Food and Drug Administration Modernization Act of 1997 (FDAMA)
In your responses and presentations, please address the questions at the end of the FDA message (and included below) from a CVM and an Agency perspective, as well as, the CVM specific questions also included below.
FDA Questions
To help focus comments, the following questions have been developed in the context of the objectives described in section 406 (b) of FDAMA.
What can FDA do to improve its explanation of the Agency's submission review processes, and make explanations more available to product sponsors and other interested parties?
How can the Agency maximize the availability and clarity of information concerning new products?
How can FDA work with its partners to ensure that products--domestic and foreign--produced and marketed by the regulated industry are of high quality and provide necessary consumer protection; and how can FDA best establish and sustain an effective, timely, and science-based postmarketing surveillance system for reporting, monitoring, evaluating, and correcting problems associated with use/consumption of FDA-regulated products?
What approach should FDA use to ensure an appropriate scientific infrastructure with continued access to scientific and technical expertise needed to meet its statutory obligations and strengthen its science-based decision-making process?
What do you believe FDA should do to adequately meet the demands that are beginning to burden the application review process, especially for non-user fee products, so that it can meet its statutory obligations to achieve timely product reviews?
What suggestions do you have for the Agency to eliminate backlogs in the review process?
What other objectives related to the Agency's statutory obligations or public expectations - beyond the six objectives - should be included in the FDA plan?
CVM Questions
Thinking about the many consumer protection functions performed by CVM (a listing of the functional activities performed by each of the offices in the Center was included in the information package mailed to you), are there some that should be changed? If so, how? Are there some that could be deleted? Are there functions not included that you would add?
Which of these functions do you believe, it would be acceptable for CVM to charge fees?
Which of these functions could, and should, CVM rely more on the efforts of third parties, such as testing laboratories, veterinary organizations, standards (domestic or international) setting organizations, states, or regulated industry?
Which of these functions do you see as having the best potential for CVM to collaborate with its external stakeholders? Please be specific and name both the functions and the collaborating stakeholder.
Which of these functions do you believe offers the greatest opportunities for CVM to place more emphasis on non-regulatory approaches -- such as education, technical assistance, and collaborative problem solving -- to protect and promote public health?
In the international arena, CVM is faced with similar questions on the allocation of its resources. Currently, the Center's international resources are split between international standard setting, such as the establishment of veterinary drug residue standards; efforts to internationally harmonize veterinary drug registration requirements; involvement in Agency efforts to develop mutual recognition agreements between the U.S. and other nations; offering technical assistance to foreign regulatory officials; and providing technical support to U.S. trade agencies. Would you maintain the current mix of effort, or change it? If you would change it, how?
We have established a docket to receive any input that you may have on the six objectives outlined in section 406(b) of FDAMA. The more specific and concrete you can be in your suggestions, the more helpful they will be in developing the 406(b) plan. The docket number is 98N-0339. Comments may be sent via hard copy to the following address:
Food and Drug Administration
Dockets Management Branch
Room 1061, HFA-305
5630 Fishers Lane
Rockville, Maryland 20852
Comments can also be provided on line at http://www.fda.gov or sent via e-mail to the following address, FDADOCKETS@BANGATE.FDA.GOV.
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