Department of Health and Human Services February 19, 2016 – Federal Register Recent Federal Regulation Documents

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 Division of Loan Repayment (DLR), 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 should 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) 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: Written comments and/or suggestions from the public and affected agencies should 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) 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 request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Steve Boehlert, Director of Operations, Division of Loan Repayment, National Institutes of Health, 6011 Executive Blvd., Room 206 (MSC 7650), Bethesda, Maryland 20892-7650. Mr. Boehlert may be contacted via email at BoehlerS@od.nih.gov or by calling 301-451-4465. 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 within 60 days of the date of this publication. Proposed Collection: National Institutes of Health (NIH) Loan Repayment Programs (LRP). Type of Information Collection Request: Extension of a currently approved collection (OMB No. 0925-0361, expiration date 06/30/17). Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., Ph.D., Pharm.D., Psy.D., D.O., D.D.S., D.M.D., D.P.M., D.C., N.D., O.D., D.V.M, or equivalent doctoral degree holders who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees or scientists funded by domestic non-profit organizations for a minimum of two years (three years for the General Research LRP) in research areas supporting the mission and priorities of the NIH. The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized by section 487A of the Public Health Service Act (42 U.S.C. 288-1); the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by section 487E (42 U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is authorized by section 487C of the Public Health Service Act (42 U.S.C. 288-3); the Clinical Research Loan Repayment Program (LRP-CR) is authorized by section 487F (42 U.S.C. 288-5a); the Pediatric Research Loan Repayment Program (PR-LRP) is authorized by section 487F (42 U.S.C. 288-6); the Extramural Clinical Research LRP for Individuals from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment to section 487E (42 U.S.C. 288-5); the Contraception and Infertility Research LRP (CIR-LRP) is authorized by section 487B (42 U.S.C. 288-2); and the Health Disparities Research Loan Repayment Program (HD-LRP) is authorized by section 464z-5 (42 U.S.C. 285t-2). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674-4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674-14, NIH 2674-15, NIH 2674-16, NIH 2674-17, NIH 2674-18, NIH 2674-19, and NIH 2674-20. The NIH Loan Repayment Programs can repay up to $35,000 per year toward a participant's extant eligible educational loans, directly to financial institutions. The information proposed for collection will be used by the Division of Loan Repayment to determine an applicant's eligibility for participation in the program. The total estimated annualized burden hours are 33,242.

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 submission of rotational plans for health warning label statements for smokeless tobacco products.

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 Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Immunogenicity- Related Considerations for Low Molecular Weight Heparin.'' This guidance discusses how applicants for low molecular weight heparin (LMWH) products should provide information on impurities and their potential impact on immunogenicity.

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 (PRA), Federal Agencies are required to publish a 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 (1) an extension of the study conducted with the original longitudinal youth cohort developed and surveyed for the outcome evaluation of FDA's General Market Youth Tobacco Prevention Campaign, (2) the development of a second longitudinal cohort for the purpose of continuing the evaluation, (3) an extension of the time period for the outcome evaluation of the Rural Male Youth Smokeless Tobacco Campaign, (4) and an extension of the media tracking survey.

In accordance with the provisions of FACA, and after consultation with the General Services Administration (GSA), the Secretary of Health and Human Services (HHS) has determined that the reestablishment of the Technical Review Panel on the Medicare Trustees Reports is in the public interest. This Panel shall advise the HHS Secretary about the econometric and actuarial techniques and economic assumptions utilized in the Hospital Insurance (HI) and Supplementary Medical Insurance (SMI) Trust Fund reports, thus enhancing her ability to fulfill duties and responsibilities imposed by the PHSA (42 U.S.C. 201 et seq.)