Advance notice of proposed
rulemaking: New Animal Drugs for Investigational Use and New Animal Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Public Health Service (PHS)
Food and Drug Administration (FDA)
21 CFR Parts 511 and 514
Docket No. 96N-0411 -- Advance notice of proposed rulemaking: New Animal Drugs for
Investigational Use and New Animal Drug Applications
Contact: George A. Mitchell, 301-594-1761
Comment Date: 01/21/97
*Proposed Rules* (FEDREGISTER 61 FR 59209 11/21/96; 171 lines.)
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.
SUMMARY: The Food and Drug Administration (FDA) is announcing
its intent to propose revisions to its 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. [p59210]
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 (21 U.S.C. 321, 351, 352, 353, 360b, 371, and
381), and under the authority of the Commissioner of Food and Drugs. [p59211]
Dated: November 15, 1996.
William B. Schultz, Deputy Commissioner for Policy.
[FR Doc. 96-29767 Filed 11-20-96; 8:45 am]
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