Office of the Director, National Institutes of Health; Notice of Meeting, 47390-47391 [2020-17022]
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Federal Register / Vol. 85, No. 151 / Wednesday, August 5, 2020 / Notices
collection is 0910–0834. Also include
the FDA docket number found in
brackets in the heading of this
document.
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:
Postmarketing Information Sharing
Among Constituent Part Applicants for
Combination Products—21 CFR 4.103
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
OMB Control Number 0910–0834—
Extension
This information collection request
applies to ‘‘constituent part applicants’’
as defined under 21 CFR 4.101 (i.e., any
person holding an application under
which a constituent part (drug, device,
or biological product) of a combination
product received marketing
authorization if the other constituent
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
part(s) received marketing authorization
under an application held by a different
person). Under this collection,
constituent part applicants must share
safety information they receive related
to certain events with the other
constituent part applicant(s) and
maintain associated records.1
In the Federal Register of April 30,
2020 (85 FR 23971), we 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 AND RECORDKEEPING BURDEN
Number of
respondents/
recordkeepers
21 CFR section; activity
Total annual
disclosures/
records
Average burden per
disclosure/recordkeeping
Total hours
4.103, Sharing information with other constituent
part applicants.
4.103(b) and 4.105(a)(2), Records of information
shared by constituent part applicants.
33
18
594
0.35 (21 minutes) ...........
208
33
18
594
0.1 (6 minutes) ...............
59
Total .............................................................
........................
........................
........................
........................................
267
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. We
note in this regard that FDA extended
the compliance date for 21 CFR part 4,
subpart B, until July 2020 for most
combination products, and until January
2021 for the remainder, in response to
stakeholder feedback, to ensure that
Combination Product Applicants have
sufficient time to update reporting and
recordkeeping systems and procedures.2
Consequently, entities subject to this
rule have not yet had to comply with
this information request.
Dated: July 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17041 Filed 8–4–20; 8:45 am]
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Number of
disclosures/
records per
respondent/
recordkeeper
1 The Postmarketing Safety Reporting (PMSR)
information collections for drugs, biological
products, and devices found in §§ 314.80, 314.81,
600.80, 600.81, 606.170, 606.171, 803.50, 803.53,
803.56, 806.10, and 806.20 (21 CFR 314.80, 314.81,
600.80, 600.81, 606.170, 606.171, 803.50, 803.53,
803.56, 806.10, and 806.20) have already been
approved and are in effect or their extension is
being sought separately as required, including with
respect to burden for combination products
(reflected in the authorization for OMB control
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
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.
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 via NIH
Videocast. Individuals who 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
Name of Committee: HEAL MultiDisciplinary Working Group Meeting.
Date: August 31, 2020.
Open: August 31, 2020, 9:00 a.m. to 1:00
p.m.
Closed: August 31, 2020, 1:00 p.m. to 2:50
p.m.
Open: August 31, 2020, 2:50 p.m. to 4:30
p.m.
Agenda: Provide an update on Helping to
End Addiction Long-Term (HEAL) Initiative
projects and obtain expertise from MDWG
relevant to the NIH HEAL Initiative and to
specific HEAL projects.
Videocast: The open portion of the 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 (Virtual Meeting).
Contact Person: Rebecca G. Baker, Ph.D.,
Office of the Director, National Institutes of
number 0910–0834, but, therefore, not addressed in
this extension request). The pertinent PMSR
information collection provisions for § 314.80(c)
and (e), as well as for § 314.81(b) are approved
under OMB control numbers 0910–0001, 0910–
0230, and 0910–0291. The information collection
provisions for §§ 600.80 and 600.81 are approved
under OMB control number 0910–0308. Those for
§ 606.170 are approved under OMB control number
0910–0116. Those for § 606.171 are approved under
OMB control number 0910–0458. The information
collection provisions for §§ 803.50, 803.53, and
803.56 are approved under OMB control numbers
0910–0291 and 0910–0437. The information
collection provisions for §§ 806.10 and 806.20 are
approved under OMB control number 0910–0359.
2 See Compliance Policy for Combination Product
Postmarketing Safety Reporting (April 2019)
(https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/compliance-policycombination-product-postmarketing-safetyreporting).
