Proposed Collection; 60-Day Comment Request; NIH Information Collection Forms To Support Genomic Data Sharing for Research Purposes (OD), 57705-57707 [2022-20467]
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57705
Federal Register / Vol. 87, No. 182 / Wednesday, September 21, 2022 / Notices
(Pub. L. 117–103), division H, title II,
which requires that ‘‘institutions that
receive funds through a grant or
cooperative agreement during fiscal year
2022 and in future years to notify the
Director when individuals identified as
a principal investigator or as key
personnel in an NIH notice of award are
removed from their position or are
otherwise disciplined due to concerns
about harassment, bullying, retaliation,
or hostile working conditions.’’ The
Harassment Web Form will be used as
a secure and confidential portal by
Harassment Web Form. All required
notifications must include, at a
minimum, the name of the Authorized
Organization Representative submitting
the notification, the name of the
individual of concern, a description of
the concerns, the action(s) taken, and
any anticipated impact on the NIHfunded award(s).
OMB approval is requested for three
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
60.
which recipient institutions notify NIH
when individuals identified as PD/PI or
other Senior/Key personnel in an NIH
notice of award are removed from their
position or are otherwise disciplined by
the recipient institution due to concerns
about harassment, bullying, retaliation
or hostile working conditions, as
specified in NOT–OD–22–129.
Notification must be provided by the
Authorized Organization Representative
within 30 days of the removal or
disciplinary action and must be
submitted to NIH through the
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Average
burden per
response
(in hours)
Total annual
burden hours
Private Sector ..................................................................................................
240
1
15/60
60
Total ..........................................................................................................
........................
240
........................
60
Dated: September 15, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National
Institutes of Health.
[FR Doc. 2022–20468 Filed 9–20–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in section
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.
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Name of Committee: Developmental
Biology Study Section.
Date: October 14, 2022.
Closed: 10 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
VerDate Sep<11>2014
19:54 Sep 20, 2022
Jkt 256001
Rockledge Drive, 2131B, Bethesda, MD
20892–7510 (Video Assisted Meeting).
Contact Person: Jolanta Maria Topczewska,
Ph.D., Scientific Review Officer, Scientific
Review Branch, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6710B Rockledge
Drive, Rm. 2131B, Bethesda, MD 20892, (301)
451–0000, jolanta.topczewska@nih.gov.
Name of Committee: Health, Behavior, and
Context Study Section.
Date: October 17, 2022.
Closed: 10 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, 2137C, Bethesda, MD
20892–7510 (Video Assisted Meeting).
Contact Person: Kimberly L. Houston, MD,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH, 6710B Rockledge Drive,
Room 2137C, Bethesda, MD 20892, (301)
827–4902, kimberly.houston@nih.gov.
Name of Committee: Obstetrics and
Maternal-Fetal Biology Study Section.
Date: October 28, 2022.
Closed: 10 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, 2127D, Bethesda, MD
20892–7510 (Video Assisted Meeting).
Contact Person: Luis E. Dettin, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH, 6710B Rockledge Drive,
Room 2127D, Bethesda, MD 20892, (301)
827–8231, luis.dettin@nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
www.nichd.nih.gov/about/org/der/srb where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.865, Research for Mothers
and Children, National Institutes of Health,
HHS.)
Dated: September 15, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–20400 Filed 9–20–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; NIH Information Collection
Forms To Support Genomic Data
Sharing for Research Purposes (OD)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, for opportunity
for public comment on proposed data
collection projects, the National
Institutes of Health Office 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
SUMMARY:
E:\FR\FM\21SEN1.SGM
21SEN1
57706
Federal Register / Vol. 87, No. 182 / Wednesday, September 21, 2022 / Notices
within 60 days of the date of this
publication.
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Julia Slutsman, Ph.D., Director,
Genomic Data Sharing Policy
Implementation Team, Office of
Extramural Research, NIH, Office of
Extramural Research, OD, NIH 6705
Rockledge Dr. (RKL1), Room 800–C,
Bethesda, MD 20892, or call non-tollfree number (301)-594–7783 or email
your request including your address to:
sharing@mail.nih.gov. 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 from 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: NIH
Information Collection Forms to
Support Genomic Data Sharing for
Research Purposes—0925–0670—
Expiration Date 11/31/2022—
FOR FURTHER INFORMATION CONTACT:
a description of the study, and an
institutional assurance (i.e., provided
through submission of an Institutional
Certification form) of the data
submission which delineates any
necessary 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 controlledaccess 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 the Database of
Genotypes and Phenotypes (dbGaP), in
an effort to minimize burden for
researchers and their institutional
officials completing the study
registration, data submission, data
access, and renewal and closeout
processes.
