Department of Health and Human Services October 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this document were developed using the process described in that guidance.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for seven approved new animal drug applications (NADAs) from Schering-Plough Animal Health Corp. to Huvepharma AD.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for five approved new animal drug applications (NADAs) from Merial Ltd., to Huvepharma AD.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``CGMP for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (``Lookback'')'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice announces the list of proposed substances that will be evaluated for CERCLA Set 22 toxicological profile development. ATSDR's Division of Toxicology and Environmental Medicine is soliciting public nominations from the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the evaluation of any additional substances that may have public health implications.

The Food and Drug Administration (FDA) is issuing this notice to explain the new direct-to-consumer (DTC) user fee program (DTC user fee program) established by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and, as required by the new law, to ask companies to notify FDA within 30 calendar days if they intend to participate in the DTC user fee program during fiscal year (FY) 2008 and, if they do plan to participate, to identify the number of DTC television advertisements for prescription drug and biological products they plan to submit for advisory review during FY 2008. The information gathered in response to this notice will be used to establish the FY 2008 fee that will be charged for each FY 2008 advisory review submission to FDA and to fund the operating reserve established under FDAAA.

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 to review and approve the information collection listed below. The proposed information collection was previously published in the Federal Register on July 25, 2007, in Volume 72, No. 142, pages 40887-40888, 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 NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: NICHD Research Partner Satisfaction Surveys. Type of Information Collection Request: Extension without change. Need and Use of Information Collection: Executive Order 12862 directs agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. With this submission, the NICHD seeks to obtain OMB's generic approval to conduct customer satisfaction surveys surrounding its research programs and activities. The NICHD was founded in 1963. Its mission is to ensure, through research, the birth of healthy infants and the opportunity for each to reach full potential in adulthood, unimpaired by physical or mental disabilities. The NICHD conducts and supports research on the many factors that protect and enhance the process of human growth and development. The developmental focus of the NICHD means that its research portfolio is unusually broad. NICHD programs include research on infant mortality, birth defects, learning disorders, developmental disabilities, vaccine development, and demographic and behavioral sciences, among others. In addition to supporting basic research, clinical trials, and epidemiological studies that explore health processes, the NICHD forms partnerships with organizations or institutions to ensure effective use of scientific findings and research products. The NICHD utilizes strategic assessments to support Institute planning and policy development, and to help determine programmatic and scientific objectives and priorities. Research partner surveys will augment NICHD's ongoing efforts to assess research-related activities. The two principal objectives are: (1) To measure the personal satisfaction of research partners with NICHD programs or initiatives, including both responsiveness to scientific aims and convenience of operations to support research and its effective use; and (2) to learn from research partners the ways in which the NICHD can improve the overall planning and management of it programs and initiatives. Findings will be used to improve NICHD's research programs and initiatives in the following ways: (1) To assess the effectiveness and efficiency of operations; (2) to identify opportunities for improving program performance; (3) to develop plans to incorporate innovations in program management; (4) to measure partner satisfaction and document program outcomes for governmental accountability reporting; and (5) to identify the need for creating new programs or initiatives or restructuring existing ones to respond to emerging scientific opportunities. Frequency of Response: Annual [As needed on an ongoing and concurrent basis]. Affected Public: Members of the public, researchers, practitioners, and other health professionals. Type of Respondents: Members of the public; eligible grant applicants and actual applicants (both successful and unsuccessful); clinicians and other health professionals; and actual or potential clinical trials participants. The annual reporting burden is as follows: Estimated Number of Respondents: 28,000; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: Varies with survey type, see below; and Estimated Total Annual Burden Hours Requested: 5,883. The annualized cost to respondents is estimated at: $109,541.46. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) is announcing a public hearing concerning FDA's policies regarding salt (sodium chloride) and sodium in food. FDA also is announcing the availability for comment of a citizen petition, submitted by the Center for Science in the Public Interest (CSPI), requesting that FDA make changes to the regulatory status of salt, require limits on salt in processed foods, and require health messages related to salt and sodium. The purpose of the hearing is for FDA to share its current framework of policies regarding salt and sodium and to solicit information and comments from interested persons on this current framework and on potential future approaches, including approaches described in the citizen petition.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Advertisements for Prescription Drugs'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.