Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.

This notice announces the award of expansion supplement grants to five grantees under the Family and Youth Services Bureau (FYSB)/ Family Violence Prevention and Services Program. Expansion supplement awards are made to four technical assistance (TA) providers to support their capacity to enhance victim services by providing more extensive TA to local domestic violence programs and State domestic violence coalitions under the Open Doors to Safety: Capacity-Building Grant (Capacity-Building) project. The supplemental funds, coupled with the TA providers' expertise, will enable Open Doors Safety Capacity- Building project grantees to receive more training and site-specific consultation, so that they may build program capacity. The awards will also support State-level collaboration between domestic violence organizations and child welfare agencies. These combined efforts will strengthen the ability of domestic violence programs and their partners to better serve survivors who have diverse backgrounds, experiences, and abilities.

The Food and Drug Administration (FDA) has determined the regulatory review period for EMEND FOR INJECTION 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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act.'' This guidance is intended for manufacturers, retailers, importers, and FDA staff. The Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), states ``A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).'' The guidance discusses certain activities that FDA believes do or do not fall within the scope of the prohibition. The guidance is not intended to be an exhaustive analysis of all activities that may or may not fall within the scope of the prohibition.

The Indian Health Service published a document in the Federal Register (FR) on September 9, 2009. The document contained three errors.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID) Office of Science Policy and Planning, the National Institute of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register, July 16, 2009 (74 FR 34580), and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC) Technical Reports Review Subcommittee (TRR Subcommittee). The primary agenda topic is the peer review of the findings and conclusions presented in six draft NTP Technical Reports of rodent toxicology and carcinogenicity studies in conventional rats and mice. The TRR Subcommittee meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on the draft reports (see ``Request for Comments'' below). The TRR Subcommittee deliberations on the draft reports will be reported to the NTP BSC at a future meeting.

Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for pandemic countermeasures based on the Secretary's finding under the Act that the 2009-H1N1 virus strain and the resulting disease, 2009-H1N1 influenza, constitutes a public health emergency.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).

The Office of Community Services (OCS) announces the award of a $500,000 single source program expansion supplement to the National Association for State Community Services Programs (NASCSP), located in Washington, DC, to support performance training and technical assistance on data collection, analysis and dissemination issues faced by state community services programs within the Community Services Block Grant (CSBG) Network; develop performance based reporting tools for ARRA CSBG funded activities; develop and maintain a catalog of innovative programs and practices related to the American Recovery and Reinvestment Act of 2009 (ARRA). The project activities are designed to support and strengthen the ability of the CSBG Network to comply with and carry out CSBG activities funded by ARRA. The training projects and resources developed under the award will include analysis and explanation of the practical impact of ARRA for States and CSBG-eligible entities so that they can work more effectively to reach the ARRA goals and document how they have in fact reached those goals and used the ARRA funds.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees of Hangar 481, at Kirtland Air Force Base, Albuquerque, New Mexico, 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 Food and Drug Administration (FDA) has determined the regulatory review period for CLEVIPREX 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) is announcing the opportunity for pharmaceutical firms (applicants) to participate in a voluntary 2-year pilot program for the evaluation of proposed proprietary names to be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The pilot program will enable participating pharmaceutical firms to evaluate proposed proprietary names and submit the data generated from those evaluations to FDA for review, as outlined in the FDA concept paper entitled ``PDUFA Pilot Project Proprietary Name Review.'' This document describes procedures to register and submit data for applicants who wish to have their proposed proprietary names evaluated under the pilot program.

The Food and Drug Administration (FDA) proposes to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, the rule will clarify the postmarketing safety reporting requirements that apply when regulated articles (drugs, devices, and biological products) are combined to create a combination product. The proposed rule is intended to promote and protect the public health by clarifying requirements for postmarketing safety reporting for combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products.

As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the U.S. Department of Health and Human Services is hereby announcing that the charter for the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 (Healthy People 2020 Advisory Committee; HPAC) has been renewed.

