Guidance Documents Related to Coronavirus Disease 2019; Availability
| Published date | 09 September 2020 |
| Record Number | 2020-19883 |
| Section | Notices |
| Court | Food And Drug Administration,Health And Human Services Department |
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Federal Register / Vol. 85, No. 175 / Wednesday, September 9, 2020 / Notices
Collection 3090–0300, Implementation
of Information Technology Security
Provision’’ on your attached document.
Instructions: Please submit comments
only and cite Information Collection
3090–0300, Implementation of
Information Technology Security
Provision, in all correspondence related
to this collection. Comments received
generally will be posted without change
to regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
check regulations.gov, approximately
two-to-three days after submission to
verify posting.
FOR FURTHER INFORMATION CONTACT
: Ms.
Johnnie McDowell, Program Analyst,
Office of Acquisition Policy, at
gsarpolicy@gsa.gov.
SUPPLEMENTARY INFORMATION
:
A. Purpose
Clause 552.239–71 requires
contractors, within 30 days after
contract award, to submit an IT Security
Plan to the Contracting Officer and
Contacting Officer’s Representative that
describes the processes and procedures
that will be followed to ensure
appropriate security of IT resources that
are developed, processed, or used under
the contract. The clause will also
require that contractors submit written
proof of IT security authorization six
months after contract award, and verify
that the IT Security Plan remains valid
annually.
B. Annual Reporting Burden
Respondents: 146.
Responses per Respondent: 2.
Total Annual Responses: 292.
Hours per Response: 5.
Total Burden Hours: 1,460.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the GSAR,
and whether it will have practical
utility; whether our estimate of the
public burden of this collection of
information is accurate, and based on
valid assumptions and methodology;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and ways in which we can
minimize the burden of the collection of
information on those who are to
respond, through the use of appropriate
technological collection techniques or
other forms of information technology.
OBTAINING COPIES OF
PROPOSALS: Requesters may obtain a
copy of the information collection
documents from the General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street NW,
Washington, DC 20405, telephone 202–
501–4755. Please cite OMB Control No.
3090–0300, Implementation of
Information Technology Security
Provision, in all correspondence.
Jeffrey A. Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Government-
wide Policy.
[FR Doc. 2020–19870 Filed 9–8–20; 8:45 am]
BILLING CODE 6820–61–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–D–1106 and FDA–
2020–D–1138]
Guidance Documents Related to
Coronavirus Disease 2019; Availability
AGENCY
: Food and Drug Administration,
Health and Human Services (HHS).
ACTION
: Notice of availability.
SUMMARY
: The Food and Drug
Administration (FDA or Agency) is
announcing the availability of FDA
guidance documents related to the
Coronavirus Disease 2019 (COVID–19)
public health emergency (PHE). This
notice of availability (NOA) is pursuant
to the process that FDA announced, in
the Federal Register of March 25, 2020,
for making available to the public
COVID–19-related guidances. The
guidances identified in this notice
address issues related to the COVID–19
PHE and have been issued in
accordance with the process announced
in the March 25, 2020, notice. The
guidance documents have been
implemented without prior comment,
but they remain subject to comment in
accordance with the Agency’s good
guidance practices.
DATES
: The announcement of the
guidances is published in the Federal
Register on September 9, 2020. The
guidances have been implemented
without prior comment, but they remain
subject to comment in accordance with
the Agency’s good guidance practices.
ADDRESSES
: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
•Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
•If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
•Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
•For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the name of the guidance
document that the comments address
and the docket number for the guidance
(see table 1). Received comments will be
placed in the docket(s) and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
•Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
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Federal Register / Vol. 85, No. 175 / Wednesday, September 9, 2020 / Notices
1
On April 21, 2020, the PHE Determination was
extended, effective April 26, 2020; on July 23, 2020,
it was extended again, effective July 25, 2020. These
PHE Determinations are available at https://
www.phe.gov/emergency/news/healthactions/phe/
Pages/default.aspx.
2
Proclamation on Declaring a National
Emergency Concerning the Novel Coronavirus
Disease (COVID–19) Outbreak (March 13, 2020),
available at https://www.whitehouse.gov/
presidential-actions/proclamation-declaring-
national-emergency-concerning-novel-coronavirus-
disease-covid-19-outbreak/.
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-2015-
09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see § 10.115(g)(5)
(21 CFR 10.115(g)(5))).
