Advisory Committee; Oncologic Drugs Advisory Committee; Renewal, 74427-74428 [2022-26363]
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Federal Register / Vol. 87, No. 232 / Monday, December 5, 2022 / Notices
Approaches to Establishing
Bioequivalence.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
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INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
David Coppersmith, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1673,
Silver Spring, MD 20993–0002, 301–
796–9193.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Statistical Approaches to Establishing
Bioequivalence.’’ This draft guidance
provides recommendations to sponsors
and applicants planning to use
equivalence criteria in analyzing in vivo
or in vitro BE studies for INDs, NDAs,
ANDAs, and supplements to these
applications. The guidance discusses
statistical approaches for BE
comparisons and focuses on how to use
these approaches both generally and in
specific situations.
These specific situations include
statistical methods for narrow
therapeutic index drugs and highly
variable drugs; recommendations for
missing data and intercurrent events;
and a discussion of statistical methods
regarding assessment of in vitro BE,
including population BE and statistical
approaches for in vitro release tests, in
vitro permeation tests, and in vitro
abuse-deterrent formulation
comparative studies.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
replace the guidance for industry
entitled ‘‘Statistical Approaches to
Establishing Bioequivalence,’’ which
was announced in the Federal Register
on February 2, 2001 (66 FR 8805), and
will represent FDA’s current thinking
on this topic.
This draft guidance does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
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74427
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: November 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–26414 Filed 12–2–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3236]
Advisory Committee; Oncologic Drugs
Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Oncologic Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Oncologic Drugs
Advisory Committee for an additional 2
years beyond the charter expiration
date. The new charter will be in effect
until the September 1, 2024, expiration
date.
DATES: Authority for the Oncologic
Drugs Advisory Committee will expire
on September 1, 2024, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: SheChia Chen, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 240–402–5343,
ODAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Oncologic Drugs
SUMMARY:
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ddrumheller on DSK30NT082PROD with NOTICES
74428
Federal Register / Vol. 87, No. 232 / Monday, December 5, 2022 / Notices
Advisory Committee (the Committee).
The Committee is a discretionary
Federal advisory committee established
to provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of cancer and
makes appropriate recommendations to
the Commissioner.
The Committee shall consist of a core
of 13 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of general
oncology, pediatric oncology,
hematologic oncology, immunology
oncology, biostatistics, and other related
professions. Members will be invited to
serve for overlapping terms of up to 4
years. Non-Federal members of this
committee will serve as Special
Government Employees,
representatives, or Ex-Officio members.
Federal members will serve as Regular
Government Employees or Ex-Officios.
The core of voting members may
include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
oncologic-drugs-advisory-committee/
oncologic-drugs-advisory-committeecharter or by contacting the Designated
Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the
fact that no change has been made to the
committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
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19:34 Dec 02, 2022
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related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: November 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–26363 Filed 12–2–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Nurse Corps Scholarship
Program—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than February 3, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the acting HRSA Information
Collection Clearance Officer at (301)
443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Nurse Corps Scholarship Program, OMB
No. 0915–0301—Extension.
Abstract: The Nurse Corps
Scholarship Program (NCSP),
administered by the HRSA Bureau of
SUMMARY:
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Health Workforce, provides
scholarships to nursing students in
exchange for a minimum two-year fulltime service commitment (or part-time
equivalent), at an eligible health care
facility with a critical shortage of nurses
(i.e. Critical Shortage Facility (CSF)).
The scholarship consists of payment of
tuition, fees, other reasonable
educational costs, and a monthly
support stipend. Program recipients are
required to fulfill NCSP service
commitments at CSFs located in the 50
States, the District of Columbia, Guam,
the Commonwealth of Puerto Rico, the
Northern Mariana Islands, the U.S.
Virgin Islands, American Samoa, the
Federated States of Micronesia, the
Republic of the Marshall Islands, and
the Republic of Palau.
Need and Proposed Use of the
Information: The NCSP collects data to
determine an applicant’s eligibility for
the program, monitor a participant’s
continued enrollment in a school of
nursing, monitor the participant’s
compliance with the NCSP service
obligation, and prepare annual reports
to Congress. The following information
will be collected (1) from the schools,
on a quarterly basis—general applicant
and nursing school data such as full
name, location, tuition/fees, and
enrollment status; (2) from the schools,
on an annual basis—data concerning
tuition/fees and overall student
enrollment status; and (3) from the
participants and their employing CSF
on a biannual basis—data concerning
the participant’s employment status,
work schedule, and leave usage.
Likely Respondents: NCSP scholars in
school, graduates, educational
institutions, and CSFs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
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]]>Agencies
[Federal Register Volume 87, Number 232 (Monday, December 5, 2022)]
[Notices]
[Pages 74427-74428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26363]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3236]
Advisory Committee; Oncologic Drugs Advisory Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Oncologic Drugs Advisory Committee by the Commissioner
of Food and Drugs (the Commissioner). The Commissioner has determined
that it is in the public interest to renew the Oncologic Drugs Advisory
Committee for an additional 2 years beyond the charter expiration date.
The new charter will be in effect until the September 1, 2024,
expiration date.
DATES: Authority for the Oncologic Drugs Advisory Committee will expire
on September 1, 2024, unless the Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: She-Chia Chen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-5343, [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Oncologic Drugs
[[Page 74428]]
Advisory Committee (the Committee). The Committee is a discretionary
Federal advisory committee established to provide advice to the
Commissioner. The Committee advises the Commissioner or designee in
discharging responsibilities as they relate to helping to ensure safe
and effective drugs for human use and, as required, any other product
for which FDA has regulatory responsibility.
The Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of cancer and makes appropriate recommendations to
the Commissioner.
The Committee shall consist of a core of 13 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of general oncology, pediatric oncology, hematologic oncology,
immunology oncology, biostatistics, and other related professions.
Members will be invited to serve for overlapping terms of up to 4
years. Non-Federal members of this committee will serve as Special
Government Employees, representatives, or Ex-Officio members. Federal
members will serve as Regular Government Employees or Ex-Officios. The
core of voting members may include one technically qualified member,
selected by the Commissioner or designee, who is identified with
consumer interests and is recommended by either a consortium of
consumer-oriented organizations or other interested persons. In
addition to the voting members, the Committee may include one non-
voting representative member who is identified with industry interests.
There may also be an alternate industry representative.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/oncologic-drugs-advisory-committee/oncologic-drugs-advisory-committee-charter or by contacting the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light of the fact that no change has
been made to the committee name or description of duties, no amendment
will be made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: November 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26363 Filed 12-2-22; 8:45 am]
BILLING CODE 4164-01-P
