0910-0117 Supporting Statement 06_12_2024

United States Food and Drug Administration

New Animal Drugs for Investigational Use

OMB Control No. 0910-0117 -- EXTENSION

SUPPORTING STATEMENT

Part A: Justification:

1. Circumstances Making the Collection of Information Necessary

This information collection helps support implementation of Agency statutory and regulatory requirements regarding the approval of new animal drugs. FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to approve new animal drugs. A new animal drug application (NADA) cannot be approved until, among other things, the new animal drug has been demonstrated to be safe and effective for its intended use(s). In order to properly test a new animal drug for an intended use, appropriate scientific investigations must be conducted. Under specific circumstances, section 512(j) of the FD&C Act (21 U.S.C. 360b(j)) permits the use of an investigational new animal drug to generate data to support a NADA approval. Section 512(j) of the FD&C Act authorizes us to issue regulations relating to the investigational use of new animal drugs.

Our regulations in part 511 (21 CFR part 511) set forth the conditions for investigational use of new animal drugs and require reporting and recordkeeping to qualify for the exemption from section 512(a) of the FD&C Act.

Our regulations require that certain information be submitted to us in a "Notice of Claimed Investigational Exemption for a New Animal Drug" (NCIE) to qualify for the exemption and to control shipment of the new animal drug and prevent potential abuse. We also require reporting by importers of investigational new animal drugs for clinical investigational use in animals (§ 511.1(b)(9)).

Sponsors use eSubmitter, a secure online, question-based submission tool, to submit the NCIE electronically (https://www.fda.gov/industry/fda-esubmitter/cvm-esubmitter-programs).

We therefore request OMB extension of OMB approval of the information collection provisions found in 21 CFR part 511 and the related collection instruments, as discussed in this supporting statement.

2. Purpose and Use of the Information Collection

The information collected is necessary to protect the public health. We use the information to determine that investigational animal drugs are distributed only to qualified investigators, adequate drug accountability records are maintained, and edible food products from treated food-producing animals are safe for human consumption. We also use the information collected to monitor the validity of the studies submitted to us to support new animal drug approval.

The information provided by the sponsor in the NCIE is needed to help ensure that the proposed investigational use of the new animal drug is safe and that any edible food will not be distributed without proper authorization from FDA. Information contained in an NCIE submission is monitored under our Bioresearch Monitoring Program. This program permits us to monitor the validity of the studies and to help ensure the proper use of the drugs is maintained by the investigators.

Description of Respondents: Respondents to this collection of information are persons who use new animal drugs for investigational purposes. Investigational new animal drugs are used primarily by drug industry firms, academic institutions, and the government (i.e., sponsors of investigational new animal drugs). Investigators may include individuals from these entities, as well as research firms and members of the medical professions. Both fee-paying and non-fee-paying sponsors are respondents with respect to this information collection.

3. Use of Improved Information Technology and Burden Reduction

The animal health industry may use eSubmitter, a secure online submission tool, for all submissions related to the investigation of new animal drugs for approval, to submit the NCIE. Instructions for submission can be found at https://www.fda.gov/media/75464/download.

CVM’s eSubmitter program is an electronic, question-based tool for submitting information electronically through the FDA Electronic Submission Gateway (ESG) and CVM Electronic Submission System (ESS). These submissions are submitted 100% electronically. Information collection associated with electronic records is currently approved under OMB control number 0910-0303.

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

There is no exemption from the section 512(j) of the FD&C Act for small businesses. We believe that our requirements for new animal drugs for investigational uses impose the minimal information collection burden necessary while still allowing us to ensure the safety of the program. 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. We estimate that approximately 93% of respondents are small businesses.

6. Consequences of Collecting the Information Less Frequently

The information collection schedule is consistent with statutory requirements and applicable 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

FDA published a 60-day notice for public comment in the Federal Register of May 2, 2024 (89 FR 35838). No comments were received.

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. Data will be kept private to the extent allowed by law.

The Privacy Act of 1974

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 includes point of contact name, business address, and point of contact signature. FDA determined that although PII is collected, the collection is not subject to the Privacy Act of 1974 and the particular notice and other requirements of the Act do not apply. Specifically, the contractor or FDA does not use name or any other personal identifier to retrieve records from the information collected. Through appropriate form and webpage design, FDA limited submission fields and minimized the PII collected to protect the privacy of the individuals.

Freedom of Information Act

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

Table 1.--Estimated Annual Reporting Burden

21 CFR Section/Activity	No. of Respondents	No. of Responses per Respondent	Total Annual Responses	Average Burden per Response	Total Hours
511.1(b)(4), 511.1(b), (5) 511.1(b)(6) 511.1(b)(8)(ii), and 511.1(b)(9); submissions of NCIE, data to obtain authorization, any additional information upon request of FDA, reporting of findings that may suggest significant hazards, and reporting by importers of investigational new animal drugs for clinical investigational use in animals.	257	5.70	1,466	1.12	1,6341

¹ Totals may not sum due to rounding.

