Proposed Collection; 60-Day Comment Request; The Genetic Testing Registry (Office of the Director), 101610 [2024-29565]

Download as PDF 101610 Federal Register / Vol. 89, No. 241 / Monday, December 16, 2024 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; The Genetic Testing Registry (Office of the Director) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the requirements of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health Office (NIH) of the Director (OD) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, SUMMARY: contact: Taunton Paine, Director, Division of Scientific Data Sharing Policy, Office of Science Policy, NIH, 6705 Rockledge Dr., Suite 631, Bethesda, MD 20892, or call non-tollfree number (301) 496–9838, or Email your request, including your address to: SciencePolicy@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address 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 minimizes the burden of the collection of information on those who are to respond, including the use of SUPPLEMENTARY INFORMATION: appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: The Genetic Testing Registry, 0925–0651, Expiration Date 1/31/2025– EXTENSION, Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: Clinical laboratory tests are available for more than 26,000 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. The GTR also has tests for microbes like for SARS–CoV–2 to diagnose COVID– 19. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2837. ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Average time per response (in hours) Total annual burden hour Form name Laboratory Personnel Using Bulk Submission ............ Minimal Fields ...... Optional Fields ..... Minimal Fields ...... Optional Fields ..... 11 250 84 57 16 16 16 16 18/60 17/60 54/60 29/60 53 1133 1210 441 .............................. 402 6,432 .......................... 2,837 Laboratory Personnel Not Using Bulk Submission ..... Total ..................................................................... Dated: December 10, 2024. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2024–29565 Filed 12–13–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health lotter on DSK11XQN23PROD with NOTICES1 Number of respondents Type of respondent National Library of Medicine, Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Biomedical Informatics, Library, and Data Sciences Review Committee. VerDate Sep<11>2014 17:41 Dec 13, 2024 Jkt 265001 The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Biomedical Informatics, Library and Data Sciences Review Committee (BILDS). Date: February 27–28, 2025. Time: February 27, 2025, 9:30 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Place: National Library of Medicine, 6705 Rockledge Drive, Suite 500, Bethesda, MD 20892 (Virtual Meeting). Date: February 28, 2025, 9:30 a.m. to 1:30 p.m. Agenda: To review and evaluate grant applications. Place: National Library of Medicine, 6705 Rockledge Drive, Suite 500, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Zoe E. Huang, MD, Chief Scientific Review Officer, Scientific Review Office, Extramural Programs, National Library of Medicine, National Institutes of Health (NIH), 6705 Rockledge Drive, Suite 500, Bethesda, MD 20892–7968, 301–594– 4937, huangz@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.879, Medical Library Assistance, National Institutes of Health, HHS) E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 89, Number 241 (Monday, December 16, 2024)]
[Notices]
[Page 101610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29565]



[[Page 101610]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; The Genetic Testing 
Registry (Office of the Director)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the requirements of the Paperwork Reduction 
Act of 1995 to provide opportunity for public comment on proposed data 
collection projects, the National Institutes of Health Office (NIH) of 
the Director (OD) will publish periodic summaries of proposed projects 
to be submitted to the Office of Management and Budget (OMB) for review 
and approval.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 60 days of the date of 
this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, contact: Taunton 
Paine, Director, Division of Scientific Data Sharing Policy, Office of 
Science Policy, NIH, 6705 Rockledge Dr., Suite 631, Bethesda, MD 20892, 
or call non-toll-free number (301) 496-9838, or Email your request, 
including your address to: [email protected]. Formal requests 
for additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires: written comments and/or suggestions 
from the public and affected agencies are invited to address 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 minimizes 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.
    Proposed Collection Title: The Genetic Testing Registry, 0925-0651, 
Expiration Date 1/31/2025-EXTENSION, Office of the Director (OD), 
National Institutes of Health (NIH).
    Need and Use of Information Collection: Clinical laboratory tests 
are available for more than 26,000 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. The GTR also has tests for microbes like for SARS-CoV-2 to 
diagnose COVID-19.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 2837.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                           Number of       Average time
              Type of respondent                                Form name                   Number of    responses per     per response    Total annual
                                                                                           respondents     respondent       (in hours)      burden hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
Laboratory Personnel Using Bulk Submission....  Minimal Fields..........................            11               16            18/60              53
                                                Optional Fields.........................           250               16            17/60            1133
Laboratory Personnel Not Using Bulk Submission  Minimal Fields..........................            84               16            54/60            1210
                                                Optional Fields.........................            57               16            29/60             441
                                                                                         ---------------------------------------------------------------
    Total.....................................  ........................................           402            6,432  ...............           2,837
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: December 10, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-29565 Filed 12-13-24; 8:45 am]
BILLING CODE 4140-01-P


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