Notice2024-06028
Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 21, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 89 Issue 56 (Thursday, March 21, 2024)</title>
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[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20221-20223]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#e1b1b3a0b295808787a1878580cf898992cf868e97"><span class="__cf_email__" data-cfemail="035351425077626565436567622d6b6b702d646c75">[email protected]</span></a>.
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:
<bullet> Form FDA 1815: Certificate/Transmittal for an Application
(21 CFR 1210.23).
<bullet> Form FDA 1993: Application for Permit To Ship or Transport
Milk and/or Cream into the United States (21 CFR 1210.20).
<bullet> Form FDA 1994: Report of Tuberculin Tests of Cattle (21
CFR 1210.13).
<bullet> Form FDA 1995: Report of Physical Examination of Cows (21
CFR 1210.12).
<bullet> Form FDA 1996: Dairy Farm Sanitary Report (21 CFR
1210.11).
<bullet> 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.
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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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\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
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