Document ID: FDA-2018-D-1041-0001
Agency: fda
Document Type: Notice
Title: Development of a Shared System Risk Evaluation and Mitigation  Strategy; Draft Guidance for Industry; Availability
Posted Date: 2018-06-01T04:00Z

[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Notices]
[Pages 25468-25469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11783]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1041]

Development of a Shared System Risk Evaluation and Mitigation 
Strategy; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled 
``Development of a Shared System REMS.'' This draft guidance provides 
recommendations on the development of a shared system risk evaluation 
and mitigation strategy (REMS) for multiple prescription drug 
(including biological) products. This guidance describes some of the 
possible benefits of a shared system REMS, and provides general 
principles and recommendations to assist industry with the development 
of these programs.

DATES: Submit either electronic or written comments on the draft 
guidance by July 31, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-1041 for ``Development of a Shared System REMS; Draft 
Guidance for Industry; Availability.'' Received comments will be placed 
in the docket and, except for those submitted as

[[Page 25469]]

``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. 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: Lubna Merchant, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4418, Silver Spring, MD 20993-0002, 301-
796-5162, email: [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 ``Development of a Shared System REMS.'' This guidance 
describes some of the possible benefits of shared system REMS, and 
provides general principles and recommendations to assist industry with 
the development of these programs.
    Section 505-l(i)(l)(B) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 355-1((i)(1)(B)) requires that a holder of an 
abbreviated new drug application (ANDA) approved under section 505(j) 
use a ``single, shared system'' with the reference listed drug (RLD) 
for any REMS with elements to assure safe use (ETASU) unless FDA waives 
this requirement.
    The requirement under section 505-1(i)(1)(B) regarding a ``single, 
shared system'' only applies to ANDAs. However, FDA recognizes that it 
may be in the interest of public health to have a shared system REMS in 
other cases because it may increase efficiencies for applicants and 
stakeholders. A shared system REMS can encompass multiple prescription 
drug products and can be developed and implemented jointly by two or 
more applicants. It can be a program shared by a drug that is the 
subject of an ANDA and the listed drug, as required in section 505-
1(i)(1)(B) (described above). It can also involve multiple new drug 
applications, ANDAs, or biologics license applications, approved under 
section 505(b)(1), (b)(2), or (j) of the FD&C Act (21 U.S.C. 355(b)(1), 
(b)(2) or (j)) or section 351(a) or (k) of the PHS Act (42 U.S.C. 
262(a) or (k)), respectively, that form a shared system voluntarily.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of a draft guidance entitled ``Waivers of the Single, 
Shared System REMS Requirement.'' Among other things, that guidance 
describes how FDA will consider granting a waiver of the requirement in 
section 505-1(i) of the FD&C Act that the applicant for an ANDA and its 
RLD use a single, shared system for REMS with ETASU.
    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 ``Development 
of a Shared System REMS.'' 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 a drug master file (as described in 21 
CFR 314.420) by applicants for their shared system REMS submissions 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 http://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. 2018-11783 Filed 5-31-18; 8:45 am]
BILLING CODE 4164-01-P