Department of Health and Human Services March 2015 – 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 National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects 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: Deshiree Belis, 6705 Rockledge Drive, Suite 6070, Bethesda, MD 20892, or call non-toll-free number (301)-435-1032, or Email your request to: deshiree.belis@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments 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: Assessment of NHLBI's Global Health Initiative Collaborating Centers of Excellence, 0925-New, National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH). Need and Use of Information Collection: This collection proposes to conduct a one-time outcome evaluation of the NHLBI Global Health Initiative Centers of Excellence (GHI COE) Program to examine the extent to which the program achieved its intended objectives in developing sustainable research and research training capacity, and advancing information about the prevention and treatment of chronic non-communicable chronic cardiovascular and pulmonary diseases (CVPD) in low- and middle-income country (LMIC) populations. The outcome evaluation will utilize a mixed-methods approach to comprehend each COE's processes, short term outcomes, and sustainability outcomes/ efforts. Specifically, the evaluation will involve triangulating quantitative data sources (e.g., archived systematic reporting data), and qualitative data sources (e.g., archival data and key informant interview data). Data collected will be used to develop a Case Study report for each COE outlining their experience with implementing their program as well as a comprehensive cross-site Lessons Learned Report describing knowledge and experiences from the overall program, including similarities and differences across a variety of project settings and conditions. Findings from interviews will be incorporated into the Case Studies report and Lessons Learned report, which will be used by CTRIS to inform NHLBI and NIH stakeholders about structural issues relevant to planning both global and domestic biomedical research and training programs with diverse operational conditions and challenges. Additionally, COEs may utilize the Case Studies report as a marketing tool to attract additional funding and media coverage. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 36.

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 invites comments on reporting requirements contained in existing FDA regulations governing State enforcement notifications.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food EstablishmentsSmall Entity Compliance Guide''. The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.''

The Administrator of the Administration for Community Living proposes priorities for the Disability and Rehabilitation Research Projects (DRRPs) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes priorities for a Center on Knowledge Translation for Employment Research and Projects for Translating Disability and Rehabilitation Research into Practice. We take this action to focus research attention on areas of national need. We intend these priorities to contribute to improved outcomes for people with disabilities through improved uptake of research-based knowledge generated by NIDILRR-sponsored research.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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 Heart, Lung and Blood Institute (NHLBI), 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, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Dr., Room 8102, MSC 7940, Bethesda, MD 20892-7940, 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 ``Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products (``products''). This draft guidance revises the guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants'' published May 19, 2009.

The Food and Drug Administration (FDA or we) 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 invites comments on the record retention requirements for the soy protein and coronary heart disease health claim.