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

With this notice, the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) announces a public meeting and requests input from interested parties on issues that the agency will consider as it develops regulations to expand the clinical trial registry and results data bank commonly known as ClinicalTrials.gov in accordance with section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) [Pub. L. 110-85]. FDAAA requires a public meeting to be held to provide an opportunity for input from interested parties with regard to regulations that are to be issued within three years of enactment of the law. The NIH seeks input from all interested parties about issues to be considered in the proposed rulemaking. Comments on these issues will inform the development of draft regulations, which will be made available for public comment via a separate Notice of Proposed Rulemaking (NPRM) that will be issued in the Federal Register at a later date. Section III of this document lists specific topics and questions on which input is sought.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Community- Acquired Bacterial Pneumonia: Developing Drugs for Treatment.'' This draft guidance informs industry of FDA's current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of community-acquired bacterial pneumonia (CABP). This draft guidance does not address the development of drugs for other purposes or populations, such as treatment of patients with hospital-acquired pneumonia or ventilator-associated pneumonia. This draft guidance revises the draft guidance for industry entitled ``Community-Acquired Pneumonia-Developing Antimicrobial Drugs for Treatment'' published July 1998.

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 Heart, Lung and Blood Institute (NHLBI), 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: Survey of NHLBI Constituents' Health Information Needs and Preferred Formats. Type of Information Collection Request: NEW. Need and Use of Information Collection: The purpose of this survey is to obtain information from NHLBI constituents (health professionals, patients and their families, and the general public) for the purpose of evaluating their health information and education needs and format preferences. The Consumer Services Team (CST) will use the data collected in this survey to create a 3-year Strategic Plan. The findings from the survey, described in the Strategic Plan, will be used to develop new health information materials for NHLBI constituents and to revise materials currently in the Institute's portfolio. Frequency of Response: Once every 3 years. Affected Public: Individuals. Type of Respondents: Individuals who have been consumers of NHLBI information within the past 3 years. The annual reporting burden is as follows: Estimated Number of Respondents: 2,450; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.2; and Estimated Total Annual Burden Hours Requested: 162. The annualized cost to respondents is estimated at: $3,518.62. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), 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 June 26, 2008, (Vol. 73 No. 124, page 36337) 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 November 15, 2008, unless it displays a currently valid OMB control number. Proposed Collection: Title: Simulations for Drug Related Science Education. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to evaluate an interactive multimedia module developed by ArchieMD. This evaluation seeks to determine whether the multimedia module Archie MD: The Science of Drugs (1) Increases students' knowledge in brain and heart biology and the effects drugs have on the body (2) Increases positive attitudes towards science education for high school students (3) Reinforce or instill negative attitudes towards substance abuse. In order to test the effectiveness of the interactive multimedia module, data will be collected in the form of pre and post test surveys from 10th and 11th grade high school students utilizing the developed module. The findings will provide valuable information regarding information pertaining to the use of interactive multimedia educational modules in high school science classrooms and their ability to increase knowledge and change attitudes and perceptions. Frequency of Response: 4. Affected Public: High school students engaged with the ArchieMD: The Science of Drugs program. Type of Respondent: Participants will include high school students enrolled in the tenth and eleventh grade. Estimated Total Annual Number of Respondents: 360. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: One high school period lasting 50 minutes. Estimated Total Annual Burden Hours Requested: 1199.95. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comments on a Draft Report to the Secretary of Health and Human Services, ``Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests'' (available at https://oba.od.nih.gov/ SACGHS/sacghspubliccomments.html). A copy can also be obtained from the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) by e-mailing faunteroytd@od.nih.gov or calling 301-496-9838.

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of an aqueous solution of silver nitrate and hydrogen peroxide as an antimicrobial agent in bottled water. This action is in response to a petition filed by Kareem I. Batarseh.