Submission for OMB Review; 30-Day Comment Request;, 73009-73010 [2022-25840]
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Federal Register / Vol. 87, No. 227 / Monday, November 28, 2022 / Notices
Oncol. 2008, Figure 1B of R21
CA135269–01A1, Figure 4B of R41
CA139802–01, and Figure 2B of R41
CA144598–01
—NSCLC (lung cancer) in Figure 11B of
R01 CA132886–01A1, R01
CA132886–01A2, P50 CA142508–01,
and R01 CA152218–01
The following administrative actions
have been implemented:
(1) For a period of three (3) years,
beginning on October 17, 2022,
Respondent is debarred from
participating in ‘‘covered transactions’’
as defined in 42 CFR § 180.200 and
procurement transactions covered under
the Federal Acquisition Regulation (48
CFR chapter 1).
(2) Respondent is prohibited from
serving in any advisory capacity to PHS
including, but not limited to, service on
any PHS advisory committee, board,
and/or peer review committee, or as a
consultant for a period of three (3) years,
beginning on October 17, 2022.
(3) In accordance with 42 CFR
93.407(a)(1) and 93.411(b), HHS will
send to the pertinent journal a notice of
ORI’s findings and the need for
retraction or correction of:
• Gynecol. Oncol. 2009 Oct;115(1):112–
20; doi: 10.1016/j.ygyno.2009.06.031
• Gynecol. Oncol. 2008 Jul;110(1):13–
21; doi: 10.1016/j.ygyno.2008.04.033
Dated: November 22, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity,
Office of the Assistant Secretary for Health.
[FR Doc. 2022–25866 Filed 11–25–22; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request;
NIH Information Collection Forms To
Support Genomic Data Sharing for
Research Purposes (Office of Director)
AGENCY: National Institutes of Health,
HHS.
ACTION: Notice.
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.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:33 Nov 25, 2022
Jkt 259001
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: Julia Slutsman,
Ph.D. Director, Genomic Data Sharing
Policy Implementation, OER, OD, NIH,
Natcher Building, Room 3AN–44D, 6705
Rockledge Dr., Suite 750, Bethesda, MD
20892, or call non-toll-free number (301)
594–7783 or email your request,
including your address to: slutsmaj@
mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on September 21, 2022, pages
57705–57707 (87 FR 57705) 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
November 30, 2022, 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: NIH Information
Collection Forms to Support Genomic
Data Sharing for Research Purposes—
0925—REVISION—expiration date 11/
30/2022, Office of the Director (OD),
National Institutes of Health (NIH).
Need and Use of Information
Collection: Sharing research data
supports the National Institutes of
Health (NIH) mission and is essential to
facilitate the translation of research
results into knowledge, products, and
procedures that improve human health.
NIH has longstanding policies to make
a broad range of research data, including
genomic data, publicly available in a
timely manner from the research
activities that it funds. Genomic
research data sharing is an integral
element of the NIH mission as it
ADDRESSES:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
73009
facilitates advances in our
understanding of factors that influence
health and disease, while also providing
opportunities to accelerate research
through the power of combining large
and information-rich datasets. To
promote robust sharing of human and
non-human data from a wide range of
large-scale genomic research and
provide appropriate protections for
research involving human data, the NIH
issued the NIH Genomic Data Sharing
Policy (NIH GDS Policy). Human
genomic data submissions and
controlled access are managed through
a central data repository, the database of
Genotypes and Phenotypes (dbGaP)
which is administered by the National
Center for Biotechnology Information
(NCBI), part of the National Library of
Medicine at NIH. Under the NIH GDS
Policy, all investigators who receive
NIH funding to conduct large-scale
genomic research are expected to
register studies with human genomic
data in dbGaP, no matter which NIHdesignated data repository will maintain
the data. As part of the registration
process, investigators must provide
basic study information such as the type
of data that will be submitted to dbGaP,
a description of the study, and an
institutional assurance (i.e. Institutional
Certification) of the data submission
which delineates any limitations on the
secondary use of the data (e.g., data
cannot be shared with for-profit
companies, data can be used only for
research of particular diseases).
