Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Notices 14505 

were approved under an emergency 

approval for 6-months and included a 

new requirement for Tribes or Tribal 

organizations to provide that charging 

fees and recovering costs will not be 

permitted. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review-Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: The final rule within 45 

CFR part 309, published in the Federal 

Register on March 30, 2004 at 69 FR 

16638, contains a regulatory reporting 

requirement that, in order to receive 

funding for a Tribal IV–D program, a 

Tribe or Tribal organization must 

submit a plan describing how the Tribe 

or Tribal organization meets or plans to 

meet the objectives of section 455(f) of 

the Social Security Act, including 

establishing paternity; establishing, 

modifying, and enforcing support 

orders; and locating noncustodial 

parents. The plan is required for all 

Tribes requesting funding; however, 

once a Tribe has met the requirements 

to operate a comprehensive program, a 

new plan is not required annually 

unless a Tribe makes changes to its title 

IV–D program. If a Tribe or Tribal 

organization intends to make any 

substantial or material changes, a Tribal 

IV–D plan amendment must be 

submitted for approval. Tribes and 

Tribal organizations must have an 

approved plan and submit any required 

plan amendments in order to receive 

funding to operate a Tribal IV–D 

program. Through an emergency 

approval request, OCSS included a new 

requirement for Tribes and Tribal 

organizations to provide that charging 

fees and recovering costs will not be 

permitted. This is due to the Final Rule 

on the Elimination of the Non-Federal 

Share published on February 12, 2024 

(see 89 FR 9784). Tribes and Tribal 

organizations that charge fees and 

recover cost must submit a plan 

amendment demonstrating compliance 

with the proposed new requirement, in 

accordance with 45 CFR 309.35(d). This 

is a one-time submission. Only three 

Tribal child support programs report 

data on the collection of fees and 

recovered costs. This request is to 

extend approval with no changes. 

Respondents: Tribes and Tribal 

Organizations. 

Burden Estimates 

The following burden estimates 

include new burden associated with the 

change in requirement, as well as 

existing burden under OMB #: 0970– 

0218. 

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

(over three 

years) 

Burden hours 

per response 

Total 

burden hours 

(over three 

years) 

Annual 

burden 

hours 

45 CFR 309—New Plan .................................................... 10 3 480 14,400 4,800 

45 CFR 309—Plan Amendment ........................................ 60 * 2 105 18,900 6,300 

45 CFR 309—Plan Amendment—Charging fees and recovering .......................................................................... 3 1 3 9 3 

Estimated Burden Hours and Costs ........................... ........................ .......................... ........................ 33,309 11,103 

* This estimate is based on an average number of about 2 amendments submitted per year per Tribe, but that does vary annually and by 

Tribe. 

Authority: Title IV–D of the Social 

Security Act; 45 CFR 309. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–03968 Filed 2–26–24; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–E–2217] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Rybrevant 

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 Rybrevant 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 

biological 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 April 29, 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 

August 26, 2024. 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 

April 29, 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: 


lotter on DSK11XQN23PROD with NOTICES1
14506 Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Notices 

• 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– 

2022–E–2217 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; RYBREVANT.’’ 

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 biologic 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 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological product becomes effective 

and runs until the approval phase 

begins. The approval phase starts with 

the initial submission of an application 

to market the human biological product 

and continues until FDA grants 

permission to market the biological 

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 biological 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 biologic product Rybrevant 

(amivantamab-vmjw). Rybrevant is 

indicated for the treatment of adult 

patients with locally advanced or 

metastatic non-small cell lung cancer 

with epidermal growth factor receptor 

exon 20 insertion mutations, as detected 

by an FDA-approved test, whose disease 

has progressed on or after platinumbased chemotherapy. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

Rybrevant (U.S. Patent No. 9,593,164) 

from Janssen Biotech, Inc., and the 

USPTO requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

September 21, 2022, FDA advised the 

USPTO that this human biological 

product had undergone a regulatory 

review period and that the approval of 

Rybrevant 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 

Rybrevant is 1,284 days. Of this time, 

1,105 days occurred during the testing 

phase of the regulatory review period, 

while 179 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 (21 U.S.C. 355(i)) 

became effective: November 16, 2017. 

