[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Notices]
[Pages 4894-4896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0114]


Referencing Approved Drug Products in Abbreviated New Drug 
Application Submissions; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled

[[Page 4895]]

``Referencing Approved Drug Products in ANDA Submissions.'' Any person 
is permitted to submit an abbreviated new drug application (ANDA) in 
order to seek approval to market a generic version of a previously 
approved drug product. The purpose of this guidance is to provide 
information to potential applicants on how to identify a reference 
listed drug (RLD), reference standard, and the basis of submission in 
an ANDA submission.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 20, 2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-0114 for ``Referencing Approved Drug Products in ANDA 
Submissions.'' 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 Division of Dockets 
Management 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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: Gail Schmerfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-9291, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Referencing Approved Drug Products in ANDA Submissions.'' To 
obtain approval of an ANDA submitted under section 505(j) of the FD&C 
Act (21 U.S.C. 355(j)), an ANDA applicant generally must show, among 
other things, that the proposed generic drug has the same active 
ingredient(s), conditions of use, route of administration, dosage form, 
strength, and, with certain permissible differences, labeling as the 
specific listed drug referred to in the ANDA, i.e., the RLD. Under 
section 505(j)(2)(A)(iv) of the FD&C Act, the ANDA applicant also must 
demonstrate that the proposed generic drug is bioequivalent to the RLD 
and, if in vivo bioequivalence studies are required for approval of the 
ANDA, the applicant must use the reference standard selected by FDA in 
such testing (21 CFR 314.3(b)). Further, under section 505(j)(2)(A)(vi) 
of the FD&C Act, a generic drug must meet the same high standards of 
quality and manufacturing as drug products approved under section 
505(c) of the FD&C Act.
    This guidance provides information to potential applicants on how 
to identify a ``reference listed drug,'' ``reference standard,'' and 
the ``basis of submission'' in ANDA submissions. A variety of factors 
has led to confusion among stakeholders on what these terms mean and 
how an ANDA applicant should use them. These factors include the 
discontinued marketing of many approved drug products and FDA's 
identification of reference standards with the RLD symbol (``+'') in 
the printed version, and under the ``RLD'' column in the electronic 
version, of FDA's ``Approved Drug Products with Therapeutic Equivalence 
Evaluations'' (the ``Orange Book''). This guidance is intended to 
address this confusion by explaining what these terms mean and 
clarifying the differences among them. This guidance provides

[[Page 4896]]

recommendations on how to accurately use these terms in an ANDA, how 
persons can request FDA designation of an RLD, and how persons can 
request FDA selection of a reference standard.
    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 Referencing 
Approved Drug Products in ANDA Submissions. 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. 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 
https://www.regulations.gov.

    Dated: January 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00820 Filed 1-13-17; 8:45 am]
 BILLING CODE 4164-01-P