[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Notices]
[Pages 23732-23733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9532]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0369]


Agency Information Collection Activities; Proposed Collection; 
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 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 of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting and 
recordkeeping requirements of FDA's regulations implementing the 
Federal Import Milk Act (FIMA).

DATES: Submit either electronic or written comments on the collection 
of information by June 19, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (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: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 301-796-5733, [email protected].

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. 
``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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

Regulations Under the Federal Import Milk Act--21 CFR Part 1210 (OMB 
Control Number 0910-0212)--Extension

    Under 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

[[Page 23733]]

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

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Number of
              21 CFR Section                         Form No.              Number of     responses per   Total annual    Average burden    Total hours
                                                                          respondents     respondent       responses      per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.11..................................  FDA 1996/Sanitary                         2             200             400              1.5            600
                                            inspection of dairy farms.
1210.12..................................  FDA 1995/Physical                         1               1               1              0.5              0.5
                                            examination of cows.
1210.13..................................  FDA 1994/Tuberculin test...               1               1               1              0.5              0.5
1210.14..................................  FDA 1997/Sanitary                         2               1               2              2                4
                                            inspections of plants.
1210.20..................................  FDA 1993/Application for                  2               1               2              0.5              1
                                            permit.
1210.23..................................  FDA 1815/Permits granted on               2               1               2              0.5              1
                                            certificates.
                                                                       ---------------------------------------------------------------------------------
    Total................................  ...........................  ..............  ..............  ..............  ...............            607
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Number of       Number of records     Total annual     Average burden per
                   21 CFR Section                        recordkeepers     per recordkeeper         records          recordkeeping        Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.15.............................................                  2                   1                   2                0.05                0.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 two respondents will submit approximately 200 Form FDA 
1996 reports annually, for a total of 600 responses. FDA estimates the 
reporting burden to be 1.5 hours per response, for a total burden of 
607 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 two respondents will submit one Form FDA 1997 
report annually, for a total of two responses. FDA estimates the 
reporting burden to be 2.0 hours per response, for a total burden of 4 
hours. FDA estimates that two respondents will submit one Form FDA 1993 
report annually, for a total of two responses. FDA estimates the 
reporting burden to be 0.5 hours per response, for a total burden of 1 
hour. FDA estimates that two respondents will submit one Form FDA 1815 
report annually, for a total of two responses. FDA estimates the 
reporting burden to be 0.5 hours per response, for a total burden of 1 
hour.
    With regard to records maintenance, FDA estimates that 
approximately two recordkeepers will spend 0.05 hours annually 
maintaining the additional pasteurization records required by Sec.  
1210.15, for a total of 0.10 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 
business activities.

    Dated: April 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-9532 Filed 4-19-12; 8:45 am]
BILLING CODE 4160-01-P