Department of Health and Human Services 2015 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the NIEHS, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on September 16, 2015, Pages 55634-55635, 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 National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This is a notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institute of Drug Abuse, National Institutes of Health, Department of Health and Human Services is contemplating the grant of an exclusive start-up option license to practice the inventions embodied in the following Patent Applications and all related continuing and foreign patents/patent applications for the technology family to EncepHeal Therapeutics, Inc., located in Winston- Salem, North Carolina.

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. 209 and 37 CFR part 404 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 or the Agency) is proposing to establish device restrictions for sunlamp products, which would restrict their use to individuals age 18 and older, require prospective users to sign a risk acknowledgement certification before use, and require the provision of user manuals.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle. This supplemental approval reflects FDA's effectiveness conclusions that relied on the National Academy of Sciences/National Research Council Drug Efficacy Study Group's evaluation of the effectiveness of this drug as well indications for use not subject to this review.

Under the National Childhood Vaccine Injury Act (NCVIA)(42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On January 9, 2015, CDC published a notice in the Federal Register (80 FR 1416) seeking public comments on proposed updated vaccine information materials for multiple pediatric vaccines (``Your Baby's First Vaccines''). Following review of comments submitted and consultation as required under the law, CDC has finalized the materials. A copy of the final vaccine information materials for multiple pediatric vaccines (``Your Child's First Vaccines'') is available to download from https://www.cdc.gov/vaccines/ hcp/vis/ or https://www.regulations.gov (see Docket Number CDC-2015-0001).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on October 1, 2015, 80 FR 59168 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 National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.

This proposed rule would implement the Workforce Innovation and Opportunity Act of 2014 and reflect the transfer of the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) from the Department of Education to the Department of Health and Human Services. The previous regulations were issued by the Department of Education. The rulemaking will consolidate the NIDILRR regulations into a single part, align the regulations with the current statute and HHS policies, and will provide guidance to NIDILRR grantees.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (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 U.S. Department of Health and Human Services (HHS) announces the intent to establish a Physical Activity Guidelines Advisory Committee (Committee). It is planned for the Committee to be established in calendar year 2016. This notice also serves to announce that an invitation is being extended for nominations of qualified candidates to be considered for appointment as a member of the Committee.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces a public webinar ``Fundamentals of Using Quantitative StructureActivity Relationship Models and Read- Across Techniques in Predictive Toxicology.'' The webinar is organized on behalf of ICCVAM by the National Toxicology Program Interagency Center for the Evaluation Alternative Toxicological Methods (NICEATM) and hosted by the U.S. Environmental Protection Agency's (EPA's) National Center for Computational Toxicology (NCCT). Interested persons may participate via Adobe[supreg] ConnectTM. Time is allotted for questions from the audience.

The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) providing for the use of nitarsone in medicated feed for chickens and turkeys. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.