Proposed Data Collections Submitted for Public Comment and Recommendations, 12219-12220 [05-4803]

Download as PDF Federal Register / Vol. 70, No. 47 / Friday, March 11, 2005 / Notices proposed paperwork collections referenced above, access the HHS Web site address at http://www.hhs.gov/ oirm/infocollect/pending/ or e-mail your request, including your address, phone number, OMB number, and OS document identifier, to naomi.cook@hhs.gov , or call the Reports Clearance Office on (202) 690– 6162. Written comments and recommendations for the proposed information collections must be mailed within 30 days of this notice directly to the Desk Officer at the address below: OMB Desk Officer: John Kraemer, OMB Human Resources and Housing Branch, Attention: (OMB #0990–NEW), New Executive Office Building, Room 10235, Washington, DC 20503. Dated: March 4, 2005. Robert E. Polson, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. 05–4778 Filed 3–10–05; 8:45 am] BILLING CODE 4168–17–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–05–0424X] Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 371–5976 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Human Resources and Housing Branch by fax to (202) 395–6974. Written comments should be received within 30 days of this notice. Proposed Project Evaluating Tools for Health Promotion and Disease Prevention— New—Office of Genomics and Disease Prevention (OGDP), Centers for Disease Control and Prevention (CDC). Background Although family history is a risk factor for most chronic diseases of public health significance, it is underutilized in the practice of preventive medicine and public health for assessing disease risk and influencing early detection and VerDate jul<14>2003 16:40 Mar 10, 2005 Jkt 205001 prevention strategies. It has been known for years that people who have close relatives with certain diseases (such as heart disease, diabetes, and cancers), are more likely to develop those diseases themselves. Geneticists have long recognized the value of family history for discovering inherited disorders, usually the result of single gene mutations. Although single gene disorders are typically associated with a large magnitude of risk, they account for a small proportion of individuals with a genetic risk for common, chronic diseases. Most of the genetic susceptibility to these disorders is the result of multiple genes interacting with multiple environmental factors. Family history is more than genetics; it reflects the consequences of inherited genetic susceptibilities, shared environment, shared cultures and common behaviors. All of these factors are important when estimating disease risk. In early 2002, the CDC Office of Genomics and Disease Prevention (OGDP) in collaboration with several CDC programs and NIH institutes began an initiative to develop a family history tool for identifying apparently healthy people who may be at increased risk for a number of common diseases. The major activities of this initiative have included: (1) Reviews of the literature for approximately 25 diseases; (2) assessments of family history tools currently in use or under development; (3) a meeting of experts to provide input into the process; (4) development of criteria for determining which diseases to include in the tool; (5) development of a framework for evaluating a family history tool and the development of a tool. As a result of this initiative, a personal computer-based familial risk assessment tool was developed to be used as a public health strategy to improve health and prevent disease. The assessment tool is called, ‘‘Family Healthware.’’ This tool will be used to collect information about the disease history of a person’s first- and seconddegree relatives (mother, father, children, siblings, grandparents, aunts, and uncles), use family history information to assess risk for common diseases of adulthood, and influence early detection and prevention strategies. The current version of the tool focuses on six diseases—heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancers. The proposed project is a study to evaluate the clinical utility of the ‘‘Family Healthware’’ tool by determining whether family history risk assessment, stratification, and personalized prevention messages have PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 12219 any impact on health behaviors, and use of medical services. In 2003, CDC awarded funding to three research centers to collaborate on a study set in primary care clinics to assess the clinical utility of the family history tool. Eligibility for the study will be determined by a brief screening test completed by patients from the primary care clinic. It is anticipated that only a small number will be ineligible to continue since the majority of patients will be pre-screened for eligibility based on a medical record review prior to the screening test. The primary care clinics affiliated with the three research centers will be randomized into two groups. Patients participating in the study will all complete the pre-test, post-test and family history tool, however, the order in which they do so is dependent upon the group to which they are randomized. In the intervention group, patients attending the primary care clinics will be asked to complete the family history tool and a pre-test that includes an assessment of risk factors, preventive behaviors, use of medical services, and perception of risk. The patients will be provided with an assessment of their familial risk (average, above average, much above average) for each of the six diseases and information about preventive measures (e.g., diet, exercise, screening tests) that is tailored to their level of familial risk for each of the six diseases. After 6 months, the patients will be asked to complete a post-test that assesses their risk factors, use of medical services, interest in modifying health behaviors, and changes in risk perception. In