Investigators interested in using
controlled-access data for secondary
research must apply through dbGaP and
be granted permission from the relevant
NIH Data Access Committee(s). As part
of the application process, investigators
and their institutions must provide
information such as a description of the
proposed research use of controlled
access datasets that conforms to any
data use limitations, agree to the
Genomic Data User Code of Conduct,
and agree to the terms of access through
a Data Use Certification agreement.
Requests to renew data access and
reports to close out data use are similar
to the initial data access request,
requiring sign-off by both the requestor
and the institution, but also ask for
information about how the data have
been used, and about publications,
presentations, or intellectual property
based on the research conducted with
the accessed data as well as any data
security issues or other data
management incidents. NIH has
developed online forms, available
through dbGaP, in an effort to reduce
the burden for researchers and their
E:\FR\FM\28NON1.SGM
28NON1
73010
Federal Register / Vol. 87, No. 227 / Monday, November 28, 2022 / Notices
institutional officials to complete the
study registration, data submission, data
access, and renewal and closeout
processes.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
158,776.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total annual
burden hour
Type of respondent
dbGaP Registration and Submission
Institutional Certification ....................
Investigator Submitting Data ............
Investigator filling out Institutional
Certification.
Institutional Official to Certify Submission.
Investigator filling out Provisional Institutional Certification.
Institutional Official to Certify Provisional Submission.
Requester Submitting Request ........
Institutional Signing Official to Certify Request.
Requester Submitting Request ........
1,050
1,050
1
1
1
45/60
1050
788
1,050
1
45/60
788
100
1
45/60
75
100
1
45/60
75
3,900
3,900
10
10
1
1
39,000
39,000
3,900
10
1
39,000
Institutional Signing Official to Certify Request.
3,900
10
1
39,000
...........................................................
18,950
159,350
........................
158,776
Institutional Certification ....................
Provisional Institutional Certification
Provisional Institutional Certification
Data Access Request .......................
Data Access Request .......................
Project Renewal or Project Close-out
form.
Project Renewal or Project Close-out
form.
Total ...........................................
Dated: November 21, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National
Institutes of Health.
[FR Doc. 2022–25840 Filed 11–25–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center or Scientific Review; Notice of
Closed Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Form name
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following 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: Center for Scientific
Review Special Emphasis Panel; Small
Business: Basic and Integrative Biological
Sciences.
Date: December 13, 2022.
Time: 10:30 a.m. to 4:00 p.m.
VerDate Sep<11>2014
19:33 Nov 25, 2022
Jkt 259001
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Raj K. Krishnaraju, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6190,
MSC 7804, Bethesda, MD 20892, (301) 435–
1047, kkrishna@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 21, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–25821 Filed 11–25–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Fiscal Year (FY) 2023 Notice of
Supplemental Funding Opportunity
Substance Abuse and Mental
Health Services Administration,
AGENCY:
PO 00000
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Sfmt 4703
Department of Health and Human
Services (HHS).
ACTION: Notice of intent to award
supplemental funding to the American
Indian and Alaska Native Addiction
Technology Transfer Center (AI/AN
ATTC) recipient funded in FY 2018
under Notice of Funding Opportunity
(NOFO) TI–18–001.
This notice is to inform the
public that the Substance Abuse and
Mental Health Services Administration
(SAMHSA) is supporting an
administrative supplement, which is
consistent with the scope of the initial
FY 2018 award, of up to $375,000 for
nine months to the only funded AI/AN
ATTC recipient. This recipient was
funded in FY 2018 under the AI/AN
ATTC Cooperative Agreement NOFO
TI–18–001 and has a project end date of
December 29, 2022. The supplemental
funds will be used to provide a 9-month
extension to continue the program
services for the AI/AN ATTC from
December 30, 2022, to September 29,
2023.
