Canned Pacific Salmon Deviating From Identity Standard; Extension of Temporary Permit for Market Testing, 383-384 [E9-31196]
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383
Federal Register / Vol. 75, No. 2 / Tuesday, January 5, 2010 / Notices
activities and the surveillance systems
maintained have expanded.
CDC and the Council of State and
Territorial Epidemiologists (CSTE)
collect data on disease and preventable
conditions in accordance with jointly
approved plans. Changes in the
surveillance program and in reporting
methods are effected in the same
manner. At the onset of this surveillance
program in 1968, the CSTE and CDC
decided on which diseases warranted
surveillance. These diseases are
reviewed and revised based on
variations in the public’s health.
Surveillance forms are distributed to the
State and local health departments who
voluntarily submit these reports to CDC
Surveillance System (HABISS) data
entry form, and the HABISS monthly
reporting form. These data are essential
on the local, state, and Federal levels for
measuring trends in diseases, evaluating
the effectiveness of current prevention
strategies, and determining the need for
modifying current prevention measures.
This request is for revision of the
currently approved data collection for
three years. The revisions include minor
changes to reporting forms already
approved under this OMB Control
Number. Because of the distinct nature
of each of the diseases, the number of
cases reported annually is different for
each. There is no cost to respondents
other than their time.
at variable frequencies, either weekly or
monthly. CDC then calculates and
publishes weekly statistics via the
Morbidity and Mortality Weekly Report
(MMWR), providing the states with
timely aggregates of their submissions.
The following diseases/conditions are
included in this program: Diarrheal
disease surveillance (includes
campylobacter, salmonella, and
shigella), foodborne outbreaks, arboviral
surveillance (ArboNet), Influenza virus,
including the annual survey and
influenza-like illness, Respiratory and
Enterovirus surveillance, rabies,
waterborne diseases, cholera and other
vibrio illnesses, Listeria, Calcinet,
Harmful Algal Bloom-related Infectious
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
responses
per
respondent
Number of
respondents
Form
Average
burden per
response
(in hours)
Total burden
(in hours)
Diarrheal Disease Surveillance: Campylobacter (electronic) ..........................
Diarrheal Disease Surveillance: Salmonella (electronic) .................................
Diarrheal Disease Surveillance: Shigella (electronic) ......................................
Foodborne Outbreak Form ..............................................................................
Arboviral Surveillance (ArboNet) .....................................................................
—Influenza virus (fax, Oct–May) .....................................................................
—Influenza virus (fax, year round) ..................................................................
*** Influenza virus (Internet; Oct–May) ............................................................
*** Influenza virus (Internet; year round) .........................................................
—Influenza virus (electronic, Oct–May) ...........................................................
—Influenza virus (electronic, year round) ........................................................
Influenza Annual Survey ..................................................................................
Influenza-like Illness (Oct–May) .......................................................................
Influenza-like Illness (year round) ....................................................................
Monthly Respiratory & Enterovirus Surveillance Report: Excel format (electronic) ...........................................................................................................
National Respiratory & Enteric Virus Surveillance System (NREVSS) ...........
Rabies (electronic) ...........................................................................................
Rabies (paper) .................................................................................................
Waterborne Diseases Outbreak Form .............................................................
Cholera and other Vibrio illnesses ..................................................................
CaliciNet ...........................................................................................................
Listeria .............................................................................................................
HABISS data entry form ..................................................................................
HABISS monthly reporting form ......................................................................
53
53
53
54
57
8
15
13
24
9
14
83
824
496
52
52
52
25
1,421
33
52
33
52
33
52
1
33
52
3/60
3/60
3/60
15/60
4/60
10/60
10/60
10/60
10/60
5/60
5/60
15/60
15/60
15/60
138
138
138
338
5,400
44
130
72
208
25
61
21
6,798
6,448
25
92
40
15
26
450
30
53
10
10
12
52
12
12
2
1
10
1
12
12
15/60
10/60
8/60
20/60
20/60
20/60
10/60
30/60
8
30/60
75
797
64
60
17
150
50
27
960
60
Total ..........................................................................................................
........................
........................
........................
22,219
Dated: December 29, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–31369 Filed 1–4–10; 8:45 am]
srobinson on DSKHWCL6B1PROD with PROPOSALS
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0119]
Canned Pacific Salmon Deviating From
Identity Standard; Extension of
Temporary Permit for Market Testing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
extension of a temporary permit issued
VerDate Nov<24>2008
16:41 Jan 04, 2010
Jkt 220001
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
to Yardarm Knot Fisheries, LLC, to
market test products designated as
‘‘skinless and boneless sockeye salmon’’
that deviate from the U.S. standard of
identity for canned Pacific salmon. The
extension will allow the permit holder
to continue to collect data on consumer
acceptance of the product while the
agency takes action on a petition to
amend the standard of identity for
canned Pacific salmon that was
submitted by Yardarm Knot Fisheries,
LLC.
