[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Notices]
[Pages 52058-52060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24353]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6231]


Use of a Drug Master File for Shared System Risk Evaluation and 
Mitigation Strategy Submissions; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``Use of a 
Drug Master File for Shared System REMS Submissions.'' The draft 
guidance provides information to applicants who are part of a shared 
system Risk Evaluation and Mitigation Strategy (REMS) on using an 
electronic Type V Drug Master File (DMF). FDA recommends that 
applicants who are part of a shared system REMS use a Type V DMF for 
their REMS submissions to improve the efficiency of the submission and 
review process.

DATES: Submit either electronic or written comments on the draft 
guidance by January 8, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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'').

[[Page 52059]]

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-D-6231 for ``Use of a Drug Master File for Shared System REMS 
Submissions; 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: Gita Toyserkani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2422, Silver Spring, MD 20993-0002, 301-
796-1783, [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 ``Use a of Drug Master File for Shared System REMS 
Submissions.''
    A REMS is a required risk management plan that uses tools beyond 
the FDA-approved prescribing information to ensure that the benefits of 
certain drugs outweigh their risks (see section 505-1 of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355-1)). FDA 
can, under certain circumstances, require that the REMS for a drug 
include one or more elements to assure safe use (ETASU) (see section 
505-1(f) of the FD&C Act). When ETASUs are required for an innovator 
drug, any abbreviated new drug application (ANDA) referencing that 
innovator drug must use an shared system REMS with the innovator 
(unless FDA waives the requirement for using a shared system) (see 
section 505-1(i) of the FD&C Act). There are also circumstances under 
which multiple applicants form an SSR to minimize the burden on the 
health care delivery system, such as for a class of similar products.
    Under a shared system REMS, multiple applicants should coordinate 
the submission of identical documents to their respective applications. 
To improve the efficiency of the submission and review process for 
shared system REMS, FDA recommends that applicants who are part of a 
shared system REMS use a Type V DMF for their REMS submissions. A DMF 
is a submission to the Agency that may be used to provide confidential 
detailed information to the Agency. Among other things, a DMF allows 
the DMF holder to authorize other applicants to reference information 
in the holder's DMF. A DMF is submitted solely at the discretion of the 
DMF holder, and the technical contents of a DMF are customarily 
reviewed by FDA only in connection with the review of an application.
    The use of a DMF is not a requirement for shared system REMS. 
However, if shared system REMS applicants choose to use the DMF option 
for their shared system REMS submissions, this guidance (and the 
technical conformance guide that supplements it, available at https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm535180.htm) is 
intended to provide an overview of the approach for doing so. Also, if 
shared system REMS applicants choose to use the DMF option, as of the 
date specified by FDA, they must submit the DMF in the Electronic 
Common Technical Document format, as previously stated in the guidance 
for industry ``Providing Regulatory Submissions in Electronic Format--
Certain Human Pharmaceutical Product Applications and Related 
Submissions Using the eCTD Specifications (Revision 4)'' (available at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm).
    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 use of a DMF 
for submission of 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.

[[Page 52060]]

II. Paperwork Reduction Act of 1995

    This draft guidance 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 314.50 have been approved under 
OMB control number 0910-0001; the collections of information in 21 CFR 
314.70 have been approved under OMB control number 0910-0001; the 
collections of information in 21 CFR 201.57 have been approved under 
OMB control number 0910-0572; the collections of information in 21 CFR 
314.420 have been approved under OMB control number 0910-0001; and the 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338.

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 or 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: November 2, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-24353 Filed 11-8-17; 8:45 am]
 BILLING CODE 4164-01-P