80 FR 26062 - Administrative Applications and the Phased Review Process; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 87 (May 6, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #132 entitled ``Administrative Applications and the Phased Review Process.'' This guidance defines the ``phased review process'' for reviewing application-level information during the investigational period of new animal drug development, and an ``administrative'' new animal drug application (NADA) or abbreviated new animal drug application (ANADA), the content, the procedures a sponsor should follow to submit such an application, and the intended time frame for its review.

[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Pages 26062-26063]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10480]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2002-D-0147 (formerly Docket No. 2002D-0449)]


Administrative Applications and the Phased Review Process; 
Guidance for Industry; 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 guidance for industry (GFI) #132 entitled 
``Administrative Applications and the Phased Review Process.'' This 
guidance defines the ``phased review process'' for reviewing 
application-level information during the investigational period of new 
animal drug development, and an ``administrative'' new animal drug 
application (NADA) or abbreviated new animal drug application (ANADA), 
the content, the procedures a sponsor should follow to submit such an 
application, and the intended time frame for its review.

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

ADDRESSES: Submit written requests for single copies of the guidance to 
the Policy and Regulations Staff (HFV-6), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your request. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance document.
    Submit electronic comments on the 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: Katherine Weld, Center for Veterinary 
Medicine (HFV-108), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0846, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 6, 2002 (67 FR 67631), FDA 
published the notice of availability for a draft guidance entitled 
``The Administrative New Animal Drug Application Process'' giving 
interested persons until January 21, 2003, to comment on the draft 
guidance. FDA received several comments on the draft guidance and those 
comments were considered as the guidance was finalized. The guidance 
was updated to clarify current processes and include information about 
generic new animal drugs. The guidance announced in this notice 
finalizes the draft guidance dated November 6, 2002.
    To be legally marketed, a new animal drug must be the subject of 
either an approved application under section 512(b) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b), a 
conditional approval under section 571 of the FD&C Act (21 U.S.C. 
360ccc), or an index listing under section 572 of the FD&C Act (21 
U.S.C. 360ccc-1). Sections 512(b)(1) and 512(n)(1) of the FD&C Act 
describes the information that must be submitted to FDA, specifically 
the Center for

[[Page 26063]]

Veterinary Medicine (CVM), as part of an NADA or ANADA, respectively.
    CVM encourages sponsors to submit data for review at the most 
appropriate and productive times in the drug development process. 
Rather than submitting all data for review as part of a complete 
application, we have found that the submission of data supporting 
discrete technical sections during the investigational phase of the new 
animal drug is the most appropriate and productive. This ``phased 
review'' of data submissions has created efficiencies for CVM and the 
animal pharmaceutical industry. These increased efficiencies have 
facilitated the approval of both pioneer and generic new animal drugs.
    This guidance defines what an administrative (A)NADA is, defines 
and describes the phased review process, and briefly discusses how 
sponsors should submit an administrative (A)NADA and the time frame for 
review.

II. Significance of Guidance

    This level 1 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 Administrative Applications and the 
Phased Review Process. It does 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.

III. 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 in 21 CFR part 514 have been approved under 
OMB control number 0910-0032. The collections of information in section 
512(n)(1) of the FD&C Act have been approved under OMB control number 
0910-0669.

IV. 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.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: April 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10480 Filed 5-5-15; 8:45 am]
 BILLING CODE 4164-01-P