[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61006-61008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21469]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1548]


Failure To Respond to an Abbreviated New Drug Application 
Complete Response Letter Within the Regulatory Timeframe; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Failure to 
Respond to an ANDA Complete Response Letter Within the Regulatory 
Timeframe.'' This guidance is intended to assist applicants in 
responding to complete response letters (CRLs) to abbreviated new drug 
applications (ANDAs) submitted to FDA under the Federal Food, Drug, and 
Cosmetic Act. This guidance provides information and recommendations 
regarding potential courses of action for an ANDA applicant after 
issuance of a CRL as well as the actions that FDA may take if the 
applicant fails to respond to a CRL. In addition, this guidance 
recommends information an applicant may submit in its request for an 
extension to respond to a CRL as well as a non-exhaustive list of 
factors that FDA will consider in determining whether such a request is 
reasonable.

DATES: Submit either electronic or written comments on the draft 
guidance by November 30, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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 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-2020-D-1548 for ``Failure to Respond to an ANDA Complete Response 
Letter Within the Regulatory Timeframe.'' 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, 240-402-7500.
     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.govinfo.gov/content/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

[[Page 61007]]

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, 
240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 or Office 
of Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, 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., 
Silver Spring, MD 20993, 240-402-6902, or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Failure to Respond to an ANDA Complete Response Letter 
Within the Regulatory Timeframe.'' This guidance provides information 
and recommendations regarding the potential courses of action for an 
ANDA applicant after issuance of a CRL as well as the actions that FDA 
may take if the applicant fails to respond to the CRL. This guidance 
also identifies information that an applicant may submit in its request 
for an extension to respond to a CRL as well as a non-exhaustive list 
of factors that FDA will consider in determining whether such a request 
is reasonable.
    As defined in 21 CFR 314.3(b), a CRL is a written communication to 
an applicant from FDA usually describing all of the deficiencies that 
the Agency has identified in an NDA or ANDA that must be satisfactorily 
addressed before it can be approved. After receiving a CRL, an 
applicant must, under Sec.  314.110(b) (21 CFR 314.110(b)): (1) 
Resubmit the ANDA (i.e., submit all materials needed to fully address 
all deficiencies identified in the CRL), (2) withdraw the application, 
or (3) request the opportunity for a hearing. If an applicant fails to 
take one of these three actions within 1 year after issuance of a CRL, 
FDA may consider this failure to be a request to withdraw the ANDA 
unless the applicant has requested an extension of time in which to 
address all deficiencies identified in the CRL.
    Historically, FDA, in its discretion, has liberally granted 
requests for multiple extensions to respond to an individual CRL. 
However, FDA has seen a steady increase of applications pending with 
industry for more than a year. Lengthy response times because of 
multiple extensions, which can result in a submission addressing 
deficiencies years after the initial assessment of the ANDA and 
issuance of the CRL, are disruptive to the assessment process and can 
create additional assessment cycles. Over time, information submitted 
in the original ANDA can become obsolete because of changes such as new 
or revised United States Pharmacopeia requirements, reference listed 
drug labeling changes, or other events such as a facility evaluation 
becoming outdated. In addition, over time, there may have been changes 
in FDA assessors, and it may take time for them to familiarize 
themselves with the original submission. For these reasons, assessing 
an amendment submitted years after the initial ANDA assessment and 
issuance of the CRL diverts the Agency's limited resources from the 
review of other applications.
    FDA is issuing this guidance as part of the ``Drug Competition 
Action Plan,'' which aims to increase competition in the market for 
prescription drugs, facilitate entry of high-quality and affordable 
generic drugs, and improve the public health. FDA intends for this 
guidance to promote efforts to address deficiencies more quickly, make 
the process for submitting and reviewing extension requests more 
efficient and predictable, and allow the Agency to focus its resources 
on ANDA assessment.
    In addition to general comments on this guidance, FDA is interested 
in responses to the following questions:
    1. Are there any categories of deficiencies in which a year would 
not be expected to be a sufficient amount of time to respond to a CRL?
    2. Why may it take an applicant more than 1 year to respond to a 
CRL?
    a. Does the patent landscape impact the timing of an applicant's 
response to a CRL?
    b. Are there disincentives (e.g., business reasons) to responding 
to a CRL within 1 year?
    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 ``Failure to 
Respond to an ANDA Complete Response Letter Within the Regulatory 
Timeframe.'' 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.

II. Paperwork Reduction Act of 1995

    This draft guidance for industry entitled, ``Failure to Respond to 
an ANDA Complete Response Letter Within the Regulatory Timeframe,'' 
describes 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. 3501-3521). In particular, the draft 
guidance refers to collection of information under Sec.  314.110, 
Complete Response Letter to the Applicant, after FDA review of an ANDA 
and issuance of a CRL identifying deficiencies in the application to 
the ANDA applicant.
    Any burden of communications, as outlined in 21 CFR 314.102 and 
314.110, incurred during the review of new drug applications, ANDAs, 
and drug master files, is already accounted for as part of the FDA 
review process and attributable to other specific references in 21 CFR 
314, within the OMB approved collection 0910-0001.
    The draft guidance also refers to previously approved collections 
of information found in FDA regulations and approved under OMB control 
numbers 0910-0001 and 0910-0191. When finalized, the guidance will be 
included in 0910-0001.

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, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances or https://www.regulations.gov.


[[Page 61008]]


    Dated: September 18, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21469 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P