81 FR 71511 - Abbreviated New Drug Application Submissions-Prior Approval Supplements Under Generic Drug User Fee Amendments; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 200 (October 17, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``ANDA Submissions--Prior Approval Supplements Under GDUFA.'' The Generic Drug User Fee Amendments of 2012 (GDUFA) enables FDA to assess user fees to fund critical and measurable improvements to FDA's generic drugs program. This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs). It describes FDA's performance metric goals for PASs and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to GDUFA performance metric goals. This guidance finalizes the draft guidance issued on July 11, 2014.

[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71511-71513]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25037]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0901]


Abbreviated New Drug Application Submissions--Prior Approval 
Supplements Under Generic Drug User Fee Amendments; 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 ``ANDA 
Submissions--Prior Approval Supplements Under GDUFA.'' The Generic Drug 
User Fee Amendments of 2012 (GDUFA) enables FDA to assess user fees to 
fund critical and measurable improvements to FDA's generic drugs 
program. This guidance is intended to assist applicants preparing to 
submit to FDA prior approval supplements (PASs) and amendments to PASs 
for abbreviated new drug applications (ANDAs). It describes FDA's 
performance metric goals for PASs and clarifies how FDA will handle a 
PAS

[[Page 71512]]

and amendments to a PAS for an ANDA subject to GDUFA performance metric 
goals. This guidance finalizes the draft guidance issued on July 11, 
2014.

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-0901 for ``ANDA Submissions--Prior Approval Supplements 
Under GDUFA.'' 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 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; or to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, rm. 3128, 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: Tamara R. Coley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20903, 240-402-6903 or Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``ANDA Submissions--Prior Approval Supplements Under GDUFA.'' 
On July 9, 2012, the President signed GDUFA (Pub. L. 112-144, Title 
III) into law. GDUFA is based on an agreement negotiated by FDA and 
representatives of the generic drug industry to address a growing 
number of regulatory challenges. GDUFA aims to ensure timely access to 
safe, high-quality, affordable generic drugs. GDUFA enables FDA to 
assess user fees to fund critical and measurable improvements to FDA's 
generic drugs program and to bring greater predictability and 
timeliness to the review of generic drug applications.
    GDUFA requires that FDA and human generic drug manufacturers meet 
certain commitments. In the GDUFA Commitment Letter, FDA committed to 
review and act on a certain percentage of PASs within a specified 
period from the date of submission for receipts in fiscal years 2015 to 
2017. The percentage of PASs that FDA has committed to review and act 
on increases with each fiscal year, and the deadlines for review depend 
on whether a PAS requires an inspection.
    This guidance describes the performance metric goals to which FDA 
agreed in the Commitment Letter and clarifies how FDA will review a PAS 
and amendments to a PAS for an ANDA subject to the GDUFA performance 
metric goals. The GDUFA performance metrics described in this guidance 
only apply to ANDA applicants who electronically submit a PAS on or 
after October 1, 2014. These performance metrics do not apply to new 
drug applications (NDAs), biologics license applications (BLAs), 
supplements filed for NDAs or BLAs, or changes being effected 
supplements and annual report filings to NDAs, BLAs, or ANDAs.
    This guidance finalizes the draft guidance that was issued under 
the same title on July 11, 2014 (79 FR 40112), and reflects FDA's 
consideration of public comments on the draft guidance. Generally, FDA 
revised the

[[Page 71513]]

draft guidance to provide clarifying and explanatory information that 
will assist human generic drug manufacturers with PAS submissions. 
Changes from the draft guidance include clarification on the point at 
which a PAS is deemed submitted to FDA and a description of the process 
through which applicants may request FDA reconsider its supplement 
reporting category determination. The draft guidance and related public 
comments are publicly available in Docket No. FDA-2014-D-0901.
    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 ``ANDA Submissions--Prior Approval 
Supplements Under GDUFA.'' 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 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 for supplements and amendments in 21 CFR 
part 314 have been approved under OMB control number 0910-0001. The 
collection of information for manufacturer registration in 21 CFR part 
207 has been approved under OMB control number 0910-0045. The 
collection of information for manufacturer compliance with current good 
manufacturing practices in 21 CFR part 211 has been approved under OMB 
control number 0910-0139.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25037 Filed 10-14-16; 8:45 am]
 BILLING CODE 4164-01-P