OMB approval is requested for three
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
72,301 hours.
REVISION—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 genomic and related
phenotypic data are managed through
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 Database of
Genotypes and Phenotypes (dbGaP), no
matter which NIH-designated data
repository will ultimately maintain the
data. As part of the study registration
process, investigators must provide
basic study information such as the type
of data that will be submitted to dbGaP,
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Number of
respondents
Type of respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
khammond on DSKJM1Z7X2PROD with NOTICES
Study Registration and Data Submission
dbGaP Registration and Submission
Institutional Certification ....................
Institutional Certification ....................
Investigator Submitting Data ............
Investigator filling out Institutional
Certification.
Institutional Official to Certify Institutional Certification.
1,050
1,050
1
1
45/60
45/60
788
788
1,050
1
30/60
525
3,900
10
45/60
29,250
Requesting Access to Data
Data Access Request .......................
VerDate Sep<11>2014
19:54 Sep 20, 2022
Requester Submitting Request ........
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PO 00000
Frm 00027
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Sfmt 4703
E:\FR\FM\21SEN1.SGM
21SEN1
57707
Federal Register / Vol. 87, No. 182 / Wednesday, September 21, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
Number of
respondents
Type of respondents
Data Access Request .......................
Institutional Signing Official to Certify Request.
Number of
responses per
respondent
3,900
Average
burden per
response
(in hours)
Total annual
burden hours
10
30/60
19,500
Project Renewal or Project Close-out
Project Renewal or Project Close-out
form.
Project Renewal or Project Close-out
form.
Requester Submitting Request ........
3,900
10
15/60
9,750
Institutional Signing Official to Certify Request.
3,900
10
18/60
11,700
Total ...........................................
...........................................................
18,750
159,150
........................
72,301
Dated: September 15, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National
Institutes of Health.
[FR Doc. 2022–20467 Filed 9–20–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Fiscal Year (FY) 2022 Notice of
Supplemental Funding Opportunity
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice of intent to award
supplemental funding.
AGENCY:
This notice is to inform the
public that the Substance Abuse and
Mental Health Services Administration
(SAMHSA) is supporting an
administrative supplement (in scope of
the parent award) up to $20,833 (total
costs) for one-year to the Improving
Access to Overdose Treatment grant
recipients for a total of up to $104,165
(total funding). These recipients were
funded in FY 2018 with a project end
date of September 30, 2023. The
supplemental funding will be utilized
specifically to increase the number of
health care providers and pharmacists
who receive training and technical
assistance on the prescribing of drugs or
devices approved or cleared under the
FDA for emergency treatment of known
or suspected opioid overdose.
FOR FURTHER INFORMATION CONTACT:
Judith Ellis, Substance Abuse and
Mental Health Services Administration,
5600 Fishers Lane, Rockville, MD
20857, telephone (240) 276–2567; email:
judith.ellis@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION: Awardees
will further collaborations with
healthcare providers and pharmacists to
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:54 Sep 20, 2022
Jkt 256001
educate them on overdose dangers and
standing orders for FDA-approved
overdose reversal drugs to patients and
individuals who support persons at
high-risk for overdose.
The required activities for this
supplement are as follows:
• Increase use of SAMHSA’s Opioid
Overdose Prevention Toolkit as a guide
to develop and implement a
comprehensive prevention program to
reduce the number of prescription drug/
opioid overdose-related deaths and
adverse events among cases of known or
suspected opioid overdose.
• Provide technical assistance to
collaborating partner organizations and
practitioners in the implementation of a
comprehensive prevention program to
reduce the number of prescription drug/
opioid overdose-related deaths and
adverse events.
• Collaborate with additional
pharmacies to distribute drugs or
devices approved or cleared under the
Federal Food, Drug, and Cosmetic Act
for emergency treatment of known or
suspected opioid overdose, as permitted
by state law.
• Provide targeted public education
on the state’s ‘‘Good Samaritan’’ laws
related to a drug overdose, if applicable,
such as those that permit bystanders to
alert emergency responders to an
overdose or to administer drugs or
devices approved or cleared under the
Federal Food, Drug, and Cosmetic Act
for emergency treatment of known or
suspected opioid overdose without fear
of civil or criminal penalties.
