[Federal Register Volume 73, Number 109 (Thursday, June 5, 2008)]
[Notices]
[Pages 32029-32030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12648]


-----------------------------------------------------------------------

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; Proposed Collection; 
Comment Request; Veterinary Feed Directive

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

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 each proposed extension 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 
drugs and animal feeds containing Veterinary Feed Directive drugs.

DATES:  Submit written or electronic comments on the collection of 
information by August 4, 2008.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the

[[Page 32030]]

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 of information, 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 these topics: (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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Annual Frequency per      Total Annual
              21 CFR Section                 No. of Respondents          Response             Responses        Hours per Response        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5)                                15,000                    25               375,000                   .25                93,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(d)(1)(i) through (d)(1)(iii)                           300                     1                   300                   .25                    75
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 Frequency per   Total Annual      Hours per
   21 CFR Section     No. of Recordkeepers      Recordkeeping         Records         Record        Total Hours
----------------------------------------------------------------------------------------------------------------
558.6(c)(1) through                112,500                    10       1,125,000           .0167          18,788
 (c)(4)
----------------------------------------------------------------------------------------------------------------
558.6(e)(1) through                  5,000                    75         375,000           .0167           6,263
 (e)(4)
----------------------------------------------------------------------------------------------------------------
Total                              117,500  ....................  ..............  ..............          25,051
----------------------------------------------------------------------------------------------------------------
\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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: May 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12648 Filed 6-4-08; 8:45 am]
BILLING CODE 4160-01-S