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Federal Register / Vol. 85, No. 151 / Wednesday, August 5, 2020 / Notices
Health, 1 Center Drive, Room 103A,
Bethesda, MD 20892, (301) 402–1994,
Rebecca.baker@nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the Office
of the Director for the NIH HEAL Initiative
home page: https://heal.nih.gov/news where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: July 30, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–17022 Filed 8–4–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
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 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 of
Allergy and Infectious Diseases Special
Emphasis Panel; Emergency Awards: Rapid
Investigation of Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS–CoV–2) and
Coronavirus Disease 2019 (COVID–19).
Date: September 1, 2020.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G30,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: John C. Pugh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
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Health, 6701 Rockledge Drive, Room 1206,
Bethesda, MD 20892, (301) 435–2398,
pughjohn@csr.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: July 30, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–17020 Filed 8–4–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Literature Selection
Technical Review Committee.
The meeting will be open to the
public as indicated below. 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 portions of the meeting devoted
to the review and evaluation of journals
for potential indexing by the National
Library of Medicine will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(9)(B), Title 5 U.S.C., as
amended. Premature disclosure of the
titles of the journals as potential titles to
be indexed by the National Library of
Medicine, the discussions, and the
presence of individuals associated with
these publications could significantly
frustrate the review and evaluation of
individual journals.
Name of Committee: Literature Selection
Technical Review Committee.
Date: October 22–23, 2020.
Open: October 22, 2020, 8:30 a.m. to 10:45
a.m.
Agenda: Program Discussion.
Place: Virtual Meeting.
Closed: October 22, 2020, 10:45 a.m. to
5:00 p.m.
Agenda: To review and evaluate journals
as potential titles to be indexed by the
National Library of Medicine.
Closed: October 23, 2020, 8:30 a.m. to 2:00
p.m.
Agenda: To review and evaluate journals
as potential titles to be indexed by the
National Library of Medicine.
Contact Person: Dianne Babski, Acting
Associate Director, Division of Library
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47391
Operations, National Library of Medicine,
8600 Rockville Pike, Building 38, Room
2W04A, Bethesda, MD 20894, 301–827–4729,
babskid@mail.nih.gov.
Any member of the public may submit
written comments no later than 15 days after
the meeting. Any interested person may file
written comments with the committee by
forwarding the statement to the Contact
Person listed on this notice. The statement
should include the name, address, telephone
number and when applicable, the business or
professional affiliation of the interested
person.
Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS).
Dated: July 31, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–17096 Filed 8–4–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; 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: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Fellowship review.
Date: September 16, 2020.
Time: 10:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NSC
Building, 6001 Executive Boulevard,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Deanna Lynn Adkins,
Ph.D., Scientific Review Officer, Scientific
Review Branch, NSC Building, Bethesda, MD
20892, 301–496–9223, deanna.adkins@
nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Translational Neural, Brain
and Pain Relief Devices.
Date: October 13–14, 2020.
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[Federal Register Volume 85, Number 151 (Wednesday, August 5, 2020)]
[Notices]
[Pages 47390-47391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17022]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of the Director, National Institutes 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 via NIH
Videocast. Individuals who 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 Multi-Disciplinary Working Group
Meeting.
Date: August 31, 2020.
Open: August 31, 2020, 9:00 a.m. to 1:00 p.m.
Closed: August 31, 2020, 1:00 p.m. to 2:50 p.m.
Open: August 31, 2020, 2:50 p.m. to 4:30 p.m.
Agenda: Provide an update on Helping to End Addiction Long-Term
(HEAL) Initiative projects and obtain expertise from MDWG relevant
to the NIH HEAL Initiative and to specific HEAL projects.
Videocast: The open portion of the 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 (Virtual Meeting).
Contact Person: Rebecca G. Baker, Ph.D., Office of the Director,
National Institutes of
[[Page 47391]]
Health, 1 Center Drive, Room 103A, Bethesda, MD 20892, (301) 402-
1994, [email protected].
Any interested person may file written comments with the
committee by forwarding the statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
Information is also available on the Office of the Director for
the NIH HEAL Initiative home page: https://heal.nih.gov/news where
an agenda and any additional information for the meeting will be
posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.853,
Clinical Research Related to Neurological Disorders; 93.854,
Biological Basis Research in the Neurosciences, National Institutes
of Health, HHS)
Dated: July 30, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-17022 Filed 8-4-20; 8:45 am]
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