OMB 0910- 0117

SUPPORTING STATEMENT

INVESTIGATIONAL USE OF NEW ANIMAL DRUGS

A. [JUSTIFICATION]{.underline}

1\. [Circumstance Making the Information Collection
Necessary]{.underline}

The Federal Food, Drug and Cosmetic Act (the Act) under the Drug
Amendments of 1962 authorized the establishment of investigational
animal drug regulations. These regulations were initially established
under section 505(i) and subsequently were authorized under section
512(j) of the act as amended by the Animal Drug Amendments of 1968. See
Attachment A. The regulations are codified in 21 CFR Part 511. See
Attachment B. 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) 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. Section512(j) authorizes
promulgation of regulations for exempting investigational use.

We are requesting OMB approval for the information collection
requirements contained in the following specific citations within 21 CFR
Part 511:

21 CFR Part 511.1

(a)(3) - Recordkeeping

Requires maintenance of records for 2 years on the shipment of new
animal drugs into interstate commerce for laboratory research.

(b)(3) - Recordkeeping

Requires maintenance of records for 2 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
tests in animals..

(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 for 2 years of complete records 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 after the termination of an investigational exemption or
approval of a New Animal Drug Application for 2 years. All records
established during the study of an investigational new animal drug must
be available for inspection by FDA officers.

(b)(8)(ii) - Reporting

Reports 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.

We are also requesting approval of FDA Form 3458 (attached)

2\. [Purpose and Use of the Information]{.underline}

In order to properly test a drug for a use, appropriate scientific
investigations must be conducted. A new animal drug cannot be granted
final approval under a New Animal Drug Application (NADA) until it has
been demonstrated to be safe and effective for its intended use(s).
Section 512(j) of the Act permits the use of an Investigational New
Animal Drug (INAD) to generate data to support NADA approval.

FDA regulations governing investigational use of new animal drugs can be
found in 21 CFR 511.1. These regulations require certain information to
be submitted under an INAD in order to qualify for the exemption and to
control shipment and subsequently the existence of any potential abuse.

If the new animal drug is to be used in food-producing animals, i.e,
cattle, swine, chickens, fish, etc., data is needed to show that
consumption of edible food products is safe to the public health. 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 of the INAD is needed to assure
that the proposed investigational use of the drug is safe and that any
edible food will not be distributed for food without proper
authorization from the FDA.

Information contained in an INAD 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 information Technology and Burden Reduction]{.underline}

We are continuously seeking ways through advances in information
technology to reduce the burden on the government and
sponsor/respondent. New electronic computerized equipment will permit
the utilization and dissemination of information. Word processing has
greatly reduced the amount of time needed to compile and arrange
documents for submission to the Agency. We recently announced a pilot
project for submission of Notice of Claimed Investigational Exemption
(NCIE), commonly known as drug shipment notices, and notices of intent
to slaughter by electronic submission, which should increase the
efficiency of the review process of the NCIE.

4\. [Efforts to Identify Duplication and Use of Similar
Information]{.underline}

There are no other regulations or Federal Agencies that require the
submission of the same type of information. There are no similar
data/information that could be substituted for that required by these
regulations.

5\. [Impact on Small Businesses or Other Small Entities]{.underline}

Our charge is to ensure the safe use of investigational drugs applies
regardless whether the studies were conducted by small or large
businesses. We believe that the law and regulations apply to all persons
equally. While we do not believe we can apply different standards with
respect to statutory requirements, we do provide special help to small
business. A small business coordinator has been established on the
Commissioner\'s staff to ensure that small businesses have an adequate
opportunity to express their concerns and to keep our management
apprised of how regulatory decisions might impact the small business
community. Furthermore, we encourage sponsors, whether large or small
businesses, to meet with the Center for Veterinary Medicine.

6\. [Consequences of Collecting the Information Less
Frequently]{.underline}

There are no specific regulatory time frames imposed on a sponsor for
the collection or recording of information.