The applicant claims November 19, 

2017, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was November 16, 

2017, which was the first date after 


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Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Notices 14507 

receipt of the IND that the 

investigational studies were allowed to 

proceed. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): November 24, 2020. FDA 

has verified the applicant’s claim that 

the biologics license application (BLA) 

for Rybrevant (BLA B761210) was 

initially submitted on November 24, 

2020. 

3. The date the application was 

approved: May 21, 2021. FDA has 

verified the applicant’s claim that BLA 

B761210 was approved on May 21, 

2021. 

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 546 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: February 22, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03961 Filed 2–26–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Ryan White 

HIV/AIDS Program Core Medical 

Services Waiver Form, OMB No. 0906– 

0065—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than April 29, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Ryan White HIV/AIDS Program Core 

Medical Services Waiver Form, OMB 

No. 0915–0065—Revision 

Abstract: In accordance with sections 

2604(c), 2612(b), and 2651(c) of the 

Public Health Service Act, recipients are 

required to spend not less than 75 

percent of funds on core medical 

services for individuals with HIV 

identified and eligible under the statute, 

after reserving permissible amounts for 

administrative and clinical quality 

management (CQM) costs. The statute 

also grants the Secretary of Health and 

Human Services authority to waive this 

requirement for a Ryan White HIV/AIDS 

Program (RWHAP) Part A, B, or C 

recipient if certain requirements are 

met, and a waiver request is submitted 

to HRSA for approval. 

As currently implemented by HRSA, 

to be approved, (1) core medical 

services must be available and 

accessible to all individuals identified 

and eligible for the RWHAP in the 

recipient’s service area within 30 days. 

This access must be without regard to 

payer source, and without the need to 

spend at least 75 percent of funds 

remaining from the recipient’s RWHAP 

award after statutorily permissible 

amounts for administrative and CQM 

costs are reserved; (2) the recipient must 

ensure there are no AIDS Drug 

Assistance Program (ADAP) waiting 

lists in their service area; and (3) a 

public process to obtain input on the 

waiver request must have occurred. This 

process must seek input from impacted 

communities including clients and 

RWHAP-funded core medical services 

providers on the availability of core 

medical services, and the decision to 

request the waiver. The public process 

may be a part of the same one used by 

recipients to seek input on community 

needs as part of the annual priority 

setting and resource allocation, 

comprehensive planning, statewide 

coordinated statement of need, public 

planning, and/or needs assessment 

processes. RWHAP Parts A, B, and C 

core medical services waiver requests 

must include funds awarded under the 

Minority AIDS Initiative. Core medical 

services waivers are effective for a 1- 

year period. 

The process for RWHAP Parts A, B, 

and C grant recipients to request a 

waiver of the minimum expenditure 

amount requirements for core medical 

services is outlined in Policy Notice 21– 

01, Waiver of the Ryan White HIV/AIDS 

Program Core Medical Services 

Expenditure Requirement. 

HRSA proposes to modify the onepage form to include the proposed 

percentages of HIV service dollars 

allocated to core medical and support 

services. Under the proposed changes, a 

field will be added to the form to 

capture the proposed percentages. This 

information will inform HRSA whether 

recipients are able to meet the statutory 

requirements in sections 2604(c), 

2612(b), and 2651(c) of the Public 

Health Service Act and will clarify what 

proposed portion of funds will be 

allocated to core medical and support 

services. Minor changes will also be 

made to the form to increase readability. 

Summary of Proposed Changes: 

Sections 2604(c), 2612(b), and 2651(c) of 

the Public Health Service Act requires 

recipients to spend not less than 75 

percent of funds on core medical 

services after reserving statutorily 


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