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[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 The guidance finalizes the draft guidance of 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

[[Page 111]]

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

[[Page 112]]

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]
BILLING CODE 4164-01-P
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