7\. [Special Circumstances relating to the Guidelines of 5 CFR
1320.5]{.underline}

Collection requirements are consistent with 5 CFR 1320.5.

8\. [Comments in Response to the Federal Register Notice and Efforts to
Consult Outside Agency]{.underline}

No comments were received in response to the Federal Register notice of
O)ctober 16, 2001.

In the course of inspections and reviews conducted by the FDA, there is
a continual communication with the regulated industry regarding these
regulations and their application to promote compliance with the Act. In
addition, sponsors are entitled to engage in dialogue with CVM to
determine investigational requirements. A number of guidances have been
issued to provide recommendations on the proper conduct of
investigations.

The following firms were contacted in September, 1997 and asked to
provide estimates of burden associated with NCIEs and slaughter
authorizations needed for testing to demonstrate effectiveness: Fort
Dodge Animal Health, Princeton, NJ; Pharmacia and Upjohn Animal Health,
Kalamazoo, MI; Elanco, Greenfield, IN; Merial, Iselin, NJ and Hoechst
Roussel Vet, Warren, NJ. We see no significant change in burden.

9\. [Explanation of Any Payment or Gift to Respondent]{.underline}

There are no payments or gifts to respondents.

10\. [Assurance of Confidentiality Provided to Respondent]{.underline}

The existence of an exemption from disclosure of the existence of
investigational use of a new animal drug is a provision to insure the
information under investigation remains confidential. All information
will be kept confidential in accordance with 18 USC 1905 and 21 USC
331(j).

11\. [Justification for Sensitive Questions]{.underline}

FDAs New Animal Drugs for Investigational Use (21 CFR Part 511) do not
contain questions or references pertaining to sex behavior, attitude,
religious beliefs, or any other matters that are commonly considered
private or sensitive in nature.

12\. [Estimates of Hour Burden]{.underline}

From consultation with several of the largest research and development
(R&D) firms, and review of our data bases, we estimate that the 10
largest R&D firms are responsible for 90% of all investigational
studies. Data from these R&D firms projects 956 studies undertaken with
1,147 NCIEs issued to allow shipment of investigational drugs in
interstate commerce. The burden on industry is estimated at
approximately 8 hours per occurrence, resulting in 9,176 hours.
Approximately 30% of the studies (287) will require a slaughter
authorization allowing for use of edible products from treated animals.
Burden estimate is 140 hours per occurrence, or 40,180 hours. Reports
required by the FDA to determine whether an investigational exemption
should be terminated or whether significant safety hazards may be
associated with a drug under study, 21 CFR 511.1(b)(6) and (8)(ii)
respectively, are rare. We estimate one of each per year with a burden
of 250 and 20 hours respectively. We estimate the burden on import drugs
for investigational use to be similar to that for NCIEs (8 hours), with
an estimate of 30 occurrences per year, or 240 hours. The above
estimated reporting burdens total 49,866 hours.

Required 2 year recordkeeping requirements are estimated to be 21,510
hours for the amount of investigational studies referenced above.

Respondents, while not all submit studies in any given year, total 190,
the number of sponsors of approved applications listed in 21 CFR
510.600.

13\. [Estimate of Total Annual Cost Burden Other Than Hour Burden to
Respondents]{.underline}

We believe that the collection of information would not result in a cost
burden beyond the hours burden to respondents cited above.

14\. [Annualized Cost to the Federal Government]{.underline}

The estimated time for processing, receipt, review, and evaluation
conducted by FDA personnel for an investigational new animal drug
submission is estimated to be approximately the same as that for
industry to report, or a total of 49,866 hours.

The cost to the Federal government is therefore estimated to be
\$1,645,578

(49,866 hours X \$33.00/hour - mid grade GS-13).

15\. [Explanation for Program Changes or Adjustments]{.underline}

There are no changes or adjustments.

16\. [Plans for Tabulation and Publication and Project Time
schedules]{.underline}

There are no plans to publish.