Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches; Public Workshop; Request for Comments; Correction, 27522 [2023-09206]
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Federal Register / Vol. 88, No. 84 / Tuesday, May 2, 2023 / Notices
claimed confidential information
redacted/blacked out, will be available
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both copies to the Dockets Management
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FOR FURTHER INFORMATION CONTACT:
Ethan Gabbour, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6306,
Silver Spring, MD 20993, 301–796–
9208, Ethan.Gabbour@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
Under the seventh iteration of the
Prescription Drug User Fee Act (PDUFA
VII), incorporated as part of the FDA
User Fee Reauthorization Act of 2022,
FDA committed to continue to
strengthen capacity to facilitate
development and use of patient-focused
methods to inform drug development
and regulatory decisions, including
issuing this Request for Information
(RFI) to elicit public input on
methodologic challenges encountered
by stakeholders, and other areas of
greatest interest or concern to public
stakeholders. These methodologic
challenges may be related to the
collection and analysis of patient
experience data, generally, or they may
be related more specifically to the
submission and evaluation of patient
experience data in the context of FDA’s
benefit-risk assessment or product
labeling.
The feedback received as part of this
RFI will be summarized in a subsequent
Federal Register document and will
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help to inform future public workshops
focused on methodologic challenges
related to patient-focused drug
development. The Federal Food, Drug,
and Cosmetic Act, as amended by the
21st Century Cures Act (Pub. L. 114–
255) and the FDA Reauthorization Act
of 2017 (FDARA) (Pub. L. 115–52),
defines patient experience data as: ‘‘data
that (1) are collected by any persons
(including patients, family members,
and caregivers of patients, patient
advocacy organizations, disease
research foundations, researchers, and
drug manufacturers); and (2) are
intended to provide information about
patients’ experiences with a disease or
condition, including (A) the impact
(including physical and psychosocial
impacts) of such disease or condition, or
a related therapy or clinical
investigation, on patients’ lives; and (B)
patient preferences with respect to
treatment of such disease or
condition.’’ 1
II. Request for Information and
Comments
Interested persons are invited to
provide detailed information and
comments on methodological challenges
relating to patient experience data,
including the submission and
evaluation of patient experience data in
the context of the benefit-risk
assessment and product labeling. Please
provide the rationale for any suggestions
and include supporting data if available.
FDA is particularly interested in
information related to the following:
(1) Describe any perceived barriers to
the use of patient experience data for
regulatory decision making (e.g.,
benefit-risk assessment, product
labeling).
(2) Describe any challenges and
limitations experienced when selecting,
modifying, or developing fit-for-purpose
Clinical Outcome Assessment measures.
(3) Describe any challenges and
statistical analysis considerations when
constructing and selecting endpoints of
interest and in understanding whether
an estimated treatment effect
corresponds to a real difference in
patients’ lives.
(4) Describe any challenges and
limitations experienced when
developing and conducting patient
preference studies to support regulatory
submissions.
(5) Describe any challenges and
limitations when submitting patient
experience data to FDA.
1 Patient
experience data is defined for purposes
of this guidance in Title III, section 3001 of the 21st
Century Cures Act, as amended by section 605 of
FDARA, https://www.congress.gov/115/plaws/
publ52/PLAW-115publ52.pdf.
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The public comments collected will
help FDA plan two workshops focused
on methodological challenges with
patient experience data and will
identify opportunities for future work.
Dated: April 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09265 Filed 5–1–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1259]
Advancing the Utilization and
Supporting the Implementation of
Innovative Manufacturing Approaches;
Public Workshop; Request for
Comments; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments; correction.
ACTION:
The Food and Drug
Administration is correcting a notice
entitled ‘‘Advancing the Utilization and
Supporting the Implementation of
Innovative Manufacturing Approaches’’
that appeared in the Federal Register of
April 24, 2023. The document
announced a public workshop. The
document was published with an
incorrect topic for discussion. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy, Legislation,
and International Affairs, Food and
Drug Administration, 301–796–9115,
Lisa.Granger@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In the Federal Register of April 24,
2023, in FR Doc. 2023–08545 (88 FR
24807), on page 24808, the following
correction is made:
• On page 24808, in the second
column, in Section II, ‘‘Topics for
Discussion at the Public Workshop,’’ the
fifth topic, ‘‘Science- and risk-based
approaches for developing and
accessing innovative technologies across
platform products and sites to
streamline adoption.’’ is corrected to
read ‘‘Science- and risk-based
approaches for developing and assessing
innovative technologies across platform
products and sites to streamline
adoption.’’
SUMMARY:
Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09206 Filed 5–1–23; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Notices]
[Page 27522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09206]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1259]
Advancing the Utilization and Supporting the Implementation of
Innovative Manufacturing Approaches; Public Workshop; Request for
Comments; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``Advancing the Utilization and Supporting the Implementation
of Innovative Manufacturing Approaches'' that appeared in the Federal
Register of April 24, 2023. The document announced a public workshop.
The document was published with an incorrect topic for discussion. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy,
Legislation, and International Affairs, Food and Drug Administration,
301-796-9115, [email protected].
SUPPLEMENTARY INFORMATION:
In the Federal Register of April 24, 2023, in FR Doc. 2023-08545
(88 FR 24807), on page 24808, the following correction is made:
On page 24808, in the second column, in Section II,
``Topics for Discussion at the Public Workshop,'' the fifth topic,
``Science- and risk-based approaches for developing and accessing
innovative technologies across platform products and sites to
streamline adoption.'' is corrected to read ``Science- and risk-based
approaches for developing and assessing innovative technologies across
platform products and sites to streamline adoption.''
Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09206 Filed 5-1-23; 8:45 am]
BILLING CODE 4164-01-P
