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

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and prevention (CDC), will conduct a public meeting to discuss current respirator standards development projects for Supplied Air Respirators (SAR); Air Fed Ensembles; and Total Inward Leakage (TIL) for respirators other than filtering facepieces and halfmasks. There will be an opportunity for discussion following NIOSH's presentations and an accompanying poster session.

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: ``CAHPS Field Test of Proposed Health Information Technology Questions and Methodology.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (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 announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). This notice solicits comments on the proposed collection of information associated with the draft guidance document entitled ``Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007.'' The draft guidance, when finalized, will assist the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA).

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Dr. Mary E. Sawaya a.k.a. Marty Sawaya (Dr. Sawaya) from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Sawaya was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, and conduct otherwise relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Dr. Sawaya failed to request a hearing. Dr. Sawaya's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Dr. Allyn M. Norman for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Norman was convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product or otherwise relating to the regulation of drug products under the act, and that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Norman failed to request a hearing and, therefore, has waived his opportunity for a hearing concerning this action.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007.'' The draft guidance, when finalized, will assist the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDA is also announcing a further delay in the implementation of the Reportable Food Registry (the Registry) of FDAAA until September 8, 2009, to consider any comments received on the draft guidance and through the agency's planned outreach initiatives, and to allow for further testing of the electronic portal for reportable foods.