Department of Health and Human Services April 8, 2010 – Federal Register Recent Federal Regulation Documents

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: