FDA — Campylobacter Risk Assessment: HHS Response to Rfr

08/01/2004

September 16, 2003

Kent D. McClure, D.V.M., J.D. 
General Counsel 
Animal Health Institute
1324 G Street, N.W. 
Suite 700
Washington, D.C. 20005

Re: Appeal of Request for Correction of Information

Dear Dr. McClure:

As Principal Associate Commissioner, I have been delegated the authority to act as the Commissioner in responding to your April 16, 2003 Information Quality Appeal regarding a Campylobacter risk assessment prepared by the Food and Drug Administration's (FDA's or agency's) Center for Veterinary Medicine (CVM). We apologize for the delay in responding.

Dissemination of accurate, non-misleading information is an important part of the agency's mission to promote and protect the public health. Public access to high quality information is critical to achieving this mission. The agency takes seriously its responsibility to ensure that the information it disseminates meets the high standards of quality set forth in section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001.

The Office of Management and Budget (OMB) has issued guidelines implementing section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001. 67 F.R. 8452 (Feb. 22, 2002). OMB's guidelines state that the administrative mechanisms allowing affected persons to seek correction of information disseminated by a federal agency should be flexible and incorporated into the agency's administrative practices. In the preamble to its guidelines, OMB recognized that many agencies already have processes in place to respond to public concerns and stated that it was not its intent to require these agencies to establish new processes. 67 F.R. at 8458.

As directed by OMB's guidelines, FDA and HHS have issued information quality guidelines to help ensure and maximize the quality, objectivity, utility, and integrity of information disseminated by the agency. http://www.hhs.gov/infoquality/part1A-9-20.htm;http://www.hhs.gov/infoquality/fda.html. Like OMB's guidelines, FDA's guidance provides that the agency intends to use existing processes to address complaints from the public concerning its information dissemination activities. The guidance lists a variety of procedures already in place to address complaints from the public, including public comment procedures for rulemakings and other formal agency actions. These procedures provide well-established procedural safeguards that allow affected persons to raise information quality issues on a timely basis. Accordingly, as provided in the guidance, FDA will use these existing procedures to respond to information quality complaints that arise in these contexts.

The formal evidentiary hearing currently underway on the agency's proposal to withdraw approval of the new animal drug application for enrofloxacin (Baytril, NADA 140 -828) is a formal agency action that provides well-established procedural safeguards allowing affected persons to raise information quality issues on a timely basis. In my capacity acting for the Commissioner in this matter, I have determined on behalf of the agency that your challenge to the risk assessment under section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 will be considered by the administrative law judge (ALJ) presiding over the hearing.1 I understand, from our meeting on June 2, 2003, as well as from the various motions and briefs filed in the hearing, that the adequacy of the risk assessment under section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 has, in fact, been raised in the context of the administrative hearing. The ALJ will consider your challenge in accordance with the FDA, HHS, and OMB guidelines in reaching his Initial Decision.2 The ALJ's findings on this issue, as on other issues, may be appealed to the Commissioner by filing exceptions to the ALJ's Initial Decision. Consequently, no other administrative process is necessary to ensure that your concerns about the quality of the risk assessment are addressed.

The agency is committed to ensuring that complaints raised under section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 are considered carefully and appropriately and, when appealed, receive an independent review. In the context of a formal evidentiary hearing under 21 CFR Part 12 there are a number of procedural tools and safeguards that ensure this. The ALJ has the authority to take any action for the fair, expeditious, and orderly conduct of the hearing. For example, he may certify for immediate review by the Commissioner his decision on any issue in order to prevent exceptional delay, expense, or prejudice to any participant, or substantial harm to the public interest.

For the reasons explained above, I find that your objections to the quality of the risk assessment are appropriately before the ALJ in the ongoing administrative hearing, and that no other administrative process is necessary to ensure that your concerns are appropriately addressed.

Sincerely,

Murray M. Lumpkin, M.D., M.Sc. 
Principal Associate Commissioner


1By separate letter (copy attached), I am informing the Administrative Law Judge of my determination.

2Of course, in addition to evaluating the risk assessment under the Data Quality Standards Act, the ALJ will consider any other issues raised with respect to the risk assessment in the course of the hearing,

Last Revised:  August, 2004