Department of Health and Human Services February 2005 – Federal Register Recent Federal Regulation Documents

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.

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.

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.

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:

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.

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.

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.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's address for Phibro Animal Health.

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.

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.