[Federal Register Volume 67, Number 160 (Monday, August 19, 2002)]
[Notices]
[Pages 53806-53807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0116]


Agency Information Collection Activities; Submission for OMB 
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 the 
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 (the PRA).

DATES: Submit written comments on the collection of information by 
September 18, 2002.

[[Page 53807]]


ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (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

    The veterinary feed directive (VFD) drugs section of the Animal 
Drug Availability Act of 1996 (ADAA) (Public Law 104-250) established a 
new class of restricted feed use drugs that may be distributed without 
invoking State pharmacy laws. In order to implement the VFD drugs 
section of the ADAA, FDA issued regulations (65 FR 76924, December 8, 
2000) that impose reporting and recordkeeping requirements on 
veterinarians, distributors of animal feeds containing VFD drugs, and 
clients using medicated feeds containing VFD drugs. All distributors of 
animal feed containing VFD drugs must notify FDA of their intent to 
distribute animal feed containing a VFD drug, and must maintain records 
of the distribution of all animal feeds containing VFD drugs (21 CFR 
558.6).
    In the Federal Register of April 30, 2002 (67 FR 21252), the agency 
requested comments on the proposed collection of information. FDA 
received one comment.
    The comment asked if the proposed collection of information was 
necessary for the proper performance of FDA functions and whether the 
information will have practical utility. The answer is yes. As 
detailed, the VFD regulation ensures protection of public health while 
enabling animal producers to obtain and use needed drugs as efficiently 
and cost-effectively as possible.
    Respondents to this collection of information are veterinarians, 
distributors of animal feeds containing VFD drugs, and clients using 
medicated feeds containing VFD drugs.
    FDA estimates the burden for this collection of information as 
follows:

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


           Table 2.--Estimated Annual Recordkeeping Burden\1\
------------------------------------------------------------------------
                                      Annual
                        No. of       Frequency    Total    Hours   Total
  21 CFR Section    Recordkeepers       per       Annual    per    Hours
                                   Recordkeeper  Records  Record
------------------------------------------------------------------------
558.6(c)(1)           112,500            10      1,125,0  .0167   18,788
 through (c)(4)                                      00
558.6(e)(1)             5,000            75      375,000  .0167   6,263
 through (e)(3)
Total                                                             25,051
------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.

    These estimates are based on agency communication with industry. 
Other information needed to calculate the total burden hours are 
derived from agency records and experience.

    Dated: August 13, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-20917 Filed 8-16-02; 8:45 am]
BILLING CODE 4160-01-S