Department of Health and Human Services August 31, 2005 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This final rule adopts, with certain revisions, the changes made to 5 CFR part 5501 in the interim final rule that was published on February 3, 2005, at 70 FR 5543. After considering comments to that rulemaking, this final rule: Clarifies the definition of an ``employee of a component;'' Amends the outside activity prior approval requirements applicable to employees of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH); Revises prior approval information collection requirements and the waiver provision applicable to the outside activities prohibitions; Removes professional associations and other science and health-related organizations from the list of entities with which NIH employees are prohibited from engaging in outside activities; Adds exceptions to the NIH outside activities prohibition for delivering a class lecture as part of a regularly scheduled university course, serving on data and safety monitoring boards and grant and scientific review committees, and presenting in Grand Rounds; Limits the prohibition on holding financial interests in substantially affected organizations to senior NIH employees, their spouses, and minor children only, permits investments in such organizations that do not exceed $15,000, and allows holdings capped at $50,000 in sector mutual funds that concentrate their investments in the securities of substantially affected organizations; and Revises the outside award limitations for senior NIH employees by applying an official responsibility test for matters potentially involving an award donor. In addition, the financial disclosure reporting requirements specified in new part 5502 that were added by the interim final rule of February 3, 2005, at 70 FR 5543, and amended by an interim final rule that was published on June 28, 2005, at 70 FR 37009, are adopted as final, subject to certain amendments. The requirement to file a supplemental disclosure of financial interests in substantially affected organizations is refocused to apply to NIH employees who file a public or confidential financial disclosure report and other NIH employees who are designated as investigators in an NIH clinical research protocol approved by an institutional review board. The due date for the initial report is also changed.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of General Medical Sciences (NIGMS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 22, 2005, pages 8594-8595 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: Survey of NIGMS Minority Opportunities in Research (MORE) Division Institutional Program Directors. Type of Information Collection Request: NEW. 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. 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. Data on student enrollment and highest degree received will be collected from 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). 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. 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: