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Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought 42 CFR Part 50 Subpart F and Responsible Prospective Contractors (NIH/OPERA)

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OMB: 0925-0417

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Federal Register / Vol. 87, No. 81 / Wednesday, April 27, 2022 / Notices
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Initial
Review Group; Clinical, Treatment and
Health Services Research Study Section.
Date: June 15, 2022.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Luis Espinoza, Ph.D.,
Scientific Review Officer, Extramural Project
Review Branch, National Institute on Alcohol
Abuse and Alcoholism, 6700B Rockledge
Drive, Room 2109, Bethesda, MD 20817,
(301) 443–8599, [email protected].
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; Individual Fellowship (F30,
F31, F32) Review Panel.
Date: June 21, 2022.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Luis Espinoza, Ph.D.,
Scientific Review Officer, Extramural Project
Review Branch, Office of Extramural
Activities, National Institute on Alcohol
Abuse and Alcoholism, 6700B Rockledge
Drive, Room 2109, Bethesda, MD 20892,
(301) 443–8599, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
Dated: April 22, 2022.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.

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 on
Aging Special Emphasis Panel; Alzheimer’s
Disease and Asians.
Date: June 8, 2022.
Time: 1:00 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Carmen Moten, Ph.D.,
MPH, Scientific Review Officer, National
Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892, 301–402–7703, cmoten@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: April 22, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–08966 Filed 4–26–22; 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; Responsibility of
Applicants for Promoting Objectivity in
Research for Which Public Health
Service (PHS) Funding is Sought 42
CFR Part 50 Subpart F and
Responsible Prospective Contractors
45 CFR Part 94 (Office of the Director)
AGENCY:

[FR Doc. 2022–08957 Filed 4–26–22; 8:45 am]

HHS.

BILLING CODE 4140–01–P

ACTION:

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
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
SUMMARY:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health

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National Institute on Aging; Notice of
Closed Meeting
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

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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: Mr. Joel A.
Snyderman, Director, Division of Grants
Compliance and Oversight, Office of
Policy for Extramural Research
Administration, Office of Extramural
Research, National Institutes of Health,
6705 Rockledge Drive, Suite 800,
Bethesda, MD 20892, or call non-tollfree number (301) 435–0930 or Email
your request, including your address to:
[email protected].
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on February 17, 2022 (FR 87—
page 9075 and allowed 60 days for
public comment. No comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The 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: Responsibility of
Applicants for Promoting Objectivity in
Research for which Public Health
Service (PHS) Funding is Sought 42 CFR
part 50 Subpart F and Responsible
Prospective Contractors 45 CFR part 94,
0925–0417, expiration date 4/30/2022,
EXTENSION, Office of Policy for
Extramural Research Administration
(OPERA), Office of Extramural Research
(OER), National Institutes of Health
(NIH).
Need and Use of Information
Collection: This request is for Office of
Management and Budget (OMB)
approval of a Reinstatement Without
Change of a currently approved
collection resulting from the
development of revised regulations
regarding the Responsibility of
Applicants for Promoting Objectivity in
Research for which PHS Funding is
Sought (42 CFR part 50, subpart F) and
Responsible Prospective Contractors (45
CFR part 94). The purpose of these

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Federal Register / Vol. 87, No. 81 / Wednesday, April 27, 2022 / Notices

regulations is to promote objectivity in
research by requiring institutions to
establish standards to ensure that there
is no reasonable expectation that the
design, conduct, or reporting of PHS-

funded research will be biased by any
Investigator Financial Conflict of
Interest (FCOI).
OMB approval is requested for 3
years. There are no costs to respondents

other than their time. The total
estimated annualized burden hours are
677,820.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hrs.)

992 ................................................

1

2

1,984

50 FCOI reports as in 42 CFR
50.605(a)(3)(ii) and 45 CFR
94.5(a)(3)(ii).
5 mitigation reports .......................
2,031 .............................................

1

2

100

1
1

2
1

10
2,031

20 ..................................................

1

10

200

1

4

8,000

Type of respondents based on applicable section of regulation

Number of respondents

Total
annual
burden
hours

Reporting
Initial Reports under 42 CFR 50.605(b)(1) and (b)(3) or 45 CFR 94.5(b)(1) and (b)(3)
from awardee Institutions.
Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) or 45 CFR
94.5(a)(3)(iii) and (b)(2) from awardee Institutions.

Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from awardee Institutions.
Subsequent Reports under 42 CFR 50.606(a) or 45 CFR 94.6 from awardee Institutions.

Recordkeeping
Under 42 CFR 50.604(i) or 45 CFR 94.4(i) from awardee institutions ...........................

2,000 .............................................

Disclosure
Under 42 CFR 50.604(a) or 45 CFR 94.4 for Investigators ............................................
Under 42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for Investigators ...................................
Under 42 CFR 50.604(b) or 45 CFR 94.4(e)(1) for Institutions ......................................
Under 42 CFR 50.604(c)(1) or 45 CFR 94.4(c)(1) from subrecipients ...........................
Under 42 CFR 50.604(d) or 45 CFR 94.4 for Institutions ...............................................
Under 42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) for Investigators ...............................
Under 42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) for Investigators ...............................
Under 42 CFR 50.604(e)(3) or 45 CFR 94.4(e)(3) for Investigators ...............................
Under 42 CFR 50.604(f) or 45 CFR 94.4(f) for institutions .............................................
Under 42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) for Institutions ..................................
Under 42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) for Institutions ..................................
Under 42 CFR 50.605(a)(3)(i) or 45 CFR 94.5(a)(3)(i) ...................................................
Under 42 CFR 50.605(a)(3)(ii) or 45 CFR 94.5(a)(3)(ii) ..................................................
Under 42 CFR 50.605(a)(3)(iii) or 45 CFR 94.5(a)(3)(iii) ................................................
Under 42 CFR 50.605(a)(4) or 45 CFR 94.5(a)(4) ..........................................................
Public Website Posting under 42 CFR 50.605(a)(5) or 45 CFR 94.5(a)(5) from awardee Institutions.
Under 42 CFR 50.606(c) or 45 CFR 94.6(c) ...................................................................

3,000 .............................................
38,000 ...........................................
2,000 .............................................
500 ................................................
3,000 1 ..........................................
38,000 ...........................................
38,000 ...........................................
992 ................................................
2,000 .............................................
2,000 2 ..........................................
500 3 .............................................
50 4 ...............................................
50 5 ...............................................
50 ..................................................
992 ................................................
2,000 .............................................

1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1

81
30/60
6
1
1
4
1
30/60
1
82
3
80
80
1
12
5

243,000
19,000
12,000
500
3,000
152,000
38,000
496
2,000
164,000
1,500
4,000
4,000
50
11,904
10,000

50 6 ...............................................

37

18/60

45

Total ..........................................................................................................................

136,282 .........................................

136,382

..................

677,820

1 Assuming

that 3,000 Institutions solicit disclosures on an annual basis by sending a notification to all Investigators.
2 Although an estimated 992 reports of Conflict of Interest are expected annually, the 2,000 responding Institutions must review all financial disclosures associated
with PHS-funded awards to determine whether any conflicts of interest exist. Thus, the review burden of 76,000 hours is based upon estimates that it will take on the
average 2 hours for an institutional official(s) to review each of 38,000 financial disclosures associated with PHS funded awards. The burden for developing a management plan for identified FCOI is estimated at 80 hours × 992 cases = 79,360 hours.
3 Assuming that this is a rare occurrence based on prior experience.
4 Assuming only a fraction of the newly identified SFIs will constitute FCOI.
5 Assuming only a fraction of the newly identified SFIs will constitute FCOI.
6 Number based on 50.605/94.5 (a)(3)(i)—of those only a fraction will relate to a project of clinical research whose purpose is to evaluate the safety or effectiveness
of a drug, medical device, or treatment, but we are calculating the maximum estimated burden.
7 Assuming an average of 3 publications annually.

Dated: April 21, 2022.
Tara A. Schwetz,
Deputy Principal Deputy Director, National
Institutes of Health.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2022–08986 Filed 4–26–22; 8:45 a.m.]

National Institute of Environmental
Health Sciences; Notice of Meeting

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BILLING CODE 4140–01–P

National Institutes of Health

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Environmental Health Sciences Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and

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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

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