WERC: A Consortium for Environmental Education and Technology Development, Annual Environmental Design Contest; Availability of Sole Source Competing Continuation Cooperative Agreement; Request for Application: RFA-FDA-CFSAN-2005-3; Catalog of Federal Domestic Assistance Number 93.103, 53230-53231 [05-17731]
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53230
Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices
fiscal year 2006 (October 1, 2005,
through September 30, 2006).
2005. The formula used to determine
the fees is as follows:
FOR FURTHER INFORMATION CONTACT:
Average Cost Per Inspection = Total
Cost of VSP ÷ Weight Number of Annual
Inspection
David Forney, Chief, Vessel Sanitation
Program, Division of Emergency and
Environmental Health Services (EEHS),
National Center for Environmental
Health (NCEH), telephone (770) 488–
7333 or e-mail DForney@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose and Background
The fee schedule for sanitation
inspections of passenger cruise ships
inspected under the Vessel Sanitation
Program (VSP) was first published in
the Federal Register on November 24,
1987 (52 FR 45019), and CDC began
collecting fees on March 1, 1988. Since
then, CDC has published the fee
schedule annually. This notice
announces fees effective October 1,
The average cost per inspection is
multiplied by a size/cost factor to
determine the fee for vessels in each
size category. The size/cost factor was
established in the proposed fee schedule
published in the Federal Register on
July 17, 1987 (52 FR 27060), and revised
in a schedule published in the Federal
Register on November 28, 1989 (54 FR
48942). The revised size/cost factor is
presented in Appendix A.
Fees
The fee schedule (Appendix A) will
be effective October 1, 2005, through
September 30, 2006. The fee schedule,
which became effective October 1, 2001,
will remain the same in Fiscal year
2006. If travel expenses continue to
increase, the fees may be adjusted before
September 30, 2006, since travel
constitutes a sizable portion of VSP’s
costs. If an adjustment is necessary, a
notice will be published in the Federal
Register 30 days before the effective
date.
Applicability
The fees will apply to all passenger
cruise vessels for which inspections are
conducted as part of CDC’s VSP.
Dated: August 30, 2005.
Kenneth Rose,
Acting Director, Centers for Disease Control
and Prevention (CDC), NCEH/ATSDR Office
of Policy, Planning, and Evaluation.
Appendix A
SIZE/COST FACTOR
GRT 1
Vessel size
Extra Small ............................................................................................................................................................
Small ......................................................................................................................................................................
Medium ..................................................................................................................................................................
Large ......................................................................................................................................................................
Extra Large ............................................................................................................................................................
Average
cost ($U.S.)
per GRT
> 3,001
3,001–15,000
15,001–30,000
30,001–60,000
> 60,000
0.25
0.50
1.00
1.50
2.00
FEE SCHEDULE OCTOBER 1, 2005–SEPTEMBER 30, 2006
GRT 1
Vessel size
Extra Small ............................................................................................................................................................
Small ......................................................................................................................................................................
Medium ..................................................................................................................................................................
Large ......................................................................................................................................................................
Extra Large ............................................................................................................................................................
Inspections and reinspections involve the
same procedure, require the same amount of
time, and are therefore charged at the same
rate.
[FR Doc. 05–17663 Filed 9–6–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
WERC: A Consortium for
Environmental Education and
Technology Development, Annual
Environmental Design Contest;
Availability of Sole Source Competing
Continuation Cooperative Agreement;
Request for Application: RFA-FDACFSAN–2005–3; Catalog of Federal
Domestic Assistance Number 93.103
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
I. Funding Opportunity Description
1 Gross
register tonnage in cubic feet, as shown in
Lloyd’s Register of Shipping.
VerDate Aug<18>2005
15:05 Sep 06, 2005
Jkt 205001
The Food and Drug Administration
(FDA) is announcing its intent to accept
and consider a single source competing
PO 00000
Frm 00083
Fmt 4703
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> 3,001
3,001–15,000
15,001–30,000
30,001–60,000
> 60,000
Fee
1,150
2,300
4,600
6,900
9,200
continuation application for the award
of a cooperative agreement to the WasteManagement Education and Research
Consortium (WERC): A Consortium for
Environmental Education and
Technology Development to support the
Annual Environmental Design Contest.
FDA anticipates providing $106,000
(direct and indirect costs combined) in
fiscal year 2005 in support of this
research project. Subject to the
availability of Federal funds and
successful performance, 4 additional
years of support up to $106,000 (direct
and indirect costs combined) per year
will be available. FDA will support the
research covered by this notice under
the authority of section 301 of the
Public Health Service Act (42 U.S.C.
