Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices 18385 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Number of 

respondents * 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

NBCCEDP Grantees ....................................................................................... 68 2 4 544 

Dated: April 15, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–9155 Filed 4–21–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0637] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Financial 

Disclosure by Clinical Investigators 

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 May 22, 

2009. 

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: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0396. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

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. 

Financial Disclosure by Clinical 

Investigators—(OMB Control Number 

0910–0396)—Extension 

Respondents are sponsors of 

marketing applications that contain 

clinical data from studies covered by the 

regulations. These sponsors represent 

pharmaceutical, biologic, and medical 

device firms. The applicant will incur 

reporting costs in order to comply with 

the final rule. Applicants will be 

required to submit, for example, the 

complete list of clinical investigators for 

each covered study, not employed by 

the applicant and/or sponsor of the 

covered study, and either certify to the 

absence of certain financial 

arrangements with clinical investigators 

or disclose the nature of those 

arrangements to FDA and the steps 

taken by the applicant or sponsor to 

minimize the potential for bias. The 

clinical investigator will have to supply 

information regarding financial interests 

or payments held in the sponsor of the 

covered study. 

In the Federal Register of December 

29, 2008 (73 FR 79493), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. Two comments were 

received, one comment expressed 

support for this information collection. 

The second comment raised several 

issues, first, the issue of the current cost 

the commenter incurs in the collection 

of Financial Disclosure and the estimate 

of substantial operating costs the 

commenter incurs in operating costs to 

support the collection of investigator 

financial information. FDA appreciates 

the comment and based on this new 

data, submitted by the commenter, will 

undertake a new evaluation whether 

there are capital costs or operating and 

maintenance costs associated with this 

collection of information. FDA also 

appreciates the comment concerning the 

definition of ‘‘clinical investigator’’ and 

will forward the comment to the FDA 

office responsible for this collection of 

information to consider in any future 

rulemaking. However, these definitions 

are codified in 21 CFR 54.2. 

FDA also appreciates the comment 

regarding the use of Form FDA 1572 to 

minimize burden. However, 21 CFR 

54.4 requires the use of Form FDA 3454 

and Form FDA 3455. This comment will 

also be forwarded to the FDA office 

responsible for this collection of 

information to consider in any future 

rulemaking. 

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 per 

Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

54.4(a)(1) and (a)(2)—Form FDA 

3454 1,000 1 1,000 5 5,000 

54.4(a)(3)—Form FDA 3455 100 1 100 20 2,000 

54.4(b) 46,000 .25 11,500 1 11,500 

Total 18,500 

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


dwashington3 on PROD1PC60 with NOTICES
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. 


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