Submit written requests for single
copies of these guidances to the address
noted in table 1. Send two self-
addressed adhesive labels to assist that
office in processing your requests. See
the
SUPPLEMENTARY INFORMATION
section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT
:
Kimberly Thomas, Center for Drug
Evaluation and Research (CDER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220,
Silver Spring, MD 20993–0002, 301–
796–2357; or Erica Takai, Center for
Devices and Radiological Health
(CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5456, (HFZ–450), Silver Spring, MD
20993–0002, 301–796–6353.
SUPPLEMENTARY INFORMATION
:
I. Background
On January 31, 2020, as a result of
confirmed cases of COVID–19, and after
consultation with public health officials
as necessary, Alex M. Azar II, Secretary
of Health and Human Services, pursuant
to the authority under section 319 of the
Public Health Service Act (PHS Act),
determined that a PHE exists and has
existed since January 27, 2020,
nationwide.
1
On March 13, 2020,
President Donald J. Trump declared that
the COVID–19 outbreak in the United
States constitutes a national emergency,
beginning March 1, 2020.
2
In the Federal Register of March 25,
2020 (the March 25, 2020, notice)
(available at https://www.govinfo.gov/
content/pkg/FR-2020-03-25/pdf/2020-
06222.pdf), FDA announced procedures
for making available FDA guidance
documents related to the COVID–19
PHE. These procedures, which operate
within FDA’s established good guidance
practices regulations, are intended to
allow FDA to rapidly disseminate
Agency recommendations and policies
related to COVID–19 to industry, FDA
staff, and other stakeholders. The March
25, 2020, notice stated that due to the
need to act quickly and efficiently to
respond to the COVID–19 PHE, FDA
believes that prior public participation
will not be feasible or appropriate before
FDA implements COVID–19-related
guidance documents. Therefore, FDA
will issue COVID–19-related guidance
documents for immediate
implementation without prior public
comment (see section 701(h)(1)(C) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 371(h)(1)(C) and
§ 10.115(g)(2). The guidances are
available at FDA’s web page titled
‘‘COVID–19-Related Guidance
Documents for Industry, FDA Staff, and
Other Stakeholders’’ (https://
www.fda.gov/emergency-preparedness-
and-response/mcm-issues/covid-19-
related-guidance-documents-industry-
fda-staff-and-other-stakeholders) and
through FDA’s web page titled ‘‘Search
for FDA Guidance Documents’’
available at https://www.fda.gov/
regulatory-information/search-fda-
guidance-documents.
The March 25, 2020, notice further
stated that, in general, rather than
publishing a separate NOA for each
COVID–19-related guidance document,
FDA intends to publish periodically a
consolidated NOA announcing the
availability of certain COVID–19-related
guidances FDA issued during the
relevant period, as included in table 1.
This notice announces COVID–19-
related guidances that are posted on
FDA’s website.
II. Availability of COVID–19-Related
Guidance Documents
Pursuant to the process described in
the March 25, 2020, notice, FDA is
announcing the availability of the
following COVID–19-related guidances:
T
ABLE
1—G
UIDANCES
R
ELATED TO THE
COVID–19 P
UBLIC
H
EALTH
E
MERGENCY
Docket No. Center Title of guidance Contact information to request single copies
FDA–2020–
D–1106. Center for Drug Evalua-
tion and Research
(CDER).
Temporary Policy for Preparation of Certain Alco-
hol-Based Hand Sanitizer Products During the
Public Health Emergency (COVID–19) (March
2020) (Updated August 7, 2020).
druginfo@fda.hhs.gov, Please include the docket
number FDA–2020–D–1106 and complete title
of the guidance in the request.
FDA–2020–
D–1106. CDER ............................ Policy for Temporary Compounding of Certain Al-
cohol-Based Hand Sanitizer Products During
the Public Health Emergency (March 2020)
(Updated August 7, 2020).
druginfo@fda.hhs.gov, Please include the docket
number FDA–2020–D–1106 and complete title
of the guidance in the request.
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Federal Register / Vol. 85, No. 175 / Wednesday, September 9, 2020 / Notices
T
ABLE
1—G
UIDANCES
R
ELATED TO THE
COVID–19 P
UBLIC
H
EALTH
E
MERGENCY
—Continued
Docket No. Center Title of guidance Contact information to request single copies
FDA–2020–
D–1106. CDER ............................ Temporary Policy for Manufacture of Alcohol for
Incorporation Into Alcohol-Based Hand Sani-
tizer Products During the Public Health Emer-
gency (COVID–19) (March 2020) (Updated Au-
gust 7, 2020).
druginfo@fda.hhs.gov, Please include the docket
number FDA–2020–D–1106 and complete title
of the guidance in the request.
