Department of Health and Human Services May 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Drugs.Com. The purpose of the MOU is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of emerging safety issues and product recalls.

This interim final rule (IFR) with request for comment is meant to comply with the statutory directive to issue a regulation defining ``underserved rural community'' for purposes of the Rural Physician Training Grant Program in section 749B of the Public Health Service Act, as amended by the Patient Protection and Affordable Care Act of 2010. This IFR is technical in nature. It will not change grant or funding eligibility for any other grant program currently available through the Office of Rural Health Policy (ORHP) or HRSA. For purposes of the Rural Physician Training Grant Program only, HRSA has combined existing definitions of ``underserved'' and ``rural'' by using the definition of rural utilized by the ORHP Rural Health Grant programs and the definition of ``underserved'' established by HRSA's Office of Shortage Designation (OSD) in the Bureau of Health Professions (BHPr).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2).'' The draft guidance provides information to the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA).

The NIH Guidelines requires certain recombinant research to be reviewed by the NIH Recombinant DNA Advisory Committee and approved by the NIH Director (Section III-A-1). Such research involves the introduction of drug resistance into a microorganism if the introduction of that drug resistance trait can compromise the ability to treat disease caused by the microorganism in humans, animals or agriculture. In order to meet the threshold for consideration under Section III-A-1, the microorganism must be able to cause disease in humans, animals or agriculture.

As part of the second phase of the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration.'' The report includes 21 draft proposals about expanding disclosure of information by the agency while maintaining confidentiality of trade secrets and individually identifiable patient information. FDA is seeking public comment on the draft proposals, as well as on which draft proposals should be given priority. Some of the draft proposals may require extensive resources to implement, and some may require changes to regulations or legislation.