Assistant Secretary for Administration; Delegation of Authority, 61279-61280 [2021-24248]
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61279
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Notices
drug products marketed outside the
monograph system.
In the Federal Register of June 30,
2021 (86 FR 34759), we published a 60-
day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section or type of respondent and activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
310.305(c)(5) .....................................................................................................
314.80(c)(1)(iii) ..................................................................................................
314.80(c)(2) .......................................................................................................
Reports of serious adverse drug events (§ 329.100) .......................................
Applicants that have a PSUR waiver for an approved application ..................
Applicants that do not have a PSUR waiver for an approved application .......
Notifying FDA when normal reporting is not feasible .......................................
3
5
820
285
55
29
350
1
1
17.32
690
3.4
2.3
1
3
5
14,202
196,650
187
67
350
1
1
60
6
1
2
8
3
5
852,120
1,179,900
187
134
2,800
Total 2 .........................................................................................................
..........................
........................
211,464
..........................
2,035,149
1 The
capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section or FD&C act section and activity
310.305 .............................................................................................................
314.80(j) ............................................................................................................
Recordkeeping of nonprescription drug adverse event reports (Section
760(e)(1) of the FD&C Act) ...........................................................................
Adding Adverse Event report planning to Continuity of Operations Plans ......
Maintaining documentation of pandemic conditions and resultant high absenteeism ............................................................................................................
Maintaining records to identify what reports have been stored and when the
reporting process was restored .....................................................................
Total 2
.........................................................................................................
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
25
352
1
1,870
25
658,240
16
16
400
10,531,840
300
100
885.6667
1
265,700
100
8
50
2,125,600
5,000
350
1
350
8
2,800
350
1
350
8
2,800
..........................
........................
924,765
..........................
12,668,440
1 There
are no capital costs or operating costs associated with this collection of information.
2 There are maintenance costs of approximately $22,000 annually.
We have increased our estimate to
reflect expected adjustments to the
information collection since our last
submission for OMB review and
approval.
Sec. 110.100 contains information that
is either duplicative of other
information we have published or no
longer reflects the Agency’s current
thinking.
Dated: November 1, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
DATES:
[FR Doc. 2021–24236 Filed 11–4–21; 8:45 am]
Tiffany Kelley, Office of Regulatory
Affairs, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–348–1970,
Tiffany.Kelley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA
originally issued CPG Sec. 110.100 on
October 1, 1980, in the Agency’s Manual
of Compliance Policy Guides. The CPG
was revised periodically but has not
been revised since April 14, 2000.
Since FDA last revised CPG Sec.
110.100, the Agency issued separate
guidance for industry on FDA export
certification in 2004. FDA revised that
guidance in 2005, 2019, and, most
recently, in August 2021. The August
2021 version of the guidance for
industry, entitled ‘‘FDA Export
Certification,’’ provides the Agency’s
current guidance regarding FDA
issuance of export certification. Persons
with access to the internet may obtain
The withdrawal is effective
November 5, 2021.
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1996–D–0405]
Compliance Policy Guide Sec. 110.100;
Withdrawal of Guidance
AGENCY:
Food and Drug Administration,
HHS.
jspears on DSK121TN23PROD with NOTICES1
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the withdrawal of
Compliance Policy Guide Sec. 110.100,
‘‘Certification for Exports’’ (CPG Sec.
110.100), which FDA issued in 1980.
We are taking this action because CPG
SUMMARY:
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the guidance at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents. Although this
guidance originally complemented the
content in CPG Sec. 110.100, changes in
the document over time have
increasingly resulted in CPG Sec.
110.100 containing duplicative and
outdated information. Thus, FDA is
withdrawing CPG Sec. 110.100 in its
entirety.
Dated: November 1, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–24234 Filed 11–4–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Assistant Secretary for Administration;
Delegation of Authority
Notice is hereby given that I have
amended the delegation of authority to
the Assistant Secretary for Preparedness
and Response (ASPR); the Director,
Centers for Disease Control and
Prevention (CDC); the Administrator,
Health Resources and Services
Administration (HRSA); the Director,
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61280
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Notices
National Institutes of Health (NIH); the
Director, Office of Global Affairs (OGA);
and the Administrator, Substance Abuse
and Mental Health Services
Administration (SAMHSA), specifically
the authority vested in the Secretary, by
section 212(l) of the Department of
Defense and Labor, Health and Human
Services, and Education Appropriations
Act, 2019 and Continuing
Appropriations Act, 2019 (FY19 HHS
Appropriations Act) Public Law 115–
245, division B, title II, (September 28,
2018), or substantially similar
authorities vested in me in the future by
Congress, in order to carry out
international health activities, including
HIV/AIDS and other infectious disease,
chronic and environmental disease, and
other health activities abroad. Section
212(l) of the FY19 HHS Appropriations
Act permits the Secretary of HHS to
exercise authority equivalent to that
available to the Secretary of State under
22 U.S.C. 2669(c) to award personal
services contracts for work performed in
foreign countries.
The authority delegated herein
includes the authority to determine the
necessity of negotiating, executing, and
performing such contracts without
regard to statutory provisions as related
to the negotiation, making, and
performance of contracts and
performance of work in the United
States. This authority is immediately
revoked in the event that any
subsequent fiscal year HHS
appropriations act does not contain the
provision currently in section 212(1) or
substantially similar authority.