This is not a formal request for
application. Assistance will only be
provided to the Improving Access to
Overdose Treatment Funding
Opportunity SP–18–006 grant recipients
based on the receipt of a satisfactory
application and associated budget that
is approved by a review group.
Funding Opportunity Title: FY 2018
Improving Access to Overdose
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Treatment Funding Opportunity SP–18–
006.
Assistance Listing Number: 93.243.
Authority: Section 516 of the Public
Health Services Act, as amended.
Justification: Eligibility for this
supplemental funding is limited the
Improving Access to Overdose
Treatment Funding Opportunity SP–18–
006 grant recipients funded in FY 2018.
These organizations are uniquely
positioned to provide training and
technical assistance to organizations
and practitioners in prescription drug
overdose prevention activities being
funded through this supplement.
Carlos Graham,
Reports Clearance Officer.
[FR Doc. 2022–20436 Filed 9–20–22; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–4665–
DR; Docket ID FEMA–2022–0001]
Missouri; Major Disaster and Related
Determinations
Federal Emergency
Management Agency, Department of
Homeland Security (DHS).
ACTION: Notice.
AGENCY:
This is a notice of the
Presidential declaration of a major
disaster for the State of Missouri
(FEMA–4665–DR), dated August 8,
2022, and related determinations.
DATES: The declaration was issued
August 8, 2022.
FOR FURTHER INFORMATION CONTACT:
Dean Webster, Office of Response and
Recovery, Federal Emergency
Management Agency, 500 C Street SW,
Washington, DC 20472, (202) 646–2833.
SUMMARY:
E:\FR\FM\21SEN1.SGM
21SEN1
]]>Agencies
[Federal Register Volume 87, Number 182 (Wednesday, September 21, 2022)]
[Notices]
[Pages 57705-57707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20467]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; NIH Information
Collection Forms To Support Genomic Data Sharing for Research Purposes
(OD)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, for opportunity for public comment on proposed data
collection projects, the National Institutes of Health Office 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
[[Page 57706]]
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: Julia
Slutsman, Ph.D., Director, Genomic Data Sharing Policy Implementation
Team, Office of Extramural Research, NIH, Office of Extramural
Research, OD, NIH 6705 Rockledge Dr. (RKL1), Room 800-C, Bethesda, MD
20892, or call non-toll-free number (301)-594-7783 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 from 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: NIH Information Collection Forms to
Support Genomic Data Sharing for Research Purposes--0925-0670--
Expiration Date 11/31/2022--REVISION--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 genomic and related phenotypic data are managed through 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 Database of Genotypes and Phenotypes
(dbGaP), no matter which NIH-designated data repository will ultimately
maintain the data. As part of the study 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., provided through submission of an
Institutional Certification form) of the data submission which
delineates any necessary 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 the Database of
Genotypes and Phenotypes (dbGaP), in an effort to minimize burden for
researchers and their institutional officials completing the study
registration, data submission, data access, and renewal and closeout
processes.
OMB approval is requested for three years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 72,301 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Form name respondents respondents responses per response (in burden hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Study Registration and Data Submission
----------------------------------------------------------------------------------------------------------------
dbGaP Registration and Investigator 1,050 1 45/60 788
Submission. Submitting Data.
Institutional Certification... Investigator 1,050 1 45/60 788
filling out
Institutional
Certification.
Institutional Certification... Institutional 1,050 1 30/60 525
Official to
Certify
Institutional
Certification.
----------------------------------------------------------------------------------------------------------------
Requesting Access to Data
----------------------------------------------------------------------------------------------------------------
Data Access Request........... Requester 3,900 10 45/60 29,250
Submitting
Request.
[[Page 57707]]
Data Access Request........... Institutional 3,900 10 30/60 19,500
Signing
Official to
Certify Request.
----------------------------------------------------------------------------------------------------------------
Project Renewal or Project Close-out
----------------------------------------------------------------------------------------------------------------
Project Renewal or Project Requester 3,900 10 15/60 9,750
Close-out form. Submitting
Request.
Project Renewal or Project Institutional 3,900 10 18/60 11,700
Close-out form. Signing
Official to
Certify Request.
---------------------------------------------------------------
Total..................... ................ 18,750 159,150 .............. 72,301
----------------------------------------------------------------------------------------------------------------
Dated: September 15, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2022-20467 Filed 9-20-22; 8:45 am]
BILLING CODE 4140-01-P
