Notice2021-12263
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
June 11, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 86 Issue 111 (Friday, June 11, 2021)</title>
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[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31327-31328]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-12263]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0369]
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, Agency, or we) 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 July 12, 2021.
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: 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,
<a href="/cdn-cgi/l/email-protection#f6a6a4b7a582979090b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="cf9f9d8e9cbbaea9a98fa9abaee1a7a7bce1a8a0b9">[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
[[Page 31328]]
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).
In the Federal Register of November 4, 2020 (85 FR 70182), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Form FDA No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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1210.11.................. 1996/Farm Inspection 1 200 200 1.5................................ 300
Report.
1210.12.................. 1995/Report of Physical 1 1 1 0.5 (30 minutes)................... 0.5
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 for 1 1 1 2.................................. 2
Sanitation Inspections
of Milk Plants.
1210.20.................. 1993/Application for 1 1 1 0.5 (30 minutes)................... 0.5
Permit to Ship or
Transport Milk and/or
Cream into United
States.
1210.23.................. 1815/Certificate/ 1 1 1 0.5 (30 minutes)................... 0.5
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 1 1 1 0.05 (3 minutes).......................... 0.05
Methods.
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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 1 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: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12263 Filed 6-10-21; 8:45 am]
BILLING CODE 4164-01-P
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