Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed, 8959-8960 [2010-3911]
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8959
Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
60
Total Annual
Responses
1
Hours per
Response
Total Hours
60
1.0
60.0
Total
60.0
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The study will involve about 60
respondents and take approximately 1
hour each to complete. These estimates
are based on the contractor’s extensive
experience with mental models
research.
Dated: February 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3912 Filed 2–25–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0083]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Substances
Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in
Ruminant Feed
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
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 recordkeeping requirements for this
collection of information concerning
substances prohibited from use in
animal food or feed and animal proteins
prohibited in ruminant feed.
DATES: Submit written or electronic
comments on the collection of
information by April 27, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., P150–
400B, Rockville, MD 20850, 301–827–
1472.
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.
Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins
Prohibited in Ruminant Feed—21 CFR
589.2000(e)(1)(iv) (OMB Control
Number 0910–0339)—Extension
This information collection was
established because epidemiological
evidence gathered in the United
Kingdom suggested that bovine
spongiform encephalopathy (BSE), a
progressively degenerative central
nervous system disease, is spread to
ruminant animals by feeding protein
derived from ruminants infected with
BSE. This regulation places general
requirements on persons that
manufacture, blend, process, and
distribute products that contain or may
contain protein derived from
mammalian tissue, and feeds made from
such products.
FDA estimates the burden of this
collection of information as follows:
sroberts on DSKD5P82C1PROD with NOTICES
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
589.2000(e)(1)(iv)
1 There
Annual Frequency per
Recordkeeping
400
1
Total Annual
Records
Hours per
Records
400
14
are no capital costs or operating and maintenance costs associated with this collection of information.
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16:39 Feb 25, 2010
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Total Hours
26FEN1
5,600
8960
Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices
Dated: February 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3911 Filed 2–25–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0501]
Agency Information Collection
Activities; Submission for Office and
Management Budget Review;
Comment Request; Third Party
Disclosure and Recordkeeping
Requirements for Reportable Food
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 March 29,
2010.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0643. Also
include the FDA docket number found
in brackets in the heading of this
document.
sroberts on DSKD5P82C1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management (P150–400B), Food and
Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 301–796–3793
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.
Third Party Disclosure and
Recordkeeping Requirements for
Reportable Food—21 U.S.C. 350f (OMB
Control Number 0910–0643)—Extension
On September 27, 2007, the President
signed into law the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Public Law 110–85).
Section 1005 of FDAAA amends the
Federal Food, Drug, and Cosmetic Act
VerDate Nov<24>2008
16:39 Feb 25, 2010
Jkt 220001
(the act) by creating a new section 417
(21 U.S.C. 350f), among other things.
Section 417 of the act requires the
Secretary of Health and Human Services
(the Secretary) to establish within the
Food and Drug Administration (FDA) a
Reportable Food Registry (the Registry).
The Secretary has delegated to the
Commissioner of FDA the responsibility
for administering the act, including
section 417.
Section 417 of the act defines
‘‘reportable food’’ as an ‘‘article of food
(other than infant formula) for which
there is a reasonable probability that the
use of, or exposure to, such article of
food will cause serious adverse health
consequences or death to humans or
animals.’’ (section 417(a)(2) of the act).
Section 417 of the act requires FDA to
establish an electronic portal (the
Reportable Food electronic portal) by
which instances of reportable food must
be submitted to FDA by responsible
parties and may be submitted by public
health officials. FDA made the decision
that the most efficient and cost effective
means to implement the requirements of
section 417 of the act relating to the
Registry was to utilize the business
enterprise system currently under
development within the agency: The
MedWatchPlus Portal. The electronic
portal became operational on September
8, 2009. The collection of information
associated with the submission of
reportable food reports to FDA using the
MedWatchPlus electronic portal has
been approved under OMB Control No.
0910–0645.
