Document ID: FDA-2018-D-1043-0001
Agency: fda
Document Type: Notice
Title: Waivers of the Single, Shared System Risk Evaluation and Mitigation
Strategy Requirement; Draft Guidance for Industry; Availability
Posted Date: 2018-06-01T04:00Z

[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Notices]
[Pages 25465-25466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11784]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1043]

Waivers of the Single, Shared System Risk Evaluation and 
Mitigation Strategy Requirement; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``Waivers of 
the Single, Shared System REMS Requirement.'' This guidance describes 
how FDA intends to consider granting a waiver of the requirement in the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) that the applicant for 
an abbreviated new drug application (ANDA) and its reference listed 
drug (RLD) use a single, shared system (SSS) for a required risk 
evaluation and mitigation strategy (REMS) with elements to assure safe 
use (ETASU).

DATES: Submit either electronic or written comments on the draft 
guidance by August 30, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2018-D-1043 for ``Waivers of the Single, Shared System Risk 
Evaluation and Mitigation Strategy Requirement; 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 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elaine Lippmann, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993, 301-796-

[[Page 25466]]

3600, [email protected]; 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 ``Waivers of the Single, Shared System REMS Requirement.'' 
This guidance describes how the Agency intends to consider granting a 
waiver of the requirement in section 505-1(i) of the FD&C Act (21 
U.S.C. 355-1(i)) that the applicant for an ANDA and its RLD use a SSS 
for a required REMS with ETASU.
    Section 505-l(i)(l)(B) of the FD&C Act requires that a holder of an 
ANDA under section 505(j) use a ``single, shared system'' with the RLD 
for any ETASU, unless FDA waives this requirement. The statute permits 
a waiver of the SSS requirement if FDA finds that (1) ``the burden of 
creating a [SSS] outweighs the benefit of a single, system, taking into 
consideration the impact on health care providers, patients, the 
applicant for the [ANDA], and the holder of the reference drug 
product,'' or (2) an aspect of the ETASU for the applicable listed drug 
is claimed by an unexpired patent or trade secret and the ANDA 
applicant certifies that it sought a license for use of the aspect, but 
was unable to obtain one. If a waiver of the SSS requirement is 
granted, the ANDA may use ``a different, comparable aspect of the 
[ETASU],'' instead of participating in a SSS with the RLD.
    This guidance is intended to explain the factors FDA will consider 
in evaluating a request for waiver of the SSS requirement and provide 
recommendations to ANDA applicants regarding the submission and content 
of waiver requests. The guidance also addresses FDA's interpretation of 
what constitutes a different, comparable aspect of the ETASU as 
described in section 505-1(i)(1)(B).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Waivers of 
the Single, Shared System REMS Requirement.'' 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. This guidance is not subject to 
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to collections of information that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The 
preparation and submission of waiver requests (as described in 21 CFR 
314.90 for new drug application applicants and 314.99(b) for ANDA 
applicants) has been approved under OMB control number 0910-0001. In 
accordance with the PRA, before publication of the final guidance 
document, FDA intends to solicit public comment and obtain OMB approval 
for any information collections recommended in this guidance that are 
new or that would represent material modifications to previously 
approved collections of information found in FDA regulations.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: May 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11784 Filed 5-31-18; 8:45 am]
BILLING CODE 4164-01-P