Department of Health and Human Services January 21, 2016 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) is requesting nominations of qualified candidates to fill expected vacancies on the Advisory Council on Blood Stem Cell Transplantation (ACBSCT). The ACBSCT was established pursuant to Public Law 109-129 as amended by Public Law 111-264; 42 U.S.C. 274k; Section 379 of the Public Health Service Act. In accordance with Public Law 92-463, the ACBSCT was chartered on December 19, 2006.

On December 19, 2012, the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention announced in the Federal Register https://www.gpo.gov/fdsys/pkg/FR-2012-12-19/pdf/ 2012-30515.pdf plans to evaluate the scientific data on silver nanomaterials and to issue its findings on the potential health risks. A draft document entitled, Health Effects of Occupational Exposure to Silver Nanomaterials, has been developed which contains a review and assessment of the currently available scientific literature on the toxicological effects of exposure to silver nanoparticles in experimental animal and cellular systems, and on the occupational exposures to silver dust and fume and the associated health effects. An emphasis area of this review is evaluating the scientific evidence on the role of particle size on the toxicological effects of silver, including the evidence basis to evaluate the adequacy of the current NIOSH recommended exposure limit (REL) for silver (metal dust and soluble compounds, as Ag) [available at: https://www.cdc.gov/niosh/npg/ npgd0557.html]. Recommendations are provided for the safe handling of silver nanoparticles, and research needs are proposed to fill important data gaps in the current scientific literature on the potential adverse health effects of occupational exposure to silver nanoparticles. NIOSH is seeking comments on the draft document and plans to have a public meeting to discuss the document. To view the notice and related materials, visit www.regulations.gov and enter CDC-2016-0001 in the field and click ``Search.'' This draft document does not have the force or effect of the law.

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 amending the animal drug regulations to reflect that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #226 entitled ``Target Animal Safety Data Presentation and Statistical Analysis.'' The purpose of this document is to provide recommendations to industry regarding the presentation and statistical analyses of target animal safety (TAS) data submitted to the Center for Veterinary Medicine (CVM) as part of a study report to support approval of a new animal drug. These recommendations apply to TAS data generated from both TAS and field effectiveness studies conducted in companion animals (e.g., dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, and poultry).

The Food and Drug Administration (FDA or Agency) has determined that MEVACOR (lovastatin) tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.'' This guidance updates and clarifies the information regarding sterilization processes that FDA recommends sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that FDA recommends sponsors include in a 510(k) submission.

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 on Minority Health and Health Disparities (NIMHD), 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 to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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: Nathan Stinson, Jr., Ph.D., MD, MPH, Director, Division of Extramural Scientific Programs, National Institute on Minority Health and Health Disparities, National Institutes of Health, 6707 Democracy Blvd., Suite 800, Bethesda, MD 20892-5465, or call non-toll free number (301-594-8704 or email your request including your address to: stinsonn@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received March 21, 2016. Proposed Collection: National Institute on Minority Health and Health Disparities Research Endowments0925NEWExisting Collection In Use without an OMB Number- National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH). Need and Use of Information Collection: The NIMHD Research Endowment Program builds research capacity and research infrastructure in order to facilitate minority health research and research regarding other health disparity populations at eligible institutions under sections 736 and 464z-4 of the Public Health Service Act (PHS Act). NIH regulations contains requirements that are subject to OMB approval under the Paperwork Reduction Act of 1995, as amended (44 U.S.C. chapter 35). Title 45 of the CFR, sections 52i.3(b)(2), 52i.4(a), 52i.4(c), 52i.5(a), 52i.9(b), 52i.11(b), and 52i.11(d) contain reporting and information collection requirements that are subject to OMB approval under the Paperwork Reduction Act. Title 45 of the CFR, sections 52i.10, 52i.11(a)(1), 52i.11(a)(2), 52i.11(a)(3), 52i.11(a)(4), and 52i.11(b) contain recordkeeping requirements that are subject to OMB review under the Paperwork Reduction Act. The respondents for this notice consist of institutions currently funded under Section 736 or Section 464z-4 of the PHS Act. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 548.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project entitled ``Measuring Perceived Self- Escape Competencies among Underground Mineworkers''. The purpose of this two-year information collection is to gather survey data from up to 800 underground coal miners to measure their perceived competence in the critical knowledge, skills, and abilities that could be required for successful escape from an underground mine emergency.

The Administration for Children and Families (ACF), Office of Child Care (OCC), Tribal Maternal, Infant, and Early Childhood Home Visiting (Tribal MIECHV) Program, announces the award of single-source program expansion supplement grants to the Confederated Salish and Kootenai Tribes in Pablo, MT; Confederated Tribes of Siletz Indians in Siletz, OR; Inter-Tribal Council of Michigan in Sault Ste. Marie, MI; Red Cliff Band of Lake Superior Chippewa in Bayfield, WI; the Choctaw Nation of Oklahoma in Durant, OK; and the Cherokee Nation of Oklahoma in Tahlequah, OK. The Fiscal Year 2015 single-source program expansion supplement grants will support the expansion of the Tribal Early Learning Initiative (TELI) program.