In addition, section 1005(f) of FDAAA
required FDA to issue guidance to
industry about submitting reports
through the electronic portal of
instances of reportable food and
providing notifications to other persons
in the supply chain of such article of
food. FDA issued guidance containing
questions and answers relating to the
requirements under section 417 of the
act, including (1) How, when and where
to submit reports to FDA; (2) who is
required to submit reports to FDA; (3)
what is required to be submitted to
FDA; and (4) what may be required
when providing notifications to other
persons in the supply chain of an article
of food. The agency announced the
availability of the guidance document
titled ‘‘Questions and Answers
Regarding the Reportable Food Registry
as Established by the Food and Drug
Administration Amendments Act of
2007,’’ on September 9, 2009 (74 FR
46434). The guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in
question 28 of the guidance have been
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
approved under OMB Control No. 0910–
0249.
Section 417 of the act established
third party disclosure and
recordkeeping burdens associated with
the Reportable Food Registry.
Specifically, FDA may require the
responsible party to notify the
immediate previous source(s) and/or
immediate subsequent recipient(s) of
the reportable food (sections
417(d)(6)(B)(i) and 417(d)(6)(B)(ii) of the
act). Similarly, FDA may also require
the responsible party that is notified
(i.e., the immediate previous source
and/or immediate subsequent recipient)
to notify their own immediate previous
source(s) and/or immediate subsequent
recipient(s) of the reportable food
(sections 417(d)(7)(C)(i) and
417(d)(7)(C)(ii) of the act).
Notification to the immediate
previous source(s) and immediate
subsequent recipient(s) of the article of
food may be accomplished by electronic
communication methods such as e-mail,
fax or text messaging or by telegrams,
mailgrams, or first class letters.
Notification may also be accomplished
by telephone call or other personal
contacts, but FDA recommends that
such notifications also be confirmed by
one of the above methods and/or
documented in an appropriate manner.
FDA may require that the notification
include any or all of the following data
elements: (1) The date on which the
article of food was determined to be a
reportable food; (2) a description of the
article of food including the quantity or
amount; (3) the extent and nature of the
adulteration; (4) the results of any
investigation of the cause of the
adulteration if it may have originated
with the responsible party, if known; (5)
the disposition of the article of food,
when known; (6) product information
typically found on packaging including
product codes, use-by dates, and the
names of manufacturers, packers, or
distributors sufficient to identify the
article of food; (7) contact information
for the responsible party; (8) contact
information for parties directly linked in
the supply chain and notified under
sections 417(d)(6)(B) or 417(d)(7)(C) of
the act, as applicable; (9) the
information required by FDA to be
included in the notification provided by
the responsible party involved under
sections 417(d)(6)(B) or 417(d)(7)(C) of
the act or required to report under
section 417(d)(7)(A) of the act; and (10)
the unique number described in section
417(d)(4) of the act. (sections
417(d)(6)(B)(iii)(I), 417(d)(7)(C)(iii)(I),
and 417(e) of the act). FDA may also
require that the notification provide
information about the actions that the
E:\FR\FM\26FEN1.SGM
26FEN1
]]>Agencies
[Federal Register Volume 75, Number 38 (Friday, February 26, 2010)]
[Notices]
[Pages 8959-8960]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3911]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0083]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Substances Prohibited From Use in Animal Food or Feed;
Animal Proteins Prohibited in Ruminant Feed
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the 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 recordkeeping requirements
for this collection of information concerning substances prohibited
from use in animal food or feed and animal proteins prohibited in
ruminant feed.
DATES: Submit written or electronic comments on the collection of
information by April 27, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B,
Rockville, MD 20850, 301-827-1472.
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.
Substances Prohibited From Use in Animal Food or Feed; Animal Proteins
Prohibited in Ruminant Feed--21 CFR 589.2000(e)(1)(iv) (OMB Control
Number 0910-0339)--Extension
This information collection was established because epidemiological
evidence gathered in the United Kingdom suggested that bovine
spongiform encephalopathy (BSE), a progressively degenerative central
nervous system disease, is spread to ruminant animals by feeding
protein derived from ruminants infected with BSE. This regulation
places general requirements on persons that manufacture, blend,
process, and distribute products that contain or may contain protein
derived from mammalian tissue, and feeds made from such products.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section Recordkeepers Recordkeeping Records Records Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
589.2000(e)(1)(iv) 400 1 400 14 5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 8960]]
Dated: February 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3911 Filed 2-25-10; 8:45 am]
BILLING CODE 4160-01-S
