Department of Health and Human Services February 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 200 of 326
Intramammary Dosage Forms; Ceftiofur
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The NADA provides for the veterinary prescription use of ceftiofur hydrochloride suspension, by intramammary infusion, for the treatment of clinical mastitis in lactating dairy cattle.
Medical Devices; Medical Device Reporting; Companion to Direct Final Rule
The Food and Drug Administration (FDA or we) is proposing to amend its regulation governing reporting of deaths, serious injuries, and certain malfunctions related to medical devices. We are revising the regulation into plain language to make the regulation easier to understand, and we are making technical corrections. Elsewhere in this issue of the Federal Register, we are publishing a direct final rule that is identical to this proposed rule. This proposed rule will provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Medical Devices; Medical Device Reporting
The Food and Drug Administration (FDA or we) is amending its regulation governing reporting of deaths, serious injuries, and certain malfunctions related to medical devices. We are revising the regulation into plain language to make the regulation easier to understand, and we are making technical corrections. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule.
Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups
This notice invites nominations of members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). Seven vacancies will exist on the Panel as of March 31, 2005. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. The advice provided by the Panel will be considered as CMS prepares its annual updates of the hospital Outpatient Prospective Payment System (OPPS) through rulemaking. The panel was recently rechartered for a 2-year period through November 21, 2006. Nominations: Nominations will be considered if received no later than March 15, 2005 at 5 p.m. e.s.t. Mail or deliver nominations to the following address: CMS; Attn: Shirl Ackerman-Ross, Designated Federal Officer (DFO), Advisory Panel on APC Groups; Center for Medicare Management (CMM), Hospital & Ambulatory Policy Group (HAPG), Division of Outpatient Care (DOC); 7500 Security Boulevard, Mail Stop C4-05-17; Baltimore, MD 21244-1850. Web Site: For additional information on the APC Panel and updates to the Panel's activities, search our Web site at: https:// www.cms.hhs.gov/faca/apc/default.asp. Advisory Committees' Information Lines: You may also refer to the CMS Advisory Committee Information Hotlines at 1-877-449-5659 (toll- free) or 410-786-9379 (local) for additional information.
Medicare Program; Changes in Geographical Boundaries of Durable Medical Equipment Regional Service Areas
This notice announces changes to the geographical boundaries of the four Durable Medical Equipment (DME) service areas applicable to future awards of the Medicare Administrative Contracts (MACs). We identify which States and territories are assigned to each of the four DME service areas, and include the factors and criteria that we used to change the geographical boundaries.
Medicare Program; Durable Medical Equipment Regional Carrier Service Areas and Related Matters
This final rule provides a mechanism for us to expeditiously make changes to the durable medical equipment regional carrier (DMERC) service area boundaries without notice and comment rulemaking. Through this mechanism, we can change the geographical boundaries served by the regional contractors that process durable medical equipment claims through issuance of a Federal Register notice and make other minor changes in the contract administration of the DMERCs. The mechanism provides a method for increasing or decreasing the number of DMERCs, changing the boundaries of DMERCs based on criteria other than the boundaries of the Common Working File sectors, and awarding new contractors to perform statistical analysis or maintain the national supplier clearinghouse. We will publish these changes and their justifications in a Federal Register notice, rather than through notice and comment rulemaking. Although we may change the number and configuration of regional carriers, we are not altering the criteria and factors that we use in awarding contracts. Through this final rule, we are improving the contracting process so that we can swiftly meet the challenges of the changing healthcare industry and address the changing needs of beneficiaries, suppliers, and the Medicare program.
Medicare Program; Procedures for Maintaining Code Lists in the Negotiated National Coverage Determinations for Clinical Diagnostic Laboratory Services
This notice finalizes the procedures proposed in the Federal Register on December 24, 2003 (68 FR 74607). It establishes the procedures for maintaining the lists of codes that were included in the national coverage determinations (NCDs) that were announced in an addendum to the final rule published in the Federal Register on November 23, 2001 (66 FR 58788). The final notice also sets forth the circumstances in which a laboratory is permitted to use the date a specimen was retrieved from storage for testing as the date of service instead of the date of collection.
Fiscal Year (FY) 2005 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $11,000,000 (total costs) for a one-year project period to the Florida Department of Children and Families. This is not a formal request for applications. Assistance will be provided only to the Florida Department of Children and Families based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: OA-05-002. Catalog of Federal Domestic Assistance (CFDA) Number: 93.003.
Medicare Program; Part D Reinsurance Payment Demonstration
This notice informs interested Prescription Drug Plan (PDP) sponsors and Medicare Advantage (MA) organizations of an opportunity to participate in the Part D Reinsurance Payment Demonstration beginning in contract year 2006.
