[Federal Register: September 28, 2005 (Volume 70, Number 187)]
[Notices]               
[Page 56707-56708]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se05-140]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[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 
28, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, inlcuding first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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

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 the passage of the Animal Drug Availability Act (ADAA), 
Congress enacted legislation establishing a new class of restricted 
feed use drugs called Veterinary Feed Directive, 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(f)), 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.

[[Page 56708]]

    In the Federal Register of June 10, 2005 (70 FR 33907), FDA 
published a 60-day notice soliciting comments on this collection of 
information. In response to this notice, no comments were received.
    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 for this collection of information as 
follows:

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


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                                     Annual Frequency per
                    21 CFR                     No. of Recordkeepers      Recordkeeper      Total Annual Records    Hours per Record       Total Hours
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558.6(c)(1) through 558.6(c)(4)                             112,500                    10             1,125,000                 .0167             18,788
558.6(e)(1) through 558.6(e)(3)                               5,000                    75               375,000                 .0167              6,263
Total Hours                                    ....................  ....................  ....................  ....................             25,051
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\1\There are no capitals cost or operating and maintenance cost 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 are derived from 
agency records and experience.

    Dated: September 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19393 Filed 9-27-05; 8:45 am]

BILLING CODE 4160-01-S