0117 SS Part A 2015

New Animal Drugs for Investigational Uses
OMB Control Number 0910-0117
Supporting Statement Part A

JUSTIFICATION
1. Circumstances Making the Collection of Information Necessary
The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Drug Amendments of
1962, authorized FDA to establish investigational new animal drug regulations. These
regulations were initially established under section 505(i) and were subsequently authorized
under section 512(j) of the act as amended by the Animal Drug Amendments of 1968. The
regulations are codified in 21 CFR Part 511. The regulations protect the public health by, among
other things, requiring that investigational animal drugs be distributed only to qualified
investigators, that adequate drug accountability records be maintained, and that edible food
products from treated food-producing animals be safe for human consumption. Section
512(a)(1) and (2) of the act state that a new animal drug or an animal feed bearing or containing
a new animal drug is unsafe unless it is the subject of an approved application. Section 512(j)
authorizes promulgation of regulations for exempting investigational use.
The Food and Drug Administration (FDA) is requesting approval of the collection of information
requirements found in the regulations at 21 CFR Part 511 and cited below.
21 CFR Part 511.1
(a)(3) - Recordkeeping
Requires maintenance of records for two years on the shipment of new animal drugs into
interstate commerce for laboratory research.
(b)(3) - Recordkeeping
Requires maintenance of records for two years on the shipment of new animal drugs into
interstate commerce for clinical investigations.
(b)(4) - Reporting
Specifies a general format for the filing of a “Notice of Claimed Investigational Exemption
(NCIE) for a New Animal Drug” prior to introducing the new animal drug into interstate
commerce for clinical investigations in animals.

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(b)(5)(i),(ii) & (iii) – Reporting
Specifies the need for data to be submitted for the authorized use of edible food products from
treated food-producing animals consistent with the public health.
(b)(6) - Reporting
Specifies requirements for transmitting information to FDA to determine if there are grounds for
terminating an exemption.
(b)(7)(ii) - Recordkeeping
Requires maintenance of complete records for two years of any investigation by a sponsor,
including shipment/delivery of the new animal drug.
(b)(8)(i) - Recordkeeping
Requires maintenance of all reports received by a sponsor from investigators for two years after
the termination of an investigational exemption or approval of a New Animal Drug Application.
All records established during the study of an investigational new animal drug must be available
for inspection by FDA officers.
(b)(8)(ii) - Reporting
Requires sponsors to report findings that may suggest significant hazards of the safety of the new
animal drug.
(b)(9) - Reporting
Requires reporting by importers of investigational new animal drugs for clinical investigational
use in animals.
FDA is also requesting approval of the electronic form entitled “Notice of Claimed
Investigational Exemption.”
2. Purpose and Use of the Information Collection
In order to properly test a new animal drug for an intended use, appropriate scientific
investigations must be conducted. A new animal drug application (NADA) cannot be approved
until the new animal drug has been demonstrated to be safe and effective for its intended use(s).
Under specific circumstances, section 512(j) of the act permits the use of an investigational new
animal drug to generate data to support an NADA approval. Regulations governing the
investigational use of new animal drugs can be found in 21 CFR 511.1. These regulations
require that certain information be submitted under a “Notice of Claimed Investigational
Exemption” (NCIE) in order to qualify for the exemption and to control shipment of the new
animal drug and prevent potential abuse. If the new animal drug is to be used in food-producing

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animals, e.g., cattle, swine, chickens, fish, etc., data is needed to show that the edible food
products are safe for human consumption. An authorization must be secured from FDA for the
use of edible food products from treated food-producing animals.
The information provided by the sponsor in the NCIE is needed to assure 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 the agency's “Bio-Research Monitoring Program.” This program permits the
agency to monitor the validity of the studies and to assure the proper use of the drugs is
maintained by the investigators.

3. Use of Improved Information Technology and Burden Reduction
As a part of the reauthorization of the Animal Drug User Fee Act (ADUFA) in 2008, FDA’s
Center for Veterinary Medicine (CVM) committed to developing an electronic submission tool
for industry submissions within 24 months of appropriated ADUFA funds for FY 2009. The tool
was made available by CVM’s Office of New Animal Drug Evaluation (ONADE), for voluntary
use by sponsors and manufacturers in the animal health industry, on March 11, 2011. The
animal health industry may now use the eSubmitter, a secure online submission tool, for all
submissions related to the investigation of new animal drugs for approval. At the same time,
paper submissions are still accepted.

