Risk Assessment of the Public Health Impact From Foodborne Listeria Monocytogenes in Smoked Finfish; and Evaluation of Food Code Provisions That Address Preventive Controls for Listeria Monocytogenes in Retail and Foodservice Establishments; Extension of Comment Period, 22888-22889 [05-8838]
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22888
Federal Register / Vol. 70, No. 84 / Tuesday, May 3, 2005 / Notices
application for a diagnostic
radiopharmaceutical to be
approximately 10,000 hours, roughly
one-fifth of which, or 2,000 hours, is
estimated to be spent preparing the
portions of the application that would
be affected by these regulations. The
regulation does not impose any
additional reporting burden for safety
and effectiveness information on
diagnostic radiopharmaceuticals beyond
the estimated burden of 2,000 hours
because safety and effectiveness
information is already required by
§ 314.50 (OMB control number 0910–
0001 approved by OMB until March 31,
2005). In fact, clarification in these
regulations of FDA’s standards for
evaluation of diagnostic
radiopharmaceuticals is intended to
streamline overall information
collection burdens, particularly for
diagnostic radiopharmaceuticals that
may have well established, low risk
safety profiles, by enabling
manufacturers to tailor information
submissions and avoid unnecessary
clinical studies. Table 1 of this
document contains estimates of the
annual reporting burden for the
preparation of the safety and
effectiveness sections of an application
that are imposed by existing regulations.
The burden totals do not include an
increase in burden. This estimate does
not include the actual time needed to
conduct studies and trials or other
research from which the reported
information is obtained.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
315.4, 315.5, and 315.6
Annual Frequency
per Response
2
Total Annual
Responses
1
Hours per
Response
2
2,000
Total
4,000
4,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–8818 Filed 5–2–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0065]
Risk Assessment of the Public Health
Impact From Foodborne Listeria
Monocytogenes in Smoked Finfish;
and Evaluation of Food Code
Provisions That Address Preventive
Controls for Listeria Monocytogenes in
Retail and Foodservice
Establishments; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Total Hours
an extension to allow interested persons
additional time to submit comments and
scientific data and information.
DATES: Submit written and electronic
comments and scientific data and
information by July 5, 2005.
ADDRESSES: Submit written comments
and scientific data and information to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments, data, and
information to https://www.fda.gov.gov/
dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Sherri B. Dennis, Center for Food Safety
and Applied Nutrition (HFS–06), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–1903.
SUPPLEMENTARY INFORMATION:
I. Background
Notice; extension of comment
period.
SUMMARY: The Food and Drug
Administration (FDA) is extending to
July 5, 2005, the comment period for the
notice that appeared in the Federal
Register of March 4, 2005 (70 FR
10650). In the notice, FDA requested
comments and scientific data and
information to assist the agency in its
plans to conduct a risk assessment for
Listeria monocytogenes in smoked
finfish and to evaluate the provisions of
the 2001 Food Code that address
preventive controls for L.
monocytogenes in retail and foodservice
establishments. The agency is taking
this action in response to a request for
VerDate jul<14>2003
15:43 May 02, 2005
Jkt 205001
In the Federal Register of March 4,
2005 (70 FR 10650), FDA published a
notice with a 60-day comment period to
request comments and scientific data
and information to assist the agency in
its plans to conduct a risk assessment
for L. monocytogenes in smoked finfish
(smoked finfish risk assessment) and to
evaluate the provisions of the 2001 Food
Code that address preventive controls
for L. monocytogenes in retail and
foodservice establishments.
For the smoked finfish risk
assessment, the agency specifically
requested information on the following
topics:
1. L. monocytogenes levels in raw
fish, smoked fish, and finished product,
PO 00000
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Fmt 4703
Sfmt 4703
2. Effect of mitigation measures (e.g.,
ozonation, acidified sodium chlorite) to
reduce L. monocytogenes levels in raw
and finished product,
3. Potential for transfer of L.
monocytogenes to food from
contaminated food contact and
noncontact surfaces during
manufacturing and/or processing (e.g.,
equipment, workers, floor drains, etc.),
4. Potential for transfer of L.
monocytogenes from the slicer to coldsmoked fish,
5. Impact of adding inhibitors (e.g.,
bacteriocins and bacteriocins-producing
bacterial strains or sodium lactate) to
smoked finfish to reduce or prevent L.
monocytogenes growth,
6. Impact of frozen versus refrigerated
storage conditions on levels of L.
monocytogenes,
7. Impact of time and temperature on
levels of L. monocytogenes for
commercial and home storage
conditions of finished product, and
8. Effect of training regarding
sanitation and hygienic practices on
reducing the levels of L. monocytogenes
in smoked finfish.
