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issued the draft guidance document 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
Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices 102913 

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 Nos. FDA– 

2024–E–0195, FDA–2024–E–0196, 

FDA–2024–E–0197, and FDA–2024–E– 

0198 for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; SOHONOS.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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 § 10.20 (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. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6200, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biological product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, SOHONOS 

(palovarotene) indicated for reduction 

in the volume of new heterotopic 

ossification in adults and children aged 

8 years and older for females and 10 

years and older for males with 

fibrodysplasia ossificans progressiva. 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for SOHONOS (U.S. Patent 

Nos. 9,314,439 and 10,292,954 filed by 

Ipsen Biopharmsaceuticals, Inc. (agent 

of Thomas Jefferson University), and 

U.S. Patent Nos. 10,864,194 and 

11,622,959, filed by Ipsen 

Biopharmaceuticals, Inc. (agent of 

Clementia Pharmaceuticals Inc.)), and 

the USPTO requested FDA’s assistance 

in determining the patents’ eligibility 

for patent term restoration. In a letter 

dated February l6, 2024, FDA advised 

the USPTO that this human drug 

product had undergone a regulatory 

review period and that the approval of 

SOHONOS represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

SOHONOS is 7,526 days. Of this time, 

6,657 days occurred during the testing 

phase of the regulatory review period, 

while 869 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: January 9, 

2003. The applicant claims April 27, 

2014, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was January 9, 2003, 

which was 30 days after FDA receipt of 

an earlier IND. 


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102914 Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: March 31, 2021. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

SOHONOS (NDA 215559) was initially 

submitted on March 31, 2021. 

3. The date the application was 

approved: August 16, 2023. FDA has 

verified the applicant’s claim that NDA 

215559 was approved on August 16, 

2023. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 69 days 1,209 days 

or 1,773 days of patent term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: December 11, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–29964 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–N–0119] 

Fiscal Year 2025 Generic Drug Science 

and Research Initiatives Workshop; 

Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the following public 

workshop entitled ‘‘FY 2025 Generic 

Drug Science and Research Initiatives 

Workshop.’’ The purpose of the public 

workshop is to provide an overview of 

the status of science and research 

initiatives for generic drugs and an 

opportunity for public input on these 

initiatives. FDA is seeking this input 

from a variety of interested parties— 

industry, academia, patient advocates, 

professional societies, and other 

interested parties—as it fulfills its 

commitment under the Generic Drug 

User Fee Amendments of 2022 (GDUFA 

III) to develop an annual list of science 

and research initiatives specific to 

generic drugs. FDA will take the 

information it obtains from the public 

workshop into account in developing its 

fiscal year (FY) 2026 Generic Drug User 

Fee Amendments (GDUFA) science and 

research initiatives. 

DATES: The public workshop will be 

held on June 3 and 4, 2025. Either 

electronic or written comments on this 

public workshop must be submitted by 

July 7, 2025. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: The public workshop will 

be held in person and will be accessible 

virtually. Registrants will have an 

opportunity to indicate their interest in 

attending the public workshop in 

person. If there are restrictions imposed 

by applicable health guidelines for inperson gatherings, or seating capacity 

limitations, registrants interested in 

attending the public workshop in 

person will be contacted. The public 

workshop will be held at the FDA White 

Oak Campus, 10903 New Hampshire 

Ave., Bldg. 31 Conference Center, the 

Great Room (Rm. 1503, sections B and 

C), Silver Spring, MD 20993–0002. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

Information, please refer to https://

www.fda.gov/about-fda/visitorinformation. 

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 July 7, 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, 

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–N–0119 for ‘‘FY 2025 Generic 

Drug Science and Research Initiatives 

Workshop; Public Workshop; Request 

for Comments.’’ Received comments, 


khammond on DSK9W7S144PROD with NOTICES