[Federal Register Volume 85, Number 135 (Tuesday, July 14, 2020)]
[Notices]
[Pages 42411-42412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15095]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1313]


Electronic Submissions; Data Standards; Support for Standard for 
the Exchange of Nonclinical Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) Center for 
Biologics Evaluation and Research (CBER) is announcing support for the 
current version of Clinical Data Interchange Standards Consortium 
(CDISC) Standard for the Exchange of Nonclinical Data (SEND) and an 
update to the FDA Data Standards Catalog for the submission of 
nonclinical data in new drug applications (NDAs), abbreviated new drug 
applications (ANDAs), certain biologics license applications (BLAs), 
and certain investigational new drug applications (INDs). This update 
does not apply to noncommercial INDs for a product that is not intended 
for commercial distribution (research and investigator-sponsored INDs); 
INDs and BLAs for devices that are regulated by CBER as biological 
products under the Public Health Services (PHS) Act; and submissions 
for blood and blood components, including Source Plasma.

[[Page 42412]]


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-2020-N-1313 for ``Electronic Submissions; Data Standards; Support 
for Standard for the Exchange of Nonclinical Data.'' 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 laws. 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.

FOR FURTHER INFORMATION CONTACT: 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: CBER is announcing support for the current 
version of CDISC SEND and an update to the FDA Data Standards Catalog 
for the submission of nonclinical data in NDAs, ANDAs, BLAs, and 
certain INDs. This update does not apply to: (1) Noncommercial INDs for 
a product that is not intended for commercial distribution (research 
and investigator-sponsored INDs); (2) INDs and BLAs for devices that 
are regulated by CBER as biological products under section 351 of the 
PHS Act (42 U.S.C. 262); and (3) submissions for blood and blood 
components, including Source Plasma. In section 745A(a) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(a)), Congress 
granted explicit statutory authorization to FDA to specify in guidance 
the format for the electronic submissions required under that section.
    In the Federal Register of December 18, 2014 (79 FR 75568), FDA 
announced a final guidance for industry entitled ``Providing Regulatory 
Submissions in Electronic Format--Standardized Study Data.'' The 
guidance is available on FDA's Study Data Standards Resources web page 
at https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources. The guidance implemented the electronic 
submission requirements of section 745A(a) of the FD&C Act for study 
data contained in NDAs, ANDAs, BLAs, applications under subsection (a) 
or (k) of section 351 of the PHS Act, and certain INDs. The initial 
timetable for the implementation of electronic submission requirements 
for study data was December 17, 2016. The guidance states that a 
Federal Register notice will specify the transition date for all new 
standards (with the month and day for the transition date corresponding 
to March 15).
    The transition date for support of CDISC SEND is March 15, 2021, 
for CBER. Although SEND is now supported by CBER and sponsors or 
applicants are encouraged to begin using it, the SEND standard will 
only be required in studies that start 24 months after the transition 
date of March 15, 2021. The Catalog will list March 15, 2023, as the 
``date requirement begins'' for CBER. When multiple versions of an FDA-
supported standard are listed in the Catalog, sponsors or applicants 
can select a version to use.

    Dated: July 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15095 Filed 7-13-20; 8:45 am]
BILLING CODE 4164-01-P


