4960 Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 

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, VOCABRIA 

(cabotegravir sodium) indicated in 

combination with EDURANT 

(rilpivirine) for short-term treatment of 

Human Immunodeficiency Virus-1 

(HIV–1) infection in adults who are 

virologically suppressed (HIV–1 RNA 

less than 50 copies/mL) on a stable 

antiretroviral regimen with no history of 

treatment failure and with no known or 

suspected resistance to either 

cabotegravir or rilpivirine, for use as: 

• oral lead-in to assess the tolerability 

of cabotegravir prior to administration 

of CABENUVA (cabotegravir; 

rilpivirine) extended-release injectable 

suspensions and 

• oral therapy for patients who will 

miss planned injection dosing with 

CABENUVA. 

Subsequent to this approval, the 

USPTO received a patent term 

restoration application for VOCABRIA 

(U.S. Patent No. 8,410,103) from ViiV 

Healthcare Company and the USPTO 

requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter 

September 28, 2022, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

VOCABRIA 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 

VOCABRIA is 4,719 days. Of this time, 

4,085 days occurred during the testing 

phase of the regulatory review period, 

while 634 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: February 22, 

2008. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on February 22, 2008. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: April 29, 2019. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

VOCABRIA (NDA 212887) was initially 

submitted on April 29, 2019. 

3. The date the application was 

approved: January 21, 2021. FDA has 

verified the applicant’s claim that NDA 

212887 was approved on January 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 1,742 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: January 22, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01438 Filed 1–24–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Solicitation of Nominations for 

Membership To Serve on the National 

Advisory Council on Nurse Education 

and Practice 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Request for nominations. 

SUMMARY: HRSA is seeking nominations 

of qualified candidates to consider for 

appointment as members of the National 

Advisory Council on Nurse Education 

and Practice (NACNEP). NACNEP 

provides advice and recommendations 

to the Secretary of HHS (Secretary) on 

policy, program development, and other 

matters of significance concerning the 

activities under Title VIII of the Public 

Health Service (PHS) Act, including the 

range of issues relating to the nurse 

workforce, education, and practice 

improvement. NACNEP also prepares 

and submits an annual report to the 

Secretary and Congress describing its 

activities, including NACNEP’s findings 

and recommendations concerning 

activities under Title VIII, as required by 

the PHS Act. HRSA is seeking 

nominations of qualified candidates to 

fill up to 11 open positions on NACNEP. 

DATES: HRSA will accept nominations 

for membership on NACNEP on a 

continuous basis. 

ADDRESSES: Nomination packages may 

be submitted electronically by email to 

BHWAdvisoryCouncil@hrsa.gov. 

Nomination packages may also be 

submitted by mail addressed to 

Advisory Council Operations, Bureau of 

Health Workforce, HRSA, 5600 Fishers 

Lane, Room 15W10, Rockville, 

Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Justin Bala-Hampton, Designated 

Federal Officer, NACNEP, by phone at 

(301) 443–2866, or by email at 

BHWNACNEP@hrsa.gov. A copy of the 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices 4961 

NACNEP charter and a list of the 

current membership may be obtained by 

accessing the NACNEP website at 

https://www.hrsa.gov/advisorycommittees/nursing. 

SUPPLEMENTARY INFORMATION: NACNEP 

advises and makes recommendations to 

the Secretary and Congress on policy 

matters arising in the administration of 

Title VIII of the PHS Act, including the 

range of issues relating to the nurse 

workforce, nursing education, and 

nursing practice improvement, as a 

means of enhancing the health of the 

public through the development of the 

nurse workforce. NACNEP meets at least 

twice each calendar year or may meet 

more frequently at the discretion of the 

Designated Federal Officer in 

consultation with the Chair. 

Nominations: HRSA is requesting 

nominations for voting members to 

serve as Special Government Employees 

(SGE) on NACNEP to fill open positions. 

The Secretary appoints NACNEP 

members with the expertise needed to 

fulfill the duties of the Advisory 

Council. The membership requirements 

are set forth at section 851(b) of Title 

VIII of the PHS Act, as amended. 

