0566 Supporting Statement 2015

Dispute Resolution Procedures for Science-Based Decisions on Products Regulated
by the Center for Veterinary Medicine (CVM)
OMB CONTROL NO. 0910-0566
SUPPORTING STATEMENT
Terms of Clearance: None.
Part A. Justification
1. Circumstances Making This Information Collection Necessary
This guidance document describes CVM’s policy for resolution of disputes relating to
scientific controversies. A scientific controversy involves issues that arise within the
context of the Center’s regulation of a specific product and are related to matters of
technical expertise that require some specialized education, training, or experience to be
understood and resolved. The guidance document #79 describes the dispute resolution
procedures that we recommend be followed by sponsors, applicants, and manufacturers
when requesting review of FDA decisions related to regulated products for animals.
The specific citation within 21 CFR Part 10 regarding information collection
requirements for which we request OMB approval is:
21 CFR 10.75 (b)(2) Internal Agency Review of Decisions
Section 404 of the Food and Drug Modernization Act of 1997 (FDAMA) amends the
Federal, Food, Drug and Cosmetic Act (the act) by adding a provision (section 562) for
dispute resolution. 21 CFR 10.75 was amended to allow the FDA centers to develop and
administer their own processes for handling requests for reviews of scientific
controversies. This guidance sets forth CVM’s processes.
This information collection does not relate to the American Recovery and Reinvestment
Act of 2009.
2. Purpose and Use of the Information Collection
This information will be submitted by sponsors, applicants, or manufacturers, who
request review of a scientific controversy relating to a decision affecting animal drugs or
other products that are regulated by CVM. The purpose of collecting this information is
to facilitate the resolution of such disputes and promote greater use of alternative dispute
resolution techniques including mediation, arbitration, and neutral intervention by the
CVM Ombudsman.
3. Use of Improved Information Technology and Burden Reduction
N/A.

4. Efforts to Identify Duplication and Use of Similar Information
This information is not collected by any other agency in the Government. The
information collection required by 21 CFR 10.75(b)(2) does not duplicate any other
information collection.
5. Impact on Small Businesses or Other Small Entities
FDA’s dispute resolution procedures and their accompanying collections of information
benefit small businesses as well as larger business concerns because they lead to informal
ombudsman intervention, mediation and/or arbitration of disputes, which will result in
time and money saved by not litigating these issues. This reduces the burden of
compliance on businesses by allowing a forum for discussion and resolution of scientific
controversies in accordance with a May 1, 1998, Presidential memorandum which sought
to encourage the use of alternative means of dispute resolution within the Federal
government.
6. Consequences of Collecting the Information Less Frequently
If this information is not collected, CVM and the CVM Ombudsman will not be able to
assess accurately the scientific controversy under dispute and this will make the
resolution process more difficult. The information is collected only for the purpose of
evaluating and deciding on the scientific issues in dispute and may not be collected less
frequently.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The information collection is consistent with 5 CFR 1320.5 and 5 CFR 1320.6.

8. Comments in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency
On November 6, 2014 (79 FR 65976), FDA published in the Federal Register, a 60-day
notice of extension of information collection 0910-0566 entitled, “Dispute Resolution
Procedures for Science-Based Decisions on Products Regulated by the Center for
Veterinary Medicine (CVM).” The public was given until January 5, 2015, to submit
comments on the extension of the information collection. One comment was received
which was not responsive to the request for comment on the information collection and
was outside the scope of this information request.
9. Explanation of any Payment or Gift to Respondents
There are no payments or gifts to respondents.

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10. Assurance of Confidentiality Provided to Respondents
Information and records from respondents are kept in a secure building and in secured
files first within the keeping of the Division Director and the Office Director, then within
the CVM Ombudsman’s keeping and finally within the keeping of the Deputy Center
Director and the Center Director for requests for review by the Ad Hoc Appeals
Committee and by an advisory committee respectively.
11. Justification for Sensitive Questions
This information does not contain questions pertaining to any matter commonly
considered private or of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Table 1. – Estimated Annual Reporting Burden1
21 CFR
Section

No. of
Respondents

10.75

2

No. of
Responses per
Respondent
4

Total Annual
Responses

8

Average
Burden per
Response
10

Total Hours

80

1

There are no capital costs or operating and maintenance costs associated with this collection of
information.

12b. Annualized Cost Burden Estimate
Type of Respondent

Industry
Compliance Officer
or Consultant

Total Burden Hours

Hourly Wage Rate

80

Total Respondent
Costs

$30

$2400

13. Estimates of Other Total Annual Costs to Respondents and/or
Recordkeepers/Capital Costs
N/A.
14. Annualized Cost to the Federal Government
The Dispute Resolution process involves potentially mediation and negotiation with staff
at all levels of CVM with widely varying rates of compensation or FTEs. This includes
the Division and Office Directors up to other senior level management. Each appeal is
unique and many do not reach the highest level because they are settled at a lower level
in the chain of command.

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There is one FTE for the CVM Ombudsman who handles the dispute resolution process,
2 FTEs for the Division Director and the Office Director and 2 FTEs for the Deputy
Center Director and the Center Director who decide the outcome of a scientific
controversy. The Ad Hoc Appeals Committee would involve a minimum of an additional
3 FTEs. Scientific disputes resolved at a lower level in the chain of command generally
only involve the FTES for the Division Director and the Office Director. The cost of
each FTE is roughly $126,000 (an average compensation rate of a GS-15, Step 1 for
2015) for a total of $1,008,000 for approximately 8 FTEs.
15. Changes from Previous Approval
This estimated annual reporting burden is based on CVM’s experience over the past 3
years in handling formal appeals for scientific disputes. The number of respondents
increased from 1 to 2 annually, the frequency of response increased from 3 to 4 annually,
the hours per response remained at 10 annually, and the total number of hours increased
from 30 to 80. This small increase in the total hourly burden is the result of a natural
fluctuation in the number of respondents taking advantage of this dispute resolution
process.
16. Plans for Tabulation and Publication and Project Time Schedule
The results of this information collection are not to be published.

17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA will display the OMB approval date.

18. Explanations to Section 19, “Certification for Paperwork Reduction Act
Submissions.”
There are no exceptions.

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