Cellular and Gene Therapies Interactive Site Tours Program for Regulatory Project Managers and Reviewers; Information Available to Industry, 57417-57418 [2024-15351]
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Federal Register / Vol. 89, No. 135 / Monday, July 15, 2024 / Notices
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10440]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by August 14, 2024.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
ddrumheller on DSK120RN23PROD with NOTICES1
DATES:
VerDate Sep<11>2014
18:25 Jul 12, 2024
Jkt 262001
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Data Collection
to Support Eligibility Determinations for
Insurance Affordability Programs and
Enrollment through Health Benefits
Exchanges, Medicaid and CHIP
Agencies; Use: Section 1413 of the
Affordable Care Act directs the
Secretary of Health and Human Services
to develop and provide to each state a
single, streamlined application form
that may be used to apply for coverage
through a Marketplace and for APTC/
CSR, Medicaid, and CHIP (which we
refer to collectively as insurance
affordability programs). The application
must be structured to maximize an
applicant’s ability to complete the form
satisfactorily, taking into account the
characteristics of individuals who may
qualify for the programs by developing
materials at appropriate literacy levels
and ensuring accessibility.
Regulations at 45 CFR 155.405(a)
provides more detail about the
application that must be used by
Marketplaces to determine eligibility
and to collect information necessary for
enrollment. Eligibility standards for the
Marketplace are set forth in 45 CFR
155.305. The information will be
required of each applicant upon initial
application, with some subsequent
information collections for the purposes
of confirming accuracy of previous
submissions and for changes in an
applicant’s circumstances. 42 CFR
435.907 and § 457.330 establish the
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57417
standards for state Medicaid and CHIP
agencies related to the use of the
application. CMS has designed a
dynamic electronic application that will
tailor the amount of data required from
an applicant based on the applicant’s
circumstances and responses to
particular questions in the FFM (please
note SBM implementations may vary
but the essence of the data collection
must adhere to the same parameters).
The paper version of the application
will not be tailored in the same way but
will require only the data necessary to
determine eligibility.
Information collected by the
Marketplace, Medicaid or CHIP agency
will be used to determine eligibility for
coverage through the Marketplace and
insurance affordability programs (i.e.,
Medicaid, CHIP, and APTC), and assist
consumers in enrolling in a QHP if
eligible. Applicants include anyone who
may be eligible for coverage through any
of these programs. Additionally, this
application provides consumers
interested in voting resources. Form
Number: CMS–10440 (OMB control
number: 0938–1191); Frequency:
Annually; Affected Public: Private
Sector (Business or other for-profits,
Not-for-Profit Institutions); Number of
Respondents: 5,550,000; Total Annual
Responses: 5,550,000; Total Annual
Hours: 2,446,440. (For policy questions
regarding this collection contact Erin
Richardson at 202–619–0630.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–15473 Filed 7–12–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2908]
Cellular and Gene Therapies
Interactive Site Tours Program for
Regulatory Project Managers and
Reviewers; Information Available to
Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or the Agency)
Center for Biologics Evaluation and
Research (CBER), Office of Therapeutic
Products (OTP) is announcing the
Cellular and Gene Therapies Interactive
Site Tours Program (the Interactive Site
Tours Program). This program is
SUMMARY:
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57418
Federal Register / Vol. 89, No. 135 / Monday, July 15, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
intended to give CBER regulatory
project managers and/or reviewers an
opportunity to tour biotechnology
manufacturing facilities developing
cellular and gene therapy products, and
to exchange regulatory experiences with
their industry counterparts. With this
program, CBER intends to enhance
review efficiency and quality by
providing CBER staff with a better
understanding of the biotechnology
manufacturing industry and its
operations. The purpose of this notice is
to invite companies developing cellular
and gene therapy products interested in
participating in this program to contact
OTP for more information.
DATES: Companies may send proposed
agendas to the Agency by August 14,
2024.
FOR FURTHER INFORMATION CONTACT: Lori
Tull, Office of Review Management and
Regulatory Review, Office of
Therapeutic Products, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 240–
402–8361, Lori.Tull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 351 of the Public
Health Service Act (PHS Act), FDA is
authorized to license biological
products if they have been
demonstrated to be ‘‘safe, pure, and
potent.’’ CBER is one of two Centers at
FDA that regulates biological products
for human use under applicable
statutory provisions of the PHS Act and
the Federal Food, Drug, and Cosmetic
Act (FD&C Act). Section 3033 of the 21st
Century Cures Act (Cures Act) (Pub. L.
