Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act, 20221-20223 [2024-06028]
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Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
such records must be made available for
inspection and copying by FDA upon
request (§ 558.6(c)(4)). These record
requirements are currently approved
under OMB control number 0910–0152,
‘‘Current Good Manufacturing Practice
Regulations for Medicated Feed.’’
C. Third-Party Disclosure Requirements
Description of Respondents: Food
Animal Veterinarians, VFD Feed
Distributors, and Clients.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
21 CFR part/activity
558.6(b)(3)(v) and (b)(7)(ix); requires veterinarians to disclose information on a VFD ...
558.6(c)(8); requires acknowledgment letter from one distributor to another ..................
5,278
2,422
40
5
211,120
12,110
Total ...........................................................................................................................
7,700
......................
......................
1 There
Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–05986 Filed 3–20–24; 8:45 am]
BILLING CODE 4164–01–P
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).
Either electronic or written
comments on the collection of
information must be submitted by May
20, 2024.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 20, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
ADDRESSES:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0972]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Regulations Under
the Federal Import Milk Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Average
burden per
disclosure
Total
hours
0.12 (7 minutes)
0.12 (7 minutes)
25,334
1,453
...........................
26,787
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on program experience, we
believe the original number of thirdparty disclosures estimate was too high
and have decreased the number of
disclosures per respondent. The VFD
regulation also contains several labeling
provisions. These labeling statements
are a ‘‘public disclosure of information
originally supplied by the Federal
government to the recipient for the
purpose of disclosure to the public’’ (5
CFR 1320.3(c)(2)) and therefore do not
constitute a ‘‘collection of information’’
under the PRA (44 U.S.C. 3501, et seq.).
After a review of the information
collection since our last request for
OMB approval, we have adjusted our
estimates based on our experience with
the VFD regulations and updated data.
As a result, the total burden for the
information collection has decreased
39,387 hours since the last OMB
approval.
lotter on DSK11XQN23PROD with NOTICES1
Total
annual
disclosures
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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:
VerDate Sep<11>2014
16:53 Mar 20, 2024
Jkt 262001
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
PO 00000
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Sfmt 4703
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–
2024–N–0972 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, 240–402–7500.
• 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
E:\FR\FM\21MRN1.SGM
21MRN1
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Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
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, 240–402–7500.
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: 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 °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.
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).
We estimate the burden of this
collection of information as follows:
lotter on DSK11XQN23PROD with NOTICES1
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
21 CFR
section
1210.11
1210.12
1210.13
1210.14
1210.20
.........
.........
.........
.........
.........
VerDate Sep<11>2014
Form FDA No./description
Number of
respondents
Number of
responses per
respondent
Total annual
responses
1
1
1
1
1
200
1
1
1
1
200
1
1
1
1
1996/Sanitary inspection of dairy farms ....
1995/Physical examination of cows ...........
1994/Tuberculin test ...................................
1997/Sanitary inspections of plants ...........
1993/Application for permit ........................
16:53 Mar 20, 2024
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Average burden
per response
1.5
0.5
0.5
2.0
0.5
............................
(30 minutes) ......
(30 minutes) ......
............................
(30 minutes) ......
21MRN1
Total hours
300
1
1
2
1
Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
20223
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2—Continued
Number of
respondents
Number of
responses per
respondent
Total annual
responses
1815/Permits granted on certificates .........
1
1
1
0.5 (30 minutes) ......
1
.....................................................................
....................
........................
....................
..................................
306
21 CFR
section
Form FDA No./description
1210.23 .........
Total .......
1 There
Average burden
per response
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
21 CFR section/activity
1210.15/Pasteurization records .................................
Number of
records per
recordkeeper
1
Total annual
records
1
Average burden
per recordkeeping
1
0.05 (3 minutes) ......
Total hours
1
1 There
lotter on DSK11XQN23PROD with NOTICES1
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers have been rounded.
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
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.
