National Institute on Drug Abuse; Notice of Closed Meeting, 14686 [2020-05096]
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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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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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
VerDate Sep<11>2014
18:16 Mar 12, 2020
Jkt 250001
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 Volume 85, Number 50 (Friday, March 13, 2020)]
[Notices]
[Page 14686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05096]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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 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, [email protected].
(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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