6206 Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of 

respondent Form name Number of respondents 

Responses 

per 

respondent 

Avg. burden 

per response 

(in hours) 

Parent ................ Social Isolation/Support ............................................................................... 178 1 2/60 

Parent ................ Strengths and Difficulties Questionnaire (SDQ) .......................................... 190 2 3/60 

Parent ................ Vanderbilt Parent Rating Scale ................................................................... 190 2 10/60 

Child .................. Brief Sensation Seeking Scale .................................................................... 190 1 1/60 

Child .................. Conflict in Adolescent Dating Relationships ................................................ 153 1 10/60 

Child .................. Health Risk Behavior Survey (Middle School) 11–13 years ....................... 37 1 15/60 

Child .................. Health Risk Behavior Survey (High School) 14+ years .............................. 153 1 25/60 

Child .................. MARSH—Self Description Questionnaire v I, 7–12 years .......................... 15 1 5/60 

Child .................. MARSH—Self Description Questionnaire v II, 13–15 years ....................... 90 1 7/60 

Child .................. MARSH—Self Description Questionnaire v III 16+ years ........................... 85 1 9/60 

Child .................. Social Inventory (High School) 14+ years ................................................... 153 1 10/60 

Child .................. Olweus Bullying Questionnaire (High School) 14+ years ........................... 153 1 7/60 

Child .................. Pediatric Quality of Life Child (8–12) ........................................................... 15 1 5/60 

Child .................. Pediatric Quality of Life Teen (13+) ............................................................. 175 1 5/60 

Child .................. Youth Demographic Survey, 16+ years ....................................................... 85 1 5/60 

Teacher ............. Teacher Survey ............................................................................................ 949 1 10/60 

Dated: February 1, 2010. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–2600 Filed 2–5–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0489] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Recommendations 

for Clinical Laboratory Improvement 

Amendments of 1988 Waiver 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by March 10, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0598. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–5156, 

Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Recommendations for Clinical 

Laboratory Improvement Amendments 

of 1988 Waiver Applications—21 CFR 

Section 493 (OMB Control Number 

0910–0598)—Extension 

Congress passed the Clinical 

Laboratory Improvements Amendment 

(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 (the 

Secretary), 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, April 27, 

2004). 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. Only new information 

collections not already approved are 

included in the estimate in the 

following table. Quick reference 

instructions are a short version of the 

instructions that are written in simple 

language and that can be posted. 

The total number of reporting and 

recordkeeping hours is 143,200 hours. 

FDA bases the burden on an agency 

analysis of premarket submissions with 

clinical trials similar to the waived 

laboratory tests. Based on previous 

years’ experience with CLIA waiver 

applications, FDA expects 40 

manufacturers to submit one CLIA 

waiver application per year. The time 

required to prepare and submit a waiver 

application, including the time needed 

to assemble supporting data, averages 

780 hours per waiver application for a 

total of 31,200 hours for reporting. 

Based on previous years experience 

with CLIA waiver applications, FDA 

expects that each manufacturer will 

spend 2,800 hours creating and 

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Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices 6207 

maintaining the record for a total of 

112,000 hours. The total operating and 

maintenance cost associated with the 

waiver application is estimated at 

$66,200. The cost consists of specimen 

collection for the clinical study 

(estimated $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 (estimated 

$10,000). This guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 801 and 21 CFR 809.10 have 

been approved under OMB control 

number 0910–0485 and the collections 

of information in 21 CFR part 803 have 

been approved under OMB control 

number 0910–0437. 

In the Federal Register of October 20, 

2009 (74 FR 53750), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

of Response 

Total Annual 

Responses 

Hours per 

Response Total Hours Operating and Maintenance Costs 

493.15(a) and (b) 40 1 40 780 31,200 $50,200 

1There are no capital costs associated with this collection of information. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours Operating and Maintenance Costs 

493.15(a) and (b) 40 1 40 2,800 112,000 $16,000 

1There are no capital costs associated with this collection of information. 

Dated: January 25, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–2598 Filed 2–5–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Lost People Finder System 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Library of Medicine (NLM), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection 

Title: Lost People Finder System; 

Type of Information Collection Request: 

Extension of currently approved 

collection [OMB No. 0925–0612, 

expiration date 07/31/2010], Form 

Number: NA; Need and Use of 

Information Collection: The National 

Library of Medicine (NLM) proposes the 

continuation of a voluntary collection of 

data to assist in the reunification of 

family members and loved ones who are 

separated during a disaster. 

Reunification is important to both the 

emotional well-being of people injured 

during a disaster and to their medical 

care. Family members often provide 

important health information to care 

providers who are treating the injured 

(e.g., providing medical history or 

information about allergies) and they 

may provide longer-term care for those 

released from emergency care. NLM 

proposes this data collection as part of 

its mission to develop and coordinate 

communication technologies to improve 

the delivery of health services. The data 

collection is authorized pursuant to 

sections 301, 307, 465 and 478A of the 

Public Health Service Act [42 U.S.C. 

241, 242l, 286 and 286d]. NLM is a 

member of the Bethesda Hospitals’ 

Emergency Preparedness Partnership 

(BHEPP), which was established in 2004 

to improve community disaster 

preparedness and response among 

hospitals in Bethesda, Maryland that 

would likely be called upon to absorb 

mass casualties in a major disaster in 

the National Capital Region. BHEPP 

hospitals include the National Naval 

Medical Center (NNMC), the National 

Institutes of Health Clinical Center (NIH 

CC), and Suburban Hospital/Johns 

Hopkins Medicine. NLM, with its 

expertise in communications, 

information management, and medical 

informatics joined BHEPP to coordinate 

the R&D program, one element of which 

is development of a lost person finder 

to assist in family reunification after a 

disaster. NLM’s Lost People Finder 

System would collect information, on a 

voluntary basis, about people who are 

missing and who are found (recovered) 

during a disaster. Information on 

recovered individuals would be 

gathered voluntarily from medical and 

relief personnel who either use a 

specialized application developed by 

NLM for the iPhone or submit 

information to NLM by e-mail via 

computer or cell phone. The iPhone 

application enables submission of 

photographs and descriptive 

information about recovered victims in 

a structured format, e.g., name (if 

available), age category, gender, general 

status (healthy, injured), location. 

Information about missing persons 

would be submitted by members of the 

public who are seeking family members, 

friends, and other loved ones. An 

interactive Web-based system offers the 

public a tool for searching for people 

who have been found (e.g., recovered by 

medical staff and other relief workers) 

and for voluntarily posting information 

about people who are still missing. In 

addition, the system would collect 

information on a regular basis from 

other publicly available systems for that 

are used for reunification during a 

disaster for information (e.g., the Google 

Person Finder system that was deployed 

during the 2010 earthquakes in Haiti). In 

addition, information submitted directly 

to NLM’s Lost People Finder System 

would be transferred to other systems 

that are endorsed by U.S. government 

agencies to ensure that users of such 

systems can search the complete set of 

available information for their family 

members and loved ones and to ensure 

that use of the NLM system in no way 

interrupts or distracts from the 

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