FDA–2020–
D–1138. Center for Devices and
Radiological Health
(CDRH).
Enforcement Policy for Viral Transport Media
During the Coronavirus Disease 2019 (COVID–
19) Public Health Emergency (July 2020).
CDRH-Guidance@fda.hhs.gov, Please include
the document number 20038 and complete title
of the guidance in the request.
Although these guidances have been
implemented immediately without prior
comment, FDA will consider all
comments received and revise the
guidances as appropriate (see
§ 10.115(g)(3)).
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The
guidances represent the current thinking
of FDA. They do not establish any rights
for any person and are not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
III. Paperwork Reduction Act of 1995
A. CDER Guidances
The guidances listed in the table
below refer to previously approved
collections of information. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in the following FDA
regulations and guidances have been
approved by OMB as listed in the table
below. These guidances also contain a
collection of information not approved
under a current collection. This
collection of information has been
granted a PHE waiver from the PRA by
the Department of Health and Human
Services (HHS) on March 19, 2020,
under section 319(f) of the PHS Act.
Information concerning the PHE PRA
waiver can be found on the HHS
website at https://aspe.hhs.gov/public-
health-emergency-declaration-pra-
waivers.
T
ABLE
2—CDER G
UIDANCES AND
C
OLLECTIONS
COVID–19 guidance title
CFR cite(s)
referenced in
COVID–19
guidance
Another guidance referenced in COVID–19 guidance OMB Control
No(s).
Temporary Policy for Prepara-
tion of Certain Alcohol-
Based Hand Sanitizer Prod-
ucts During the Public
Health Emergency (COVID–
19)—UPDATE of guidance
announced in March 2020.
27 CFR parts
20 and 21. —Policy for Temporary Compounding of Certain Alcohol-
Based Hand Sanitizer Products During the Public Health
Emergency.
—Temporary Policy for Manufacture of Alcohol for Incorpo-
ration Into Alcohol-Based Hand Sanitizer Products During
the Public Health Emergency (COVID–19).
—Providing Regulatory Submissions in Electronic Format—
Drug Establishment Registration and Drug Listing.
—Postmarketing Adverse Event Reporting for Nonprescrip-
tion Human Drug Products Marketed Without an Ap-
proved Application.
0910–0045, 0910–0139,
0910–0230, 0910–0291,
0910–0340, 0910–0641,
0910–0645, 0910–0800.
Temporary Policy for Manufac-
ture of Alcohol for Incorpora-
tion Into Alcohol-Based
Hand Sanitizer Products
During the Public Health
Emergency (COVID–19)—
UPDATE of guidance an-
nounced in March 2020.
27 CFR parts
20 and 21. —Policy for Temporary Compounding of Certain Alcohol-
Based Hand Sanitizer Products During the Public Health
Emergency.
—Temporary Policy for Preparation of Certain Alcohol-
Based Hand Sanitizer Products During the Public Health
Emergency (COVID–19).
—Providing Regulatory Submissions in Electronic Format—
Drug Establishment Registration and Drug Listing.
0910–0045, 0910–0139,
0910–0230, 0910–0291,
0910–0340, 0910–0641,
0910–0645.
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T
ABLE
2—CDER G
UIDANCES AND
C
OLLECTIONS
—Continued
COVID–19 guidance title
CFR cite(s)
referenced in
COVID–19
guidance
Another guidance referenced in COVID–19 guidance OMB Control
No(s).
Policy for Temporary
Compounding of Certain Al-
cohol-Based Hand Sanitizer
Products During the Public
Health Emergency—UP-
DATE of guidance an-
nounced in March 2020.
.......................... —Current Good Manufacturing Practices for Finished Phar-
maceuticals and Medical Gases.
—Postmarketing Adverse Drug Experience Reporting.
—MedWatch: Adverse Event and Product Experience Re-
porting System (Paper-Based).
—Format and Content Requirements for Over-the-Counter
Drug Product Labeling.
—FDA Adverse Event and Product Experience Reports;
Electronic Submissions.
—Adverse Event Reporting for Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic
Act.
—Temporary Policy for Preparation of Certain Alcohol-
Based Hand Sanitizer Products During the Public Health
Emergency (COVID–19).
—Temporary Policy for Manufacture of Alcohol for Incorpo-
ration Into Alcohol-Based Hand Sanitizer Products During
the Public Health Emergency (COVID–19).
0910–0045, 0910–0139,
0910–0230, 0910–0291,
0910–0340, 0910–0641,
0910–0645.
