[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Notices]
[Pages 84348-84349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28560]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-4303]


Providing Regulatory Submissions in Electronic Format--Content of 
the Risk Evaluation and Mitigation Strategies Document Using Structured 
Product Labeling; 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 Electronic Format--Content of the Risk 
Evaluation and Mitigation Strategies Document Using Structured Product 
Labeling.'' This guidance is being issued in accordance with the Food 
and Drug Administration Safety and Innovation Act (FDASIA), which 
amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require 
that certain submissions under the FD&C Act and the Public Health 
Service Act (PHS Act) be submitted in electronic format, beginning no 
earlier than 24 months after issuance of final guidance on electronic 
format for submissions. The guidance describes how FDA plans to 
implement the requirements for the electronic submission of Risk 
Evaluation and Mitigation Strategies (REMS) documents in certain 
submissions under new drug applications (NDAs), abbreviated new drug 
applications (ANDAs), and certain biologics license applications 
(BLAs), beginning December 28, 2022. This guidance finalizes the draft 
guidance entitled ``Providing Regulatory Submissions in Electronic 
Format--Content of the Risk Evaluation and Mitigation Strategies 
Document Using Structured Product Labeling'' published September 5, 
2017.

DATES: The announcement of the guidance is published in the Federal 
Register on December 28, 2020.

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: 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.
    <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-2017-D-4303 for ``Providing Regulatory Submissions in Electronic 
Format--Content of the Risk Evaluation and Mitigation Strategies 
Document Using Structured Product Labeling.'' 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.
    <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 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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).

[[Page 84349]]

    Submit written requests for single copies of this 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 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: Nancy Guan, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-348-1549; 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 Electronic Format--
Content of the Risk Evaluation and Mitigation Strategies Document Using 
Structured Product Labeling.'' FDASIA amended the FD&C Act to require 
that certain submissions under the FD&C Act and the PHS Act be 
submitted in electronic format, beginning no earlier than 24 months 
after issuance of final guidance on electronic format for submissions. 
This guidance describes how FDA plans to implement the requirements for 
the electronic submission of REMS documents in certain submissions 
under NDAs, ANDAs, and certain BLAs, beginning December 28, 2022.
    This guidance finalizes the draft guidance entitled ``Providing 
Regulatory Submissions in Electronic Format--Content of the Risk 
Evaluation and Mitigation Strategies Document Using Structured Product 
Labeling'' issued September 5, 2017 (82 FR 41968). FDA has considered 
all the public comments received on the draft guidance in finalizing 
this guidance. FDA made editorial changes to improve clarity and 
address comments as appropriate. FDA also amended language in Part 
III.C of the guidance to reflect the recent publication of exemption 
and waiver criteria for eCTD submissions in a separate guidance.
    FDA guidances ordinarily contain standard language explaining that 
guidances should be viewed only as recommendations unless specific 
regulatory or statutory requirements are cited. FDA is not including 
this standard language in this guidance because this guidance contains 
binding provisions. In section 745A(a) of the FD&C Act, Congress 
granted explicit authorization to FDA to specify in guidance the format 
for the electronic submissions required under that section. 
Accordingly, this guidance explains such requirements under section 
745A(a) of the FD&C Act, indicated by the use of the words must or 
required, and therefore is not subject to the usual restrictions in 
FDA's good guidance practice regulations, such as the requirement that 
guidances not establish legally enforceable responsibilities. See 21 
CFR 10.115(d). This guidance represents the Agency's current thinking 
on ``Providing Regulatory Submissions in Electronic Format--Content of 
the Risk Evaluation and Mitigation Strategies Document Using Structured 
Product Labeling.''

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 314 have been approved under OMB control 
number 0910-0001.

III. Electronic Access

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

    Dated: December 21, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28560 Filed 12-23-20; 8:45 am]
BILLING CODE 4164-01-P