[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33758-33759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0725]


Draft Guidance for Industry on Abbreviated New Drug Application 
Submissions; Content and Format of Abbreviated New Drug Applications; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``ANDA 
Submissions--Content and Format of Abbreviated New Drug Applications.'' 
The guidance document is intended to assist applicants in preparing 
complete and high-quality original abbreviated new drug applications 
(ANDAs) for submission to FDA under the Federal Food, Drug, and 
Cosmetic Act. The guidance summarizes the statutory and regulatory 
requirements for ANDAs, references existing guidance documents, and 
incorporates additional recommendations on the content and format of 
ANDA submissions. This guidance describes the Common Technical Document 
format for human pharmaceutical product applications and specifies the 
information to be submitted in each section of the application.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 11, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10903 New

[[Page 33759]]

Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or 
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electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, 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, email: [email protected], or Stephen Ripley, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver 
Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``ANDA Submissions--Content and Format of Abbreviated New Drug 
Applications.'' On July 9, 2012, the Generic Drug User Fee Amendments 
(GDUFA) was signed into law by the President to speed the delivery of 
safe and effective generic drugs to the public and reduce costs to 
industry. Under GDUFA, FDA agreed to certain obligations as laid out in 
the GDUFA Commitment Letter. Among these obligations is FDA's 
commitment to performance metrics for the review of original ANDAs. For 
example, FDA has committed to review and act on 90 percent of original 
ANDA submissions within 10 months from the date of submission in Year 5 
of the program, which begins on October 1, 2016.
    In an effort to increase the number of original ANDAs that the 
Agency can receive upon initial submission and to decrease the number 
of review cycles required to approve an application for marketing, FDA 
prepared this guidance on improving the quality of original ANDA 
submissions. FDA is committed to providing comprehensive assistance in 
the early stages of the application process to ensure that an original 
ANDA contains all information necessary for FDA to complete its review 
in one review cycle.
    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 Agency's current thinking on ``ANDA 
Submissions--Content and Format of Abbreviated New Drug Applications.'' 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statutes and regulations.

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 
0910-0001. The collection of information in Form FDA 356h has been 
approved under 0910-0338. The collection of information for Form FDA 
3674 has been approved under 0910-0616. The collection of information 
for Form FDA 3794 has been approved under 0910-0727. The collection of 
information for Form FDA 3454 has been approved under 0910-0393. The 
collection of information for Form FDA 3455 has been approved under 
0910-0396. The collection information for 21 CFR part 11, Electronic 
Records, has been approved under 0910-0303.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

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

    Dated: June 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13641 Filed 6-11-14; 8:45 am]
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