FOR FURTHER INFORMATION CONTACT:
Twyla Adams, Substance Abuse and
Mental Health Services Administration,
5600 Fishers Lane, Rockville, MD
20857, telephone (240) 276–1576; email:
twyla.adams@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION: This
extension will allow SAMHSA to align
the project periods of the AI/AN ATTC
with the Addiction Technology Transfer
Centers (ATTC), Mental Health
SUMMARY:
E:\FR\FM\28NON1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 227 (Monday, November 28, 2022)]
[Notices]
[Pages 73009-73010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25840]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request;
NIH Information Collection Forms To Support Genomic Data Sharing
for Research Purposes (Office of 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 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: Julia Slutsman, Ph.D. Director, Genomic Data
Sharing Policy Implementation, OER, OD, NIH, Natcher Building, Room
3AN-44D, 6705 Rockledge Dr., Suite 750, Bethesda, MD 20892, or call
non-toll-free number (301) 594-7783 or email your request, including
your address to: [email protected].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on September 21, 2022,
pages 57705-57707 (87 FR 57705) 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 November 30, 2022, 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: NIH Information Collection Forms to Support
Genomic Data Sharing for Research Purposes--0925--REVISION--expiration
date 11/30/2022, Office of the Director (OD), National Institutes of
Health (NIH).
Need and Use of Information Collection: Sharing research data
supports the National Institutes of Health (NIH) mission and is
essential to facilitate the translation of research results into
knowledge, products, and procedures that improve human health. NIH has
longstanding policies to make a broad range of research data, including
genomic data, publicly available in a timely manner from the research
activities that it funds. Genomic research data sharing is an integral
element of the NIH mission as it facilitates advances in our
understanding of factors that influence health and disease, while also
providing opportunities to accelerate research through the power of
combining large and information-rich datasets. To promote robust
sharing of human and non-human data from a wide range of large-scale
genomic research and provide appropriate protections for research
involving human data, the NIH issued the NIH Genomic Data Sharing
Policy (NIH GDS Policy). Human genomic data submissions and controlled
access are managed through a central data repository, the database of
Genotypes and Phenotypes (dbGaP) which is administered by the National
Center for Biotechnology Information (NCBI), part of the National
Library of Medicine at NIH. Under the NIH GDS Policy, all investigators
who receive NIH funding to conduct large-scale genomic research are
expected to register studies with human genomic data in dbGaP, no
matter which NIH-designated data repository will maintain the data. As
part of the registration process, investigators must provide basic
study information such as the type of data that will be submitted to
dbGaP, a description of the study, and an institutional assurance (i.e.
Institutional Certification) of the data submission which delineates
any limitations on the secondary use of the data (e.g., data cannot be
shared with for-profit companies, data can be used only for research of
particular diseases). Investigators interested in using controlled-
access data for secondary research must apply through dbGaP and be
granted permission from the relevant NIH Data Access Committee(s). As
part of the application process, investigators and their institutions
must provide information such as a description of the proposed research
use of controlled access datasets that conforms to any data use
limitations, agree to the Genomic Data User Code of Conduct, and agree
to the terms of access through a Data Use Certification agreement.
Requests to renew data access and reports to close out data use are
similar to the initial data access request, requiring sign-off by both
the requestor and the institution, but also ask for information about
how the data have been used, and about publications, presentations, or
intellectual property based on the research conducted with the accessed
data as well as any data security issues or other data management
incidents. NIH has developed online forms, available through dbGaP, in
an effort to reduce the burden for researchers and their
[[Page 73010]]
institutional officials to complete the study registration, data
submission, data access, and renewal and closeout processes.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 158,776.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
dbGaP Registration and Investigator 1,050 1 1 1050
Submission. Submitting Data.
Institutional Certification... Investigator 1,050 1 45/60 788
filling out
Institutional
Certification.
Institutional Certification... Institutional 1,050 1 45/60 788
Official to
Certify
Submission.
Provisional Institutional Investigator 100 1 45/60 75
Certification. filling out
Provisional
Institutional
Certification.
Provisional Institutional Institutional 100 1 45/60 75
Certification. Official to
Certify
Provisional
Submission.
Data Access Request........... Requester 3,900 10 1 39,000
Submitting
Request.
Data Access Request........... Institutional 3,900 10 1 39,000
Signing
Official to
Certify Request.
Project Renewal or Project Requester 3,900 10 1 39,000
Close-out form. Submitting
Request.
Project Renewal or Project Institutional 3,900 10 1 39,000
Close-out form. Signing
Official to
Certify Request.
---------------------------------------------------------------
Total..................... ................ 18,950 159,350 .............. 158,776
----------------------------------------------------------------------------------------------------------------
Dated: November 21, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2022-25840 Filed 11-25-22; 8:45 am]
BILLING CODE 4140-01-P
