Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 78313 

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, DAYBUE 

(trofinetide). DAYBUE is indicated for 

the treatment of Rett syndrome in adults 

and pediatric patients 2 years of age and 

older. Subsequent to this approval, the 

USPTO received a patent term 

restoration application for DAYBUE 

(U.S. Patent No. 9,212,204) from Acadia 

Pharmaceuticals Inc., and the USPTO 

requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

January 24, 2024, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

DAYBUE 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 

DAYBUE is 5,106 days. Of this time, 

4,864 days occurred during the testing 

phase of the regulatory review period, 

while 242 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: March 19, 

2009. The applicant claims December 

20, 2012, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

March 19, 2009, which was 30 days 

after FDA receipt of an earlier IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: July 12, 2022. FDA has 

verified the applicant’s claim that the 

new drug application (NDA) for 

DAYBUE (NDA 217026) was initially 

submitted on July 12, 2022. 

3. The date the application was 

approved: March 10, 2023. FDA has 

verified the applicant’s claim that NDA 

217026 was approved on March 10, 

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 application for patent extension, 

this applicant seeks 1,443 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: September 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21941 Filed 9–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–2381] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

Recall Authority 

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. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by October 25, 

2024. 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
78314 Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 

by using the search function. The OMB 

control number for this information 

collection is 0910–0432. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Medical Device Recall Authority 

OMB Control Number 0910–0432— 

Extension 

This collection of information helps 

to implement section 518(e) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360h(e)) and 

regulations in part 810 (21 CFR part 

810) which set forth mandatory medical 

device recall authority provisions. 

Section 518(e) of the FD&C Act provides 

FDA with the authority to issue an order 

requiring an appropriate person, 

including manufacturers, importers, 

distributors, and retailers of a device, if 

FDA finds that there is reasonable 

probability that the device intended for 

human use would cause serious, 

adverse health consequences or death, 

to: (1) Immediately cease distribution of 

such device and (2) immediately notify 

health professionals and device-user 

facilities of the order and to instruct 

such professionals and facilities to cease 

use of such device. 

The person named in the order will 

have an opportunity for a regulatory 

hearing or to provide a written request 

to FDA asking that the order be 

modified, vacated, or amended. FDA 

may later amend the order to require a 

mandatory recall of the device. FDA 

currently allows for these requests, 

along with other reports and records 

concerning mandatory recalls, to be 

submitted to the Agency using 

electronic methods including email and 

FDA’s eSubmitter program (https://

www.fda.gov/industry/fda-esubmitter). 

FDA issued part 810 to implement the 

provisions of section 518 of the FD&C 

Act. The information collected under 

the mandatory recall authority 

provisions is used by FDA to implement 

mandatory recalls. 

Description of Respondents: 

Respondents for this collection of 

information are firms, including 

medical device manufacturers, 

importers, distributors, and retailers, 

that have been issued a cease 

distribution and notification order or 

mandatory recall order in accordance 

with the provisions under part 810, 

during the timeframe(s) specified in the 

order. 

In the Federal Register of June 5, 2024 

(89 FR 48174), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Collection activity—21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

Submission of information to FDA about device distribution and remedial 

actions to be taken, as specified in the order—810.10(d) ....................... 2 1 2 8 16 

Submission of a written request for regulatory hearing—810.11(a) ........... 1 1 1 8 8 

Submission of a written request to FDA asking that the order be modified 

or vacated—810.12(a–b) .......................................................................... 1 1 1 8 8 

Submission of a strategy for compliance with cease distribution and notification or mandatory recall order—810.14 .............................................. 2 1 2 16 32 

Submission of periodic status reports to FDA to enable the Agency to assess progress in compliance with the order—810.16(a–b) ..................... 2 12 24 40 960 

Submission of a written request to FDA to certify compliance with and 

terminate the order—810.17(a) ................................................................ 2 1 2 8 16 

Total Hours ........................................................................................... .................... ........................ .................. .................... 1,040 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Collection activity—21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 

Documentation of communications to appropriate person(s)—810.15(b) 2 1 2 8 16 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Collection activity—21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

responses 

Average 

burden per 

disclosure 

Total 

hours 

Communications to appropriate person(s) concerning a cease distribution 

and notification or mandatory recall order—810.15(a)–(c) .......................... 2 1 2 12 24 

Follow up communications to appropriate person(s) who fail to respond to 

the initial communication—810.15(d) ........................................................... 2 1 2 4 8 


ddrumheller on DSK120RN23PROD with NOTICES1

I I 
Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 78315 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued 

Collection activity—21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

responses 

Average 

burden per 

disclosure 

Total 

hours 

Notifications provided by recipients of communications to appropriate consignees—810.15(e) ...................................................................................... 10 1 10 1 10 

Total .......................................................................................................... .................... .................... .................. .................... 42 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The burden per response, burden per 

recordkeeping, and burden per 

disclosure estimates are based on FDA’s 

recent experience with voluntary recalls 

under 21 CFR part 7. Based on an 

analysis of cease distribution and 

notification and mandatory recall order 

activity over the last 3 years, FDA 

expects no more than two of such 

actions per year as a conservative 

estimate. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: September 19, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21904 Filed 9–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–E–2829] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ELUCIREM 

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 ELUCIREM and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application 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 November 25, 2024. 

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 

March 24, 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 

November 25, 2024. 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–E–2829 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; ELUCIREM.’’ 

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 


ddrumheller on DSK120RN23PROD with NOTICES1