Department of Health and Human Services November 25, 2014 – Federal Register Recent Federal Regulation Documents

Proposed Collection; 60-Day Comment Request; The Genetic Testing Registry
Document Number: 2014-27898
Type: Notice
Date: 2014-11-25
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 Office of the Director (OD), 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. Sarah Carr, Acting Director, Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, 6705 Rockledge Dr., Suite 750, Bethesda, MD 20892, or call non-toll-free number (301) 496-9838, or Email your request, including your address to: OCRBP-OSP@od.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: The Genetic Testing Registry, 0925-0651, Expiration Date 02/28/2015EXTENSION, Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: Clinical laboratory tests are available for more than 5,000 genetic conditions. The Genetic Testing Registry (GTR) provides a centralized, online location for test developers, manufacturers, and researchers to voluntarily submit detailed information about the availability and scientific basis of their genetic tests. The GTR is of value to clinicians by providing information about the accuracy, validity, and usefulness of genetic tests. The GTR also highlights evidence gaps where additional research is needed. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 5,536.
Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-27857
Type: Notice
Date: 2014-11-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry and FDA staff entitled ``Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators.'' FDA is issuing this guidance to recommend the addition of specific safety statements to the product labeling for laparoscopic power morcellators (LPMs). The Agency is making these recommendations in light of scientific information that suggests that the use of these devices contributes to the dissemination and upstaging of an occult uterine malignancy in women undergoing laparoscopic gynecologic surgery for presumed fibroids. FDA believes this effort will promote the safe and effective use of LPMs when used for gynecologic surgeries.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-27851
Type: Notice
Date: 2014-11-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-27850
Type: Notice
Date: 2014-11-25
Agency: Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2014-27838
Type: Notice
Date: 2014-11-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Office of Public Health Preparedness and Response: Notice of Charter Amendment
Document Number: 2014-27837
Type: Notice
Date: 2014-11-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Interagency Committee on Smoking and Health (ICSH)
Document Number: 2014-27836
Type: Notice
Date: 2014-11-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2014-27835
Type: Notice
Date: 2014-11-25
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0330, scheduled to expire on 12/31/14. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2014-27822
Type: Notice
Date: 2014-11-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2014-27821
Type: Notice
Date: 2014-11-25
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2014-27820
Type: Notice
Date: 2014-11-25
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Center for Advancing Translational Sciences; Notice of Meeting
Document Number: 2014-27819
Type: Notice
Date: 2014-11-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-27818
Type: Notice
Date: 2014-11-25
Agency: Department of Health and Human Services, National Institutes of Health
Findings of Research Misconduct
Document Number: 2014-27813
Type: Notice
Date: 2014-11-25
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Dr. Igor Dzhura, Vanderbilt University: Based on an inquiry conducted and admission obtained by Vanderbilt University (VU) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Igor Dzhura, former Senior Research Associate, Department of Biomedical Engineering, VU, engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grants R01 HL070250, R01 HL062494, P01 HL046681, and K08 HL03727, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH, grant R01 AR044864, National Institute of Mental Health (NIMH), NIH, grant R01 MH063232, National Institute of Allergy and Infectious Diseases (NIAID), NIH, grant U01 AI06223, and National Cancer Institute (NCI), NIH, grant U54 CA113007. ORI found that Respondent engaged in research misconduct by providing falsified and/or fabricated data to his supervisor and colleagues. Specifically, Respondent:
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-27687
Type: Notice
Date: 2014-11-25
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed changes to the currently approved information collection project: ``Medical Expenditure Panel Survey (AMPS) Household Component'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 29th, 2014 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.