[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)]
[Notices]
[Pages 49210-49211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23029]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5436]


Electronic Study Data Submission; Data Standards; Support for 
Version Update of World Health Organization Drug Global

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
support for the most current B3-format annual version of the World 
Health Organization (WHO) Drug Global (WHODG) (formerly named WHO Drug 
Dictionary) (available at https://www.who-umc.org), end of support for 
earlier versions of WHODG, 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 certain investigational new drug applications 
(INDs) to the Center for Biologics Evaluation and Research (CBER) and 
the Center for Drug Evaluation and Research (CDER).

ADDRESSES: You may submit either electronic or written comments at any 
time as follows:

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 ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-5436 for ``Electronic Study Data Submission; Data Standards; 
Support for Version Update of World Health Organization Drug Global.'' 
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, email: [email protected]; or Stephen Ripley, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

[[Page 49211]]

I. Background

    On December 17, 2014, FDA published a final guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Standardized Study Data'' (eStudy Data Guidance), posted on FDA's Study 
Data Standards Resources Web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The eStudy Data Guidance 
implements the electronic submission requirements of section 745A(a) of 
the Federal Food, Drug, and Cosmetic Act for study data contained in 
NDAs, ANDAs, BLAs, and certain INDs to CBER or CDER by specifying the 
format for electronic submissions. The initial timetable for the 
implementation of electronic submission requirements for study data was 
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 the use of WHODG for the coding of 
concomitant medications in studies submitted to CBER or CDER in NDAs, 
ANDAs, BLAs, and certain INDs in the electronic common technical 
document format. Generally, the studies included in a submission are 
conducted over many years and may have used different WHODG versions to 
code concomitant medications. The expectation is that sponsors and 
applicants will use the most current B3-format annual version of WHODG 
at the time of study start. However, there is no requirement to recode 
earlier studies. The transition date for support of the most current 
B3-format annual version of WHODG is March 15, 2018. Although the use 
of the current B3-format annual version of WHODG is supported as of 
this Federal Register notice and sponsors or applicants are encouraged 
to begin using it, the use of the most current B3-format annual 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 addition information and recommendations on the coding of 
concomitant medications (https://www.fda.gov/downloads/forindustry/datastandards/studydatastandards/ucm384744.pdf).
    FDA support for earlier versions of WHODG will end for studies that 
start after March 15, 2019. The 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 B3-format annual 
version of WHODG.

    Dated: October 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23029 Filed 10-23-17; 8:45 am]
 BILLING CODE 4164-01-P