18384 Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Teachers & Support Personnel ....................................................................... 6,450 1 0.5 3,225 

Total .......................................................................................................... ........................ ........................ ........................ 3,225 

Dated: April 15, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Office of 

the Chief Science Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–9156 Filed 4–21–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–09–0571] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

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 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 or send 

comments to Maryam I. Daneshvar, CDC 

Acting Reports Clearance Officer, 1600 

Clifton Road, MS D–74, Atlanta, GA 

30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is 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. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Minimum Data Elements (MDEs) for 

the National Breast and Cervical Cancer 

Early Detection Program (NBCCEDP)— 

Extension—National Center for Chronic 

Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

Many cancer-related deaths in women 

could be avoided by increased 

utilization of appropriate screening and 

early detection tests for breast and 

cervical cancer. Mammography is 

extremely valuable as an early detection 

tool because it can detect breast cancer 

well before the woman can feel the 

lump, when the cancer is still in an 

early and more treatable stage. 

Similarly, a substantial proportion of 

cervical cancer-related deaths could be 

prevented through the detection and 

treatment of precancerous lesions. The 

Papanicolaou (Pap) test is the primary 

method of detecting both precancerous 

cervical lesions as well as invasive 

cervical cancer. Mammography and Pap 

tests are underused by women who have 

no source or no regular source of health 

care and women without health 

insurance. 

Despite the availability and increased 

use of effective screening and early 

detection tests for breast and cervical 

cancers, the American Cancer Society 

(ACS) estimated that 182,460 new cases 

of breast cancer would be diagnosed 

among women in 2008, and that 40,480 

women would die of this disease. The 

ACS also estimated that 11,070 new 

cases of invasive cervical cancer would 

be diagnosed in 2008, and that 3,870 

women would die of this disease. 

The CDC’s National Breast and 

Cervical Cancer Early Detection Program 

(NBCCEDP) provides screening services 

to underserved women through 

cooperative agreements with 50 States, 

the District of Columbia, 5 U.S. 

Territories, and 12 American Indian/ 

Alaska Native tribal programs. The 

program was established in response to 

the Breast and Cervical Cancer Mortality 

Prevention Act of 1990. Screening 

services include clinical breast 

examinations, mammograms and Pap 

tests, as well as timely and adequate 

diagnostic testing for abnormal results, 

and referrals to treatment for cancers 

detected. Awardees collect patient level 

screening and tracking data to manage 

the program and clinical services. A deidentified subset of data on patient 

demographics, screening tests and 

outcomes are reported by each awardee 

to CDC twice per year in the Minimum 

Data Elements (MDE) OMB No. 0920– 

0571, exp. 1/31/2010). Burden to 

respondents was significantly reduced 

in 2008 when the annual requirement to 

report infrastructure information 

(System for Technical Assistance 

Reporting, STAR), previously associated 

with collection of MDE information, 

was discontinued. 

CDC plans to request OMB approval 

to collect MDE information for an 

additional three years. Because 

awardees already collect and aggregate 

data at the state, territory and tribal 

level, the additional burden of 

submitting data to CDC will be small. 

CDC will use the information to monitor 

and evaluate NBCCEDP awardees; 

improve the availability and quality of 

screening and diagnostic services for 

underserved women; develop outreach 

strategies for women who are never or 

rarely screened for breast and cervical 

cancer, and report program results to 

Congress and other legislative 

authorities. There are no costs to 

respondents other than their time. 


dwashington3 on PROD1PC60 with NOTICES
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. 


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