Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices 1621 

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 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 medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of USPTO may award 

(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 medical device will include all of the 

testing phase and approval phase as 

specified in 35 U.S.C. 156(g)(3)(B). 

FDA has approved for marketing the 

medical device PROACT ADJUSTABLE 

CONTINENCE THERAPY FOR MEN. 

PROACT ADJUSTABLE CONTINENCE 

THERAPY FOR MEN is indicated for 

the treatment of adult men who have 

stress incontinence arising from 

intrinsic sphincter deficiency of at least 

12 months duration following radical 

prostatectomy or transurethral resection 

of the prostate and who have failed to 

respond adequately to conservative 

therapy. Subsequent to this approval, 

the USPTO received patent term 

restoration applications for PROACT 

ADJUSTABLE CONTINENCE THERAPY 

FOR MEN (U.S. Patent Nos. 7,014,606 

and 7,828,716) from Uromedica, Inc., 

and the USPTO requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated November 10, 2016, FDA 

advised the USPTO that this medical 

device had undergone a regulatory 

review period and that the approval of 

PROACT ADJUSTABLE CONTINENCE 

THERAPY FOR MEN 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 

PROACT ADJUSTABLE CONTINENCE 

THERAPY FOR MEN is 3,892 days. Of 

this time, 3,179 days occurred during 

the testing phase of the regulatory 

review period, while 713 days occurred 

during the approval phase. These 

periods of time were derived from the 

following dates: 

1. The date an exemption under 

section 520(g) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

360j(g)) involving this device became 

effective: March 31, 2005. The applicant 

claims that the investigational device 

exemption (IDE) required under section 

520(g) of the FD&C Act for human tests 

to begin became effective on August 29, 

2005. However, FDA records indicate 

that the IDE was determined 

substantially complete for clinical 

studies to have begun on March 31, 

2005, which represents the IDE effective 

date. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the FD&C 

Act (21 U.S.C. 360e): December 12, 

2013. The applicant claims June 19, 

2013, as the date the premarket approval 

application (PMA) for PROACT 

ADJUSTABLE CONTINENCE THERAPY 

FOR MEN (PMA 130018) was initially 

submitted. However, FDA records 

indicate that the PMA as submitted was 

not administratively complete for the 

Agency to undertake a substantive 

review. FDA did not file this application 

and notified the applicant of this fact by 

letter dated September 13, 2013. The 

complete PMA was then submitted on 

December 12, 2013, which is considered 

to be the initially submitted date. 

3. The date the application was 

approved: November 24, 2015. FDA has 

verified the applicant’s claim that PMA 

130018 was approved on November 24, 

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 applications for patent extension, 

this applicant seeks 1,827 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 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00404 Filed 1–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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 on 

Drug Abuse Special Emphasis Panel, Digital 

Markers for Marijuana Intoxication (1218). 

Date: January 30, 2018. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 


sradovich on DSK3GMQ082PROD with NOTICES
1622 Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices 

Contact Person: Julia Berzhanskaya, Ph.D., 

Scientific Review Officer, Office of 

Extramural Policy and Review, Division of 

Extramural Research, National Institute on 

Drug Abuse, NIH, DHHS, 6001 Executive 

Boulevard, Room 4234, MSC 9550, Bethesda, 

MD 20892, 301–827–5840, 

julia.berzhanskaya@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No.: 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health, HHS) 

Dated: January 9, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–00445 Filed 1–11–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Fogarty International Center; 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 Fogarty International 

Center Advisory Board. 

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. 

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/or 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 grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Fogarty 

International Center Advisory Board. 

Date: February 12–13, 2018. 

Place: National Institutes of Health 

Lawton L. Chiles International House 

(Stone House), Building 16, Conference 

Room, 16 Center Drive, Bethesda, MD 

20892. 

Closed Session: February 12, 2018, 

2:00 p.m. to 5:00 p.m. 

Agenda: Second level review of grant 

applications. 

Date: February 13, 2018. 

Place: National Institutes of Health. 

Lawton L. Chiles International House 

(Stone House), Building 16, Conference 

Room, 16 Center Drive, Bethesda, MD 

20892. 

Open Session: February 13, 2018, 9:00 

a.m. to 3:00 p.m. 

Agenda: Update and discussion of 

current and planned FIC activities. 

Contact Person: Kristen Weymouth, 

Executive Secretary, Fogarty 

International Center, National Institutes 

of Health, 31 Center Drive, Room 

B2C02, Bethesda, MD 20892, (301) 496– 

1415, kristen.weymouth@nih.gov. 

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: http://

www.fic.nih.gov/About/Advisory/Pages/ 

default.aspx, where an agenda and any 

additional information for the meeting 

will be posted when available. 

(Catalogue of Federal Domestic 

Assistance Program Nos. 93.106, 

Minority International Research 

Training Grant in the Biomedical and 

Behavioral Sciences; 93.154, Special 

International Postdoctoral Research 

Program in Acquired Immunodeficiency 

Syndrome; 93.168, International 

Cooperative Biodiversity Groups 

Program; 93.934, Fogarty International 

Research Collaboration Award; 93.989, 

Senior International Fellowship Awards 

Program, National Institutes of Health, 

HHS) 

Dated: January 9, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–00440 Filed 1–11–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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 on 

Drug Abuse Special Emphasis Panel, 

Development of Portable Neuromodulatory 

Devices for the Treatment of Substance Use 

Disorders (8941). 

Date: January 17, 2018. 

Time: 12:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: Julia Berzhanskaya, Ph.D., 

Scientific Review Officer, Office of 

Extramural Policy and Review, Division of 

Extramural Research, National Institute on 

Drug Abuse, NIH, DHHS, 6001 Executive 

Boulevard, Room 4234, MSC 9550, Bethesda, 

MD 20892, 301–827–5840, 

julia.berzhanskaya@nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program No.: 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health, HHS) 

Dated: January 9, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–00444 Filed 1–11–18; 8:45 am] 

BILLING CODE 4140–01–P 


sradovich on DSK3GMQ082PROD with NOTICES