[Federal Register Volume 82, Number 212 (Friday, November 3, 2017)]
[Notices]
[Pages 51277-51279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23947]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1147]


Controlled Correspondence Related to Generic Drug Development; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Controlled 
Correspondence Related to Generic Drug Development.'' This guidance 
provides information regarding the process by which generic drug 
manufacturers and related industry can submit controlled correspondence 
to FDA requesting information related to generic drug development and 
the Agency's process for providing communications related to such 
correspondence. This guidance also describes the process by which 
generic drug manufacturers and related industry can submit requests to 
clarify ambiguities in FDA' controlled correspondence response and the 
Agency's process for responding to those requests. This draft guidance 
revises the guidance for industry ``Controlled Correspondence Related 
to Generic Drug Development'' issued in September 2015.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 2, 2018.

ADDRESSES: You may submit comments as follows:

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

[[Page 51278]]

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-2014-D-1147 for ``Controlled Correspondence Related to Generic Drug 
Development; Draft Guidance for Industry; Availability.'' Received 
comments 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.
    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, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, 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.

FOR FURTHER INFORMATION CONTACT: Lisa Bercu, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 1611, Silver Spring, MD 20993-0002, 240-402-6902.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Controlled Correspondence Related to Generic Drug 
Development.'' This guidance provides information regarding the process 
by which generic drug manufacturers and related industry can submit to 
FDA controlled correspondence requesting information related to generic 
drug development and the Agency's process for providing communications 
related to such correspondence. This guidance also describes the 
process by which generic drug manufacturers and related industry can 
submit requests to clarify ambiguities in FDA's controlled 
correspondence response and the Agency's process for responding to 
those requests. In accordance with the Generic Drug User Fee Amendments 
(GDUFA) Reauthorization Performance Goals and Program Enhancements 
Fiscal Years 2018-2022 (GDUFA II Goals Letter or GDUFA II Commitment 
Letter), FDA agreed to certain review goals and procedures for the 
review of controlled correspondence received both before, and on or 
after October 1, 2017.
    The GDUFA II Commitment Letter defines standard controlled 
correspondence and complex controlled correspondence, and the draft 
guidance provides additional details and recommendations concerning 
what inquiries FDA considers controlled correspondence for the purposes 
of meeting the Agency's GDUFA II commitment. In addition, this guidance 
provides details and recommendations concerning what information 
requestors should 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 requestors 
that have submitted controlled correspondence. The GDUFA II Commitment 
Letter also states that FDA will review and respond to requests to 
clarify ambiguities in the controlled correspondence response, and the 
guidance provides information on how requestors may submit these 
requests and the Agency's process for responding to them.
    This guidance revises the guidance for industry ``Controlled 
Correspondence Related to Generic Drug Development'' issued in 
September 2015 available at: https://www.fda.gov/downloads/drugs/guidances/ucm411478.pdf. When finalized, this guidance will replace the 
September 2015 final guidance. Changes from the 2015 version include: 
Recommendations on requests concerning postapproval submission 
requirements and complex controlled correspondence, and information on 
how requestors can submit requests to clarify ambiguities in FDA's 
controlled correspondence response and the Agency's process for 
responding to those requests.
    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 current thinking of FDA on controlled 
correspondence related to generic drug development. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

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 (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
title and 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.

[[Page 51279]]

    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--OMB Control Number 0910-0797--Revision.
    Description: FDA has agreed to specific program enhancements and 
performance goals specified in the 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 time frames. To facilitate 
FDA's prompt consideration of the controlled correspondence 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) 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 time frames. To 
facilitate FDA's prompt consideration of the request, 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) 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.
    The following information is based on inquiries considered 
controlled correspondence and submitted to FDA for fiscal years 2014, 
2015, and 2016. FDA estimates approximately 390 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 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 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 7,480 total hours annually for industry 
to prepare and submit inquiries considered controlled correspondence.

                                                     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.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: October 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23947 Filed 11-2-17; 8:45 am]
BILLING CODE 4164-01-P