National Institute on Aging; Notice of Closed Meeting, 14686-14687 [2020-05144]
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Federal Register / Vol. 85, No. 50 / Friday, March 13, 2020 / Notices
meet the other statutory requirements,
FDA is required to respond to each
request within 45 days. If multiple
requests for nonbinding feedback are
not timely, then these requests will not
be subject to a response from FDA
within 45 days.
Finally, FDA acknowledges that when
the inspectional observations involve a
public health priority, implicate a
systemic or major action, or relate to an
emerging safety issue, continued
communication between FDA and the
firm may be needed after issuance of the
nonbinding feedback to ensure adequate
protection of public health. In such
cases, FDA may continue
communication with the firm and/or
take any action necessary to ensure
adequate protection of public health.
FDA received one comment regarding
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
(Comment 8) One commenter
requested that FDA develop templates
for manufacturers to submit when
requesting nonbinding feedback.
(Response) At this time, FDA does not
believe that providing a template would
be appropriate since the content of the
request for nonbinding feedback is
expected to be situationally dependent
and different firms may have different
preferred formats for requesting
nonbinding feedback. FDA believes that
use of a template may be too restrictive
and could result in pertinent
information not being included in the
request for nonbinding feedback.
Nonetheless, FDA may choose to utilize
a template at a later date if it determines
it would be beneficial to firms to do so.
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
Average
burden
per response
Total hours
Requests for nonbinding feedback after certain FDA inspections of device establishments .................................
220
1
220
500
110,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate that 220 respondents per
year will request nonbinding feedback is
based on recent inspectional data. Based
on the recommendations in the
guidance and our experience with
similar information collections, we
believe it will take approximately 500
hours to complete a request for
nonbinding feedback. Therefore, we
estimate the burden of this information
collection to be 110,000 hours.
Dated: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05131 Filed 3–12–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSKJLSW7X2PROD with NOTICES
National Institute on Drug Abuse;
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, NIDA.
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 ON DRUG
ABUSE, including consideration of
personnel qualifications and
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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, NIDA.
Date: May 7–8, 2020.
Time: 8:00 a.m. to 3:15 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Intramural Research Program,
Biomedical Research Center, Johns Hopkins
Bayview Campus, 251 Bayview Boulevard,
Room BRC 03C219, Baltimore, MD 21224.
Contact Person: Joshua Kysiak, Program
Specialist, Biomedical Research Center,
Intramural Research Program, National
Institute on Drug Abuse, NIH, DHHS, 251
Bayview Boulevard, Baltimore, MD 21224,
443–740–2465, kysiakjo@nida.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.277, Drug Abuse Scientist
Development Award for Clinicians, Scientist
Development Awards, and Research Scientist
Awards; 93.278, Drug Abuse National
Research Service Awards for Research
Training; 93.279, Drug Abuse and Addiction
Research Programs, National Institutes of
Health, HHS)
Dated: March 9, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–05096 Filed 3–12–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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
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; Member
Conflict SEP.
Date: April 14, 2020.
Time: 12:00 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Ramesh Vemuri, Ph.D.,
Chief, Scientific Review Branch, Scientific
Review Branch, National Institute on Aging,
National Institutes of Health, 7201 Wisconsin
Avenue, Gateway Building, Suite 2W200,
Bethesda, MD 20892, (301) 402–7700, rv23r@
nih.gov.
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Federal Register / Vol. 85, No. 50 / Friday, March 13, 2020 / Notices
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: March 9, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–05144 Filed 3–12–20; 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
jbell on DSKJLSW7X2PROD with NOTICES
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: Center for Scientific
Review Special Emphasis Panel;
Neurolinguistics and Language Learning.
Date: March 26, 2020.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: Andrea B Kelly, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3182,
MSC 7770, Bethesda, MD 20892, (301) 455–
1761, kellya2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: AIDS and Related Research.
Date: April 6, 2020.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: Kenneth A Roebuck, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106,
MSC 7852, Bethesda, MD 20892, (301) 435–
1166, roebuckk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Neuropsychiatric and Neurodegenerative
Disorders and Diseases.
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Date: April 6, 2020.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: Samuel C Edwards, Ph.D.,
Chief, BDCN IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846,
Bethesda, MD 20892, (301) 435–1246,
edwardss@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RM18–009:
NIH Transformative Research Awards (R01)
Review.
Date: April 7, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, Bethesda, MD 20814.
Contact Person: Raymond Jacobson, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5858,
MSC 7849, Bethesda, MD 20892, (301) 996–
7702, jacobsonrh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Biobehavioral Processes of Cognition and
Stress.
Date: April 8, 2020.
Time: 2:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: Katherine Colona Morasch,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3170,
Bethesda, MD 20892, moraschkc@
csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Virology.
Date: April 15–16, 2020.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Susan Daum, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3202,
Bethesda, MD 20892, (301) 827–7233,
susan.boyle-vavra@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Virology.
Date: April 15, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Marci Scidmore, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
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Health, 6701 Rockledge Drive, Room 3192,
MSC 7808, Bethesda, MD 20892, (301) 435–
1149, marci.scidmore@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: March 9, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–05113 Filed 3–12–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Insitutes of Health; Notice of Meeting
Notice is hereby given of a meeting of
the HEAL (Helping to End Addiction
Long-term) Multi-Disciplinary Working
Group
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
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 section
552b(c)(6), Title 5 U.S.C., as amended.
The program documents and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the program
documents, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: HEAL MultiDisciplinary Working Group Meeting.
Date: March 18, 2020.
Open: March 18, 2020, 8:30 a.m. to 10:30
a.m.
Closed: March 18, 2020, 10:30 a.m. to 3:20
p.m.
Open: March 18, 2020, 3:20 p.m. to 4:00
p.m.
Agenda: Provide an update on Helping to
End Addiction Long-Term (HEAL) Initiatives
and obtain expertise from the MDWG
relevant to the NIH HEAL Initiative and to
specific HEAL projects.
Videocast: For those not able to attend in
person, this meeting will be live webcast at:
https://videocast.nih.gov/.
Place: National Institutes of Health,
Building 1, Wilson Hall, 1 Center Drive,
Bethesda, MD 20892.
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[Federal Register Volume 85, Number 50 (Friday, March 13, 2020)]
[Notices]
[Pages 14686-14687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05144]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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 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; Member Conflict SEP.
Date: April 14, 2020.
Time: 12:00 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Ramesh Vemuri, Ph.D., Chief, Scientific Review
Branch, Scientific Review Branch, National Institute on Aging,
National Institutes of Health, 7201 Wisconsin Avenue, Gateway
Building, Suite 2W200, Bethesda, MD 20892, (301) 402-7700,
[email protected].
[[Page 14687]]
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging
Research, National Institutes of Health, HHS)
Dated: March 9, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-05144 Filed 3-12-20; 8:45 am]
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