
[Federal Register: December 4, 2008 (Volume 73, Number 234)]
[Notices]               
[Page 73939-73940]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de08-43]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[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: 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: 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)

    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 
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 Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Annual
           21 CFR Section                           Form No.                  No. of       Frequency per   Total Annual      Hours per      Total Hours
                                                                            Respondents      Response        Responses       Response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.11                                  FDA 1996/Sanitary inspection of               8             200           1,600             1.5           2,400
                                                             dairy farms
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.12                                 FDA 1995/Physical examination of               1               1               1             0.5             0.5
                                                                    cows
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 73940]]


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
                                                                  plants
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                            certificates
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 Burden\1\
----------------------------------------------------------------------------------------------------------------
                         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
----------------------------------------------------------------------------------------------------------------
\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 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 
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
