Notice2021-14201
Providing Regulatory Submissions in Alternate Electronic Format; Guidance for Industry; Availability
Primary source
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Published
July 2, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 This guidance replaces the draft guidance of the same title issued on March 11, 2020.
Full Text
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<title>Federal Register, Volume 86 Issue 125 (Friday, July 2, 2021)</title>
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[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35302-35303]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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