41276 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 

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(b) of the FD&C Act: April 30, 2013. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

KENGREAL (NDA 204958) was initially 

submitted on April 30, 2013. 

3. The date the application was 

approved: June 22, 2015. FDA has 

verified the applicant’s claim that NDA 

204958 was approved on June 22, 2015. 

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 5 years 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 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 21 

CFR 60.30, including but not limited to: 

Must be timely (see DATES), must be 

filed in accordance with 21 CFR 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: August 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18380 Filed 8–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

CDC/HRSA Advisory Committee on 

HIV, Viral Hepatitis and STD Prevention 

and Treatment 

AGENCY: Health Resources and Service 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, notice 

is hereby given that a meeting is 

scheduled for the Centers for Disease 

Control and Prevention (CDC)/HRSA 

Advisory Committee on HIV, Viral 

Hepatitis and STD Prevention and 

Treatment. This meeting will be open to 

the public. Information about the CDC/ 

HRSA Advisory Committee on HIV, 

Viral Hepatitis and STD Prevention and 

Treatment and the agenda for this 

meeting can be obtained by contacting 

CDR Holly Berilla at (301) 443–9965 or 

hberilla@hrsa.gov. 

DATES: October 25, 2017, 9:00 a.m. to 

5:30 p.m. (Eastern) and October 26, 

2017, 9:00 a.m. to 4:15 p.m. (Eastern). 

ADDRESSES: This meeting will be held in 

person and offer virtual access through 

teleconference and Adobe Connect. The 

address for the meeting is 5600 Fishers 

Lane, Pavilion, Rockville, Maryland 

20857. The conference call-in number is 

(888) 469–0566 and passcode is 

6012320. The webinar link is https://

hrsa.connectsolutions.com/october_

chac_meeting/. 

FOR FURTHER INFORMATION CONTACT: 

Those requesting information regarding 

the CDC/HRSA Advisory Committee on 

HIV, Viral Hepatitis and STD Prevention 

and Treatment should contact CDR 

Holly Berilla, Senior Public Health 

Analyst, Division of Policy and Data 

(DPD), HIV/AIDS Bureau (HAB), HRSA, 

in one of three ways: (1) Mail a request 

to CDR Holly Berilla, Senior Public 

Health Analyst, HRSA/HAB/DPD, 5600 

Fishers Lane, 9N164C, Rockville, 

Maryland 20857; (2) call (301) 443– 

9965; or (3) send an email to hberilla@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: The CDC/ 

HRSA Advisory Committee on HIV, 

Viral Hepatitis and STD Prevention and 

Treatment was established under 

Section 222 of the Public Health Service 

Act, [42 U.S.C. Section 217a], as 

amended. 

The purpose of the CDC/HRSA 

Advisory Committee on HIV, Viral 

Hepatitis and STD Prevention and 

Treatment is to advise the Secretary of 

HHS, the Director of CDC, and the 

Administrator of HRSA regarding 

objectives, strategies, policies, and 

priorities for HIV, viral hepatitis, and 

other STDs; prevention and treatment 

efforts including surveillance of HIV 

infection, AIDS, viral hepatitis and 

other STDs, and related behaviors; 

epidemiologic, behavioral, health 

services, and laboratory research on 

HIV/AIDS, viral hepatitis, and other 

STDs; identification of policy issues 

related to HIV/viral hepatitis/STD 

professional education, patient 

healthcare delivery, and prevention 

services; HHS policies about prevention 

of HIV/AIDS, viral hepatitis and other 

STDs; treatment, healthcare delivery, 

and research and training; strategic 

issues influencing the ability of CDC 

and HRSA to fulfill their missions of 

providing prevention and treatment 

services; programmatic efforts to 

prevent and treat HIV, viral hepatitis, 

and other STDs; and support to CDC 

and HRSA in their development of 

responses to emerging health needs 

related to HIV, viral hepatitis, and other 

STDs. 