NICEATM announces availability of the ICCVAM Test Method Evaluation Report: The Reduced Murine Local Lymph Node Assay: An Alternative Test Method Using Fewer Animals to Assess the Allergic Contact Dermatitis Potential of Chemicals and Products (NIH Publication 09-6439). The TMER provides ICCVAM's evaluation and recommendations for the reduced Murine Local Lymph Node Assay (rLLNA) test method as a reduction alternative that uses fewer animals compared to the traditional Murine Local Lymph Node Assay (LLNA) for assessing the potential of test substances to cause allergic contact dermatitis (ACD). The report includes ICCVAM's recommendations on (a) the usefulness and limitations of the rLLNA, (b) an updated ICCVAM LLNA test method protocol, which includes the procedures for conducting the rLLNA, (c) future studies to further characterize the usefulness and limitations of the rLLNA, and (d) rLLNA test method performance standards. The TMER includes the report of an international independent scientific peer review panel (hereafter, Panel) and the final rLLNA background review document (BRD). The BRD provides the data and analyses used to evaluate the current validation status of the rLLNA test method for assessing the ACD potential of chemicals and products. ICCVAM concluded that the scientific validity of the rLLNA has been adequately evaluated and that the performance of the rLLNA, when conducted in accordance with the ICCVAM-recommended LLNA test method protocol, is sufficient to distinguish between skin sensitizers and non-sensitizers. ICCVAM also concluded that the rLLNA would reduce animal use by 40% for each test compared to the traditional, multi-dose LLNA. Accordingly, ICCVAM recommends that the rLLNA test method should be routinely considered before conducting the traditional, multi-dose LLNA, and used where appropriate as the initial test to determine the potential of chemicals and products to produce ACD. For testing situations that require dose-response information, rLLNA-positive substances will need to be tested with the traditional multi-dose LLNA. This testing should be done using the updated ICCVAM-recommended test method protocol, which reduces animal use by 20% compared to the original ICCVAM-recommended test method protocol by decreasing the minimum number of animals per dose group from five to four.

The Centers for Disease Control and Prevention (CDC) is seeking information on development and operation of a national transplantation sentinel network (TSN) for the United States, including resources needed for management of such a system. The purpose of the network is to detect and prevent disease transmission from organ and tissue allografts recovered for transplantation.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Clinical Center, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 14, 2009, page 22749 and allowed 60-days for public comment. One comment was received:

This proposed rule would implement a case-mix adjusted bundled prospective payment system (PPS) for Medicare outpatient end-stage renal disease (ESRD) dialysis facilities beginning January 1, 2011, in compliance with the statutory requirement of the Medicare Improvements for Patients and Providers Act (MIPPA), enacted July 15, 2008. The proposed ESRD PPS would replace the current basic case-mix adjusted composite payment system and the methodologies for the reimbursement of separately billable outpatient ESRD services.

This notice announces the request for nominations for consideration for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other things, the MEDCAC advises the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services, as requested by the Secretary, whether medical items and services are ``reasonable and necessary'' and therefore eligible for coverage under Title XVIII of the Social Security Act.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 11, 2009 (74 FR 6896). The document announced the withdrawal of approval of 103 new drug applications (NDAs) and 35 abbreviated new drug applications (ANDAs). The document published with an error in the identification of the ANDA for Amiodarone Hydrochloride Injection, 50 milligrams/ milliliter, held by Hospira, Inc. This document corrects that error.

This notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.

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 Office of Extramural Research, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (0MB) for review and approval.

This notice announces a listening session being conducted as part of the proposal to further the Medicare program's ability to assess the relative resources used for beneficiary care using episodes of care as the unit of measurement. This listening session will solicit comments on the range of issues in the analysis of the applicability of currently available tools to identify discrete episodes of care for Medicare beneficiaries. Physicians, physician associations, and all other interested parties are invited to participate. The meeting is open to the public, but attendance is limited to space and teleconference lines available.

This final notice announces our decision to approve the American Osteopathic Association (AOA) for continued recognition as a national accreditation program for ambulatory surgical centers (ASCs) seeking to participate in the Medicare or Medicaid programs.

This notice announces the annual Medicare Provider Feedback Group (MPFG) Town Hall meeting. This meeting is open to all Medicare Fee-for-Service (FFS) providers and suppliers that participate in the Medicare program, including physicians, hospitals, home health agencies, third-party billers, and interested parties, to present their individual views and opinions on selected FFS Medicare topics. In addition, we will be soliciting input on how we can improve communications to better serve the Medicare providers and suppliers.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on July 17, 2009, Volume 74, Number 136, pages 34760-34761 and allowed 60 days for public comment. Two public comments were received. One questioned the value of this study and suggested that the study could not possibly be completed within the stated cost estimates. We have always conducted extremely efficient studies within stated cost estimates. The value of this research is demonstrated by the involvement of multiple government agencies. The second e-mail simply expressed interest in more information. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

This Federal Register Notice announces the non-competitive extension of Grant Number U69HA07626, Supporting Networks of HIV Care by Enhancing Primary Medical Care (SNHC by EPMC), to the CAEAR Coalition Foundation, Inc., the awardee of record, for one additional year, through August 31, 2010, at a funding level of approximately $1,451,445. The purpose of the award extension is to allow for the completion of ongoing work and an external evaluation assessment of the project's activities undertaken during the project period of September 1, 2006, through August 31, 2009, before a new competitive cycle is started. Evaluation findings will help HRSA frame a new competitive opportunity in fiscal year (FY) 2010. The authority for this funding is the Public Health Service Act, section 2692, 42 U.S.C. Sec. 300ff-111, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Pub. L. 109-415); it can be viewed under the Catalog for Federal Domestic Assistance (CFDA) Number 93.145.