Table 2.--Estimated Annual Recordkeeping Burden

21 CFR Section/Activity	No. of Recordkeepers	No. of Records per Recordkeeper	Total Annual Records	Average Burden per Recordkeeping	Total Hours
511.1(a)(3), 511.1(b)(3), 511.1(b)(7), and 511.1(b)(8)(ii); Maintain records showing the name and post office address of the expert or expert organization to whom the new animal drug, or feed containing the same is shipped and the date, quantity, and batch or code mark of each shipment and delivery; maintain records of the investigation and all reports received by a sponsor from investigators.	257	17.43	4,482	2.57	11,5191

¹ Totals may not sum due to rounding.

The NCIE must contain, among other things, the following specific information: (1) identity of the new animal drug, (2) labeling, (3) statement of compliance of any non-clinical laboratory studies with good laboratory practices, (4) name and address of each clinical investigator, (5) the approximate number of animals to be treated or amount of new animal drug(s) to be shipped, and (6) information regarding the use of edible tissues from investigational animals (§ 511.1(b)(4) (21 CFR 511.1(b)(4))). If the new animal drug is to be used in food-producing animals (e.g., cattle, swine, chickens, fish, etc.), certain data must be submitted to us to obtain authorization for the use of edible food products from treated food-producing animals (§ 511.1(b)(5)). We require sponsors upon request to submit information with respect to the investigation to determine whether there are grounds for terminating the exemption (§ 511.1(b)(6)). We require sponsors to report findings that may suggest significant hazards pertinent to the safety of the new animal drug (§ 511.1(b)(8)(ii)).

If the new animal drug is only for tests in vitro or in laboratory research animals, the person distributing the new animal drug must maintain records showing the name and post office address of the expert or expert organization to whom it is shipped and the date, quantity, and batch or code mark of each shipment and delivery for a period of 2 years after such shipment or delivery (§ 511.1(a)(3) and (b)(3)).

We require complete records of the investigation, including records of the receipt and disposition of each shipment or delivery of the investigational new animal drug (§ 511.1(b)(7)). We also require records of all reports received by a sponsor from investigators to be retained for 2 years after the termination of an investigational exemption or approval of a new animal drug application (§ 511.1(b)(8)(i)).

The estimate of the time required for reporting requirements, record preparation, and maintenance for this collection of information is based on our informal communication with industry. Based on the number of sponsors subject to animal drug user fees, we estimate that there are 257 respondents. We use this estimate throughout both tables to calculate the "number of responses per respondent" by dividing the total annual responses by number of respondents. The burden we attribute to reporting and recordkeeping activities is assumed to be distributed among the individual elements of the respective information collection activities.

Additional information needed to make a final calculation of the total burden hours (i.e., the number of respondents, the number of recordkeepers, the number of NCIEs received, etc.) is derived from our records.

The total burden for this information collection is 13,153 hours.

12b. Annualized Cost Burden Estimate

The annual hourly burden for the information collection requirements in these regulations is estimated at 13,153 burden hours. The cost to the respondents is estimated by assuming a cost of $56.89 per hour for 13,153 burden hours for a total cost of $748,274.17.

Type of Respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Industry Compliance Officer	13,153	$56.89	$748,274.17

¹ May 2022 National Industry-Specific Occupational Employment and Wage Estimates, Bureau of Labor Statistics and including 30% for benefits (https://www.bls.gov/oes/current/oes131041.htm).

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 collection.

14. Annualized Cost to the Federal Government

The agency believes the time it expends for receipt, processing, review, and evaluation for an investigational new animal drug submission is commensurate with that for industry. We therefore estimate the cost of the information collection to the Federal government to be $792,994.37. This is based on the 2024 OPM wage rates for a GS-13- Step 3 employee in the Washington-Baltimore-Arlington, DC-MD-VA-WV-PA area, $60.29/hour (13,153 burden hours x $60.29/hour = $792,994.37).

15. Explanation for Program Changes or Adjustments

There have been no changes to the information collection. Since our last renewal, there is an adjustment decrease in the total burden hours of 2,401, which we attribute to a decrease in the number of respondents, annual responses and records.

Plans for Tabulation and Publication and Project Time Schedule

This information collected will not be published or tabulated.

16. Reason(s) Display of OMB Expiration Date is Inappropriate

FDA will display the OMB expiration date as required by 5 CFR 1320.5.

17. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

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