Published 60-Day Federal Register Notice

ATTACHMENT 2
Federal Register Notice

18384

Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–09–0571]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

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Number of
responses per
respondent

Number of
respondents

Respondents

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
[email protected].
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

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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

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(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.

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18385

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

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.

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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.

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.

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
[email protected]. All
SUMMARY:

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
No. of
Respondents

21 CFR Section
54.4(a)(1) and (a)(2)—Form FDA
3454

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Total Annual
Responses

Hours per
Response

1

1,000

5

5,000

100

1

100

20

2,000

46,000

.25

11,500

1

11,500

Total
1There

Total Hours

1,000

54.4(a)(3)—Form FDA 3455
54.4(b)

Annual Frequency per
Response

18,500
are no capital costs or operating and maintenance costs associated with this collection of information.

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