[Federal Register Volume 85, Number 209 (Wednesday, October 28, 2020)]
[Notices]
[Pages 68336-68337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23848]


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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; 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 
``Referencing Approved Drug Products in Abbreviated New Drug 
Application 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), a 
reference standard, and the basis of submission in an ANDA submission.

DATES: The announcement of the guidance is published in the Federal 
Register on October 28, 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-2017-D-0114 for ``Referencing Approved Drug Products in Abbreviated 
New Drug Application Submissions.'' Received comments will be placed in

[[Page 68337]]

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, 240-402-7500.
     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, 240-402-7500.
    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., Silver Spring, MD, 20993, 240-402-7936.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Referencing Approved Drug Products in Abbreviated New Drug 
Submissions'' To obtain approval of an ANDA submitted under section 
505(j) of the Federal Food, Drug, and Cosmetic Act (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 any in vivo bioequivalence study is 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 past 
practice of identifying reference standards with the RLD symbol (``+'') 
in the printed version, and with a ``Yes'' 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 by clarifying the differences among them. This guidance 
provides recommendations on how applicants can 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 guidance finalizes the draft guidance announced in the Federal 
Register on January 17, 2017 (82 FR 4894). The final guidance 
incorporates clarifying revisions in light of comments received on the 
draft guidance. The final guidance also explains that a controlled 
correspondence may be submitted to FDA instead of a citizen petition to 
request that FDA designate a different listed drug as an RLD.
    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 ``Referencing Approved Drug Products in 
Abbreviated New Drug Application 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. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required.
    However, this guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by OMB under the PRA. The collections of 
information in 21 CFR part 314 for the submission of new drug 
applications and ANDAs have been approved under OMB control number 
0910-0001, the submission of citizen petitions is approved under OMB 
control number 0910-0191, and the submission of controlled 
correspondence pertaining to ANDAs is 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: October 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23848 Filed 10-27-20; 8:45 am]
BILLING CODE 4164-01-P