During the October 25 to 26, 2017, 

meeting, the CDC/HRSA Advisory 

Committee on HIV, Viral Hepatitis and 

STD Prevention and Treatment will 

discuss strategies to link, retain, and reengage people living with HIV into the 

Ryan White HIV/AIDS Program system 

of care; HAB’s benchmarking and risk 

adjustment initiatives; HRSA and CDC 

initiatives regarding congenital syphilis; 

and committee workgroup reports. 

Agenda items are subject to change as 

priorities dictate. 

Members of the public will have the 

opportunity to provide comments. Oral 

comments will be honored in the order 

they are requested and may be limited 

as time allows. Requests to make oral 

comments or provide written comments 

to the CDC/HRSA Advisory Committee 

on HIV, Viral Hepatitis and STD 

Prevention and Treatment should be 

sent to CDR Holly Berilla, using the 

contact information listed above, by 

October 11, 2017. 

The building at 5600 Fishers Lane, 

Rockville, MD 20857, requires a security 

screening on entry. To facilitate your 

access to the building please contact 

CDR Holly Berilla (contact information 

provided above). Individuals who plan 

to attend and need special assistance, 

such as sign language interpretation or 

other reasonable accommodations, 

should notify CDR Holly Berilla (contact 

information provided above) at least 10 

days prior to the meeting. 

mstockstill on DSK30JT082PROD with NOTICES

Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41277 

Status: This advisory committee 

meeting will be open to the public. 

Amy McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2017–18426 Filed 8–29–17; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Heart, Lung, 

and Blood Advisory Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: National Heart, Lung, 

and Blood Advisory Council. 

Date: September 12, 2017. 

Closed: 8:00 a.m. to 12:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Open: 2:30 p.m. to 4:30 p.m. 

Agenda: To discuss program policies and 

issues. 

Place: National Institutes of Health, 

Building 35A, Porter Building, Room 640, 

35A Convent Drive, Bethesda, MD 20892. 

Contact Person: Laura K. Moen, Ph.D., 

Director, Division of Extramural Research 

Activities, National Heart, Lung, and Blood 

Institute, National Institutes of Health, 6701 

Rockledge Drive, Room 7100, Bethesda, MD 

20892, 301–435–0260, moenl@mail.nih.gov. 

This notice is being amended to reflect 

changes in open and closed sessions. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: 

www.nhlbi.nih.gov/meetings/nhlbac/ 

index.htm, where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: August 24, 2017. 

Jennifer S, Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–18340 Filed 8–29–17; 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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, 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 NIAID Peer Review Meeting, 

Date: September 27, 2017. 

Time: 12:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Kelly Y. Poe, Ph.D., 

Scientific Review Program, Division of 

Extramural Activities, Room 3F40B, National 

Institutes of Health, NIAID, 5601 Fishers 

Lane, MSC 9823, Bethesda, MD 20892–9823, 

(240) 669–5036,poeky@mail.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: August 24, 2017. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–18337 Filed 8–29–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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: Center for Scientific 

Review, Special Emphasis Panel; PAR17– 

033: Integrative Research to Understand the 

Impact of Sex Differences on the Molecular 

Determinants of AD Risk and Responsiveness 

to Treatment. 

Date: September 25, 2017. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Alexei Kondratyev, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5200, 

MSC 7846, Bethesda, MD 20892, 301–435– 

1785, kondratyevad@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review, Special Emphasis Panel; PAR15– 

357: Understanding Alzheimer’s Disease in 

the Context of the Aging Brain. 

Date: September 25, 2017. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Alexei Kondratyev, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5200, 

MSC 7846, Bethesda, MD 20892, 301–435– 

1785, kondratyevad@csr.nih.gov. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group; Pathophysiological Basis of Mental 

Disorders and Addictions Study Section. 

Date: September 28–29, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Wyndham Grand Chicago 

Riverfront, 71 East Wacker Drive, Chicago, IL 

60601. 

Contact Person: Boris P Sokolov, Ph.D., 

Scientific Review Officer, Center for 

mstockstill on DSK30JT082PROD with NOTICES