Document ID: FDA-2017-D-5974-0001
Agency: fda
Document Type: Notice
Title: ‘‘Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application;’’ Draft Guidance for Industry; Availability
Posted Date: 2017-10-13T04:00Z

[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Notices]
[Pages 47749-47750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22196]

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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Application or a 505(b)(2) Application;'' Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled 
``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 (the FD&C Act) 
is appropriate for the submission of a marketing application to FDA.

DATES: Submit either electronic or written comments on the draft 
guidance by December 12, 2017 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 http://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 http://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 http://www.regulations.gov and insert the

[[Page 47750]]

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: 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, 
elizabeth.giaquinto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
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 under 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 under section 505(b)(2) 
of the FD&C Act. This guidance does not discuss stand-alone NDAs.
    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 factors for 
applicants to consider when 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 draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated October 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22196 Filed 10-12-17; 8:45 am]
BILLING CODE 4164-01-P