Department of Health and Human Services February 2012 – Federal Register Recent Federal Regulation Documents

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: ``Use of Deliberative Methods to Enhance Public Engagement in the Agency for Healthcare Research and Quality's (AHRQ's) Effective Healthcare (EHC) Program and Comparative Effectiveness Research (CER) Enterprise.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on December 1st, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of an Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) test method evaluation report (TMER) that includes recommendations on the usefulness and limitations of the LUMI-CELL[supreg] estrogen receptor (ER) transcriptional activation (TA) test method (hereafter referred to as the BG1Luc ER TA test method) to identify human ER agonist and antagonist activity of chemicals. The report also provides (1) performance standards that can be used to evaluate functionally and mechanistically similar test methods, (2) recommended test method protocols, (3) a final background review document (BRD) describing the current validation status of this test method, and (4) recommendations for future studies. ICCVAM recommends that the BG1Luc ER TA test method can be used as a screening test to identify substances with in vitro estrogen agonist and antagonist activity. This use is based on an evaluation of results from an international validation study and corresponding accuracy and reliability. The report and recommendations have been transmitted to Federal agencies to review and respond to ICCVAM in accordance with the provisions of the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-2).

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in US Patent application 61/535,668 entitled ``Pseudomonas Exotoxin A with Less Immunogenic B Cell Epitopes'' [HHS Ref. E-263-2011/0-US-01], US Patent application 61/495,085 entitled ``Pseudomonas Exotoxin A with Less Immunogenic T Cell Epitopes'' [HHS Ref. E-174-2011/0-US-01], US Patent application 61/483,531 entitled ``Recombinant Immunotoxin Targeting Mesothelin'' [HHS Ref. E-117-2011/0-US-01], U.S. Patent Application 61/241,620 entitled ``Development of an Immunotoxin in Which All B-Cell Epitopes Have Been Removed and Which Has High Cytotoxic Activity'' [HHS Ref. E-269-2009/0-US-01], U.S. Patent Application 60/969,929 entitled ``Deletions in Domain II of Pseudomonas Exotoxin A That Reduce Non-Specific Toxicity'' [HHS Ref. E-292-2007/0- US-01], U.S. Patent Application 60/703,798 entitled ``Mutated Pseudomonas Exotoxins with Reduced Antigenicity'' [HHS Ref. E-262-2005/ 0-US-01], U.S. Patent Application 60/160,071 entitled ``Immunoconjugates Having High Binding Affinity'' [HHS Ref. E-139-1999/ 0-US-01], U.S. Patent Application 60/067,175 entitled ``Antibodies, Including Fv Molecules, and Immunoconjugates Having High Binding Affinity for Mesothelin and Methods for Their Use'' [HHS Ref. E-021- 1998/0-US-01], U.S. Patent Application 60/010,166 entitled ``Molecular Cloning of Mesothelin, a Differentiation Antigen Present on Mesothelium, Mesotheliomas and Ovarian Cancers'' [HHS Ref. E-002-1996/ 0-US-01], PCT Application PCT/US97/00224 entitled ``Mesothelin Antigen and Methods and Kits for Targeting It'' [HHS Ref. E-002-1996/1-PCT-01], U.S. Patent 5,747,654 entitled ``Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity'' [HHS Ref. E-163- 1993/0-US-01], PCT application PCT/US96/16327 entitled ``Immunotoxin Containing A Disulfide-Stabilized Antibody Fragment'' [HHS Ref. E-163- 1993/2-PCT-01], and all continuing applications and foreign counterparts, to Hoffman-La Roche, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to:

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 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 medical device reporting (MDR); manufacturer, importer, user facility, and distributor reporting.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.'' The draft guidance is intended to assist manufacturers of PET drugs in submitting investigational new drug applications (INDs).

This document contains final regulations regarding the summary of benefits and coverage and the uniform glossary for group health plans and health insurance coverage in the group and individual markets under the Patient Protection and Affordable Care Act. This document implements the disclosure requirements under section 2715 of the Public Health Service Act to help plans and individuals better understand their health coverage, as well as other coverage options. A guidance document published elsewhere in this issue of the Federal Register provides further guidance regarding compliance.

The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Bioequivalence Recommendations for Rifaximin,'' one for the 200- milligram (mg) strength (rifaximin-200) and one for the 550-mg strength (rifaximin-550). The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for rifaximin tablets.

The Food and Drug Administration (FDA) has determined that WILPO (phentermine hydrochloride) Tablets, 8 Milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve Abbreviated New Drug Applications (ANDAs) for phentermine hydrochloride tablets, 8 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) has determined that KAPVAY (clonidine hydrochloride) Extended-Release Tablets, 0.2 milligram (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for clonidine hydrochloride extended- release tablets, 0.2 mg, if all other requirements are met.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through February 2013.