Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advanced Manufacturing Technologies Designation Program, 102911-102912 [2024-29954]
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Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices
Specifically, the FD&C Act establishes
three tiers of regulatory control for
medical devices, by establishing three
classes of medical devices, and
requiring that all devices be classified
into one of these three classes. The
classification of a device depends upon
the degree of regulatory control
necessary to provide a reasonable
assurance of the safety and effectiveness
of the device. The three tiers of
regulatory control are: (1) Class I—
general controls, subject to sections 501
adulteration, 502 misbranding, 510
registration, 516 banned devices, 518
notification and other remedies, 519
records and reports, and 520 general
provisions of the FD&C Act; (2) Class
II—performance standards; and (3) Class
III—premarket approval.
Implementing regulations in 21 CFR
part 860, subpart C (parts 860.120
through 860.136) provide that any
person may petition for reclassification
of a device from any class to any other
class and prescribe requisite format and
content elements for reclassification
petitions submitted to the Agency. We
also provide information on our website
at https://www.fda.gov/about-fda/cdrhtransparency/reclassification regarding
medical device reclassification, which
may serve as a helpful resource to
respondents.
FDA is responsible for reviewing
petitions for reclassification and
determining whether the subject device
will be reclassified. In some instances,
FDA also submits such petitions to one
of its medical device advisory panels for
review and recommendations. FDA’s
102911
decision regarding the reclassification of
a device is based primarily upon the
information contained in the petition.
Respondents to the information
collection are private sector, for-profit
businesses. We have not identified
reclassification petitions as a type of
submission we are currently prepared to
accept electronically. Submission
instructions, including addresses, are
provided in § 860.123(b).
In the Federal Register of July 9, 2024
(89 FR 56390), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
One comment was received, but it was
not related to this information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR part; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden
per response
Total
hours
§ 860.123; supporting data for reclassification petitions .....
12
1
12
497
5,964
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Reclassification petitions must be
submitted as set forth in the applicable
regulations, which provide for the
submission of an original and two
copies (§ 860.123(b)(4)). Each petition
must include supporting data to show
why reclassification of the device type
will provide reasonable assurance of the
safety and effectiveness of the device
type. The principal data in such a
petition will typically be reports of
clinical trials.
Our estimated burden for the
information collection reflects an
increase of 6 responses and a
corresponding increase of 2,982 hours.
We attribute this adjustment to an
increase in the number of submissions
we received over the last few years.
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:
[FR Doc. 2024–29955 Filed 12–17–24; 8:45 am]
BILLING CODE 4164–01–P
DATES:
VerDate Sep<11>2014
18:09 Dec 17, 2024
SUMMARY:
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 https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
Jkt 265001
PO 00000
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Notice.
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).
Dated: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
khammond on DSK9W7S144PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Frm 00060
Fmt 4703
Sfmt 4703
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/
E:\FR\FM\18DEN1.SGM
18DEN1
102912
Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices
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 https://www.fda.gov/
emergency-preparedness-and-response/
mcm-issues/advanced-manufacturing,
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 BURDEN1
Section 506L(c) FD&C Act
Number of
respondents
Number of
responses per
respondents
Total annual
responses
Average
burden per
response
Total
hours
Submitting AMT designation requests; FDA Guidance for
Industry, section III.B ........................................................
20
1
20
10
200
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]
khammond on DSK9W7S144PROD with NOTICES
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:09 Dec 17, 2024
Jkt 265001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2024–E–0195; FDA–
2024–E–0196; FDA–2024–E–0197; FDA–
2024–E–0198]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SOHONOS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for SOHONOS and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
SUMMARY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
incorrect may submit either electronic
or written comments and ask for a
redetermination by February 18, 2025.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
June 16, 2025. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
February 18, 2025. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
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,
E:\FR\FM\18DEN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102911-102912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29954]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.reginfo.gov/public/do/PRAMain. 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,
[email protected].
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 https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/advanced-manufacturing, 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Section 506L(c) FD&C Act Number of responses per Total annual Average burden Total hours
respondents respondents responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting AMT designation requests; FDA Guidance for Industry, 20 1 20 10 200
section III.B.....................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
