53230 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 

1 Gross register tonnage in cubic feet, as shown in 

Lloyd’s Register of Shipping. 

fiscal year 2006 (October 1, 2005, 

through September 30, 2006). 

FOR FURTHER INFORMATION CONTACT: 

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, 

2005. The formula used to determine 

the fees is as follows: 

Average Cost Per Inspection = Total 

Cost of VSP ÷ Weight Number of Annual 

Inspection 

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

Vessel size GRT 1

Average 

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 

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 

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 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, 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 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, 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 http://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’’

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 http:// 

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