Document ID: FDA-2011-N-0554-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Veterinary Feed Directive
Posted Date: 2011-11-01T04:00Z

[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67460-67461]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28240]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0554]

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.

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

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 
December 1, 2011.

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) 395-7285, or emailed to oira_submission@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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-7651, 
juanmanuel.vilela@fda.hhs.gov.

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 of 1996 (ADAA) 
(Pub. L. 104-250), the Congress enacted legislation establishing a new 
class of restricted feed use drugs, veterinary feed directive (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 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.
    In the Federal Register of August 3, 2011(76 FR 46818), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments that pertained to 
the information collection burden estimates.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
        21 CFR section            Number of     responses per   Total annual     Average burden     Total hours
                                 respondents     respondent       responses       per response
----------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5)...          15,000              25         375,000                .25          93,750
558.6(d)(1)(i) through                    300               1             300                .25              75
 (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                  3
                              ----------------------------------------------------------------------------------

[[Page 67461]]

 
    Total....................  ..............  ..............  ..............  .................          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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Number of
                           21 CFR section                               Number of      records per    Total annual    Average burden per    Total hours
                                                                      Recordkeepers   recordkeeper       records        recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(c)(1) through (c)(4).........................................         112,500              10       1,125,000                .0167          18,788
558.6(e)(1) through (e)(4).........................................           5,000              75         375,000                .0167           6,263
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ..............  ..............  ..............  ...................          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.

    Dated: October 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28240 Filed 10-31-11; 8:45 am]
BILLING CODE 4160-01-P