B. CDRH Guidances
The guidance indicated in the table
below refers to previously approved
collections of information. These
collections of information are subject to
review by the OMB under the PRA. The
collections of information in the
following FDA regulations and guidance
have been approved by OMB as listed in
the table below. This guidance also
contains a new collection of information
not approved under a current collection.
This new collection of information has
been granted a PHE waiver from the
PRA by HHS on March 19, 2020, under
section 319(f) of the PHS Act.
Information concerning the PHE PRA
waiver can be found on the HHS
website at https://aspe.hhs.gov/public-
health-emergency-declaration-pra-
waivers.
T
ABLE
3—CDRH G
UIDANCES AND
C
OLLECTIONS
COVID–19 guidance title CFR cites(s) referenced
in COVID–19 guidance Another guidance referenced
in COVID–19 guidance OMB Control
No(s). New collection covered by
PHE PRA waiver
Enforcement Policy for Viral
Transport Media During the
Coronavirus Disease 2019
(COVID–19) Public Health
Emergency (July 2020).
Emergency Use Authorization
of Medical Products and
Related Authorities; Guid-
ance for Industry and Other
Stakeholders.
0910–0595
Administrative Procedures for
Clinical Laboratory Im-
provement Amendments of
1988 Categorization.
0910–0607
21 CFR parts 800, 801, and
809. ................................................ 0910–0485
21 CFR part 803 .................... ................................................ 0910–0437
21 CFR part 806 .................... ................................................ 0910–0359
21 CFR part 807, subparts A
through D. ................................................ 0910–0625
21 CFR part 807, subpart E .. ................................................ 0910–0120
21 CFR part 820 .................... ................................................ 0910–0073
21 CFR part 830 and 21 CFR
801.20. ................................................ 0910–0720
Manufacturer voluntary report-
ing to FDA of viral transport
media manufacturing ca-
pacity information.
Manufacturer voluntary report-
ing to FDA of sterile phos-
phate buffered saline/saline
manufacturing capacity in-
formation.
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Federal Register / Vol. 85, No. 175 / Wednesday, September 9, 2020 / Notices
IV. Electronic Access
Persons with access to the internet
may obtain COVID–19-related guidances
at:
•The FDA web page entitled
‘‘COVID–19-Related Guidance
Documents for Industry, FDA Staff, and
Other Stakeholders,’’ available at
https://www.fda.gov/emergency-
preparedness-and-response/mcm-
issues/covid-19-related-guidance-
documents-industry-fda-staff-and-other-
stakeholders;
•the FDA web page entitled ‘‘Search
for FDA Guidance Documents’’
available at https://www.fda.gov/
regulatory-information/search-fda-
guidance-documents; or
•https://www.regulations.gov.
Dated: September 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–19883 Filed 9–8–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; 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
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 Heart, Lung,
and Blood Institute Special Emphasis Panel;
Disease Modifying Therapies for Chronic
Lung Diseases.
Date: October 8, 2020.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge I, 6705 Rockledge Drive, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Kristen Page, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, National Institutes of Health,
6705 Rockledge Drive, Room 209–B,
Bethesda, MD 20892, (301) 827–7953,
kristen.page@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: September 2, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–19835 Filed 9–8–20; 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 & 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 sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or 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 grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel Completion of
Ongoing MFMU Network Protocols.
Date: October 30, 2020.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Child Health
and Human Development, 6710B Rockledge
Drive, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Helen Huang, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH, 6710B Rockledge Drive,
Bethesda, MD 20817, (301) 435–8380,
helen.huang@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Intellectual and
Developmental Disabilities Research Centers
[IDDRC] FY 2021 (P50).
Date: November 19–20, 2020.
Time: 8:00 a.m. to 5:00 p.m..
Agenda: To review and evaluate grant
applications.
Place: National Institute of Child Health
and Human Development, 6710B Rockledge
Drive, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Clayton W. Mash, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH, 6710B Rockledge Drive,
Bethesda, MD 20892, (301) 496–6866,
mashc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.865, Research for Mothers
and Children, National Institutes of Health,
HHS)
Dated: September 2, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–19833 Filed 9–8–20; 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: Emerging
Technologies and Training Neurosciences
Integrated Review Group Molecular
Neurogenetics Study Section.
Date: October 8–9, 2020.
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: Mary G. Schueler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5214,
MSC 7846, Bethesda, MD 20892, (301) 915–
6301, marygs@csr.nih.gov.
Name of Committee: Interdisciplinary
Molecular Sciences and Training Integrated
Review Group; Enabling Bioanalytical and
Imaging Technologies Study Section.
Date: October 8–9, 2020.
Time: 8:30 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
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