The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of five new drug applications (NDAs) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications.

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.

In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), this notice announces that the Administration for Children and Families (ACF), Office of Human Services Emergency Preparedness and Response (OHSEPR) intends to submit to notice in the Federal Register for comments on the ACF Disaster Case Management Implementation Guide, dated December 10, 2008.

The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and Office of New Animal Drugs (ONADE) is announcing the availability of grant funds for the support of a sole source, cooperative agreement award to Georgetown University, Lombardi Cancer Research Center and Department of Oncology entitled: ``Genome Wide Methylation Arrays for Detection Markers of Increased Susceptibility to Mammary Cancer Caused by In-Utero Exposures to Endocrine Disruptors (U01).'' The main purpose of this study is to help gain an understanding of the extent to which exposures to endocrine disruptors early in life increase later susceptibility to developing breast cancer by inducing heritable epigenetic changes in transcription factors, which are linked to increased breast cancer risk. The study is subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331, et seq.) regulations issued under it and applicable Department of Health and Human Services statutes and regulations.

HRSA has issued a non-competitive replacement award under the Rural Health Network Development Program to White River Rural Health Center, Inc. (WRRHC). The original grantee, Siloam Springs Memorial Hospital, is no longer eligible to serve as the lead entity for this network of rural health care providers serving a five county area in Arkansas and Oklahoma. This replacement award will ensure that the medically underserved residents of western Benton and Washington counties in Arkansas and Adair, Cherokee, and Delaware counties in Oklahoma continue receiving necessary medical care and services without disruption.

Concerns about the emergence of a pandemic influenza virus have spurred research on influenza viruses that have either caused pandemics or are believed to have the potential to cause a pandemic. These viruses include human H2N2 virus, which circulated from 1957- 1968, the 1918-1919 H1N1, which caused the deadliest pandemic in the past century, and the Highly Pathogenic Avian Influenza (HPAI) H5N1 virus that is thought to have pandemic potential. The public health benefits of this research include developing a better understanding of the pathogenicity of pandemic influenza viruses, their virulence mechanisms, mechanisms of host adaptation, and ultimately the development of vaccines and antiviral drugs. These benefits are balanced against the potential risks that might include the inadvertent release of a highly transmissible and potentially virulent influenza virus. Consequently, explicit and uniform biosafety containment practices are critical to the safe conduct of research with these agents. The NIH Guidelines provide a framework for assessing the risks of such research. However, after extensive consultation with the NIH Recombinant DNA Advisory Committee (RAC), experts in biosafety and influenza, the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA), the NIH Office of Biotechnology Activities (OBA) concluded that more specific guidance in the NIH Guidelines is warranted to promote uniform biosafety practices for recombinant research with these viruses.

The Centers for Disease Control and Prevention (CDC) is seeking information on development and operation of a national transplantation sentinel network (TSN) for the United States, including resources needed for management of such a system. The purpose of the network is to detect and prevent disease transmission from organ and tissue allografts recovered for transplantation.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``End-of-Phase 2A Meetings.'' This guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs). The purpose of an EOP2A meeting is to facilitate interaction between FDA and sponsors who seek guidance related to clinical trial design employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, disease, placebo), designing trials for better dose response estimation and dose selection, and other related issues. This guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and improve the quality of drug applications through early meetings with sponsors.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 14, 2009, pages 17195-17196, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995 unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines'' dated September 2009. The draft guidance document provides recommendations to sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine on critical clinical considerations for investigational studies of these products. The draft guidance applies to therapeutic cancer vaccines that are intended to be administered to patients with an existing cancer for the purpose of treatment. The draft guidance does not apply to products intended to be administered to patients to prevent or decrease the incidence of cancer and does not apply to adoptive immunotherapeutic products such as T cell or NK cell products.

HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. Therefore, we are requesting comments on the PIN referenced above. Comments will be reviewed and analyzed, and a summary and general response will be published as soon as possible after the deadline for receipt of comments.