03-12922. Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 Burden¹

21 CFR Section	No. of Recordkeepers	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
515.10(b)	7	1	7	0.25	1.75
515.11(b)	100	1	100	0.25	25.00
515.23	25	1	25	0.25	6.25
515.30(c)	0.15	1	0.15	24	3.60
Total Burden Hours					36.6
1 There are no capital cost or operating and maintenance costs associated with this collection of information.

Table 2.—Estimated Annual Recordkeeping Burden ¹

21 CFR Section	No. of Recordkeepers	Annual Frequency per Recordkeeping	Total Annual Records	Hours per Recordkeeper	Total Hours
510.305	1,160	1	1,160	0.03	34.80
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.