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’’). 


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