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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)

Page Range15013-15013
FR Document2015-06370

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, [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer.

Federal Register, Volume 80 Issue 54 (Friday, March 20, 2015)
[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]


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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]
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  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
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ContactTo 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 Citation80 FR 15013 

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