E8-28692. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 January 5, 2009.

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: [phone], or e-mailed to [e-mail]. All comments should be identified with the OMB control number 0910-0212. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Jonna Capezzuto, Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3794.

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.

Regulations Under the Federal Import Milk Act—(OMB Control Number 0910-0212—Extension)

Under the Federal Import Milk Act (FIMA) (21 U.S.C. 141-149), milk or cream may be imported into the United States only by the holder of a valid import milk permit (21 U.S.C. 141). Before such permit is issued: (1) All cows from which import milk or cream is produced must be physically examined and found healthy; (2) if the milk or cream is imported raw, all such cows must pass a tuberculin test; (3) the dairy farm and each plant in which the milk or cream is processed or handled must be inspected and found to meet certain sanitary requirements; (4) bacterial counts of the milk at the time of importation must not exceed specified limits; and (5) the temperature of the milk or cream at time of importation must not exceed 50° F (21 U.S.C. 142).

FDA's regulations in part 1210 (21 CFR part 1210) implement the provisions of FIMA. Sections 1210.11 and 1210.14 require reports on the sanitary conditions of, respectively, dairy farms and plants producing milk and/or cream to be shipped to the United States. Section 1210.12 requires reports on the physical examination of herds, while § 1210.13 requires the reporting of tuberculin testing of the herds. In addition, the regulations in part 1210 require that dairy farmers and plants maintain pasteurization records (§ 1210.15) and that each container of milk or cream imported into the United States bear a tag with the product type, permit number, and shipper's name and address (§ 1210.22). Section 1210.20 requires that an application for a permit to ship or transport milk or cream into the United States be made by the actual shipper. Section 1210.23 allows permits to be granted based on certificates from accredited officials.

In the Federal Register of August 25, 2008 (73 FR 50031), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section	Form No.	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
1210.11	FDA 1996/Sanitary inspection of dairy farms	8	200	1,600	1.5	2,400
1210.12	FDA 1995/Physical examination of cows	1	1	1	0.5	0.5
1210.13	FDA 1994/Tuberculin test	1	1	1	0.5	0.5
1210.14	FDA 1997/Sanitary inspections of plants	8	1	8	2.0	16.0
1210.20	FDA 1993/Application for permit	8	1	8	0.5	4.0
1210.23	FDA 1815/Permits granted on certificates	8	1	8	0.5	4.0
Total						2,425.0
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.—Estimated Annual Recordkeeping Burden¹

21 CFR Section	No. of Recordkeepers	Annual Frequency per Recordkeeping	Total Annual Records	Hours per Record	Total Hours
1210.15	8	1	8	0.05	0.40
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimated number of respondents and hours per response are based on FDA's experience with the import milk permit program and the average number of import milk permit holders over the past 3 years. FDA estimates that 8 respondents will submit approximately 200 Form FDA 1996 reports annually, for a total of 1,600 responses. FDA estimates the reporting burden to be 1.5 hours per response, for a total burden of 2,400 hours.

The Secretary of Health and Human Services has the discretion to allow Form FDA 1815, a duly certified statement signed by an accredited official of a foreign government, to be submitted in lieu of Forms FDA 1994 and 1995. To date, Form FDA 1815 has been submitted in lieu of these forms. Because FDA has not received any Forms FDA 1994 and 1995 in the last 3 years, the agency estimates no more than one will be submitted annually. FDA estimates the reporting burden for each to be 0.5 hours per response for a total burden reporting burden of 0.5 hours each.

FDA estimates that eight respondents will submit one Form FDA 1997 report annually, for a total of eight responses. FDA estimates the reporting burden to be 2.0 hours per response, for a total burden of 16 hours. FDA estimates that eight respondents will submit one Form FDA 1993 report annually, for a total of eight responses. FDA estimates the reporting burden to be 0.5 hours per response, for a total burden of 4 hours. FDA estimates that eight respondents will submit one Form FDA 1815 report annually, for a total of eight responses. FDA estimates the reporting burden to be 0.5 hours per response, for a total burden of 4 hours.

With regard to records maintenance, FDA estimates that approximately eight recordkeepers will spend 0.05 hours annually maintaining the additional pasteurization records required by § 1210.15, for a total of 0.40 hours annually.

No burden has been estimated for the tagging requirement in § 1210.22 because the information on the tag is either supplied by FDA (permit number) or is disclosed to third parties as a usual and customary part of the shipper's normal business activities (type of product, shipper's name and address). Under 5 CFR 1320.3(c)(2), the public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public is not a collection of information. Under 5 CFR 1320.3(b)(2)), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities.

Dated: November 25, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.