation of PMA FDA-1998-N-0050 3/16/1993
Applications for Testicular Prostheses.
16. Emergency Resuscitator Guidance........... FDA-1998-N-0050 4/14/1993
17. 510(k) Submission Requirements for Peak FDA-1998-N-0050 1/3/1994
Flow Meters.
18. Reviewer Guidance on Face Masks and Shield FDA-1998-N-0050 3/16/1994
for CPR.
19. Reviewer Guidance for Ventilators......... FDA-1998-N-0050 7/1/1995
20. Testing MR Interaction with Aneurysm Clips FDA-1998-N-0050 5/22/1996
21. A Primer on Medical Device Interactions FDA-1997-D-0423 2/7/1997
with Magnetic Resonance Imaging Systems.
22. Review Criteria Assessment of Portable FDA-2006-P-0022-0003 2/28/1997
Blood Glucose Monitoring In Vitro Diagnostic
Devices Using Glucose Oxidase, Dehydrogenase
or Hexokinase Methodology.
23. Distribution and Public Availability of FDA-1998-N-0050-0002 10/10/1997
Premarket Approval Application Summary of
Safety and Effectiveness Data Packages (P97-
1).
24. Premarket Submissions and Labeling FDA-2003-D-0373 12/2/2003
Recommendations for Drugs of Abuse Screening
Tests.
25. Class II Special Controls Guidance FDA-2005-D-0085 11/8/2005
Document: Tinnitus Masker Devices.
26. Class II Special Controls Guidance FDA-2006-D-0356 10/31/2006
Document: Absorbable Hemostatic Device.
27. Class II Special Controls Guidance FDA-2008-D-0603 12/22/2008
Document: Tissue Expander.
28. Heart Valves: Investigational Device FDA-2009-D-0559 1/20/2010
Exemption and Premarket Approval Applications.
29. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010
Document: Electroconductive Media.
30. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010
Document: Cutaneous Electrode.
31. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010
Document: Transcutaneous Electrical Nerve
Stimulator for Pain Relief.
32. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010
Document: Transcutaneous Electrical Nerve
Stimulator with Limited Output for Pain
Relief.
33. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010
Document: Transcutaneous Electrical
Stimulator for Aesthetic Purposes.
34. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010
Document: Transcutaneous Electrical
Stimulator with Limited Output for Aesthetic
Purposes.
35. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010
Document: Powered Muscle Stimulator for
Rehabilitation.
36. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010
Document: Powered Muscle Stimulator with
Limited Output for Rehabilitation.
37. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010
Document: Powered Muscle Stimulator for
Muscle Conditioning.
38. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010
Document: Powered Muscle Stimulator with
Limited Output for Muscle Conditioning.
39. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010
Document: Transcutaneous Electrical Nerve
Stimulator for Pain Relief Intended for Over
the Counter Use.

[[Page 26061]]

40. Recommended Warning for Surgeon's Gloves FDA-2011-D-0030 2/7/2011
and Patient Examination Gloves.
41. Class II Special Controls Guidance FDA-2011-D-0102 5/18/2011
Document: In Vitro Diagnostic Devices for
Bacillus spp. Detection.
42. Use of Antibiotic Resistance Marker Genes FDA-1998-N-0050 9/4/1998
in Transgenic Plants.
43. Drugs, Biologics, and Medical Devices FDA-2002-D-0135 9/11/2002
Derived from Bioengineered Plants for Use in
Humans and Animals.
44. Preliminary Timetable for the Review of FDA-2009-D-0563 11/27/2009
Applications for Modified Risk Tobacco
Products under the Federal Food, Drug, and
Cosmetic Act.
45. Guidance for Industry: Regulatory FDA-1998-N-0050 11/5/2002
Procedures Manual--Chapter 9, Subchapter:
Guidance Concerning Recommending Customs'
Seizure and Destruction of Imported Human and
Animal Food That has Not Been Reconditioned;
Draft Guidance.
46. Submission of Laboratory Packages By FDA-2008-D-0510 1/2009
Accredited Laboratories.
47. Guidance for the Public and FDA Staff on FDA-2008-D-0417 8/1/2008
Convening Advisory Committee Meetings.
----------------------------------------------------------------------------------------------------------------

Dated: April 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10477 Filed 5-5-15; 8:45 am]
BILLING CODE 4164-01-P

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