[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20221-20223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (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 our regulations implementing the Federal 
Import Milk Act (FIMA).

DATES: Either electronic or written comments on the collection of 
information must be submitted by May 20, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 20, 2024. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2024-N-0972 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Regulations Under the Federal 
Import Milk Act.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including

[[Page 20222]]

the claimed confidential information, in its consideration of comments. 
The second copy, which will have the claimed confidential information 
redacted/blacked out, will be available for public viewing and posted 
on https://www.regulations.gov. Submit both copies to the Dockets 
Management Staff. If you do not wish your name and contact information 
to be made publicly available, you can provide this information on the 
cover sheet and not in the body of your comments and you must identify 
this information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), 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 (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).
    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       Total
            21 CFR section                  Form FDA No./        Number of    responses per     annual       Average burden per response     Total hours
                                             description        respondents    respondent     responses
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1210.11..............................  1996/Sanitary                      1             200          200  1.5..............................          300
                                        inspection of dairy
                                        farms.
1210.12..............................  1995/Physical                      1               1            1  0.5 (30 minutes).................            1
                                        examination of cows.
1210.13..............................  1994/Tuberculin test...            1               1            1  0.5 (30 minutes).................            1
1210.14..............................  1997/Sanitary                      1               1            1  2.0..............................            2
                                        inspections of plants.
1210.20..............................  1993/Application for               1               1            1  0.5 (30 minutes).................            1
                                        permit.

[[Page 20223]]

 
1210.23..............................  1815/Permits granted on            1               1            1  0.5 (30 minutes).................            1
                                        certificates.
                                                               -----------------------------------------------------------------------------------------
    Total............................  .......................  ...........  ..............  ...........  .................................          306
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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.


                                                 Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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                                                                  Number of
           21 CFR section/activity                Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
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1210.15/Pasteurization records...............               1               1               1  0.05 (3 minutes).........................               1
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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.

    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.
    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: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06028 Filed 3-20-24; 8:45 am]
BILLING CODE 4164-01-P