[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Pages 58491-58492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24621]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1167]


Controlled Correspondence Related to Generic Drug Development; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Controlled 
Correspondence Related to Generic Drug Development''. The guidance 
document provides information regarding the process by which human 
generic drug manufacturers and related industry can submit 
correspondence to FDA requesting information on generic drug 
development. This guidance also describes FDA's process for providing 
communications related to such correspondence.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 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: Maryll Toufanian, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave, Bldg. 75, Rm. 1684, Silver Spring, MD 20993-0002, 240-
402-7944, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Controlled Correspondence Related to Generic Drug 
Development''. The guidance document provides information regarding the 
process by which human generic drug manufacturers and related industry 
can submit correspondence to FDA requesting information on generic drug 
development. This guidance also describes FDA's process for providing 
communications related to such correspondence.
    Under the provisions of the Generic Drug User Fee Amendments of 
2012 (GDUFA), FDA agreed to certain obligations as laid out in the 
Generic Drug User Fee Act Program Performance Goals and Procedures for 
fiscal years 2013 through 2017 (the GDUFA Commitment Letter) that 
accompanies the legislation (Ref. 1). Among those obligations is FDA's 
commitment to performance metrics for its responses to controlled 
correspondence for fiscal years 2015 through 2017.
    This guidance finalizes the draft guidance announced in the Federal 
Register on August 27, 2014 (79 FR 51180). The Agency considered 
comments on the draft guidance while finalizing this guidance. 
Generally, we revised the draft guidance to provide clarifying and 
explanatory information that will assist human generic drug 
manufacturers and related industry as they submit controlled 
correspondence to FDA. Changes from the draft guidance include a 
description of a process to submit information to update the Agency's 
Inactive Ingredient Database and a description of enhanced 
communication to requestors regarding the status of their controlled 
correspondence.
    Two comment threads on the draft guidance benefit from additional

[[Page 58492]]

discussion here. Specifically, FDA received numerous comments regarding 
two categories of requests that FDA proposed in the draft guidance to 
exclude from the controlled correspondence process. First, FDA received 
comments requesting that the Agency refrain from excluding requests for 
product-specific guidance on demonstrating bioequivalence. FDA declines 
to revise the guidance in this fashion. As set out in the draft 
guidance, the short timeframe contemplated for the controlled 
correspondence responses is inconsistent with the well-established 
process for issuing product-specific recommendations described in the 
guidance for industry on ``Bioequivalence Recommendations for Specific 
Products (June 2010)'', as well as with the principles in the GDUFA 
Commitment Letter regarding the Regulatory Science Initiative. Rather 
than incorporating such guidance development into the controlled 
correspondence process, FDA's Office of Generic Drugs (OGD) is 
developing a separate process for product-specific guidance 
development.
    This approach is being managed by the Division of Therapeutic 
Performance (DTP) within OGD's Office of Research and Standards, 
involves representatives from numerous divisions and offices within 
OGD, and provides for timely posting of product-specific 
recommendations to facilitate generic drug development. Requests for 
product-specific guidance development received through the general 
[email protected] email account are forwarded directly to DTP 
for consideration and tracking. Prioritization of guidance development 
is based on a variety of factors, including public health needs, 
industry demand for generic development, anticipated expiration of 
reference listed drug exclusivity, formulation features and 
predictability of in vivo performance, OGD experience with similar 
formulations or product types, and the feasibility of different 
approaches to demonstrate bioequivalence (e.g., pharmacokinetic/
pharmacodynamics studies, comparative clinical endpoint studies, and in 
vitro approaches). FDA anticipates that this targeted development 
approach will expedite the availability of product-specific guidances 
while supporting the important policies of transparency and maximizing 
benefit to the public health.
    Second, FDA received comments regarding its proposed method of 
responding to requests related to issues for which the Agency has not 
yet determined a policy. Upon review of the comments, FDA is revising 
its recommendations related to such inquiries. As described in the 
guidance, if there is a better mechanism for a requestor to obtain 
comment from FDA on the subject of the request than through a 
controlled correspondence, the Agency will direct the requestor to such 
a mechanism, e.g., a pre-abbreviated new drug application meeting 
request or the Regulatory Science Initiative. For requests for which 
the controlled correspondence pathway is the best mechanism, but that 
raise issues for which FDA has not determined appropriate policy, such 
requests will remain open until such policy decision is made.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on controlled correspondence related to generic 
drug development. 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.

II. Paperwork Reduction Act of 1995

    This 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 (44 U.S.C. 3501-3520). The collection 
of information has been approved under OMB control number 0910-0797.

III. 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.

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.

V. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and is 
available electronically at http://www.regulations.gov.
(FDA has verified the Web site address in this reference section, 
but we are not responsible for any subsequent changes to the Web 
site after this document publishes in the Federal Register.)
    1. Generic Drug User Fee Act Program Performance Goals and 
Procedures (GDUFA Commitment Letter) for fiscal years 2013 through 
2017, available at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.

    Dated: September 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24621 Filed 9-28-15; 8:45 am]
 BILLING CODE 4164-01-P