75568 Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices 

1Available at http://www.fda.gov/forindustry/

datastandards/studydatastandards/default.htm. 

2For purposes of this guidance, the study start 

date for clinical studies is the earliest date of 

informed consent among any subject that enrolled 

in the study. For example, see Study Start Date (also 

known as the study initiation date) in the SDTM 

Trial Summary Domain (TSPARMCD = SSTDTC). 

For nonclinical studies, the study start date is the 

date on which the study protocol or plan is 

Dated: December 11, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29612 Filed 12–17–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0097] 

Providing Regulatory Submissions in 

Electronic Format—Standardized 

Study Data; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Standardized Study Data.’’ The 

guidance announced in this document 

is being issued in accordance with the 

Food and Drug Administration Safety 

and Innovation Act (FDASIA), which 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) to require 

that certain submissions under the 

FD&C Act and Public Health Service Act 

(PHS Act) be submitted in electronic 

format, beginning no earlier than 24 

months after issuance of final guidance 

on that topic. The guidance describes 

how FDA plans to implement the 

requirements for the electronic 

submission of standardized study data 

contained in certain submissions under 

new drug applications (NDAs), 

abbreviated new drug applications 

(ANDAs), biologics license applications 

(BLAs), and investigational new drug 

applications (INDs). This finalizes the 

revised draft guidance that was issued 

on February 6, 2014. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the documents to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993; or 

the Office of Communication, Outreach 

and Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the documents. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1192, Silver Spring, 

MD 20993–0002, ronald.fitzmartin@

fda.hhs.gov; or Stephen Ripley, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, Bldg. 

71, rm. 7301, Silver Spring, MD 20993, 

stephen.ripley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDASIA (Pub. L. 112–144), signed by 

the President on July 9, 2012, amended 

the FD&C Act to add section 745A, 

entitled ‘‘Electronic Format for 

Submissions.’’ Section 745A(a)(1) of the 

FD&C Act requires that submissions 

under section 505(b), (i), or (j) of the 

FD&C Act (21 U.S.C. 355(b), (i), or (j)) 

and submissions under sections 351(a) 

or (k) of the PHS Act (42 U.S. C. 262(a) 

or (k)) be submitted to FDA in electronic 

format no earlier than 24 months after 

FDA issues final guidance on that topic. 

In accordance with section 745A(a)(1) 

of the FD&C Act, FDA is issuing this 

guidance, announcing its determination 

that the study data contained in the 

submission types identified in this 

guidance must be submitted 

electronically (except for submissions 

that are exempted), in a format that FDA 

can process, review, and archive. 

Currently, the Agency can process, 

review, and archive electronic 

submissions of study data that use the 

standards, formats, and terminologies 

specified in the Data Standards Catalog 1

posted to the FDA’s Study Data 

Standards Resources Web page. 

In the Federal Register of February 6, 

2014 (79 FR 7201), FDA announced the 

availability of the revised draft guidance 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Standardized Study Data.’’ The 

comment period on the revised draft 

guidance ended on May 6, 2014. We 

reviewed all comments received on the 

draft guidance and revised several 

sections of the guidance. The updates 

include: 

Section II.A: (1) Clarified which INDs 

and BLAs are addressed in this 

guidance. Specifically, a footnote was 

added to clarify the meaning of 

‘‘certain’’ in the context of BLAs and 

INDs and states that the guidance is not 

applicable to INDs for devices that are 

regulated by CBER as biological 

products under section 351 of the PHS 

Act and to INDs that are 

noncommercial. Further, the guidance is 

not applicable to those devices that are 

regulated by CBER as biological 

products under section 351 of the PHS 

Act. Examples are provided in this 

regard. (2) Clarified that both clinical 

and nonclinical study data are within 

the scope of the guidance. 

Section II.C: (1) Clarified that the 

Agency may refuse to file an NDA or 

BLA or refuse to receive an ANDA 

containing study data that are not in 

conformance with the required 

standards. (2) Clarified that both the 

Clinical Data Interchange Standards 

Consortium (CDISC) Study Data 

Tabulation Model (SDTM) and Standard 

Exchange for Nonclinical Data (SEND) 

are examples of study data standards for 

tabulations data. (3) Clarified that some 

controlled terminologies are extensible 

and permit additions to existing code 

lists. It is the expectation that sponsors 

or applicants will use the controlled 

terminologies maintained by external 

organizations as the standard. 

Section II.D: Clarified the waiver 

process. 

