National Institute of Mental Health; Notice of Closed Meetings, 53751-53752 [2022-18955]
Download as PDF
<![CDATA[
Federal Register / Vol. 87, No. 169 / Thursday, September 1, 2022 / Notices
fostering of an environment that
promotes research integrity and
discourages research misconduct.
Institutions receiving funding for
research from any of the PHS funding
components 1 must adhere to these
requirements to receive PHS funding.
ORI conducts oversight of
institutional research misconduct
proceedings (inquiries and
investigations) as well as institutional
compliance with the PHS Policies on
Research Misconduct at 42 CFR part 93.
ORI also conducts outreach and
develops educational resources that aid
institutional efforts ‘‘to teach the
responsible conduct of research,
promote research integrity, prevent
research misconduct, and . . . respond
effectively to allegations of research
misconduct. . . .’’ 65 FR 30600, 30601
(May 12, 2000).
The Public Health Service Policies on
Research Misconduct (42 CFR part 93) 2
became effective in June 2005, replacing
the Responsibilities of Awardee and
Applicant Institutions for Dealing with
and Reporting Possible Misconduct in
Science (42 CFR part 50), which was
promulgated in August 1989. ORI
contemplates beginning a regulatory
revision process for the 2005 ORI
regulation at 42 CFR part 93 in the near
future, using conventional rulemaking
processes and channels for public
notification and comment.
jspears on DSK121TN23PROD with NOTICES
Input on the 2005 Public Health Service
Policies on Research Misconduct
ORI seeks the perspectives of
individuals, research funding agencies,
institutional officials, organizations,
institutions, and other members of the
general public to help structure ORI’s
future work toward an updated
regulation. To this end, ORI issues this
RFI to collect input on the current
regulation at 42 CFR part 93.
ORI is not seeking specific regulatory
language at this time, only the
identification of potential topic(s),
1 PHS funding components are ‘‘any
organizational unit of the PHS authorized to award
grants, contracts, or cooperative agreements for any
activity that involves the conduct of biomedical or
behavioral research, research training or activities
related to that research or research training, e.g.,
agencies, bureaus, centers, institutes, divisions, or
offices and other awarding units within the PHS.’’
42 CFR 93.209. This includes the: National
Institutes of Health (NIH), Centers for Disease
Control and Prevention (CDC), FDA, Substance
Abuse and Mental Health Services Administration
(SAMHSA), Health Resources and Services
Administration (HRSA), Indian Health Service
(IHS), Agency for Healthcare Research and Quality
(AHRQ), Agency for Toxic Substances and Disease
Registry (ATSDR), Office of the Assistant Secretary
for Health (OASH), and Administration for Strategic
Preparedness and Response (ASPR).
2 Hereafter referred to as the ‘‘2005 ORI regulation
at 42 CFR part 93.’’
VerDate Sep<11>2014
17:15 Aug 31, 2022
Jkt 256001
issue(s), or area(s) that stakeholders and
other members of the general public see
as being important to consider when
revising the 2005 ORI regulation at 42
CFR part 93. Responders may find it
helpful to consider the following
questions when preparing responses
(the order of the questions below should
not be taken to imply importance,
priority, or precedence):
(1) Which section(s) should be
changed or augmented when revising 42
CFR part 93? Why? How should the
section(s) be changed or augmented?
(2) Which section(s) should be
retained as it currently is in 42 CFR part
93? Why?
(3) Which section(s) should be
considered for removal when revising
42 CFR part 93? Why?
ORI views this RFI as a brainstorming
process. Short responses, limited to just
a few words on a given topic, issue, or
area will facilitate the organization and
categorization of responses. If an idea
specifically relates to a part of the
current regulation, citing that section
(e.g., § 314.3) would be helpful.
Collection of Information Requirements
Please note: This RFI is issued solely
for information and planning purposes.
It does not constitute a solicitation for:
Request for Proposals (RFPs),
applications, proposal abstracts, or
quotations. This RFI does not commit
the U.S. Government to contract for any
supplies or services or to make a grant
award. Further, ORI is not seeking
proposals through this RFI and will not
accept unsolicited proposals.
Responders are advised that the U.S.
Government will not pay for any
information or administrative costs
incurred in responding to this RFI; all
costs associated with responding to this
RFI will be solely at the expense of the
responding parties. ORI notes that not
responding to this RFI does not
preclude participation in future
conventional rulemaking concerning 42
CFR part 93. It is the responsibility of
the potential responders to monitor this
RFI announcement for additional
information pertaining to this request.
ORI will actively consider all input
received as our office initiates the rule
making process in the near future. ORI
may or may not choose to contact
individual responders. Such
communications would be for the sole
purpose of clarifying statements in the
responders’ written responses.
Responses to this notice are not offers
and cannot be accepted by the U.S.
Government to form a binding contract
or to issue a grant. Information obtained
from this RFI may be used by the U.S.
Government on a non-attribution basis.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
53751
Responders should not include any
information that might be considered
proprietary or confidential. This RFI
should not be construed as a
commitment or authorization to incur
cost for which reimbursement would be
required or sought. All submissions
become U.S. Government property and
will not be returned.
Dated: August 29, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity,
Office of the Assistant Secretary for Health.
[FR Doc. 2022–18884 Filed 8–31–22; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
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 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 Institute of
Mental Health Initial Review Group;
Effectiveness of Mental Health Interventions
Study Section.
Date: September 30, 2022.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Marcy Ellen Burstein,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Room 6143, MSC 9606, Bethesda, MD 20892–
9606, 301–443–9699, bursteinme@
mail.nih.gov.
