[Federal Register: March 15, 2005 (Volume 70, Number 49)]
[Page 12699-12700]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003D-0167]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Final Guidance for 
Industry on Dispute Resolution Procedures for Science-Based Decisions 
on Products Regulated by the Center for Veterinary Medicine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
14, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
rm. 4B-41, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION:  In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.
    Title: Dispute Resolution Procedures for Science-Based Decisions on 
Products Regulated by the Center for Veterinary Medicine
    Description: FDA is issuing a final guidance on the Center for 
Veterinary Medicine (CVM) process for formally resolving disputes 
relating to scientific controversies. The final guidance describes 
procedures for formally appealing such disputes. The final guidance 
provides information on how the agency intends to interpret and apply 
provisions of the existing regulations regarding internal agency review 
of decisions (Sec.  10.75 (21 CFR 10.75)). In a final rule issued in 
the Federal Register of November 18, 1998 (63 FR 63978), FDA amended 
Sec.  10.75 to reflect the provisions of FDAMA. This final guidance 
document outlines the recommended procedures for persons who are 
applicants for approval of animal drugs or other products regulated by 
CVM who wish to submit a request for review of a scientific dispute.
    The final guidance recommends a procedure whereby applicants first 
seek review through the supervisory chain of command. If the issue is 
not resolved at the supervisor's level, the interested person may 
request in writing that the matter be reviewed at the next higher 
supervisory level. This process may continue throughout the agency's 
entire supervisory chain of command through CVM and up to the level of 
the Commissioner of Food and Drugs (Commissioner). At each level of 
review (Division, Office Director, Deputy Center Director, and Center 
Director levels) CVM recommends that the applicant identify the 
information in the administrative file upon which the request is based. 
If the appeal contains new information not previously contained in the 
administrative file, the matter will, in accordance with 21 CFR 
10.75(d), be returned to the appropriate lower level in CVM for 
reevaluation based on that new information. After the applicant has 
appealed the decision through the supervisory chain of command, they 
may request review through an ad hoc appeals committee or review by the 
Veterinary Medicine Advisory Committee (VMAC) in writing to the CVM 
Ombudsman. If the applicant seeks review by the Ad Hoc Committee, the 
Chair should provide them the opportunity to submit written arguments 
to the Committee. The applicant may submit a letter appealing the Ad 
Hoc Committee's decision to the CVM Director and then to the 
Commissioner. CVM recommends that persons filing a request for review 
by VMAC provide the CVM Ombudsman with a concise summary of the 
scientific issue in dispute, including a summary of the particular FDA 
action or decision to which the requesting party objects, the results 
of all efforts that have been made to resolve the dispute to date, and 
a clear articulated summary of the arguments and relevant data and 
    The information collected will form the basis for resolving the 
dispute between the requester and FDA. The likely respondents to this 
collection of information are applicants for approval of animal drugs 
or other products regulated by CVM who have a scientific dispute with 
FDA and who request a review of the matter.
    Based on FDA's experience with dispute resolution, the agency 
expects that most persons seeking formal dispute resolution will have 
gathered the materials during any previous efforts to resolve the 
dispute with the agency. CVM considered the number and substance of 
similar appeals made to FDA in recent years under Guide 1240.3130 to 
arrive at numbers reflected in table 1 of this document. Guidance 
79 will supercede Guide 1240.3130 and CVM will eliminate the 
guide from the P & P Manual.
    In the Federal Register of May 19, 2003 (68 FR 27094), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 

[[Page 12700]]

                                 Table 1.--Estimated Annual Reporting Burden\1\
                         No. of        Annual Frequency     Total Annual        Hours  per
                      Respondents        per Response        Responses          Respondent        Total Hours
Guidance                           1                  2                  2                 30                 60
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    The use of VMAC for resolving scientific disputes represents a new 
process for CVM. Although the procedures for requesting dispute 
resolution by a scientific advisory committee as set forth in the final 
guidance document are new, CVM estimates that the number of respondents 
who would submit requests would not increase. The number of hours per 
respondent (30) encompasses a wide range depending on the dispute 
involved. The estimate was based on discussions with industry and is an 
average of hours per respondent.

    Dated: March 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-5040 Filed 3-14-05; 8:45 am]