Medicare and Medicaid Programs; Solicitation of Proposals for the Private, For-Profit Demonstration Project for the Program of All-Inclusive Care for the Elderly (PACE); Cancellation of Withdrawal
This document cancels the withdrawal of the ``Notice for the Solicitation of Proposals for the Private, For-Profit Demonstration Project for the Program of All-Inclusive Care for the Elderly (PACE)'' published in the Federal Register on November 26, 2004. The November 26, 2004 notice was published in error, and we do not wish to withdraw the original notice of solicitation published on August 10, 2001. The solicitation notice solicited proposals from private, for- profit organizations for a fully-capitated joint Medicare and Medicaid demonstration. The goal of the solicitation notice was to determine whether the risk-based long-term care model employed by the nonprofit PACE could be replicated successfully by for-profit organizations.
Medicare Program; Meeting of the Advisory Panel on Medicare Education-March 22, 2005
In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) on March 22, 2005. The Panel advises and makes recommendations to the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public. This meeting replaces the February 24, 2005 meeting that was canceled.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2004
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2004 through December 2004, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. Finally, this notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.
Agency Emergency Processing Under the Office of Management and Budget Review; Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice; Withdrawal
The Food and Drug Administration (FDA) is withdrawing a notice that published in the Federal Register on January 26, 2005 (70 FR 3712).
Implantation or Injectable Dosage Form New Animal Drugs; Euthanasia Solution
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for use of an injectable solution of pentobarbital sodium and phenytoin sodium for humane, painless, and rapid euthanasia of dogs.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Radioactive Drug Research Committees
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Radioactive Drug Research Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms'' dated February 2005. The draft document is intended to provide guidance to manufacturers using spore- forming microorganisms in the production of certain biological products. The draft guidance document provides recommendations to industry in response to changes made to the requirements for spore- forming microorganisms to allow greater flexibility in manufacturing.
Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps),'' dated November 2004. The guidance document provides medical device manufacturers with information about performing studies to support modifying the indication for use of communicable disease tests to include testing of cadaveric blood specimens to screen donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance document recommends a suggested protocol to modify the indication for use to include testing of cadaveric blood specimens.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; 2005 Survey of Area Agencies on Aging
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recordkeeping and Records Access Requirements for Food Facilities
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recordkeeping and Records Access Requirements for Food Facilities'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Application for Participation in the Medical Device Fellowship Program
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Application for Participation in the Medical Device Fellowship Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Final Nurse Practitioner and Nurse-Midwifery Education Program Guidelines
On November 3, 2003, the Health Resources and Services Administration (HRSA) published for comment proposed revisions to the Nurse Practitioner and Nurse-Midwifery Education Program Guidelines (Guidelines) for use in the Advanced Education Nursing Grant Program. HRSA has considered the comments received and is publishing the final Guidelines with responses to the comments.
Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Correction
The Food and Drug Administration (FDA) is correcting a final regulation that appeared in the Federal Register of December 9, 2004 (69 FR 71562). The document issued a final regulation that requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records allow for the identification of the immediate previous sources and immediate subsequent recipients of food. The document was published with some errors. This document corrects those errors.
Proposed Collection; Comment Request; Survey of NIGMS Minority Opportunities in Research (MORE) Division Institutional Program Directors
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of General Medical Sciences (NIGMS), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Survey of NIGMS Minority Opportunities in Research (MORE) Division Institutional Program Directors. Type of Information Collection Request: New collection. Need and Use of Information Collection: NIGMS provides research and research training support in the basic biomedical sciences through a variety of programs and grant mechanisms. Several of these programs are targeted toward support of underrepresented minority students at various educational levels and research faculty at minority-serving institutions. Although significant resources are dedicated to funding these programs, there is a lack of quantitative information on program outcomes. With this submission, NIGMS seeks to obtain OMB's approval to conduct a survey of the institutional program directors in the following programs: Minority Access to Research Careers Undergraduate Student Training in Academic Research (U*STAR), Minority Biomedical Research Support Initiative for Minority Student Development (IMSD), and Minority Biomedical Research Support Research Initiative for Scientific Enhancement (RISE). Information collected in the survey will include data on student enrollment and highest degree received. This proposed one-time survey is part of a larger study that will provide NIGMS with the high-quality data needed to evaluate the educational outcomes and research activity of students and faculty who are supported by NIGMS training and research support programs. Other data will be collected from existing sources, including grant records and Medline databases. Taken together, the data will be used as a baseline for future assessments, as well to further develop current programs and in the creation of proposals for new initiatives in minority recruitment and training. These results will be reported to the National Advisory General Medical Sciences Council (NAGMSC) and shared with the community of NIGMS grantees. The survey is planned to launch in July 2005 and to be in the field for two months. Frequency of Response: Once. Affected Public: Individuals or households; Not-for- profits. Type of Respondents: Training grant program directors. The annual reporting burden is as follows:
Solicitation for the Nomination of Candidates To Serve as Members of the National Vaccine Advisory Committee
The National Vaccine Program Office (NVPO), a program office within the Office of Public Health and Science, Department of Health and Human Services (DHHS), is soliciting nominations of qualified candidates to be considered for appointment as members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his/ her capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102, 2103, and 2104 of the PHS Act; and identifies annually the most important areas of government and non- government cooperation that should be considered in implementing Sections 2102, 2103, and 2104 of the PHS Act.
