Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Notices 75543 

of the information collection described 

above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

OPREinfocollection@acf.hhs.gov. 

Identify all requests by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: The purpose of the SRAE 

program is to educate youth on how to 

voluntarily refrain from nonmarital 

sexual activity and prevent other youth 

risk behaviors. Data will continue to be 

used to determine if the SRAE grant 

recipients are meeting performance 

benchmarks related to their program’s 

mission and priorities. 

The SRAE PAS collects performance 

measures data from SRAE grant 

recipients, program providers, and 

participants. The data include 

information on program structure, cost, 

and support for implementation; 

program attendance, reach, and dosage; 

the characteristics of youth involved in 

programming; youth sexual and other 

risky behavior prior to program 

participation; and youth sexual and 

other risky behavior intentions at 

program exit. The performance 

measures help the ACF program office 

and grant recipients to monitor and 

report on progress in implementing 

SRAE programs and inform technical 

assistance. 

Some of the performance measures 

data come from youth participants 

through surveys SRAE grant recipients 

administer at program entry and exit. 

There are separate versions of the entry 

and exit surveys for middle school 

youth, which exclude some of the more 

sensitive items that are included in the 

versions for high school and older 

youth. There is also a shorter version of 

the entry survey for programs 

conducting impact studies, to reduce 

the burden on participants in those 

programs who are likely responding to 

other surveys as part of their impact 

study. Although there was a version of 

the exit survey for programs conducting 

impact studies in the past, it was 

removed through the previous OMB 

request, and youth in these programs 

now complete the same version of the 

exit survey as other youth. 

ACF is currently working on future 

revisions to this information collection, 

which will be submitted to OMB for 

review and approval in 2025. Notices 

inviting public comment on those 

revisions will accompany that request, 

but comments received in response to 

this notice could also inform those 

revisions. 

Respondents: General Departmental 

(GDSRAE), State (SSRAE), and 

Competitive (CSRAE) grant recipients, 

their subrecipients, and program 

participants. 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request period) 

Number of 

responses per 

respondent 

(total over 

request period) 

Average 

burden per 

response 

(in hours) 

Total/ 

annual burden 

(in hours) 

(1) Participant Entry Survey: 

GDSRAE participants ........................................................................... 126,130 1 0.1333 16,813 

SSRAE participants .............................................................................. 317,633 1 0.1333 42,340 

CSRAE participants .............................................................................. 20,136 1 0.1333 2,684 

(2) Participant Exit Survey: 

GDSRAE participants ........................................................................... 100,904 1 0.1667 16,821 

SSRAE participants .............................................................................. 254,106 1 0.1667 42,360 

CSRAE participants .............................................................................. 16,109 1 0.1667 2,685 

(3) Performance reporting data entry form: grant recipients: 

GDSRAE grant recipients ..................................................................... 119 2 16 3,808 

SSRAE grant recipients ........................................................................ 39 2 16 1,248 

CSRAE grant recipients ....................................................................... 34 2 16 1,088 

(4) Performance reporting data entry form: subrecipients: 

GDSRAE subrecipients ........................................................................ 252 2 13 6,552 

SSRAE subrecipients ........................................................................... 426 2 13 11,076 

CSRAE subrecipients ........................................................................... 63 2 13 1,638 

Estimated Total Annual Burden 

Hours: 149,113. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 42 U.S.C 1310. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–20953 Filed 9–13–24; 8:45 am] 

BILLING CODE 4184–73–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2023–E–3224, FDA– 

2023–E–3225, FDA–2023–E–3221, and FDA– 

2023–E–3223] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ORSERDU 

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 ORSERDU and is publishing this 


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75544 Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Notices 

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 must submit either electronic 

or written comments and ask for a 

redetermination by November 15, 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 17, 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 15, 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 Nos. FDA– 

2023–E–3224, FDA–2023–E–3225, 

FDA–2023–E–3221, and FDA–2023–E– 

3223 for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; ORSERDU.’’ 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, ORSERDU 

(elacestrant dihydrochloride). 

ORSERDU is indicated for treatment of 

postmenopausal women or adult men, 

with ER-positive, HER2-negative, ESR1- 

mutated advanced or metastatic breast 


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Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Notices 75545 

cancer with disease progression 

following at least one line of endocrine 

therapy. Subsequent to this approval, 

the USPTO received patent term 

restoration applications for ORSERDU 

(U.S. Patent Nos. 7,612,114 and 

8,399,520 filed by Eisai R&D 

Management Co., Ltd., and U.S. Patent 

Nos. 10,071,066 and 10,420,734, filed by 

Duke University), and the USPTO 

requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

January 30, 2024, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

ORSERDU 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 

ORSERDU is 2,965 days. Of this time, 

2,740 days occurred during the testing 

phase of the regulatory review period, 

while 225 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: December 17, 

2014. FDA has verified the applicants’ 

claims that the date the investigational 

new drug application became effective 

was on December 17, 2014. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: June 17, 2022. FDA 

has verified the applicants’ claims that 

the new drug application (NDA) for 

ORSERDU (NDA 217639) was initially 

submitted on June 17, 2022. 

3. The date the application was 

approved: January 27, 2023. FDA has 

verified the applicants’ claims that NDA 

217639 was approved on January 27, 

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 the applications for patent extension, 

the applicants seek 724 days, 841 days, 

or 1,595 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 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20893 Filed 9–13–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1216] 

Electronic Common Technical 

Document; Data Standards; Center for 

Drug Evaluation and Research and 

Center for Biologics Evaluation and 

Research Supporting Electronic 

Common Technical Document Version 

4.0 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Drug Evaluation and Research 

and Center for Biologics Evaluation and 

Research are announcing support for 

Electronic Common Technical 

Document (eCTD) Version 4.0 (v4.0)- 

based electronic submissions. 

DATES: Support for eCTDv4.0 electronic 

submissions begins September 16, 2024. 

FDA will also continue to support 

eCTDv3.2.2 electronic submissions. 

Submit either electronic or written 

comments at any time. 

ADDRESSES: You may submit comments 

as follows: 

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 ‘‘Instruction.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–1216 for ‘‘Electronic Common 

Technical Document; Data Standards; 

Center for Drug Evaluation and Research 

and Center for Biologics Evaluation and 

Research Supporting Electronic 

Common Technical Document Version 

4.0.’’ Received comments 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 


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