0032 NADAs and Vet Master Files SSA 2022 Ext

UNITED STATES FOOD & DRUG ADMINISTRATION

New Animal Drug Applications and Veterinary Master Files

OMB Control No. 0910-0032

SUPPORTING STATEMENT – Part A: Justification

1. Circumstances Making the Collection of Information Necessary

This information collection supports implementation of section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b), which governs new animal drugs. Agency regulations in 21 CFR part 514 and associated regulations in 21 CFR part 558, establish format and content requirements regarding new animal drug application (NADA) submissions, as well as provide for pre-application submissions, amended applications, and application supplements. This information collection also supports implementation of section 571 of the FD&C Act (21 U.S.C. 360ccc) regarding application for conditional approval of new animal drug (CNADA) submissions. As set forth in the FD&C Act and Agency regulations, requisite elements include safety and effectiveness data, proposed labeling, product manufacturing information, and, where necessary, complete information on food safety (including microbial food safety) and any methods used to determine residues of drug chemicals in edible tissue from food producing animals. Applications must be prepared as appropriate to support the particular submission.

We developed Form FDA 356v (Application for Approval of a New Animal Drug (or Submission to Support New Animal Drug Approval)) to provide a uniform format for submitting requisite information and to ensure efficient processing by the Agency. Form FDA 356v is available for download from our website at https://www.fda.gov/about-fda/reports-manuals-forms/forms. We also develop Agency guidance documents that may assist respondents with understanding NADA/CNADA requirements and related information collection activity. This includes FDA Guidance #152¹, which outlines a risk assessment approach for evaluating the microbial food safety of antimicrobial new animal drugs and includes Agency recommendations in this regard.

Under section 512(b)(3) of the FD&C Act, any person intending to file a NADA or supplemental NADA or a request for an investigational exemption under section 512(j) of the FD&C Act may request a conference prior to making a submission. Section 514.5 of our regulations (21 CFR 514.5) sets forth procedures for presubmission conferences and describes documentation associated with making requests, and preparing for and conducting meetings. We encourage sponsors to submit data for review at the most appropriate and productive times in the drug development process. Rather than submitting all data for review as part of a complete application, we have found that the submission of data supporting discrete technical sections during the investigational phase is most appropriate and productive. This “phased review” of data submissions has created efficiencies for us and the animal pharmaceutical industry.

We also encourage, as appropriate, the submission of a veterinary master file (VMF). For more information on VMFs, we invite you to visit https://www.fda.gov/animal-veterinary/development-approval-process/veterinary-master-files. A VMF provides detailed information used in support of application submissions. Questions regarding VMF submissions may be directed to our Center for Veterinary Medicine at cvmesubmitter@fda.hhs.gov. We have found that utilizing VMFs has increased the efficiency of the animal drug development and animal drug review processes for FDA and the animal pharmaceutical industry, providing for the confidential exchange of information with FDA and a process for reporting information outside of a NADA/CNADA or an investigational new animal drug file, as well as an opportunity for increased communication with FDA during the early stages of product development. A holder of a VMF may also authorize other parties to reference information included in the VMF without disclosing information in the file to those parties. VMFs can be used as repositories for information that can be referenced in multiple submissions to the Agency.

Section 558.5(i) of FDA regulations (21 CFR 558.5(i)) describes the procedure for requesting a waiver of the labeling requirements in § 558.5(h) in the event that there is evidence to indicate that it is unlikely a new animal drug would be used in the manufacture of a liquid medicated feed.

Finally, section 571 of the FD&C Act establishes requirements for the conditional approval of certain drugs² and the procedures for submitting applications for conditional approval. Although FDA receives fewer than one application submission under section 571 of the FD&C Act annually when averaged over a 3-year period, we use a placeholder of one response and 1 hour annually to account for the burden associated with these submissions.

Information collection associated with NADAs/CNADAs and related submissions is necessary to ensure that new animal drugs are in compliance with sections 512(b)(1) and 571 of the FD&C Act. We review the information, including data, labeling, and manufacturing controls and procedures, to evaluate the safety and effectiveness of the proposed new animal drug.

Therefore, we request extension of OMB approval of the information collection requirements in section 512 and 571 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b); in Form FDA 356V, New Animal Drug Application; and in Guidance #152: “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern” (October 2003).

2. Purpose and Use of the Information Collection

Information collection associated with NADAs/CNADAs and related submissions is necessary to ensure that new animal drugs are in compliance with sections 512(b)(1) and 571 of the FD&C Act. We review the information, including data, labeling, and manufacturing controls and procedures, to evaluate the safety and effectiveness of the proposed new animal drug. Description of Respondents: Respondents include persons developing, manufacturing, and/or researching new animal drugs, such as animal drug manufacturers (sponsors). Respondents include individuals and the private sector (for-profit businesses).

3. Use of Improved Information Technology and Burden Reduction

Submissions related to the new animal drug approval process contain summaries of data and narrative text. The animal health industry may use the free FDA eSubmitter software to prepare all submissions related to the new animal drug approval process. 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). CVM is moving to 100% electronic submission as required by the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, signed into law on August 14, 2018. We estimate that 100% of the NADA submissions will be submitted electronically in the next three years.