Opportunity for Cosponsorship of the HealthierUS Fitness Festival
The Office of the President's Council on Physical Fitness and Sports (PCPFS) announces the opportunity for both Federal and non- Federal public and private sector entities to cosponsor a fitness festival depicting activities to help all Americans get moving for health and fitness in celebration of May, National Physical Fitness and Sports Month. Potential cosponsors must have a demonstrated interest in physical activity/fitness and/or sports and be willing to participate substantively in the cosponsored activity.
Oral Dosage Form New Animal Drugs; Ivermectin Paste
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for oral use of ivermectin paste in horses for treatment and control of various internal parasites or parasitic conditions.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability
The Food and Drug Administration (FDA) is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments made by sponsors of approved drug and biological products. This is the agency's report on the status of the studies sponsors have agreed to or are required to conduct.
Reviewer Guidance on Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review; Availability
The Food and Drug Administration (FDA) is announcing the availability of a reviewer guidance entitled ``Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review.'' The guidance is intended to provide an annotated outline of the safety component of a clinical review of a new drug or biologic product application and guidance on how to conduct and organize the safety review. The guidance is also intended to provide standardization and consistency in the format, content, and quality of safety reviews. This reviewer guidance has been developed as part of the agency's good review practices initiative.
Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, Clotrimazole Ointment; Technical Amendment
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The supplemental ANADA provides for a new container size, a 20-gram dropper bottle, from which gentamicin sulfate, betamethasone valerate, clotrimazole ointment may be administered for the treatment of acute and chronic canine otitis externa. The regulations are also being amended to correct the indications for use to agree with approved product labeling. This action is being taken to improve the accuracy of the regulations.
Oral Dosage Form New Animal Drugs; Sulfamethazine Sustained-Release Boluses; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Boehringer Ingelheim Vetmedica, Inc. to Phoenix Scientific, Inc.
New Animal Drugs; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's address for Phibro Animal Health.
National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
New Methodology and Increase in Low Income Levels for Various Health Professions and Nursing Training and Assistance Programs
HRSA uses ``low-income'' levels to determine whether an individual is from an economically disadvantaged background in making eligibility and funding determinations for participants in various health professions and nursing grant and cooperative agreement programs authorized by Titles III, VII and VIII of the Public Health Service (PHS) Act. In the past, an individual's economically disadvantaged background status, as a basis for participation in certain programs, was based on the income level of the individual's parents. However, many potential program participants are well above the age of majority. Accordingly, questions have been raised by potential program participants and program officials regarding the feasibility and fairness in determining economically disadvantaged status based solely on the parent's income. This notice updates the low-income levels published by HRSA on August 5, 2003 (68 FR 46199-46200), and changes the methodology used to determine low income for use in these programs beginning in Fiscal Year (FY) 2005.
Annual Update of the HHS Poverty Guidelines
This notice provides an update of the HHS poverty guidelines to account for last (calendar) year's increase in prices as measured by the Consumer Price Index.
Blood Pressure Measurement Devices (Sphygmomanometers)-Accuracy; Draft Revised Compliance Policy Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for FDA staff and industry entitled ``Compliance Policy Guide (CPG) Sec. 310.210 Blood Pressure Measurement Devices (Sphygmomanometers)Accuracy (CPG 7124.23).'' This draft CPG provides guidance concerning accuracy and exhaust rate criteria for sphygmomanometers. This draft guidance is being issued for public comment only and will not be implemented until a final CPG is announced in the Federal Register.
Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone and Estradiol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for an additional dose of trenbolone acetate and estradiol implant for use in feedlot heifers for increased rate of weight gain and improved feed efficiency.
Draft Guidance for Industry: Considerations for Plasmid Deoxyribonucleic Acid Vaccines for Infectious Disease Indications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications'' dated February 2005. The draft guidance document is intended to assist manufacturers and/or sponsors in the development and testing of deoxyribonucleic acid (DNA) vaccines to prevent infectious diseases. The draft guidance, when finalized, will update and replace the guidance document entitled ``Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications'' dated December 1996.
