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Federal Register / Vol. 70, No.

47 / Friday, March 11, 2005 / Notices 12219

proposed paperwork collections prevention strategies. It has been known any impact on health behaviors, and use
referenced above, access the HHS Web for years that people who have close of medical services. In 2003, CDC
site address at http://www.hhs.gov/ relatives with certain diseases (such as awarded funding to three research
oirm/infocollect/pending/ or e-mail your heart disease, diabetes, and cancers), are centers to collaborate on a study set in
request, including your address, phone more likely to develop those diseases primary care clinics to assess the
number, OMB number, and OS themselves. Geneticists have long clinical utility of the family history tool.
document identifier, to recognized the value of family history Eligibility for the study will be
naomi.cook@hhs.gov , or call the for discovering inherited disorders, determined by a brief screening test
Reports Clearance Office on (202) 690– usually the result of single gene completed by patients from the primary
6162. Written comments and mutations. Although single gene care clinic. It is anticipated that only a
recommendations for the proposed disorders are typically associated with a small number will be ineligible to
information collections must be mailed large magnitude of risk, they account for continue since the majority of patients
within 30 days of this notice directly to a small proportion of individuals with will be pre-screened for eligibility based
the Desk Officer at the address below: a genetic risk for common, chronic on a medical record review prior to the
OMB Desk Officer: John Kraemer, OMB diseases. Most of the genetic screening test.
Human Resources and Housing Branch, susceptibility to these disorders is the The primary care clinics affiliated
Attention: (OMB #0990–NEW), New result of multiple genes interacting with with the three research centers will be
Executive Office Building, Room 10235, multiple environmental factors. Family randomized into two groups. Patients
Washington, DC 20503. history is more than genetics; it reflects participating in the study will all
Dated: March 4, 2005. the consequences of inherited genetic complete the pre-test, post-test and
susceptibilities, shared environment, family history tool, however, the order
Robert E. Polson,
shared cultures and common behaviors. in which they do so is dependent upon
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer. All of these factors are important when the group to which they are
estimating disease risk. In early 2002, randomized. In the intervention group,
[FR Doc. 05–4778 Filed 3–10–05; 8:45 am]
the CDC Office of Genomics and Disease patients attending the primary care
BILLING CODE 4168–17–P
Prevention (OGDP) in collaboration clinics will be asked to complete the
with several CDC programs and NIH family history tool and a pre-test that
institutes began an initiative to develop includes an assessment of risk factors,
DEPARTMENT OF HEALTH AND
a family history tool for identifying preventive behaviors, use of medical
HUMAN SERVICES
apparently healthy people who may be services, and perception of risk. The
Centers for Disease Control and at increased risk for a number of patients will be provided with an
Prevention common diseases. The major activities assessment of their familial risk
of this initiative have included: (1) (average, above average, much above
[30Day–05–0424X] Reviews of the literature for average) for each of the six diseases and
approximately 25 diseases; (2) information about preventive measures
Proposed Data Collections Submitted
assessments of family history tools (e.g., diet, exercise, screening tests) that
for Public Comment and
currently in use or under development; is tailored to their level of familial risk
Recommendations
(3) a meeting of experts to provide input for each of the six diseases. After 6
The Centers for Disease Control and into the process; (4) development of months, the patients will be asked to
Prevention (CDC) publishes a list of criteria for determining which diseases complete a post-test that assesses their
information collection requests under to include in the tool; (5) development risk factors, use of medical services,
review by the Office of Management and of a framework for evaluating a family interest in modifying health behaviors,
Budget (OMB) in compliance with the history tool and the development of a and changes in risk perception. In the
Paperwork Reduction Act (44 U.S.C. tool. control group, patients will initially
Chapter 35). To request a copy of these As a result of this initiative, a complete the pre-test only (not the
requests, call the CDC Reports Clearance personal computer-based familial risk family history tool) and will be given
Officer at (404) 371–5976 or send an e- assessment tool was developed to be standard public health messages about
mail to omb@cdc.gov. Send written used as a public health strategy to preventing the six diseases of interest
comments to CDC Desk Officer, Human improve health and prevent disease. (messages will not be tailored to risk
Resources and Housing Branch by fax to The assessment tool is called, ‘‘Family level). After 6 months, the patients in
(202) 395–6974. Written comments Healthware.’’ This tool will be used to the control group will also complete the
should be received within 30 days of collect information about the disease post-test and the family history tool.
this notice. history of a person’s first- and second- Physicians will complete a post-visit
degree relatives (mother, father, assessment if they have a visit with a
Proposed Project children, siblings, grandparents, aunts, participating patient during the course
Evaluating Tools for Health and uncles), use family history of the study.
Promotion and Disease Prevention— information to assess risk for common The purpose of having patients in the
New—Office of Genomics and Disease diseases of adulthood, and influence control group complete the family
Prevention (OGDP), Centers for Disease early detection and prevention history tool post intervention is so that
Control and Prevention (CDC). strategies. The current version of the the analysis can be stratified by familial
tool focuses on six diseases—heart risk level in both patient groups. The
Background disease, stroke, diabetes, and colorectal, hypothesis to be tested in this study is
Although family history is a risk breast, and ovarian cancers. that patients who are provided with
factor for most chronic diseases of The proposed project is a study to personalized prevention messages based
public health significance, it is evaluate the clinical utility of the on an assessment of their family history
underutilized in the practice of ‘‘Family Healthware’’ tool by of disease will be more motivated to
preventive medicine and public health determining whether family history risk make behavior changes and use
for assessing disease risk and assessment, stratification, and preventive health services. There is no
influencing early detection and personalized prevention messages have cost to respondents participating in this

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12220 Federal Register / Vol. 70, No. 47 / Friday, March 11, 2005 / Notices

study other than their time. The estimated annualized burden is 5,922
hours.

