Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act, 13992-13994 [2018-06595]
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13992
Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
Evaluation and Research and Center for
Biologics and Research committed to
further our efforts to enhance benefitrisk assessment and communication in
the human drug review process in FY
2013–2017. Enhancing and
communicating benefit-risk assessment
continues to be an Agency priority in
PDUFA VI. The draft plan describes the
progress made on PDUFA V in benefitrisk assessment. This progress includes
revision of FDA’s review/decision
templates and manuals to incorporate
FDA’s approach to benefit-risk
assessment, training review and
management of staff on the revised
templates and manuals, developing an
evaluation plan to ascertain the impact
of FDA’s implementation of the BenefitRisk Framework in drug review, holding
two public workshops on benefit-risk
considerations from the regulator’s
perspective, and advancing FDA’s
Patient-Focused Drug Development
initiative. This draft plan also
summarizes the third-party evaluation
of FDA’s implementation of the BenefitRisk Framework into FDA’s new drug
review.
The plan also includes an overview of
FDA’s commitments in PDUFA VI for
continued implementation of structured
benefit-risk assessment during FY 2018–
2022. These commitments include
participating in a meeting to gather
stakeholder input on key topics,
publishing a draft guidance on benefitrisk assessment for new drugs and
biologics, continuing to revise relevant
Manuals for Policies and Procedures
and Standard Operating Practices and
Procedures to incorporate benefit-risk
assessment approaches, and conducting
a second evaluation of the
implementation of the Benefit-Risk
Framework beginning in 2021. In
addition to these commitments, FDA
also plans to explore additional
opportunities to enhance our use and
communication of benefit-risk
assessments.
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III. Electronic Access
FDA has published the draft plan on
its website: https://www.fda.gov/
ForIndustry/UserFees/Prescription
DrugUserFee/ucm326192.htm. The
period for public comment on the draft
plan will remain open for 60 days
following the publication of this notice.
After consideration of public comments,
FDA will finalize the plan. Throughout
PDUFA VI, the Agency will update the
plan as necessary and post all updates
on FDA’s website.
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Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06531 Filed 3–30–18; 8:45 am]
BILLING CODE 4164–01–P
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
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 June 1, 2018.
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 June 1, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of June 1, 2018. 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.
SUMMARY:
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
PO 00000
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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.
• 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
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Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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.
Under the
PRA (44 U.S.C. 3501–3520), 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
SUPPLEMENTARY INFORMATION:
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
Under FIMA (21 U.S.C. 141–149),
milk or cream may be imported into the
United States only by the holder of a
13993
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.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Form FDA No.
1210.11 ......
1210.12 ......
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 US.
1815/Certificate/Transmittal for an Application.
2
1
200
1
400
1
1.5 ..................
.5 (30 minutes)
600
.5
1
2
1
1
1
2
.5 (30 minutes)
2 .....................
.5
4
2
1
2
.5 (30 minutes)
1
2
1
2
.5 (30 minutes)
1
.....................................................................
........................
........................
........................
........................
607
1210.13 ......
1210.14 ......
1210.20 ......
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1210.23 ......
Total ....
1 There
Number of
respondents
Average
burden per
response
21 CFR
section
Total annual
responses
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total hours
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Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
1210.15 ..........................................................................
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1 There
Number of
records per
recordkeeper
2
Average
burden per
recordkeeping
Total annual
records
1
2
.05 (3 minutes)
Total hours
.10 (6 minutes)
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
2.0 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
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).
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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 the Office of Management and
Budget under the Paperwork Reduction
Act. 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: March 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06595 Filed 3–30–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0549]
Prescription Polyethylene Glycol 3350;
Denial of a Hearing and Order
Withdrawing Approval of Abbreviated
New Drug Applications
AGENCY:
Notice.
The Commissioner of Food
and Drugs (the Commissioner) is
denying requests for a hearing and
issuing an order withdrawing approval
of abbreviated new drug applications
(ANDAs) for certain prescription
laxatives with the active ingredient
polyethylene glycol 3350 (PEG 3350),
listed in this document, because the
drug products are misbranded under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act).
