[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Notices]
[Pages 38211-38212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16358]



[[Page 38211]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Controlled Correspondence Related to Generic Drug Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
3, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the title. Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry on Controlled Correspondence Related to Generic 
Drug Development OMB Control Number 0910-NEW

    In the Federal Register of August 27, 2014 (79 FR 51180), FDA 
announced the availability of a draft guidance for industry entitled 
``Controlled Correspondence Related to Generic Drug Development.'' The 
draft guidance provided information regarding the process by which 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 described FDA's process for providing 
communications related to such correspondence.
    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).
    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 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.
    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.
    In the Federal Register of August 27, 2014 (79 FR 51180), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received several comments pertaining to 
the scope of controlled correspondence. We summarize the comments and 
provide our response below:
    (Comment) Several comments expressed concern related to three types 
of requests that FDA proposed to exclude from the definition of 
controlled correspondence. The three exclusions are: (1) Requests for 
recommendations on the appropriate design of bioequivalence (BE) 
studies for a specific drug product (BE guidance requests); (2) 
requests for review of BE clinical protocols (clinical protocol 
requests); and (3) requests for meetings to discuss generic drug 
development prior to ANDA submission (pre-ANDA meeting requests).
    (Response) FDA has not changed its policy regarding its 
consideration of requests for bioequivalence guidance, clinical 
protocol reviews, and pre-ANDA meetings. FDA will consider them 
promptly upon their electronic submission and will respond as 
expeditiously as practicable. Although the guidance states that these 
requests are not considered controlled correspondence submissions, 
requests for BE guidance and pre-ANDA meetings are included in the 
1,020 total annual responses estimated in table 1 because these 
requests will utilize the same information collection pathway as a 
request that is considered controlled correspondence. For reasons 
described in the draft guidance, however, controlled correspondence 
GDUFA metrics will not apply to FDA's responses to the three excluded 
requests.
    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 
representatives would each submit an average of 4.7 inquiries annually 
for a

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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.
    Description of Respondents: Respondents are human generic drug 
manufacturers and related industry.

                                                     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.

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: June 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16358 Filed 7-1-15; 8:45 am]
 BILLING CODE 4164-01-P