85892 Federal Register / Vol. 88, No. 236 / Monday, December 11, 2023 / Notices 

timely feedback on service delivery 

while ensuring that the information 

collected is useful and minimally 

burdensome for the public, as required 

by the Paperwork Reduction Act of 

1995. ACF created this generic clearance 

in response to this effort by OMB. 

To work continuously to ensure that 

the ACF programs are effective and meet 

our customers’ needs, we use this Fast 

Track generic clearance process to 

collect qualitative feedback on our 

service delivery. This collection of 

information is necessary to enable ACF 

to garner customer and stakeholder 

feedback in an efficient, timely manner 

in accord with our commitment to 

improving service delivery. The 

information collected from our 

customers and stakeholders helps 

ensure that users have an effective, 

efficient, and satisfying experience with 

the programs. This feedback provides 

insights into customer or stakeholder 

perceptions, experiences, and 

expectations; provides an early warning 

of issues with service; or focus attention 

on areas where communication, 

training, or changes in operations might 

improve delivery of products or 

services. These collections allow for 

ongoing, collaborative, and actionable 

communications between ACF and its 

customers and stakeholders. They also 

allow feedback to contribute directly to 

the improvement of program 

management. 

Per Memorandum M–11–26, 

information collection requests 

submitted under this Fast Track generic 

will be considered approved unless 

OMB notifies ACF otherwise within 5 

days. 

Respondents: ACF program 

participants, potential program 

participants, stakeholders, and other 

customers. 

Annual Burden Estimates 

Burden Estimates—Approved 

Information Collection 

The request to OMB will include an 

extension request for approved 

information collections that are planned 

to continue beyond May 2024. Find 

currently approved information 

collections here: https://

www.reginfo.gov/public/do/ 

PRAICList?ref_nbr=202305-0970-012. 

Burden Estimates—New Requests 

The following table includes burden 

estimates for new requests under this 

generic over the next 3 years. Based on 

the use of this generic clearance over the 

past 3 years, ACF is requesting an 

increase to the estimated number of 

responses per respondent from 1 to 2. 

Type of collection 

Total 

number of 

respondents 

Average total 

number of 

responses per 

respondent 

Average burden 

hours per 

response for 

types of 

collections 

Total 

burden 

hours 

Surveys ............................................................................................................ 175,000 2 .5 50,000 

Comment Cards/Forms ................................................................................... .25 

Feedback Questions ........................................................................................ .083 

Focus Groups, Discussions, Cognitive Studies ............................................... 1 

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: Social Security Act, Sec. 

1110. [42 U.S.C. 1310]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–27093 Filed 12–8–23; 8:45 am] 

BILLING CODE 4184–88–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2022–E–2095 and FDA– 

2022–E–2096] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; WELIREG 

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 WELIREG 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 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 9, 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 

June 10, 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 

February 9, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is 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 


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Federal Register / Vol. 88, No. 236 / Monday, December 11, 2023 / Notices 85893 

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– 

2022–E–2095 and FDA–2022–E–2096 

for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; WELIREG.’’ 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 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 WELIREG 

(belzutifan). WELIREG is indicated for 

the treatment of adult patients with von 

Hippel-Lindau disease who require 

therapy for associated renal cell 

carcinoma, central nervous system 

hemangioblastomas, or pancreatic 

neuroendocrine tumors, not requiring 

immediate surgery. Subsequent to this 

approval, the USPTO received patent 

term restoration applications for 

WELIREG (U.S. Patent Nos. 9,908,845; 

9,969,689) from Peloton Therapeutics, 

Inc, and the USPTO requested FDA’s 

assistance in determining the patents’ 

eligibility for patent term restoration. In 

a letter dated September 13, 2022, FDA 

advised the USPTO that this human 

drug product had undergone a 

regulatory review period and that the 

approval of WELIREG 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 

WELIREG is 1,752 days. Of this time, 

1,541 days occurred during the testing 

phase of the regulatory review period, 

while 211 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: October 28, 

2016. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on October 28, 2016. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: January 15, 2021. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

WELIREG (NDA 215383) was initially 

submitted on January 15, 2021. 

