Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request, 86333-86336 [2023-27309]
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86333
Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices
President) 1 Memorial Drive, Kansas
City, Missouri, 64198–0001. Comments
can also be sent electronically to
KCApplicationComments@kc.frb.org:
1. The Marital Trust created under
Indenture of the James S. Birkbeck
Revocable Trust, dated April 20, 1995,
Holton, Kansas, Paula Birkbeck Taylor,
Holton, Kansas, and J. Patrick Birkbeck,
Topeka, Kansas, as co-trustees; Paula N.
Birkbeck Taylor Revocable Trust UIT
dated August 8, 2002, Holton, Kansas,
Paula Birkbeck Taylor, as trustee; Paula
Birkbeck as co-trustee of the Mary Lou
Birkbeck Trust dated April 20, 1995,
Holton, Kansas; J. Patrick Birkbeck
Revocable Trust UIT dated March 31,
2008, Topeka, Kansas, J. Patrick
Birkbeck, as trustee; and Ryan Patrick
Taylor, Holton, Kansas; to become
members of the Birkbeck/Taylor Family
Control Group, a group acting in
concert, to retain voting shares of
Denison Bancshares, Inc. of Holton, and
thereby indirectly retain voting shares of
Denison State Bank, both of Holton,
Kansas.
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2023–27357 Filed 12–12–23; 8:45 am]
BILLING CODE P
Administration for Children and
Families
Proposed Information Collection
Activity; Interstate Administrative
Subpoena and Notice of Lien (Office of
Management and Budget OMB #:
0970–0152)
Office of Child Support
Services, Administration for Children
and Families, U.S. Department of Health
and Human Services.
AGENCY:
ACTION:
You can obtain copies of the
proposed collection of information and
submit comments by emailing
infocollection@acf.hhs.gov. Identify all
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The Administrative
Subpoena is used by State child support
agencies to obtain income and other
financial information regarding
noncustodial parents for purposes of
establishing, enforcing, and modifying
child support orders. The Notice of Lien
imposes liens in cases with overdue
support and allows a State child support
agency to file liens across State lines,
when it is more efficient than involving
the other State’s IV–D agency.
Section 452(a)(11) of the Social
Security Act requires the Secretary of
the Department of Health and Human
Services to promulgate forms for
administrative subpoenas and
imposition of liens used by State child
support agencies in interstate cases.
Section 454(9)(E) of the Social Security
Act requires each State to cooperate
with any other State in using the
Federal forms for issuance of
administrative subpoenas and
imposition of liens in interstate child
support cases.
Respondents: State, local, or Tribal
agencies administering a child support
program under title IV–D of the Social
Security Act.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for public comments.
The Administration for
Children and Families (ACF) is
requesting a 3-year extension with
proposed revisions to the Interstate
Administrative Subpoena and Notice of
Lien forms (Office of Management and
Budget #0970–0152, expiration 6/30/
2024). The forms are updated to reflect
the name change of the Federal child
support program office from the Office
of Child Support Enforcement to the
Office of Child Support Services.
SUMMARY:
Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
DATES:
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
khammond on DSKJM1Z7X2PROD with NOTICES
Administrative Subpoena .................................................................................
Notice of Lien ...................................................................................................
Estimated Total Annual Burden
Hours: 816,048.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
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54
54
Annual
number of
responses per
respondent
462
29,762
Average
burden hours
per response
Annual
burden
hours
.5
.5
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 652; 42 U.S.C.
654.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary B. Jones,
ACF/OPRE Certifying Officer.
[Docket No. FDA–2023–D–4974]
[FR Doc. 2023–27313 Filed 12–12–23; 8:45 am]
BILLING CODE 4184–41–P
PO 00000
12,474
803,574
Food and Drug Administration
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.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
SUMMARY:
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86334
Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices
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:
khammond on DSKJM1Z7X2PROD with NOTICES
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
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
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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-201509-18/pdf/2015-23389.pdf.
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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, PRAStaff@fda.hhs.gov.
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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Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices
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 CBERregulated 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
Number of
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
Section 506L of the FD&C Act
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
AMT designation request; Guidance for industry section III.B ........
20
1
20
10
200
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
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including chemistry, proposed
manufacturing procedures and controls,
and requests for meetings have been
approved under OMB control number
0910–0014. The collections of
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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
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Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
that requirement ends for version 3.2 of
the CDISC SDTMIG (SDTMIGv3.2). The
Agency will update the FDA Data
Standards Catalog (Catalog) to reflect
these changes. The Agency will publish
in the technical specifications document
entitled ‘‘Study Data Technical
Conformance Guide’’ additional details
on how to implement new variables.
DATES: Support for version CDISC
SDTMv2.0, SDTMIGv3.4, and SENDIGGenetoxv1.0 begins December 13, 2023.
The requirement for electronic
submissions to be submitted using
CDISC SDTMv2.0, SDTMIGv3.4, and
SENDIG-Genetoxv1.0 begins March 15,
2025, for new drug applications (NDAs),
abbreviated new drug applications
(ANDAs), certain biologics license
applications (BLAs), and certain
investigational new drug applications
(INDs). The requirement for electronic
submissions to be submitted using
version CDISC SDTMIGv3.2 ends
December 13, 2023.
ADDRESSES: You may submit comments
as follows.
Food and Drug Administration
Electronic Submissions
[Docket No. FDA–2023–N–5022]
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
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’’).
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-regulatoryinformation/guidances-drugs, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-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
Data Standards; Support and
Requirement Begins for the Clinical
Data Interchange Standards
Consortium Version 2.0 of the Study
Data Tabulation Model, Version 3.4 of
the Study Data Tabulation Model
Implementation Guide, and Version 1.0
of the Standard for Exchange of
Nonclinical Data Implementation
Guide—Genetox; Requirement Ends
for the Clinical Data Interchange
Standards Version 3.2 of the Study
Data Tabulation Model Implementation
Guide
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Biologics Evaluation and
Research (CBER) and Center for Drug
Evaluation and Research (CDER) are
announcing that support begins for
version 2.0 of the Clinical Data
Interchange Standards Consortium
(CDISC) Study Data Tabulation Model
(SDTMv2.0), version 3.4 of the CDISC
Study Data Tabulation Model
Implementation Guide (SDTMIGv3.4),
and version 1.0 of the Standard for
Exchange of Nonclinical Data
Implementation Guide—Genetox
(SENDIG-Genetoxv1.0) and announcing
the date that these version updates are
required in certain submissions. CBER
and CDER are also announcing the date
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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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.
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
• 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–N–5022 for ‘‘Data Standards;
Requirement Begins for the Clinical
Data Interchange Standards Consortium
Version 2.0 of the Study Data
Tabulation Model and Version 3.4 of the
Study Data Tabulation Model
Implementation Guide; Requirement
Ends for the Clinical Data Interchange
Standards Version 3.2 of the Study Data
Tabulation Model Implementation
Guide.’’ 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-201509-18/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
E:\FR\FM\13DEN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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.
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 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, [email protected].
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\
----------------------------------------------------------------------------------------------------------------
Number of Total Average
Section 506L of the FD&C Act Number of responses per annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
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
