[Federal Register Volume 79, Number 234 (Friday, December 5, 2014)]
[Notices]
[Pages 72185-72186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28540]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1891]


How To Obtain a Letter From the Food and Drug Administration 
Stating That Bioequivalence Study Protocols Contain Safety Protections 
Comparable to Applicable Risk Evaluation and Mitigation Strategies for 
Reference Listed Drugs; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``How to Obtain 
a Letter from FDA Stating that Bioequivalence Study Protocols Contain 
Safety Protections Comparable to Applicable REMS for RLD.'' This draft 
guidance describes how a prospective abbreviated new drug application 
(ANDA) applicant may request a letter stating that FDA has determined 
the following: The potential applicant's bioequivalence (BE) study 
protocol contains safety protections comparable to those in the risk 
evaluation and mitigation strategy (REMS) with elements to assure safe 
use (ETASU) applicable to the reference listed drug (RLD) and FDA will 
not consider it a violation of the REMS for the RLD sponsor to provide 
a sufficient quantity of the RLD to the interested generic firm or its 
agent to allow the firm to perform the testing necessary to support its 
ANDA.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 3, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, 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.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993, 240-402-
7930, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``How to Obtain a Letter from FDA Stating that Bioequivalence 
Study Protocols Contain Safety Protections Comparable to Applicable 
REMS for RLD.'' Section 505-1(a)(1) of the FD&C Act authorizes FDA to 
require applicants to submit a proposed REMS as a part of the relevant 
application \1\ if FDA determines that a REMS is necessary to ensure 
that the benefits of a drug outweigh its risks (21 U.S.C. 355-1(a)(1)). 
A REMS is a required risk management plan that uses tools beyond 
routine professional labeling (such as a medication guide, a patient 
package insert, and/or a communication plan) to ensure that the 
benefits of a drug outweigh its risks (section 505-1(f) of the FD&C 
Act). In addition, FDA may require ETASU in some circumstances when 
such elements are necessary to mitigate the risks associated with the 
drug. ETASU may include, for example, requirements that health care 
providers who prescribe or administer the drug have particular training 
or certification; that patients using the drug be monitored and/or 
enrolled in a registry; or that pharmacies, practitioners, or health 
care settings that dispense the drug be specially certified.
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    \1\ Section 505-1 of the FD&C Act applies to any application for 
approval of a prescription drug submitted under section 505(b) or 
(j) of the FD&C Act (including both NDAs submitted under section 
505(b)(2) and ANDAs submitted under section 505(j)), as well as 
applications submitted under section 351 of the Public Health 
Service Act (42 U.S.C. 262).
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    FDA is aware of instances in which an RLD sponsor has refused to 
sell drug products to a prospective ANDA applicant seeking to conduct 
the testing needed to obtain approval, and the RLD sponsor has cited 
the REMS ETASU as justification. In the interest of facilitating 
prospective generic applicants' access to RLD products to conduct the 
testing necessary to support ANDA approval, FDA has, on request, 
reviewed the BE study protocols proposed by a prospective ANDA

[[Page 72186]]

applicant to assess whether they provide safety protections comparable 
to those in the applicable REMS ETASU. When the Agency has determined 
that comparable protections existed, FDA has issued letters to the RLD 
sponsor stating so, and indicating that FDA would not consider it to be 
a violation of the REMS for the RLD sponsor to provide drug product to 
the prospective ANDA applicant or its agent.
    Requesting or obtaining such a letter from FDA is not a legal 
requirement. If a prospective ANDA applicant chooses to request such a 
letter, this guidance is intended to clarify the process for doing so.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the Agency's current thinking on how a prospective generic applicant 
can obtain a letter stating that its BE study protocols contain safety 
protections comparable to those in the applicable REMS for the RLD. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). 
The collections of information in 21 CFR parts 312 and 314 have been 
approved under OMB control numbers 0910-0014 and 0910-0001.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28540 Filed 12-4-14; 8:45 am]
BILLING CODE 4164-01-P