Nominees sought are individuals 

representing leading authorities in the 

various fields of nursing, higher and 

secondary education, and associate 

degree schools of nursing; 

representatives of advanced education 

nursing groups (such as nurse 

practitioners, nurse midwives, clinical 

nurse specialists, and nurse 

anesthetists); hospitals and other 

institutions and organizations which 

provide nursing services; practicing 

professional nurses; the general public; 

and full-time students enrolled in 

schools of nursing. In making such 

appointments, the Secretary shall 

ensure a fair balance between the 

nursing specialties, a broad geographic 

representation of members, and a 

balance between urban and rural 

members. Members shall be appointed 

based on their competence, interest, and 

knowledge of the mission of the 

profession involved. As required by 

PHS Act section 851(b)(3), the Secretary 

shall ensure the adequate representation 

of minorities. HRSA is particularly 

interested in seeking nominations from 

individuals who can represent 

underrepresented groups in the nursing 

profession. 

The majority of NACNEP members 

shall be nurses. Interested applicants 

may self-nominate or be nominated by 

another individual or organization. 

Individuals selected for appointment 

to NACNEP will be invited to serve a 

term of 4 years. Members appointed as 

SGEs receive a stipend and 

reimbursement for per diem and travel 

expenses incurred for attending 

NACNEP meetings and/or conducting 

other business on behalf of NACNEP, as 

authorized by section 5 U.S.C. 5703 for 

persons employed intermittently in 

government service and PHS Act section 

762(g). 

The following information must be 

included in the package of materials 

submitted for each individual 

nominated for consideration: (1) if 

nominated by another individual or 

organization, a letter of nomination from 

the nominator stating the basis for the 

nomination (i.e., what specific 

attributes, perspectives, and/or skills 

does the individual possess that would 

benefit the workings of NACNEP, and 

the nominee’s field(s) of expertise), as 

well as the nominator’s name, 

affiliation, and contact information 

(address, daytime telephone number, 

and email address); (2) letter of interest 

from the applicant stating the reasons 

the applicant would like to serve on 

NACNEP; (3) a biographical sketch of 

the applicant, including the applicant’s 

curriculum vitae and contact 

information (address, daytime telephone 

number, and email address). 

Nomination packages may be submitted 

directly by the applicant or by the 

person/organization nominating the 

candidate. 

HHS endeavors to ensure that the 

membership of NACNEP is balanced 

fairly in terms of points of view 

represented. Appointments shall be 

made without discrimination of age, 

race, ethnicity, gender, sexual 

orientation, or cultural, religious, or 

socioeconomic status. 

Individuals who are selected to be 

considered for appointment will be 

required to provide detailed information 

regarding their financial holdings, 

consultancies, and research grants or 

contracts. Disclosure of this information 

is required for HRSA ethics officials to 

determine whether there is a potential 

conflict of interest between the SGE’s 

public duties as a member of NACNEP 

and their private interests, including an 

appearance of a loss of impartiality as 

defined by federal laws and regulations, 

and to identify any required remedial 

action needed to address the potential 

conflict. 

Authority: NACNEP is authorized by 

section 851 of the PHS Act (42 U.S.C. 

297t), as amended. NACNEP is governed 

by provisions of the Federal Advisory 

Committee Act of 1972 (5 U.S.C. 

Chapter 10). 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–01396 Filed 1–24–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

the Public Health Service (PHS) Act, as 

amended. While the Secretary of HHS is 

named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact Lisa L. Reyes, Clerk of 

Court, United States Court of Federal 

Claims, 717 Madison Place NW, 

Washington, DC 20005, (202) 357–6400. 

For information on HRSA’s role in the 

Program, contact the Director, National 

Vaccine Injury Compensation Program, 

5600 Fishers Lane, Room 08W–25A, 

Rockville, Maryland 20857; (301) 443– 

6593, or visit our website at: https://

www.hrsa.gov/vaccinecompensation/ 

index.html. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 

the United States Court of Federal 

Claims and to serve a copy of the 

petition to the Secretary of HHS, who is 

named as the respondent in each 

proceeding. The Secretary has delegated 

this responsibility under the Program to 

HRSA. The Court is directed by statute 

to appoint special masters who take 

evidence, conduct hearings as 

appropriate, and make initial decisions 


khammond on DSKJM1Z7X2PROD with NOTICES