Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act, 31155-31156 [2018-14266]
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Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices
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amikacin liposome inhalation
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Dated: June 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14240 Filed 7–2–18; 8:45 am]
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31155
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.
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
(PRA).
DATES: Fax written comments on the
collection of information by August 2,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0212. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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.
SUMMARY:
Regulations Under the Federal Import
Milk Act (FIMA)—21 CFR Part 1210
OMB Control Number 0910–0212—
Extension
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
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Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices
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
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.
In the Federal Register of April 2,
2018 (83 FR 13992), 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
21 CFR
Section
1210.11
1210.12
1210.13
1210.14
1210.20
1210.23
Number of
responses per
respondent
Number of
respondents
Form FDA No.
Total
annual
responses
Average
burden per
response
Total
hours
..........
..........
..........
..........
..........
..........
1996/Sanitary inspection of dairy farms ......
1995/Physical examination of cows .............
1994/Tuberculin test ....................................
1997/Sanitary inspections of plants .............
1993/Application for permit ..........................
1815/Permits granted on certificates ...........
2
1
1
2
2
2
200
1
1
1
1
1
400
1
1
2
2
2
1.5 .........................
0.5 (30 minutes) ....
0.5 (30 minutes) ....
2 ............................
0.5 (30 minutes) ....
0.5 (30 minutes) ....
600
0.5
0.5
4
1
1
Total ........
......................................................................
........................
........................
........................
...............................
607
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR
Section
1210.15 ..........
sradovich on DSK3GMQ082PROD with NOTICES
1 There
Number of
records per
recordkeeper
Number of
recordkeepers
2
Average
burden per
recordkeeping
Total hours
0.05 (3 minutes) .............................................................
0.10 (6 minutes).
Total annual
records
1
2
are no capital costs or operating and maintenance costs associated with this collection of information.
Upon review of the information
collection, we have retained the
currently approved estimated burden.
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. Assuming two respondents
will submit approximately 200 Form
FDA 1996 reports annually for a total of
600 responses, and that each response
requires 1.5 hours, we estimate the total
burden is 600 hours.
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. To date, 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. We also assume
each submission requires 0.5 hour for a
total of 0.5 burden hour annually.
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We estimate that two respondents will
submit one Form FDA 1997 report
annually, for a total of two responses.
We estimate the reporting burden to be
2 hours per response, for a total burden
of 4 hours.
We estimate that two respondents will
submit one Form FDA 1993 report
annually, for a total of two responses.
We estimate the reporting burden to be
0.5 hour per response, for a total burden
of 1 hour.
We estimate that two respondents will
submit one Form FDA 1815 report
annually, for a total of two responses.
We estimate the reporting burden to be
0.5 hour per response, for a total burden
of 1 hour.
With regard to records maintenance,
we estimate that approximately two
recordkeepers will spend 0.05 hour
annually maintaining the additional
pasteurization records required by
§ 1210.15, for a total of 0.10 hour
annually.
No burden has been estimated for the
tagging requirement in § 1210.22
because the information on the tag is
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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.
Dated: June 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14266 Filed 7–2–18; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)]
[Notices]
[Pages 31155-31156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14266]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 (PRA).
DATES: Fax written comments on the collection of information by August
2, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0212.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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
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
[[Page 31156]]
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.
In the Federal Register of April 2, 2018 (83 FR 13992), 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Form FDA No. Number of responses per Total annual Average burden per response Total
respondents respondent responses hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.11....................... 1996/Sanitary inspection of 2 200 400 1.5............................... 600
dairy farms.
1210.12....................... 1995/Physical examination 1 1 1 0.5 (30 minutes).................. 0.5
of cows.
1210.13....................... 1994/Tuberculin test....... 1 1 1 0.5 (30 minutes).................. 0.5
1210.14....................... 1997/Sanitary inspections 2 1 2 2................................. 4
of plants.
1210.20....................... 1993/Application for permit 2 1 2 0.5 (30 minutes).................. 1
1210.23....................... 1815/Permits granted on 2 1 2 0.5 (30 minutes).................. 1
certificates.
--------------------------------------------------------------------------------------------
Total..................... ........................... .............. .............. .............. .................................. 607
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper records per recordkeeping
----------------------------------------------------------------------------------------------------------------
1210.15............. 2 1 2 0.05 (3 minutes). 0.10 (6 minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Upon review of the information collection, we have retained the
currently approved estimated burden. 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. Assuming two respondents will submit
approximately 200 Form FDA 1996 reports annually for a total of 600
responses, and that each response requires 1.5 hours, we estimate the
total burden is 600 hours.
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. To date, 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. We also assume each submission requires 0.5 hour for a total
of 0.5 burden hour annually.
We estimate that two respondents will submit one Form FDA 1997
report annually, for a total of two responses. We estimate the
reporting burden to be 2 hours per response, for a total burden of 4
hours.
We estimate that two respondents will submit one Form FDA 1993
report annually, for a total of two responses. We estimate the
reporting burden to be 0.5 hour per response, for a total burden of 1
hour.
We estimate that two respondents will submit one Form FDA 1815
report annually, for a total of two responses. We estimate the
reporting burden to be 0.5 hour per response, for a total burden of 1
hour.
With regard to records maintenance, we estimate that approximately
two recordkeepers will spend 0.05 hour annually maintaining the
additional pasteurization records required by Sec. 1210.15, for a
total of 0.10 hour 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.
Dated: June 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14266 Filed 7-2-18; 8:45 am]
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