[Federal Register Volume 62, Number 89 (Thursday, May 8, 1997)]
[Proposed Rules]
[Pages 25152-25153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11845]


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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; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; reopening of comment 
period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening to June 9, 
1997 the comment period for the advance notice of proposed rulemaking 
(ANPRM) for investigational use new animal drug (INAD) regulations and 
the new animal drug applications (NADA) regulations that published in 
the Federal Register of November 21, 1996. The comment period is being 
reopened for the sole purpose of inviting interested persons to submit 
comments that will give FDA guidance in developing proposed regulations 
defining ``good study practices.'' Elsewhere in this issue of the 
Federal Register, FDA is publishing a related document, a proposed rule 
further defining adequate and well-controlled studies. The definition 
of adequate and well-controlled studies requires that such a study, 
when conducted in the target animal, be conducted in compliance with 
good study practices.

DATES: Written comments by June 9, 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: Herman M. Schoenemann, Center for 
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1638.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 21, 1996 
(61 FR 59209), FDA published an advance notice of proposed rulemaking 
announcing the agency's intention to propose revisions to the INAD 
regulations and the NADA regulations. The purpose of these revisions is 
to: (1) Implement the Animal Drug Availability Act of 1996 (ADAA) (Pub. 
L. 104-250) and (2) fulfill FDA's commitment as announced in the 
President's National

[[Page 25153]]

Performance Report, ``Reinventing the Regulation of Animal Drugs,'' May 
1996. FDA solicited comments on all aspects of its proposed rulemaking 
relating to INAD and NADA regulations and requested comments on 
specific issues including defining ``adequate and well-controlled.''
    Section 2(e) of the ADAA, enacted on October 9, 1996, directed FDA 
to issue, within 6 months of its enactment, proposed regulations to 
further define the term ``adequate and well-controlled'' to require 
that field investigations be designed and conducted in a scientifically 
sound manner, taking into account practical conditions in the field and 
differences between field conditions and laboratory conditions. 
Elsewhere in this issue of the Federal Register, FDA has issued a 
proposed rule further defining adequate and well-controlled studies. As 
proposed, one characteristic of an adequate and well-controlled study 
is that such a study, when conducted in the target animal, be conducted 
in compliance with good study practices. As explained in the preamble 
to the proposed regulation defining adequate and well-controlled 
studies, FDA intends to define good study practices when the agency 
publishes the revised INAD regulations.
    FDA is reopening the comment period on the ANPRM for the sole 
purpose of inviting interested persons to submit comments which will 
give FDA guidance in developing proposed regulations defining good 
study practices. The agency is particularly interested in specific 
comments explaining which study practices, including practices such as 
those specified in good laboratory practices or specific practices 
recommended by the Center for Veterinary Medicine during the conduct 
studies or in guidance, could not be followed, in whole or in part, 
when studies are conducted under actual use conditions in field 
studies. These comments should include specific examples whenever 
possible.
    Interested persons may, on or before June 9, 1997 submit to the 
Dockets Management Branch (address above) written comments regarding 
good study practices. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to 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.

    Dated: April 29, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-11845 Filed 5-7-97; 8:45 am]
BILLING CODE 4160-01-F