[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Notices]
[Pages 10449-10451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03574]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1216]


Electronic Common Technical Document v4.0 Technical Conformance 
Guide; Food and Drug Administration Electronic Common Technical 
Document v4.0 Module 1 Implementation Package; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
requesting comment on the draft Electronic Common Technical Document 
(eCTD) v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Module 1 
Implementation Package. The eCTD v4.0 Technical Conformance Guide will 
provide specifications, recommendations, and general considerations on 
how to submit eCTD v4.0-based electronic submissions to the Center for 
Drug Evaluation and Research (CDER) or the Center for Biologics 
Evaluation and Research (CBER) using the International Council for 
Harmonisation eCTD v4.0 Implementation Package and the FDA eCTD v4.0 
Module 1 Implementation Package. The Agency is seeking comment on the 
eCTD v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Module 1 
Implementation Package for the accuracy, suitability, and 
appropriateness of these specifications for the submission of eCTD v4.0 
submissions. These versions of the documents are not for 
implementation.

[[Page 10450]]


DATES: Submit either electronic or written comments by April 9, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 9, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 9, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instruction.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-1216 for ``Electronic Common Technical Document (eCTD) v4.0 
Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation 
Package.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. The eCTD v4.0 Technical Conformance 
Guide and FDA eCTD v4.0 Module 1 Implementation Package are available 
on FDA's eCTD v4.0 web page at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm309911.htm.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the eCTD v4.0 
Technical Conformance Guide or FDA eCTD v4.0 Module 1 Implementation 
Package to the Division of Drug Information, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to 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 these documents.

FOR FURTHER INFORMATION CONTACT: Jonathan Resnick, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 3160, Silver Spring, MD 20993-0002, 301-
796-7997; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    The eCTD v4.0 Technical Conformance Guide and the FDA eCTD v4.0 
Module 1 Implementation Package are draft versions of the eCTD standard 
format. FDA will continue to only accept eCTD v3.2.2 submissions until 
eCTD version 4.0 is finalized. Once eCTD v4.0 is finalized, FDA will 
accept both eCTD v3.2.2 and eCTD v4.0 submissions for a lengthy phase-
in period before eventually only accepting eCTD v4.0 submissions. FDA 
is requesting comments on the draft eCTD v4.0 Technical Conformance 
Guide and the FDA eCTD v4.0 Module 1 Implementation Package for eCTD 
v4.0 submissions only. After receiving comments, the Agency will update 
the eCTD v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Module 
1 Implementation Package to facilitate the Agency's future acceptance 
of eCTD v4.0 submissions.
    The eCTD v4.0 Technical Conformance Guide will provide 
specifications, recommendations, and general considerations on how to 
submit eCTD v4.0-based electronic submissions to CDER or CBER when the 
Agency implements eCTD v4.0. The eCTD v4.0 Technical Conformance Guide 
is organized as follows:

[[Page 10451]]

Section 1: Introduction

     Provides information on regulatory policy and guidance 
background, purpose, document control, new features of eCTD v4.0, and 
guidelines for an eCTD v4.0 submission.

Section 2: Submission Contents

     Recommends and provides details on specific topics 
organized by their placement (by module) in the eCTD submission.

Section 3: Combination Products

     Recommends and provides details on device combination 
product information organized by their placement in the eCTD 
submission.

Section 4: Two-Way Communications

     Provides details on the two-way communication process.

Section 5: Rules for Submission Tracking Information

     Provides details on the submission tracking relationships 
for an FDA eCTD submission.
    The FDA eCTD v4.0 Module 1 Implementation Package will provide the 
detailed specifications to create Module 1 of an eCTD v4.0-based 
electronic submission for CDER or CBER. The Implementation Package will 
provide the technical specifications and the necessary components to 
create a valid FDA eCTD v4.0 submission. The Implementation Package 
contains the following components:

FDA eCTD Module 1 Implementation Guide

     The technical specification for the FDA eCTD v4.0 Module 1 
using the Health Level Seven Regulated Product Submission Release 2, 
Normative standard.

FDA Regional Genericode Controlled Vocabulary Files

     Includes region-specific vocabulary and the files intended 
for implementers to use as a computable version of the controlled 
vocabulary content.

FDA Regional Module XML Samples

     Includes samples of M1 eCTD v4.0 xml.

FDA Object Identifiers (OID) Listing

     Provides the OIDs to be used for the FDA Module 1 
controlled vocabulary.

FDA Regional Controlled Vocabulary

     Includes region-specific vocabulary and these files are 
intended as the human readable version of the controlled vocabulary 
content.

FDA Regional Controlled Vocabulary for Transition Mapping Message DTD 
2.01

     Provides a human readable version of the controlled 
vocabulary transition mapping for the transition from Module 1 DTD 
2.01.

FDA Regional Controlled Vocabulary for Transition Mapping Message DTD 
3.3

     Provides a human readable version of the controlled 
vocabulary transition mapping for the transition from Module 1 DTD 3.3.

II. Electronic Access

    Persons with access to the internet may obtain the eCTD v4.0 
Technical Conformance Guide and the FDA eCTD v4.0 Module 1 
Implementation Package at either https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm309911.htm or https://www.regulations.gov.

    Dated: February 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03574 Filed 2-21-20; 8:45 am]
BILLING CODE 4164-01-P


