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

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). Elsewhere in this issue of the Federal Register, FDA is announcing that a proposed collection of information regarding dietary supplement labeling requirements and recommendations has been submitted for OMB review.

The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) at the Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services (DHHS) seeks one or more companies that have developed or are distributing rapid diagnostic tests for HIV or HCV and are interested in marketing the tests for use in the United States. The Division of HIV/AIDS Prevention and the Division of Viral Hepatitis are interested in evaluating such tests. The evaluation will include determination of sensitivity and specificity of the test, and may also evaluate the predictive value of two or more different tests used in combination in populations of low prevalence. This collaboration will have an expected duration of two (2) to three (3) years. The goals of the collaboration include the timely development of data to be used to determine whether the test could be used in screening and/or diagnosis for HIV or HCV in the United States, and to examine laboratory-based or rapid point-of-care tests. These tests require high sensitivity to detect persons with acute and longer-standing HIV infection; or high specificity to distinguish persons with acute infection from those with longer- standing infection; or high specificity for tests that can be used as to confirm HIV-1 or HIV-2 infection. Acute HIV infection is defined as the early infection period associated with a transient symptomatic illness, high viral load, and expansive immunologic response. For HCV testing, rapid tests to be used in the screening setting require high sensitivity and confirmatory tests with high specificity. Confidential proposals, preferably six pages or less (excluding appendices), are solicited from companies who have a product that is suitable for commercial distribution.

The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), the American College of Chest Physicians (ACCP), the Society of Critical Care Medicine (SCCM), and the American Thoracic Society (ATS) regarding scientific issues in clinical trial design for hospital- acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). This public workshop is intended to provide information about, and gain perspective from, health care providers, academia, and industry on various aspects of antimicrobial drug development for HAP and VAP, including diagnosis of HAP and VAP, effect of antimicrobial treatment for HAP and VAP, endpoints for trials of HAP and VAP, and statistical issues in analysis of results of trials in HAP and VAP. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on March 31, 2009, from 8 a.m. to 6 p.m. and on April 1, 2009, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited and available only on a first-come, first-served basis. Contact: Chris Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, Office of Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, Silver Spring, MD 20993- 0002, 301-796-1300. Registration: To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax numbers) to HAPwkshp@fda.hhs.gov by March 23, 2009. Persons without access to the Internet can call 301-796-1300 to register. Registration is free for the public workshop. Interested parties are encouraged to register early because space is limited. Seating will be available on a first-come, first-served basis. Persons needing a sign language interpreter or other special accommodations should notify Chris Moser or Lori Benner (see Contact) at least 7 days in advance.

The Food and Drug Administration (FDA) is postponing the meeting of the Arthritis Advisory Committee scheduled for March 5, 2009. This meeting was announced in the Federal Register of January 29, 2009 (74 FR 5165). The postponement is due to the need to complete the review of additional data submitted by the applicant. Future meeting dates will be announced in the Federal Register.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 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 U.S. Provisional Patent Application No. 60/335,705, filed October 18, 2001, now abandoned, entitled ``Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation and Regeneration'' [HHS Ref. No. E-353- 2001/0-US-01]; U.S. Provisional Patent Application No. 60/343,854, filed October 25, 2001, now abandoned, entitled ``Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation And Regeneration'' [HHS Ref. No. E-353-2001/1-US-01]; PCT Patent Application No. PCT/US02/33570, filed October 17, 2002, now abandoned, entitled ``Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation and Regeneration'' [HHS Ref. No. E-353-2001/2-PCT- 01]; U.S. Patent Application No. 10/492,901, filed April 15, 2004, which issued as U.S. Patent No. 7,229,963, on June 12, 2007, entitled ``Methods of Using Deacetylase Inhibitors as Tools to Promote Cell Differentiation and Regeneration'' [HHS Ref. No. E-353-2001/2-US-02]; and U.S. Patent Application No. 11/800,151, filed May 4, 2007, which published as 2008/0248994, on October 9, 2008, entitled ``Methods of Using Deacetylase Inhibitors to Promote Cell Differentiation and Regeneration'' [HHS Ref. No. E-353-2001/2-US-03] to ADVANCELL Advanced In Vitro Cell Technologies, S.A. which has an office in Barcelona, Spain. The patent rights in these inventions have been assigned to the United States of America and The Salk Institute for Biological Studies. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to ``the use of deacetylase inhibitors to treat dystrophies and other disorders involving tissue degeneration.''

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 the Director, the 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. Proposed Collection: Title: A Process Evaluation of the NIH Director's New Innovator Award (NIA) Program. Type of Information Collection Request: New collection. Need and Use of Information Collection: This study will assess the NIA Program operations and the outputs of the identification, evaluation and selection process. The primary objectives of the study are to: (1) Assess the NIA award selection process; (2) determine if the program was implemented as planned; and (3) determine if the process was conducted in accordance with the overall mission of the NIA program. The findings will provide valuable information concerning: (1) The characteristics of applicants and reviewers; (2) the criteria used to evaluate and select awardees; and (3) aspects of the process that could be revised or improved. Frequency of Response: Once. Affected Public: none. Type of Respondents: Applicants, Reviewers. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimated Number of Respondents: 662; Estimated Number of Responses per Respondent: 1: Average Burden Hours Per Response: .28 (15 minutes for applicants and 30 minutes for Extramural Reviewers), and Estimated Total Annual Burden Hours Requested: 188.5 and the annualized cost to respondents is estimated at $12,199.72. Table l and Table 2 respectively present data concerning the burden hours and cost burdens for this data collection.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Influenza: Developing Drugs for Treatment and/or Prophylaxis.'' Recent concerns about the possibility of pandemic spread of novel influenza strains have increased interest in influenza drug development for both seasonal and pandemic settings. The purpose of this guidance is to assist sponsors in all phases of influenza drug development and to address questions FDA often receives regarding the potential for emergency use of influenza drugs for the treatment and/or prophylaxis of influenza.

In accordance with the memorandum of January 20, 2009, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Review Plan,'' this action temporarily delays for 60 days the effective date of the final rule entitled ``Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)'' published in the January 16, 2009 Federal Register (74 FR 2873). The temporary 60-day delay in effective date is necessary to give Department officials the opportunity for further review of the issues of law and policy raised by this rule. In addition, this action solicits additional comments on the delay of the effective date.

The Office of the Assistant Secretary for Preparedness and Response (ASPR), Office of Preparedness and Emergency Operations (OPEO) announces the opportunity to cosponsor a national tactical medicine education program to train medical personnel serving on military, Federal, state and local law enforcement special response teams. Potential cosponsors must have a demonstrated interest in the subject matter and be willing to contribute substantively to the cosponsored activity.