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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameSecretary's Advisory Committee on Genetics, Health, and SocietyAgency NameDepartment of Health and Human Services
Fiscal Year2011Committee Number13886
Original Establishment Date11/17/1962Committee StatusTerminated
Actual Termination Date2/28/2011Committee URLhttp://oba.od.nih.gov/SACGHS/sacghs_home.html
New Committee This FYNoPresidential Appointments*No
Terminated This FYYesMax Number of Members*32
Current Charter Date9/23/2010Designated Fed Officer Position Title*EXECUTIVE SECRETARY
Date Of Renewal Charter Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*SARAH
Exempt From Renewal*NoDesignated Federal Officer Middle Name
Specific Termination AuthorityDepartmental DeterminationDesignated Federal Officer Last Name*CARR
Establishment Authority*Authorized by LawDesignated Federal Officer Suffix
Specific Establishment Authority*42 USC 217aDesignated Federal Officer Phone*(301) 496-9838
Effective Date Of Authority*11/17/1962Designated Federal Officer Fax*301-496-9839
Committee Type*ContinuingDesignated Federal Officer Email*carrs@mail.nih.gov
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Terminate
Legislation to Terminate RequiredNo
Legislation Status 
How does cmte accomplish its purpose?*Advised and recommended on the range of complex and sensitive medical, ethical, legal, and social issues raised by new technological developments in human genetics. The Committee explored, analyzed, and deliberated on the broad range of human health and societal issues raised by the development and use, as well as potential misuse of genetic technologies and made recommendations to the Secretary of Health and Human Services.
How is membership balanced?*The Committee consisted of up to 17 members, including the Chair, appointed by the Secretary from authorities knowledgeable about biomedical sciences, human genetics, health care delivery, evidence-based practice, public health, bioinformatics, behavioral sciences, social sciences, health services research, health policy, health disparities, ethics, economics, law, health care financing, consumer issues, and other relevant fields. Of the appointed members, at least two members were selected for their knowledge of consumer issues and concerns and the views and perspectives of the general public.
How frequent & relevant are cmte mtgs?*SACGHS held one meeting in FY 2011 before the expiration of its charter on February 28, 2011. At its October 2010 meeting, SACGHS discussed the revised draft report on genetics education and training and the revised draft recommendations, implications of affordable whole-genome sequencing, the implementation of the Genetic Information Nondiscrimination Act, the clinical utility and comparative effectiveness research of genetic tests, and perspectives on group risks and benefits of genomic data sharing. SACGHS also drafted a final letter to the Secretary recommending a specific course of action that HHS could take to further its understanding of genetic-related issues and develop policy solutions that address these issues.
Why advice can't be obtained elsewhere?*The Committee provided a forum for expert discussion and deliberation and the formulation of advice and recommendations on the range of complex and sensitive medical, ethical, legal, and social issues raised by new technological developments in human genetics.
Why close or partially close meetings?N/A
Recommendation RemarksThis committee did not produce any reports during the reporting period. NIH and HHS have determined that the subject areas covered by this committee will be incorporated into other existing committees.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*No
Outcome Trust In GovernmentNoAction Reallocate ResourcesNo
Outcome Major Policy ChangesYesAction Issued New RegulationsNo
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionNoAction CommentA number of SACGHS recommendations are being considered by HHS agencies and action is underway to address some recommendations. For example, the Centers for Medicare & Medicaid (CMS) is working with the Clinical Laboratory Improvement Advisory Committee towards the development of a notice for proposed rulemaking to update requirements for proficiency testing, which would address one of the recommendations in the SACGHS report on the oversight of genetic testing. The proposed rule is expected in 2011. CMS has also worked with its Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to examine whether the use of genetic tests can improve health outcomes for the Medicare population. In 2009 and 2010, MEDCAC held three meetings that focused on diagnostic genetic tests, genetic tests used for screening purposes, and pharmacogenomic tests to inform cancer treatments. MEDCAC examined issues pertinent to recommendations in SACGHS reports on pharmacogenomics and the coverage and reimbursement of genetic tests and services. The SACGHS report on the oversight of genetic testing recommended that the Food and Drug Administration (FDA) apply its risk-based regulatory approach to laboratory-developed tests (LDTs). FDA held a meeting July 19-20, 2010, to gather public input on an oversight framework for LDTs that encourage innovation and improve patient outcomes. The Federal Register notice announcing this meeting cited the SACGHS recommendation. In March 2011, the FDA held a public meeting on direct-to-consumer (DTC) genetic testing. One of the meeting agenda items—regarding the level and type of scientific evidence