80 FR 15013 - Submission for OMB Review; 30-Day Comment Request: The Genetic Testing Registry
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 54 (March 20, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 54 (March 20, 2015)
| Page Range | 15013-15013 | |
| FR Document | 2015-06370 |
[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)] [Notices] [Page 15013] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06370] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: The Genetic Testing Registry SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) 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 November 25, 2014 (79 FR 70194), 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 Office of the Director (OD), 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. DATES: 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. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments 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. Proposed Collection: The Genetic Testing Registry, 0925-0651, Reinstatment Without Change,--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. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form name Number of responses per per response Total annual respondents respondent (in hours) burden hours ---------------------------------------------------------------------------------------------------------------- Laboratory Personnel Using Minimal Fields.. 190 29 18/60 1,653 Bulk Submission. Optional Fields. 159 29 14/60 1,076 Laboratory Personnel Not Using Minimal Fields.. 116 29 30/60 1,682 Bulk Submission. Optional Fields. 97 29 24/60 1,125 ---------------------------------------------------------------------------------------------------------------- Dated: March 13, 2015. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2015-06370 Filed 3-19-15; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Notices 15013
must be resolved through the Disputes Reduction Act of 1995, the National Office of Clinical Research and
clause. Any audits requested by the Institutes of Health (NIH) has submitted Bioethics Policy, Office of Science
commercial supplier or licensor will be to the Office of Management and Budget Policy, NIH, 6705 Rockledge Dr., Suite
performed at supplier or licensor’s (OMB) a request for review and 750, Bethesda, MD 20892, or call non-
expense. approval of the information collection toll-free number (301) 496–9838, or
This class deviation will apply to all listed below. This proposed information Email your request, including your
new awards for GSA acquisitions for collection was previously published in address to: OCRBP-OSP@od.nih.gov.
commercial supplies or services. the Federal Register on November 25, Formal requests for additional plans and
Existing contracts will be required to 2014 (79 FR 70194), and allowed 60- instruments must be requested in
incorporate the new terms whenever an days for public comment. No public writing.
option period is exercised or the comments were received. The purpose
contract is otherwise modified. of this notice is to allow an additional Proposed Collection: The Genetic
This effort will reduce risk by 30 days for public comment. The Office Testing Registry, 0925–0651,
uniformly addressing common of the Director (OD), National Institutes Reinstatment Without Change,—Office
unacceptable Commercial Supplier of Health, may not conduct or sponsor, of the Director (OD), National Institutes
Agreement terms, facilitate efficiency and the respondent is not required to of Health (NIH)
and effectiveness in the contracting respond to, an information collection
process by reducing the administrative that has been extended, revised, or Need and Use of Information
burden for the Government and implemented on or after October 1, Collection: Clinical laboratory tests are
industry, and promote competition by 1995, unless it displays a currently valid available for more than 5,000 genetic
reducing barriers to industry, OMB control number. conditions. The Genetic Testing Registry
particularly small businesses. Direct Comments to OMB: Written (GTR) provides a centralized, online
Dated: March 17, 2015. comments and/or suggestions regarding location for test developers,
Jeffrey A. Koses, the item(s) contained in this notice, manufacturers, and researchers to
Senior Procurement Executive, Office of especially regarding the estimated voluntarily submit detailed information
Acquisition Policy, Office of Government- public burden and associated response about the availability and scientific
wide Policy. time, should be directed to the: Office basis of their genetic tests. The GTR is
[FR Doc. 2015–06422 Filed 3–19–15; 8:45 am] of Management and Budget, Office of of value to clinicians by providing
BILLING CODE 6820–61–P Regulatory Affairs, OIRA_submission@ information about the accuracy,
omb.eop.gov or by fax to 202–395–6974, validity, and usefulness of genetic tests.
Attention: NIH Desk Officer. The GTR also highlights evidence gaps
DEPARTMENT OF HEALTH AND DATES: Comment Due Date: Comments where additional research is needed.
HUMAN SERVICES regarding this information collection are
best assured of having their full effect if OMB approval is requested for 3
National Institutes of Health received within 30-days of the date of years. There are no costs to respondents
this publication. other than their time. The total
Submission for OMB Review; 30-Day estimated annualized burden hours are
FOR FURTHER INFORMATION CONTACT: To
Comment Request: The Genetic 5,536.
obtain a copy of the data collection
Testing Registry
plans and instruments or request more
SUMMARY: Under the provisions of information on the proposed project
section 3507(a)(1)(D) of the Paperwork contact: Ms. Sarah Carr, Acting Director,
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total annual
Type of respondent Form name responses per
respondents response burden hours
respondent (in hours)
Laboratory Personnel Using Bulk Minimal Fields .................................. 190 29 18/60 1,653
Submission.
Optional Fields ................................. 159 29 14/60 1,076
Laboratory Personnel Not Using Minimal Fields .................................. 116 29 30/60 1,682
Bulk Submission.
Optional Fields ................................. 97 29 24/60 1,125
Dated: March 13, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015–06370 Filed 3–19–15; 8:45 am]
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BILLING CODE 4140–01–P
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Document Created: 2015-12-18 11:34:12
Document Modified: 2015-12-18 11:34:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Contact | To obtain a copy of the data collection plans and instruments 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 | |
| FR Citation | 80 FR 15013 |
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