[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Pages 23692-23693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10856]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry: 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, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on controlled correspondence 
related to generic drug development.

DATES: Submit either electronic or written comments on the collection 
of information by July 23, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 23, 2018. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-1592 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Draft Guidance for Industry: 
Controlled Correspondence Related to Generic Drug Development.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites 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

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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.

Guidance for Industry: Controlled Correspondence Related to Generic 
Drug Development

OMB Control Number 0910-0797--Extension

    FDA has agreed to specific program enhancements and performance 
goals specified in the Generic Drug User Fee Act 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 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 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. This information collection supports this Agency 
guidance.
    We 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.

    This is the first extension of the information collection and 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 total hours annually for industry 
to prepare and submit inquiries considered controlled correspondence.

    Dated: May 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10856 Filed 5-21-18; 8:45 am]
 BILLING CODE 4164-01-P