The Director, CDC, may redelegate
this authority to the Chief Operating
Officer, CDC. This authority may not be
further redelegated except as noted
above.
The delegatees shall consult with the
Secretary of State and relevant Chief of
Mission to ensure that this authority is
exercised in a manner consistent with
section 207 of the Foreign Service Act
of 1980 and other applicable statutes
administered by the Department of
State.
This amended delegation rescinds
and supersedes the February 7, 2020,
amended delegation concerning this
authority. However, all prior
redelegations of authority consistent
with the content of this memorandum
will remain in effect pending further
redelegation.
This amended delegation became
effective upon date of signature. In
addition, I hereby affirm and ratify any
actions taken by you or your
subordinates which involved the
exercise of the authorities delegated
herein, or substantially similar
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authorities vested in me by prior annual
HHS appropriations acts, prior to the
effective date of the delegation.
Dated: November 2, 2021.
Xavier Becerra,
Secretary.
[FR Doc. 2021–24248 Filed 11–4–21; 8:45 am]
BILLING CODE 4151–17–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer 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 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 purpose of this
meeting is to evaluate requests for
preclinical development resources for
potential new therapeutics for the
treatment of cancer. The outcome of the
evaluation will provide information to
internal NCI committees that will
decide whether NCI should support
requests and make available contract
resources for development of the
potential therapeutic to improve the
treatment of various forms of cancer.
The research proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the
proposed research projects, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; OCT2021
Cycle 39 NExT SEP Committee Meeting.
Date: December 14, 2021,
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To evaluate the NCI Experimental
Therapeutics Program Portfolio.
Place: National Institutes of Health, 9000
Rockville Pike, Building 31, Room 3A44,
Bethesda, Maryland 20892 (WebEx Meeting).
Contact Persons: Barbara Mroczkowski,
Ph.D., Executive Secretary, Discovery
Experimental Therapeutics Program,
National Cancer Institute, NIH, 31 Center
Drive, Room 3A44, Bethesda, Maryland
20817, 301–496–4291, mroczkoskib@
mail.nih.gov.
Toby Hecht, Ph.D., Executive Secretary,
Development Experimental Therapeutics
Program, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 3W110,
Rockville, Maryland 20850, 240–276–5683,
toby.hecht2@nih.gov.
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: November 2, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–24237 Filed 11–4–21; 8:45 am]
BILLING CODE 4140–01–P
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 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 Support for Research
Excellence (SuRE) Award (R16).
Date: November 30–December 1, 2021.
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 3G31,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Cynthia Louise De La
Fuente, Ph.D., Scientific 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)
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[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Notices]
[Pages 61279-61280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24248]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Assistant Secretary for Administration; Delegation of Authority
Notice is hereby given that I have amended the delegation of
authority to the Assistant Secretary for Preparedness and Response
(ASPR); the Director, Centers for Disease Control and Prevention (CDC);
the Administrator, Health Resources and Services Administration (HRSA);
the Director,
[[Page 61280]]
National Institutes of Health (NIH); the Director, Office of Global
Affairs (OGA); and the Administrator, Substance Abuse and Mental Health
Services Administration (SAMHSA), specifically the authority vested in
the Secretary, by section 212(l) of the Department of Defense and
Labor, Health and Human Services, and Education Appropriations Act,
2019 and Continuing Appropriations Act, 2019 (FY19 HHS Appropriations
Act) Public Law 115-245, division B, title II, (September 28, 2018), or
substantially similar authorities vested in me in the future by
Congress, in order to carry out international health activities,
including HIV/AIDS and other infectious disease, chronic and
environmental disease, and other health activities abroad. Section
212(l) of the FY19 HHS Appropriations Act permits the Secretary of HHS
to exercise authority equivalent to that available to the Secretary of
State under 22 U.S.C. 2669(c) to award personal services contracts for
work performed in foreign countries.
The authority delegated herein includes the authority to determine
the necessity of negotiating, executing, and performing such contracts
without regard to statutory provisions as related to the negotiation,
making, and performance of contracts and performance of work in the
United States. This authority is immediately revoked in the event that
any subsequent fiscal year HHS appropriations act does not contain the
provision currently in section 212(1) or substantially similar
authority.
The Director, CDC, may redelegate this authority to the Chief
Operating Officer, CDC. This authority may not be further redelegated
except as noted above.
The delegatees shall consult with the Secretary of State and
relevant Chief of Mission to ensure that this authority is exercised in
a manner consistent with section 207 of the Foreign Service Act of 1980
and other applicable statutes administered by the Department of State.
This amended delegation rescinds and supersedes the February 7,
2020, amended delegation concerning this authority. However, all prior
redelegations of authority consistent with the content of this
memorandum will remain in effect pending further redelegation.
This amended delegation became effective upon date of signature. In
addition, I hereby affirm and ratify any actions taken by you or your
subordinates which involved the exercise of the authorities delegated
herein, or substantially similar authorities vested in me by prior
annual HHS appropriations acts, prior to the effective date of the
delegation.
Dated: November 2, 2021.
Xavier Becerra,
Secretary.
[FR Doc. 2021-24248 Filed 11-4-21; 8:45 am]
BILLING CODE 4151-17-P