DATES: The new expiration date of the
permit will be either the effective date
of a final rule to amend the standard of
E:\FR\FM\05JAN1.SGM
05JAN1
srobinson on DSKHWCL6B1PROD with PROPOSALS
384
Federal Register / Vol. 75, No. 2 / Tuesday, January 5, 2010 / Notices
identity for canned Pacific salmon that
may result from the petition or 30 days
after denial of the petition, whichever
the case may be.
FOR FURTHER INFORMATION CONTACT:
´
Catalina Ferre-Hockensmith, Center for
Food Safety and Applied Nutrition
(HFS–820), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301–
436–2371.
SUPPLEMENTARY INFORMATION: In
accordance with § 130.17 (21 CFR
130.17), FDA issued a temporary permit
to Yardarm Knot Fisheries, LLC, 3600
15th Avenue West, Suite 300, Seattle,
Washington 98119, to market test
canned Pacific salmon that deviates
from the U.S. standard of identity for
canned Pacific salmon (§ 161.170 (21
CFR 161.170)) (73 FR 12180, March 6,
2008). The agency issued the permit to
facilitate market testing of a food
deviating from the requirements of the
standards of identity issued under
section 401 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 341).
The permit covers limited interstate
marketing tests of a product identified
as Yardarm Knot ‘‘Skinless and
Boneless Sockeye Salmon.’’ This canned
salmon product may deviate from the
U.S. standard of identity for canned
Pacific salmon (§ 161.170) in that the
product is prepared by removing the
skin and bones of the salmon used.
Therefore, in addition to the optional
forms of pack provided in
§ 161.170(a)(3), this temporary
marketing permit provides for an
alternative ‘‘skinless and boneless’’ form
of pack. The test product meets all the
requirements of the standard with the
exception of the ‘‘skinless and boneless’’
form of pack.
On April 9, 2009, Yardarm Knot
Fisheries, LLC, requested that its
temporary marketing permit be
extended to allow for additional time for
the market testing of its test product and
indicated that it had moved its
corporate office to the address stated
below. The petitioner has also
submitted a petition requesting that
FDA amend the standard of identity for
canned Pacific salmon.
The agency finds that it is in the
interest of consumers to issue an
extension of the time period for the
market testing of the product identified
in the original permit (73 FR 12180,
March 6, 2008). FDA is inviting
interested persons to participate in the
market test under the conditions that
apply to Yardarm Knot Fisheries, LLC,
except that the designated area of
distribution shall not apply. Any person
who wishes to participate in the
VerDate Nov<24>2008
16:41 Jan 04, 2010
Jkt 220001
extended market test must notify, in
writing, the Supervisor, Product
Evaluation and Labeling Team, Food
Labeling and Standards Staff, Office of
Nutrition, Labeling and Dietary
Supplements, Center for Food Safety
and Applied Nutrition (HFS–820), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740.
The notification must include a
description of the test product to be
distributed, a justification statement for
the amount requested, the area of
distribution, and the labeling that will
be used for the test product (i.e., a draft
label for each size of container and each
brand of product to be market tested).
The information panel of the label must
bear nutrition labeling in accordance
with 21 CFR 101.9. Each of the
ingredients used in the food must be
declared on the label as required by
applicable sections of 21 CFR part 101.
Therefore, under the provisions of
§ 130.17(i), FDA is extending the
temporary permit granted to Yardarm
Knot Fisheries, LLC, 2440 West
Commodore Way, Suite 200, Seattle,
Washington 98199 to provide for
continued marketing tests of not more
than 1.35 million pounds (or 612
thousand kilograms in weight) annually
of the canned Pacific salmon identified
in this notice. FDA is extending the
expiration date of the permit so that the
permit expires either on the effective
date of a final rule to amend the
standard of identity for canned Pacific
salmon that may result from the petition
or 30 days after denial of the petition.
All other conditions and terms of this
permit remain the same.
Dated: December 16, 2009.
Barbara Schneeman,
Director, Office of Nutrition, Labeling and
Dietary Supplements, Center for Food Safety
and Applied Nutrition.
[FR Doc. E9–31196 Filed 1–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0576]
Event Problem Codes Web Site; Center
for Devices and Radiological Health;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a Web site where the
Center for Devices and Radiological
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Health (CDRH) is posting updates to the
problem codes used in conjunction with
the medical device adverse event
reports (MDR) regulation.
DATES: Submit electronic or written
comments at any time.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Terrie L. Reed, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., rm. 3324, Silver Spring, MD
20993, 301–796–6130.
SUPPLEMENTARY INFORMATION:
I. Background
Under part 803 (21 CFR part 803),
user facilities and importers are
required to submit FDA Form 3500A for
deaths and serious injuries that a
medical device may have caused or to
which it may have contributed. Block
F10 of FDA Form 3500A asks user
facilities and importers to provide event
problem codes for both the patient and
the device. Manufacturers are required
by § 803.52(f)(11)(i) to include ‘‘Any
information missing on the user facility
report or importer report, including any
event codes that were not reported
* * *.’’ The patient problem codes
indicate the effects that an event may
have had on the patient, including
signs, symptoms, syndromes, or
diagnoses. The device codes describe
device failures or issues related to the
device that are encountered during the
event. The medical device reporting
regulation also states that if CDRH
makes modifications to these reporting
codes, the information will be made
available to all reporters (§ 803.21(b)).
