1620 Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. This draft 

guidance is not subject to Executive 

Order 12866. 

Based on public interest in the draft 

guidance, FDA is extending the 

comment period for the notice of 

availability for 30 days, until February 

28, 2018. The Agency believes that a 30- 

day extension allows adequate time for 

interested persons to submit comments 

without significantly delaying guidance 

on these important issues. 

Dated: January 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00418 Filed 1–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2016–E–2516 and FDA– 

2016–E–2514] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; PROACT ADJUSTABLE 

CONTINENCE THERAPY FOR MEN 

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 PROACT ADJUSTABLE 

CONTINENCE THERAPY FOR MEN 

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 a 

patent which claims that medical 

device. 

DATES: Anyone with knowledge that any 

of the dates as published (in the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by March 13, 2018. 

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 

July 11, 2018. 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. Electronic comments must 

be submitted on or before March 13, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 13, 2018. 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 

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– 

2016–E–2516 and FDA–2016–E–2514 

for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; PROACT ADJUSTABLE 

CONTINENCE THERAPY FOR MEN.’’ 

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. 

• 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.gpo.gov/ 

fdsys/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. 

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 


sradovich on DSK3GMQ082PROD with NOTICES
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