80 FR 60389 - Electronic Common Technical Document Technical Conformance Guide; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 193 (October 6, 2015)

The Food and Drug Administration (FDA) is announcing the availability of an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Version 1.0. The eCTD Technical Conformance Guide supplements the guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specification'' and provides specifications, recommendations, and general considerations on how to submit eCTD-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60389-60390]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25353]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3390]


Electronic Common Technical Document Technical Conformance Guide; 
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 an Electronic Common Technical Document (eCTD) 
Technical Conformance Guide, Version 1.0. The eCTD Technical 
Conformance Guide supplements the guidance for industry entitled 
``Providing Regulatory Submissions in Electronic Format--Certain Human 
Pharmaceutical Product Applications and Related Submissions Using the 
eCTD Specification'' and provides specifications, recommendations, and 
general considerations on how to submit eCTD-based electronic 
submissions to the Center for Drug Evaluation and Research (CDER) or 
the Center for Biologics Evaluation and Research (CBER).

DATES: Although you can comment on this notice at any time, to ensure 
that the Agency considers your comments, submit either electronic or 
written comments by November 20, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-3390 for ``Electronic Common Technical Document Technical 
Conformance Guide.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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, Center for Biologics Evaluation and Research, 
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.

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, 
[email protected]; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, Bldg.

[[Page 60390]]

71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of an eCTD Technical Conformance 
Guide, Version 1.0. The eCTD Technical Conformance Guide supplements 
the final guidance for industry ``Providing Regulatory Submissions in 
Electronic Format--Certain Human Pharmaceutical Product Applications 
and Related Submissions Using the eCTD Specification'' (eCTD Guidance) 
and provides specifications, recommendations, and general 
considerations on how to submit eCTD-based electronic submission to 
CDER or CBER. The eCTD guidance will implement the electronic 
submission requirements of section 745A(a) of the Food, Drug & Cosmetic 
Act with respect to electronic submissions for certain investigational 
new drug applications (INDs); new drug applications (NDAs); abbreviated 
new drug applications(ANDAs); certain biologics license 
applications(BLAs); and Master Files that are submitted to the CDER or 
CBER.
    The Guide provides specifications, recommendations, and general 
considerations on how to submit eCTD-based electronic submissions to 
CDER or CBER and is intended to complement and promote interactions 
between sponsors and applicants and FDA's review divisions. It is not 
intended to replace the need for sponsors and applicants to communicate 
directly with review divisions regarding their eCTD-based submissions. 
The Guide is organized as follows:
     Section 1: Introduction--provides information on 
regulatory policy and guidance background, purpose, and document 
control.
     Section 2: General Considerations--recommends and provides 
general details on preparing an eCTD submission.
     Section 3: Organization of the eCTD--presents specific 
topics organized by their placement (by module) in the eCTD submission.
     Section 4: Issues and Solutions--presents instructions for 
correcting common problems seen in eCTD submissions.

II. Electronic Access

    Persons with access to the Internet may obtain the Guide at either 
http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm or http://www.regulations.gov.

    Dated: September 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25353 Filed 10-5-15; 8:45 am]
 BILLING CODE 4164-01-P