[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Notices]
[Pages 43494-43496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17588]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1006]


Revised Draft Guidance for Industry on Providing Regulatory 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 or Agency) is announcing 
the availability of a revised draft guidance for industry entitled 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 The draft guidance announced in this notice is 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 (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 the final version of the guidance on that topic. The draft guidance 
outlines Electronic Common Technical Document (eCTD) specification 
requirements for 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 This draft guidance revises and 
replaces a previous draft guidance entitled ``Providing Regulatory 
Submissions in Electronic Format--Certain Human Pharmaceutical Product 
Applications and Related Submissions Using the eCTD Specifications'' 
that was issued in January 2013 (2013 draft guidance on eCTD 
Specifications). When finalized, this revised draft guidance will 
supersede the guidance for industry entitled ``Providing Regulatory 
Submissions in Electronic Format--Human Pharmaceutical Product 
Applications and Related Submissions Using the eCTD Specifications'' 
that was issued in 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 September 23, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance 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, Center for 
Biologics Evaluation and Research, 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 draft guidance.
    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, Food and Drug Administration, 10903 New

[[Page 43495]]

Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Certain Human Pharmaceutical Product Applications and Related 
Submissions Using the eCTD Specifications.'' FDASIA (Public Law 112-
144), signed by the President on July 9, 2012, amended the FD&C Act to 
add section 745A (21 U.S.C.379k-1) 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 section 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 
submission types identified in this draft guidance must be submitted 
electronically (except for submissions that are exempted), in the 
format specified in this guidance.
    This guidance (and the technical specification documents it 
incorporates by reference) describes how submissions under section 
745A(a) of the FD&C Act \1\ must be organized and submitted in 
electronic format using eCTD specifications version 3.2.2. The eCTD is 
an International Conference on Harmonization (ICH) format based on 
specifications 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 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.
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    \1\ For more information concerning how the FDA interprets 
section 745(a), see the draft guidance for industry ``Providing 
Regulatory Submissions in Electronic Format--Submissions Under 
Section 745A(a) of the Federal Food, Drug, and Cosmetic Act'' 
(available at http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/default.htm).
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    This guidance revises and replaces the previous 2013 draft guidance 
on eCTD specifications. This revised version of the draft guidance, 
when finalized, will supersede the guidance for industry titled 
``Providing Regulatory Submissions in Electronic Format--Human 
Pharmaceutical Product Applications and Related Submissions Using the 
eCTD Specifications'' that was issued in June 2008. This revised draft 
guidance, when finalized, will be applicable to all submissions within 
the scope of section 745A(a) of the FD&C Act, i.e., certain NDAs, 
ANDAs, BLAs, and INDs and all subsequent submissions, including 
amendments, supplements, and reports, to these submission types.\2\
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    \2\ See id.
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    In general, this revised draft guidance contains the following 
changes from the previous 2013 draft guidance on eCTD specifications:
     It is now explicit that certain master files are within 
the scope of section 745A(a) of the FD&C Act.
     Similarly, it is now explicit that advertising and 
promotional labeling materials are also within the scope of section 
745A(a) of the FD&C Act.
     Use of the FDA Electronic Submissions Gateway (ESG) will 
be required.
     Use of FDA fillable forms will be required with all eCTD 
submissions.
     Specified file formats and software versions will be 
required for submissions filed with the FDA.
    After publication of the Federal Register notice of availability of 
the final version of the guidance, all submissions with a filing date 
24 months after the Federal Register notice must use the appropriate 
FDA-supported eCTD specifications for certain NDA, ANDA, and BLA 
submissions. IND submissions must use the FDA-supported eCTD 
specifications for electronic submissions filed 36 months after the 
Federal Register notice of availability is published.
    In section 745A(a) of the FD&C Act, Congress granted explicit 
authorization to FDA to implement the statutory electronic submission 
requirements by specifying in a guidance document the format for the 
submissions. Accordingly, to the extent that this draft guidance 
provides the 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, 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, 
INDs, and master files electronically since 2003, and the majority of 
these submissions are already received in electronic format. Under 
section 745A(a) of the FD&C Act, sponsors and applicants are required 
to file most of these submissions electronically. These requirements 
will be phased in over 2- and 3-year periods after the issuance of the 
final version of the guidance.
    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 version of the 
guidance, because some sponsors and applicants may have to upgrade eCTD 
specifications and/or change their method of submitting information to 
the FDA. FDA estimates that for some sponsors and applicants the costs 
may be as follows:
     eCTD Publishing Software: $25,000 to $150,000;
     Publishing Operations Support: $50,000 to $1,000,000; and
     Training: $5,000 to $50,000.

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 
http://

[[Page 43496]]

www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: July 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17588 Filed 7-24-14; 8:45 am]
BILLING CODE 4164-01-P