August 28, 2000
FDA PROPOSES RULES FOR NADA PRESUBMISSION CONFERENCES
FDA published a proposed regulation to describe the procedures to be followed for requesting, conducting, and documenting presubmission conferences in the August 25, 2000, Federal Register. Under the Animal Drug Availability Act (ADAA) amendments to the Federal Food, Drug, and Cosmetic Act, any person intending to file a new animal drug application (NADA), supplemental NADA,
or to investigate a new animal drug is entitled to one or more conferences with FDA to reach an agreement establishing a submission or investigational requirement.
A submission or investigational requirement includes, among other things, identification of the number and types of studies that are necessary to demonstrate the safety and effectiveness of a new animal drug for the intended uses and conditions of use prescribed, recommended, or suggested in the proposed labeling for the new animal drug. Presubmission conferences give FDA and a potential applicant a means to identify the least burdensome appropriate requirements that have a reasonable likelihood of resulting in approval.
This proposed regulation describes how a person would request a presubmission conference and describes the procedures for the conduct of the presubmission conference.
Copies of this proposed rule may be obtained from CVM's Home Page on the Internet at: http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755.
Interested persons may submit written comments on the proposed rule by November 8, 2000, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should include Docket No. OON-1399.
Written comments on the information collection provisions should be submitted by September 25, 2000, to the Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Bldg., 725 17th St. NW, Room 10235, Washington, DC 20503, Attn: Desk Officer for FDA.
Further information about this proposed rule is available from Gail L. Schmerfeld, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1620.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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