[Federal Register Volume 78, Number 2 (Thursday, January 3, 2013)]
[Notices]
[Pages 310-311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-31577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1256]


Draft Revision of Guidance for Industry on Providing Regulatory 
Submissions in Electronic Format--Certain Human Pharmaceutical Product 
Applications and Related Submissions Using the Electronic Common 
Technical Document Specifications; 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availability of draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Certain Human 
Pharmaceutical Product Applications and Related Submissions Using the 
eCTD Specifications.'' The draft guidance announced in this notice is 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 2 years after publication 
of the final version of the draft guidance. The draft guidance 
describes how FDA plans to implement the requirements for the 
electronic submission of applications for certain human pharmaceutical 
products and is being issued for public comment. In its final form, 
this document will also supersede the guidance titled ``Guidance for 
Industry Providing Regulatory Submissions in Electronic Format--Human 
Pharmaceutical Product Applications and Related Submissions Using the 
eCTD Specifications'' that was issued in October 2005 and revised in 
April 2006 and June 2008.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 4, 2013.

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: 
Virginia Hussong, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1161, 
Silver Spring, MD 20993, email: [email protected];

or

Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    The electronic Common Technical Document (eCTD) is an International 
Conference on Harmonisation (ICH) standard based on specifications

[[Page 311]]

developed by ICH and its member parties. FDA's Center for Drug 
Evaluation and Research (CDER) and Center for Biologics Evaluation and 
Research (CBER) have been receiving submissions in the eCTD format 
since 2003, and the eCTD has been the recommended format for electronic 
submissions to CDER and CBER since January 1, 2008. The majority of new 
electronic submissions are now received in eCTD format.
    FDASIA (Pub. L. 112-144, 126 Stat. 993 (2012)), signed by the 
President on July 9, 2012, amended the FD&C Act to add section 745A, 
titled ``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, and submissions under sections 351(a) or (k) of the PHS 
Act, be submitted to FDA in electronic format no earlier than 24 months 
after FDA issues the final guidance described in this section.
    In accordance with section 745A(a)(1) of the FD&C Act, FDA is 
issuing this draft guidance, announcing its determination that 
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 made using the eCTD 
version 3.2.2 specifications. Requirements for electronic submission 
will be phased in according to the following schedule: (1) 24 months 
after publication of the final version of this draft revised guidance, 
the requirements will apply to new drug application (NDA), abbreviated 
new drug application (ANDA), and biologics license application (BLA) 
submissions and (2) 36 months after publication of the final guidance, 
the requirements will apply to investigational new drug application 
(IND) submissions. Section 745A(a) of the FD&C Act does not apply to 
master files and advertising and promotional labeling submissions. 
However, FDA accepts and strongly encourages the submission of master 
files and advertising and promotional labeling materials 
electronically, as described in the draft guidance.
    In Section 745A(a), Congress granted explicit authorization to FDA 
to implement the statutory electronic submission requirements by 
specifying the format for such submissions in guidance. To the extent 
that the 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 (GGP) regulations, such as the requirement that 
guidances not establish legally enforceable responsibilities. See 21 
CFR 10.115(d).
    At the same time, the draft guidance also provides guidance on 
FDA's interpretation of the statutory electronic submission requirement 
and the Agency's current thinking on the best means for implementing 
other aspects of the electronic submission program. Therefore, to the 
extent that the draft guidance includes provisions that are not part of 
the requirements under section 745A(a), it is being issued in 
accordance with FDA's GGP regulation (21 CFR 10.115). Such parts of the 
draft guidance, when finalized, will represent the Agency's current 
thinking on this topic, and do not create or confer any rights for or 
on any person and do not operate to bind FDA or the public. You can use 
an alternative approach for these recommendations if such an approach 
would satisfy the requirements of the applicable statutes and 
regulations. The use of the word should in the draft guidance means 
that something is suggested or recommended, but not required. 
Accordingly, the final guidance will contain both binding and 
nonbinding provisions.

II. Paperwork Reduction Act of 1995

    The draft guidance refers to collections of information that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (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, INDs, master files, and advertising and promotional labeling. 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 submitting NDAs, ANDAs, BLAs, and 
INDs electronically since 2003, and the majority of these submissions 
are already received in electronic format. Under FDASIA, sponsors and 
applicants will be required to make all of these submissions 
electronically. These requirements will be phased in over 2 and 3 year 
periods after the issuance of the final guidance.
    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 convert from paper-based submissions to electronic 
submissions. In accordance with the PRA, prior to publication of the 
final guidance document, FDA intends to solicit public comment and 
obtain OMB approval for any costs that are new or that would represent 
material modifications to these previously approved collections of 
information found in FDA regulations.

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/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm, http://www.regulations.gov, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm, http://www.regulations.gov, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: December 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31577 Filed 12-31-12; 8:45 am]
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