the control group, patients will initially complete the pre-test only (not the family history tool) and will be given standard public health messages about preventing the six diseases of interest (messages will not be tailored to risk level). After 6 months, the patients in the control group will also complete the post-test and the family history tool. Physicians will complete a post-visit assessment if they have a visit with a participating patient during the course of the study. The purpose of having patients in the control group complete the family history tool post intervention is so that the analysis can be stratified by familial risk level in both patient groups. The hypothesis to be tested in this study is that patients who are provided with personalized prevention messages based on an assessment of their family history of disease will be more motivated to make behavior changes and use preventive health services. There is no cost to respondents participating in this E:\FR\FM\11MRN1.SGM 11MRN1 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 Number of respondents Type of respondents Patients ........................................................... 4180 Physicians ....................................................... 140 Dated: March 7, 2005. Betsey Dunaway, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 05–4803 Filed 3–10–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Disease, Disability, and Injury Prevention and Control; Special Emphasis Panel: Grants for Education Programs in Occupational Safety and Health, Request for Applications (RFA) OH–05–001 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting: Name: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Grants for Education Programs in Occupational Safety and Health, Request for Applications (RFA) OH–05–001. Times and Dates: 8 a.m.–6 p.m., March 28, 2005 (Closed). Place: Embassy Suites Hotels, 1900 Diagonal Road, Alexandria, VA 23114, telephone 703.684.5900. Status: The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters to be Discussed: The meeting will include the review, discussion, and evaluation of applications received in response to Request for Applications OH–05– 001. For Further Information Contact: S. Price Connor, Ph.D., Scientific Review Administrator, Office of Extramural Programs, National Institute for Occupational Safety and Health, CDC, 1600 Clifton Road, NE, MS–E74, Atlanta, GA 30333, Telephone 404–498–2530. The Director, Management Analysis and Services Office has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and VerDate jul<14>2003 16:40 Mar 10, 2005 Jkt 205001 Screening ....................................................... Questionnaire (pre-test and post-test) ........... Family HealthwareTM Tool ............................. Post Visit Assessment ................................... other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: March 4, 2005. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention (CDC). [FR Doc. 05–4808 Filed 3–10–05; 8:45 am] BILLING CODE 4163–19–P Centers for Disease Control and Prevention DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Environmental Health/Agency for Toxic Substances and Disease Registry The Program Peer Review Subcommittee of the Board of Scientific Counselors (BSC), National Center for Environmental Health (NCEH)/Agency for Toxic Substances and Disease Registry (ATSDR): Teleconference In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), NCEH/ATSDR announces the following subcommittee meeting: Name: Program Peer Review Subcommittee (PPRS). Time and Date: 12:30 p.m.–2 p.m., April 4, 2005. Place: The teleconference will originate at the National Center for Environmental Health/Agency for Toxic Substances and Disease Registry in Atlanta, Georgia. Please see Supplementary Information for details on accessing the teleconference. Status: Open to the public, teleconference access limited only by availability of telephone ports. Purpose: Under the charge of the Board of Scientific counselors (BSC), NCEH/ATSDR, the Program Peer Review Subcommittee establishes and monitors working groups of technical experts that perform program peer reviews of NCEH and ATSDR. The Subcommittee, working with the NCEH/ ATSDR, Office of Sciences (OS), will establish the schedule and process for program peer reviews, nominate working group members, review summary reports and PO 00000 Frm 00050 Frequency of response Type of response Fmt 4703 Sfmt 4703 Average time per response (in hrs) 1 2 1 30 2/60 30/60 20/60 3/60 recommendations, and report back to the Board. The OS will establish agency policy for program peer review and directly support each working group by collating program documents, and organizing the working groups review and site visit. Each NCEH/ ATSDR program eligible for review will be reviewed every 5 years according to CDC/ ATSDR policy. Matters To Be Discussed: The teleconference agenda will include a review of action items from the previous meeting, discussion and updates on the program peer review process, and the draft outline of a generic self-assessment process. Agenda items are tentative and subject to change as priorities changes. Supplementary Information: This conference call is scheduled to begin at 12:30 p.m. Eastern Standard Time. To participate in the teleconference, please dial (877) 315– 6535 and enter conference code 383520. For Further Information Contact: Drue Barrett, Ph.D., Executive Secretary, PRRS, NCEH/ATSDR, M/S E–28, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone 404 498–0003. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and ATSDR. Dated: March 4, 2005. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 05–4806 Filed 3–10–05; 8:45 am] BILLING CODE 4163–70–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–R–211, CMS–R– 306, CMS–R–185, and CMS–R–238] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the AGENCY: E:\FR\FM\11MRN1.SGM 11MRN1

