
[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)]
[Notices]
[Pages 41416-41417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4565]


Electronic Study Data Submission; Data Standards; Support for 
Version Update of the Medical Dictionary for Regulatory Activities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
support for the most current version of Medical Dictionary for 
Regulatory Activities (MedDRA), end of support for earlier versions of 
MedDRA, and an update to the FDA Data Standards Catalog (Catalog) for 
study data provided in new drug applications (NDAs), abbreviated new 
drug applications (ANDAs), biologics license applications (BLAs), and 
investigational new drug applications (INDs) to the Center for 
Biologics Evaluation and Research (CBER) and the Center for Drug 
Evaluation and Research (CDER).

DATES: Submit either electronic or written comments on this document at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submission

    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 ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-4565 for ``Electronic Study Data Submission; Data Standards; 
Support for Version Update of the Medical Dictionary for Regulatory 
Activities.'' Received comments 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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1115, Silver Spring, MD 20993-0002, 301-
796-5333, cderdatastandards@fda.hhs.gov; or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 
240-402-7911, stephen.ripley@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On December 17, 2014, FDA published final 
guidance for industry ``Providing Regulatory Submissions in Electronic 
Format--Standardized Study Data'' (eStudy Data) posted on FDA's Study 
Data Standards Resources Web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The eStudy Data guidance

[[Page 41417]]

implements the electronic submission requirements of section 745A(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379k-1(a)) for 
study data contained in NDAs, ANDAs, BLAs, and INDs to CBER or CDER by 
specifying the format for electronic submissions. This provision 
required that the electronic format for submission of applications be 
specified in guidance and effective no sooner than 24 months after 
issuance of the final guidance. The initial timetable for the 
implementation of electronic submission requirements for study data is 
December 17, 2016 (24 months after issuance of final guidance for NDAs, 
BLAs, ANDAs, and 36 months for INDs). The eStudy Data guidance states 
that a Federal Register notice will specify the transition date for all 
version updates (with the month and day for the transition date 
corresponding to March 15).
    FDA currently supports and requires MedDRA for the coding of 
adverse events in studies submitted to FDA's CBER or CDER in NDAs, 
ANDAs, BLAs, and INDs in the electronic common technical document 
(eCTD) format. However, the requirement to code adverse events using 
MedDRA in the most current version (available at https://www.meddra.org) does not apply to postmarketing studies that are 
submitted in eCTD sections 5.3.5.4 and 5.3.6 (https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163175.pdf).
    Generally, the studies included in a submission are conducted over 
many years and may have used different MedDRA versions to code adverse 
events. The expectation is that sponsors or applicants will use the 
most current version of MedDRA at the time of study start. However, 
there is no requirement to recode earlier studies. The transition date 
for support and requirement to use the most current version of MedDRA 
is March 15, 2018. Although the use of the most current version is 
supported as of this Federal Register notice and sponsors or applicants 
are encouraged to begin using it, the use of the most current version 
will only be required in submissions for studies that start after March 
15, 2019. The Catalog will list March 15, 2019, as the ``date 
requirement begins.'' The Study Data Technical Conformance Guide 
provides additional information and recommendations on the coding of 
adverse events (https://www.fda.gov/downloads/forindustry/datastandards/studydatastandards/ucm384744.pdf).
    FDA will no longer support version 8 or earlier of MedDRA. FDA 
support for earlier versions of MedDRA will end for studies that start 
after March 15, 2019. The FDA Data Standards Catalog will be updated to 
list March 15, 2019, as the ``date support ends.'' Studies that start 
after March 15, 2019, will be required to use the most current version 
of MedDRA.

    Dated: August 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-18471 Filed 8-30-17; 8:45 am]
 BILLING CODE 4164-01-P


