Department of Health and Human Services August 30, 2011 – Federal Register Recent Federal Regulation Documents

The Office of Refugee Resettlement, ACF, HHS published a document in the Federal Register of August 16, 2011 (76 FR 50744), concerning the issuance of an urgent single-source grant to Survivors of Torture, International (SOTI), San Diego, CA. The document contained incorrect information in citing the statutory authority for making this award. Correction: In the Federal Register of August 16, 2011 (76 FR 50744), ORR omitted the primary authority for issuing this award. The notice should have included the following: Awards announced in this notice are authorized by the Torture Victims Relief Act (TVRA) of 1998,'' Public Law 105-320 (22 U.S.C. 2152 note), reauthorized by Public Law 109-165 in January 2006. Section 5 (a) of the TVRA of 1998 provides for ``Assistance for Treatment of Torture Victims. The Secretary of Health and Human Services may provide grants to programs in the United States to cover the cost of the following services: (1) Services for the rehabilitation of victims of torture, including treatment of the physical and psychological effects of torture. (2) Social and legal services for victims of torture. (3) Research and training for health care providers outside of treatment centers, or programs for the purpose of enabling such providers to provide the services described in paragraph (1).'' And by Section 412 (c)(1)(A) of the Immigration and Nationality Act (INA) (8 U.S.C. 1522(c)(1)(A), as amended, and the Refugee Assistance Extension Act of 1986, Public Law 99-605, Nov 6, 1986, 100 Stat. 3449.

The Food and Drug Administration (FDA) has determined that TALWIN COMPOUND (aspirin; pentazocine hydrochloride (HCl)) tablets, 325 milligrams (mg); equivalent to (EQ) 12.5 mg base, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for aspirin; pentazocine HCl tablets, 325 mg; EQ 12.5 mg base, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) has determined that OPANA ER (oxymorphone hydrochloride (HCl)) extended-release tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs for oxymorphone HCl extended- release tablets, 7.5 mg and 15 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name and function of the Anesthetic and Life Support Drugs Advisory Committee. This action is being taken to reflect changes made to the charter for this advisory committee.

This notice announces the availability of one toxicological profile, prepared by ATSDR for the Department of Defense, on Royal Demolition eXplosive (RDX), chemical name hexahydro-1,3,5-trinitro- 1,3,5-triazine, also known as cyclonite.

The Food and Drug Administration (FDA) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee to be submitted to FDA with applications using a priority review voucher is determined each FY based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the priority review fee rate for FY 2012.