Agencies

[Federal Register Volume 70, Number 47 (Friday, March 11, 2005)]
[Notices]
[Pages 12219-12220]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4803]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-05-0424X]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 371-5976 or send an e-mail 
to omb@cdc.gov. Send written comments to CDC Desk Officer, Human 
Resources and Housing Branch by fax to (202) 395-6974. Written comments 
should be received within 30 days of this notice.

Proposed Project

    Evaluating Tools for Health Promotion and Disease Prevention--New--
Office of Genomics and Disease Prevention (OGDP), Centers for Disease 
Control and Prevention (CDC).

Background

    Although family history is a risk factor for most chronic diseases 
of public health significance, it is underutilized in the practice of 
preventive medicine and public health for assessing disease risk and 
influencing early detection and prevention strategies. It has been 
known for years that people who have close relatives with certain 
diseases (such as heart disease, diabetes, and cancers), are more 
likely to develop those diseases themselves. Geneticists have long 
recognized the value of family history for discovering inherited 
disorders, usually the result of single gene mutations. Although single 
gene disorders are typically associated with a large magnitude of risk, 
they account for a small proportion of individuals with a genetic risk 
for common, chronic diseases. Most of the genetic susceptibility to 
these disorders is the result of multiple genes interacting with 
multiple environmental factors. Family history is more than genetics; 
it reflects the consequences of inherited genetic susceptibilities, 
shared environment, shared cultures and common behaviors. All of these 
factors are important when estimating disease risk. In early 2002, the 
CDC Office of Genomics and Disease Prevention (OGDP) in collaboration 
with several CDC programs and NIH institutes began an initiative to 
develop a family history tool for identifying apparently healthy people 
who may be at increased risk for a number of common diseases. The major 
activities of this initiative have included: (1) Reviews of the 
literature for approximately 25 diseases; (2) assessments of family 
history tools currently in use or under development; (3) a meeting of 
experts to provide input into the process; (4) development of criteria 
for determining which diseases to include in the tool; (5) development 
of a framework for evaluating a family history tool and the development 
of a tool.
    As a result of this initiative, a personal computer-based familial 
risk assessment tool was developed to be used as a public health 
strategy to improve health and prevent disease. The assessment tool is 
called, ``Family Healthware.'' This tool will be used to collect 
information about the disease history of a person's first- and second-
degree relatives (mother, father, children, siblings, grandparents, 
aunts, and uncles), use family history information to assess risk for 
common diseases of adulthood, and influence early detection and 
prevention strategies. The current version of the tool focuses on six 
diseases--heart disease, stroke, diabetes, and colorectal, breast, and 
ovarian cancers.
    The proposed project is a study to evaluate the clinical utility of 
the ``Family Healthware'' tool by determining whether family history 
risk assessment, stratification, and personalized prevention messages 
have any impact on health behaviors, and use of medical services. In 
2003, CDC awarded funding to three research centers to collaborate on a 
study set in primary care clinics to assess the clinical utility of the 
family history tool. Eligibility for the study will be determined by a 
brief screening test completed by patients from the primary care 
clinic. It is anticipated that only a small number will be ineligible 
to continue since the majority of patients will be pre-screened for 
eligibility based on a medical record review prior to the screening 
test.
    The primary care clinics affiliated with the three research centers 
will be randomized into two groups. Patients participating in the study 
will all complete the pre-test, post-test and family history tool, 
however, the order in which they do so is dependent upon the group to 
which they are randomized. In the intervention group, patients 
attending the primary care clinics will be asked to complete the family 
history tool and a pre-test that includes an assessment of risk 
factors, preventive behaviors, use of medical services, and perception 
of risk. The patients will be provided with an assessment of their 
familial risk (average, above average, much above average) for each of 
the six diseases and information about preventive measures (e.g., diet, 
exercise, screening tests) that is tailored to their level of familial 
risk for each of the six diseases. After 6 months, the patients will be 
asked to complete a post-test that assesses their risk factors, use of 
medical services, interest in modifying health behaviors, and changes 
in risk perception. In the control group, patients will initially 
complete the pre-test only (not the family history tool) and will be 
given standard public health messages about preventing the six diseases 
of interest (messages will not be tailored to risk level). After 6 
months, the patients in the control group will also complete the post-
test and the family history tool. Physicians will complete a post-visit 
assessment if they have a visit with a participating patient during the 
course of the study.
    The purpose of having patients in the control group complete the 
family history tool post intervention is so that the analysis can be 
stratified by familial risk level in both patient groups. The 
hypothesis to be tested in this study is that patients who are provided 
with personalized prevention messages based on an assessment of their 
family history of disease will be more motivated to make behavior 
changes and use preventive health services. There is no cost to 
respondents participating in this

[[Page 12220]]

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

                                             Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
                                                                                                   Average time
          Type of respondents              Number of        Type of response       Frequency of    per response
                                          respondents                                response        (in hrs)
----------------------------------------------------------------------------------------------------------------
Patients..............................            4180  Screening...............               1            2/60
                                        ..............  Questionnaire (pre-test                2           30/60
                                                         and post-test).
                                        ..............  Family HealthwareTM Tool               1           20/60
Physicians............................             140  Post Visit Assessment...              30            3/60
----------------------------------------------------------------------------------------------------------------


    Dated: March 7, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 05-4803 Filed 3-10-05; 8:45 am]
BILLING CODE 4163-18-P