Office of Child Support Enforcement; Special Improvement Project (SIP) Grants
The Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE) invites eligible applicants to submit competitive grant applications for special improvement projects, which further the national child support mission, vision, and goals. For FY 2005, OCSE is looking for projects that reflect the goals of the new FY 2005-2009 strategic plan including the goals that all children have parentage established; and all children in IV-D (child support) cases have support orders established, have medical coverage and receive financial support from parents as ordered. The last goal of the strategic plan is that the IV-D program will be efficient and responsive in its operations. Applications will be screened and evaluated as indicated in this program announcement. Awards will be contingent upon the outcome of the competition and the availability of funds. For FY 2005, approximately $1.8 million is available for all priority areas. A non-Federal match is not required. The anticipated start date for the new awards is August 1, 2005; projects under Priority 1 may run through December 31, 2006, for a period of up to 17 months; projects under Priorities 2, 4 and 5 may run through July 31, 2007, for a period of up to 24 months and projects under Priority 3 may run through July 31, 2008, for a period of up to 36 months. Legislative Authority: Section 452(j) of the Social Security Act, 42 U.S.C. 652(j), provides Federal funds for information dissemination and technical assistance to States, training of Federal and State staff to improve child support programs, and research, demonstration, and special projects of regional or national significance relating to the operation of State child support enforcement programs.
State Median Income Estimate for a Four-Person Family (FFY 2006); Notice of the Federal Fiscal Year (FFY) 2006 State Median Income Estimates for Use Under the Low Income Home Energy Assistance Program (LIHEAP) Administration by the Administration for Children and Families, Office of Community Services, Division of Energy Assistance
This notice announces the estimated median income for four- person families in each State and the District of Columbia for FFY 2006 (October 1, 2005 to September 30, 2006). LIHEAP grantees may adopt the State median income estimates beginning with the date of this publication of the estimates in the Federal Register or at a later date as discussed below. This means that LIHEAP grantees could choose to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2005, or by the beginning of a grantee's fiscal year, whichever is later, LIHEAP grantees using State median income estimates must adjust their income eligibility criteria to be in accord with the FFY 2006 State median income estimates. This listing of estimate State median incomes provides one of the maximum income criteria that LIHEAP grantees may use in determining a household's income eligibility for LIHEAP.
Announcement of Anticipated Availability of Funds for Family Planning Services Grants
The Office of Population Affairs, Office of Public Health and Science, Department of Health and Human Services, published a notice in the Federal Register July 7, 2004, announcing the anticipated availability of funds for family planning services grants. This notice contained an error. An eligible Population/area was not listed as available for competition in 2005. A document correcting the omission of the Seattle, Washington Population/area as competitive in 2005 was published in the Federal Register August 10, 2004. Later, two additional Populations/areas, Illinois, Chicago area and Arizona, Navajo Nation, became available for competition in 2005. A second correction notice was published in the Federal Register November 22, 2004, which included all Populations/areas available for competition in 2005. Since that time, it has been recognized that the project period start date indicated in Table I for the Seattle, Washington Population/ area is incorrect. This notice corrects the project period start date to 09/30/2005 for the FY 2005 competitive year. However, the first year of the project period beginning 09/30/2005 will be abbreviated. The budget period for the 01-year will end on 06/30/2006. In subsequent years, the annualized budget period will begin on 07/01 of each project period year, and will end on 06/30 of each project period year. The purpose of this change is to modify the project period start and end dates for the Seattle, Washington Population/area in order to enhance project oversight.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Acacia (Gum Arabic)
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of acacia (gum arabic) as a thickener, emulsifier, or stabilizer in alcoholic beverages at a maximum use level of 20 percent. This action is in response to a petition filed by Kerry, Inc.
Kerry, Inc.; Withdrawal of Generally Recognized as Safe Affirmation Petition
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a generally recognized as safe (GRAS) affirmation petition (GRASP 3G0287) proposing that the use of gum acacia (arabic) in alcoholic beverages up to a maximum level of 20 percent in the finished preparation (liqueur) is GRAS.
Scientific Considerations Related to Developing Follow-On Protein Products; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening until March 16, 2005, the comment period for the notice that appeared in the Federal Register of August 16, 2004 (69 FR 50386). In the notice, FDA announced a public workshop on scientific and technical considerations related to the development of follow-on protein pharmaceutical products and plans to develop draft guidance and requested comments related to developing and approving follow-on protein pharmaceutical products. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Health Professions Preparatory, Health Professions Pregraduate and Indian Health Professions Scholarship Programs: Correction
The Indian Health Service published a document in the Federal Register on January 19, 2005. The document contained two errors.
Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop
The Food and Drug Administration (FDA) Philadelphia District, in cooperation with the Society of Clinical Research Associates (SoCRA), is announcing a workshop on FDA Clinical trial statutory and regulatory requirements. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. Date and Time: The public workshop is scheduled for Wednesday, April 13, 2005, from 8:15 a.m. to 5 p.m. and Thursday, April 14, 2005, from 8:15 a.m. to 4 p.m. Location: The public workshop will be held at the Sheraton University City Hotel Philadelphia, 3549 Chestnut St., Philadelphia, PA 19104, 215-387-8000, FAX: 215-387-7920. Contact: Marie Falcone, Food and Drug Administration, U.S. Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215- 597-2120 ext. 4003, FAX: 215-597-5798, e-mail: mfalcone@ora.fda.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $485 (member), $560 (nonmember), or $460 (government employee nonmember). (Registration fee for nonmemebers includes a 1 year membership.) The registration fee for FDA employees is waived. Make the registration fee payable to SoCRA, P.O. Box 101, Furlong, PA 18925. To register via the Internet go to https://www.socra.org/FDA Conference.htm. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) The registrar will also accept payment by major credit cards. For more information on the meeting, or for questions on registration, contact 800-SoCRA92 (800-762-7292), or 215-345-7369, or via e-mail: socramail@aol.com. Attendees are responsible for their own accommodations. To make reservations at the Sheraton University City Hotel at the reduced conference rate, contact the Sheraton University City Hotel (see Location) before March 13, 2005. The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited, therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please contact Marie Falcone (see Contact) at least 7 days in advance of the workshop.
Food and Drug Administration Drug Educational Forum; Public Workshop; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 3, 2005 (70 FR 5686). The document announced a public workshop. The document was published with a typographical error in the Supplementary Information section. This document corrects that error.
Announcement of the CDC-Wide Research Agenda Development Public Participation Meetings
The Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry (CDC) is developing a CDC-Wide Research Agenda, and invites the public to provide input. Four Research Agenda Development Public Participation Meetings will be held across the country (March 8, 2005, Arlington, VA; March 18, 2005, Atlanta, GA; March 24, 2005, Seattle, WA; and March 31, 2005, Columbus, OH). Background: On January 10, 2005, the Centers for Disease Control and Prevention launched an effort to develop its first ever, agency- wide public health research agenda. The new agenda will address and support CDC's health protection goals (https://www.cdc.gov/futures/ Goals01-6-05.pdf). The agenda will also provide overall guidance for CDC's intramural and extramural research as well as serve as an effective planning and communication tool for CDC's public health research. Request for Comments: The public is invited to participate in the development of the CDC-Wide Research Agenda. The CDC will host four Research Agenda Development Public Participation Meetings. These events will give researchers, representatives of CDC key partner organizations and the public the opportunity to voice their opinions regarding the future direction of CDC's public health research. The four meetings will be held: March 8, 2005, 8:30 a.m.-5 p.m., Hilton Crystal City Hotel at Ronald Reagan National Airport, 2399 Jefferson Davis Highway, Arlington, VA 22202; telephone 703-418-6800. Registration begins February 25, 2005. March 18, 2005, 8:30 a.m.-5 p.m., National Center for Primary Care at Morehouse School of Medicine, 720 Westview Dr., SW., Atlanta, GA 30310; telephone 404-756-5740. Registration begins March 4, 2005. March 24, 2005, 8:30 a.m.-5 p.m., Crowne Plaza Seattle, 1113 Sixth Avenue, Seattle, WA 98101; telephone 206-464-1980. Registration begins March 11, 2005. March 31, 2005, 8:30 a.m.-5 p.m., Hyatt Regency, 350 North High Street, Columbus, OH, 43215; telephone 614-463-1234. Registration begins March 18, 2005. Attendance by the public will be limited to the space available. Please communicate with the individuals listed below to request special accommodations for persons with disabilities. All those wishing to attend any of the meetings must register. See specific meeting above for date of registration. To register, please visit https://www.maximumtechnology.com/cdcreg.htm. Additional information will be available as of February 21st via the Office of Public Health Research Web site, https://www.cdc.gov/od/ophr/, or may be obtained by communicating with the contact whose name and telephone number is listed below. Contacts: Ms. Mollie Ergle, Meeting Coordinator, Office of Public Health Research, Centers for Disease Control and Prevention, Mail Stop E-72 1600 Clifton Rd. NE., Atlanta, GA 30333, E-mail: mergle@cdc.gov. Phone: 404-498-0132; Fax: 404-498-0011. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and ATSDR.