241). FDA’s research program is
described in the Catalog of Federal
Domestic Assistance No. 93.103. Before
entering into cooperative agreements,
E:\FR\FM\07SEN1.SGM
07SEN1
Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices
FDA carefully considers the benefits
such agreements will provide to the
public. The cooperative agreement
ensures FDA’s continued participation
and support in the Annual
Environmental Design Contest. Through
a mix of science and engineering, it
creates new resources and stimulates
new and timely solutions to real world
environmental problems.
II. Eligibility Information
Competition is limited to WERC
because it is a unique educational
opportunity and is the only college level
competition of its kind.
WERC, a Consortium for
Environmental Education and
Technology Development, a program of
the College of Engineering at New
Mexico State University, was
established in 1990 under a cooperative
agreement with the U.S. Department of
Energy. Starting in 1991, WERC has
conducted an Annual Environmental
Design Contest which is a unique
educational experience for students
from throughout the world. The contest
provides an opportunity for students to
address real world environmental and
food safety related problems, experience
a team developed project, publish
research papers, and network with
experts and potential employers. The
contest is open to any 2-year, 4-year, or
graduate degree institution. A high
school-level competition has been held
concurrently with the university contest
since 1997. Many of the tasks deal with
waste disposal, ground water
contamination, nuclear waste treatment,
and similar subjects; however in 2001,
a food safety track was added and the
contest was broadened to include
disciplines such as microbiology and
chemical contaminants in foods. The
FDA has supported this program since
Fiscal Year 2000. This notice confirms
FDA’s intent to fund for another 5-year
project period.
As of October 1, 2003, applicants are
required to have a Dun and Bradstreet
Number (DUNS) to apply for a grant or
cooperative agreement from the Federal
Government. The DUNS number is a 9digit identification number, which
uniquely identifies business entities.
Obtaining a DUNS number is easy and
there is no charge. To obtain a DUNS
number, call 1–866–705–5711. You
should identify yourself as a Federal
grant applicant when you contact Dun
and Bradstreet, Inc.
III. Application and Submission
For further information or a copy of
the complete Request for Applications
(RFA) contact Cynthia Polit, Grants
Management Specialist, Division of
VerDate Aug<18>2005
15:05 Sep 06, 2005
Jkt 205001
Contracts and Grants Management
(HFA–500), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7180, email: cynthia.polit@fda.gov or
cpolit@oc.fda.gov. This RFA can be
viewed on Grants.gov under ‘‘Grant
Find.’’ A copy of the complete RFA can
also be viewed on the FDA/CFSAN
website at https://www.cfsan.fda.gov/
list.html. For issues regarding the
programmatic aspects of this notice:
Wendy Buckler, Center for Food Safety
and Applied Nutrition, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–1926, email:
wendy.buckler@fda.gov.
Dated: September 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–17731 Filed 9–6–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D–0044]
Draft Guidance for Industry and Food
and Drug Administration Staff:
Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 Waiver Applications;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) Waiver Applications.’’
FDA is issuing this draft guidance to
recommend an approach for
determining whether a laboratory test
may be performed by laboratories with
a certificate of waiver under CLIA. This
draft guidance replaces the previous
draft guidance entitled ‘‘Guidance for
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Criteria for
Waiver,’’ March 1, 2001.
DATES: Submit written or electronic
comments on this draft guidance by
December 6, 2005. Submit written
comments on the information collection
provisions by November 7, 2005.
ADDRESSES: Submit written requests for
single copies on a 3.5″ diskette of the
draft guidance document entitled
‘‘Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) for Waiver Applications’’
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
53231
to the Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–443–8818. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit written comments concerning
this draft guidance and the information
collection provisions to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Carol Benson, Center for Devices and
Radiological Health (HFZ–440), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–0443, ext. 144.
SUPPLEMENTARY INFORMATION:
I. Background
CLIA requires that clinical
laboratories obtain a certificate from the
Secretary of Health and Human Services
(the Secretary) before accepting
materials derived from the human body
for laboratory tests (42 U.S.C. 263(b)).
Laboratories that perform only tests
that are ‘‘simple’’ and that have an
‘‘insignificant risk of an erroneous
result’’ may obtain a certificate of
waiver (42 U.S.C. 263a(c)(2)). The
Secretary has delegated to FDA the
authority to determine under CLIA
whether particular tests (waived tests)
are ‘‘simple’’ and have ‘‘an insignificant
risk of an erroneous result’’ (April 27,
2004, 69 FR 22849). This draft guidance
document describes recommendations
for device manufacturers submitting to
FDA an application for determination
that a cleared or approved device meets
this CLIA standard (CLIA waiver
application).
