Notice2023-27309
Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
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Published
December 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Advanced Manufacturing Technologies Designation Program."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 This draft guidance provides recommendations to persons and organizations interested in participating in FDA's Advanced Manufacturing Technologies Designation Program, which is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.
Full Text
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<title>Federal Register, Volume 88 Issue 238 (Wednesday, December 13, 2023)</title>
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[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86333-86336]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Advanced Manufacturing Technologies Designation Program; Draft
Guidance for Industry; Availability; Agency Information Collection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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
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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..................
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Total................................ .............. .............. 20 ........... 200
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\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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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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