**\[Docket No: 01N-0006\] OMB 0910-0032**

**SUPPORTING STATEMENT**

**NEW ANIMAL DRUG APPLICATIONS,**

**FORM FDA 356V AND SUPPORTING REGULATIONS**

**A. [JUSTIFICATION]{.underline}**

**1. [Circumstances Making the Information Collection
Necessary]{.underline}**

**A New Animal Drug Application (NADA) for marketing a drug for animal
use is required under Section 512(b) of the Federal Food, Drug and
Cosmetic Act (Act). Part 514.1 of the Code of Federal Regulations, Title
21, interprets 512(b) of the Act and details further the specific
requirements needed for gaining approval. To gain approval for the
marketing of a drug for animal use, an applicant must file a New Animal
Drug Application with the Food and Drug Administration. The application
must provide safety and efficacy data, appropriate labeling, product
manufacturing information and where necessary, complete information on
any methods used to determine residues of drug chemicals in edible
tissue from food producing animal(s).**

**The law prohibits the approval of food additives, new animal drugs and
color additives which have been shown to induce cancer in animals or
humans, but provides for exceptions to this prohibition for new animal
drugs under specified conditions. One of the specified conditions is
contained in Section 512(d)(1)(H) of the Act which allows approval when
such drug will not adversely affect the animals for which it is intended
and no residue of the drug will be found in the edible portions of the
animal. FDA has established an operational definition of no residue in
21 CFR Part 500 Subpart E.**

**As part of the approval, Section 512(i) of the Act requires the
publication of the names and addresses of the sponsors of approved new
animal drugs. This information is listed in 21 CFR 510.600.
Additionally, under the NADA, these sponsors are required by regulation
to be in compliance with current good manufacturing practice (CGMP)
regulations for the proper manufacture of new animal drug products. The
burdens associated with these CGMP regulations are accounted for under
the following clearances: 21 CFR Part 211, Pharmaceutical Dosage Forms -
OMB No. 0910-0139; 21 CFR Part 225 Medicated Feeds - OMB No. 0910-0152
and 21 CFR Part 226, Type A Medicated Articles - OMB No. 0910-0154.**

**The FDA requests approval for the collection of information
requirements in the**

**following:**

**21 CFR 514.1 - Reporting**

**Specifies content and format of the New Animal Drug Application**

**21 CFR 514.6 - Reporting**

**Specifies requirements for applicants amending an application that is
pending.**

**21 CFR 514.8 - Reporting**

**Requirements for supplemental new animal drug applications.**

**21 CFR 514.11 - Reporting**

**Specifies requirements for summaries of information and data for an
NADA approved on or after July 1,1975 for public disclosure..**

**Approval is also requested for Form FDA 356V - New Animal Drug
Application (attached).**

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

**The purpose of the NADA information requirements is to limit the
marketing of animal drugs to those products whose safety and
effectiveness has been demonstrated by scientific testing. The
information is used by the FDA scientific staff to determine whether or
not a product is safe and effective. If these data were not collected,
FDA could not perform the mission assigned to it by the Federal Food,
Drug, and Cosmetic Act.**

**Additionally, if the data were not collected, potent chemicals would
be permitted (in the form of bulk drug and/or drug products) to enter
the market place without any scrutiny. Such activities would permit
uncontrolled use of chemicals in (1) the food supply (milk, eggs, and
meat/meat-by-products) of the nation\'s human population and (2) the
treatment of animals.**

**Animal drugs may be administered as pharmaceutical dosage form
products, in drinking water, or in medicated livestock and poultry
feeds. Therefore, the labeling requirements for animal drugs are to
provide the necessary information to assure that they are safe and
effective in the hands of the user. Certain animal drugs are solely
intended for dispensing on a veterinarian\'s prescription order, in
which case, full disclosure information must be provided to the
practitioner, who in turn provides relevant information to the client on
the manner in which the drug is to be administered. Most drugs used in
animals for food-producing purposes are sold over-the-counter (OTC) to
producers. Other drugs may be made available in a premix that is used by
a feed mill for further mixing and commercial sale or to producers who
may mix their own medicated feed.**

**It is essential that users of all animal drug products have available
to them directions for use that when followed will assure that the drug
is safe and effective. Lack of proper directions for use of drugs
intended for treatment of food-producing animals may result in
adulterated and unsafe meat, milk, and eggs.**

**The information submitted is reviewed by professional personnel in the
Center for Veterinary Medicine in the FDA. The type of professional
reviewers include veterinarians, chemists, microbiologists,
toxicologists, physiologists, pharmacologists, nutritionists,
statisticians, consumer safety officers and paid FDA consultants, as
needed. Each professional reviewer conducts a scientific and/or
technical evaluation of the submitted information based in their area of
expertise.**

**In summary, the following Information (required by the act) must be
submitted to FDA**

**in order to gain approval:**

**C information from well-controlled investigations to make a scientific
and technical determination that the proposed product is effective for
its indicated uses and safe for the animal and user,**

**C information to demonstrate the safety of the proposed product to
the**

> **environment, and**

**C information to demonstrate that edible products from
food-producing**

> **animals are safe for human consumption.**

**3. [Use of Information Technology]{.underline}**

**FDA encourages the submission of NADA data electronically,
particularly protocols and study data which can be quite voluminous. FDA
will consider any such electronic submissions of NADA data which will be
more efficient for industry and facilitate review by the Agency.**

**4. [Efforts to Identify Duplication and Similar Sources of
Information]{.underline}**

**The information as provided in an application is unique to the
particular product cited.**

**There are no other regulations that require the submission of this
same information. The information required specifically for approval of
an animal drug product covered in an NADA is unique to the product. The
information is generally not available from any recognized scientific
sources, unless the information has been made public by the NADA
applicant.**

