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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act, 73939-73940 [E8-28692] :: Food And Drug Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Food And Drug Administration Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act, 73939-73940 [E8-28692]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act, 73939-73940 [E8-28692]
Download as PDF 73939 Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 860.123 1There 6 Total Annual Responses 1 Hours per Response 6 Total Hours 500 3,000 are no capital costs or operating and maintenance costs associated with this collection of information. Based on the last 3 years, and actual reclassification petitions received, FDA anticipates that six petitions will be submitted each year. The time required to prepare and submit a reclassification petition, including the time needed to assemble supporting data, averages 500 hours per petition. This average is based upon estimates by FDA administrative and technical staff that are familiar with the requirements for submission of a reclassification petition, have consulted and advised manufacturers on these requirements, and have reviewed the documentation submitted. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. Dated: November 25, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–28695 Filed 12–3–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 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: 202–395–6974, or e-mailed to oira_submission@omb.eop.gov. 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) [Docket No. FDA–2008–N–0453] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act AGENCY: Annual Frequency per Response Food and Drug Administration, HHS. 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 mstockstill on PROD1PC66 with NOTICES 21 CFR Section No. of Respondents Form No. 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 VerDate Aug<31>2005 17:35 Dec 03, 2008 Jkt 217001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\04DEN1.SGM 04DEN1 73940 Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 21 CFR Section No. of Respondents Form No. Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 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 1 There 2,425.0 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 1210.15 mstockstill on PROD1PC66 with NOTICES 1 There Annual Frequency per Recordkeeping No. of Recordkeepers 21 CFR Section 8 Total Annual Records 1 Hours per Record 8 Total Hours 0.05 0.40 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 VerDate Aug<31>2005 17:35 Dec 03, 2008 Jkt 217001 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. [FR Doc. E8–28692 Filed 12–3–08; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1999–D–0128] (formerly Docket No. 1999D–2013) Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics,’’ dated November 2008. The guidance document provides information concerning cooperative manufacturing arrangements applicable to biological products subject to licensure under the U.S. Public Health Service Act (PHS Act). The guidance describes the licensing strategies for meeting the increased need for flexible manufacturing arrangements. The guidance announced in this notice finalizes the draft guidance of the same title. DATES: Submit written or electronic comments on agency guidances at any time. Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and ADDRESSES: E:\FR\FM\04DEN1.SGM 04DEN1
[Pages 73939-73940]
[FR Doc No: E8-28692]
[Docket No. FDA-2008-N-0453]
of Management and Budget Review; Comment Request; Regulations Under the
comments should be identified with the OMB control number 0910-0212.
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[deg] 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 Sec.
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 (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
(Sec.  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
21 CFR Section                           Form No.                  No. of       Frequency per   Total Annual      Hours per      Total Hours
1210.11                                  FDA 1996/Sanitary inspection of               8             200           1,600             1.5           2,400
1210.12                                 FDA 1995/Physical examination of               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               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               8               1               8             0.5             4.0
Total                                                                                                                                            2,425.0
No. of        Annual Frequency     Total Annual
21 CFR Section     Recordkeepers    per Recordkeeping       Records       Hours per  Record     Total Hours
1210.15                            8                  1                  8               0.05               0.40
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
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
1815 report annually, for a total of eight responses. FDA estimates the
With regard to records maintenance, FDA estimates that
approximately eight recordkeepers will spend 0.05 hours annually
maintaining the additional pasteurization records required by Sec.
1210.15, for a total of 0.40 hours annually.
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). Under 5 CFR 1320.3(c)(2), the
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