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

The Food and Drug Administration (FDA) has determined the regulatory review period for MOZOBIL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) Baltimore District, in co-sponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public educational forum entitled ``Drugs & Medical Device Supplier Management Forum.'' This 2-day public educational forum, a component of AFDO's Annual Educational Conference, is intended to provide information about FDA drug and device regulation to the regulated industry.

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 requests for exemption from the food additive listing regulation requirements that are submitted under part 170 (21 CFR part 170).

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Kevin Xu 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 Mr. Xu was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. Mr. Xu was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of September 23, 2009, Mr. Xu has failed to respond. Mr. Xu's failure to respond constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of the remaining portion of a color additive petition (CAP 8C0262) proposing an amendment of the color additive regulations to provide for the safe use of composite pigments prepared from synthetic iron oxide, mica, and titanium dioxide to color food.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to substantially revise ``Public Health Service (PHS) and National Health Service Corps (NHSC) Scholarship/Loan Repayment Participants Records System, HHS/HRSA/BPHC,'' HRSA Systems of Records No. 09-15-0037, to reflect organizational and physical location changes, and to update the categories of individuals and records covered by the system. HRSA is also proposing to (a) delete the Nursing Student Education Direct Loan Program, which is not administered by HRSA; (b) add records pertaining to the Nursing Scholarship Program and the Student/Resident Experiences and Rotations in Community Health (SEARCH) Program; and (c) incorporate the Faculty Loan Repayment Program and the Physician Shortage Area Scholarship Program, which previously had their own System of Records Notices (09-15-0058, and 09- 15-0042 respectively). These changes will require renaming the system of records and expanding the Authority to maintain the system. HRSA has updated the section on maintenance and storage of records to reflect current technologies, as well as Purpose(s), Safeguards, Retention and Disposal (of records), Notification Procedures, and Records source categories to detail current operations. HRSA is proposing to delete routine uses that are obsolete and to add new routine uses that cover disclosures of information needed for effective program operations.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Ames Laboratory, Ames, Iowa, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:

The National Cancer Institute, Division of Cancer Treatment and Diagnosis, is seeking comments on a proposed revision to its policy on intellectual property agreements with certain funding recipients, entitled the Cancer Therapy Evaluation Program (CTEP) INTELLECTUAL PROPERTY OPTION. The proposed policy, if finalized, would establish that potential applicants for CTEP funding should include an assurance of agreement with the recommended Intellectual Property Option and Institution Notification if they wish to be considered for funding support to carry out any CTEP-sponsored clinical trial for which CTEP holds the investigational new drug (IND) application.

The Food and Drug Administration (FDA) has determined the regulatory review period for FANAPT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.