Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices 102911 

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 

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 

1There 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. 

Dated: December 11, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–29955 Filed 12–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

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, PRAStaff@

fda.hhs.gov. 

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/ 


khammond on DSK9W7S144PROD with NOTICES
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 

1There 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 

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. 

SUMMARY: 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 

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, 


khammond on DSK9W7S144PROD with NOTICES