[Federal Register Volume 84, Number 91 (Friday, May 10, 2019)]
[Notices]
[Pages 20637-20638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5974]


Determining Whether To Submit an Abbreviated New Drug Application 
or a 505(b)(2) Application; 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 entitled ``Determining Whether to 
Submit an ANDA or a 505(b)(2) Application.'' This guidance is intended 
to serve as a foundational guidance to assist applicants in determining 
which one of the abbreviated approval pathways under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of 
a marketing application to FDA. The guidance announced in this notice 
finalizes the draft guidance with the same name dated October 2017.

DATES: The announcement of the guidance is published in the Federal 
Register on May 10, 2019.

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-2017-D-5974 for ``Determining Whether to Submit an ANDA or a 
505(b)(2) Application.'' 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

[[Page 20638]]

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 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: Elizabeth Giaquinto Friedman, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Rm. 1670, Silver Spring, MD 20993, 240-402-7930, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final guidance entitled 
''Determining Whether to Submit an ANDA or a 505(b)(2) Application.'' 
This guidance is intended to serve as a foundational guidance to assist 
applicants in determining which one of the abbreviated approval 
pathways under the FD&C Act is appropriate for the submission of a 
marketing application to FDA. This guidance highlights criteria for 
submitting applications under the abbreviated approval pathways 
described in section 505(j) and 505(b)(2) of the FD&C Act (21 U.S.C. 
355(j) and 21 U.S.C. 355(b)(2), respectively), identifies 
considerations to help potential applicants determine whether an 
application would be more appropriately submitted under section 505(j) 
or pursuant to section 505(b)(2) of the FD&C Act, and provides 
direction to potential applicants on requesting assistance from FDA in 
making this determination.
    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Pub. L. 98-417) (the Hatch-Waxman Amendments) added section 505(b)(2) 
and 505(j) of the FD&C Act, which describe abbreviated approval 
pathways for drug products regulated by the Agency under the FD&C Act. 
The Hatch-Waxman Amendments reflect Congress's efforts to balance the 
need to ``make available more low cost generic drugs by establishing a 
generic drug approval procedure'' with new incentives for drug 
development in the form of exclusivities and patent term extensions. 
With the passage of the Hatch-Waxman Amendments, the FD&C Act describes 
different routes for obtaining approval of two broad categories of drug 
applications: New drug applications (NDAs) and abbreviated new drug 
applications (ANDAs).
    This guidance focuses on those applications that can be submitted 
as ANDAs under section 505(j) of the FD&C Act, petitioned ANDAs under 
section 505(j)(2)(C) of the FD&C Act, or NDAs pursuant to section 
505(b)(2) of the FD&C Act. This guidance does not discuss stand-alone 
NDAs.
    In the Federal Register of October 13, 2017 (82 FR 47749), FDA 
announced the availability of the draft guidance of the same title 
dated October 2017. FDA received four comments on the draft guidance 
and those comments were considered as the guidance was finalized. We 
note that we received comments requesting clarification on the process 
for obtaining therapeutic equivalence evaluations. We will address 
therapeutic equivalence in a forthcoming guidance document (see 
``Guidance Agenda: New and Draft Guidances CDER Plans to Publish During 
Calendar Year 2019''). The final guidance contains minor clarifications 
to the draft guidance. The guidance announced in this notice finalizes 
the draft guidance dated October 2017.
    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 ``Determining Whether to Submit an ANDA or a 
505(b)(2) Application.'' 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 found in FDA regulations. These collections of information 
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 have been approved under 
OMB control number 0910-0001. The collection of information for 
controlled correspondence and pre-ANDA meeting requests has 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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: May 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09662 Filed 5-9-19; 8:45 am]
 BILLING CODE 4164-01-P