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

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.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Synerx Pharma, LLC. The ANADA provides for the veterinary prescription use of fomepizole injectable solution as an antidote for ethylene glycol (antifreeze) poisoning in dogs.

The Food and Drug Administration (FDA) is announcing an extension of the deadline for submitting requests to participate in a pilot program involving the submission of quality (chemistry, manufacturing, and controls (CMC)) information for biotechnology products in an Expanded Change Protocol consistent with the principles of quality-by-design and risk management in pharmaceutical manufacturing. Because the deadline for requests to participate in the pilot is being extended, FDA is also extending the application submission deadlines. FDA is also announcing an increase in the number of original applications being accepted into the pilot program.