Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act, 70182-70184 [2020-24428]
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70182
Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
20852, 301–796–7726, 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.
Generic Clearance for the Collection of
Qualitative Feedback on Agency
Service Delivery
OMB Control Number 0910–0697—
Extension
The information collection activity
will garner qualitative customer and
stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative,
and actionable communications
between the Agency and its customers
and stakeholders. It will also allow
feedback to contribute directly to the
improvement of program management.
Feedback collected under this generic
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance. Such data uses require
more rigorous designs that address the
following: The target population to
which generalizations will be made, the
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
methods for assessing potential non-
response bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior to
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results.
Respondents to this collection of
information cover a broad range of
stakeholders who have specific
characteristics related to certain
products or services regulated by FDA.
These stakeholders include members of
the general public, healthcare
professionals, the industry, and other
stakeholders who are related to a
product under FDA’s jurisdiction.
In the Federal Register of April 3,
2020 (85 FR 18989), we published a 60day notice requesting public comment
on the proposed collection of
information. Although two comments
were received, they were not responsive
to the four collection of information
topics solicited and therefore will not be
discussed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Focus groups .......................................................................
Customer comment cards/forms ..........................................
Small discussion groups ......................................................
Customer satisfaction surveys .............................................
Usability Studies ..................................................................
800
1,325
800
12,000
800
1
1
1
1
1
800
1,325
800
12,000
800
1.75
* .25
1.75
† .33
1.75
1,400
331.25
1,400
3,960
1,400
Total ..............................................................................
........................
........................
........................
........................
8,491.25
khammond on DSKJM1Z7X2PROD with NOTICES
* (15 minutes).
† (20 minutes).
In the 60-day notice published on
April 3, 2020, the number of responses
and number of burden hours did not
match OMB approved inventory. This
notice corrects the burden in table 1 of
that notice. In addition, the burden for
this collection of information has
increased by 800 responses from 14,925
to 15,725 responses due to an
inadvertent omission of responses of
usability studies for this collection. This
addition to responses will correct the
number of responses for this collection.
The burden hours in OMB’s inventory
will remain the same.
Dated: October 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–24422 Filed 11–3–20; 8:45 am]
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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.
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
SUMMARY:
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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
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Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
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.
khammond on DSKJM1Z7X2PROD with NOTICES
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
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18:16 Nov 03, 2020
Jkt 253001
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-201509-18/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.
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70183
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 °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
§ 1210.13 requires the reporting of
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Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
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.
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
Number of
respondents
Number of
responses per
respondent
Total annual
responses
1
1
1
1
200
1
1
1
200
1
1
1
1.5 ..........................
0.5 (30 minutes) .....
0.5 (30 minutes) .....
2 .............................
300
0.5
0.5
2
1
1
1
0.5 (30 minutes) .....
0.5
1210.23 ......
1996/Farm Inspection Report .............................
1995/Report of Physical Examination of Cows ..
1994/Report of Tuberculin Tests of Cattle .........
1997/Score Card for Sanitation Inspections of
Milk Plants.
1993/Application for Permit to Ship or Transport
Milk and/or Cream into United States.
1815/Certificate/Transmittal for an Application ...
1
1
1
0.5 (30 minutes) .....
0.5
Total ....
.............................................................................
....................
........................
....................
................................
304
21 CFR
section
1210.11
1210.12
1210.13
1210.14
......
......
......
......
1210.20 ......
1 There
Form FDA No.
Average
burden per
response
Total
hours
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
1210.15 Pasteurization; Equipment, and Methods .........
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1
Number of
records per
recordkeeper
1
Total
annual
records
1
Average
burden per
recordkeeping
1
Total
hours
0.05 (3 minutes) .....
0.05
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 § 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
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18:16 Nov 03, 2020
Jkt 253001
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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Charter Renewal of the Advisory
Committee on Blood and Tissue Safety
and Availability
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services is hereby giving notice
that the charter for the Advisory
Committee on Blood and Tissue Safety
and Availability (ACBTSA) has been
renewed.
SUMMARY:
Mr.
James Berger, Designated Federal Officer
for the ACBTSA, Senior Advisor for
Blood and Tissue Policy, Office of the
Assistant Secretary for Health,
Department of Health and Human
Services, 330 C Street SW, Suite L600,
Washington, DC 20024. Phone: (202)
795–7608. Email: ACBTSA@hhs.gov.
SUPPLEMENTARY INFORMATION: The
ACBTSA is a non-discretionary federal
advisory committee. The ACBTSA is
authorized under 42 U.S.C. 217a,
Section 222 of the Public Health Service
FOR FURTHER INFORMATION CONTACT:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[email protected].
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\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section Form FDA No. Number of responses per annual Average burden per Total
respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------
Total....... ............... ........... .............. ........... ........................ 304
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.15 Pasteurization; Equipment, and Methods. 1 1 1 0.05 (3 minutes).......................... 0.05
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
