You are on page 1of 2

53230 Federal Register / Vol. 70, No.

172 / Wednesday, September 7, 2005 / Notices

fiscal year 2006 (October 1, 2005, 2005. The formula used to determine which became effective October 1, 2001,
through September 30, 2006). the fees is as follows: will remain the same in Fiscal year
FOR FURTHER INFORMATION CONTACT: 2006. If travel expenses continue to
Average Cost Per Inspection = Total
David Forney, Chief, Vessel Sanitation increase, the fees may be adjusted before
Cost of VSP ÷ Weight Number of Annual
Program, Division of Emergency and September 30, 2006, since travel
Inspection
Environmental Health Services (EEHS), constitutes a sizable portion of VSP’s
National Center for Environmental The average cost per inspection is costs. If an adjustment is necessary, a
Health (NCEH), telephone (770) 488– multiplied by a size/cost factor to notice will be published in the Federal
7333 or e-mail DForney@cdc.gov. determine the fee for vessels in each Register 30 days before the effective
SUPPLEMENTARY INFORMATION: size category. The size/cost factor was date.
established in the proposed fee schedule
Purpose and Background Applicability
published in the Federal Register on
The fee schedule for sanitation July 17, 1987 (52 FR 27060), and revised The fees will apply to all passenger
inspections of passenger cruise ships in a schedule published in the Federal cruise vessels for which inspections are
inspected under the Vessel Sanitation Register on November 28, 1989 (54 FR conducted as part of CDC’s VSP.
Program (VSP) was first published in 48942). The revised size/cost factor is
Dated: August 30, 2005.
the Federal Register on November 24, presented in Appendix A.
1987 (52 FR 45019), and CDC began Kenneth Rose,
Fees Acting Director, Centers for Disease Control
collecting fees on March 1, 1988. Since
then, CDC has published the fee The fee schedule (Appendix A) will and Prevention (CDC), NCEH/ATSDR Office
of Policy, Planning, and Evaluation.
schedule annually. This notice be effective October 1, 2005, through
announces fees effective October 1, September 30, 2006. The fee schedule, Appendix A

SIZE/COST FACTOR
Average
Vessel size GRT 1 cost ($U.S.)
per GRT

Extra Small ............................................................................................................................................................ > 3,001 0.25


Small ...................................................................................................................................................................... 3,001–15,000 0.50
Medium .................................................................................................................................................................. 15,001–30,000 1.00
Large ...................................................................................................................................................................... 30,001–60,000 1.50
Extra Large ............................................................................................................................................................ > 60,000 2.00

FEE SCHEDULE OCTOBER 1, 2005–SEPTEMBER 30, 2006


Vessel size GRT 1 Fee

Extra Small ............................................................................................................................................................ > 3,001 1,150


Small ...................................................................................................................................................................... 3,001–15,000 2,300
Medium .................................................................................................................................................................. 15,001–30,000 4,600
Large ...................................................................................................................................................................... 30,001–60,000 6,900
Extra Large ............................................................................................................................................................ > 60,000 9,200

Inspections and reinspections involve the DEPARTMENT OF HEALTH AND continuation application for the award
same procedure, require the same amount of HUMAN SERVICES of a cooperative agreement to the Waste-
time, and are therefore charged at the same Management Education and Research
rate. Food and Drug Administration Consortium (WERC): A Consortium for
[FR Doc. 05–17663 Filed 9–6–05; 8:45 am] Environmental Education and
BILLING CODE 4163–18–P
WERC: A Consortium for Technology Development to support the
Environmental Education and Annual Environmental Design Contest.
Technology Development, Annual
FDA anticipates providing $106,000
Environmental Design Contest;
(direct and indirect costs combined) in
Availability of Sole Source Competing
fiscal year 2005 in support of this
Continuation Cooperative Agreement;
research project. Subject to the
Request for Application: RFA-FDA-
availability of Federal funds and
CFSAN–2005–3; Catalog of Federal
Domestic Assistance Number 93.103 successful performance, 4 additional
years of support up to $106,000 (direct
AGENCY: Food and Drug Administration, and indirect costs combined) per year
HHS. will be available. FDA will support the
research covered by this notice under
ACTION: Notice.
the authority of section 301 of the
Public Health Service Act (42 U.S.C.
I. Funding Opportunity Description
241). FDA’s research program is
The Food and Drug Administration described in the Catalog of Federal
1 Grossregister tonnage in cubic feet, as shown in (FDA) is announcing its intent to accept Domestic Assistance No. 93.103. Before
Lloyd’s Register of Shipping. and consider a single source competing entering into cooperative agreements,

VerDate Aug<18>2005 15:05 Sep 06, 2005 Jkt 205001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1
Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 53231