3. The date the application was 

approved: August 13, 2021. FDA has 


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85894 Federal Register / Vol. 88, No. 236 / Monday, December 11, 2023 / Notices 

verified the applicant’s claim that NDA 

215383 was approved on August 13, 

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 applications for patent extension, 

this applicant seeks 342 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 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27044 Filed 12–8–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Theodoric Mattes at 240–627–3827, or 

theodoric.mattes@nih.gov. Licensing 

information may be obtained by 

communicating with the Technology 

Transfer and Intellectual Property 

Office, National Institute of Allergy and 

Infectious Diseases, 5601 Fishers Lane, 

Rockville, MD 20852; tel. 301–496– 

2644. A signed Confidential Disclosure 

Agreement will be required to receive 

copies of unpublished information 

related to the invention. 

SUPPLEMENTARY INFORMATION: 

Technology description follows: 

Vaccine for Cats To Block Toxoplasma 

Gondii Oocyst Shedding and 

Transmission 

Description of Technology: 

Toxoplasma gondii is the zoonotic 

causative agent of toxoplasmosis, a 

disease of significant concern for 

pregnant persons and livestock. A 

member of the phylum Apicomplexa, 

Toxoplasma gondii can infect almost 

any cell type found in mammals and 

birds. There are multiple transmission 

pathways, including consumption of 

undercooked meat from infected 

animals, consumption of unwashed 

plants, contaminated water supplies, 

blood transfers, and congenital transfer. 

Felines are considered the definitive 

host of Toxoplasma gondii. Direct or 

indirect transmission can occur via 

contact with the stool of infected 

felines. 

Researchers at the National Institute 

of Allergy and Infectious Diseases 

(NIAID), the U.S. Department of 

Agriculture (USDA), and the University 

of South Bohemia (Cˇ eske ́ Budeˇjovice, 

Czechia) have demonstrated that T. 

gondii strains lacking expression of 

either the intracellular transport protein 

IFT88 or the CYS–6-type surface antigen 

SRS15B prevent the formation of 

oocysts and have potential for broad 

immunity to T. gondii. The inventors 

propose that mass inoculation of felines, 

specifically wild or feral felines, with a 

live vaccine developed from these 

strains could result in a significant 

reduction in oocyst production and 

environment contamination, reducing 

further infection in a geographical area. 

It is also proposed that loss of IFT88 or 

SRS15B homologs in other 

Apicomplexa parasites, like Neospora, 

Sarcocystis, or Cryptosporidium could 

have a similar impact. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration. 

Potential Commercial Applications: 

• Live vaccine for felines against 

Toxoplasma gondii infection 

• Reduction in environmental 

Toxoplasma gondii oocysts 

Competitive Advantages: 

• 100% blocked Toxoplasma gondii 

oocyst shedding in felines 

• Detectable seroconversion protective 

against future Toxoplasma gondii 

infection 

• Scalable production strain with 

predictable inactivation of IFT88 or 

SRS15B gene 

• Materials available for development 

or licensing 

Development Stage: 

• Pre-Clinical 

Inventors: Michael Grigg (NIAID), 

Aline Sardinha da Silva (NIAID), 

Viviana Pszenny (NIAID), Jitender 

Dubey (USDA), and Julius Lukesˇ

(University of South Bohemia, Czechia). 

Intellectual Property: HHS Reference 

No. E–118–2023–2. U.S. Provisional 

Patent Application No. 63/470,773 filed 

June 4, 2023. 

Licensing Contact: To license this 

technology, please contact Theodoric 

Mattes at 240–627–3827, or 

theodoric.mattes@nih.gov., and 

reference E–118–2023–2. 

Collaborative Research Opportunity: 

The National Institute of Allergy and 

Infectious Diseases is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this technology. For 

collaboration opportunities, please 

contact Theodoric Mattes at 240–627– 

3827, or theodoric.mattes@nih.gov. 

Dated: December 5, 2023. 

Surekha Vathyam, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2023–27113 Filed 12–8–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 


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