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 

53232 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 

available for every device type (although 

devices should be traceable to methods 

of known accuracy when true reference 

methods are available); (3) additional 

emphasis on use of quality control 

procedures; (4) greater emphasis on 

intended users during studies testing 

the device; and (5) updated study 

recommendations with emphasis on use 

of patient specimens, in an intended use 

environment, over time. 

FDA bases the recommendations in 

this draft guidance on its interpretation 

of CLIA, FDA’s experience with CLIA 

complexity determinations, and the 

agency’s interactions with stakeholders. 

One of the interactions with 

stakeholders was at an open public 

workshop on August 14 and 15, 2000. 

In addition, a proposal presented by 

(Advanced Medical Technology 

Association) AdvaMed at the September 

2003 Clinical Laboratory Improvement 

Advisory Committee (CLIAC) meeting, 

and recommendations proposed by 

CLIAC during the February 2004 

meeting were considered in the 

development of this guidance. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance when finalized will 

represent the agency’s current thinking 

on recommendations for CLIA Waiver 

Applications. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

To receive ‘‘Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) Waiver Applications,’’ you may 

either send a fax request to 301–443–

8818 to receive a hard copy of the 

document, or send an e-mail request to 

gwa@cdrh.fda.gov to receive a hard copy 

or an electronic copy. Please use the 

document number (1171) to identify the 

guidance you are requesting. 

Persons interested in obtaining a copy 

of the draft guidance may also do so by 

using the Internet. CDRH maintains an 

entry on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501–

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on the following topics: (1) 

Whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 

including whether the information will 

have practical utility; (2) the accuracy of 

FDA’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Recommendations for CLIA 

Waiver Applications 

Description: Congress passed the 

CLIA (Public Law 100–578) in 1988 to 

establish quality standards for all 

laboratory testing. The purpose was to 

ensure the accuracy, reliability, and 

timeliness of patient test results 

regardless of where the test took place. 

CLIA requires that clinical laboratories 

obtain a certificate from the Secretary of 

Health and Human Services before 

accepting materials derived from the 

human body for laboratory tests (42 

U.S.C. 263a(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 

whether particular tests (waived tests) 

are ‘‘simple’’ and have ‘‘an insignificant 

risk of an erroneous result’’ under CLIA 

(69 FR 22849). This 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). 

The guidance recommends that CLIA 

waiver applications include a 

description of the features of the device 

that make it ‘‘simple’’; a report 

describing a hazard analysis that 

identifies potential sources of error, 

including a summary of the design and 

results of flex studies and conclusions 

drawn from the flex studies; a 

description of fail-safe and failure alert 

mechanisms and a description of the 

studies validating these mechanisms; a 

description of clinical tests that 

demonstrate the accuracy of the test in 

the hands of intended operators; and 

statistical analyses of clinical study 

results. The guidance also makes 

recommendations concerning labeling 

of waived tests. The burden associated 

with most of these labeling 

recommendations is approved under 

OMB control number 0910–0485. Only 

new information collections not already 

approved are included in the estimate 

below. The recommendation for quick 

reference instructions is a new 

information collection which FDA is 

submitting to OMB for review. Quick 

reference instructions are a short 

version of the instructions that are 

written in simple language and that can 

be posted. The guidance also notes that 

waived tests remain subject to 

applicable reporting and recordkeeping 

requirements under 21 CFR part 803. 

The burden associated with this 

provision is approved under OMB 

control number 0910–0437. 

Respondents to this collection of 

information are manufacturers of in 

vitro diagnostic devices. 

FDA estimates the burden of this 

collection as follows. 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 53233 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency per 

Response Total Annual Responses Hours per response Total Hours Operating and Maintenance Costs 

40 1 40 780 31,200 $5,500 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

No. of Recordkeepers Annual Frequency per 

Recordkeeping Total Annual Records Hours per Record Total Hours Operating and Maintenance Costs 

40 1 40 2,800 112,000 $60,700 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on previous years’ experience 

with CLIA waiver applications, FDA 

expects 40 manufacturers to apply for 

one CLIA waiver per year. The annual 

reporting burden to respondents is 

estimated to be 31,200 hours, and 

recordkeeping burdens for respondents 

is estimated to be 112,000 hours. FDA 

based the reporting and recordkeeping 

burden on an agency analysis of 

premarket submissions with clinical 

trials similar to the waived laboratory 

tests. 

The total operating and maintenance 

cost associated with the implementation 

of this draft guidance is estimated to be 

$66,200. The cost consists of specimen 

collection for the clinical study 

(estimated at $23,500); laboratory 

supplies, reference testing and study 

oversight (estimated $26,700); shipping 

and office supplies (estimated $6,000); 

and educational materials, including 

quick reference instructions ($10,000). 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments 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: August 31, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17732 Filed 9–1–05; 4:00 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0334] 

Draft Guidance for Industry on the 

Pediatric Research Equity Act; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘How to Comply with 

the Pediatric Research Equity Act.’’ This 

draft guidance provides 

recommendations on how to interpret 

the requirements of the Pediatric 

Research Equity Act (PREA), which 

requires pediatric studies of certain 

drugs and biological products to ensure 

that those products that are likely to be 

commonly used in children or that 

represent a meaningful therapeutic 

benefit over existing treatments contain 

adequate pediatric labeling for approved 

indications. 

DATES: Submit written or electronic 

comments on the draft guidance by 

November 7, 2005. General comments 

on agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857; or to the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835–

4709 or 301–827–1800. Submit written 

comments on the draft guidance 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. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Grace Carmouze, Center for Drug 

Evaluation and Research (HFD–

950), Food and Drug 

Administration,5600 Fishers Lane, 

Rockville, MD 20857, 301–594–

2041, or 

Leonard Wilson, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 

1401 Rockville Pike, suite 200N 

Rockville, MD 20852–1448, 301–

827–0373. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘How to Comply with the Pediatric 

Research Equity Act.’’ On December 3, 

2003, the Pediatric Research Equity Act 

was signed into law. PREA amends the 

Federal Food, Drug, and Cosmetic Act 

(the act) by adding section 505B (21 

U.S.C. 355B). In PREA, Congress 

codified many of the elements of the 

Pediatric Rule, a final rule issued by 

FDA on December 2, 1998 (63 FR 

66632), and suspended by court order 

on October 17, 2002. Association of 

American Physicians, and Surgeons, 

Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 

2002). Specifically, PREA, in adding 

section 505B(a) of the act, requires all 

applications (or supplements to an 

application) submitted under section 

505 of the act (21 U.S.C. 355) or section 

351 of the Public Health Service Act 

(PHS Act) (42 U.S.C. 262) for a new 

active ingredient, new indication, new 

dosage form, new dosing regimen, or