84156 Federal Register / Vol. 89, No. 203 / Monday, October 21, 2024 / Notices 

‘‘Office of Child Support Enforcement 

(OCSE)’’ to ‘‘Office of Child Support 

Services (OCSS)’’ and minor formatting 

enhancements. The current OMB 

approval expires on June 30, 2025. 

DATES: Comments due December 20, 

2024. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: The Federal Tax Refund 

Offset and Administrative Offset 

programs collect past-due child and 

spousal support by intercepting certain 

federal payments, including federal tax 

refunds, of parents who have been 

ordered to pay support and are 

delinquent. The Federal Offset Program 

is a cooperative effort among the 

Department of the Treasury’s Bureau of 

the Fiscal Service, OCSS, and state child 

support agencies (CSAs). The Passport 

Denial Program reports noncustodial 

parents who owe child and spousal 

support above a specified threshold to 

the Department of State, which will 

then deny passports to these 

individuals. State CSAs routinely 

submit the names, Social Security 

numbers, and the amount(s) of past-due 

child and spousal support of 

noncustodial parents who are 

delinquent in making payments to 

OCSS. 

Respondents: Child Support 

Agencies. 

ANNUAL BURDEN ESTIMATES

Information collection instrument Number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

annual 

burden 

hours per 

response 

Annual 

burden 

hours 

Input Record Specifications ..................................................................................... 54 52 .3 842.4 

Output Record Specifications .................................................................................. 54 52 .46 1,291.68 

Payment File (Charts 4–5) ...................................................................................... 54 52 .14 393.12

Annual Certification Letter ....................................................................................... 54 1 .4 21.6 

Child Support Portal Processing Screens ............................................................... 173 281 .01 486.13 

Estimated Total Annual Burden 

Hours: 3,034.93. 

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. 652(b); 42 U.S.C. 

664; 26 U.S.C. 6402(c); 31 CFR 285.3; 45 

CFR 302.60; 45 CFR 303.72; 31 U.S.C. 

3701 et seq.; 31 U.S.C. 3716(h); 31 CFR 

285.1; 42 U.S.C. 652(k); 42 U.S.C. 

654(31); 22 CFR 51.60; 42 U.S.C. 

654(31); 42 U.S.C. 664; 31 CFR 285.1; 

and 31 CFR 285.3. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–24228 Filed 10–18–24; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–E–3056] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Pascal Precision 

Transcatheter Valve Repair System 

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 PASCAL PRECISION 

TRANSCATHETER VALVE REPAIR 

SYSTEM 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 

medical device. 

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 December 20, 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 

April 21, 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 

December 20, 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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 203 / Monday, October 21, 2024 / Notices 84157 

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–3056 for Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; PASCAL 

PRECISION TRANSCATHETER VALVE 

REPAIR SYSTEM. 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. 6250, 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 medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of USPTO may award 

(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 medical device will include all of the 

testing phase and approval phase as 

specified in 35 U.S.C. 156(g)(3)(B). 

FDA has approved for marketing the 

medical device PASCAL PRECISION 

TRANSCATHETER VALVE REPAIR 

SYSTEM. PASCAL PRECISION 

TRANSCATHETER VALVE REPAIR 

SYSTEM is indicated for the 

percutaneous reduction of significant, 

symptomatic mitral regurgitation 

(MR>=3+) due to primary abnormality 

of the mitral apparatus (degenerative 

MR) in patients who have been 

determined to be at prohibitive risk for 

mitral valve surgery by a heart team, 

which includes a cardiac surgeon 

experienced in mitral valve surgery and 

a cardiologist experienced in mitral 

valve disease, and in whom existing 

comorbidities would not preclude the 

expected benefit from reduction of the 

mitral regurgitation. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

PASCAL PRECISION 

TRANSCATHETER VALVE REPAIR 

SYSTEM (U.S. Patent No. 10,507,102) 

from Edwards Lifesciences Corp., and 

the USPTO requested FDA’s assistance 

in determining this patent’s eligibility 

for patent term restoration. In a letter 

dated January 18, 2024, FDA advised 

the USPTO that this medical device had 

undergone a regulatory review period 

and that the approval of PASCAL 

PRECISION TRANSCATHETER VALVE 

REPAIR SYSTEM 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 

PASCAL PRECISION 

TRANSCATHETER VALVE REPAIR 

SYSTEM is 1,879 days. Of this time, 

1,698 days occurred during the testing 

phase of the regulatory review period, 

while 181 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 520(g) of the Federal Food, Drug, 

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

360j(g)) involving this device became 

effective: July 25, 2017. FDA has 

verified the applicant’s claim that the 

date the investigational device 

exemption for human tests to begin, as 

required under section 520(g) of the 

FD&C Act, became effective July 25, 

2017. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the FD&C 

Act (21 U.S.C. 360e): March 18, 2022. 

The applicant claims March 16, 2022, as 

the date the premarket approval 


lotter on DSK11XQN23PROD with NOTICES1
84158 Federal Register / Vol. 89, No. 203 / Monday, October 21, 2024 / Notices 

application (PMA) for PASCAL 

PRECISION TRANSCATHETER VALVE 

REPAIR SYSTEM (PMA P220003) was 

initially submitted. However, FDA 

records indicate that PMA P220003 was 

submitted on March 18, 2022. 

3. The date the application was 

approved: September 14, 2022. FDA has 

verified the applicant’s claim that PMA 

P220003 was approved on September 

14, 2022. 

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 592 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: October 15, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24244 Filed 10–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2023–E–2830 and FDA– 

2023–E–2831] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Gore Tag Thoracic Branch 

Endoprosthesis 

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 GORE TAG THORACIC BRANCH 

ENDOPROSTHESIS 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 

patents which claims that medical 

device. 

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 December 20, 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 

April 21, 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 

December 20, 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–2830 and FDA–2023–E–2831 

for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; GORE TAG THORACIC 

BRANCH ENDOPROSTHESIS.’’ 

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 


lotter on DSK11XQN23PROD with NOTICES1