[Federal Register Volume 90, Number 1 (Thursday, January 2, 2025)]
[Notices]
[Pages 110-112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31493]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-4974]
Advanced Manufacturing Technologies Designation Program; Guidance
for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Advanced
Manufacturing Technologies Designation Program.'' FDA encourages the
early adoption of advanced manufacturing technologies (AMTs) by the
pharmaceutical industry, which can improve the reliability and
robustness of the manufacturing process and can benefit patients by
enhancing product quality and reducing drug development time or
increasing or maintaining the supply of drugs that are life-supporting,
life-sustaining, of critical importance to providing health care, or in
shortage. This guidance provides recommendations to persons and
organizations interested in participating in FDA's Advanced
Manufacturing Technologies Designation Program, which facilitates the
development of drugs manufactured using an AMT that has been designated
as such under the program. The guidance finalizes the draft guidance of
the same title issued on December 13, 2023.
DATES: The announcement of the guidance is published in the Federal
Register on January 2, 2025.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note
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that if you include your name, contact information, or other
information that identifies you in the body of your comments, that
information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-D-4974 for ``Advanced Manufacturing Technologies Designation
Program.'' 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-2015-09-18/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 this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research
(CDER), Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Ranjani Prabhakara, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993, 240-402-
4652; or James Myers, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Advanced Manufacturing Technologies Designation Program.''
FDA's Advanced Manufacturing Technologies Designation Program, which is
required under section 506L of the Federal Food, Drug, and Cosmetic Act
(FD&C Act, 21 U.S.C. 356l), offers a framework for persons or
organizations (e.g., applicants, contract manufacturers, technology
developers) to request designation of a method or combination of
methods of manufacturing a drug as an AMT. The program facilitates the
development of drugs as described in section 506L(b) of the FD&C Act
that are manufactured using a designated AMT, submitted in an
application under section 505 of the FD&C Act (21 U.S.C. 355) or
section 351 of the Public Health Service Act (42 U.S.C. 262), and
regulated by CDER or CBER. An application or supplemental application
referencing a designated AMT can receive certain benefits under the
program, such as FDA's early interaction with applicants regarding the
development and manufacture of drugs using a designated AMT, as
described in section 506L(c)(1) of the FD&C Act.
The guidance outlines the eligibility criteria for AMT designation,
the submission and assessment process for requests, including data and
information to be submitted, and the benefits of receiving an AMT
designation, among other information, and includes a questions and
answers section to cover additional details about key concepts
important for program utilization. The guidance finalizes the draft
guidance of the same title issued on December 13, 2023 (88 FR 86333).
FDA considered comments received on the draft guidance in finalizing
the guidance. FDA made changes from the draft guidance to improve
clarity about the AMT designation process, the content of AMT
designation requests, the roles and responsibilities of different
entities involved in the development and use of designated AMTs, and
the relationship between the Advanced Manufacturing Technologies
Designation Program and other FDA programs addressing emerging or
advanced technologies.
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 ``Advanced Manufacturing Technologies
Designation Program.'' 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.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. FDA is issuing this guidance, as final, in
accordance with section 506L of the FD&C Act, which directs FDA to
initiate a program and establish a process for
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AMT designation, including information collection provisions subject to
review and approval by OMB under the PRA. Section 506L(e)(2) of the
FD&C Act further directs FDA to issue program guidance. Before
implementing the information collection provisions of the guidance, FDA
will publish a notice in the Federal Register continuing to invite
public comment on the proposed collections of information (see 88 FR
86333) and announce OMB's decision to approve, modify, or disapprove
the collections of information, including the OMB control number(s).
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.
Dated: December 27, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31493 Filed 12-31-24; 8:45 am]
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