Name of Committee: National Institute of
Mental Health Initial Review Group; Mental
Health Services Study Section.
Date: October 3–4, 2022.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
E:\FR\FM\01SEN1.SGM
01SEN1
53752
Federal Register / Vol. 87, No. 169 / Thursday, September 1, 2022 / Notices
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Aileen Schulte, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Room 6136, MSC 9606, Bethesda, MD 20852,
301–443–1225, aschulte@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: August 29, 2022.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–18955 Filed 8–31–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Cancer Therapy
Evaluation Program (CTEP) Branch
and Support Contracts Forms and
Surveys (National Cancer Institute)
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.
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/
SUMMARY:
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
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Michael Montello, Cancer
Therapy Evaluation Program, Division
of Cancer Treatment and Diagnosis,
National Cancer Institute, 9609 Medical
Center Drive, Bethesda, Maryland 20892
or call non-toll-free number (240) 276–
6080 or email your request, including
your address to: montellom@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
published in the Federal Register on
May 31, 2022 (Vol. 87, No. 104, P.
32427) 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 Cancer Institute
(NCI), National Institutes of Health
(NIH), 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
Office of Management and Budget
(OMB) control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, NIH has
submitted to OMB a request for review
and approval of the information
collection listed below.
Proposed Collection: Cancer Therapy
Evaluation Program (CTEP) Support
Contracts Forms and Survey (NCI)
(0925–0753), Expiration Date 05/31/
2024, REVISION, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: This revision removes one
form, adds one new form, revises three
forms, and includes an updated Privacy
Impact Assessment. The National
Cancer Institute (NCI) Cancer Therapy
Evaluation Program (CTEP) and the
Division of Cancer Prevention (DCP)
fund an extensive national program of
cancer research, sponsoring clinical
trials in cancer prevention, symptom
management, and treatment for
qualified clinical investigators. As part
of this effort, CTEP implements
programs to register clinical site
investigators and clinical site staff and
to oversee the conduct of research at the
clinical sites. CTEP and DCP also
oversee two support programs, the NCI
Central Institutional Review Board
(CIRB) and the Cancer Trial Support
Unit (CTSU). The combined systems
and processes for initiating and
managing clinical trials are termed the
Clinical Oncology Research Enterprise
(CORE) and represents an integrated set
of information systems and processes
which support investigator registration,
trial oversight, patient enrollment, and
clinical data collection. The information
collected is required to ensure
compliance with applicable federal
regulations governing the conduct of
human subjects research (45 CFR 46 and
21 CRF 50), and when CTEP acts as the
Investigational New Drug (IND) holder
(Food and Drug Administration (FDA)
regulations pertaining to the sponsor of
clinical trials and the selection of
qualified investigators (21 CRF 312.53).
Survey collections assess satisfaction
and provide feedback to guide
improvements with processes and
technology. OMB approval is requested
for 3 years. There are no costs to
respondents other than their time. The
total estimated annualized burden is
151,769 hours.
jspears on DSK121TN23PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
annual
burden
hours
Form name
Type of respondent
CTSU IRB/Regulatory Approval Transmittal Form
(Attachment A01).
CTSU IRB Certification Form (Attachment A02) .......
Withdrawal from Protocol Participation Form (Attachment A03).
Site Addition Form (Attachment A04) ........................
CTSU Request for Clinical Brochure (Attachment
A06).
CTSU Supply Request Form (Attachment A07) ........
RTOG 0834 CTSU Data Transmittal Form (Attachment A10).
Health Care Practitioner ..
2,444
12
2/60
978
Health Care Practitioner ..
Health Care Practitioner ..
2,444
279
12
1
10/60
10/60
4,888
47
Health Care Practitioner ..
Health Care Practitioner ..
80
360
12
1
10/60
10/60
160
60
Health Care Practitioner ..
Health Care Practitioner ..
90
12
12
76
10/60
10/60
180
152
VerDate Sep<11>2014
17:15 Aug 31, 2022
Jkt 256001
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
E:\FR\FM\01SEN1.SGM
01SEN1
]]>Agencies
[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Notices]
[Pages 53751-53752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18955]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health; 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 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 Institute of Mental Health Initial
Review Group; Effectiveness of Mental Health Interventions Study
Section.
Date: September 30, 2022.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).
Contact Person: Marcy Ellen Burstein, Ph.D., Scientific Review
Officer, Division of Extramural Activities, National Institute of
Mental Health, National Institutes of Health, Neuroscience Center,
6001 Executive Blvd., Room 6143, MSC 9606, Bethesda, MD 20892-9606,
301-443-9699, [email protected].
Name of Committee: National Institute of Mental Health Initial
Review Group; Mental Health Services Study Section.
Date: October 3-4, 2022.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive
[[Page 53752]]
Boulevard, Rockville, MD 20852 (Virtual Meeting).
Contact Person: Aileen Schulte, Ph.D., Scientific Review
Officer, Division of Extramural Activities, National Institute of
Mental Health, National Institutes of Health, Neuroscience Center,
6001 Executive Blvd., Room 6136, MSC 9606, Bethesda, MD 20852, 301-
443-1225, [email protected].
(Catalogue of Federal Domestic Assistance Program No. 93.242, Mental
Health Research Grants, National Institutes of Health, HHS)
Dated: August 29, 2022.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-18955 Filed 8-31-22; 8:45 am]
BILLING CODE 4140-01-P
