Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act, 73939-73940 [E8-28692]
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73939
Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
860.123
1There
6
Total Annual
Responses
1
Hours per
Response
6
Total Hours
500
3,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the last 3 years, and actual
reclassification petitions received, FDA
anticipates that six petitions will be
submitted each year. The time required
to prepare and submit a reclassification
petition, including the time needed to
assemble supporting data, averages 500
hours per petition. This average is based
upon estimates by FDA administrative
and technical staff that are familiar with
the requirements for submission of a
reclassification petition, have consulted
and advised manufacturers on these
requirements, and have reviewed the
documentation submitted.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: November 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–28695 Filed 12–3–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 5,
2009.
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:
202–395–6974, or e-mailed 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:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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—(OMB Control Number 0910–
0212—Extension)
[Docket No. FDA–2008–N–0453]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Regulations Under
the Federal Import Milk Act
AGENCY:
Annual Frequency
per Response
Food and Drug Administration,
HHS.
Under the Federal Import Milk Act
(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).
FDA’s 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 August 25,
2008 (73 FR 50031), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
mstockstill on PROD1PC66 with NOTICES
21 CFR Section
No. of
Respondents
Form No.
Annual
Frequency per
Response
Total Annual
Responses
Hours per
Response
Total Hours
1210.11
FDA 1996/Sanitary inspection of
dairy farms
8
200
1,600
1.5
2,400
1210.12
FDA 1995/Physical examination of
cows
1
1
1
0.5
0.5
VerDate Aug<31>2005
17:35 Dec 03, 2008
Jkt 217001
PO 00000
Frm 00039
Fmt 4703
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E:\FR\FM\04DEN1.SGM
04DEN1
73940
Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section
No. of
Respondents
Form No.
Annual
Frequency per
Response
Total Annual
Responses
Hours per
Response
Total Hours
1210.13
FDA 1994/Tuberculin test
1
1
1
0.5
0.5
1210.14
FDA 1997/Sanitary inspections of
plants
8
1
8
2.0
16.0
1210.20
FDA 1993/Application for permit
8
1
8
0.5
4.0
1210.23
FDA 1815/Permits granted on
certificates
8
1
8
0.5
4.0
Total
1 There
2,425.0
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
1210.15
mstockstill on PROD1PC66 with NOTICES
1 There
Annual Frequency
per Recordkeeping
No. of
Recordkeepers
21 CFR Section
8
Total Annual
Records
1
Hours per
Record
8
Total Hours
0.05
0.40
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of respondents
and hours per response are based on
FDA’s experience with the import milk
permit program and the average number
of import milk permit holders over the
past 3 years. FDA estimates that 8
respondents will submit approximately
200 Form FDA 1996 reports annually,
for a total of 1,600 responses. FDA
estimates the reporting burden to be 1.5
hours per response, for a total burden of
2,400 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 FDA has not received any
Forms FDA 1994 and 1995 in the last 3
years, the agency estimates no more
than one will be submitted annually.
FDA estimates the reporting burden for
each to be 0.5 hours per response for a
total burden reporting burden of 0.5
hours each.
FDA estimates that eight respondents
will submit one Form FDA 1997 report
annually, for a total of eight responses.
FDA estimates the reporting burden to
be 2.0 hours per response, for a total
burden of 16 hours. FDA estimates that
eight respondents will submit one Form
FDA 1993 report annually, for a total of
eight responses. FDA estimates the
reporting burden to be 0.5 hours per
response, for a total burden of 4 hours.
FDA estimates that eight respondents
will submit one Form FDA 1815 report
VerDate Aug<31>2005
17:35 Dec 03, 2008
Jkt 217001
annually, for a total of eight responses.
FDA estimates the reporting burden to
be 0.5 hours per response, for a total
burden of 4 hours.
With regard to records maintenance,
FDA estimates that approximately eight
recordkeepers will spend 0.05 hours
annually maintaining the additional
pasteurization records required by
§ 1210.15, for a total of 0.40 hours
annually.
No burden has been estimated for the
tagging requirement in § 1210.22
because the information on the tag is
either supplied by FDA (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 a
collection of information. 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
activities.
Dated: November 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–28692 Filed 12–3–08; 8:45 am]
BILLING CODE 4160–01–S
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Fmt 4703
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1999–D–0128] (formerly
Docket No. 1999D–2013)
Guidance for Industry: Cooperative
Manufacturing Arrangements for
Licensed Biologics; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Cooperative
Manufacturing Arrangements for
Licensed Biologics,’’ dated November
2008. The guidance document provides
information concerning cooperative
manufacturing arrangements applicable
to biological products subject to
licensure under the U.S. Public Health
Service Act (PHS Act). The guidance
describes the licensing strategies for
meeting the increased need for flexible
manufacturing arrangements. The
guidance announced in this notice
finalizes the draft guidance of the same
title.
DATES: Submit written or electronic
comments on agency guidances at any
time.
Submit written requests for
single copies of the guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
ADDRESSES:
E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 73, Number 234 (Thursday, December 4, 2008)]
[Notices]
[Pages 73939-73940]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28692]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0453]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Regulations Under the
Federal Import Milk Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
5, 2009.
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: 202-395-6974, or e-mailed 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: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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--(OMB Control Number
0910-0212--Extension)
Under the Federal Import Milk Act (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).
FDA's 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 August 25, 2008 (73 FR 50031), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Form No. No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.11 FDA 1996/Sanitary inspection of 8 200 1,600 1.5 2,400
dairy farms
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.12 FDA 1995/Physical examination of 1 1 1 0.5 0.5
cows
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 73940]]
1210.13 FDA 1994/Tuberculin test 1 1 1 0.5 0.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.14 FDA 1997/Sanitary inspections of 8 1 8 2.0 16.0
plants
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.20 FDA 1993/Application for permit 8 1 8 0.5 4.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.23 FDA 1815/Permits granted on 8 1 8 0.5 4.0
certificates
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 2,425.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
1210.15 8 1 8 0.05 0.40
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimated number of respondents and hours per response are
based on FDA's experience with the import milk permit program and the
average number of import milk permit holders over the past 3 years. FDA
estimates that 8 respondents will submit approximately 200 Form FDA
1996 reports annually, for a total of 1,600 responses. FDA estimates
the reporting burden to be 1.5 hours per response, for a total burden
of 2,400 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 FDA has not received any Forms FDA 1994 and 1995
in the last 3 years, the agency estimates no more than one will be
submitted annually. FDA estimates the reporting burden for each to be
0.5 hours per response for a total burden reporting burden of 0.5 hours
each.
FDA estimates that eight respondents will submit one Form FDA 1997
report annually, for a total of eight responses. FDA estimates the
reporting burden to be 2.0 hours per response, for a total burden of 16
hours. FDA estimates that eight respondents will submit one Form FDA
1993 report annually, for a total of eight responses. FDA estimates the
reporting burden to be 0.5 hours per response, for a total burden of 4
hours. FDA estimates that eight respondents will submit one Form FDA
1815 report annually, for a total of eight responses. FDA estimates the
reporting burden to be 0.5 hours per response, for a total burden of 4
hours.
With regard to records maintenance, FDA estimates that
approximately eight recordkeepers will spend 0.05 hours annually
maintaining the additional pasteurization records required by Sec.
1210.15, for a total of 0.40 hours annually.
No burden has been estimated for the tagging requirement in Sec.
1210.22 because the information on the tag is either supplied by FDA
(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 a collection of information. 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
activities.
Dated: November 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28692 Filed 12-3-08; 8:45 am]
BILLING CODE 4160-01-S
