[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35302-35303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0420]


Providing Regulatory Submissions in Alternate Electronic Format; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Providing 
Regulatory Submissions in Alternate Electronic Format.'' Under the 
Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress granted FDA 
the authority to implement the statutory electronic submission 
requirements in guidance. In response, FDA implemented binding guidance 
requiring that new drug applications (NDAs), abbreviated new drug 
applications (ANDAs), certain drug master files (DMFs), certain 
biologics license applications (BLAs), and certain investigational new 
drug applications (INDs) be submitted to the Agency in electronic 
common technical document format. Recognizing that some submissions are 
exempt from this requirement and that waivers of the requirement may be 
granted on a case-by-case basis, the Agency is issuing this guidance to 
provide recommendations on an alternate electronic format for 
submissions covered under such exemptions and waivers. This guidance 
replaces the draft guidance of the same title issued on March 11, 2020.

DATES: The announcement of the guidance is published in the Federal 
Register on July 2, 2021.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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-D-0420 for ``Providing Regulatory Submissions in Alternate 
Electronic Format.'' 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, 240-
402-7500.
     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

[[Page 35303]]

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, 240-402-7500.
    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 guidance 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 the guidance document.

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 3334, Silver Spring, MD 20993-0002, 240-402-8926; 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:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Providing Regulatory Submissions in Alternate Electronic 
Format.'' This guidance provides recommendations on an alternate 
electronic format for submissions that are covered under an exemption 
from or granted a waiver of the requirements of section 745A(a) of the 
FD&C Act (21 U.S.C. 379k-1). These recommendations pertain to the 
electronic format of content in NDAs, ANDAs, certain DMFs, certain 
BLAs, and certain INDs submitted to the Center for Drug Evaluation and 
Research or to the Center for Biologics Evaluation and Research.
    This guidance includes information on: (1) How to submit in 
alternate electronic format (without XML backbone), (2) submission of 
FDA forms, (3) pre-submission considerations, (4) submission structure, 
(5) file formats and versions, (6) datasets and study information, (7) 
transmitting electronic submissions, and (8) receipt dates.
    This guidance finalizes the draft guidance of the same title issued 
on March 11, 2020 (85 FR 14202). FDA considered comments received on 
the draft guidance as the guidance was finalized. Changes from the 
draft to final guidance include: (1) Minor edits to clarify 
recommendations for the location of the Table of Contents for the 
alternate electronic format, (2) an example of the folder structure, 
and (3) the process for submission if an electronic signature is not 
possible. In addition, editorial changes were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This final guidance represents 
FDA's current thinking on ``Providing Regulatory Submissions in 
Alternate Electronic Format.'' It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 312 have been approved under OMB control 
number 0910-0014; the collections of information in 21 CFR part 314 
have been approved under OMB control number 0910-0001; and the 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or 
https://www.regulations.gov.

    Dated: June 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14201 Filed 7-1-21; 8:45 am]
BILLING CODE 4164-01-P


