[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86333-86336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27309]


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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Advanced Manufacturing Technologies Designation Program; Draft 
Guidance for Industry; Availability; Agency Information Collection 
Activities; Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a

[[Page 86334]]

draft guidance for industry entitled ``Advanced Manufacturing 
Technologies Designation Program.'' FDA encourages the early adoption 
of advanced manufacturing technologies (AMTs) that have the potential 
to benefit patients by improving manufacturing and supply dependability 
and optimizing development time of drug and biological products. These 
technologies can be integral to ensuring quality and supporting a 
robust supply of drugs that are life-supporting, life-sustaining, of 
critical importance to providing healthcare, or in shortage. AMTs can 
directly improve product quality through higher capability 
manufacturing designs and enhanced controls (e.g., leading to fewer 
human errors). This draft guidance provides recommendations to persons 
and organizations interested in participating in FDA's Advanced 
Manufacturing Technologies Designation Program, which is intended to 
facilitate the development of drugs, including biological products, 
manufactured using an AMT that has been designated as such under the 
program.

DATES: Submit either electronic or written comments on the draft 
guidance by February 12, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance. Submit electronic or written comments on the 
proposed collection of information in the draft guidance by February 
12, 2024.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, 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, 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: 
    With regard to the draft guidance: 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 Anne Taylor, 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.
    With regard to the proposed collection of information: Domini Bean, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, <a href="/cdn-cgi/l/email-protection#eebebcafbd9a8f8888ae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="4a1a180b193e2b2c2c0a2c2e2b64222239642d253c">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Advanced Manufacturing Technologies Designation Program.'' 
On December 29, 2022, the Food and Drug Omnibus Reform Act of 2022 
(FDORA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by 
adding section 506L (21 U.S.C. 356l), which requires the establishment 
of an Advanced Manufacturing Technologies Designation Program and the 
publication of a related guidance. FDA's

[[Page 86335]]

Advanced Manufacturing Technologies Designation Program 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 is intended to facilitate the development of drugs 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 (PHS Act) (42 U.S.C. 262), and regulated by 
the Center for Drug Evaluation and Research (CDER) or the Center for 
Biologics Evaluation and Research (CBER). FDA will expedite development 
and assessment of an application, including supplements, for drugs that 
are manufactured using a designated AMT as described in section 
506L(d)(1) of the FD&C Act.
    The development of this guidance takes into consideration feedback 
provided at a public meeting (see section 506L(e) of the FD&C Act) and 
comments submitted to the public docket (Docket No. FDA-2023-N-1259) 
about the public meeting. The meeting was held on June 8, 2023 (April 
24, 2023, 88 FR 24807), to discuss the use of innovative manufacturing 
technologies for CDER- and CBER-regulated products and to solicit 
industry and public feedback regarding the Advanced Manufacturing 
Technologies Designation Program.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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. ``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 provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Advanced Manufacturing Technologies Designation Program

OMB Control Number 0910-0139--Revision
    This information collection supports implementation of requirements 
under section 506L of the FD&C Act. The Advanced Manufacturing 
Technologies Designation Program encourages early adoption of new 
technological advances in manufacturing processes by the pharmaceutical 
industry or other drug/biologic developers to ensure that regulatory 
assessments and new drug and biologic development are based on state-
of-the-art pharmaceutical science. Any request for AMT designation will 
be reviewed by a team of FDA experts in quality assessment to evaluate 
the data and information submitted and to determine if the method of 
manufacturing or combination of methods meets the criteria of an AMT in 
section 506L of the FD&C Act. If AMT designation is granted, then 
future new drug application (NDA), abbreviated new drug application 
(ANDA), or biologics license application (BLA) applicants may use or 
reference the designated AMT, noting specific application of the 
designated AMT to specific product development and inclusion in NDA, 
ANDA, or BLA submissions describing development and manufacturing 
processes.
    We are issuing a draft guidance for industry entitled ``Advanced 
Manufacturing Technologies Designation Program,'' which outlines the 
process for submitting an AMT designation request; when and how FDA 
will communicate receipt of and provide advice on AMT designation 
requests; when and how FDA will assess AMT designation requests; the 
process by which FDA will engage with designated AMT holders and 
applicants for drugs manufactured using, referencing, or relying upon a 
designated AMT; and benefits related to drug development and 
application assessment.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                              Number of       Total       Average
       Section 506L of the FD&C Act           Number of     responses per     annual     burden per  Total hours
                                             respondents     respondent     responses     response
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AMT designation request; Guidance for                  20               1           20           10          200
 industry section III.B..................
                                          ----------------------------------------------------------------------
    Total................................  ..............  ..............           20  ...........          200
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.

    This draft guidance also refers to previously approved FDA 
collections of information. The collections of information in 21 CFR 
part 312 regarding product development including chemistry, proposed 
manufacturing procedures and controls, and requests for meetings have 
been approved under OMB control number 0910-0014. The collections of 
information in 21 CFR part 314 regarding applicable manufacturing 
information for NDAs are approved under OMB control number 0910-0001; 
and the collections of information in 21

[[Page 86336]]

CFR part 601 regarding applicable manufacturing information for BLAs 
are approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the draft guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27309 Filed 12-12-23; 8:45 am]
BILLING CODE 4164-01-P


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