For evaluating the Food Code
provisions for preventive controls for L.
monocytogenes in retail and foodservice
establishments, the agency specifically
requested the following data and
information:
1. L. monocytogenes levels in
products stored in retail and foodservice
establishments,
2. Levels of environmental
contamination and harborage of L.
monocytogenes on food contact and
nonfood contact surfaces in retail and
foodservice establishments (e.g.,
equipment, workers, floor drains, etc.),
E:\FR\FM\03MYN1.SGM
03MYN1
Federal Register / Vol. 70, No. 84 / Tuesday, May 3, 2005 / Notices
3. Effects of short- and long-term
refrigerated storage on levels of L.
monocytogenes in retail and foodservice
establishments,
4. Impact of time and temperature on
levels of L. monocytogenes in products
stored in retail and foodservice
establishments,
5. Efficacy of cleaning procedures and
sanitizing agents on environmental
surfaces and utensils,
6. Frequency of use and impact of
adding inhibitors to food products in
retail and foodservice establishments to
reduce or prevent L. monocytogenes
growth, and
7. Effect of training regarding hygienic
practices and sanitation on levels of L.
monocytogenes in products in retail and
foodservice establishments.
Interested persons were given until
May 3, 2005, to submit comments and
scientific data and information.
The agency has received a request for
a 60-day extension of the comment
period for the notice. The request
conveyed concern that the current 60day comment period does not allow
sufficient time to develop a meaningful
response to the notice.
FDA has considered the request and
is extending the comment period for the
notice for an additional 60 days, until
July 5, 2005. However, the agency does
not anticipate granting any further
extensions of the comment period.
II. Request for Comments and for
Scientific Data and Information
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments, scientific data, and
information on this document. Submit a
single copy of electronic comments,
scientific data, and information or two
paper copies of any mailed comments,
except that individuals may submit one
paper copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: April 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–8838 Filed 4–29–05; 11:30 am]
BILLING CODE 4160–01–S
VerDate jul<14>2003
15:43 May 02, 2005
Jkt 205001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Funding Opportunity Title: Food Safety
Task Force Conference Announcement
Type: New Request for Applications
Funding Opportunity Number: RFA–
FDA–ORA–2005–3 Catalog of Federal
Domestic Assistance (CFDA)
Number(s):93–103
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is issuing a
revised request for application (RFA)
that will replace the announcements
published June 25, 2004 (69 FR 35651)
and February 4, 2005 (70 FR 6015).
FDA, in collaboration with the Centers
for Disease Control and Prevention
(CDC), is announcing the availability of
conference grant funding for meetings of
State Food Safety and Food Security
Task Forces. The original
announcement of availability of funding
for State Food Safety Task Force
Meetings, published in the Federal
Register on January 24, 2000 (65 FR
3720), is superseded by this
announcement. This revised
announcement provides new policies
that apply to the State Food Safety and
Food Security Task Force Meetings
Conference Grant Program. The FDA
views this program as an ongoing
program announcement, contingent on
the availability of funds.
DATES: The application receipt date is
July 5, 2005.
ADDRESSES: Applicants are strongly
encouraged to apply electronically by
visiting the Web site at https://
www.grants.gov and following
instructions under ‘‘APPLY.’’
Applications also are available from,
and completed applications may be
submitted to, Michelle Caraffa, Division
of Contracts and Grants Management
(HFA–500), Food and Drug
Administration, 5600 Fishers Lane, rm.
2129, Rockville, MD 20857, 301–827–
7025, e-mail: mcaraffa@oc.fda.gov.
Application forms PHS 5161–1 are
available via the internet at: https://
www.psc.gov/forms (Revised 7/00).
Applications hand carried or
commercially delivered should be
addressed to 5630 Fishers Lane (HFA–
500), rm. 2129, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Regarding the administrative and
financial management aspects of
this notice: Michelle N. Caraffa (see
ADDRESSES).
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22889
Regarding the programmatic issues of
this notice: Stephen Toigo, Division
of Federal-State Relations (DFSR),
Office of Regulatory Affairs (ORA),
Food and Drug Administration
(HFA–150), 5600 Fishers Lane, rm.
12–07, Rockville, MD 20857, 301–
827–2906, E-mail:
stoigo@ora.fda.gov, or access the
Internet at https://www.fda.gov/ora/
fedlstate/default.htm.
For general ORA program
information: Contact your Regional
Food Specialists at https://
www.fda.gov/ora/fedlstate/
DFSRlActivities/food
specialists.htm.
The
purpose of the Food Safety and Food
Security Task Force meetings is to foster
communication and cooperation within
the States among State and local food
safety regulatory agencies. The meetings
should: (1) Provide a forum for all the
stakeholders of the food safety system—
regulatory agencies, academia, industry,
consumers, State legislators, and other
interested parties; (2) assist in adopting
or implementing the Food Code; and (3)
promote the integration of an efficient
statewide food safety system that
maximizes the protection of the public
health through early detection and
containment of foodborne illness. Each
Task Force shall develop its own
guidelines for work, consensus
decision-making, size and format, at its
initial meeting. FDA DFSR will provide
meeting guidelines and organization
documents as requested.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
FDA is issuing a revised RFA which
will replace the announcements
published June 25, 2004 (69 FR 35651)
and February 4, 2005 (70 FR 6015).
