Document ID: FDA-2017-E-4282-0003
Agency: fda
Document Type: Notice
Title: Providing Regulatory Submissions in Electronic Format--Content of 
the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability
Posted Date: 2017-09-05T04:00Z

[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)]
[Notices]
[Pages 41968-41969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18506]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-E-4282]

Providing Regulatory Submissions in Electronic Format--Content of 
the Risk Evaluation and Mitigation Strategies Document Using Structured 
Product Labeling; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Content of the Risk 
Evaluation and Mitigation Strategies Document Using Structured Product 
Labeling.'' This draft guidance is being issued in accordance with the 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 (the 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 The draft guidance describes how FDA 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, abbreviated new drug 
applications, and biologics license applications, beginning no earlier 
than 24 months after issuance of the final guidance.

DATES: Submit either electronic or written comments on the draft 
guidance by March 5, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-E-4282] for '' Providing Regulatory Submissions in Electronic 
Format--Content of the Risk Evaluation and Mitigation Strategies 
Document Using Structured Product Labeling; Draft Guidance for 
Industry; Availability.'' 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 office 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.
    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 draft 
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: Adam Kroetsch, Center for Drug 
Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm. 
1168, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
3842; or Aaron Sherman, Center for Drug Evaluation and Research, Food 
and Drug Administration, Bldg. 51, Rm.

[[Page 41969]]

6366, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-
0493; 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 draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Content of the Risk Evaluation and Mitigation Strategies Document Using 
Structured Product Labeling; Draft Guidance for Industry.''
    FDASIA (Pub. L. 112-144), amended the FD&C Act to add section 745A 
(21 U.S.C. 379k-1), entitled ``Electronic Format for Submissions.'' 
Section 745A(a)(1) of the FD&C Act requires that submissions under 
section 505(b), (i), or (j) of the FD&C Act (21 U.S.C. 355(b), (i), or 
(j)) and submissions under section 351(a) or (k) of the PHS Act (42 
U.S.C. 262(a) or (k)) be submitted to FDA in electronic format no 
earlier than 24 months after FDA issues final guidance on electronic 
format for submissions. In accordance with section 745A(a)(1) of the 
FD&C Act, FDA is issuing this draft guidance, announcing its 
determination that submission types identified in the guidance must be 
submitted electronically in the format specified in the guidance 
beginning 24 months after the issuance of the final guidance.
    This draft guidance (and the technical specification documents it 
references) describes how certain REMS documents will be required to be 
submitted in electronic format using Structured Product Labeling (SPL) 
as outlined in the FDA ``Structured Product Labeling (SPL) 
Implementation Guide with Validation Procedures'' (available at http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM321876.pdf). (FDA has verified the Web 
site addresses, as of the date this document publishes in the Federal 
Register, but Web sites are subject to change over time.) SPL is a 
Health Level 7 data standard used by FDA since 2005. For more 
information on how FDA interprets section 745A(a) of the FD&C Act, see 
the guidance for industry ``Providing Regulatory Submissions in 
Electronic Format--Submissions Under Section745A(a) of the Federal 
Food, Drug, and Cosmetic Act'' (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384686.pdf).
    Development of this guidance was facilitated by completion of the 
``Pharmacy Systems Under REMS Project: Standardizing REMS Information 
for Inclusion Into Pharmacy Systems Using Structured Product Labeling 
(SPL).'' More information on this project--one of four predefined 
priority projects that are a part of the larger REMS Integration 
Initiative--can be found in the report ``Standardizing and Evaluating 
Risk Evaluation and Mitigation Strategies (REMS)'' (available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM415751.pdf).

II. Paperwork Reduction Act of 1995

    This notice refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). 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 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: August 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-18506 Filed 9-1-17; 8:45 am]
 BILLING CODE 4164-01-P