Early Alzheimer's Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability, 19329 [C1-2024-05178]
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Federal Register / Vol. 89, No. 53 / Monday, March 18, 2024 / Notices
the review of controlled correspondence
received on or after October 1, 2022.
The GDUFA III commitment letter
defines level 1 controlled
correspondence and level 2 controlled
correspondence, and this guidance
provides additional details and
recommendations concerning what
inquiries FDA considers controlled
correspondence for the purposes of
meeting the Agency’s performance goals
under the GDUFA III commitment letter.
In addition, this guidance provides
details and recommendations
concerning what information requestors
should include in a controlled
correspondence to facilitate FDA’s
consideration of and response to a
controlled correspondence and what
information FDA will provide in its
communications to requestors that have
submitted controlled correspondence.
As described in the GDUFA III
commitment letter, FDA has also agreed
to review and respond to requests to
clarify ambiguities in the controlled
correspondence response, and the
guidance provides information on how
requestors can submit these requests
and the Agency’s process for responding
to them.
This guidance finalizes the draft
guidance for industry entitled
‘‘Controlled Correspondence Related to
Generic Drug Development’’ issued on
December 22, 2022 (87 FR 78691). FDA
considered comments received on the
draft guidance as the guidance was
finalized. Changes from the draft to the
final guidance include updating the
guidance to clarify the role of a cover
letter to a controlled correspondence;
clarify that authorized agents submitting
controlled correspondence should
include the name of and contact
information for the generic drug
manufacturer or related industry they
are representing; and explain that FDA
intends to alert requestors whether their
inquiry is a level 1 or level 2 controlled
correspondence and if FDA changes the
level of the controlled correspondence
(e.g., from level 1 to level 2) during
substantive review. In addition,
editorial changes were made to improve
clarity.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Controlled
Correspondence Related to Generic Drug
Development.’’ It 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.
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II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively. The collections of
information for controlled
correspondence, covered product
authorizations, and GDUFA III meetings
are approved under OMB control
number 0910–0727. The collections of
information for risk evaluation and
mitigation strategies and medication
guides are approved under OMB control
number 0910–0393. The collections of
information for citizen petitions are
approved under OMB control number
0910–0191. The collections of
information for premarket approval of
drug-device combination products as
described in the draft guidance for
industry entitled ‘‘Comparative
Analyses and Related Comparative Use
Human Factors Studies for a DrugDevice Combination Product Submitted
in an ANDA’’ have been approved
under OMB control number 0910–0231.
III. Electronic Access
Persons with access to the internet
may obtain the 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: March 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–05687 Filed 3–15–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0077]
Early Alzheimer’s Disease: Developing
Drugs for Treatment; Draft Guidance
for Industry; Availability
Correction
In notice document 2024–05178,
appearing on pages 17850 through
17851 in the issue of Tuesday, March
12, 2024, make the following correction:
PO 00000
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19329
On page 17850, in the second column,
on the third line, ‘‘May 13, 2024’’
should read ‘‘June 10, 2024’’.
[FR Doc. C1–2024–05178 Filed 3–15–24; 8:45 am]
BILLING CODE 0099–10–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory Board
on Medical Rehabilitation Research. The
meeting will be held as a virtual
meeting and is open to the public.
Individuals who plan to attend as well
as those who need special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify the Contact Person listed
as below in advance of the meeting. The
meeting will be videocast and can be
accessed from the NIH Videocasting
website (https://videocast.nih.gov).
Name of Committee: National Advisory
Board on Medical Rehabilitation Research.
Date: May 6–7, 2024.
Time: May 6, 2024, 10:00 a.m. to 2:00 p.m.
Agenda: NICHD Director’s Report, NCMRR
Director’s report; Scientific Presentation on
Promoting Function and Inclusion for people
with Spinal Cord Injury; Review of NINDS
Traumatic Brain Injury Nomenclature
Workshop; Concept Clearance.
Place: Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, National Institutes of Health,
6710B Rockledge Drive, Bethesda, MD
20892–7510 (Virtual Meeting).
Time: May 7, 2024, 10:00 a.m. to 2:30 p.m.
Agenda: Science Talk: Advocating for
Cerebral Palsy Research; Update from NICHD
Office of Health Equity; Pediatric Medical
Device Public-Private Partnerships; Updates
from The Advanced Research Projects
Agency for Health; Updating the NIH
Rehabilitation Research Plan; Words from
Retiring Board Members; Planning for Next
Board Meeting in December 2024.
Place: Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, National Institutes of Health,
6710B Rockledge Drive, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Ralph M. Nitkin, Ph.D.,
Deputy, National Center for Medical
Rehabilitation Research, Eunice Kennedy
Shriver National Institute of Child Health
and Human Development, National Institutes
of Health, 6710B Rockledge Drive, Room
2116, Bethesda, MD 20892–7510, (301) 402–
4206, nitkinr@mail.nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
www.nichd.nih.gov/about/advisory/nabmrr,
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[Federal Register Volume 89, Number 53 (Monday, March 18, 2024)]
[Notices]
[Page 19329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: C1-2024-05178]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0077]
Early Alzheimer's Disease: Developing Drugs for Treatment; Draft
Guidance for Industry; Availability
Correction
In notice document 2024-05178, appearing on pages 17850 through
17851 in the issue of Tuesday, March 12, 2024, make the following
correction:
On page 17850, in the second column, on the third line, ``May 13,
2024'' should read ``June 10, 2024''.
[FR Doc. C1-2024-05178 Filed 3-15-24; 8:45 am]
BILLING CODE 0099-10-D
