[Federal Register Volume 89, Number 141 (Tuesday, July 23, 2024)]
[Notices]
[Pages 59739-59740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16101]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0972]


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.

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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: Submit written comments (including recommendations) on the 
collection of information by August 22, 2024.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0212. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

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 (FIMA)--21 CFR Part 1210

OMB Control Number 0910-0212--Extension

    This information collection supports FDA regulations. 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).
    Our 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.
    To assist respondents with the regulatory requirements, we have 
developed the following forms:
     Form FDA 1815: Certificate/Transmittal for an Application 
(21 CFR 1210.23).
     Form FDA 1993: Application for Permit To Ship or Transport 
Milk and/or Cream into the United States (21 CFR 1210.20).
     Form FDA 1994: Report of Tuberculin Tests of Cattle (21 
CFR 1210.13).
     Form FDA 1995: Report of Physical Examination of Cows (21 
CFR 1210.12).
     Form FDA 1996: Dairy Farm Sanitary Report (21 CFR 
1210.11).
     Form FDA 1997: Score Card for Sanitary Inspection of Milk 
Plants (21 CFR 1210.14).
    The information collected is used by FDA to determine whether a 
permit to import milk and/or cream into the United States should be 
granted.
    Description of Respondents: Respondents include foreign dairy farms 
and plants engaged in transporting milk and/or cream into the United 
States. Respondents are from the private sector (for-profit 
businesses).
    In the Federal Register of March 21, 2024 (89 FR 20221), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden 1 2
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                                                                                Number of
        21 CFR section         Form FDA number/ description     Number of     responses per   Total annual   Average burden per response    Total hours
                                                               respondents     respondent       responses
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1210.11......................  1996/Sanitary inspection of                1             200             200  1.5........................             300
                                dairy farms.
1210.12......................  1995/Physical examination of               1               1               1  0.5 (30 minutes)...........               1
                                cows.
1210.13......................  1994/Tuberculin test........               1               1               1  0.5 (30 minutes)...........               1

[[Page 59740]]

 
1210.14......................  1997/Sanitary inspections of               1               1               1  2.0........................               2
                                plants.
1210.20......................  1993/Application for permit.               1               1               1  0.5 (30 minutes)...........               1
1210.23......................  1815/Permits granted on                    1               1               1  0.5 (30 minutes)...........               1
                                certificates.
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    Total....................  ............................  ..............  ..............  ..............  ...........................             306
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                               Table 2--Estimated Annual Recordkeeping Burden 1 2
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                                                   Number of                     Average burden
    21 CFR section/activity        Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
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1210.15/Pasteurization records               1               1               1  0.05 (3 minutes)               1
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    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. In the past, Form FDA 1815 has been submitted in lieu of 
these forms. Because we have not received any Forms FDA 1994 or 1995 in 
the last 3 years, we assume no more than one will be submitted 
annually.
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    \1\ There are no capital costs or operating and maintenance 
costs associated with this collection of information.
    \2\ Numbers have been rounded.
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    No burden has been estimated for the tagging requirement in Sec.  
1210.22 because the information on the tag is either supplied by us 
(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 subject to review by OMB under the PRA. 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.
    Based on a review of the information collection since our last OMB 
approval, we have retained our burden estimate. The estimated number of 
respondents and hours per response are based on our experience with the 
import milk permit program and the average number of import milk permit 
holders over the past 3 years. However, we have not received any 
responses in the last 3 years; therefore, we estimate that one or fewer 
to be submitted annually. Although we have not received any responses 
in the last 3 years, we believe these information collection provisions 
should be extended to provide for the potential future need for a milk 
importer.

    Dated: July 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16101 Filed 7-22-24; 8:45 am]
BILLING CODE 4164-01-P