Notice2024-29954
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advanced Manufacturing Technologies Designation Program
Primary source
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Published
December 18, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).
Full Text
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<title>Federal Register, Volume 89 Issue 243 (Wednesday, December 18, 2024)</title>
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[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102911-102912]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-29954]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-4974]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Advanced
Manufacturing Technologies Designation Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by January 17, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0139. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: 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#f2a2a0b3a186939494b2949693dc9a9a81dc959d84"><span class="__cf_email__" data-cfemail="520200130126333434123436337c3a3a217c353d24">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Advanced Manufacturing Technologies Designation Program
OMB Control Number 0910-0139--Revision
This information collection supports the establishment of an FDA
Advanced Manufacturing Technologies (AMT) Designation Program, as
provided for in section 506L of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 356l). Intending to enhance the development
of and combat the shortage of critical medical products, the AMT
Designation Program encourages early adoption of new technological
advances in manufacturing processes by the pharmaceutical industry or
other drug/
[[Page 102912]]
biologic developers. FDA regulations in 21 CFR parts 210 and 211 govern
current good manufacturing practice in the manufacturing, processing,
packing, or holding of drugs and finished pharmaceuticals (including
medical gases and active pharmaceutical ingredients), respectively.
Applicable information collection and attendant burden are currently
discussed, accounted for, and approved in OMB control number 0910-0139.
We are revising the information collection to include the AMT
Designation Program within the scope of activity, as authorized by
section 506L of the FD&C Act, and account for attendant burden.
Requests for AMT designation are reviewed by FDA to evaluate whether
the data and information submitted meets the criteria established in
section 506L of the FD&C Act. If a request for 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. Also required by section 506L of the FD&C Act, we engaged
with our stakeholders in a public meeting on June 8, 2023 (April 24,
2023, 88 FR 24807), to discuss innovative manufacturing technologies
for drug and biological products and included a discussion of the AMT
Designation Program. For more information regarding AMT, we invite
readers to visit our website at <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/advanced-manufacturing">https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/advanced-manufacturing</a>, which
includes regular updates on Agency implementation of its AMT
Designation Program.
Finally, section 506L of the FD&C Act also provides for the
issuance of guidance. In the Federal Register of December 13, 2023 (88
FR 86333), we issued the draft guidance document entitled ``Advanced
Manufacturing Technologies Designation Program,'' to communicate the
goals, scope, and framework of the new program. We invited public
comment under both our good guidance practices regulation in 21 CFR
10.115, and applicable PRA regulations in 5 CFR part 1320 and received
a few comments. The comments included some requests for procedural
clarification but focused mostly on requests for clarification of
technical specifications and technologies that might qualify for AMT
designation. Although we have updated the guidance document to address
a number of public comments, we continue to implement the program and
refine Agency processes.
FDA estimates the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden\1\
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Number of
Section 506L(c) FD&C Act Number of responses per Total annual Average burden Total hours
respondents respondents responses per response
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Submitting AMT designation requests; FDA Guidance for Industry, 20 1 20 10 200
section III.B.....................................................
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\1\ There are no capital or operating and maintenance costs associated with the information collection.
Based on our experience with similar information collection
activities that involve requests for FDA determinations, along with
related preliminary and followup communications, we assume 10 hours is
needed to complete the activities provided for in section 506L of the
FD&C Act and discussed in the referenced guidance document. Although we
have received fewer than 10 requests for AMT designation thus far, we
are hopeful that 20 respondents will submit requests for AMT
designation under the program.
Dated: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-29954 Filed 12-17-24; 8:45 am]
BILLING CODE 4164-01-P
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