Notice2024-16101
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
July 23, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 141 (Tuesday, July 23, 2024)</title>
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[Federal Register Volume 89, Number 141 (Tuesday, July 23, 2024)]
[Notices]
[Pages 59739-59740]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#154547544661747373557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="16464457456277707056707277387e7e6538717960">[email protected]</span></a>.
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:
<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).
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
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