National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting, 12486 [2021-04366]
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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
IRB shall determine whether adequate
provisions are made for soliciting
assent. Generally, assent requires
securing the signature of a minor
potentially participating in the research
on a separate assent form, in addition to
the consent form the parent or legal
guardian signs. An assent document
should: (1) Contain an explanation of
the study; (2) a description of what is
required of the subject (e.g., what he or
she will experience (whether the minor
will be in the hospital, whether the
minor’s parents will be with him or her,
etc.)); (3) an explanation of any risks
and pain associated with the study; (4)
an explanation of any anticipated
change in the minor’s appearance; and
(5) an explanation of the benefits to the
minor or others.
FDA plans to use the data collected
under the generic clearance to inform
the following information for education,
interventions, outcomes, regulatory
science programs, materials and
resources, and disease prevention and
treatment. FDA expects the data to
guide the formulation of the Agency’s
educational and public health objectives
on FDA-regulated products and support
development of subsequent research
efforts. The data will not be used to
make policy or regulatory decisions.
Rather, these data will: (1) Inform FDA’s
public education campaigns and other
educational/interventional materials
directed to informing consumers,
patients, caregivers, and public health
professionals about human and animal
health issues; and (2) provide
information on the safety, efficacy, and
usage of FDA-regulated products.
If these conditions are not met, FDA
will submit an information collection
request to OMB for approval through the
normal PRA process.
To obtain approval for a collection
that meets the conditions of this generic
clearance, an abbreviated supporting
statement will be submitted to OMB,
along with supporting documentation
(e.g., a copy of the interview or
moderator guide, screening
questionnaire).
FDA will submit individual
qualitative and quantitative collections
under this generic clearance to the
OMB. Individual collections will also
undergo review by FDA’s IRB, senior
leadership for the primary investigator’s
respective offices, and PRA specialists.
Description of Respondents: The
respondents to this collection of
information are all FDA stakeholders,
including general population
individuals, as well as consumers of
certain products, patients and their
caregivers, academic/scientific experts,
individuals from specific target labor
groups, such as physicians, medical
specialists, pharmacists, dentists,
nurses, veterinarians, dietitians, and
other public health professionals.
In the Federal Register of July 7, 2020
(85 FR 40655), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
Although five comments were received,
they were not responsive to the four
collection of information topics
solicited and, therefore, will not be
discussed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Interviews/Surveys/Focus Groups .................................
2,520
14.6
36,792
1 There
0.25 (15 minutes)
Total hours
9,198
are no capital costs or operating and maintenance costs associated with this collection of information.
This is a new collection of
information whose total estimated
annual reporting burden is 9,198 hours.
The number of participants to be
included in each individual generic
submission under this collection of
information will vary, depending on the
nature of the compliance efforts and the
target audience.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04407 Filed 3–2–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSKJLSW7X2PROD with NOTICES
Average
burden per
response
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
VerDate Sep<11>2014
17:29 Mar 02, 2021
Jkt 253001
meeting of the Board of Scientific
Counselors, NIAMS.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended for the review, discussion,
and evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE OF ARTHRITIS
AND MUSCULOSKELETAL AND SKIN
DISEASES, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Board of Scientific
Counselors, NIAMS.
Date: April 27–28, 2021.
Time: April 27, 2021, 12:30 p.m. to 4:45
p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health, 10
Center Drive, Bethesda, MD 20892, (Virtual
Meeting).
Time: April 28, 2021, 12:00 p.m. to 4:15
p.m.
PO 00000
Frm 00077
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Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health, 10
Center Drive, Bethesda, MD 20892, (Virtual
Meeting).
Contact Person: John J. O’Shea, MD, Ph.D.,
Scientific Director, National Institute of
Arthritis & Musculoskeletal and Skin
Diseases, Building 10, Room 6N204,
Bethesda, MD 20892, (301) 496–2612,
osheajo@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: _February 25, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–04366 Filed 3–2–21; 8:45 am]
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[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Page 12486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04366]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin
Diseases; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the Board of Scientific
Counselors, NIAMS.
The meeting will be closed to the public as indicated below in
accordance with the provisions set forth in sections 552b(c)(4) and
552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and
evaluation of individual intramural programs and projects conducted by
the NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN
DISEASES, including consideration of personnel qualifications and
performance, and the competence of individual investigators, the
disclosure of which would constitute a clearly unwarranted invasion of
personal privacy.
Name of Committee: Board of Scientific Counselors, NIAMS.
Date: April 27-28, 2021.
Time: April 27, 2021, 12:30 p.m. to 4:45 p.m.
Agenda: To review and evaluate personnel qualifications and
performance, and competence of individual investigators.
Place: National Institutes of Health, 10 Center Drive, Bethesda,
MD 20892, (Virtual Meeting).
Time: April 28, 2021, 12:00 p.m. to 4:15 p.m.
Agenda: To review and evaluate personnel qualifications and
performance, and competence of individual investigators.
Place: National Institutes of Health, 10 Center Drive, Bethesda,
MD 20892, (Virtual Meeting).
Contact Person: John J. O'Shea, MD, Ph.D., Scientific Director,
National Institute of Arthritis & Musculoskeletal and Skin Diseases,
Building 10, Room 6N204, Bethesda, MD 20892, (301) 496-2612,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.846,
Arthritis, Musculoskeletal and Skin Diseases Research, National
Institutes of Health, HHS)
Dated: _February 25, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-04366 Filed 3-2-21; 8:45 am]
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