[Federal Register: August 8, 2003 (Volume 68, Number 153)]
[Notices]
[Page 47331-47332]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08au03-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0198]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Requirements for Medicated Feed Mill License
AGENCY: Food
[[Page 47332]]
and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments on the collection of information by
September 8, 2003.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs (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 License Application--21 CFR Part 515 (OMB Control
Number 0910-0037)--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 of 1966 (Public Law 104-250). The
rule added a new 21 CFR part 515 to provide the requirements for
medicated feed mill licensing.
The rule sets forth the information to be included in medicated
feed mill license applications and supplemental applications. It also
sets forth the 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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Annual
No. of Frequency Total Hours Total
21 CFR Section Respondents per Annual per Hours
Responses Responses Response
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515.10 7 1 7 0.25 1.75
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515.11 100 1 100 0.25 25.00
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515.23 25 1 25 0.25 6.25
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515.30 0.15 1 0.15 24.00 3.60
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Total Burden Hours ........... ......... ......... ........ 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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Annual Total
21 CFR Section No. of Frequency per Annual Hours per Total
Recordkeepers Recordkeeping Records Recordkeeper Hours
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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: August 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20201 Filed 8-7-03; 8:45 am]
BILLING CODE 4160-01-S