VerDate Sep<11>2014
16:53 Mar 20, 2024
Jkt 262001
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: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–06028 Filed 3–20–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0644]
Eli Lilly and Company; Withdrawal of
Approval of SARAFEM (Fluoxetine
Hydrochloride) Capsules, Equivalent to
10 Milligrams Base and Equivalent to
20 Milligrams Base, Including the
Premenstrual Dysphoric Disorder
Indication Approved Under New Drug
Application 018936
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of SARAFEM
(fluoxetine hydrochloride (HCl))
capsules, equivalent to (EQ) 10
milligrams (mg) base and EQ 20 mg
base, including the premenstrual
dysphoric disorder (PMDD) indication,
approved under new drug application
(NDA) 018936. This NDA is held by Eli
Lilly and Co., Lilly Corporate Center,
Indianapolis, IN 46285 (Lilly). Lilly
notified the Agency in writing that
SARAFEM (fluoxetine HCl) capsules,
EQ 10 mg base and EQ 20 mg base,
SUMMARY:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
indicated for the treatment of PMDD,
was no longer marketed and requested
that the approval of SARAFEM
(fluoxetine HCl) capsules, including the
PMDD indication, be withdrawn.
DATES: Approval is withdrawn as of
April 22, 2024.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
On
December 29, 1987, FDA approved NDA
018936 for PROZAC (fluoxetine HCl)
capsules, EQ 20 mg base, for major
depressive disorder. On July 6, 2000,
FDA approved a supplement to NDA
018936 for SARAFEM (fluoxetine HCl)
capsules, EQ 10 mg base and EQ 20 mg
base, indicated for the treatment of
PMDD. SARAFEM (fluoxetine HCl)
capsules are only approved for the
PMDD indication. SARAFEM
(fluoxetine HCl) capsules and PROZAC
(fluoxetine HCl) capsules, EQ 10 mg
base and EQ 20 mg base, were marketed
by Lilly under the same NDA with
distinct labeling, including distinct
Prescribing Information, carton and
container labels, and labeling for
patients and caregivers.
On June 10, 2010, Lilly informed FDA
that it had discontinued marketing of
SARAFEM (fluoxetine HCl) capsules,
EQ 10 mg base and EQ 20 mg base. On
August 4, 2023, Lilly requested, in
writing, that FDA withdraw approval of
SARAFEM (fluoxetine HCl) capsules,
EQ 10 mg base and EQ 20 mg base,
including the PMDD indication, under
§ 314.150(c) (21 CFR 314.150(c)). Lilly
also waived its opportunity for a
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20221-20223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06028]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0972]
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, Agency, or we) 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: Either electronic or written comments on the collection of
information must be submitted by May 20, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 20, 2024. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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-2024-N-0972 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, 240-402-7500.
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
[[Page 20222]]
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, 240-402-7500.
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: 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 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).
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section Form FDA No./ Number of responses per annual Average burden per response Total hours
description respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.11.............................. 1996/Sanitary 1 200 200 1.5.............................. 300
inspection of dairy
farms.
1210.12.............................. 1995/Physical 1 1 1 0.5 (30 minutes)................. 1
examination of cows.
1210.13.............................. 1994/Tuberculin test... 1 1 1 0.5 (30 minutes)................. 1
1210.14.............................. 1997/Sanitary 1 1 1 2.0.............................. 2
inspections of plants.
1210.20.............................. 1993/Application for 1 1 1 0.5 (30 minutes)................. 1
permit.
[[Page 20223]]
1210.23.............................. 1815/Permits granted on 1 1 1 0.5 (30 minutes)................. 1
certificates.
-----------------------------------------------------------------------------------------
Total............................ ....................... ........... .............. ........... ................................. 306
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.15/Pasteurization records............... 1 1 1 0.05 (3 minutes)......................... 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
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 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: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06028 Filed 3-20-24; 8:45 am]
BILLING CODE 4164-01-P
