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

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. At this time, FDA is issuing final regulations to implement the act. These regulations describe the procedures for designating a new animal drug as a minor use or minor species drug. Such designation establishes eligibility for the incentives provided by the MUMS act.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Emergency Use Authorization of Medical Products.'' The guidance explains FDA's policies for authorizing the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency. This guidance finalizes the draft guidance published in the Federal Register of July 5, 2005 (70 FR 38689).

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)'' dated July 2007. The draft guidance document discusses certain cell selection devices that minimally manipulate autologous PBSCs at the point of care for specific clinical indications, and the applicability of the requirements to such PBSCs. The guidance also discusses the submission of data intended to support approval of cell selection devices.

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.

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 Institute of Child Health and Human Development (NICHD), 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: NICHD Research Partner Satisfaction Surveys. Type of Information Collection Request: RENEWAL of OMB Clearance 0925-0532. 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 National Institute of Child Health and Human Development (NICHD), Office of Science Policy, Analysis and Communication (OSPAC), 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 processes 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 laboratory research, clinical trials, and epidemiological studies that explore health processes, the NICHD disseminates information that emanates from its research programs to its customers, or those who are partners with the Institute. This includes scientists, practitioners, other health professionals, and the public. Survey information will augment the NICHD's on-going efforts to assess their research funding mechanisms, activities, and programs, as well as the information products that are used to disseminate research findings. Primary objectives are: (1) To identify opportunities and barriers to achieving scientific aims; (2) to learn about emerging scientific opportunities and unmet public health needs; (3) to measure customer satisfaction with information products; and (4) to identify strengths and weaknesses of the NICHD's program operations. The OSPAC will use the survey results to better respond to its customers, including its various partners in research, and to improve the NICHD's research programs and activities. Findings will help to: (1) Formulate strategies to help enhance research opportunities and remove barriers; (2) target the NICHD's research programs and activities to take advantage of emerging scientific opportunities and meet public health needs related to its mission; (3) develop information products tailored to the NICHD audience; and (4) improve program planning, management, and operations. Frequency of Response: Annual [As needed on an on-going 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.

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 (OMB) for review and approval. Proposed Collection: Title: Research and Research Training Grant Applications and Related Forms. Type of Information Collection Request: Revision, OMB 0925-0001, Expiration Date 9/30/07. Form Numbers: PHS 398, 2590, 2271, 3734 and HHS 568. Need and Use of Information Collection: The application is used by applicants to request Federal assistance for research and research-related training. The other related forms are used for trainee appointment, final invention reporting, and to relinquish rights to a research grant. Frequency of response: Applicants may submit applications for published receipt dates. If awarded, annual progress is reported and trainees may be appointed or reappointed. Affected Public: Individuals or Households; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: Adult scientific professionals. The annual reporting burden is as follows: Estimated Number of Respondents: 158,820; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 15.8; and Estimated Total Annual Burden Hours Requested: 2,517,466. The estimated annualized cost to respondents is $88,058,547. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's regulations governing batch certification of color additives manufactured for use in foods, drugs, cosmetics or medical devices in the United States.