Section II.E: (1) Clarified that FDA 

recognizes that version updates to 

standards may be released in the 

interval between the start of a study and 

the submission of study data to the 

Agency and the Data Standards Catalog 

may list more than one version of a 

supported standard. (2) Specified the 

definition of study start date for both 

clinical and nonclinical studies. (3) 

Revised terminology to more clearly 

state when a particular requirement 

becomes required. 

This guidance implements the 

electronic submission requirements of 

section 745A(a) of the FD&C Act by 

specifying the format for electronic 

submission of study data contained in 

NDA, ANDA, BLA, and IND 

submissions. With the publication of 

this Federal Register notice of 

availability, all studies with a start 

date 2 24 months or later after the 

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Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices 75569 

approved (signed) by the Study Director. For 

example, see Study Start Date in the SEND Trial 

Summary Domain (TSPARMCD = STSTDTC), 

http://www.cdisc.org. 

Federal Register notice must use the 

appropriate FDA-supported standards, 

formats, and terminologies specified in 

the Data Standards Catalog for NDA, 

ANDA, and certain BLA submissions. 

Study data contained in certain IND 

submissions must use the specified 

formats for electronic submission in 

studies with a start date 36 months or 

later after this Federal Register notice of 

availability. 

In section 745A(a) of the FD&C Act, 

Congress granted explicit authorization 

to FDA to implement the statutory 

electronic submission requirements by 

specifying the format for such 

submissions in guidance. Because this 

guidance provides such requirements 

under section 745A(a) of the FD&C Act, 

indicated by the use of the words must 

or required, it is not subject to the usual 

restrictions in FDA’s good guidance 

practice regulations, such as the 

requirement that guidances not establish 

legally enforceable responsibilities. See 

21 CFR 10.115(d). 

II. Paperwork Reduction Act of 1995 

The guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The guidance 

pertains to sponsors and applicants 

making regulatory submissions to FDA 

in electronic format for NDAs, ANDAs, 

BLAs, and INDs. The information 

collection discussed in the guidance is 

contained in our IND regulations (21 

CFR part 312) and approved under OMB 

control number 0910–0014, our NDA 

regulations (including ANDAs) (21 CFR 

part 314) and approved under OMB 

control number 0910–0001, and our 

BLA regulations (21 CFR part 601) and 

approved under OMB control number 

0910–0338. 

Sponsors and applicants have been 

voluntarily submitting standardized 

study data in electronic format. Under 

FDASIA, sponsors and applicants will 

be required to make all of these 

submissions electronically in 

compliance with the specified 

standards, formats, and terminologies. 

These requirements will be phased in 

over 2- and 3-year periods after the 

issuance of this guidance. 

For many years sponsors and 

applicants have been submitting 

electronically using the electronic 

common technical document format and 

have included electronic study data in 

both legacy and standardized formats. 

For some sponsors and applicants there 

may be new costs, including capital 

costs or operating and maintenance 

costs, which would result from the 

requirements under FDASIA and this 

guidance, because some sponsors and 

applicants would have to change from 

submissions that have included legacy 

(non-standard) study data to 

submissions in compliance with this 

guidance. FDA estimates that for some 

sponsors and applicants the costs may 

be as follows: 

• Data management (hardware/

software): $350,000–$1,000,000 

• Initial data management operations: 

$500,000–$1,000,000 

• Training: $100,000—$250,000 

III. Comments 

Interested persons may submit either 

electronic comments to http://

www.regulations.gov or written 

comments regarding this document to 

the Division of Dockets Management 

(see ADDRESSES). It is only necessary to 

send one set of comments. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday, and will be 

posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://www.fda.

gov/BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, or http://

www.regulations.gov. 

Dated: December 12, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29608 Filed 12–17–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0085] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry: Cooperative Manufacturing 

Arrangements for Licensed Biologics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 20, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0629. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry: Cooperative 

Manufacturing Arrangements for 

Licensed Biologics—(OMB Control 

Number 0910–0629)—Extension 

The guidance document provides 

information concerning cooperative 

manufacturing arrangements applicable 

to biological products subject to 

licensure under section 351 of the 

Public Health Service Act (42 U.S.C. 

262). The guidance addresses several 

types of manufacturing arrangements 

(i.e., short supply arrangements, divided 

manufacturing arrangements, shared 

manufacturing arrangements, and 

contract manufacturing arrangements) 

and describes certain reporting and 

recordkeeping responsibilities, 

associated with these arrangements, 

including the following: (1) Notification 

of all important proposed changes to 

production and facilities; (2) 

notification of results of tests and 

investigations regarding or possibly 

impacting the product; (3) notification 

of products manufactured in a contract 

facility; and (4) standard operating 

procedures. 

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