Department of Health and Human Services February 2008 – Federal Register Recent Federal Regulation Documents

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow information collection related to implementation of the Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to 299b-26, in: ``Patient Safety Organization Certification and Related Forms and a Patient Safety Confidentiality Complaint Form.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

The Agency for Healthcare Research and Quality (AHRQ) invites individuals and organizations to nominate primary and secondary prevention topics pertaining to clinical preventive services that they would like the United States Preventive Services Task Force (USPSTF) to consider for review. All topics previously reviewed by the USPSTF are available on AHRQ's Web site, https://www.preventiveservices.ahrq.gov. The USPSTF is an independent panel of experts that makes evidence- based recommendations regarding the provision of clinical preventive services. Clinical preventive services include screening, counseling and preventive medications associated with primary care. The USPSTF makes recommendations about preventive services for asymptomatic peoplepeople without recognized signs or symptoms of the specific conditions targeted by the preventive service. Topics can be nominated by individuals, organizations, evidence- based practice centers (EPC) and USPSTF members. The USPSTF will consider nominations in two steps. The USPSTF will first determine if the service is eligible, i.e., constitutes primary or secondary prevention applicable to healthy asymptomatic persons; is primary care feasible or referable from primary care; and addresses a condition with a substantial health burden. As a second step, within eligible topics, the USPSTF will prioritize based on the following set of criteria: public health importance (burden of suffering, potential of preventive service to reduce the burden); and potential for greatest Task Force impact (e.g., clinical controversy, practice does not reflect evidence, inappropriate timing in delivery of services).

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Division of Select Agents and Toxins (DSAT) of the Centers for Disease Control and Prevention (CDC). The purpose of this MOU is to establish a procedure to allow CDC/DSAT to confirm that FDA has accepted or approved, under the authority of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq), an Investigational New Drug application (IND), a request to establish an Investigational New Animal Drug file (INAD), or an Investigational Device Exemption application (IDE) for a clinical trial involving the use of an investigational product that is, bears, or contains a select agent or toxin.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to FDA's adverse experience reporting (AER) for licensed biological products, and general records associated with the manufacture and distribution of biological products.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Safety Testing of Drug Metabolites.'' This guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. It also provides recommendations on the timing and type of nonclinical studies that should be conducted to investigate the potential for clinical toxicity of drug metabolites. This guidance applies to small molecule nonbiologic drug products under development. This guidance finalizes the draft guidance published on June 6, 2005.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Anti-Infective Drugs Advisory Committee. This meeting was announced in the Federal Register of January 11, 2008 (73 FR 2055). The amendment is being made to reflect a change in the Date and Time and Agenda portions of the document. There are no other changes.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Improving Quality through Health IT: Testing the Feasibility and Assessing the Impact of Using Existing Health IT Infrastructure for Better Care Delivery.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) is amending certain regulations regarding generally recognized as safe (GRAS) substances to remove references to FDA development of food-grade specifications in cooperation with the National Academy of Sciences (NAS, now the National Academies). This action is editorial in nature and is intended to ensure the accuracy of the agency's regulations.