Department of Health and Human Services May 9, 2013 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443- 1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence and Prevention Services (DFVPS) announces the award of a single-source cooperative agreement in the amount of $275,000 to the National Council on Family Violence in Austin, TX, for the Hotline. The Hotline, currently funded under the Family Violence Prevention and Services Act, provides direct services and referrals nationally for victims of family violence, domestic violence, and dating violence.

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 Heart, Lung, and Blood Institute (NHBLI), 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. 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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Victoria Pemberton, Clinical Trials Specialist, National Heart, Lung, and Blood Institute, NIH, 6701 Rockledge Drive, Room 8102, MSC 7940, Bethesda, MD, or call non-toll-free number 301-435-0510, or Email your request, including your address to: pembertonv@nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Charging for Investigational Drugs Under an INDQs & As.'' This guidance is intended to provide information for industry, researchers, and physicians on how FDA is implementing its regulation on charging for an investigational drug under an investigational new drug (IND) application. FDA has received a number of questions about how it is implementing the charging regulation. Therefore, FDA is providing this draft guidance in a question and answer format, addressing the most frequently asked questions and answers, including questions about charging for investigational drugs made available under expanded access programs.

The Food and Drug Administration (FDA) is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. FDA is also designating special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information.