Performance Improvement 2000. Veterinary Medicine

01/01/2000

Electronic Submissions to CVM via the Internet

This study is part of a larger ongoing initiative to submit information to the Center electronically. CVM started receiving electronic submissions of Notices of Investigation Exemptions (NCIEs) during September 1997 on a pilot basis with a limited number of drug sponsors. Performance during the pilot period was evaluated and showed that processing time for electronic submissions was reduced to a third of that for comparable paper submissions before the pilot. As a result, in 1999 the Center released guidance allowing any registered sponsors to submit information in electronic format through e-mail. The advantages of this new system included: reduction in transmittal time from the sponsor to the Center, reduced processing time within the Center, reduced paper handling and storage requirements, increased customer satisfaction, and the ability of the Center to review, process, store and retrieve electronic records. The Center is preparing guidance documents to expand the scope of the electronic transmission process to include other reporting requirements. A report of this endeavor appears on FDA's home page under the electronic submissions section.

AGENCY SPONSOR: Center for Veterinary Medicine

FEDERAL CONTACT: Parbuoni, Elizabeth
301-827-7562

PIC ID: 7288

PERFORMER: Food and Drug Administration
Rockville MD

EXPECTED DATE OF COMPLETION: 9/30/2000

Organization Study on Bioresearch Monitoring (BIMO) Activities at the Center for Vet. Medicine and the Relationship of Quality Assurance as a Function. of the BIMO Program.

The objective of this study was to review and evaluate current bioresearch monitoring (BIMO) functions and recommend changes, if appropriate, and determine the correlation between the Quality Assurance/Quality Control responsibilities of drug sponsors and the BIMO program. The report recommends actions to consider (such as timeliness of inspections) for improving the Center for Veterinary Medicine's (CVM's) existing BIMO program. With the possible exception of expanding the BIMO staff, the recommendations may be accomplished by using the Center's current resources. The report also presents a plan whereby the Office of Surveillance and Compliance and the Office of New Animal Drug Evaluation can make the BIMO program more efficient and relevant to the review process by providing as many tools as possible (especially to the reviewers) through center-wide access to BIMO information.

AGENCY SPONSOR: Center for Veterinary Medicine

FEDERAL CONTACT: Larkins, Marcia
301-827-0137

PIC ID: 7271

PERFORMER: Food and Drug Administration
Rockville MD

EXPECTED DATE OF COMPLETION: 9/30/2000