38764 Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Notices 

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, RUKOBIA 

(fostemsavir tromethamine). RUKOBIA, 

indicated in combination with other 

antiretrovirals, is indicated for the 

treatment of HIV–1 infection in heavily 

treatment-experienced adults with 

multidrug-resistant HIV–1 infection 

failing their current antiretroviral 

regimen due to resistance, intolerance, 

or safety considerations. Subsequent to 

this approval, the USPTO received a 

patent term restoration application for 

RUKOBIA (U.S. Patent No. 8,168,615) 

from ViiV Healthcare UK, and the 

USPTO requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

March 1, 2021, FDA advised the USPTO 

that this human drug product had 

undergone a regulatory review period 

and that the approval of RUKOBIA 

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 

RUKOBIA is 5,322 days. Of this time, 

5,110 days occurred during the testing 

phase of the regulatory review period, 

while 212 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 8, 

2005. The applicant claims November 8, 

2005, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was December 8, 

2005, which was 30 days after FDA 

receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: December 4, 2019. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

RUKOBIA (NDA 212950) was initially 

submitted on December 4, 2019. 

3. The date the application was 

approved: July 2, 2020. FDA has verified 

the applicant’s claim that NDA 212950 

was approved on July 2, 2020. 

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 1,597 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: June 23, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13856 Filed 6–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Amended Notice 

of Meeting 

Notice is hereby given of a change in 

the meeting of the National Institute of 

Neurological Disorders and Stroke 

Special Emphasis Panel, June 27, 2022, 

08:00 a.m. to June 28, 2022, 03:00 p.m., 

National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 which 

was published in the Federal Register 

on June 07, 2022, FR Doc 2022–12174, 

87 FR 34694. 

This notice is being amended to 

change the dates of this meeting from 

June 27–28, 2022, to July 11–12, 2022. 

The meeting time remains the same. The 

meeting is closed to the public. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Notices 38765 

Dated: June 23, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–13798 Filed 6–28–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIH Support for 

Conferences and Scientific Meetings (Parent 

R13 Clinical Trial Not Allowed). 

Date: July 25–27, 2022. 

Time: 7:00 a.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F21B, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Maryam Feili-Hariri, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F21B, 

Rockville, MD 20852, (240) 669–5026, 

haririmf@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: June 23, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–13797 Filed 6–28–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; The Clinical Trials Reporting 

Program (CTRP) Database (NCI) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995 to provide 

opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 60 days of the date of this 

publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments, submit 

comments in writing, or request more 

information on the proposed project, 

contact: Gisele Sarosy, MD, 

Coordinating Center for Clinical Trials 

(CCCT), National Cancer Institute, 9609 

Medical Center Drive, 6W134, 

Rockville, MD 20852 or call non-tollfree number 240–276–6172 or Email 

your request, including your address to: 

gisele.sarosy@nih.gov. Formal requests 

for additional plans and instruments 

must be requested in writing. 

SUPPLEMENTARY INFORMATION: Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires: written 

comments and/or suggestions from the 

public and affected agencies are invited 

to address one or more of the following 

points: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimizes 

the burden of the collection of 

information on those who are to 

respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Proposed Collection Title: The 

Clinical Trials Reporting Program 

(CTRP) Database, 0925–0600, Expiration 

Date 10/31/2022–EXTENSION, National 

Cancer Institute (NCI), National 

Institutes of Health (NIH). 

Need and Use of Information 

Collection: The Clinical Trials Reporting 

Program (CTRP) Database is an 

electronic resource that serves as a 

single, definitive source of information 

about all NCI-supported clinical 

research. This resource allows the NCI 

to consolidate reporting, aggregate 

information and reduce redundant 

submissions. Information is submitted 

by clinical research administrators as 

designees of clinical investigators who 

conduct NCI-supported clinical 

research. The designees can 

electronically access the CTRP website 

to complete the initial trial registration. 

Subsequent to registration, four 

amendments and four study subject 

accrual updates occur per trial annually. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The estimated 

annualized burden hours are 18,000. 

ESTIMATED ANNUALIZED BURDEN HOURS

Form name Type of respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average time 

per response 

(in hours) 

Total annual 

burden hours 

Initial Registration ............................. Clinical Trials .................................... 3,000 1 1 3,000 

Amendment ....................................... 1,500 4 1 6,000 

Update ............................................... 1,500 4 1 6,000 

Accrual Updates ................................ 3,000 4 15/60 3,000 

Totals ......................................... 9,000 27,000 18,000 


lotter on DSK11XQN23PROD with NOTICES1