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

This collection poses no undue burden on small entities. The FD&C Act and our regulations require all respondents to submit the same information. There is no exemption from the requirements of the regulation for small businesses. We estimate that approximately 50% of the estimated 187 respondents reported in table 1, or approximately 91 firms, are small businesses. FDA aids small businesses in complying with its requirements through the Agency’s Regional Small Business Representatives and through the scientific and administrative staffs within the Agency. FDA also provides a Small Business Guide on the Agency’s website at http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm.

6. Consequences of Collecting the Information Less Frequently

Data collection occurs occasionally. There are no specific regulatory time frames imposed on an applicant for the collection or recording of information. Original NADAs are submitted only once and therefore cannot be collected less frequently.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances associated with 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 March 2, 2022 (87 FR 11713). Although one comments was received, the comment was not responsive to the four collection of information topics solicited.

9. Explanation of Any Payment or Gift to Respondents

We do not provide any payments or gifts to respondents.

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. Although the ICR collects personally identifiable information (PII), it is collected in the context of the subject individuals’ professional capacity and the FDA-related work performed for their employer (e.g., point of contact at a regulated entity).  The PII submitted via Form FDA 356V (Application for Approval of a New Animal Drug or submission to support new animal drug approval) is name, address, telephone number, fax number, and email address. We determined that although PII is collected it is not subject to the Privacy Act of 1974 and the particular notice and other requirements of the Privacy Act do not apply. Specifically, the contractor or FDA  do not use name or any other personal identifier to routinely retrieve records from the information collected. Through appropriate form design, FDA limited submission fields and 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

This information collection does not involve questions that are of a personally sensitive nature.

12. Estimates of Annualized Burden Hours and Costs

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
§§ 514.1 and 514.6; applications and amended applications	187	0.07	13	212	2,756
§§ 514.1(b)(8) and 514.8(c)(1)1; evidence to establish safety and effectiveness	187	0.44	82	90	7,380
§ 514.5(b), (d), and (f); requesting presubmission conferences	187	0.67	125	50	6,250
§ 514.8(b); manufacturing changes to an approved application	187	2	374	35	13,090
§ 514.8(c)(1); labeling and other changes to an approved application	187	0.06	11	71	781
§ 514.8(c)(2) and (3); labeling and other changes to an approved application	187	0.84	157	20	3,140
§ 514.11; submission of data studies and other information	187	0.13	24	1	24
§ 558.5(i); requirements for liquid medicated feed	187	0.01	2	5	10
Applications for conditional approval submitted under section 571 of the FD&C Act	1	1	1	1	1
Form FDA 356V	187	36.5	6,825	0.75 (45 minutes)	5,118
VMF submissions	15	1	15	20	300
Total			7,628		38,849

¹ NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as part of the overall preapproval safety evaluation.

We base our estimate of the number of respondents on the number of sponsors subject to animal drug user fees. We base our estimates of the average burden per response and total annual responses on our experience with NADAs and related submissions. Although we have characterized the information collection activity as a reporting burden, we include in our estimate time required for searching data sources, and preparing and maintaining necessary and applicable records. As stated above, although we receive fewer than one submission annually when averaged over a 3-year period, we attribute one response and 1 hour annually to account for CNADA submissions.

12b. Annualized Cost Burden Estimate

We estimate that the average hourly wage for respondents is equivalent to a GS-11-7 level in the locality pay area of Washington-Baltimore-Arlington, DC-MD-VA-WV-PA in 2022, approximately $43.09/hour. Increasing this wage by 30% to account for overhead costs ($12.93), FDA estimates the average hourly cost to respondents to be $56.02/hour. The overall estimated cost incurred by the respondents is $2,176,320.98 (38,849 burden hours x $56.02/hr = $2,176,320.98).

13. Estimates of Other Total Annual Cost Burden to Respondents and Recordkeepers

There are no capital, start-up, operating, or maintenance costs associated with this collection.

14. Annualized Cost to the Federal Government

Although we estimate an annualized cost to the Federal government for the review and evaluation of submissions to be $11,110,880, this amount is offset by user fees. These figures are only an analysis of pioneer animal drug review work (NADAs) and do not include review hours and FTEs for generic animal drug review work (ANADA). We estimate that we expend approximately 176,000 person hours annually in review, support and supervisory support of the review of submissions. We estimate the average hourly wage for personnel to review and evaluate a submission to be at the GS-13-8 level in the locality pay area of Washington-Baltimore-Arlington, DC-MD-VA-WV-PA in 2022, approximately $63.13/hour. The estimated annualized cost to the Federal government is $11,110,880 (176,000 hours x $63.13/hr = $11,110,880).

15. Explanation for Program Changes or Adjustments

We have adjusted the information collection to reflect an increase in respondents, resulting in 6,620 additional responses and 16,766 additional hours annually.

16. Plans for Tabulation and Publication and Project Time Schedule

We have no plans to tabulate and publish information from this information collection.

17. Reasons Display of OMB Expiration Date is Inappropriate

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

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

1 Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-152-evaluating-safety-antimicrobial-new-animal-drugs-regard-their-microbiological-effects.

2 Animal drugs intended for use in minor species, minor use in major species, or for serious or life-threatening conditions or unmet animal or human health needs where a demonstration of effectiveness would require a complex or particularly difficult study or studies.