18386 Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices 

The sponsors of covered studies will 

be required to maintain complete 

records of compensation agreements 

with any compensation paid to 

nonemployee clinical investigators, 

including information showing any 

financial interests held by the clinical 

investigator, for a time period of 2 years 

after the date of approval of the 

applications. This time is consistent 

with the current recordkeeping 

requirements for other information 

related to marketing applications for 

human drugs, biologics, and medical 

devices. Currently, sponsors of covered 

studies must maintain many records 

with regard to clinical investigators, 

including protocol agreements and 

investigator resumes or curriculum 

vitae. FDA estimates than an average of 

15 minutes will be required for each 

recordkeeper to add this record to 

clinical investigators’ file. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency per 

Recordkeeping 

Total Annual 

Records Hours per Record Total Hours 

54.6 1,000 1 1,000 .25 250 

Total 250 

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

Dated: April 15, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–9148 Filed 4–21–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer on (240) 276– 

1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Parent-Child 

Assistance Program (P–CAP) in the 

Fetal Alcohol Spectrum Disorder 

(FASD) Center of Excellence—New 

Since 2001, SAMHSA’s Center for 

Substance Abuse Prevention has been 

operating a Fetal Alcohol Spectrum 

Disorder (FASD) Center of Excellence 

which addresses FASD mainly by 

providing trainings and technical 

assistance; and developing and 

supporting systems of care that respond 

to FASD using effective evidence based 

practices and interventions. 

Currently the integration of evidencebased practices into service delivery 

organizations is being accomplished 

through subcontracts. One such 

intervention which integrates 

prevention strategies into service 

delivery organizations is the ParentChild Assistance Program (PCAP) 

targeting pregnant or postpartum 

women. The PCAP programs uses the 

following 12 data collection tools. 

Description of Instruments/Activity for 

Parent-Child Assistance Program (P– 

CAP) 

Instrument/activity Description 

At Baseline/Enrollment: 

CRSQ .......................................................... The Community Referral Screening Questionnaire (CRSQ) is a screening form administered to 

individuals referred to PCAP. The purpose of the form is to determine eligibility for enrollment in PCAP. 

ASI—Part A ................................................. The Alcohol Severity Index (ASI) Part A is an intake interview administered at client enrollment. The ASI Part A includes questions about past 30 day alcohol use, lifetime use, age at 

first use, month and year of last use, range of use (T–ACE), and use during pregnancy, 

thereby providing a thorough assessment of alcohol consumption. 

ASI—Part B & Twin ..................................... The Alcohol Severity Index (ASI) Part B is an intake interview administered as soon as possible after the target child birth. The ASI Part B includes questions about the target child at 

birth and alcohol use during the pregnancy. If the target birth is of twins then the Twins Addendum form is administered. 

Demographic Data ....................................... The Demographic Questionnaire is administered after client enrollment. The questionnaire includes race, educational attainment, martial status, and an alcohol assessment. 

Process Monitoring: 

Weekly Advocate Time Summary ............... The PCAP Weekly Advocate Time Summary Sheet is administered on a weekly basis. The 

form tracks time spent on the phone, in person, or providing transportation to each client. 

Monthly Updates .......................................... The Monthly Update form is administered on a monthly basis. The form records any changes 

in drug and alcohol use, pregnancy, child custody, and sources of income. 


dwashington3 on PROD1PC60 with NOTICES
Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices 18387 

Instrument/activity Description 

Biannual Documentation of Progress (every 

6 months).

The Biannual Documentation of Progress is administered every six months. The form documents changes in alcohol/drug treatment, abstinence from alcohol/drugs, birth control and 

pregnancy, connection to other services, and family stability and client activity. 

At Exit: 

Exit ASI ........................................................ The Exit ASI Follow-Up is administered at the end of the program, at 36 months. The Exit ASI 

uses a format that is identical to the Addiction Severity Index administered at intake, providing pre- and post-test data for the intervention. 

Client Exit Close Out form ........................... The Client Exit Close-Out Form documents the total number of months the client spent in 

PCAP, number of different advocates who worked with the client, and whether the client 

ever moved out of the area while enrolled in PCAP. 

Ad hoc: 

Advocate Accounting of Tracing Activity on 

Missing Post-Exit Client.

The Advocate Accounting of Tracing Activity on Missing Post-Exit Client is used to track activity to locate a missing client. When a client is missing, the form is to be completed each 

month, instead of the Monthly Update form, until the missing post-exit client is brought in for 

an Exit Interview. 

Lost Post-Exit Client Form .......................... The Lost Post-Exit Client Form is used when the client is at least six months past her three 

year exit date in the program and has not completed the ASI exit interview. The form documents the reason the client has not completed the ASI exit interview. 

Two PCAP subcontracts were 

awarded in February 2008. PCAP uses 

an intensive paraprofessional home 

visitation model to reduce risk 

behaviors in pregnant women with 

substance abuse problems. The primary 

goal of PCAP is to prevent future births 

of alcohol and drug exposed children to 

women who are at risk. The program 

uses a holistic case management 

approach, which is a complement to 

traditional substance abuse treatment. In 

addition to addressing alcohol and drug 

use, the program also aims at reducing 

other risk behaviors and addressing the 

health and social well being of mothers 

and their children. 

