National Institutes of Health
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 Human Genome Research Institute (NHGRI), 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 any 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 Contact: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Laura M. Koehly, Ph.D., Senior Investigator, Social and Behavioral Research Branch, NHGRI, NIH, 31 Center Drive MSC 2073, Building 31, Room B1B54, Bethesda, MD 20892, or call non-toll-free number (301) 451- 3999, or Email your request, including your address to: firstname.lastname@example.org. Formal requests for additional plans and instruments must be requested in writing.
Meeting of the President's Council on Fitness, Sports, and Nutrition; Correction
The Department of Health and Human Services published a notice in the Federal Register of April 11, 2013 to announce a meeting of the President's Council on Fitness, Sports, and Nutrition that will be held on May 7, 2013, from 10:00 a.m. to 4:30 p.m., at the Department of Health and Human Services, 200 Independence Ave. SW., Room 800; Washington, DC 20201. The meeting location has changed.
Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Assay Migration Studies for In Vitro Diagnostic Devices.'' This guidance presents a least burdensome regulatory approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved assay is migrating (i.e., transitioning) to a new system for which the assay has not been previously approved, licensed, or cleared.