Document ID: FDA-2005-N-0474-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive
Posted Date: 2008-09-05T04:00Z

[Federal Register: September 5, 2008 (Volume 73, Number 173)]
[Notices]               
[Page 51822-51823]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se08-56]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0474] (formerly Docket No. 2005N-0210)

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October 
6, 2008.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0363. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Veterinary Feed Directive--21 CFR Part 558 (OMB Control Number 0910-
0363)--Extension

    With passage of the Animal Drug Availability Act, Congress enacted 
legislation establishing a new class of restricted feed use drugs 
called Veterinary Feed Directive (VFD) drugs. The VFD class of drugs 
may be distributed without involving State pharmacy laws. Although 
controls on the distribution and use of VFD drugs are similar to 
controls for prescription drugs regulated under section 503(f) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 503(f)), the 
implementing VFD regulation under section 558.6 (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 the distribution 
records of all medicated feeds containing VFD must be maintained. The 
VFD regulation ensures the protection of the public health while 
enabling animal producers to obtain and use needed drugs as efficiently 
and cost-effectively as possible.
    In the Federal Register of June 5, 2008 (73 FR 32029), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
558.6(a)(3)                15,000                    25            375,000                .25             93,750
 through
 (a)(5)
----------------------------------------------------------------------------------------------------------------
558.6(d)(1)(i)                300                     1                300                .25                 75
 through
 (d)(1)(iii)
----------------------------------------------------------------------------------------------------------------
558.6(d)(1)(iv                 20                     1                 20                .25                  5
 )
----------------------------------------------------------------------------------------------------------------
558.6(d)(2)                 1,000                     5              5,000                .25              1,250
----------------------------------------------------------------------------------------------------------------
514..1(b)(9)                    1                     1                  1               3.00                  3
----------------------------------------------------------------------------------------------------------------
Total                      16,321  ....................  .................  .................             95,083
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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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                      No. of         Annual Frequency       Total Annual
21 CFR Section    Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
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)(4)
----------------------------------------------------------------------------------------------------------------
Total                     117,500  ....................  .................  .................             25,051
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 51823]]

    Dated: August 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20579 Filed 9-4-08; 8:45 am]

BILLING CODE 4160-01-S