82 FR 41968 - Providing Regulatory Submissions in Electronic Format-Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 170 (September 5, 2017)

Page Range		41968-41969
FR Document		2017-18506

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Content of the Risk Evaluation and Mitigation Strategies Document Using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 This draft guidance is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act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 The draft guidance describes how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain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.

Federal Register, Volume 82 Issue 170 (Tuesday, September 5, 2017)

[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)]
[Notices]
[Pages 41968-41969]
From the Federal Register Online [www.thefederalregister.org]
[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Product Labeling; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Providing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.thefederalregister.org/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

Document Created: 2017-09-02 03:25:06
Document Modified: 2017-09-02 03:25:06

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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. 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.
FR Citation		82 FR 41968

82 FR 41968 - Providing Regulatory Submissions in Electronic Format-Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 170 (September 5, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration