[Federal Register Volume 71, Number 219 (Tuesday, November 14, 2006)]
[Notices]
[Page 66335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0329]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medicated Feed Mill 
License Application

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 
December 14, 2006

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.

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

Medicated Feed Mill Licensing Application--21 CFR Part 515 (OMB Control 
No. 0910-0337)--Extension

    The Animal Drug Availability Act (ADAA) of October 9, 1996, amended 
section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360b) to replace the system for the approval of specific medicated feed 
with a general licensing system for feed mills. Before passage of the 
ADAA, medicated feed manufacturers were required to obtain approval of 
Medicated Feed Applications (MFAs) in order to manufacture certain 
types of medicated feeds. An individual approved MFA was required for 
each and every applicable medicated feed. The ADAA streamlined the 
paperwork process for gaining approval to manufacture medicated feeds 
by replacing the MFA system with a facility license for each medicated 
feed manufacturing facility. Implementing regulations are at part 515 
(21 CFR part 515).
    In the Federal Register of August 25, 2006 (71 FR 50433), FDA 
solicited comments on the information collection provisions of this 
proposed collection. In response to that request, FDA received no 
comments.
    Description of Respondents: Medicated feed manufacturers.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                      No. of       Annual Frequency per      Total Annual          Hours per
21 CFR Section     Respondents           Response              Responses            Response        Total Hours
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515.10(b)                       7                     1                     7               0.25            1.75
515.11(b)                     100                     1                   100               0.25              25
515.23                         25                     1                    25               0.25            6.25
515.30(c)                    0.15                     1                  0.15                 24             3.6
Total           .................  ....................  ....................  .................            36.6
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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                              Hours per
21 CFR Section   Recordkeepers  per Recordkeeping  Total Annual Records      Recordkeeper         Total Hours
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510.305                  1,070                  1                 1,070                  0.03              32.10
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated annual reporting burden on industry is 36.6 hours as 
shown in table 1 of this document. Industry estimates it takes about 1/
4 hour to submit the application. We estimate 132 original and 
supplemental applications, and voluntary revocations for a total of 33 
hours (132 submissions x 1/4 hour). An additional 3.6 hours is added 
for the rare notice of opportunity for a hearing to not approve or 
revoke an application. Finally, we estimate 36 hours for maintaining 
and retrieving labels as required by 21 CFR 510.305. We estimated .03 
hours for each of approximately 1,070 licensees. Thus, the total burden 
for recordkeeping requirements is 32.10 hours (1,070 x 0.03).

    Dated: November 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19152 Filed 11-13-06; 8:45 am]
BILLING CODE 4160-01-S