4. Efforts to Identify Duplication and Use of Similar Information
FDA is the only agency that requires this information. The required information is not available
from any other source.

5. Impact on Small Businesses or Other Small Entities
FDA believes that its 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. While the regulations do not provide exceptions for small businesses, all sponsors
of new animal drugs for investigational uses are encouraged to meet with CVM staff.
6. Consequences of Collecting the Information Less Frequently
The information is collected once.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for the collection of information requirements.

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8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the Agency
In accordance with 5 CFR 1320.8(d), in the Federal Register of April 2, 2015 (80 FR 37269),
FDA published a 60-day notice seeking public comment on this information collection. Two
comments were received but did not respond to any of the four information collection topics
solicited and therefore were not addressed by the agency.

9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
FDA regulations (21 CFR 514.12) prohibit the agency from disclosing the existence of an
investigational new animal drug notice unless it has been previously disclosed or acknowledged.
All information will be kept confidential in accordance with 18 USC 1905 and 21 USC 331(j).
11. Justification for Sensitive Questions
This collection of information does not contain questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
FDA estimates the burden of this information collection as follows:
Table 1. – Estimated Annual Reporting Burden1
21 CFR
Section

No. of
Respondents

No. of Responses per
Respondent

Total Annual
Responses

Average Burden per
Response

Total
Hours

511.1(b)(4)

263

5.30

1,395

1

1,395

511.1(b)(5)

263

.26

69

8

552

511.1(b)(6)

263

.01

2

1

2

511.1(b)(8)(ii)

263

.06

15

2

30

511.1(b)(9)

263

.06

15

8

120

Total
1

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

2,099

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Table 2—Estimated Annual Recordkeeping Burden1
21 CFR
Section

No. of
Recordkeepers

No. of Records per
Recordkeeper

Total Annual
Records

Average Burden per
Recordkeeping

Total
Hours

511.1(a)(3)

263

2.07

545

1

545

511.1(b)(3)

263

5.30

1,395

1

1,395

511.1(b)(7)(ii)

263

5.30

1,395

3.5

4,882.5

511.1(b)(8)(i)

263

5.30

1,395

3.5

4,882.5

Total
1

11,705

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

The estimate of the time required for reporting requirements, record preparation, and
maintenance for this collection of information is based on informal Agency communication with
industry. Based on the number of sponsors subject to animal drug user fees, FDA estimates that
there are 263 respondents. We use this estimate consistently throughout the table and calculate
the “annual frequency per respondent” by dividing the total annual responses by number of
respondents. 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 Agency records.

12b. Annualized Cost Burden Estimate
Type of Respondent
Compliance officer

Total Burden Hours

Hourly Wage Rate

13,804

$44

Total Respondent
Costs
$607,376

FDA estimates the cost of the information collection request to industry to be $607,376. This
figure was calculated by multiplying the hourly wage rate for an industry compliance officer
($44) by the total number of burden hours (13,804).

13. Estimates of Other Total Annual Costs and/or Recordkeepers/Capital Costs
There are no start-up or other costs associated with this collection of information.
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

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$640,782 (rounded to the nearest dollar), as calculated by multiplying the hourly wage rate of
GS-13, step 3, employee ($46.42) by the total number of burden hours (640,782.68).
15. Explanation of Program Changes or Adjustments
This request for approval reflects an overall increase that FDA attributes to an increase in the
number of new animal drugs and thus a corresponding increase in the number of respondents to
this collection. Specifically the number of respondents increased by 57 and results in an hourly
burden increase of 1,477 and an increase in the total number of responses by 698. The agency
also notes that the cost to industry for the information collection was not previously included in
our submission. We have included that information in this instant request at Question 12b.
above.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no plans to publish this collection of information.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA is not seeking approval to exempt display of the expiration date for OMB approval.
18. Exception to Certification for Paperwork Reduction Act Submissions
There are no exceptions.