[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Pages 26057-26058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10539]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Providing Regulatory Submissions in Electronic Format--Certain 
Human Pharmaceutical Product Applications and Related Submissions Using 
the Electronic Common Technical Document Specifications; Guidance for 
Industry; 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 guidance for industry entitled ``Providing Regulatory 
Submissions in Electronic Format--Certain Human Pharmaceutical Product 
Applications and Related Submissions Using the Electronic Common 
Technical Document Specifications.'' The guidance 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 outlines Electronic Common 
Technical Document (eCTD) specification requirements for submissions to 
new drug applications (NDAs), abbreviated new drug applications 
(ANDAs), certain biologics license applications (BLAs), and certain 
investigational new drug applications (INDs).

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 (CDER), 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 (CBER), Food and Drug Administration, 10903 New 
Hampshire Avenue, 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: Virginia Hussong, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993, email: 
[email protected]; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 
7301, Silver Spring, MD 20993, 240-402-7911.

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 (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 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 submission 
types identified in this 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 must be organized and submitted in electronic 
format using eCTD specifications listed in the FDA Data Standards 
Catalog (http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm). For more information concerning how 
the FDA interprets section 745A(a), see the guidance for industry 
``Providing Regulatory Submissions in Electronic Format--Submissions 
Under Section745A(a) of the Federal Food, Drug, and Cosmetic Act'' 
(available at http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/default.htm). The 
eCTD is an International Conference on Harmonization (ICH) format based 
on specifications developed by ICH and its member parties. FDA's CDER 
and 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.
    This guidance finalizes and replaces the previous 2013 draft 
guidance on eCTD specifications. This supersedes 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. This guidance is applicable to all submissions within the scope 
of section 745A(a) of the FD&C Act, i.e., NDAs, ANDAs, certain BLAs, 
and certain INDs and all subsequent submissions, including amendments, 
supplements, and reports, to these submission types. This guidance is 
not applicable to submissions for blood and blood components, including 
Source Plasma.
    In the Federal Register of July 25, 2014 (79 FR 43494), FDA 
announced the availability of the revised draft guidance entitled 
``Providing Regulatory Submissions in Electronic Format--Certain Human 
Pharmaceutical Product Applications and Related Submissions Using the 
Electronic Common Technical Document Specifications.'' The comment 
period on the revised draft guidance ended on September 23, 2014. We 
reviewed all comments received on the draft guidance and revised 
several sections of the guidance. The updates include:
    Section I: Clarified that in addition to this guidance and existing 
technical specifications, more detailed technical instructions will be 
issued in the form of a technical conformance guide.
    Section III.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 FDA considers master files to be submissions to an NDA, 
ANDA, BLA, or IND, and therefore to fall within the scope of 
requirements set forth in section 745A(a). These include new drug 
master files (DMFs) (21 CFR 314.420), new biological product files 
(BPFs) (21 CFR

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601.51), and any amendments to or annual reports on previously 
submitted DMFs or BPFs. This guidance also applies to submissions for 
drug/device combination products filed pursuant to section 505 of the 
FD&C Act or subsection (a) or (k) of section 351 of the PHS Act.
    Section Technical Specification Documents Incorporated by 
Reference: Provides a list of documents incorporated by reference into 
this guidance and provides a complete listing of technical supportive 
files on the FDA eCTD Web page at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm.
    We also received a comment concerning the implementation timeline 
for the Portable Document Format (PDF) technical specification. As 
discussed in the guidance for industry ``Providing Regulatory 
Submissions in Electronic Format--Submissions Under Section 745A(a) of 
the Federal Food, Drug, and Cosmetic Act,'' certain technical 
specifications are required no earlier than 2 years after the final 
guidance is published.
    This guidance implements the electronic submission requirements of 
section 745A(a) of the FD&C Act by specifying the format for electronic 
submissions. All submissions submitted 24 months after the publication 
of this guidance must use the appropriate FDA-supported eCTD 
specifications for NDA, ANDA, and certain BLA submissions. Certain IND 
submissions must use the FDA-supported eCTD specifications for 
electronic submissions submitted 36 months after publication of this 
guidance.
    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

    This 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, INDs, master files, and advertising and promotional labeling. 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 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 this 
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 this guidance, because some 
sponsors and applicants may have to upgrade eCTD specifications and/or 
change their method of submitting information to 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 million
     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://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: April 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10539 Filed 5-5-15; 8:45 am]
 BILLING CODE 4164-01-P