[Federal Register: May 23, 2003 (Volume 68, Number 100)]
[Notices]
[Page 28236-28237]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my03-102]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0198]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medicated Feed Mill License
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 for an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
for medicated feed mill licensing requirements.
DATES: Submit written or electronic comments on the collection of
information by July 22, 2003.
ADDRESSES: Submit electronic comments on the collection of information
via the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of
information to the Dockets Management Branch (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, Office of Information
Resources Management (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 Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor. A
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 listed below.
With respect to the following collection of information, FDA
invites comments on: (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.
Medicated Feed Mill License Application--21 CFR Part 515 (OMB
Control Number 0910-0337)--Extension
In the Federal Register of November 19, 1999 (64 FR 63195), FDA
published a final rule implementing the feed mill licensing provisions
of the Animal Drug Availability Act (the ADAA) of 1966 (Public Law 104-
250). The rule added a new part 515 to title 21 CFR to provide the
requirements for medicated feed mill licensing.
The rule set forth the information to be included in medicated feed
mill license applications and supplemental applications. Also, it set
forth criteria for, among other things, the approval and refusal to
approve a medicated feed mill license application, as well as the
criteria for the revocation and/or suspension of a license.
Respondents to this collection of information are individuals or
firms that manufacture medicated animal feed.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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21 CFR No. of Annual Frequency Total Annual
Section Recordkeepers per Response Responses Hours per Response Total Hours
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515.10(b) 7 1 7 0.25 1.75
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515.11(b) 100 1 100 0.25 25.00
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[[Page 28237]]
515.23 25 1 25 0.25 6.25
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515.30(c) 0.15 1 0.15 24 3.60
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Total Burden Hours 36.6
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\1\ There are no capital cost or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\ 1\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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510.305 1,160 1 1,160 0.03 34.80
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of respondents is derived from agency data on
the number of medicated feed manufacturers entering the market each
year, changing ownership or address, requesting voluntary revocation of
a medicated feed mill license, and those involved in revocation and/or
suspension of a license. The estimate of the time required for this
reporting requirement is based on the agency communication with
industry.
Dated: May 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12922 Filed 5-22-03; 8:45 am]
BILLING CODE 4160-01-S