0669 ss 8-14-2019

Abbreviated New Animal Drug Applications
0910-0669
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
Under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360b(b)(2)), any person may file an abbreviated new animal drug application
(ANADA) seeking approval of a generic copy of an approved new animal drug. The
information required to be submitted as part of an ANADA is described in section
512(n)(1) of the FD&C Act (21 U.S.C. 360b(n)(1)). Among other things, an ANADA is
required to contain information to show that the proposed generic drug is bioequivalent
to, and has the same labeling as, the approved new animal drug. We allow applicants to
submit a complete ANADA or to submit information in support of an ANADA for
phased review. Applicants may submit Form FDA 356v with a complete ANADA or a
phased review submission to ensure efficient and accurate processing of information.
Form FDA 356v is approved under OMB Control No. 0910-0032.
We believe the demonstration of bioequivalence required by the statute does not need to
be established on the basis of in vivo studies (blood level bioequivalence or clinical
endpoint bioequivalence) for soluble powder oral dosage form products and certain Type
A medicated articles. We are adding to this information collection applicant requests to
waive the requirement to establish bioequivalence through in vivo studies (biowaiver
requests) for soluble powder oral dosage form products or certain Type A medicated
articles based upon either of two methods. We will consider granting a biowaiver request
if it can be shown that the generic soluble powder oral dosage form product or Type A
medicated article contains the same active and inactive ingredient(s) and is produced
using the same manufacturing processes as the approved comparator product or article.
Alternatively, we will consider granting a biowaiver request without direct comparison to
the pioneer product’s formulation and manufacturing process if it can be shown that the
active pharmaceutical ingredient(s) (API) is the same as the pioneer product, is soluble,
and that there are no ingredients in the formulation likely to cause adverse pharmacologic
effects.
Additionally, we have found that various uses of veterinary master files have increased
the efficiency of the drug development and drug review processes for both us and the
animal pharmaceutical industry. A veterinary master file is a repository for submission to
FDA’s Center for Veterinary Medicine of confidential detailed information about
facilities, processes, or articles used in the manufacturing, processing, packaging, and
storing of one or more veterinary drugs. Veterinary master files are used by the animal

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pharmaceutical industry in support of information being submitted for new animal drug
applications (NADAs), ANADAs, investigational new animal drug (INAD) files, and
generic investigational new animal drug (JINAD) files. In previous information
collection requests, we included the time necessary to compile and submit such
information to veterinary master files within the burden estimates provided for
applications and amended applications (for NADAs and INAD files) and abbreviated
applications and amended abbreviated applications (for ANADAs and JINAD files),
respectively. We recently combined the time necessary to compile and submit such
information to veterinary master files within the burden estimates provided in the
collection of information supporting new animal drug applications (OMB control number
0910-0032).
We request extension of OMB approval of the information collection requirements in 21
U.S.C. 360b(b)(2) and (n)(1) and this use of Form FDA 356V, New Animal Drug
Application. We also request OMB approval of biowaiver requests and the proposed
increased use of veterinary master files to submit information to us.
2. Purpose and Use of the Information Collection
The reporting associated with ANADAs and related submissions is necessary to ensure
that new animal drugs are in compliance with section 512(b)(2) of the FD&C Act. We
use the information submitted, among other things, to assess bioequivalence to the
originally approved drug and thus, the safety and effectiveness of the generic new animal
drug. We use the information submitted by applicants in the biowaiver request as the
basis for our decision whether to grant the request.
3. Use of Improved Information Technology and Burden Reduction
Sponsors and manufacturers of generic animal drug products may use eSubmitter, a
secure online submission tool created by CVM, for all submissions related to the
abbreviated new animal drug approval process. 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 ANADA submissions will be submitted electronically in the next three years.
4. Efforts to Identify Duplication and Use of Similar Information
The information provided in an ANADA is unique to the particular product covered by
the application. There are no other regulations that require the submission of this same
information. The information is generally not available from any recognized scientific
sources, unless the information has been made public by the ANADA applicant.
5. Impact on Small Businesses or Other Small Entities
We estimate that most of the veterinary pharmaceutical manufacturers that would be
sponsors of ANADAs would have revenues greater than $1.0 million. Consequently, we

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estimate that one or fewer respondents would qualify as a small business. We assist
small businesses to meet the requirements of sections 512(b)(2) and (n)(1) of the FD&C
Act through our Regional Small Business Representatives and through the scientific and
administrative staff within the Center.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. There are no specific regulatory time frames
imposed on an applicant for submitting an application or supplement. After the initial
submission of an application, the applicant can submit any required information as he/she
sees fit or as may be imposed by the regulations under 21 CFR parts 514, 211, 225, or
226.
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
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment
in the Federal Register of April 18, 2019 (84 FR 16270). FDA received one comment
letter, which contained multiple comments that were outside the scope of the four
collection of information topics on which the notice requested comments and will not be
discussed in this document.
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
This information collection request (ICR) is collecting personally identifiable information
(PII). PII is collected in the context of the individuals’ professional capacity. The PII
submitted for FDA Form 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. This ICR involves the submission to FDA of an ANADA
(an application for approval to legally market a generic new animal drug). The FD&C
Act and FDA’s regulations specify the information that must be submitted to FDA by
persons seeking to manufacture generic new animal drugs.
FDA further 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, FDA does not use name or any other personal identifier to routinely
retrieve records from the information collected. FDA also minimized the PII to be
collected to protect the privacy of the individuals.

