0325 CVM Extra Label Use SSA 2018 Ext

U.S. Food and Drug Administration
Extra Label Drug Use in Animals
OMB Control No. 0910-0325

SUPPORTING STATEMENT Part A: Justification

1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration regulations regarding
specific reporting requirements as identified below. The Animal Medicinal Drug Use
Clarification Act of 1994 (P.L. 103-396) amended the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to allow veterinarians to prescribe extralabel use of approved new
animal drugs. It also permits FDA, if FDA finds that there is a reasonable probability that
the extralabel use of an animal drug may present a risk to public health, to establish a safe
level for a residue from the extralabel use of the drug, and to require the development of an
analytical method for the detection of residues above that established safe level. This
requirement is codified at 21 CFR 530.22(b). The requirement to establish an analytical
method may be fulfilled by any interested person. We believe that the sponsor of the drug
will be willing to develop the method in most cases. Alternatively, FDA, the sponsor, and
perhaps a third party may cooperatively arrange for method development. Accordingly, we
request extension of OMB approval of the information collection provisions found in 21
CFR 530.22(b), which requires the development and submission of an analytical
methodology for drug residue quantification above any safe level established, as prescribed
under the FD&C Act.
2. Purpose and Use of the Information Collection
The analytical method developed would be used by FDA and other State and Federal
agencies to assure the safety of the food supply when drugs are used in an extralabel
manner. Respondents to the information collection are private sector drug sponsors or
veterinary associations, or veterinarians, state, local, and tribal governments, and Federal
agencies.
3. Use of Improved Information Technology and Burden Reduction
The regulation does not specifically prescribe the use of automated, electronic, mechanical,
or other technological techniques. Firms are free to use whatever forms of information
technology may best assist them in development and submission of acceptable analytical
methodology for drug residue quantification above any safe level established.

4. Efforts to Identify Duplication and Use of Similar Information
The information collection requires the development and submission of an acceptable
analytical methodology for drug residue quantification when such methodology is not
available. We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
We estimate 75% of respondents are small businesses. FDA assists small businesses in
complying with its regulatory requirements through Regional Small Business
Representatives and through the scientific and administrative staffs within the agency. We
also provide guidance on our website at
http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm.
6. Consequences of Collecting the Information Less Frequently
Information collection schedule is consistent with statutory requirements under the FD&C
Act and applicable agency regulations.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in
the Federal Register of June 26, 2017 (82 FR 28858). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
There are no payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
Information will be kept confidential in accordance with 18 USC 1905 and 21 USC 331(j),
as well as section 301(j) of the FD&C Act.
11. Justification for Sensitive Questions
This information collection does not contain questions pertaining to sexual behavior,
attitude, religious beliefs, or any other matter commonly considered private or of a sensitive
nature.

2

12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
This information collection requires reporting of an analytical method for residue detection
of an extralabel use in animals of an approved animal or human drug. Although no
submissions have been received under the information collection, we believe there will be
instances when analytical methodology will be required. Thus, we continue to estimate
burden based on the possibility of requiring development and submission of methodology
for up to two drugs per year.
Table 1.--Estimated Annual Reporting Burden1
Average
Total
21 CFR Section
No. of
No. of
Burden per
Annual
Respondents Responses per
Responses Response
Respondent
530.22(b); Submission(s)
of analytical method
2
1
2
4,160
1

Total
Hours

8,320

There are no capital r operating and maintenance costs associated with the information collection.

12b. Annualized Cost Burden Estimate
Type of Respondent
Industry compliance
Officer1

Total Burden Hours

Hourly Wage Rate

8,320

Total Respondent
Costs

$43.90

$365,248

1

May 2016 National Industry-Specific Occupational Employment and Wage Estimates, US Department of Labor, Bureau
of Labor Statistics (https://www.bls.gov/oes/current/oes131041.htm) $33.77 hourly wage plus 30% adjusted for benefits.

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
We estimate Federal costs associated with the information collection will be absorbed by
existing resource allocations.
15. Explanation for Program Changes or Adjustments
The burden has not changed from the burden shown in the current inventory.
16. Plans for Tabulation and Publication and Project Time Schedule
Information is not to be published for statistical use.

3

17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

4