Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices 6205 

Dated: February 3, 2010. 

Karen V. Gregory, 

Secretary. 

[FR Doc. 2010–2705 Filed 2–5–10; 8:45 am] 

BILLING CODE 6730–01–P 

FEDERAL MARITIME COMMISSION 

Sunshine Act Meetings 

TIME AND DATE: February 10, 2010—10 

a.m. 

PLACE: 800 North Capitol Street, NW., 

First Floor Hearing Room, Washington, 

DC. 

STATUS: The meeting will be in Open 

Session. 

MATTERS TO BE CONSIDERED: 

Open Session 

1. Docket No. 06–01: Worldwide 

Relocations, Inc.; et al.,—Possible 

Violations of Sections 8, 10, and 19 of 

the Shipping Act of 1984 and the 

Commission’s Regulations at 46 CFR 

515.3, 515.21, and 520.3—Request for 

Extension of Time. 

2. Docket No. 08–04: Tienshan, Inc. v. 

Tianjin Hua Feng Transport Agency Co., 

Ltd—Request for Extension of Time. 

3. FY 2010 Budget Status Update. 

4. Petition P1–08—Petition of the 

National Customs Brokers and 

Forwarders Association of America, Inc. 

for Exemption from Mandatory Rate 

Tariff Publication. 

CONTACT PERSON FOR MORE INFORMATION: 

Karen V. Gregory, Secretary, (202) 523– 

5725. 

Karen V. Gregory, 

Secretary. 

[FR Doc. 2010–2616 Filed 2–4–10; 4:15 pm] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–10–0747] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call Maryam I. Daneshvar, the 

CDC Reports Clearance Officer, at (404) 

639–5960 or send an e-mail to 

omb@cdc.gov. Send written comments 

to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Longitudinal follow-up of Youth with 

Attention-Deficit/Hyperactivity Disorder 

identified in Community Settings: 

Examining Health Status, Correlates, 

and Effects associated with treatment for 

ADHD (OMB #0920–0747, exp. 7/31/ 

2010)—Revision—National Center on 

Birth Defects and Developmental 

Disabilities (NCBDDD), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

This project will collect data from 

proxy respondents and youths with and 

without Attention-Deficit/Hyperactivity 

Disorder (ADHD). This program 

addresses the Healthy People 2010 focus 

area of Mental Health and Mental 

Disorders, and describes the prevalence, 

incidence, long-term outcomes, 

treatment(s), select co-morbid 

conditions, secondary conditions, and 

health risk behavior of youth with 

ADHD relative to youth without ADHD. 

The National Center on Birth Defects 

and Developmental Disabilities at CDC 

promotes the health of children with 

developmental disorders. As part of 

these efforts, two contracts were 

awarded in FY 2007–2010 to follow up 

a sample of children originally enrolled 

in community-based epidemiological 

research on ADHD among elementaryaged youth, known as the Project to 

Learn about ADHD in Youth (PLAY 

Study Collaborative), which informed 

community-based prevalence, rates of 

comorbidity, and rates of health risk 

behaviors among elementary-age youth 

with and without ADHD as determined 

by a rigorous case definition developed 

by the principal investigators and in 

collaboration with CDC scientists. 

The purpose of the longitudinal 

follow-up program is to study the longterm outcomes and health status for 

children with ADHD identified and 

treated in community settings through a 

systematic follow-up of the subjects 

who participated in the PLAY Study 

Collaborative. There is a considerable 

interest in the long-term outcomes of 

youth with ADHD as well as the effects 

of treatment, lack of treatment, and 

quality of care in average U.S. 

communities, emphasizing the public 

health importance of longitudinal 

research in this area. 

Given the lack of detailed information 

about longitudinal development in 

children with and without ADHD, there 

is need to continue assessing the 

children into older adolescence. This 

program extends data collection for two 

additional waves. 

Minor changes to the assessment 

instruments are planned in order to 

include age appropriate assessment of 

treatment and health risk behaviors in 

older adolescents, such as 

understanding motor vehicle operation 

and dating behavior. 

There are no costs to the respondents 

other than their time. The total annual 

burden hours are 765. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondent Form name Number of respondents 

Responses 

per 

respondent 

Avg. burden 

per response 

(in hours) 

Parent ................ ADHD Communication and Knowledge ....................................................... 190 1 10/60 

Parent ................ ADHD Treatment, Cost, and Client Satisfaction Questionnaire .................. 190 1 10/60 

Parent ................ ADHD Treatment Questionnaire .................................................................. 190 3 7/60 

Parent ................ Brief Impairment Scale ................................................................................ 190 1 4/60 

Parent ................ Critical School Events (Middle School) ....................................................... 37 2 4/60 

Parent ................ Critical School Events (High School) ........................................................... 153 2 4/60

Parent ................ Demographic Survey ................................................................................... 190 1 5/60 

Parent ................ Health Risk Behavior Survey (Middle School) 11–13 years ....................... 37 1 18/60 

Parent ................ Health Risk Behavior Survey High School, 14+ years ................................ 153 1 22/60 

Parent ................ Parent-Child Relationship Inventory ............................................................ 190 1 15/60 

Parent ................ Parents’ Mental Health Questionnaire ......................................................... 178 1 5/60 

Parent ................ Quarterly update form .................................................................................. 190 3 1/60 

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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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