[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Pages 26062-26063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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published the notice of availability for a draft guidance entitled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interested persons until January 21, 2003, to comment on the draft
guidance. FDA received several comments on the draft guidance and those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]
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