Department of Health and Human Services December 4, 2014 – Federal Register Recent Federal Regulation Documents

Proposed Collection; 60-Day Comment Request; Health Information National Trends Survey (HINTS)
Document Number: 2014-28513
Type: Notice
Date: 2014-12-04
Agency: Department of Health and Human Services, 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 Cancer Institute (NCI), 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: Bradford W. Hesse, Ph.D., Health Communication and Informatics Research Branch, 9609 Medical Center Drive, MSC 9761, Room 3E610, Rockville, MD 20850 or call non-toll free number 240-276-6721 or Email your request, including your address, to hesseb@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 within 60 days of the date of this publication. Proposed Collection: Health Information National Trends Survey (HINTS) 0925-0538, Reinstatement with Change, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This partnership between NCI and FDA will include assessing the public's knowledge of medical devices, communications related to product recalls, nutritional supplement labeling, and topics to inform FDA's regulatory authority over tobacco, such as risk perceptions about new tobacco products, product pack color gradations, perceptions of product harm, and tobacco product claims and labels. This HINTS survey will couple knowledge- related questions with inquiries into the communication channels through which understanding is being obtained, and assessment of FDA- regulated material. This survey will extend the information collected and priorities from HINTS which have been to provide a comprehensive assessment of the American public's current access to, and use of, information about cancer across the cancer care continuum from cancer prevention, early detection, diagnosis, treatment, and survivorship. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,159.
Proposed Collection; 60-Day Comment Request; Surveys and Interviews To Support an Evaluation of the Innovative Molecular Analysis Technologies (IMAT) Program (NCI)
Document Number: 2014-28498
Type: Notice
Date: 2014-12-04
Agency: Department of Health and Human Services, 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 Cancer Institute (NCI), 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: Anthony Dickherber, NCI Center for Strategic Scientific Initiatives, 31 Center Drive, Rm10A33, Bethesda, MD 20892 or call non-toll-free number 301- 547-9980 or Email your request, including your address to: dickherberaj@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 within 60 days of the date of this publication. Proposed Collection: Surveys and Interviews to Support an Evaluation of the Innovative Molecular Analysis Technologies (IMAT) Program (NCI), 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of the proposed evaluation is to pursue a comprehensive process and outcome assessment of the 15-year old Innovative Molecular Analysis Technologies (IMAT) program. While the program consistently offers promising indicators of success, the full program has not been evaluated since 2008, and never in as comprehensive a manner as has been formulated in the current evaluation plan. An outcome evaluation of the long-standing National Cancer Institute's (NCI) IMAT program presents a rich and unique opportunity likely to serve institutes across the National Institutes of Health (NIH), and perhaps other federal agencies, considering the costs and benefits of directing resources towards supporting technology development. An award through the NIH Evaluation Set-Aside program to support this evaluation, for which NIH-wide relevance is a principle element of determining merit for support, is testament to this. The evaluation serves as an opportunity to gauge the impact of investments in technology development and also to assess the strengths and weaknesses of phased innovation award mechanisms. Like all institutes and centers (ICs) of the NIH, NCI seeks opportunities for improving their programs' utility for the broad continuum of researchers, clinicians and ultimately patients. NCI Director Harold Varmus and other leadership across NCI, as well as the NCI Board of Scientific Advisors, will be the primary users of the evaluation results. Findings are primarily intended for considering the long-term strategy to support innovative technology development and how to more efficiently translate emerging capabilities through such technologies into the promised benefits for cancer research and clinical care. Interviews with grantees, program officers, review officers, and other NIH awardees make up a crucial component of the evaluation plan and will largely follow set survey protocols. Specific near-term aims include the use of this information to consider the utility of continued investment through existing solicitations and in strategic planning generally for institute support for innovative technology development. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 575.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2014-28493
Type: Notice
Date: 2014-12-04
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// beta.samhsa.gov/workplace.
Administration for Native Americans; Statement of Organization, Functions, and Delegations of Authority
Document Number: 2014-28486
Type: Notice
Date: 2014-12-04
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) has reorganized the Administration for Native Americans (ANA). This reorganization creates the Division of Policy and makes other technical changes to reflect the current functions within ANA. The realignment of functions better reflects the current work environment and priorities within ANA, manifests ANA's commitment to Federal/Tribal government-to- government relationships, and promotes self-determination for all Native Americans. The statement of mission, organization, functions, and delegations of authority conforms to and carries out the statutory requirements of the Native American Programs Act (NAPA).
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability
Document Number: 2014-28242
Type: Notice
Date: 2014-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This draft guidance is intended to assist applicants in complying with the new content and format requirements in the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products, as described in the final rule, Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling. The rule, which is being published concurrently with this draft guidance, is referred to as the ``Pregnancy and Lactation Labeling Rule'' (PLLR). The draft guidance will assist applicants in developing labeling for new products, revising existing labeling, and implementing the content and format requirements of the PLLR for human prescription drug and biological products.
Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling
Document Number: 2014-28241
Type: Rule
Date: 2014-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the ``Pregnancy,'' ``Labor and delivery,'' and ``Nursing mothers'' subsections of the ``Use in Specific Populations'' section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the ``Labor and delivery'' subsection because information about labor and delivery is included in the ``Pregnancy'' subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.