Submission for OMB Review; Comment Request; Hazardous Waste Worker Training
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 8, 2004, pages 71061-71062, and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Hazardous Waste Worker Training42 CFR Part 65. Type of Information Collection Request: Revision of OMB No. 0925-0348, expiration date February 28, 2005. Need and Use of Information Collection: This request for OMB review and approval of the information collection is required by regulation 42 CFR part 65(a)(6). The National Institute of Environmental Health Sciences (NIEHS) has been given major responsibility for initiating a worker safety and health training program under Section 126 of the Superfund Amendments and Reauthorization Act of 1986 (SARA) for hazardous waste workers and emergency responders. A network of non-profit organizations that are committed to protecting working and their communities by delivering high-quality, peer-reviewed safety and health curricula to target populations of hazardous waste workers and emergency responders has been developed. In seventeen years (FY 1987-2004), the NIEHS Worker Training program has successfully supported 20 primary grantees that have trained more than 1.3 million workers across the country and presented over 69,000 classroom and hands-on training courses, which have accounted for nearly 18 million contact hours of actual training. Generally, the grant will initially be for one year, and subsequent continuation awards are also for one year at a time. Grantees must submit a separate application to have the support continued for each subsequent year. Grantees are to provide information in accordance with S65.4 (a), (b), (c) and 65.6 (b) on the nature, duration, and purpose of the training, selection criteria for trainees' qualifications and competency of the project director and staff, cooperative agreements in the case of joint applications, the adequacy of training plans and resources, including budget and curriculum, and response to meeting training criteria in OSHA's Hazardous Waste Operations and Emergency Response Regulations (29 CFR 1910.120). As a cooperative agreement, there are additional requirements for the progress report section of the application. Grantees are to provide their information in hard copy as well as enter information into the WETP Grantee Data Management System. The information collected is used by the Director through officers, employees, experts, and consultants to evaluate applications based on technical merit to determine whether to make awards. Frequency of Response: Biannual. Affected Public: Non-profit organizations. Type of Respondents: Grantees. The annual reporting burden is as follows: Estimated Number of Respondents: 18; Estimated Number of Responses per Respondent: 2; Average Burden Hours Per Response: 10; and Estimated Total Annual Burden Hours Requested: 360. The annualized cost to respondents is estimated at: $10,764. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Joseph T. Hughes, Jr., Director, Worker Education and Training Program, Division of Extramural Research and Training, NIEHS, P.O. Box 12233, Research Triangle Park, NC 27709 or call non-toll-free number (919) 541-0217 or E-mail your request, including your address to wetp@niehs.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Draft Guidance on the Open Public Hearing; Food and Drug Administration Advisory Committee Meetings; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``The Open Public Hearing; FDA Advisory Committee Meetings.'' This draft guidance is for members of the public who choose to participate in the open public hearing (OPH) session of an FDA advisory committee meeting. The draft guidance is intended to answer more fully questions about how the public may participate at an OPH session, and it includes topics such as meeting logistics and administrative requirements.
Draft Guidance for Industry on Internal Radioactive Contamination-Development of Decorporation Agents; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Internal Radioactive ContaminationDevelopment of Decorporation Agents.'' This draft document provides guidance to industry on the development of decorporation agents for the treatment of internal radioactive contamination when evidence is needed to demonstrate the effectiveness of the agents, but human efficacy studies are unethical or infeasible. In such instances, the Animal Efficacy Rule may be invoked to approve new medical products not previously marketed or new indications for previously marketed products. Specifically, this draft guidance addresses chemistry, manufacturing and controls (CMC) information; animal efficacy, safety pharmacology, and toxicology studies; clinical pharmacology, biopharmaceutics, and human safety studies; and postapproval commitments.
Secondary Direct Food Additives Permitted in Food for Human Consumption
The Food and Drug Administration (FDA) is amending the food additive regulations to permit the manufacture of chlorine dioxide by electrolysis of an aqueous solution of sodium chlorite. This action is in response to a petition filed by Vulcan Chemicals.
