Submission for OMB Review; 30-Day Comment Request; The Genetic Testing Registry (Office of the Director), 67068-67069 [2021-25670]
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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:
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17:05 Nov 23, 2021
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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
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]]>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]
-----------------------------------------------------------------------
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
