Department of Health and Human Services April 2013 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Service (HHS), Office of Minority Health (OMH), is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Minority Health (hereafter referred to as the ``Committee or ACMH''). In accordance with Public Law 105-392, the Committee provides advice to the Deputy Assistant Secretary for Minority Health, on improving the health of each racial and ethnic minority group and on the development of goals and specific program activities of OMH designed to improve the health status and outcomes of racial and ethnic minorities. Nominations of qualified candidates are being sought to fill upcoming vacancies on the Committee.

The Food and Drug Administration (FDA) is announcing that the generic drug facility self-identification reporting period for fiscal year (FY) 2014 will begin on May 1, 2013, and close on June 1, 2013. Generic drug facilities, certain sites, and organizations identified in a generic drug submission are required by the Generic Drug User Fee Amendments of 2012 (GDUFA) to submit, update, or reconfirm identification information to FDA annually.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: David Sharlip, NLM Project Clearance Liaison, Office of Administrative and Management Analysis Services, OAMAS, NLM, NIH, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number (301) 496-5441, or Email your request, including your address to: sharlipd@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.

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: ``Evaluating the Knowledge and Educational Needs of Students of Health Professions on Patient-Centered Outcomes Research.'' 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 January 28th, 2013 and allowed 60 days for public comment. No substantive comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Office of Disease Prevention (ODP), National Institutes of Health (NIH), is amending the due date for responses to its Request for Information (RFI), published in Vol. 78, Issue 49, of the Federal Register on March 13, 2013. The due date has been extended from April 14, 2013, to April 30, 2013, to allow more time for review. Comments must be submitted electronically using the web-based form available at https://prevention.nih.gov/aboutus/strategic_plan/rfi.aspx.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0001, which expires on September 30, 2013. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Baker Brothers site in Toledo, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 6, 2013, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

HRSA will be issuing a non-competitive one-year extension with funds for the Black Lung/Coal Miner Clinics Program awards to the current grantees (included in attached chart), in amounts between $299,000 and $1.5 million over the one-year extension project period. The level of support is at the same annual rate that was authorized in fiscal year (FY) 2012. The Black Lung/Coal Miner Clinics Program supports projects that seek to prevent, monitor, and treat pulmonary and respiratory diseases in active and inactive miners. This extension with funds will allow the Office of Rural Health Policy (ORHP) to reassess the priorities and scope of the program. The extension will also allow for greater pre-application technical assistance and opportunity to ensure funding levels can adequately address target population needs in various parts of the country.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the President's Council on Fitness, Sports, and Nutrition (PCFSN) will hold a meeting. The meeting will be open to the public.

The NIOSH National Personal Protective Technology Laboratory is initiating a research study in support of American Society for Testing and Materials (ASTM) International standards development to establish minimum performance requirements for isolation gowns for health care workers. NIOSH is seeking to identify currently marketed isolation gown products. All manufacturers are requested to submit samples to NIOSH free of charge for testing. There will be no cost to the manufacturers for testing. Not all submitted products may be tested, depending on the response to this announcement and the results of screening tests. Each manufacturer that submits gowns that are tested will receive the test results from their gowns. Through submission of the gown samples, manufacturers will be making an important contribution to ASTM, International's process to establish an important standard for evaluating the protection provided for health care workers by isolation gowns. Participating manufacturers will be recognized as contributing to the establishment of the performance standard. Manufacturers whose products are tested will also receive the results of all gowns tested in a blinded format. Gown Criteria: Candidate gowns for inclusion in the research program must meet the following criteria: (1) The gowns must be identified (labeled) as ``isolation gowns'' and have full coverage in the back to provide protection for the health care worker and the patient; (2) A minimum of 100 units for each code (model) of disposable (single use) gown submitted; (3) A minimum of 200 ``new'' (unprocessed, unused, unwashed) reusable gowns for each model submitted. Reusable gown submissions must include a labeling recommendation for the maximum number of laundering cycles to be included in this study. Half of the gown samples will be tested after one laundering and drying cycle and half of the gown samples will be tested as laundered for the maximum number of cycles claimed by the manufacturer; and, (4) Samples should be provided in finished package format, with any claims that may not be noted on the packaging or labels provided by the manufacturer. NIOSH will not return any gowns submitted for this testing.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.