Department of Health and Human Services September 23, 2020 – Federal Register Recent Federal Regulation Documents

The Building Interdisciplinary Research Careers in Women's Health (BIRCWH) Annual Meeting, held virtually December 14, 2020, sponsored by the Office of Research on Women's Health (ORWH), will focus on mentoring young investigators, present their research findings, and celebrate the 20th anniversary of the program. The Specialized Centers of Research Excellence on Sex Differences (SCORE) Annual Meeting keynote address, held virtually on December 16, 2020, sponsored by ORWH, will offer the perspective of an editor of The Lancet on sex differences research and the health of women. Both of these programs are signature programs created by ORWH in partnership with a number of National Institutes of Health (NIH) institutes and centers.

HRSA's Federal Office of Rural Health Policy (FORHP) has sought to identify clear, consistent, and data-driven methods of defining rural areas in the United States. FORHP uses the Office of Management and Budget (OMB)'s list of counties designated as part of a Metropolitan Statistical Area (MSA) as the basis for determining eligibility to apply for or receive services funded by its rural health grant programs. FORHP designates all counties that are not part of a MSA as ``rural'' and eligible for rural health grant funding or services. In addition, FORHP designates census tracts within MSAs as rural for grant purposes using Rural-Urban Commuting Area (RUCA) codes. FORHP is proposing modifications to how it designates areas to be eligible for its rural health grant programs so that community organizations serving rural populations within MSAs will be able to apply for resources and allow more of the rural populations within MSAs to access services provided using grant funds. This notice seeks comments on the proposed methodology for designating areas eligible for rural health grant programs.

The Food and Drug Administration (FDA or Agency) has determined that PREXXARTAN (valsartan) oral solution, 20 milligrams (mg)/5 milliliters (mL) and 80 mg/20 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for valsartan oral solution, 20 mg/5 mL and 80 mg/20 mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its medical product ``intended use'' regulations. This action, if finalized, will amend FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA's implementing regulations, including whether an approved or cleared medical product is intended for a new use. This action will also repeal and replace the portions of a final rule issued on January 9, 2017, that never became effective. This action is intended to provide direction and clarity to regulated industry and other stakeholders.