[Federal Register Volume 85, Number 51 (Monday, March 16, 2020)]
[Notices]
[Pages 14948-14949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0065]


Competitive Generic Therapies; 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 final guidance for industry entitled 
``Competitive Generic Therapies.'' This guidance provides a description 
of the process that applicants should follow to request designation of 
a drug as a competitive generic therapy (CGT) and the criteria for 
designating a drug as a CGT. In addition, this guidance includes 
information on the actions that FDA may take to expedite the 
development and review of an abbreviated new drug application (ANDA) 
for a drug designated as a CGT. Further, this guidance provides 
information on how FDA implements the statutory provision for a 180-day 
exclusivity period for certain first approved applicants that submit 
ANDAs for drugs designated as a CGT. This guidance finalizes the draft 
guidance of the same title dated February 19, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on March 16, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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-2019-D-0065 for ``Competitive Generic Therapies.'' 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.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 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Susan Levine, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-0002, 240-
402-7936.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Competitive Generic Therapies.'' This guidance finalizes the 
draft guidance of the same title dated February 19, 2019.
    On August 18, 2017, the FDA Reauthorization Act of 2017 (FDARA) 
(Pub. L. 115-52) was signed into law. Section 803 of FDARA amended the 
Federal Food, Drug, and Cosmetic Act to add section 506H (21 U.S.C. 
356h), which established a new process to designate and expedite the 
development and review of certain drugs for which there is ``inadequate 
generic competition.'' FDA recognizes that various factors may 
influence a generic drug applicant's decision to develop a certain 
drug, including drugs with

[[Page 14949]]

inadequate generic competition. For instance, some drugs may not 
attract a high level of interest from generic drug applicants if there 
is a limited market for the products and/or if the products are more 
difficult to develop. Nevertheless, these drugs can play an important 
role in diagnosing, treating, and preventing various types of diseases 
or conditions, and incentivizing generic competition for these products 
can help ensure that patients have access to the medicines they need. 
The provisions associated with CGTs are intended to incentivize 
effective development, efficient review, and timely market entry for 
drugs for which there is inadequate generic competition.
    This guidance provides a description of the process that applicants 
should follow to request designation of a drug as a CGT and the 
criteria for designating a drug as a CGT. Also, this guidance includes 
information on the actions that FDA may take to expedite the 
development and review of ANDAs for drugs designated as a CGT. These 
actions may help to clarify applicants' regulatory expectations for a 
particular drug, assist applicants in developing a more complete 
submission, and ultimately both promote a more efficient and effective 
ANDA review process and help reduce the number of review cycles 
necessary to obtain ANDA approval. In addition, this guidance provides 
information on how FDA implements the 180-day exclusivity period under 
FDARA for certain first approved applicants that submit ANDAs for drugs 
designated as CGTs. FDARA created a new type of 180-day exclusivity, 
different from 180-day patent challenge exclusivity, for the first 
approved applicant of a drug with a CGT designation for which there 
were no unexpired patents or exclusivities listed in the Orange Book at 
the time of original submission of the ANDA. This new 180-exclusivity 
under FDARA (``CGT exclusivity'') is intended to incentivize 
competition for drugs that are not protected by a patent or exclusivity 
and for which there is inadequate generic competition.
    This guidance finalizes the draft guidance entitled ``Competitive 
Generic Therapies'' issued on February 19, 2019 (84 FR 4826). FDA 
considered comments received on the draft guidance as the guidance was 
finalized. Editorial changes were made to clarify that each applicant 
should request CGT designation for a drug product that is subject of 
their application. We have also clarified that, although FDA may 
expedite development and strive to act on applications for drug 
products with a CGT designation prior to the Generic Drug User Fee 
Amendments (GDUFA) goal date, a CGT designation does not result in a 
shorter GDUFA goal date. Additional explanation was also added to note 
that pre-ANDA meetings may be granted for both complex and non-complex 
products on a case-by-case basis and that these meetings are intended 
to expedite development, but that they will not necessarily take place 
on an expedited basis. We also updated terminology to further delineate 
180-day patent exclusivity from 180-day CGT exclusivity. Finally, 
editorial changes were made to clarify the operation of 180-day CGT 
exclusivity and forfeiture.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Competitive Generic Therapies.'' 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 guidance refers to previously approved collections of 
information 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). The collections of information in 21 CFR 314.94, including the 
submission of ANDAs and requests for CGT designation, have been 
approved under OMB control number 0910-0001 (including 0910-0338 for 
Form FDA 356h). The collections of information associated with product 
development meetings, presubmission meetings, and mid-review cycle 
meetings between applicants and FDA have been approved under OMB 
control number 0910-0797.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: March 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05293 Filed 3-13-20; 8:45 am]
 BILLING CODE 4164-01-P