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In preparing this Supporting Statement, FDA staff consulted with the FDA Privacy
Office to ensure appropriate handling of information collected.
We expect that an ANADA will contain trade secret and commercial confidential
information. As a result, all files are maintained in a secured area. Confidentiality of the
information submitted under these reporting requirements is protected under 21 CFR
514.11. Only information that is releasable under the agency’s regulations in 21 CFR
part 20 would be released to the public. This information is also safeguarded by section
301(j) of the FD&C Act and would be protected from disclosure under the Freedom of
Information Act (FOIA) under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)).
11. Justification for Sensitive Questions
The information collection does not involve questions that are of a personally sensitive
nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:

Activity

ANADA

Table 1.--Estimated Annual Reporting Burden
FDA Number of Number of
Total
Average Total
Form Respondents Responses
Annual
Burden Hours
No.
per
Responses
per
Respondent
Response
356v 18
1
18
159
2,862

Phased Review with
356v
Administrative ANADA
Biowaiver request for
N/A
soluble powder oral
dosage form product,
using same
formulation/manufacturing
process approach
Biowaiver request for
N/A
soluble powder oral
dosage form product,
using same API/solubility
approach

3

5

15

31.8

477

1

1

1

5

5

5

1

5

10

50

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Table 1.--Estimated Annual Reporting Burden
Activity
FDA Number of Number of
Total
Average Total
Form Respondents Responses
Annual
Burden Hours
No.
per
Responses
per
Respondent
Response
Biowaiver request for
N/A
2
1
2
5
10
Type A medicated article,
using same
formulation/manufacturing
process approach
Biowaiver request for
N/A
10
1
10
20
200
Type A medicated article,
using same API/solubility
approach
Total
51
3,604
We base our estimates on our records of generic drug applications. We estimate that we
will receive 21 ANADA submissions per year over the next 3 years and that 3 of those
submissions will request phased review. We estimate that each applicant that uses the
phased review process will have approximately 5 phased reviews per application. We
estimate that an applicant will take approximately 159 hours to prepare either an
ANADA or the estimated 5 ANADA phased review submissions and the administrative
ANADA. Our estimates of the burden of biowaiver requests for generic soluble powder
oral dosage form products and Type A medicated articles differ based on the type of
product and the basis for the request, as shown in table 1. We estimate that an applicant
will take between 5 and 20 hours to prepare a biowaiver request.
12b. Annualized Cost Burden Estimate

Type of
Respondent
Industry
Compliance Officer

Total Burden
Hours
3,604

Hourly Wage Rate
$51.821

Total Respondent
Costs
$186,759.28

1May

2018 National Industry-Specific Occupational Employment and Wage Estimates, U.S. Department of Labor,
Bureau of Labor Statistics, 13-1041 Compliance Officer (www.bls.gov), $39.86 plus 30% adjusted for benefits equals
approximately $51.82 per hour wage.

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

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We estimate the annualized cost to the Federal government for the review and evaluation
of submissions for the next three years to be $4,995,680 annually. For calendar year
2018, we expended approximately 80,392 person hours in review and support, and
approximately 15,560 person hours of 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-13-2 level in the locality pay area of Washington-Baltimore-Arlington,
DC-MD-VA-WV-PA in 2019, approximately $49.10/hour, and the average hourly wage
for supervisory personnel at the GS-14-7 level in the locality pay area of WashingtonBaltimore-Arlington, DC-MD-VA-WV-PA in 2019, approximately $67.38/hour. The
estimated annualized cost to the Federal government is $4,995,680 [(80,392 hours x
$49.10/hour) + (15,560 hours x $67.38/hour) = $4,995,680].
15. Explanation for Program Changes or Adjustments
Based on a review of the information collection since our last request for OMB approval,
we have made no adjustments to our previous estimate of the number of respondents
submitting generic drug applications. However, as discussed, the burden for this
information collection (a program change) was increased by 265 hours and 18 responses
since the last OMB approval. This is due to adding to this collection burden hours and
responses for biowaiver requests. We have also added to this collection a discussion of
the use of veterinary master files by the animal pharmaceutical industry in support of
information being submitted for NADAs, ANADAs, INAD files, and JINAD files.
16. Plans for Tabulation and Publication and Project Time Schedule
We have no plans to tabulate and publish information from this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5.
18. Exceptions to Cert1ification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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