Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act, 59739-59740 [2024-16101]
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Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Notices
In the
Federal Register of June 26, 2024, FDA
published a notice announcing a request
for comments entitled ‘‘FDA
Information Technology Strategy and
Customer Experience Strategy; Request
for Comments.’’
Interested persons were originally
given until July 31, 2024, to comment
on the document. The Agency has
elected to extend the comment period so
that all interested parties are able to
consider the request for input more
thoroughly. FDA is extending the
comment period for 30 days, until
August 30, 2024. The Agency believes
that this 30-day extension allows
adequate time for interested persons to
submit comments.
SUPPLEMENTARY INFORMATION:
Dated: July 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16089 Filed 7–22–24; 8:45 am]
Regulations Under the Federal Import
Milk Act (FIMA)—21 CFR Part 1210
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 °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.
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.
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
SUMMARY:
Section 1210.12 requires reports on the
physical examination of herds, while
§ 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
(§ 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 (§ 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).
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:
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
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, PRAStaff@
fda.hhs.gov.
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.
BILLING CODE 4164–01–P
59739
ddrumheller on DSK120RN23PROD with NOTICES1
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
21 CFR
section
Form FDA number/
description
1210.11 ........
1996/Sanitary inspection of
dairy farms.
1995/Physical examination
of cows.
1994/Tuberculin test ............
1210.12 ........
1210.13 ........
VerDate Sep<11>2014
18:47 Jul 22, 2024
Jkt 262001
Number of
responses per
respondent
Number of
respondents
PO 00000
Total
annual
responses
Average burden per
response
Total hours
1
200
200
1.5 .......................................
300
1
1
1
0.5 (30 minutes) ..................
1
1
1
1
0.5 (30 minutes) ..................
1
Frm 00025
Fmt 4703
Sfmt 4703
E:\FR\FM\23JYN1.SGM
23JYN1
59740
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2—Continued
Number of
responses per
respondent
Form FDA number/
description
1210.14 ........
1997/Sanitary inspections of
plants.
1993/Application for permit
1815/Permits granted on
certificates.
1
1
1
2.0 .......................................
2
1
1
1
1
1
1
0.5 (30 minutes) ..................
0.5 (30 minutes) ..................
1
1
..............................................
........................
........................
........................
..............................................
306
1210.20 ........
1210.23 ........
Total ......
Number of
respondents
Total
annual
responses
21 CFR
section
Average burden per
response
Total hours
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
21 CFR section/activity
ddrumheller on DSK120RN23PROD with NOTICES1
1210.15/Pasteurization records ........
1
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 § 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
1 There are no capital costs or operating and
maintenance costs associated with this collection of
information.
2 Numbers have been rounded.
VerDate Sep<11>2014
18:47 Jul 22, 2024
Jkt 262001
Number of
records per
recordkeeper
Total
annual
records
1
Average burden per
recordkeeping
1
Total hours
0.05 (3 minutes) ...............................
1
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.
biosimilar products licensed under the
Public Health Service Act (PHS Act).
DATES: Submit either electronic or
written comments on the draft guidance
by September 23, 2024 to ensure that
the Agency considers your comment on
this draft guidance before it begins work
on the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Dated: July 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
Electronic Submissions
[FR Doc. 2024–16101 Filed 7–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–2581]
Postapproval Manufacturing Changes
to Biosimilar and Interchangeable
Biosimilar Products: Questions and
Answers; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Postapproval Manufacturing Changes
to Biosimilar and Interchangeable
Biosimilar Products: Questions and
Answers.’’ This draft guidance provides
answers to commonly asked questions
from applicants and other interested
parties regarding postapproval
manufacturing changes made to
biosimilar and interchangeable
SUMMARY:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\23JYN1.SGM
23JYN1
]]>Agencies
[Federal Register Volume 89, Number 141 (Tuesday, July 23, 2024)]
[Notices]
[Pages 59739-59740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16101]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.reginfo.gov/public/do/PRAMain. 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,
[email protected].
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:
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).
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Form FDA number/ description Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------
Total.................... ............................ .............. .............. .............. ........................... 306
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 2--Estimated Annual Recordkeeping Burden 1 2
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section/activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
1210.15/Pasteurization records 1 1 1 0.05 (3 minutes) 1
----------------------------------------------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance
costs associated with this collection of information.
\2\ Numbers have been rounded.
---------------------------------------------------------------------------
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