FDA is announcing the availability of
a Web site that will make modifications
to the problem codes available to all
reporters and will also fully describe the
problem codes. The Web site is located
at https://www.fda.gov/MedicalDevices/
Safety/ReportaProblem/EventProblem
Codes/default.htm. This Web site
reflects the current updates to the
problem codes, provides a description
for each problem code, and notes that
April 2, 2010, is the target date to reject
all inactivated and retired codes
specified in this update. After April 2,
2010, no old codes or code numbers will
be accepted. The Web site also describes
a joint project between CDRH and the
E:\FR\FM\05JAN1.SGM
05JAN1
Agencies
[Federal Register Volume 75, Number 2 (Tuesday, January 5, 2010)]
[Notices]
[Pages 383-384]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-31196]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0119]
Canned Pacific Salmon Deviating From Identity Standard; Extension
of Temporary Permit for Market Testing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
extension of a temporary permit issued to Yardarm Knot Fisheries, LLC,
to market test products designated as ``skinless and boneless sockeye
salmon'' that deviate from the U.S. standard of identity for canned
Pacific salmon. The extension will allow the permit holder to continue
to collect data on consumer acceptance of the product while the agency
takes action on a petition to amend the standard of identity for canned
Pacific salmon that was submitted by Yardarm Knot Fisheries, LLC.
DATES: The new expiration date of the permit will be either the
effective date of a final rule to amend the standard of
[[Page 384]]
identity for canned Pacific salmon that may result from the petition or
30 days after denial of the petition, whichever the case may be.
FOR FURTHER INFORMATION CONTACT: Catalina Ferr[eacute]-Hockensmith,
Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2371.
SUPPLEMENTARY INFORMATION: In accordance with Sec. 130.17 (21 CFR
130.17), FDA issued a temporary permit to Yardarm Knot Fisheries, LLC,
3600 15th Avenue West, Suite 300, Seattle, Washington 98119, to market
test canned Pacific salmon that deviates from the U.S. standard of
identity for canned Pacific salmon (Sec. 161.170 (21 CFR 161.170)) (73
FR 12180, March 6, 2008). The agency issued the permit to facilitate
market testing of a food deviating from the requirements of the
standards of identity issued under section 401 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 341).
The permit covers limited interstate marketing tests of a product
identified as Yardarm Knot ``Skinless and Boneless Sockeye Salmon.''
This canned salmon product may deviate from the U.S. standard of
identity for canned Pacific salmon (Sec. 161.170) in that the product
is prepared by removing the skin and bones of the salmon used.
Therefore, in addition to the optional forms of pack provided in Sec.
161.170(a)(3), this temporary marketing permit provides for an
alternative ``skinless and boneless'' form of pack. The test product
meets all the requirements of the standard with the exception of the
``skinless and boneless'' form of pack.
On April 9, 2009, Yardarm Knot Fisheries, LLC, requested that its
temporary marketing permit be extended to allow for additional time for
the market testing of its test product and indicated that it had moved
its corporate office to the address stated below. The petitioner has
also submitted a petition requesting that FDA amend the standard of
identity for canned Pacific salmon.
The agency finds that it is in the interest of consumers to issue
an extension of the time period for the market testing of the product
identified in the original permit (73 FR 12180, March 6, 2008). FDA is
inviting interested persons to participate in the market test under the
conditions that apply to Yardarm Knot Fisheries, LLC, except that the
designated area of distribution shall not apply. Any person who wishes
to participate in the extended market test must notify, in writing, the
Supervisor, Product Evaluation and Labeling Team, Food Labeling and
Standards Staff, Office of Nutrition, Labeling and Dietary Supplements,
Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. The
notification must include a description of the test product to be
distributed, a justification statement for the amount requested, the
area of distribution, and the labeling that will be used for the test
product (i.e., a draft label for each size of container and each brand
of product to be market tested). The information panel of the label
must bear nutrition labeling in accordance with 21 CFR 101.9. Each of
the ingredients used in the food must be declared on the label as
required by applicable sections of 21 CFR part 101.
Therefore, under the provisions of Sec. 130.17(i), FDA is
extending the temporary permit granted to Yardarm Knot Fisheries, LLC,
2440 West Commodore Way, Suite 200, Seattle, Washington 98199 to
provide for continued marketing tests of not more than 1.35 million
pounds (or 612 thousand kilograms in weight) annually of the canned
Pacific salmon identified in this notice. FDA is extending the
expiration date of the permit so that the permit expires either on the
effective date of a final rule to amend the standard of identity for
canned Pacific salmon that may result from the petition or 30 days
after denial of the petition. All other conditions and terms of this
permit remain the same.
Dated: December 16, 2009.
Barbara Schneeman,
Director, Office of Nutrition, Labeling and Dietary Supplements, Center
for Food Safety and Applied Nutrition.
[FR Doc. E9-31196 Filed 1-4-10; 8:45 am]
BILLING CODE 4160-01-S