114–255), was signed into law on
December 13, 2016, and amended
section 506 of the FD&C Act to
specifically address the expedited
development and review of certain
regenerative medicine therapies,
including cell therapies, therapeutic
tissue engineering products, and human
cell and tissue products.
An important part of CBER’s
commitment to make safe and effective
biological products available to all
Americans is optimizing the efficiency
and quality of the biologics review
process. To support this goal, CBER has
initiated various training and
development programs to promote high
performance in its regulatory project
management and review staff. OTP
seeks to enhance review efficiency and
review quality by providing staff with a
better understanding of the
biotechnology industry and its
operations. To this end, CBER/OTP is
offering regulatory project managers and
reviewers the opportunity to tour
VerDate Sep<11>2014
18:25 Jul 12, 2024
Jkt 262001
biotechnology manufacturing facilities.
The goals are to provide the following:
(1) firsthand exposure to industry’s
product development processes and (2)
a venue for sharing information about
project management best practices (but
not product-specific information) with
industry representatives.
II. The Interactive Site Tours Program
In this program, which may last a few
days, a small group of OTP regulatory
project managers and/or reviewers,
potentially also including senior level
staff, can observe operations of biologics
manufacturing and/or packaging
facilities, pathology/toxicology
laboratories, and regulatory affairs
operations. Neither this tour nor any
part of the program is intended as a
mechanism to inspect, assess, judge, or
perform a regulatory function, but is
meant rather to provide an avenue for
open dialogue between CBER/OTP staff
and industry representatives. During the
Interactive Site Tours Program,
regulatory project managers and
reviewers may also participate in daily
workshops with their industry
counterparts, focusing on selective
regulatory issues important to both OTP
staff and industry. The primary
objective of the daily workshops is to
understand the team approach to
biological product development,
including discovery, nonclinical and
clinical evaluation, postmarketing
activities, and regulatory submission
operations. The overall benefit to
regulatory project managers and
reviewers will be exposure to project
management, team techniques, and
processes employed by the
biotechnology industry. By participating
in this program, the regulatory project
managers and reviewers will gain a
better understanding of industry
processes and procedures.
III. Site Selection
All travel expenses associated with
the Interactive Site Tours Program will
be the responsibility of OTP; therefore,
selection of facility tour sites will be
based on the availability of funds and
resources for the program. Selection will
also be based on firms having a
favorable facility status as determined
by FDA’s Office of Regulatory Affairs
District Offices in the firms’ respective
locations. Firm participation in the
program is limited to companies
developing cellular and/or gene therapy
products. Firms that want to learn more
about this opportunity or that are
interested in offering a site tour should
respond by sending a proposed agenda
via email directly to Lori Tull (see DATES
and FOR FURTHER INFORMATION CONTACT).
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Dated: July 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–15351 Filed 7–12–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3165]
Takeda Pharmaceuticals U.S.A., Inc.;
Withdrawal of Approval of New Drug
Application for EXKIVITY
(Mobocertinib Succinate) Capsule,
Equivalent to 40 Milligrams Base
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of the new drug
application (NDA) for EXKIVITY
(mobocertinib succinate) capsule,
equivalent to (EQ) 40 milligrams (mg)
base, held by Takeda Pharmaceuticals
U.S.A., Inc., 95 Hayden Ave., Lexington,
MA 02421 (Takeda). Takeda has
voluntarily requested that FDA
withdraw approval of this application
and has waived its opportunity for a
hearing.
DATES: Approval is withdrawn as of July
15, 2024.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
September 15, 2021, FDA approved
NDA 215310 for EXKIVITY
(mobocertinib succinate) capsule, EQ 40
mg base, for the treatment of adult
patients with locally advanced or
metastatic non-small cell lung cancer
(NSCLC) with epidermal growth factor
receptor (EGFR) exon 20 insertion
mutations, as detected by an FDAapproved test, whose disease has
progressed on or after platinum-based
chemotherapy (EGFR exon 20 insertionmutated NSCLC), under the Agency’s
accelerated approval regulations, 21
CFR part 314, subpart H. The
accelerated approval of EXKIVITY
(mobocertinib succinate) capsule, EQ 40
mg base, for EGFR exon 20 insertionmutated NSCLC included a required
postmarketing trial intended to verify
the clinical benefit of EXKIVITY.