ANNUALIZED BURDEN TABLE


Average time
Number of Frequency of
Type of respondents Type of response per response
respondents response (in hrs)

Patients ........................................................... 4180 Screening ....................................................... 1 2/60


Questionnaire (pre-test and post-test) ........... 2 30/60
Family HealthwareTM Tool ............................. 1 20/60
Physicians ....................................................... 140 Post Visit Assessment ................................... 30 3/60

Dated: March 7, 2005. other committee management activities, for recommendations, and report back to the
Betsey Dunaway, both CDC and the Agency for Toxic Board. The OS will establish agency policy
Substances and Disease Registry. for program peer review and directly support
Acting Reports Clearance Officer, Centers for
each working group by collating program
Disease Control and Prevention. Dated: March 4, 2005.
documents, and organizing the working
[FR Doc. 05–4803 Filed 3–10–05; 8:45 am] Alvin Hall, groups review and site visit. Each NCEH/
BILLING CODE 4163–18–P Director, Management Analysis and Services ATSDR program eligible for review will be
Office, Centers for Disease Control and reviewed every 5 years according to CDC/
Prevention (CDC). ATSDR policy.
DEPARTMENT OF HEALTH AND [FR Doc. 05–4808 Filed 3–10–05; 8:45 am] Matters To Be Discussed: The
HUMAN SERVICES teleconference agenda will include a review
BILLING CODE 4163–19–P
of action items from the previous meeting,
Centers for Disease Control and discussion and updates on the program peer
Prevention review process, and the draft outline of a
DEPARTMENT OF HEALTH AND generic self-assessment process.
HUMAN SERVICES Agenda items are tentative and subject to
Disease, Disability, and Injury
change as priorities changes.
Prevention and Control; Special Centers for Disease Control and Supplementary Information: This
Emphasis Panel: Grants for Education Prevention conference call is scheduled to begin at 12:30
Programs in Occupational Safety and p.m. Eastern Standard Time. To participate
Health, Request for Applications (RFA) National Center for Environmental in the teleconference, please dial (877) 315–
OH–05–001 Health/Agency for Toxic Substances 6535 and enter conference code 383520.
and Disease Registry For Further Information Contact: Drue
In accordance with section 10(a)(2) of Barrett, Ph.D., Executive Secretary, PRRS,
the Federal Advisory Committee Act The Program Peer Review NCEH/ATSDR, M/S E–28, 1600 Clifton Road,
(Pub. L. 92–463), the Centers for Disease Subcommittee of the Board of Scientific NE., Atlanta, Georgia 30333, telephone 404
Control and Prevention (CDC) Counselors (BSC), National Center for 498–0003.
announces the following meeting: Environmental Health (NCEH)/Agency The Director, Management Analysis and
for Toxic Substances and Disease Services Office, has been delegated the
Name: Disease, Disability, and Injury authority to sign Federal Register notices
Prevention and Control Special Emphasis Registry (ATSDR): Teleconference
pertaining to announcements of meetings and
Panel (SEP): Grants for Education Programs In accordance with section 10(a)(2) of other committee management activities for
in Occupational Safety and Health, Request the Federal Advisory Committee Act both CDC and ATSDR.
for Applications (RFA) OH–05–001. (Pub. L. 92–463), NCEH/ATSDR
Times and Dates: 8 a.m.–6 p.m., March 28, Dated: March 4, 2005.
announces the following subcommittee
2005 (Closed). Alvin Hall,
Place: Embassy Suites Hotels, 1900
meeting:
Director, Management Analysis and Services
Diagonal Road, Alexandria, VA 23114, Name: Program Peer Review Subcommittee Office, Centers for Disease Control and
telephone 703.684.5900. (PPRS). Prevention.
Status: The meeting will be closed to the Time and Date: 12:30 p.m.–2 p.m., April 4,
public in accordance with provisions set 2005. [FR Doc. 05–4806 Filed 3–10–05; 8:45 am]
forth in section 552b(c)(4) and (6), Title 5 Place: The teleconference will originate at BILLING CODE 4163–70–P
U.S.C., and the Determination of the Director, the National Center for Environmental
Management Analysis and Services Office, Health/Agency for Toxic Substances and
CDC, pursuant to Public Law 92–463. Disease Registry in Atlanta, Georgia. Please DEPARTMENT OF HEALTH AND
Matters to be Discussed: The meeting will see Supplementary Information for details HUMAN SERVICES
include the review, discussion, and on accessing the teleconference.
evaluation of applications received in Status: Open to the public, teleconference Centers for Medicare & Medicaid
response to Request for Applications OH–05– access limited only by availability of Services
001. telephone ports.
For Further Information Contact: S. Price Purpose: Under the charge of the Board of [Document Identifier: CMS–R–211, CMS–R–
Connor, Ph.D., Scientific Review Scientific counselors (BSC), NCEH/ATSDR, 306, CMS–R–185, and CMS–R–238]
Administrator, Office of Extramural the Program Peer Review Subcommittee
Programs, National Institute for Occupational establishes and monitors working groups of Agency Information Collection
Safety and Health, CDC, 1600 Clifton Road, technical experts that perform program peer Activities: Submission for OMB
NE, MS–E74, Atlanta, GA 30333, Telephone reviews of NCEH and ATSDR. The Review; Comment Request
404–498–2530. Subcommittee, working with the NCEH/
The Director, Management Analysis and ATSDR, Office of Sciences (OS), will AGENCY: Centers for Medicare &
Services Office has been delegated the establish the schedule and process for Medicaid Services, HHS.
authority to sign Federal Register notices program peer reviews, nominate working In compliance with the requirement
pertaining to announcements of meetings and group members, review summary reports and of section 3506(c)(2)(A) of the

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