Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 1365 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

FDA Center/Activity 

Number of respondents 

(investigational 

applications) 

Number of respondents 

(marketing applications) 

Number of responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

OGD 

Original Applications .................... ........................ 1,036 1 ........................ 0.75 (45 minutes) ...... 777 

Bioequivalence Supplements/ 

Amendments.

........................ 698 1 ........................ 0.75 (45 minutes) ...... 524 

Total ...................................... ........................ ........................ ........................ ........................ .................................... 7,175 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: January 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00354 Filed 1–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2016–E–3310 and FDA– 

2016–E–3341] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ENTYCE 

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 ENTYCE 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 animal drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by March 12, 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 10, 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 12, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 12, 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–3310 and FDA–2016–E–3341 

for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; ENTYCE.’’ 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 


srobinson on DSK9F5VC42PROD with NOTICES
1366 Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 

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 

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 animal drug 

products, the testing phase begins on 

the earlier date when either a major 

environmental effects test was initiated 

for the drug or when an exemption 

under section 512(j) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360b(j)) became effective and 

runs until the approval phase begins. 

The approval phase starts with the 

initial submission of an application to 

market the animal 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 an animal 

drug product will include all of the 

testing phase and approval phase as 

specified in 35 U.S.C. 156(g)(4)(B). 

FDA has approved for marketing the 

animal drug product ENTYCE 

(capromorelin). ENTYCE is indicated for 

appetite stimulation in dogs. 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for ENTYCE (U.S. Patent 

Nos. 6,107,306 and 6,673,929) from 

RaQualia Pharma Inc., and the USPTO 

requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

December 1, 2016, FDA advised the 

USPTO that this animal drug product 

had undergone a regulatory review 

period and that the approval of ENTYCE 

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 

ENTYCE is 1,645 days. Of this time, 

1,589 days occurred during the testing 

phase of the regulatory review period, 

while 56 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 FD&C Act (21 

U.S.C. 355(i)) became effective: 

November 16, 2011. The applicant 

claims December 5, 2002, as the date the 

investigational new animal drug 

application (INAD) became effective. 

However, FDA records indicate that the 

INAD effective date was November 16, 

2011, which was the date a major health 

or environmental effects test is begun or 

the date on which the Agency 

acknowledges the filing of a notice of 

claimed investigational exemption for a 

new animal drug, whichever is earlier. 

2. The date the application was 

initially submitted with respect to the 

animal drug product under section 512 

of the FD&C Act (21 U.S.C. 360b): March 

22, 2016. The applicant claims March 

21, 2016, as the date the new animal 

drug application (NADA) for ENTYCE 

(NADA 141–457) was initially 

submitted. However, FDA records 

indicate that NADA 141–457 was 

submitted on March 22, 2016. 

3. The date the application was 

approved: May 16, 2016. FDA has 

verified the applicant’s claim that 

NADA 141–457 was approved on May 

16, 2016. 

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 1,826 and 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 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00358 Filed 1–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2015–E–2657, FDA– 

2015–E–2658, FDA–2015–E–2659, and FDA– 

2015–E–2891] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; EPANOVA 

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 EPANOVA and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 


srobinson on DSK9F5VC42PROD with NOTICES