**5. [Impact on Small Business or Other Small Entities]{.underline}**

**Because of the critical nature of the products, their uses and the
impact on the consumer or user, any submission of an application for
approval of an animal drug product from a small business concern is
treated with the same rigorous scientific and technical review as that
submitted by a large pharmaceutical firm. The labeling requirements of a
specific new animal drug are the same regardless of who produces or
markets the product. However, FDA does assist small businesses to meet
the Part 514 requirements through the Office of Small Manufacturers
Assistance through the scientific and administrative staffs within the
Center**

**.**

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

**There are no specific regulatory time frames imposed on an applicant
for the collection or recording of information. 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 514 , 211, 225 or 226.**

**7. [Special Circumstances Relating to Guidelines of 5 CFR
1320.5.]{.underline}**

**There are no reports required to be submitted which are inconsistent
with 5 CFR**

**1320.5.**

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

**This regulation was subject to public comment under the Administrative
Procedures Act**

**and public comments were addressed as part of the public rule making
process. No changes have been made in the regulatory requirements and no
comments were submitted in response to the Federal Register Notice,
(62FR66632).**

**9. [Explanation of Any Payment or Gifts to Respondents]{.underline}**

**There are no payments or gifts to respondents.**

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

**The Center for Veterinary Medicine and the FDA are required under 21
CFR Parts 20 and 514.11 to maintain the confidentiality of all
information received in conjunction with the submissions of NADAs. Very
often under the NADA, trade secrets must be submitted by the applicant
to support CVM action necessary to approve a drug for use. Trade secrets
are privileged and confidential information and are treated as such.
They are defined in 21 CFR 20.61. Any unauthorized use or disclosure of
trade secrets that are presented in a NADA is specifically prohibited
under Section 301(j) of the Act (21U.S. C. 311 (j)).**

**In addition to the requirements of 21 CFR 514.11, the Center exercises
security precautions in the handling of documents. A security controlled
document file room, locked files, drawers and doors are required for
in-house protection. Unused documents are destroyed by shredding. This
protection is continued after approval of the drug.**

**The Center has a Freedom of Information Officer who is responsible for
administering**

**the policies relative to the release of information.**

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

**There are no questions of a sensitive nature.**

**12. [Estimates of Hour Burden Including Annualized Hourly
Cost]{.underline}**

**The estimated total annual burden for information collection for the
requirements of 21**

**CFR 514.1 through 514.11 is 383,793 hours. .For FY 1999, there were
190 sponsors listed as approved holders of new animal drug applications.
During this same fiscal period, the sponsors submitted a total of 1,582
applications. This total consisted of 83 original and 1,499 supplemental
applications. These numbers account for approximately 8.33 submissions
per sponsor. Center officials have estimated in the reporting/disclosure
burden for these requirements at an average of 242.6 hours per
submission. FDA estimates the burden for this collection of information
as follows:**

**ESTIMATED ANNUAL REPORTING BURDEN** 1

+------------+----------+-------------+---------+--------+-----------+
| **21 CFR** | **No. of | **No. Of    | **Total | *      | **Total   |
|            | Respo    | Responses   | Annual  | *Hours | Hours**   |
|            | ndents** | per         | Resp    | per    |           |
|            |          | R           | onses** | Resp   |           |
|            |          | espondent** |         | onse** |           |
+------------+----------+-------------+---------+--------+-----------+
| **514.1 &  | **190**  | **8.33**    | **      | **2    | **        |
| 514.6**    |          |             | 1,582** | 11.6** | 334,751** |
|            | **190**  | **8.33**    |         |        |           |
| **514.8**  |          |             | **      | **30** | *         |
|            | **190**  | **8.33**    | 1,582** |        | *47,460** |
| **514.11** |          |             |         | **1**  |           |
|            |          |             | **      |        | **1,582** |
|            |          |             | 1,582** |        |           |
+------------+----------+-------------+---------+--------+-----------+
| **Total**  |          |             |         |        | **        |
|            |          |             |         |        | 383,793** |
+------------+----------+-------------+---------+--------+-----------+

**1 There are no capital costs or operating and maintenance costs
associated with this collection.**

**13. [Estimate of Other Total Annual Cost Burden to Respondent or
Recordkeeper]{.underline}**

> **There are no additional annual cost burden to respondents or
> recordkeepers.**

**14. [Annualized Costs to the Federal Government]{.underline}**

> **For calendar year 2000, we expended approximately 135,000 person
> hours in review, support and supervisory support of the review of
> NADAs. We estimate about 1650 hours of work is performed per FTE. So,
> about 81.8 FTEs are used for application review work. We estimate a
> compensation cost of \$67,427 per FTE, which the salary of a GS13/3,
> the average grade among the personnel involved in the review.
> Multiplying this figure by 81.8 FTEs = \$5,515,528 as the cost for one
> year of review work.**

**15. [Explanation of Program Changes or Adjustments]{.underline}**

**The increase of 101,755 hours from the previous approval level of
282,038 is an**

**adjustment resulting from an increase in the number of applications
submitted to the agency for review and approval.**

**16. [Plans for Tabulation and Publication and Project Time
Schedule]{.underline}**

**Data collected by firms are for use with their submissions to gain
approval for drug products. There is no intent on the part of the
Federal Government to publish this data, nor is any general statistical
analysis by the Federal Government anticipated.**

Attachments

Form: <http://forms.psc.gov/forms/FDA/fda-356v.pdf>

Regulation : \< [http://frwebgate.access.gpo.gov/cgi-bin/get-
cfr.cgi?TITLE=21&PART=514&SECTION=1&YEAR=2000&TYPE=TEXT](http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=514&SECTION=1&YEAR=2000&TYPE=TEXT)\>