[Federal Register Volume 70, Number 111 (Friday, June 10, 2005)]
[Notices]
[Pages 33907-33908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-11581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0210]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Veterinary Feed Directive

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 Veterinary Feed Directive (VFD) drugs and 
animal feeds containing VFD drugs.

DATES: Submit written or electronic comments on the collection of 
information by August 9, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.fda.gov/dockets/ecomments. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug 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 Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
rm. 4B-41, 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 extension of an existing collection 
of information, before submitting the collection to OMB for approval. 
To comply with this requirement, FDA is publishing notice of a proposed 
collection of information as set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether

[[Page 33908]]

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 (OMB Control Number 0910-0363)--Extension

    With the passage of Animal Drug Availability Act (ADAA), the 
Congress enacted legislation establishing a new class of restricted 
feed use drugs, 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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353(f)), the implementing VFD regulation (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 feed containing VFD drugs must notify FDA of 
their intent to distribute, and records must be maintained of the 
distribution of all medicated feed 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.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                      Annual Frequency per      Total Annual         Hours per
21 CFR Section   No. of Respondents         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)
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558.6(d)(1)(i)                   500                     1                   500            0.25             125
 through
 (d)(1)(iii)
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558.6(d)(1)(iv                    20                     1                    20            0.25               5
 )
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558.6(d)(2)                    1,000                     5                 5,000            0.25           1,250
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514.1(b)(9)                        1                     1                     1            3.00               3
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Total Hours                   16,521  ....................  ....................  ..............          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 per   Total Annual      Hours per
   21 CFR Section     No. of Recordkeepers      Recordkeeper          Records         Record        Total Hours
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558.6(c)(1) through                112,500                    10       1,125,000           .0167          18,788
 (c)(4)
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558.6(e)(1) through                  5,000                    75         375,000           .0167           6,263
 (e)(4)
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Total Hours           ....................  ....................  ..............  ..............          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 and agency 
records and experience.

    Dated: June 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11581 Filed 6-9-05; 8:45 am]
BILLING CODE 4160-01-S