New Animal Drugs for Investigational Use and New Animal Drug Applications; Reopening of Comment Period

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]

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