Proposed Collection; Comment Request; The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture
In compliance with the requirement of Section 3506(c0(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Agricultural Health StudyA Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture: Phase III. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of this information collection is to update occupational and environmental exposure information as well as medical history information for subjects enrolled in the in the Agriculture Health Study. The primary objectives of the study are to determine the health effects resulting from occupational and environmental exposures in the agricultural environmental. The findings will provide valuable information concerning the potential link between agricultural exposures and cancer and other chronic diseases among agricultural Health Study cohort members, and this information may be generalized to the entire agricultural community. Frequency of Response: Single time reporting. Affected Public: Individuals or households; farms; Type of Respondents: Licensed pesticide applicators and their spouses. The annual reporting burden is as follows: Estimated Number of Respondents: 74,714; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.6179; and Estimated Total Annual Burden Hours Requested: 46,166. The annualized cost to respondents is estimated at: $461,660.00. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
National Institutes of Health/National Institute of Environmental Health Sciences; Proposed Collection; Comment Request; Active Living by Design Program Evaluation
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Active Living by Design Program Evaluation. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of this study is to provide NIEHS with an overall evaluation of the Active Living by Design (ALbD) program to determine the extent to which program strategies to increase physical activity influence change, as measured by increased physical activity and reduction of Body Mass Index (BMI), in residents of participating communities. The two objectives of this study are to determine: The degree to which the changes in the built environment, communication strategies and policy as a result of ALbD's program has impacted physical activity and BMI in residents within the twenty-five (25) participating communities relative to a set of ten (10) control communities; and The degree to which the ALbD program's communication strategies has positively impacted residents' knowledge and perceptions of features and conditions that impede and facilitate physical activity within their (participating) communities. Two types of data collection will occur throughout the study. A telephone and Internet survey, which relies on self-reports, will be conducted on a large sample of the population. A smaller population sample will be used during clinical surveys, which will collect physical activity data using measures of physical activity such as, accelerometers; measures of BMI and include a face-to-face interview on respondents' perceptions of their neighborhood. The findings of this study will provide valuable information concerning: (1) The direct impact ALbD strategies have on increasing physical activity and bringing about positive changes in health associated with exercise, such as weight loss: (2) possible reduction of health risks and diseases related to physical inactivity through implementation of ALbD strategies. Frequency of Response: Three times over a period of five (5) years; specifically during study years One (1), Three (3), and Five (5). Affected Public: Individuals or households. Type of Respondents: Respondents to telephone and internet surveys, includes adults, children ages 12 through 17 years and parents responding on behalf of children ages 6 through 11; Respondents to clinical surveys, includes adults and children ages 6-17. The clinical procedures require respondents under 18 years of age to be accompanied by their parent/guardian, therefore the burden has been doubled for these respondents. The annual reporting burden is represented in the following table:
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (VICH GL-36); Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (159) entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI'' (VICH GL36). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document provides guidance for assessing the human food safety of residues from veterinary antimicrobial drugs with regard to effects on the human intestinal flora.
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of January 5, 2005 (70 FR 824). The document provided the agency's annual comprehensive list of guidance documents. The list provided information on current guidance documents and those that have been withdrawn. The document was published with some inadvertent errors. This document corrects those errors.
Public Meeting of the President's Council on Bioethics on March 3-4, 2005
The President's Council on Bioethics (Leon R. Kass, M.D., Chairman) will hold its twentieth meeting, at which, among other things, it will continue its discussion of ethical issues relating to the treatment of the aged, and end-of-life care. Subjects discussed at past Council meetings (though not on the agenda for the present one) include: cloning, assisted reproduction, reproductive genetics, IVF, ICSI, PGD, sex selection, inheritable genetic modification, patentability of human organisms, neuroscience, aging retardation, lifespan-extension, and organ procurement for transplantation. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), and Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004).
Policy on Enhancing Public Access to Archived Publications Resulting From NIH-Funded Research
The National Institutes of Health (NIH) announces its policy on enhancing public access to archived publications resulting From NIH- funded research. Beginning May 2, 2005, NIH-funded investigators are requested to submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported, in whole or in part, with direct costs\1\ from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.
Chiropractor Loan Repayment Demonstration Project
