83 FR 41077 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Controlled Correspondence Related to Generic Drug Development

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 160 (August 17, 2018)

The Food and Drug Administration (FDA, Agency, 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.

[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Pages 41077-41078]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17787]


-----------------------------------------------------------------------

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, 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.

DATES: Fax written comments on the collection of information by 
September 17, 2018.

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 OMB control number 0910-0797. 
Also include the FDA docket number found 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.m.-12 
midnight, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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: Controlled Correspondence Related to Generic 
Drug Development

OMB Control Number 0910-0797--Extension

    This information collection supports the above captioned Agency 
guidance. FDA has agreed to specific program enhancements and 
performance goals specified in the Generic Drug User Fee 
Reauthorization (GDUFA II) Commitment Letter. One of the performance 
goals applies to controlled correspondence related to generic drug 
development. The GDUFA II Commitment Letter includes details on FDA's 
commitment to respond to questions submitted as controlled 
correspondence within certain timeframes. To support these program 
goals, we have developed the guidance entitled ``Controlled 
Correspondence Related to Generic Drug Development.'' The guidance 
document is intended to facilitate FDA's prompt consideration of 
controlled correspondence and to assist in meeting the prescribed 
timeframes by providing procedural recommendations to include the 
following information in the inquiry: (1) Name, title, address, phone 
number, and entity of the person submitting the inquiry; (2) a letter 
of authorization, if applicable; (3) 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; (4) the relevant reference listed drug(s), as 
applicable, including the application number, proprietary (brand) name, 
manufacturer, active ingredient, dosage form, and strength(s); (5) 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; (6) a concise 
statement of the inquiry; (7) a recommendation of the appropriate FDA 
review discipline; and (8) relevant prior research and supporting 
materials.
    The GDUFA II Commitment Letter also includes details on FDA's 
commitment to respond to requests to clarify ambiguities in FDA's 
controlled correspondence response within certain timeframes. To 
facilitate FDA's prompt consideration of the request and to assist in 
meeting the prescribed timeframes, the guidance document recommends 
including the following information in the inquiry: (1) Name, title, 
address, phone number, and entity of the person submitting the inquiry; 
(2) a letter of authorization, if applicable; (3) the FDA-assigned 
control number, submission date of the controlled correspondence on 
which the requestor is seeking clarification, a copy of that previous 
controlled correspondence, and FDA's response to the controlled 
correspondence; and (4) 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 requesting public comment on the proposed 
collection of

[[Page 41078]]

information. No comments were received.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
              Submission of controlled correspondence                   Number of      responses per    Total  annual   Average  burden    Total  hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Generic drug manufacturers, related industry, and representatives..             390              3.8            1,496                5            7,480
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This is the first extension of the information collection. 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: August 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17787 Filed 8-16-18; 8:45 am]
 BILLING CODE 4164-01-P