DATES: This order is applicable May 2,
2018.
ADDRESSES: For access to the docket, 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
SUMMARY:
PO 00000
I. Background
A. Procedural Background
On February 18, 1999, the U.S. Food
and Drug Administration (FDA or the
Agency) approved a new drug
application (NDA) submitted by
Braintree Laboratories, Inc., (Braintree)
for prescription (or ‘‘Rx’’) PEG 3350
(MiraLAX) (NDA 20–698).
Subsequently, FDA approved five
ANDAs for prescription PEG 3350.1 On
October 6, 2006, FDA approved a new
NDA (NDA 22–015) submitted by
Braintree, removing their PEG 3350
laxative drug product from prescription
dispensing requirements of section
503(b) of the FD&C Act (21 U.S.C.
353(b)).2
Section 503(b)(1) of the FD&C Act
requires that a drug which: (1) Because
Food and Drug Administration,
HHS.
ACTION:
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852
between 9 a.m. and 4 p.m., Monday
through Friday. Publicly available
submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Julie
Finegan, Office of Scientific Integrity,
Office of the Chief Scientist, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, Rm. 4218,
Silver Spring, MD 20993–0002, 301–
796–8618.
SUPPLEMENTARY INFORMATION:
Frm 00052
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1 The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417) (the HatchWaxman Amendments) created new section 505(j)
of the FD&C Act, which established the current
ANDA approval process. To obtain approval, an
ANDA applicant is not required to submit evidence
to establish the clinical safety and effectiveness of
the drug product; instead, an ANDA relies on FDA’s
previous finding that the reference listed drug is
safe and effective. To rely on a previous finding of
safety and effectiveness, an ANDA applicant must
demonstrate, among other things, that the drug
product described in an ANDA has the same active
ingredient(s), indications for use, route of
administration, dosage form, strength, and labeling
as the reference listed drug (section 505(j)(2)(A)(i)–
(v) and (j)(4) of the FD&C Act). In addition, the
ANDA applicant must submit evidence that its
proposed drug product is bioequivalent to the
reference listed drug (section 505(j)(2)(A)(iv) of the
FD&C Act).
2 On October 10, 2008, Braintree requested that
FDA withdraw approval of the NDA for
prescription MiraLAX (NDA 20–698) under 21 CFR
314.150(c) because it had stopped marketing the
product. On February 11, 2009, FDA withdrew
approval of the NDA for prescription MiraLAX in
a Federal Register notice (effective March 13,
2009)(74 FR 6896 at 6899 (February 11, 2009)).
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]]>Agencies
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 13992-13994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06595]
-----------------------------------------------------------------------
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 June 1, 2018.
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 June 1, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of June 1, 2018. 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.
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
[[Page 13993]]
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.gpo.gov/fdsys/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.
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: Under the PRA (44 U.S.C. 3501-3520), 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
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.
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 hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.11.................... 1996/Farm Inspection Report 2 200 400 1.5........................... 600
1210.12.................... 1995/Report of Physical 1 1 1 .5 (30 minutes)............... .5
Examination of Cows.
1210.13.................... 1994/Report of Tuberculin 1 1 1 .5 (30 minutes)............... .5
Tests of Cattle.
1210.14.................... 1997/Score Card for 2 1 2 2............................. 4
Sanitation Inspections of
Milk Plants.
1210.20.................... 1993/Application for Permit 2 1 2 .5 (30 minutes)............... 1
to Ship or Transport Milk
and/or Cream into US.
1210.23.................... 1815/Certificate/ 2 1 2 .5 (30 minutes)............... 1
Transmittal for an
Application.
-----------------------------------------------------------------------------------------------
Total.................. ........................... .............. .............. .............. .............................. 607
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 13994]]
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of records per Total annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.15................................ 2 1 2 .05 (3 minutes)................ .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 2.0 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 the Office of Management and Budget under
the Paperwork Reduction Act. 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: March 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06595 Filed 3-30-18; 8:45 am]
BILLING CODE 4164-01-P
