0325 ss 1-13-2021

0325 ss 1-13-2021.pdf

Extra Label Drug Use in Animals

OMB: 0910-0325

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United States Food and Drug Administration
Extralabel Drug Use in Animals
OMB Control No. 0910-0325
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.
We therefore request OMB extension of OMB approval of 0910-0325 Extralabel Drug Use for
Animals found in 21 CFR Part 530 as discussed in this supporting statement.
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
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
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
6. Consequences of Collecting the Information Less Frequently
Without this information, FDA would not be able to assess the public health risk from certain
extralabel use of drugs in animals. This is only requested or when it has been identified as a
potential issue.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this information collection.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
FDA published a 60-day notice for public comment in the Federal Register of August 06, 2020
(85 FR 47794). Although one comment was received, it was not responsive to the four collection
of information topics solicited.
9. Explanation of Any Payment or Gift to Respondents
There are no incentives, payments or gifts associated with this information collection.
10. Assurance of Confidentiality Provided to Respondents
In preparing this Supporting Statement, we consulted our Privacy Office to ensure appropriate
identification and handling of information collected.
This ICR collects personally identifiable information (PII). PII is collected in the context of the
subject individuals’ professional capacity and the FDA-related work they perform for their
employer (e.g., point of contact at a regulated entity). The PII submitted is name, work email
address, and title. This information collection supports Food and Drug Administration regulations
allowing veterinarians to prescribe extralabel use of approved new animal drugs. Through
appropriate instruction, FDA minimized the PII collected to protect the privacy of the individuals.
Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), the public has broad access to
government documents. However, FOIA provides certain exemptions from mandatory public
disclosure of government records (5 U.S.C. 552(b)(1-9)). FDA will make the fullest possible
disclosure of records to the public, consistent with the rights of individuals to privacy, the property
rights of persons in trade and confidential commercial or financial information.
11. Justification for Sensitive Questions
The collection of information does not involve sensitive questions.
12. Estimates of Annualized Burden Hours and Cost

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

21 CFR Section

530.22(b); Submission(s) of
analytical method

No. of

No. of
Responses per


Burden per






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

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

Total Burden

Hourly Wage
Total Respondent Costs

May 2019 National Industry-Specific Occupational Employment and Wage Estimates, US Department of Labor,
Bureau of Labor Statistics (https://www.bls.gov/oes/current/oes131041.htm)$39.67 hourly wage plus 30% adjusted
for benefits.

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
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*
There were no program changes or adjustments.
16. Plans for Tabulation and Publication and Project Time Schedule
This information collected will not be published or tabulated.
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.

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