[Federal Register Volume 61, Number 226 (Thursday, November 21, 1996)]
[Proposed Rules]
[Pages 59209-59211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29767]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 511 and 514

[Docket No. 96N-0411]


New Animal Drugs for Investigational Use and New Animal Drug 
Applications

Agency: Food and Drug Administration, HHS.

Action: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
intent to propose revisions to its

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regulations governing new animal drugs for investigational use and new 
animal drug applications (NADA's). On October 9, 1996, President 
Clinton signed into law the Animal Drug Availability Act of 1996 (the 
ADAA). FDA intends to propose revisions to the investigational new 
animal drug (INAD) and NADA regulations to implement the ADAA. FDA also 
intends to propose revisions to the INAD and NADA regulations to 
fulfill its commitment under the National Performance Review to 
reinvent the regulation of animal drugs. In the President's National 
Performance Report, ``Reinventing the Regulation of Animal Drugs,'' May 
1996, the President announced FDA's proposal to revise its regulations 
to create a more efficient process for reviewing and approving new 
animal drugs (NAD's). FDA's proposal for changes in the process for 
reviewing and approving animal drugs is intended to minimize the 
regulatory burden upon industry without compromising FDA's ability to 
ensure that the animal drugs it approves are safe and effective.

DATES: Written comments before January 21, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: George A. Mitchell, Center for 
Veterinary Medicine (HFV-1), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1761.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 9, 1996, President Clinton signed into law the ADAA. The 
purpose of the ADAA is to build into the NAD approval process needed 
flexibility to facilitate more efficient and expeditious approval of 
NAD's without decreasing FDA's existing authority to ensure that animal 
drug products are safe for use in animals and for humans who consume 
food products derived from animals. The ADAA does this, in large part, 
by redefining substantial evidence, the standard by which FDA 
determines whether a NAD is effective. The ADAA redefines the term 
``substantial evidence'' to mean:

    evidence consisting of one or more adequate and well-controlled 
investigations, such as--a study in a target species; a study in 
laboratory animals; any field investigation that may be required 
under [section 512(d)(3)] and that meets the requirements of 
subsection (b)(3) if a presubmission conference is requested by the 
applicant; a bioequivalence study; or an in vitro study; by experts 
qualified by scientific training and experience to evaluate the 
effectiveness of the drug involved, on the basis of which it could 
fairly and reasonably be concluded by such experts that the drug 
will have the effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the 
labeling or proposed labeling thereof.

    Section 2(e) of the ADAA directs FDA to further define by 
regulation the term ``substantial evidence'' and the term ``adequate 
and well-controlled'' as it relates to field investigations that alone 
or along with other studies may establish substantial evidence that a 
NAD is effective. The ADAA also requires FDA to publish regulations to 
address dose range labeling. FDA has 6 months from the enactment of the 
ADAA to publish proposed regulations to further define ``adequate and 
well-controlled'' and 12 months to publish proposed regulations to 
address dose range labeling and further define ``substantial 
evidence.''
    In the President's National Performance Report, ``Reinventing the 
Regulation of Animal Drugs,'' May 1996, the President announced FDA's 
proposal to revise its regulations to create a more efficient process 
for reviewing and approving NAD's. Historically, FDA has reviewed 
NADA's using a process that emphasized centralized coordination of an 
application review. Although this approach has advantages, FDA has 
found that this approach for processing applications has also resulted 
in delays. FDA has introduced numerous process changes intended to 
foster a more streamlined animal drug application review and approval 
process and reduce the regulatory burden on industry. For example, FDA 
tested an evaluation process described as direct review. Under direct 
reviews of sponsors' technical submissions, individuals conducting 
reviews of technical submissions are responsible for the scientific 
evaluation and administrative processing of a particular section of a 
submission and for communicating directly with the appropriate 
responsible official of the drug sponsor. To implement FDA's 
reinventing government proposal, FDA intends to propose revisions to 
its INAD and NADA regulations to reflect such process changes. The 
proposed changes to the INAD and NADA regulations will also reflect, 
among other things, CVM's use of presubmission conferences, phased 
review of data submissions, direct review of sponsors' technical 
submissions, and sponsor-monitored methods trials.

II. Revisions Under Consideration

    The agency intends to propose revisions to the INAD and NADA 
regulations to further define ``substantial evidence'' and ``adequate 
and well-controlled,'' as well as address dose range labeling, as 
directed by the ADAA. FDA also anticipates proposing revisions to these 
regulations to implement other aspects of the ADAA, i.e., presubmission 
conferences, combination animal drugs, Veterinary Feed Directive (VFD) 
drugs, and feed mill licensing. Finally, FDA intends to propose 
revisions to the INAD and NADA regulations to implement FDA's 
reinventing government proposal to reinvent the regulation of animal 
drugs.

III. Agency Request for Comments

    FDA is soliciting comments on all aspects of this advance notice of 
proposed rulemaking (ANPRM), and specifically requests comments on the 
following issues:
    (1) Further definition of ``substantial evidence.''
    (2) Defining ``adequate and well-controlled'' as it relates to 
field investigations.
    (3) Regulations to address dose range labeling.
    (4) Regulations to implement presubmission conferences.
    (5) Regulations to implement the streamlined approval process for 
certain combination animal drugs.
    (6) The content and format of a VFD.
    (7) CVM's use of a phased review process for reviewing NADA's.
    (8) CVM's use of direct review of sponsors' technical submissions 
for reviewing NADA's.
    (9) CVM's review of manufacturing supplements.

IV. Comments

    Interested persons may, on or before January 21, 1997, submit to 
the Dockets Management Branch (address above) written comments 
regarding this ANPRM. Because the ADAA requires FDA to publish 
regulations within short timeframes, FDA encourages that comments be 
submitted as soon as possible. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This ANPRM is issued under section 2(e) of the ADAA, sections 201, 
501, 502, 503, 512, 701, and 801 of the Federal Food, Drug, and 
Cosmetic Act

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(21 U.S.C. 321, 351, 352, 353, 360b, 371, and 381), and under the 
authority of the Commissioner of Food and Drugs.

    Dated: November 15, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-29767 Filed 11-20-96; 8:45 am]
BILLING CODE 4160-01-F