SUMMARY:
E:\FR\FM\15JYN1.SGM
15JYN1
]]>Agencies
[Federal Register Volume 89, Number 135 (Monday, July 15, 2024)]
[Notices]
[Pages 57417-57418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15351]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2908]
Cellular and Gene Therapies Interactive Site Tours Program for
Regulatory Project Managers and Reviewers; Information Available to
Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA or the Agency) Center
for Biologics Evaluation and Research (CBER), Office of Therapeutic
Products (OTP) is announcing the Cellular and Gene Therapies
Interactive Site Tours Program (the Interactive Site Tours Program).
This program is
[[Page 57418]]
intended to give CBER regulatory project managers and/or reviewers an
opportunity to tour biotechnology manufacturing facilities developing
cellular and gene therapy products, and to exchange regulatory
experiences with their industry counterparts. With this program, CBER
intends to enhance review efficiency and quality by providing CBER
staff with a better understanding of the biotechnology manufacturing
industry and its operations. The purpose of this notice is to invite
companies developing cellular and gene therapy products interested in
participating in this program to contact OTP for more information.
DATES: Companies may send proposed agendas to the Agency by August 14,
2024.
FOR FURTHER INFORMATION CONTACT: Lori Tull, Office of Review Management
and Regulatory Review, Office of Therapeutic Products, Center for
Biologics Evaluation and Research, Food and Drug Administration, 240-
402-8361, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Under section 351 of the Public Health Service Act (PHS Act), FDA
is authorized to license biological products if they have been
demonstrated to be ``safe, pure, and potent.'' CBER is one of two
Centers at FDA that regulates biological products for human use under
applicable statutory provisions of the PHS Act and the Federal Food,
Drug, and Cosmetic Act (FD&C Act). Section 3033 of the 21st Century
Cures Act (Cures Act) (Pub. L. 114-255), was signed into law on
December 13, 2016, and amended section 506 of the FD&C Act to
specifically address the expedited development and review of certain
regenerative medicine therapies, including cell therapies, therapeutic
tissue engineering products, and human cell and tissue products.
An important part of CBER's commitment to make safe and effective
biological products available to all Americans is optimizing the
efficiency and quality of the biologics review process. To support this
goal, CBER has initiated various training and development programs to
promote high performance in its regulatory project management and
review staff. OTP seeks to enhance review efficiency and review quality
by providing staff with a better understanding of the biotechnology
industry and its operations. To this end, CBER/OTP is offering
regulatory project managers and reviewers the opportunity to tour
biotechnology manufacturing facilities. The goals are to provide the
following: (1) firsthand exposure to industry's product development
processes and (2) a venue for sharing information about project
management best practices (but not product-specific information) with
industry representatives.
II. The Interactive Site Tours Program
In this program, which may last a few days, a small group of OTP
regulatory project managers and/or reviewers, potentially also
including senior level staff, can observe operations of biologics
manufacturing and/or packaging facilities, pathology/toxicology
laboratories, and regulatory affairs operations. Neither this tour nor
any part of the program is intended as a mechanism to inspect, assess,
judge, or perform a regulatory function, but is meant rather to provide
an avenue for open dialogue between CBER/OTP staff and industry
representatives. During the Interactive Site Tours Program, regulatory
project managers and reviewers may also participate in daily workshops
with their industry counterparts, focusing on selective regulatory
issues important to both OTP staff and industry. The primary objective
of the daily workshops is to understand the team approach to biological
product development, including discovery, nonclinical and clinical
evaluation, postmarketing activities, and regulatory submission
operations. The overall benefit to regulatory project managers and
reviewers will be exposure to project management, team techniques, and
processes employed by the biotechnology industry. By participating in
this program, the regulatory project managers and reviewers will gain a
better understanding of industry processes and procedures.
III. Site Selection
All travel expenses associated with the Interactive Site Tours
Program will be the responsibility of OTP; therefore, selection of
facility tour sites will be based on the availability of funds and
resources for the program. Selection will also be based on firms having
a favorable facility status as determined by FDA's Office of Regulatory
Affairs District Offices in the firms' respective locations. Firm
participation in the program is limited to companies developing
cellular and/or gene therapy products. Firms that want to learn more
about this opportunity or that are interested in offering a site tour
should respond by sending a proposed agenda via email directly to Lori
Tull (see DATES and FOR FURTHER INFORMATION CONTACT).
Dated: July 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15351 Filed 7-12-24; 8:45 am]
BILLING CODE 4164-01-P
