[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51180-51182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Controlled Correspondence Related 
to Generic Drug Development; 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availability of a draft guidance for industry entitled ``Controlled

[[Page 51181]]

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: 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 27, 2014. Submit either electronic or written 
comments concerning the collection of information proposed in the draft 
guidance by October 27, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance and the collection 
of information proposed in the draft guidance to http://www.regulations.gov.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. 1682, Silver Spring, MD 20993-0002, 240-
402-7944, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Controlled Correspondence Related to Generic Drug 
Development.'' On July 9, 2012, the Generic Drug User Fee Amendments of 
2012 (GDUFA) were signed into law by the President to speed the 
delivery of safe and effective generic drugs to the public and to 
reduce costs to industry. Under GDUFA, FDA agreed to certain 
obligations as laid out in the GDUFA Commitment Letter that accompanies 
the legislation (Ref. 1). Among these obligations is FDA's commitment 
to performance metrics for the response to controlled correspondence 
for fiscal years (FYs) 2015 through 2017. For example, FDA has 
committed to respond to 90 percent of controlled correspondence within 
2 months from the date of submission in Year 5 of the program, which 
begins on October 1, 2016.
    The GDUFA Commitment Letter described controlled correspondence as 
follows: ``FDA's Office of Generic Drugs provides assistance to 
pharmaceutical firms and related industry regarding a variety of 
questions posed as `controlled documents.' See [http://www.fda.gov/AboutFDA/CentersOffices/officeofmedicalproductsandtobacco/CDER/ucm120610.htm (Ref. 2)]. Controlled correspondence does not include 
citizen petitions, petitions for reconsideration, or requests for 
stay.'' The draft guidance is intended to further refine this 
description to best support the aims of the identified in the GDUFA 
Commitment Letter of ensuring the safety of generic drug products; 
enhancing access by expediting the availability of these products; and 
enhancing transparency by, among other things, improving FDA's 
communications and feedback with industry in order to expedite product 
access. In addition, this guidance provides detail and recommendations 
concerning what inquiries FDA considers as controlled correspondence 
for the purposes of meeting the Agency's GDUFA commitment, what 
information requestors can include in a controlled correspondence to 
facilitate FDA's consideration of and response to a controlled 
correspondence, and what information FDA will provide in its 
communications to entities that have submitted a controlled 
correspondence.
    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 Agency's current thinking on controlled 
correspondence related to generic drug development. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions 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 title, 
description, and respondent description of the information collection 
are given under this section with an estimate of the reporting burden. 
Included in the estimate is the time for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing the collection of information.
    We invite comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Controlled Correspondence Related to Generic Drug 
Development.
    Description: Under GDUFA, FDA has agreed to specific program 
enhancements and performance goals specified in the GDUFA Commitment 
Letter. One of the performance goals applies to controlled 
correspondence related to generic drug development. The Commitment 
Letter includes details on FDA's commitment to respond to questions 
submitted as controlled correspondence within certain time frames. To 
facilitate FDA's prompt consideration of the controlled correspondence 
and response, and to assist in meeting the prescribed time frames, FDA 
recommends including the following information in the inquiry: (1) 
Name, title, address, phone number, and entity of the person submitting 
the inquiry; (2) an email address; (3) an FDA-assigned control number 
and submission date of any previous related correspondence, if 
applicable; (4) the relevant reference listed drug, as applicable, 
including the application number, proprietary (brand) name, 
manufacturer, active ingredient, dosage form, and strength(s); (5) a 
concise statement of the inquiry; (6) a recommendation of the 
appropriate FDA review discipline; and (7) relevant prior research and 
supporting materials.
    The following information is based on inquiries considered 
controlled correspondence and submitted to FDA for FYs 2011, 2012, and 
2013. FDA estimates approximately 217 generic drug manufacturers and 
related industry (e.g., contract research organizations conducting 
bioanalytical or bioequivalence clinical trials) or their

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representatives would each submit an average of 4.7 inquiries annually 
for a total of 1,020 inquiries [1,020 / 217 = 4.7]. Information 
submitted with each inquiry varies widely in content, depending on the 
complexity of the request. Inquiries that are defined as controlled 
correspondence (i.e., inquiries that request information on a specific 
element of generic drug product development) may range from a simple 
inquiry on generic drug labeling to a more complex inquiry for a 
formulation assessment for a specific proposed generic drug product. As 
a result, these inquiries can vary between 1 to 10 burden hours, 
respectively.
    Because the content of inquiries considered controlled 
correspondence is widely varied, we are providing an average burden 
hour for each inquiry. We estimate that it will take an average of 5 
hours per inquiry for industry to gather necessary information, prepare 
the request, and submit the request to FDA. As a result, we estimate 
that it will take an average of 5,100 total hours annually for industry 
to prepare and submit inquiries considered controlled correspondence.

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
              Submission of controlled correspondence                   Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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Manufacturers, Related Industry, and Representatives...............             217              4.7            1,020                5            5,100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

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. References

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).
2. Id. at p. 15. The Web page quoted in the controlled 
correspondence definition has been updated as the link provided in 
the GDUFA Commitment Letter is no longer accessible.

    Dated: August 22, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20359 Filed 8-26-14; 8:45 am]
BILLING CODE 4164-01-P