Submission for OMB Review; 30-Day Comment Request; The Genetic Testing Registry (Office of the Director), 67068-67069 [2021-25670]

Download as PDF 67068 Federal Register / Vol. 86, No. 224 / Wednesday, November 24, 2021 / Notices Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Charles Hall, Chief, Pharmaceutical Management Branch, Cancer Therapy Evaluation Program, Division of Cancer Diagnosis and Treatment, National Cancer Institute, 9609 Medical Center Drive, Bethesda, Maryland, 20892 or call nontoll-free number (240) 276–6575 or email your request, including your address to: HallCh@mail.nih.gov. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on September 14, 2021 (Vol. 86 FR 51168) 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 National ADDRESSES: Institute/Division of Cancer Treatment and Diagnosis/Cancer Therapy Evaluation Program (NCI/DCTD/CTEP) is managed by the Pharmaceutical Management Branch (PMB) at CTEP. The Investigational Agent Accountability Records (a.k.a. Drug Accountability Record Forms—DARF) are used to provide a standardized method of tracking of agent disposition across all institutions participating in trials for which the NCI provides agent. Institutional auditors verify information on the agent accountability forms for compliance. In addition, PMB staff review Investigational Agent Accountability Record Forms against records maintained in PMB systems to ensure there is no inappropriate use or diversion of investigational agents. Additionally, the International Investigator Statement (IIS) will be used by non-U.S. investigators, that are unable to sign the FDA 1572 (OMB No. 0925–0753, Expiration 05/31/2024) to attest compliance with applicable country-specific regulations. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden are 4,831 hours. Cancer Institute (NCI), 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. In compliance with 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. Proposed Collection: Investigational Agent Accountability Record Forms and International Investigator Statement in the Conduct of Investigational Trials for the Treatment of Cancer (National Cancer Institute), 0925–0613, Expiration Date 3/31/2022, REVISION, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Food and Drug Administration (FDA) require Investigational New Drug Application (IND) sponsors to maintain adequate records on the shipment and disposition of agents to investigators. The agent accountability effort for National Cancer ESTIMATED ANNUALIZED BURDEN HOURS A1: Investigational Agent Accountability Record Form (DARF). A2: Investigational Agent Accountability Record for Oral Agents Form (DARF-Oral). A3: Electronic Agent Accountability Record Form (eDARF). A4: International Investigator Statement (IIS) (Initial Response). Individuals ........ 760 20 4/60 1,013 Individuals ........ 2,280 20 4/60 3,040 Individuals ......... 760 20 1/60 253 Individuals ........ 2,100 1 15/60 525 ........................... 5,900 78,100 ........................ 4,831 Dated: November 18, 2021. Diane Kreinbrink, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2021–25605 Filed 11–23–21; 8:45 am] Submission for OMB Review; 30-Day Comment Request; The Genetic Testing Registry (Office of the Director) BILLING CODE 4140–01–P khammond on DSKJM1Z7X2PROD with NOTICES Average time per response (in hours) Category of respondent Totals ......................................................................... Number of respondents Number of responses per respondent Form name National Institutes of Health AGENCY: National Institutes of Health, Notice. In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management SUMMARY: VerDate Sep<11>2014 17:05 Nov 23, 2021 Jkt 256001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 and Budget (OMB) a request for review and approval of the information collection listed below. Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. DATES: HHS. ACTION: Total annual burden hours Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open ADDRESSES: E:\FR\FM\24NON1.SGM 24NON1 Federal Register / Vol. 86, No. 224 / Wednesday, November 24, 2021 / Notices for Public Comments’’ or by using the search function. 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: SciencePolicy@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on September 7, 2021, page 50140 (86 FR 50140) and allowed 60 days for public comment. No public 67069 Need and Use of Information Collection: Clinical laboratory tests are available for more than 18,000 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 now 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 2,299. 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. In compliance with 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. Proposed Collection Title: The Genetic Testing Registry, 0925–0651, Expiration Date 11/30/21–EXTENSION, Office of the Director (OD), National Institutes of Health (NIH). ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Number of respondents Form name Laboratory Personnel Using Bulk Submission. Laboratory Personnel Not Using Bulk Submission. 11 16 18/60 53 Optional Fields ................................. Minimal Fields .................................. 250 84 16 16 17/60 30/60 1133 672 Optional Fields ................................. 57 16 29/60 441 402 6432 ........................ 2,299 Dated: November 18, 2021. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2021–25670 Filed 11–23–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health khammond on DSKJM1Z7X2PROD with NOTICES National Institute on Deafness and Other Communication Disorders; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a virtual meeting and will be open to the public as indicated below. The URL link to this meeting is: https:// www.nidcd.nih.gov/about/advisorycouncil/upcoming-meetings. The 17:05 Nov 23, 2021 Total annual burden hour Minimal Fields .................................. Total ........................................... VerDate Sep<11>2014 Average time per response (in hours) Number of responses per respondent Jkt 256001 meeting is partially Closed to the public. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. 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 material, 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: National Deafness and Other Communication Disorders Advisory Council. Date: January 27–28, 2022. Closed: January 27, 2022, 10:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Place: National Institutes of Health, NSC, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Open: January 27, 2022, 1:00 p.m. to 4:00 p.m. Agenda: Staff reports on divisional, programmatical, and special activities. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Open: January 28, 2022, 10:00 a.m. to 12:30 p.m. Agenda: Staff reports on divisional, programmatical, and special activities. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Rebecca Wagenaar-Miller, Ph.D., Director, Division of Extramural Activities, NIDCD/NIH, 6001 Executive Boulevard, Rockville, MD 20852, (301) 496– 8693, rebecca.wagenaar-miller@nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. E:\FR\FM\24NON1.SGM 24NON1

Agencies

[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Notices]
[Pages 67068-67069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25670]


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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 (Office of the Director)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with 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.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open

[[Page 67069]]

for Public Comments'' or by using the search function.

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: This proposed information collection was 
previously published in the Federal Register on September 7, 2021, page 
50140 (86 FR 50140) 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.
    In compliance with 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.
    Proposed Collection Title: The Genetic Testing Registry, 0925-0651, 
Expiration Date 11/30/21-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 18,000 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 now 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 2,299.

                                        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      Minimal Fields..              11              16           18/60              53
 Bulk Submission.
                                Optional Fields.             250              16           17/60            1133
Laboratory Personnel Not Using  Minimal Fields..              84              16           30/60             672
 Bulk Submission.
                                Optional Fields.              57              16           29/60             441
                                                 ---------------------------------------------------------------
    Total.....................                               402            6432  ..............           2,299
----------------------------------------------------------------------------------------------------------------


    Dated: November 18, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-25670 Filed 11-23-21; 8:45 am]
BILLING CODE 4140-01-P