FDA, in collaboration with the CDC, is
announcing the availability of
conference grant funding for meetings of
State Food Safety and Food Security
Task Forces. The original
announcement of availability of funding
for State Food Safety Task Force
Meetings, published in the Federal
Register on January 24, 2000, is
superseded by this announcement. This
revised announcement provides new
policies that apply to the State Food
Safety and Food Security Task Force
Meetings Conference Grant Program.
The FDA views this program as an
ongoing program announcement,
contingent on the availability of funds.
FDA and CDC view State based Food
Safety and Food Security Task Forces as
important mechanisms for promoting
food safety, food security program
coordination, and information
E:\FR\FM\03MYN1.SGM
03MYN1
]]>Agencies
[Federal Register Volume 70, Number 84 (Tuesday, May 3, 2005)]
[Notices]
[Pages 22888-22889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-88]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0065]
Risk Assessment of the Public Health Impact From Foodborne
Listeria Monocytogenes in Smoked Finfish; and Evaluation of Food Code
Provisions That Address Preventive Controls for Listeria Monocytogenes
in Retail and Foodservice Establishments; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending to July 5,
2005, the comment period for the notice that appeared in the Federal
Register of March 4, 2005 (70 FR 10650). In the notice, FDA requested
comments and scientific data and information to assist the agency in
its plans to conduct a risk assessment for Listeria monocytogenes in
smoked finfish and to evaluate the provisions of the 2001 Food Code
that address preventive controls for L. monocytogenes in retail and
foodservice establishments. The agency is taking this action in
response to a request for an extension to allow interested persons
additional time to submit comments and scientific data and information.
DATES: Submit written and electronic comments and scientific data and
information by July 5, 2005.
ADDRESSES: Submit written comments and scientific data and information
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments, data, and information to https://
www.fda.gov.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Sherri B. Dennis, Center for Food
Safety and Applied Nutrition (HFS-06), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1903.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 4, 2005 (70 FR 10650), FDA
published a notice with a 60-day comment period to request comments and
scientific data and information to assist the agency in its plans to
conduct a risk assessment for L. monocytogenes in smoked finfish
(smoked finfish risk assessment) and to evaluate the provisions of the
2001 Food Code that address preventive controls for L. monocytogenes in
retail and foodservice establishments.
For the smoked finfish risk assessment, the agency specifically
requested information on the following topics:
1. L. monocytogenes levels in raw fish, smoked fish, and finished
product,
2. Effect of mitigation measures (e.g., ozonation, acidified sodium
chlorite) to reduce L. monocytogenes levels in raw and finished
product,
3. Potential for transfer of L. monocytogenes to food from
contaminated food contact and noncontact surfaces during manufacturing
and/or processing (e.g., equipment, workers, floor drains, etc.),
4. Potential for transfer of L. monocytogenes from the slicer to
cold-smoked fish,
5. Impact of adding inhibitors (e.g., bacteriocins and
bacteriocins-producing bacterial strains or sodium lactate) to smoked
finfish to reduce or prevent L. monocytogenes growth,
6. Impact of frozen versus refrigerated storage conditions on
levels of L. monocytogenes,
7. Impact of time and temperature on levels of L. monocytogenes for
commercial and home storage conditions of finished product, and
8. Effect of training regarding sanitation and hygienic practices
on reducing the levels of L. monocytogenes in smoked finfish.
For evaluating the Food Code provisions for preventive controls for
L. monocytogenes in retail and foodservice establishments, the agency
specifically requested the following data and information:
1. L. monocytogenes levels in products stored in retail and
foodservice establishments,
2. Levels of environmental contamination and harborage of L.
monocytogenes on food contact and nonfood contact surfaces in retail
and foodservice establishments (e.g., equipment, workers, floor drains,
etc.),
[[Page 22889]]
3. Effects of short- and long-term refrigerated storage on levels
of L. monocytogenes in retail and foodservice establishments,
4. Impact of time and temperature on levels of L. monocytogenes in
products stored in retail and foodservice establishments,
5. Efficacy of cleaning procedures and sanitizing agents on
environmental surfaces and utensils,
6. Frequency of use and impact of adding inhibitors to food
products in retail and foodservice establishments to reduce or prevent
L. monocytogenes growth, and
7. Effect of training regarding hygienic practices and sanitation
on levels of L. monocytogenes in products in retail and foodservice
establishments.
Interested persons were given until May 3, 2005, to submit comments
and scientific data and information.
The agency has received a request for a 60-day extension of the
comment period for the notice. The request conveyed concern that the
current 60-day comment period does not allow sufficient time to develop
a meaningful response to the notice.
FDA has considered the request and is extending the comment period
for the notice for an additional 60 days, until July 5, 2005. However,
the agency does not anticipate granting any further extensions of the
comment period.
II. Request for Comments and for Scientific Data and Information
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments, scientific data, and
information on this document. Submit a single copy of electronic
comments, scientific data, and information or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: April 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8838 Filed 4-29-05; 11:30 am]
BILLING CODE 4160-01-S
