Document ID: FDA-2019-D-0065-0001
Agency: fda
Document Type: Notice
Title: Competitive Generic Therapies; Draft Guidance for Industry; Availability
Posted Date: 2019-02-19T05:00Z

[Federal Register Volume 84, Number 33 (Tuesday, February 19, 2019)]
[Notices]
[Pages 4826-4828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02598]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Competitive Generic Therapies; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled 
``Competitive Generic Therapies.'' On August 18, 2017, the FDA 
Reauthorization Act of 2017 (FDARA), which amended the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), was signed into law. Under FDARA, a 
section was added to the FD&C Act that established a new process to 
designate, and expedite the development and review of, certain drugs 
intended for submission or submitted in an abbreviated new drug 
application (ANDA) and for which there is ``inadequate generic 
competition.'' This draft guidance provides a description of the 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. This draft guidance also includes information on the 
actions FDA may take to expedite the development and review of an ANDA 
for a drug designated as a CGT. This draft guidance also provides 
information on how FDA implements the statutory provisions providing 
for a 180-day exclusivity period for certain first approved applicants 
that submit ANDAs for drugs designated as CGTs.

DATES: Submit either electronic or written comments on the draft 
guidance by April 22, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

[[Page 4827]]

     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.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.
    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. 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: 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 draft guidance for industry 
entitled ``Competitive Generic Therapies.'' On August 18, 2017, FDARA 
(Pub. L. 115-52) was signed into law. As part of FDARA, the Generic 
Drug User Fee Amendments were reauthorized (Title III) to continue 
timely access to high-quality affordable generic medicines. FDARA also 
created other enhancements associated with generic drugs. Specifically, 
section 803 of FDARA amended the FD&C 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 intended for 
submission or submitted in an ANDA and 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. 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 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. This guidance also includes 
information on the actions FDA may take to expedite the development and 
review of ANDAs for drugs designated as CGT. These actions may help to 
clarify the regulatory expectations for a particular drug, assist 
applicants in developing a more complete submission, and ultimately 
promote a more efficient and effective ANDA review process and help 
reduce the number of review cycles necessary to obtain ANDA approval.
    This guidance also provides information on how FDA implements the 
statutory provisions providing for a 180-day exclusivity period for 
certain first approved applicants that submit ANDAs for 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 patent or exclusivity and for which there is 
inadequate generic competition.
    This draft guidance is being issued consistent with FDA's good 
guidance

[[Page 4828]]

practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft 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-
3520). The collections of information in 21 CFR 314.94, including the 
submission of ANDAs and designations such as CGT product development, 
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 draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: February 12, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02598 Filed 2-15-19; 8:45 am]
 BILLING CODE 4164-01-P