[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Pages 70182-70184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24428]


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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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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: Submit either electronic or written comments on the collection 
of information by January 4, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 4, 2021. The https://www.regulations.gov electronic filing system will accept

[[Page 70183]]

comments until 11:59 p.m. Eastern Time at the end of January 4, 2021. 
Comments received by mail/hand delivery/courier (for written/paper 
submissions) will be considered timely if they are postmarked or the 
delivery service acceptance receipt is 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-2012-N-0369 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, 240-420-7500.
     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 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, 240-420-7500.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

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

[[Page 70184]]

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.
    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\
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                                                   Number of       Total
 21 CFR section     Form FDA No.    Number of    responses per     annual       Average burden per       Total
                                   respondents    respondent     responses           response            hours
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1210.11.........  1996/Farm                  1             200          200  1.5.....................        300
                   Inspection
                   Report.
1210.12.........  1995/Report of             1               1            1  0.5 (30 minutes)........        0.5
                   Physical
                   Examination of
                   Cows.
1210.13.........  1994/Report of             1               1            1  0.5 (30 minutes)........        0.5
                   Tuberculin
                   Tests of
                   Cattle.
1210.14.........  1997/Score Card            1               1            1  2.......................          2
                   for Sanitation
                   Inspections of
                   Milk Plants.
1210.20.........  1993/                      1               1            1  0.5 (30 minutes)........        0.5
                   Application
                   for Permit to
                   Ship or
                   Transport Milk
                   and/or Cream
                   into United
                   States.
1210.23.........  1815/                      1               1            1  0.5 (30 minutes)........        0.5
                   Certificate/
                   Transmittal
                   for an
                   Application.
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    Total.......  ...............  ...........  ..............  ...........  ........................        304
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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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; Equipment, and Methods.               1               1               1  0.05 (3 minutes)..........................         0.05
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 decreased 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: October 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24428 Filed 11-3-20; 8:45 am]
BILLING CODE 4164-01-P


