Document ID: FDA-2009-N-0511-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2010-01-22T05:00Z

[Federal Register: January 22, 2010 (Volume 75, Number 14)]
[Notices]               
[Page 3735-3736]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ja10-54]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0511]

 
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 
February 22, 2010.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0337. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 License Application--(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 (the 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.
    In the Federal Register of October 28, 2009 (74 FR 55556), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 3736]]

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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515.10(b)                                                           20                        1              20                  0.25               5
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515.11(b)                                                           75                        1              75                  0.25              18.75
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515.23                                                              40                        1              40                  0.25              10
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515.30(c)                                                            0.15                     1               0.15              24                  3.6
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Total Burden Hours                                                                                                                                 37.35
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\1\ There are no capital costs or maintenance costs associated with this information collection.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records          Recordkeeper       Total Hours
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510.305                                                             1,000                     1              1,000               0.03                 30
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\1\ There are no capital costs or maintenance costs associated with this information collection.

    The estimated annual reporting burden on industry is 37.35 hours as 
shown in table 1 of this document. Industry estimates it takes about 1/
4 hour to submit the application. We estimate 135 original and 
supplemental applications, and voluntary revocations for a total of 
33.75 hours (135 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 30 hours for maintaining 
and retrieving labels as required by 21 CFR 510.305 and shown in table 
2 of this document. We estimated .03 hours for each of approximately 
1,000 licensees. Thus, the total annual burden for reporting and 
recordkeeping requirements is estimated be 67.35 hours.

    Dated: January 15, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1154 Filed 1-21-10; 8:45 am]
BILLING CODE 4160-01-S