National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 24634-24635 [2021-09746]
Download as PDF
<![CDATA[
24634
Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Class II Special Controls Guidance
Document: Labeling for Natural Rubber
Latex Condoms—21 CFR 884.5300 OMB
Control Number 0910–0633—Extension
Under the Medical Device
Amendments of 1976 (Pub. L. 94–295),
class II devices were defined as those
devices for which there was insufficient
information to show that general
controls themselves would provide a
reasonable assurance of safety and
effectiveness but for which there was
sufficient information to establish
performance standards to provide such
assurance. Accordingly, FDA has
established the above captioned special
controls guidance document regarding
the labeling of natural rubber latex
condoms.
Condoms without spermicidal
lubricant containing nonoxynol 9 are
classified in class II. They were
originally classified before the
enactment of provisions of the Safe
Medical Devices Act of 1990 (Pub. L.
101–629), which broadened the
definition of class II devices and now
permits FDA to establish special
controls beyond performance standards,
including guidance documents, to help
provide reasonable assurance of the
safety and effectiveness of such devices.
In December 2000, Congress enacted
Public Law 106–554, which directed
FDA to ‘‘reexamine existing condom
labels’’ and ‘‘determine whether the
labels are medically accurate regarding
the overall effectiveness or lack of
effectiveness in preventing sexually
transmitted diseases . . .’’ In response,
FDA recommended labeling intended to
provide important information for
condom users, including the extent of
protection provided by condoms against
various types of sexually transmitted
diseases.
Respondents to this collection of
information are manufacturers and
repackagers of male condoms made of
natural rubber latex without spermicidal
lubricant. FDA expects approximately
five new manufacturers or repackagers
to enter the market yearly and to
collectively have a third-party
disclosure burden of 60 hours. Our
assumption of the burden per disclosure
is based on our history with the
information collection. Because the
packaging requirements for condoms are
similar to those of many over-the-
counter (OTC) drugs, we believe the
burden to design the labeling for OTC
drugs is an appropriate proxy for the
estimated burden to design condom
labeling.
The special controls guidance
document also refers to previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485; the
collections of information in 21 CFR
part 807, subpart E have been approved
under OMB control number 0910–0120;
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
The collection of information under
21 CFR 801.437 does not constitute a
‘‘collection of information’’ under the
PRA. Rather, it is a ‘‘public disclosure
of information originally supplied by
the Federal Government to the recipient
for the purpose of disclosure to the
public’’ (5 CFR 1320.3(c)(2)).
In the Federal Register of January 4,
2021 (86 FR 109), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
‘‘Class II Special Controls Guidance Document: Labeling
for Natural Rubber Latex Condoms Classified Under 21
CFR 884.5300’’ ................................................................
5
1
5
12
60
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
[FR Doc. 2021–09620 Filed 5–6–21; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:55 May 06, 2021
Jkt 253001
National Institutes of Health
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Small Business Innovation
Research (SBIR) Phase II Program Contract
Solicitation (PHS 2018–1) QrumPharma
Topic 051: Inhaled Delivery of Clofazimine
(CFZ).
Date: May 28, 2021.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G31,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Cynthia L. De La Fuente,
Ph.D., Scientific Review Officer, Scientific
E:\FR\FM\07MYN1.SGM
07MYN1
Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G31,
Rockville, MD 20852, 240–669–2740,
delafuentecl@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: May 4, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–09746 Filed 5–6–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Biobehavioral and
Behavioral Processes Integrated Review
Group; Motor Function, Speech and
Rehabilitation Study Section.
Date: June 3–4, 2021.
Time: 9:00 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Biao Tian, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 3166, MSC 7848, Bethesda, MD
20892, 301–402–4411, tianbi@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Cell
Signaling and Molecular Endocrinology.
Date: June 4, 2021.
Time: 9:30 a.m. to 10:30 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Elaine Sierra-Rivera, Ph.D.,
IRG Chief, EMNR IRG, Center for Scientific
VerDate Sep<11>2014
19:55 May 06, 2021
Jkt 253001
Review, National Institutes of Health, 6701
Rockledge Drive, Room 6182, MSC 7892,
Bethesda, MD 20892, 301–435–2514,
riverase@csr.nih.gov.
Name of Committee: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group; Imaging Guided
Interventions and Surgery Study Section.
Date: June 10–11, 2021.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Ileana Hancu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5116,
Bethesda, MD 20817, (301) 402–3911,
ileana.hancu@nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Behavioral
Neuroendocrinology, Neuroimmunology,
Rhythms, and Sleep Study Section.
Date: June 15–16, 2021.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Michael Selmanoff, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5164,
MSC 7844, Bethesda, MD 20892, 301–435–
1119, selmanom@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Mechanisms of Memory and Sound
Processing.
Date: June 16, 2021.
Time: 10:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Sepandarmaz Aschrafi,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040D,
Bethesda, MD 20892, (301) 451.4251,
Armaz.aschrafi@nih.gov.
(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: May 4, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–09742 Filed 5–6–21; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
24635
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Biobehavioral and
Behavioral Processes Integrated Review
Group; Biobehavioral Regulation, Learning
and Ethology Study Section.
Date: June 4, 2021
Time: 8:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Sara Louise Hargrave,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 3170,
Bethesda, MD 20892, (301) 443–7193,
hargravesl@mail.nih.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Kidney, Nutrition, Obesity and Diabetes
Study Section.
Date: June 8–9, 2021.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Steven Michael Frenk,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 3141,
Bethesda, MD 20892, (301) 480–8665,
frenksm@mail.nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Skeletal Biology Development and Disease
Study Section.
Date: June 9–11, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Aruna K. Behera, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
E:\FR\FM\07MYN1.SGM
07MYN1
]]>Agencies
[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Notices]
[Pages 24634-24635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09746]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; 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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; Small Business Innovation Research
(SBIR) Phase II Program Contract Solicitation (PHS 2018-1)
QrumPharma Topic 051: Inhaled Delivery of Clofazimine (CFZ).
Date: May 28, 2021.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G31,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Cynthia L. De La Fuente, Ph.D., Scientific
Review Officer, Scientific
[[Page 24635]]
Review Program, Division of Extramural Activities, National
Institute of Allergy and Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G31, Rockville, MD 20852, 240-669-
2740, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: May 4, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-09746 Filed 5-6-21; 8:45 am]
BILLING CODE 4140-01-P
