[Federal Register Volume 67, Number 83 (Tuesday, April 30, 2002)]
[Notices]
[Pages 21252-21253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10563]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0116]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Veterinary Feed Directive (VFD)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including renewal of an existing collection of information, and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on reporting and recordkeeping requirements for 
distribution and use of VFD drugs and animal feeds containing VFD 
drugs.

DATES: Submit written or electronic comments on the collection of 
information by July 1, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug

[[Page 21253]]

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-26, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Veterinary Feed Directive--21 CFR Part 558 (OMB Control No. 0910-
0363)--Extension

    Upon passage of the Animal Drug Availability Act, Congress enacted 
legislation establishing a new class of restricted feed use drugs 
called VFD, which can 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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353), the 
implementing VFD regulation under 21 CFR 558.6 is tailored to the 
unique circumstances relating to the distribution of medicated feeds. 
The content of the VFD is spelled out in the regulation. All 
distributors of medicated feeds containing VFD drugs must notify FDA of 
their intent to distribute, and records must be maintained of the 
distribution of all medicated feeds containing VFD drugs. 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. The respondents for VFD drugs are 
veterinarians, distributors of animal feeds containing VFD drugs, and 
clients utilizing medicated feeds containing VFD drugs.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                         Annual Frequency      Total Annual        Hours per
 21 CFR Section    No. of Respondents      per Response          Responses          Response       Total Hours
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558.6(a)(3)            15,000                   25             375,000                  0.25        93,750
 through (a)(5)
558.6(d)(1)(i)          1,500                    1                 500                  0.25           125
 through
 (d)(1)(iii)
558.6 (d)(1)(iv)           20                    1                  20                  0.25             5
558.6(d)(2)             1,000                    5               5,000                  0.25         1,250
514.1(b)(9)                 1                    1                   1                  3.00             3
Total                                                                                               95,133
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                         Annual Frequency      Total Annual        Hours per
 21 CFR Section   No. of Recordkeepers   per Recordkeeping        Records         Recordkeeper     Total Hours
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558.6(c)(1)           112,500                   10           1,125,000                   .0167      18,788
 through (c)(4)
558.6(e)(1)             5,000                   75             375,000                   .0167       6,263
 through (e)(3)
Total                                                                                               25,051
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

The estimate of the times required for record preparation and 
maintenance is based on agency communication with industry. Other 
information needed to calculate the total burden hours is derived from 
agency records and experience.

    Dated: April 19, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-10563 Filed 4-29-02; 8:45 am]
BILLING CODE 4160-01-S