Delegation of Authority, 67067 [2021-25632]
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Federal Register / Vol. 86, No. 224 / Wednesday, November 24, 2021 / Notices
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: June 29, 2012. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
June 29, 2012.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): May 18, 2018. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
TRODELVY (BLA 761115) was initially
submitted on May 18, 2018.
3. The date the application was
approved: April 22, 2020. FDA has
verified the applicant’s claim that BLA
761115 was approved on April 22, 2020.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,780 days of patent
term extension.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
VerDate Sep<11>2014
17:05 Nov 23, 2021
Jkt 256001
Dated: November 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–25612 Filed 11–23–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Delegation of Authority
Notice is hereby given that I have
withdrawn the delegations to the
Director, Office for Civil Rights (OCR),
or their successor, with respect to the
Religious Freedom Restoration Act
(RFRA) and the Religion Clauses of the
First Amendment, as well as any other
delegation of authority to OCR with
respect to enforcing or complying with
RFRA or the First Amendment.
On December 7, 2017, the then-Acting
Secretary of the Department of Health
and Human Services issued a notice,
published on January 19, 2018 (83 FR
2804), that delegated authority for
implementation and compliance with
the Religious Freedom Restoration Act,
42 U.S.C. 2000bb et seq., within the
Department to the Director of OCR.
On January 15, 2021, the Secretary
further delegated to OCR authority to
receive and investigate complaints,
conduct compliance reviews, provide
technical assistance and training,
evaluate complaint processing and
provide reports, and ensure uniform
compliance with the Religion Clauses of
the First Amendment. This delegation
was not published in the Federal
Register.
The Department takes its obligations
to comply with RFRA and the First
Amendment seriously, and it will
continue to do so. Department
components have the greatest
knowledge about their respective
programs and are best able to determine
whether the Department has a
compelling interest in a particular
action and whether less restrictive
means are available to further that
interest, critical aspects of the legal test
under RFRA. Furthermore, under the
current Statement of Organization,
Functions, and Delegations of Authority
for the Office of General Counsel (OGC),
OGC provides legal advice to the
Secretary, Deputy Secretary, and all
subordinate organization components of
the Department. See 85 FR 47228 (July
7, 2020). Department components, in
consultation with OGC, have the
responsibility, and are best positioned,
to evaluate RFRA-based requests for
exemptions, waivers, and modifications
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
67067
of program requirements in the
programs they operate or oversee.
Department components, further, are
best situated to craft exemptions or
other modifications when required
under RFRA and to monitor the impact
of such exemptions or modifications on
programs and those they serve.
Moreover, they are best positioned to
evaluate how their programs must be
run to comply with the Free Exercise
Clause and the Establishment Clause of
the First Amendment.
I therefore rescind the December 7,
2017, and the January 15, 2021
delegations with respect to the Religion
Clauses of the First Amendment and/or
RFRA, as well as any other delegation
of authority to OCR with respect to
enforcing or complying with RFRA or
the First Amendment. Effective today, I
delegate responsibility to Department
components to ensure full compliance
with RFRA and other constitutional
requirements. Department components
must consult with OGC on such matters
and provide appropriate consideration
to RFRA- or Constitution-based
objections or requests, as well as take
any actions that may be appropriate.
This delegation of authority is
effective upon date of signature.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–25632 Filed 11–23–21; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Investigational
Agent Accountability Record Forms
and International Investigator
Statement in the Conduct of
Investigational Trials for the Treatment
of Cancer (National Cancer Institute)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:
E:\FR\FM\24NON1.SGM
24NON1
]]>Agencies
[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Notices]
[Page 67067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25632]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Delegation of Authority
Notice is hereby given that I have withdrawn the delegations to the
Director, Office for Civil Rights (OCR), or their successor, with
respect to the Religious Freedom Restoration Act (RFRA) and the
Religion Clauses of the First Amendment, as well as any other
delegation of authority to OCR with respect to enforcing or complying
with RFRA or the First Amendment.
On December 7, 2017, the then-Acting Secretary of the Department of
Health and Human Services issued a notice, published on January 19,
2018 (83 FR 2804), that delegated authority for implementation and
compliance with the Religious Freedom Restoration Act, 42 U.S.C. 2000bb
et seq., within the Department to the Director of OCR.
On January 15, 2021, the Secretary further delegated to OCR
authority to receive and investigate complaints, conduct compliance
reviews, provide technical assistance and training, evaluate complaint
processing and provide reports, and ensure uniform compliance with the
Religion Clauses of the First Amendment. This delegation was not
published in the Federal Register.
The Department takes its obligations to comply with RFRA and the
First Amendment seriously, and it will continue to do so. Department
components have the greatest knowledge about their respective programs
and are best able to determine whether the Department has a compelling
interest in a particular action and whether less restrictive means are
available to further that interest, critical aspects of the legal test
under RFRA. Furthermore, under the current Statement of Organization,
Functions, and Delegations of Authority for the Office of General
Counsel (OGC), OGC provides legal advice to the Secretary, Deputy
Secretary, and all subordinate organization components of the
Department. See 85 FR 47228 (July 7, 2020). Department components, in
consultation with OGC, have the responsibility, and are best
positioned, to evaluate RFRA-based requests for exemptions, waivers,
and modifications of program requirements in the programs they operate
or oversee.
Department components, further, are best situated to craft
exemptions or other modifications when required under RFRA and to
monitor the impact of such exemptions or modifications on programs and
those they serve. Moreover, they are best positioned to evaluate how
their programs must be run to comply with the Free Exercise Clause and
the Establishment Clause of the First Amendment.
I therefore rescind the December 7, 2017, and the January 15, 2021
delegations with respect to the Religion Clauses of the First Amendment
and/or RFRA, as well as any other delegation of authority to OCR with
respect to enforcing or complying with RFRA or the First Amendment.
Effective today, I delegate responsibility to Department components to
ensure full compliance with RFRA and other constitutional requirements.
Department components must consult with OGC on such matters and provide
appropriate consideration to RFRA- or Constitution-based objections or
requests, as well as take any actions that may be appropriate.
This delegation of authority is effective upon date of signature.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-25632 Filed 11-23-21; 8:45 am]
BILLING CODE 4153-01-P
