Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 39587 

structure in order to (1) improve the 

measurement of covered health topics, 

(2) reduce respondent burden by 

shortening the length of the 

questionnaire and seamlessly 

integrating supplements, (3) harmonize 

overlapping content with other federal 

health surveys, (4) establish a long-term 

structure of ongoing and periodic topics, 

and (5) incorporate advances in survey 

methodology and measurement. 

As in past years, and in accordance 

with the 1995 initiative to increase the 

integration of surveys within the DHHS, 

respondents to the 2018 NHIS will serve 

as the sampling frame for the Medical 

Expenditure Panel Survey. In addition, 

a subsample of NHIS respondents and/ 

or members of commercial survey 

panels may be identified to participate 

in short, Web-based methodological and 

cognitive testing activities to evaluate 

the redesigned questionnaire and/or 

inform the development of new rotating 

and supplemental content using Web 

and/or mail survey tools. 

There is no cost to the respondents 

other than their time. Clearance is 

sought for three years, to collect data for 

2018–2020. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Adult Household Member ................. Main Household Composition and 

Family Core.

39,375 1 23/60 15,094 

Sample Adult ..................................... Main Adult Core ............................... 31,500 1 15/60 7,875 

Adult Family Member ........................ Main Child Core ............................... 12,250 1 10/60 2,042 

Adult Family Member ........................ Main Supplements ........................... 45,000 1 20/60 15,000 

Adult Household Member ................. Redesigned Family Core ................. 5,625 1 23/60 2,156 

Sample Adult ..................................... Redesigned Adult Core .................... 4,500 1 15/60 1,125 

Adult Family Member ........................ Redesigned Child Core .................... 1,750 1 10/60 292 

Adult Family Member ........................ Methodological Projects ................... 15,000 1 20/60 5,000 

Adult Family Member ........................ Reinterview Survey .......................... 5,000 1 5/60 417 

Total ........................................... ........................................................... ........................ ........................ ........................ 49,000 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–17582 Filed 8–18–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2013–E–0264; FDA– 

2013–E–0263; and FDA–2013–E–0218] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; RECUVYRA 

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 RECUVYRA 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 (in the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by October 20, 2017. 

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 

February 20, 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 October 20, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 20, 2017. 

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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
39588 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket Nos. FDA– 

2013–E–0264; FDA–2013–E–0263; and 

FDA–2013–E–0218 for ‘‘Determination 

of Regulatory Review Period for 

Purposes of Patent Extension; 

RECUVYRA.’’ 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 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 

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 (the 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 RECUVYRA 

(fentanyl). RECUVYRA is indicated for 

the control of postoperative pain 

associated with surgical procedures in 

dogs. Subsequent to this approval, the 

USPTO received patent term restoration 

applications for RECUVYRA (U.S. 

Patent Nos. 6,299,900; 6,818,226; and 

6,916,486) from Acrux DDS Pty. Ltd., 

and the USPTO requested FDA’s 

assistance in determining the patents’ 

eligibility for patent term restoration. In 

a letter dated April 26, 2016, FDA 

advised the USPTO that this animal 

drug product had undergone a 

regulatory review period and that the 

approval of RECUVYRA 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 

RECUVYRA is 2,092 days. Of this time, 

2,037 days occurred during the testing 

phase of the regulatory review period, 

while 55 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: October 

3, 2006. The applicant claims August 

31, 2005, as the date the investigational 

new animal drug application (INAD) 

became effective. However, FDA records 

indicate that the INAD effective date 

was October 3, 2006, which was the 

date a major health or environmental 

effects test began. 

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): April 

30, 2012. The applicant claims April 18, 

2012, as the date the new animal drug 

application (NADA) for RECUVYRA 

(NADA 141–337) was initially 

submitted. However, FDA records 

indicate that NADA 141–337 was 

submitted on April 30, 2012. 

3. The date the application was 

approved: June 23, 2012. FDA has 

verified the applicant’s claim that 

NADA 141–337 was approved on June 

23, 2012. 