The authority for the Demonstration Project has been extended with respect to chiropractors (see legislative authority below). The Health Resources and Services Administration (HRSA) announces that applications from qualified chiropractors who agree to serve underserved populations in Primary Care Health Professional Shortage Areas (HPSAs) throughout the Nation will be accepted by the National Health Service Corps (NHSC) for loan repayment awards. A two-year service commitment is required. There is no guarantee that participants in this demonstration project will have an opportunity to continue their service and loan repayments beyond the initial two-year service period. Chiropractors, with qualifying educational loans, must serve at organized primary health care sites in Primary Care HPSAs that have another NHSC clinician on staff who will be concurrently fulfilling an NHSC service commitment through the scholarship or loan repayment program and who is licensed to prescribe medications. This demonstration project will include an evaluation component to determine whether adding chiropractors as permanent NHSC members would enhance the effectiveness of the NHSC. A maximum of 40 individuals will be awarded loan repayment contracts under this demonstration project. Purpose: Eligible chiropractors will participate in the Loan Repayment Demonstration Project to determine whether their services will enhance the effectiveness of the NHSC. Legislative Authority: These applications are solicited under section 338L of the Public Health Service (PHS) Act, as amended by Public Law. 107-251 and Public Law 108-447. See also H.R. Conf. Rep. No. 108-792, at 1113, 1155 (2004); S. Rep. No. 108-345, at 41-42 (2004). Eligible Applicants: Eligible applicants must (1) be citizens or nationals of the United States, (2) possess a current unrestricted license to practice as a chiropractor in the State in which they intend to practice, (3) be negotiating or have secured employment at an eligible community site, and (4) meet the additional eligibility requirements outlined in the application materials. Chiropractors must also have a doctor of chiropractic degree from a four-year chiropractic college that is currently fully accredited by the Commission on Accreditation of the Council on Chiropractic Education, and successfully passed the entire examination by the National Board of Chiropractic Examiners. Funding Priorities or Preferences: Priority will be given to (A) applicants who have characteristics that increase the probability of their continuing to practice in HPSAs after they have completed service, and (B) subject to paragraph (A), applicants from disadvantaged backgrounds. A funding preference will also be given to applicants serving Primary Care HPSAs of greatest shortage (based on the HPSA scores). Statutory Matching or Cost Sharing Requirement: None. Review Criteria: Loan repayment applications will be evaluated to determine (1) the eligibility of the applicant, and (2) the applicant's priority for funding. Estimated Amount of this Competition: $2,000,000. Estimated Number of Awards: 40. Estimated or Average Size of Each Award: $50,000. Estimated Project Period: 2 years. Application Requests, Availability, Dates and Addresses: Application materials are available for downloading via the Web at https://nhsc.bhpr.hrsa.gov. Applicants may also request a hard copy of the application materials by contacting the National Health Service Corps at 1-800-638-0824. All application materials must be submitted in hard copy format. In order to be considered for an award, applications from chiropractors must be postmarked or delivered to the HRSA National Health Service Corps by no later than June 17, 2005 at 5 p.m. ET. Completed applications must be mailed or delivered to: Division of National Health Service Corps, NHSC Loan Repayment Program, c/o I.Q. Solutions, 11300 Rockville Pike, Suite 901, Rockville, MD, 20852. Applicants should request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing. Applications postmarked or submitted after the deadline date, or sent to any address other than that above, will be returned to the applicant and not processed. The NHSC will acknowledge receipt of the application if the applicant chooses to complete the notification postcard that is included in the application materials. Application Availability Date: February 2005. Application Deadline: June 17, 2005 at 5 p.m. et. Projected Award Date: September 30, 2005.
Implantation or Injectable Dosage Form New Animal Drugs; Zeranol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Schering-Plough Animal Health Corp. The supplemental NADAs provide for the addition of statements to labeling of subcutaneous implants containing zeranol warning against the use of these products in calves to be processed for veal.
New Mexico State University/Food and Drug Administration Food Labeling; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Small Business Representative Program (SWR SBR), in collaboration with New Mexico State University (NMSU), Department of Extension Home Economics is announcing a public workshop entitled ``NMSU/FDA Food Labeling Workshop.'' This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. Date and Time: The public workshop will be held on March 21, 2005, from 8 a.m. to 5 p.m. and on March 22, 2005, from 8 a.m. to 3 p.m. Location: The public workshop will be held at NMSU, Las Cruces, NM 88003, Gerald Thomas Hall, rm. 337. Directions to the facility are available at https://www.nmsu.edu/General/Maps/.\1\
International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q8 Pharmaceutical Development.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This draft guidance describes the suggested contents for the pharmaceutical development section in the quality module of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The draft guidance is intended to assist in the development of pharmaceutical studies that provide scientific understanding to support the establishment of specifications and manufacturing controls and serve as the basis for evaluating risk management over the life cycle of the product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs: Study 1
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on a proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study of consumer evaluations of various consumer-friendly formats for the brief summary in direct-to-consumer (DTC) prescription drug print advertisements.
International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S8 Immunotoxicity Studies for Human Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes a weight-of-evidence approach to determining whether additional immunotoxicity testing for nonbiological pharmaceuticals is appropriate when the findings from standard toxicity studies indicate signs of immunotoxicity. The draft guidance is intended to provide recommendations on nonclinical testing to identify compounds that have the potential to be immunosuppressive and guidance on a weight-of-evidence decision making approach for immunotoxicity testing.
Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (173) entitled ``Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA).'' This guidance describes how FDA intends to implement the Federal Food, Drug, and Cosmetic Act (the act) as it relates to animal drug sponsor fees.
Draft Guidance for Industry on Clinical Lactation Studies-Study Design, Data Analysis, and Recommendations for Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Lactation StudiesStudy Design, Data Analysis, and Recommendations for Labeling.'' This guidance discusses agency recommendations on how and when to conduct clinical lactation studies and how to assess the influence of drugs or biologic products on lactation. The goals of this guidance are to provide the basic framework for designing, conducting, and analyzing clinical lactation studies and to stimulate further study and research to assist in rational therapeutics for lactating patients.
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