SUPPORTING STATEMENT -- OMB 0910-0363

\[Docket No. O2N - 0116\]

> VETERINARY FEED DIRECTIVE

A. JUSTIFICATION

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

With the passage of Animal Drug Availability Act (ADAA), the Congress
enacted legislation establishing a new class of restricted feed use
drugs, veterinary feed directive (VFD) drugs, which may be distributed
without involving State pharmacy laws. Although controls on the
distribution and use of VFD drugs are similar to those for prescription
drugs regulated under section 503(f) of the act, the implementing VFD
regulation (21CFR558.6) is tailored to the unique circumstances relating
to the distribution of medicated feeds. The VFD regulation ensures the
protection of public health while enabling animal producers to obtain
and use needed drugs as efficiently and cost‑effectively as possible.

We request OMB approval for information collection required by the
following citations:

21CFR 514. 1(b)(9) Reporting

Requires submission of a VFD form as a part of the new animal drug
application for

each VFD drug.

21CFR 558. 6(a)(3‑5) Reporting

Requires production of a VFD with specific information.

21CFR 558.6(c)(1-4) Recordkeeping

Requires maintenance of VFD records two years after the date of
issuance.

21CFR 558.6 (d)(1)(i,ii,iii) Reporting

Requires notification to the FDA by the distributor upon first engaging
in distribution.

21CFR558.6(d)(iv) Reporting

Requires a change of address notification when applicable.

21CFR 558.6(d)(2) Reporting

Allows a distributor, in lieu of a VFD order, to ship VFD feed if the
consignee

furnishes an acknowledgement letter affirming that it will only
distribute feed

bearing or containing a VFD drug to an animal producer who holds a valid
VFD or to

another distributor who furnishes an acknowledgement letter.

21CFR 558.6(e)(1-3) Recordkeeping

Requires the distributor to keep records of receipt and distribution of
all medicated

animal feeds containing VFD drugs.

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

A VFD drug is limited to use under a valid veterinary‑client‑patient
relationship where the veterinarian assumes the responsibility for safe
and effective use of the VFD drug and the client has agreed to follow
the instructions of the veterinarian.

Control of certain antimicrobials is critical to reducing unnecessary
use of such drugs in animals and to slowing or preventing the
development of bacteria resistance to antimicrobial drugs. Safety
concerns relating to difficulty of diagnosis of disease conditions, high
toxicity, or other reasons, may also require that the use of an animal
drug in animal feed be limited to use by order and under the supervision
of a licensed veterinarian.

Although statutory controls on the distribution and use of VFD drugs are
similar to those for prescription animal drugs regulated under section
503(f) of the act, the implementing VFD regulations are tailored to the
unique circumstances relating to the distribution of animal feeds
containing a VFD drug. The information collected by FDA staff will help
assure compliance with the VFD regulation and provide assurance that the
medicated feeds will be safe and effective for their labeled conditions
of use and that edible products from treated animals will be free of
unsafe drug residues.

[3. Use of Information Technology and Burden Reduction]{.underline}

The industry is increasingly turning to the use of automated production
facilities. The use of information technology is acceptable for the
purposes of recordkeeping for FDA inspections.

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

Each veterinarian and manufacturer/distributor is responsible for
his/her own recordkeeping. Further, there are no other regulations that
would require the submission or retention of this material. Duplication
would, therefore, not occur.

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

The proposed collection of information carries the same burden, per VFD,
for small or large firms. The regulation should not have a significant
effect on small business, as the cost of the additional veterinary
service and paperwork burden is minimal and constitutes an insignificant
percentage of revenue of the affected firms.

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

All reporting and recordkeeping are one time events associated with
issuance of a VFD for the recordkeeper\'s benefit.

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

All of the reporting requirements are consistent with 5 CFR 1320.5

[8. Efforts to Obtain Comments on the Information Collection Before
Submission to OMB.]{.underline}

To a large extent, the amendment to the statute, which included
reporting and paperwork collection, was crafted by the Coalition for
Animal Health (a group that represented veterinarians, animal producers
and the feed industry). In addition, we consulted with several segments
of the industry to obtain concurrence with the projected recordkeeping
statistics.

Also, in a recent 60 day **Federal Register** notice, that published
April 30, 2002, (67 FR 21252), the agency requested comments on this
collection of information. In response, FDA received one comment. The
comment asked if the proposed collection of information was necessary
for the proper performance of FDA function and would the information
have practical utility. In response, FDA answered yes. The VFD
regulations ensures protection of the public health while enabling
animal producers to obtain and use needed drugs as efficientlly and cost
effectively as possible.

[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}

Information will be kept confidential in accordance with 18 USC 1905 and
21 USC 3310), as well as section 3010) of the Act.

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

This information does not contain questions pertaining to sex behavior,
attitude, religious beliefs, or any other matter commonly considered
private or of a sensitive nature.

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

Estimated Annual Reporting Burden

  --------------- ------------- ----------- ----------- ----------- -----------
  21 CFR          \# Of         Annual      Total       Hours per   Total Hours
                                            Annual                  

                  Respondents   Frequency   Responses   Response    
                                of                                  

                                Response                            

  558.6(a)(3‑5)   15,000        25          375,000     0.25        93,750

  558.6(d)(1)     1500          1           500         0.25        125
  (i‑iii)                                                           

  558.6           20            1           20          0.25        5
  (d)(1)(iv)                                                        

  558.6(d)(2)     1000          5           5,000       0.25        1,250

  514.1(b)(9)     1             1           1           3           3

  Total hours                                                       95,133
  --------------- ------------- ----------- ----------- ----------- -----------

Estimated Annual Recordkeeping Burden

  --------------- --------------- -------------- ----------- ----------- -----------
  21CFR           \# Of           Annual         Total       Hours per   Total Hours
                  Recordkeepers   Frequency of   Annual      Record      
                                  Recordkeeper   Records                 

  558.6 (c)(1-4)  112,500         10             1,125,000   .0167       18,788

  558.6(e)(1-3)   5,000           75             375,000     .0167       6,263

  Total Hours                                                            25,051
  --------------- --------------- -------------- ----------- ----------- -----------

[13. Estimate of Other Total Cost Burden to Respondents and
Recordkeepers]{.underline}

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}

Based on agency estimates of 10 minutes for a GS‑7 government employee
to process the notification, total costs per year are estimated at about
\$4000.00.

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

Our records for the last three years show that our initial estimate of
the number of distribution notifications was too high. The hourly burden
and recordkeeping charts have been adjusted to reflect the actual number
of notifications we have received.

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

Information is not to be published for statistical use.