81 FR 58516 - Abbreviated New Drug Application Submissions-Refuse To Receive for Lack of Justification of Impurity Limits; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 165 (August 25, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Abbreviated New Drug Application Submissions--Refuse to Receive for Lack of Justification of Impurity Limits.'' This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements for which the applicant is seeking approval of a new strength of the drug product. The guidance highlights deficiencies about impurity information that may cause FDA to refuse to receive (RTR) an ANDA.

[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Notices]
[Pages 58516-58517]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20399]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1292]


Abbreviated New Drug Application Submissions--Refuse To Receive 
for Lack of Justification of Impurity Limits; 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 guidance for industry entitled ``Abbreviated New 
Drug Application Submissions--Refuse to Receive for Lack of 
Justification of Impurity Limits.'' This guidance is intended to assist 
applicants preparing to submit to FDA abbreviated new drug applications 
(ANDAs) and prior approval supplements for which the applicant is 
seeking approval of a new strength of the drug product. The guidance 
highlights deficiencies about impurity information that may cause FDA 
to refuse to receive (RTR) an ANDA.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments 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): 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-2014-D-1292 for ``Abbreviated New Drug Application Submissions--
Refuse to Receive for Lack of Justification of Impurity Limits.'' 
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 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

[[Page 58517]]

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 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 http://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 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., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 
240-402-7930.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Abbreviated New Drug Application Submissions--Refuse to 
Receive for Lack of Justification of Impurity Limits.'' This guidance 
is intended to assist applicants preparing to submit to FDA ANDAs and 
prior approval supplements to ANDAs for which the applicant is seeking 
approval of a new strength of the drug product. The guidance highlights 
serious deficiencies in impurity information that may cause FDA to RTR 
an ANDA. Specifically, these deficiencies include: (1) Failing to 
provide justification for proposed limits for specified identified 
impurities in drug substances and drug products that are above 
qualification thresholds; (2) failing to provide justification for 
specified unidentified impurities that are above identification 
thresholds; and (3) proposing limits for unspecified impurities (e.g., 
any unknown impurity) that are above identification thresholds.
    FDA evaluates each submitted ANDA individually to determine whether 
it is sufficiently complete to permit a substantive review and thus can 
be received by FDA. The Agency cannot receive an ANDA unless it 
contains the information required under section 505(j) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) and related regulations 
(e.g., 21 CFR 314.101(b)(1)). FDA issued the guidance for industry 
``Abbreviated New Drug Application Submissions--Refuse-to-Receive 
Standards'' to explain in some detail the kind of omissions that can 
lead to a RTR determination. A draft of this guidance was published on 
September 17, 2014, with the title ``ANDA Submissions--Refuse to 
Receive for Lack of Proper Justification of Impurity Limits.'' Upon 
review of the comments submitted to the draft guidance, FDA removed the 
word ``proper'' from the title to emphasize that this guidance does not 
apply to the technical review of impurity limit justifications 
submitted in an ANDA.
    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 ``Abbreviated New Drug Application 
Submissions--Refuse to Receive for Lack of Justification of Impurity 
Limits.'' 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 guidance at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20399 Filed 8-24-16; 8:45 am]
 BILLING CODE 4164-01-P