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 1,279 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 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 be 

timely (see DATES) and contain sufficient 

facts to merit an FDA investigation. (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. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 39589 

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 15, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17566 Filed 8–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–2363] 

Electronic Study Data Submission; 

Data Standards; Support for Standard 

for Exchange of Nonclinical Data 

Implementation Guide Version 3.1 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Drug Evaluation and Research 

(CDER) is announcing support for the 

3.1 version of Clinical Data Interchange 

Standards Consortium (CDISC) Standard 

for Exchange of Nonclinical Data (SEND 

IG 3.1), the end of support for the 3.0 

version of SEND IG, and an update to 

the FDA Data Standards Catalog 

(Catalog). (See http://www.fda.gov/ 

forindustry/datastandards/ 

studydatastandards/default.htm.) SEND 

IG 3.1 has been available from CDISC 

(www.cdisc.org) since July 2016. FDA is 

encouraging sponsors and applicants to 

use SEND IG 3.1 in investigational study 

data provided in regulatory submissions 

to CDER. 

FOR FURTHER INFORMATION CONTACT: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1115, Silver Spring, 

MD 20993–0002, 301–796–5333, email: 

CDERDataStandards@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 17, 2014, FDA 

published final guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Standardized Study Data’’ (eStudy 

Data), posted on FDA’s Study Data 

Standards Resources Web page at 

https://www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm. The eStudy Data guidance 

implements the electronic submission 

requirements of section 745A(a) of the 

Food, Drug and Cosmetic Act (21 U.S.C. 

379k–1(a)) for study data contained in 

new drug applications (NDAs), 

abbreviated new drug applications 

(ANDAs), biologics license applications 

(BLAs), and investigational new drug 

applications (INDs) to FDA’s Center for 

Biologics Evaluation and Research or 

CDER by specifying the format for 

electronic submissions. The initial 

timetable for implementing electronic 

submission requirements for study data 

was December 17, 2016 (24 months after 

issuance of final guidance for NDAs, 

BLAs, ANDAs, and 36 months for INDs). 

The eStudy Data guidance states that a 

Federal Register notice will specify the 

transition date for all version updates 

(with the month and day for the 

transition date corresponding to March 

15). 

The transition date for support of 

version 3.1 of CDISC SEND IG is March 

15, 2018. Although SEND IG version 3.1 

is supported as of this Federal Register 

notice and sponsors or applicants are 

encouraged to begin using it, the new 

version will only be required in 

submissions for studies that start after 

March 15, 2019. The Catalog will list 

March 15, 2019, as the ‘‘date 

requirement begins.’’ When multiple 

versions of an FDA-supported standard 

are listed in the Catalog, sponsors or 

applicants can select a version to use. 

The transition date for the end of FDA 

support for SEND IG 3.0 is March 15, 

2018. Therefore, FDA support for SEND 

IG 3.0 will end for studies that start after 

March 15, 2019. The Catalog will be 

updated to list March 15, 2019, as the 

‘‘date support ends.’’ 

II. Electronic Access 

Persons with access to the Internet 

may obtain the referenced material at 

https://www.fda.gov/ectd. 

Dated: August 15, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17567 Filed 8–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–1956] 

Identifying Trading Partners Under the 

Drug Supply Chain Security Act; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Identifying Trading Partners Under the 

Drug Supply Chain Security Act’’ (draft 

trading partner guidance). FDA is 

issuing this guidance to assist industry 

and State and local governments in 

understanding how to categorize the 

entities in the drug supply chain in 

accordance with the Drug Supply Chain 

Security Act (DSCSA). This guidance 

explains how to determine when certain 

statutory requirements will apply to 

entities that may be considered trading 

partners in the drug supply chain. FDA 

is also soliciting public input specific to 

the activities of ‘‘private-label 

distributors’’ of drug products and 

whether those activities fall within the 

definitions under DSCSA of the various 

trading partners. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by October 20, 

2017. 

ADDRESSES: You may submit comments 

as follows: 

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’’). 


asabaliauskas on DSKBBXCHB2PROD with NOTICES