Department of Health and Human Services January 2009 – Federal Register Recent Federal Regulation Documents

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the act) addressing the agency's treatment of certain citizen petitions and petitions for stay of agency action (collectively, petitions), as well as related applications. The draft guidance describes how FDA will determine if the new provisions apply to a particular petition and how FDA will determine if a petition would delay approval of a pending abbreviated new drug application (ANDA) or 505(b)(2) application. The draft guidance also describes how FDA will interpret the requirements that such petitions include a certification and that supplemental information or comments to such petitions include a verification. The draft guidance also addresses the relationship between the review of petitions and pending ANDAs and 505(b)(2) applications for which the agency has not yet made a decision on approvability.

The Food and Drug Administration (FDA) is announcing the availability of two draft documents. The first is entitled ``Report of Quantitative Risk and Benefit Assessment of Commercial Fish Consumption, Focusing on Fetal Neurodevelopmental Effects (Measured by Verbal Development in Children) and on Coronary Heart Disease and Stroke in the General Population'' (draft risk and benefit assessment report). The draft risk and benefit assessment report describes an analysis done by FDA that results in quantitative estimates of the net effect on fetal neurodevelopment in children of maternal consumption of commercial fish, as measured by verbal development and the net effect of eating commercial fish on coronary heart disease and stroke in the general population. Effects with respect to each of these health endpoints has been associated in the scientific literature with methylmercury exposure (which primarily occurs through fish consumption) and with the consumption of fish and of omega-3 fatty acids, which are found in fish. The second draft document entitled ``Summary of Published Research on the Beneficial Effects of Fish Consumption and Omega-3 Fatty Acids for Certain Neurodevelopmental and Cardiovascular Endpoints'' (draft summary of published research) is a compendium of research prepared by FDA for use in developing its quantitative risk and benefit assessment. When peer and public review are complete, the draft risk and benefit assessment report and the draft summary of published research are intended to add to the growing body of scientific literature investigating the likelihood, magnitude, and direction of health impacts linked to consumption of commercial fish. FDA is seeking public comment on the draft risk and benefit assessment report and the draft summary of published research.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) Vaccine Safety Working Group will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Audio conferencing will be available for listening only.

The Food and Drug Administration (FDA) is announcing the withdrawal of the guidance entitled ``Guidance for Industry and FDA: Interim Evidence-Based Ranking System for Scientific Data'' that was issued on July 10, 2003.

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, March 18, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of Bayesian statistics to interpret evidence in making coverage decisions. The meeting will introduce Bayesian concepts, contrast Bayesian approaches with frequentist approaches, and provide some examples of using Bayesian techniques for meta-analyses. Bayesian analysis is a statistical technique in which prior evidence is used to update or to newly infer the probability that a hypothesis may be true. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

This interim final rule with comment period implements certain provisions of section 154 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) related to the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) Competitive Acquisition Program. Specifically, this rule: Implements certain MIPPA provisions that delay implementation of Round 1 of the program; requires CMS to conduct a second Round 1 competition (the ``Round 1 rebid'') in 2009; and mandates certain changes for both the Round 1 rebid and subsequent rounds of the program, including a process for providing feedback to suppliers regarding missing financial documentation and requiring contractors to disclose to CMS information regarding subcontracting relationships.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Voluntary Third- Party Certification Programs for Foods and Feeds.'' This guidance describes the general attributes FDA believes a voluntary third-party certification program should have in order to help ensure its certification is a reliable reflection that the foods and feeds (hereinafter foods) from certified establishments meet applicable FDA requirements, as well as other certification criteria.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Submission of Laboratory Packages by Accredited Laboratories.'' The draft guidance document provides information and recommendations about accreditation standards for laboratories and the quality and type of data that accredited laboratories produce to support testing results submitted to FDA about the admissibility of detained articles offered for import. We are taking this action under a recommendation made by the President's Interagency Working Group on Import Safety (Working Group).