FDA carefully considers the benefits Contracts and Grants Management to the Division of Small Manufacturers,
such agreements will provide to the (HFA–500), Food and Drug International, and Consumer Assistance
public. The cooperative agreement Administration, 5600 Fishers Lane, (HFZ–220), Center for Devices and
ensures FDA’s continued participation Rockville, MD 20857, 301–827–7180, e- Radiological Health, Food and Drug
and support in the Annual mail: cynthia.polit@fda.gov or Administration, 1350 Piccard Dr.,
Environmental Design Contest. Through cpolit@oc.fda.gov. This RFA can be Rockville, MD 20850. Send one self-
a mix of science and engineering, it viewed on Grants.gov under ‘‘Grant addressed adhesive label to assist that
creates new resources and stimulates Find.’’ A copy of the complete RFA can office in processing your request, or fax
new and timely solutions to real world also be viewed on the FDA/CFSAN your request to 301–443–8818. See the
environmental problems. website at http://www.cfsan.fda.gov/ SUPPLEMENTARY INFORMATION section for
II. Eligibility Information list.html. For issues regarding the information on electronic access to the
programmatic aspects of this notice: guidance.
Competition is limited to WERC Wendy Buckler, Center for Food Safety Submit written comments concerning
because it is a unique educational and Applied Nutrition, 5100 Paint this draft guidance and the information
opportunity and is the only college level Branch Pkwy., College Park, MD 20740, collection provisions to the Division of
competition of its kind. 301–436–1926, email: Dockets Management (HFA–305), Food
WERC, a Consortium for wendy.buckler@fda.gov. and Drug Administration, 5630 Fishers
Environmental Education and Lane, rm. 1061, Rockville, MD 20852.
Technology Development, a program of Dated: September 1, 2005.
Jeffrey Shuren,
Submit electronic comments to http://
the College of Engineering at New www.fda.gov/dockets/ecomments.
Mexico State University, was Assistant Commissioner for Policy.
Identify comments with the docket
established in 1990 under a cooperative [FR Doc. 05–17731 Filed 9–6–05; 8:45 am] number found in brackets in the
agreement with the U.S. Department of BILLING CODE 4160–01–S heading of this document.
Energy. Starting in 1991, WERC has
conducted an Annual Environmental FOR FURTHER INFORMATION CONTACT:
Design Contest which is a unique DEPARTMENT OF HEALTH AND Carol Benson, Center for Devices and
educational experience for students HUMAN SERVICES Radiological Health (HFZ–440), Food
from throughout the world. The contest and Drug Administration, 9200
provides an opportunity for students to Food and Drug Administration Corporate Blvd., Rockville, MD 20850,
address real world environmental and 240–276–0443, ext. 144.
[Docket No. 2001D–0044]
food safety related problems, experience SUPPLEMENTARY INFORMATION:
a team developed project, publish Draft Guidance for Industry and Food I. Background
research papers, and network with and Drug Administration Staff:
experts and potential employers. The Recommendations for Clinical CLIA requires that clinical
contest is open to any 2-year, 4-year, or Laboratory Improvement Amendments laboratories obtain a certificate from the
graduate degree institution. A high of 1988 Waiver Applications; Secretary of Health and Human Services
school-level competition has been held Availability (the Secretary) before accepting
concurrently with the university contest materials derived from the human body
since 1997. Many of the tasks deal with AGENCY: Food and Drug Administration, for laboratory tests (42 U.S.C. 263(b)).
waste disposal, ground water HHS. Laboratories that perform only tests
contamination, nuclear waste treatment, ACTION: Notice. that are ‘‘simple’’ and that have an
and similar subjects; however in 2001, ‘‘insignificant risk of an erroneous
SUMMARY: The Food and Drug result’’ may obtain a certificate of
a food safety track was added and the Administration (FDA) is announcing the
contest was broadened to include waiver (42 U.S.C. 263a(c)(2)). The
availability of the draft guidance Secretary has delegated to FDA the
disciplines such as microbiology and entitled ‘‘Recommendations for Clinical
chemical contaminants in foods. The authority to determine under CLIA
Laboratory Improvement Amendments whether particular tests (waived tests)
FDA has supported this program since of 1988 (CLIA) Waiver Applications.’’
Fiscal Year 2000. This notice confirms are ‘‘simple’’ and have ‘‘an insignificant
FDA is issuing this draft guidance to risk of an erroneous result’’ (April 27,
FDA’s intent to fund for another 5-year recommend an approach for
project period. 2004, 69 FR 22849). This draft guidance
determining whether a laboratory test document describes recommendations
As of October 1, 2003, applicants are
may be performed by laboratories with for device manufacturers submitting to
required to have a Dun and Bradstreet
a certificate of waiver under CLIA. This FDA an application for determination
Number (DUNS) to apply for a grant or
draft guidance replaces the previous that a cleared or approved device meets
cooperative agreement from the Federal
draft guidance entitled ‘‘Guidance for this CLIA standard (CLIA waiver
Government. The DUNS number is a 9-
Clinical Laboratory Improvement application).
digit identification number, which
Amendments of 1988 (CLIA) Criteria for FDA previously issued a draft
uniquely identifies business entities.
Waiver,’’ March 1, 2001. guidance entitled ‘‘Clinical Laboratory
Obtaining a DUNS number is easy and
there is no charge. To obtain a DUNS DATES: Submit written or electronic Improvement Amendments of 1988
number, call 1–866–705–5711. You comments on this draft guidance by (CLIA) Criteria for Waiver’’ on March 1,
should identify yourself as a Federal December 6, 2005. Submit written 2001. This new draft guidance replaces
grant applicant when you contact Dun comments on the information collection the previous draft guidance.
and Bradstreet, Inc. provisions by November 7, 2005. The changes compared to the
ADDRESSES: Submit written requests for previous draft guidance include the
III. Application and Submission single copies on a 3.5″ diskette of the following: (1) Greater emphasis on
For further information or a copy of draft guidance document entitled scientifically-based flex studies and
the complete Request for Applications ‘‘Recommendations for Clinical validation studies, linked to the hazard
(RFA) contact Cynthia Polit, Grants Laboratory Improvement Amendments analysis for each device; (2) recognition
Management Specialist, Division of of 1988 (CLIA) for Waiver Applications’’ that reference methods may not be

VerDate Aug<18>2005 15:05 Sep 06, 2005 Jkt 205001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1