FDA previously issued a draft
guidance entitled ‘‘Clinical Laboratory
Improvement Amendments of 1988
(CLIA) Criteria for Waiver’’ on March 1,
2001. This new draft guidance replaces
the previous draft guidance.
The changes compared to the
previous draft guidance include the
following: (1) Greater emphasis on
scientifically-based flex studies and
validation studies, linked to the hazard
analysis for each device; (2) recognition
that reference methods may not be
E:\FR\FM\07SEN1.SGM
07SEN1
]]>Agencies
[Federal Register Volume 70, Number 172 (Wednesday, September 7, 2005)]
[Notices]
[Pages 53230-53231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17731]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
WERC: A Consortium for Environmental Education and Technology
Development, Annual Environmental Design Contest; Availability of Sole
Source Competing Continuation Cooperative Agreement; Request for
Application: RFA-FDA-CFSAN-2005-3; Catalog of Federal Domestic
Assistance Number 93.103
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
I. Funding Opportunity Description
The Food and Drug Administration (FDA) is announcing its intent to
accept and consider a single source competing continuation application
for the award of a cooperative agreement to the Waste-Management
Education and Research Consortium (WERC): A Consortium for
Environmental Education and Technology Development to support the
Annual Environmental Design Contest. FDA anticipates providing $106,000
(direct and indirect costs combined) in fiscal year 2005 in support of
this research project. Subject to the availability of Federal funds and
successful performance, 4 additional years of support up to $106,000
(direct and indirect costs combined) per year will be available. FDA
will support the research covered by this notice under the authority of
section 301 of the Public Health Service Act (42 U.S.C. 241). FDA's
research program is described in the Catalog of Federal Domestic
Assistance No. 93.103. Before entering into cooperative agreements,
[[Page 53231]]
FDA carefully considers the benefits such agreements will provide to
the public. The cooperative agreement ensures FDA's continued
participation and support in the Annual Environmental Design Contest.
Through a mix of science and engineering, it creates new resources and
stimulates new and timely solutions to real world environmental
problems.
II. Eligibility Information
Competition is limited to WERC because it is a unique educational
opportunity and is the only college level competition of its kind.
WERC, a Consortium for Environmental Education and Technology
Development, a program of the College of Engineering at New Mexico
State University, was established in 1990 under a cooperative agreement
with the U.S. Department of Energy. Starting in 1991, WERC has
conducted an Annual Environmental Design Contest which is a unique
educational experience for students from throughout the world. The
contest provides an opportunity for students to address real world
environmental and food safety related problems, experience a team
developed project, publish research papers, and network with experts
and potential employers. The contest is open to any 2-year, 4-year, or
graduate degree institution. A high school-level competition has been
held concurrently with the university contest since 1997. Many of the
tasks deal with waste disposal, ground water contamination, nuclear
waste treatment, and similar subjects; however in 2001, a food safety
track was added and the contest was broadened to include disciplines
such as microbiology and chemical contaminants in foods. The FDA has
supported this program since Fiscal Year 2000. This notice confirms
FDA's intent to fund for another 5-year project period.
As of October 1, 2003, applicants are required to have a Dun and
Bradstreet Number (DUNS) to apply for a grant or cooperative agreement
from the Federal Government. The DUNS number is a 9-digit
identification number, which uniquely identifies business entities.
Obtaining a DUNS number is easy and there is no charge. To obtain a
DUNS number, call 1-866-705-5711. You should identify yourself as a
Federal grant applicant when you contact Dun and Bradstreet, Inc.
III. Application and Submission
For further information or a copy of the complete Request for
Applications (RFA) contact Cynthia Polit, Grants Management Specialist,
Division of Contracts and Grants Management (HFA-500), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7180,
e-mail: cynthia.polit@fda.gov or cpolit@oc.fda.gov. This RFA can be
viewed on Grants.gov under ``Grant Find.'' A copy of the complete RFA
can also be viewed on the FDA/CFSAN website at https://
www.cfsan.fda.gov/list.html. For issues regarding the programmatic
aspects of this notice: Wendy Buckler, Center for Food Safety and
Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740,
301-436-1926, email: wendy.buckler@fda.gov.
Dated: September 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17731 Filed 9-6-05; 8:45 am]
BILLING CODE 4160-01-S
