[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7201-7203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02555]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0097]


Revised Draft Guidance for Industry on Providing Regulatory 
Submissions in Electronic Format--Standardized Study Data; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised draft guidance for industry entitled 
``Providing

[[Page 7202]]

Regulatory Submissions in Electronic Format--Standardized Study Data.'' 
The draft guidance announced in this notice is being issued in 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 The draft guidance describes how FDA plans to 
implement the requirements for the electronic submission of 
standardized study data contained in certain submissions to new drug 
applications (NDAs), abbreviated new drug applications (ANDAs), 
biologics license applications (BLAs), and investigational new drug 
applications (INDs) and is being issued for public comment. This 
document supersedes the guidance entitled ``Providing Regulatory 
Submissions in Electronic Format--Standardized Study Data'' that was 
issued in February 2012.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 7, 2014. Submit either electronic or written comments 
concerning the collection of information by April 7, 2014.

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, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002 or the Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448. 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 draft 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. 1160, Silver Spring, MD 20993, 
[email protected]; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852, 301-827-6210.

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 draft guidance, announcing its determination that the 
study data contained in the submission types identified in this draft 
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 Study Data Standards Catalog \1\ posted 
to FDA's Study Data Standards Resources Web page.
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    \1\ Available at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.
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    This revised draft guidance on standardized study data will 
supersede the draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Standardized Study Data'' 
that was issued in February 2012. When finalized, 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. After 
publication of the Federal Register notice of availability of the final 
guidance, all studies with a start date \2\ 24 months after the 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 after the Federal 
Register notice of availability.
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    \2\ For purposes of this guidance, the study start date is the 
earliest date of informed consent among any subject that enrolled in 
the study. For example, see Study Start Date in the SDTM Trial 
Summary Domain (TSPARMCD = SSTDTC), http://www.cdisc.org.
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    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 draft 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 draft 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 draft 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 draft 
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 the final 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 the final guidance, 
because some sponsors and applicants would have to change from 
submissions that have included

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legacy (non-standard) study data to submissions in compliance with the 
final 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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02555 Filed 2-5-14; 8:45 am]
BILLING CODE 4160-01-P