At the initial client visit, the women 

receive a comprehensive assessment 

which includes an assessment for 

alcohol consumption, contraception 

use, and use of community services. Atrisk women receive case management 

and every 4 months women are reevaluated to determine their clinical 

goals. Counselors complete 

‘‘Documentation of Client Progress’’ 

form every 6 months and a final 

‘‘Documentation of Client Progress’’ at 

36 months. In addition, the counselors 

complete a weekly advocate time sheet, 

summarizing their activities within the 

program. All forms are completed 

online using the Web-portal. All 

participating subcontractors will 

maintain identifiable information on 

clients for service delivery purposes but 

no identifiable information will be 

transmitted to SAMHSA. 

The data collection is designed to 

evaluate the implementation of PCAP by 

measuring whether abstinence from 

alcohol is achieved and risk for alcoholexposed births is eliminated. 

ESTIMATED ANNUALIZED BURDEN HOURS

Instrument/activity 

Number of 

respondents 

2 sites 

Number of 

responses per 

respondent 

Average burden 

per response 

Total burden 

hours per 

collection 

At Baseline/Enrollment: 

CRSQ ....................................................................................... 190 1 0.08 15 

ASI—Part A .............................................................................. 190 1 2.75 523 

ASI—Part B & Twin .................................................................. 190 1 0.25 47.5 

Demographic Data .................................................................... 190 1 0.08 15 

Process Monitoring: 

Weekly Advocate Time Summary ............................................ 190 52 0.50 4,940 

Monthly Updates ....................................................................... 190 12 0.50 1,140 

Biannual Documentation of Progress (every 6 months) .......... 161 2 0.33 106 

At Exit: 

Exit ASI ..................................................................................... 190 1 2.25 428 

Client Exit Close Out form ........................................................ 161 1 0.25 40 

Ad hoc: 

Advocate Accounting of Tracing Activity on Missing Post-Exit 

Client ..................................................................................... 29 1 0.25 7 

Lost Post-Exit Client Form ........................................................ 29 1 0.25 7 

Total ................................................................................... 1,710 74 ............................ 7,269 


dwashington3 on PROD1PC60 with NOTICES
18388 Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail her a 

copy at summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: April 13, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–9193 Filed 4–21–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer on (240) 276– 

1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Mandatory 

Guidelines for Federal Workplace Drug 

Testing Programs (OMB No. 0930– 

0158)—Extension 

SAMHSA’s Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs will request OMB approval for 

the Federal Drug Testing Custody and 

Control Form for Federal agency and 

federally regulated drug testing 

programs which must comply with the 

HHS Mandatory Guidelines for Federal 

Workplace Drug Testing Programs (69 

FR 19644) dated April 13, 2004, and for 

the information provided by laboratories 

for the National Laboratory Certification 

Program (NLCP). 

The Federal Drug Testing Custody 

and Control Form is used by all Federal 

agencies and employers regulated by the 

Department of Transportation to 

document the collection and chain of 

custody of urine specimens at the 

collection site, for laboratories to report 

results, and for Medical Review Officers 

to make a determination. The Federal 

Drug Testing Custody and Control Form 

approved by OMB three years ago is 

being resubmitted for OMB approval 

without any revision. 

Prior to an inspection, a laboratory is 

required to submit specific information 

regarding its laboratory procedures. 

Collecting this information prior to an 

inspection allows the inspectors to 

thoroughly review and understand the 

laboratory’s testing procedures before 

arriving at the laboratory. 

The NLCP application form has not 

been revised compared to the previous 

form. 

The annual total burden estimates for 

the Federal Drug Testing Custody and 

Control Form, the NLCP application, the 

NLCP inspection checklist, and NLCP 

recordkeeping requirements are shown 

in the following table. 

Form/respondent 

Burden/ 

response 

(hrs.) 

Number of 

responses 

Total annual 

burden 

(hrs.) 

Custody and Control Form: 

Donor .................................................................................................................................... .08 7,096,000 567,680 

Collector ................................................................................................................................ .07 7,096,000 496,720 

Laboratory ............................................................................................................................. .05 7,096,000 354,800 

Medical Review Officer ......................................................................................................... .05 7,096,000 354,800 

Laboratory Application ................................................................................................................. 3.00 3 9 

Laboratory Inspection Checklist .................................................................................................. 3.00 100 300 

Laboratory Recordkeeping .......................................................................................................... 250.00 50 12,500 

Total ...................................................................................................................................... ........................ ........................ 1,786,809 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail her a 

copy at summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: April 13, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–9187 Filed 4–21–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel, Nutrition and 

Aging of Brain. 

Date: June 9, 2009. 

Time: 11 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

National Institutes of Health, Gateway 

Building, Room 2C/212, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Alexander Parsadanian, 

PhD, Scientific Review Officer, National 


dwashington3 on PROD1PC60 with NOTICES