[Federal Register: July 26, 1999 (Volume 64, Number 142)] [Notices] [Page 40379-40380] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr26jy99-75] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 99N-0296] Agency Information Collection Activities; Submission for OMB 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 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 (the PRA). DATES: Submit written comments on the collection of information by August 25, 1999. ADDRESSES: Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy Taylor, Desk Officer for FDA. FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223. SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA (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--21 CFR Part 1210 (OMB Control Number 0910-021)--Extension Under the regulations (part 1210 (21 CFR part 1210)) implementing the Federal Import Milk Act (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. 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 deg.F. In addition, the regulations require that dairy farmers and plants maintain pasteurization records (Sec. 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. In the Federal Register of April 30, 1999 (64 FR 23333), the agency requested comments on the proposed collections of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1.--Estimated Annual Reporting Burden1 ---------------------------------------------------------------------------------------------------------------- Annual Form 21 CFR No. of Frequency per Total Annual Hours per Total Hours Section Respondents Response Responses Response ---------------------------------------------------------------------------------------------------------------- FDA 1815/Permits 1210.23 4 1 4 0.5 2.0 granted on certificates FDA 1993/ 1210.20 4 4 4 0.5 2.0 Applicant of permit FDA 1994/ 1210.13 Tuberculin test2 FDA 1995/ 1210.12 Physical examination of cows2 FDA 1996/ 1210.11 4 2003 800 1.5 1200.0 Sanitary inspection of dairy farms FDA 1997/ 1210.14 4 1 4 2.0 8.0 Sanitary inspection of plants Total 1212.0 ---------------------------------------------------------------------------------------------------------------- \1\There are no capital costs or operating and maintenance costs associated with this collection of information. \2\No burden has been estimated for Forms FDA 1994 and 1995 because they are not currently being used. \3\Due to a clerical error, the reporting burden hours for FDA 1996/Sanitary inspection of daily farms that appeared in a notice issued in the Federal Register of April 30, 1999 (64 FR 23333) were incorrect. Table 1 of this document contains the correct estimates. Table 2.--Estimated Annual Recordkeeping Burden1 ---------------------------------------------------------------------------------------------------------------- Annual 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Recordkeepers Recordkeeping Records Recordkeeper ---------------------------------------------------------------------------------------------------------------- 1210.15 4 1 4 0.05 0.20 ---------------------------------------------------------------------------------------------------------------- \1\There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 40380]] No burden has been estimated for the tagging requirement in Sec. 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). No burden has been estimated for Forms FDA 1994 and 1995 because they are not currently being used. 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. Dated: July 19, 1999. William K. Hubbard, Senior Associate Commissioner for Policy, Planning and Legislation. [FR Doc. 99-18927 Filed 7-23-99; 8:45 am] BILLING CODE 4160-01-F