[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Pages 61062-61063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1592]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; 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 or we) 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 (PRA).

DATES: Fax written comments on the collection of information by 
December 12, 2019.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0797. 
Also include the FDA docket number found

[[Page 61063]]

in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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.

Controlled Correspondence Related to Generic Drug Development

OMB Control No. 0910-0797--Revision

    This information collection supports implementation of the Generic 
Drug User Fee Amendments (GDUFA) of the FDA Reauthorization Act of 2017 
(Pub. L. 115-52, Title III). As established in the ``Reauthorization 
Performance Goals And Program Enhancements Fiscal Years 2018-2022 
Letter'' (``The GDUFA II Commitment Letter'') under GDUFA, certain 
goals have been identified with regard to controlled correspondence 
relating to generic drug development. The GDUFA II Commitment Letter 
includes details of our commitment to respond to questions submitted as 
controlled correspondence within certain timeframes. The GDUFA II 
Commitment Letter also includes details regarding our commitment to 
respond to requests to clarify FDA ambiguities in a controlled 
correspondence response within certain timeframes.
    To support these program goals, we developed the associated 
guidance entitled ``Controlled Correspondence Related to Generic Drug 
Development.'' The guidance is intended to facilitate our prompt 
consideration of controlled correspondence and to assist in meeting the 
prescribed GDUFA II performance goals and timeframes. Specifically, the 
guidance provides procedural instruction, including recommendations 
that the following information be included in controlled correspondence 
submitted to FDA and requests to clarify FDA response to controlled 
correspondence:
     Name, title, address, phone number, and entity of the 
person submitting the inquiry;
     a letter of authorization, if applicable;
     the FDA-assigned control number and submission date of any 
previous, related controlled correspondence that was accepted for 
substantial review and response, if any, as well as a copy of that 
previous controlled correspondence and FDA's response, if any;
     the relevant reference listed drug(s), as applicable, 
including the application number, proprietary (brand) name, 
manufacturer, active ingredient, dosage form, and strength(s);
     a statement that the controlled correspondence is related 
to a potential abbreviated new drug application (ANDA) submission to 
the Office of Generic Drugs and the ANDA number, if applicable;
     a concise statement of the inquiry;
     a recommendation of the appropriate FDA review discipline;
     relevant prior research and supporting materials; and
     the clarifying questions and the corresponding section(s) 
of FDA's controlled correspondence response on which the requestor is 
seeking clarification.
    In the Federal Register of May 22, 2018 (83 FR 23692), we published 
a 60-day notice under the PRA requesting public comment on the proposed 
collection of information. No comments were received in response to the 
PRA notice. Separately, in the Federal Register of November 3, 2017 (82 
FR 51277), we announced the availability of a revised draft version of 
the associated guidance. Because the guidance is currently being 
revised to reflect 2018 through 2022 GDUFA reauthorization goals, we 
are revising the supporting information collection request.
    The guidance is being issued consistent with FDA's good guidance 
practice regulation (21 CFR part 10.115), we intend no changes to the 
information collection elements recommended, and have not modified the 
burden estimate we ascribe to the related activities.
    We therefore estimate the burden of the information collection as 
follows:

                                                     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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Generic drug manufacturers, related industry, and representatives..             390              3.8            1,496                5            7,480
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimate on a review of Agency data of fiscal year 
submissions for 2014, 2015, and 2016, which reflects an increase in 
submissions that we attribute to an increase in generic drug 
development. Accordingly, we estimate 390 generic drug manufacturers 
and related industry (e.g., contract research organizations conducting 
bioanalytical or bioequivalence clinical trials) or their 
representatives will each submit an average of 3.8 inquiries annually 
for a total of 1,496 inquiries [1,496 / 390 = 3.8]. Information 
submitted with each inquiry varies widely in content, depending on the 
complexity of the request. Inquiries that are defined as controlled 
correspondence 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 and 10 burden hours.
    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 7,480 hours annually for industry to 
prepare and submit inquiries considered controlled correspondence.

    Dated: November 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24562 Filed 11-8-19; 8:45 am]
 BILLING CODE 4164-01-P