appropriate for supporting DTC genetic testing claims—addressed the Committee’s concern about the absence of FDA review of claims and promotional materials for DTC genetic tests, which was raised in the 2010 SACGHS report on this topic.The SACGHS oversight report also recommended that HHS identify and address deficiencies in knowledge about appropriate genetic and genomic test applications in practice and educate key groups such as health care practitioners. Consistent with this recommendation, the Agency for Healthcare Research and Quality (AHRQ) held a workshop in February 2010 to examine issues that primary care clinicians face in using genetic and genomic tests. To complement this workshop, AHRQ produced a draft white paper on the primary care perspective on the appropriate use of genomics. AHRQ’s efforts have identified deficiencies in the knowledge base and potential remedies that would assist primary care clinicians in the appropriate use of gene-based tests.In May 2010, AHRQ issued the technology assessment (TA) Quality, Regulation and Clinical Utility of Laboratory-developed Molecular Tests. This TA examined several issues raised in the SACGHS reports on the oversight of genetic testing and DTC genetic testing, such as inadequate data to assess the clinical utility of tests, insufficient analysis of the standard of evidence on which clinical utility should be evaluated, and inadequate regulation of marketing claims. Under development is an AHRQ report on analytic validity, quality rating, and evaluation frameworks of genetic and other laboratory tests. The AHRQ report examines concerns raised in SACGHS oversight report on gaps in the extent to which analytic validity data can be generated and evaluated for genetic tests.
Outcome Implement Laws/Reg RequirementsNoGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentNANumber Of Grants Recommended0
Cost Savings*NoneDollar Value Of Grants Recommended$0.00
Cost Savings CommentNIH supported basic and clinical research accomplishments often take many years to unfold into new diagnostic tests and new ways to treat and prevent diseases.Grants Review CommentNA
Number Of Recommendations*90Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentIn recommendations made in October 2010, SACGHS identified salient concerns in genomic data sharing, implications of affordable whole-genome sequencing, comparative effectiveness research in genomic and personalized medicine, and public health implications of genomics. The Committee also made seven recommendations that proposed steps that could be taken by HHS to develop policy solutions addressing those concerns. The Committee also provided a set of principles to guide the integration of genetics and genomics in clinical care and public health as new issues arise. In February 2011, SACGHS submitted to the Secretary the report Genetics Education and Training identifying needs in genetics education and training for point-of-care health professionals, the public health workforce, and patients and consumers and making six recommendations to address those needs.Access Agency WebsiteNo
% of Recs Fully Implemented*0.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentDue to the large breadth and complexity of the recommendations made by this committee to the Secretary, NIH/OD staff is unable to determine which recommendations have been fully implemented solely in response to this committee’s activities. Additionally, since this committee was terminated on February 28, 2011, the final recommendations by the committee were forwarded to the Secretary and we are waiting to hear a determination on what recommendations will be accepted.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*22.00%Access PublicationsYes
% of Recs Partially Implemented CommentRecommendations implemented: Recommendation from the 2008 SACGHS report U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services that called for HHS to develop and maintain a mandatory registry for laboratory tests. On March 18, 2010, the National Institutes of Health (NIH) announced that it plans to develop a voluntary registry for genetic tests (http://www.nih.gov/news/health/mar2010/od-18.htm).Recommendation from the 2008 SACGHS report U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services that called for HHS to ensure the coordination and implementation of efforts to advance the appropriate use of interoperable patient-level data for research and enhance the quality of decisionmaking. The criteria for the meaningful use of electronic health records (EHRs)—developed by the Office of the National Coordinator for Health Information Technology and the Centers for Medicare & Medicaid Services—support the use of EHRs to advance research (http://edocket.access.gpo.gov/2010/E9-31216.htm).Recommendation from the 2008 SACGHS report U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services that called for resources to translate genetic and genomic research into evidence-based clinical practice guidelines that enhance the quality of clinical health care and public health care outcomes. The Centers for Disease Control and Prevention has initiated the Genomic Applications in Practice and Prevention Network (GAPPNet™) to accelerate and streamline the effective and responsible use of validated and useful genomic knowledge and applications, such as genetic tests, technologies, and family history, into clinical and public health practice (http://www.cdc.gov/genomics/translation/GAPPNet/). Recommendation from the 2007 SACGHS report Policy Issues Associated with Undertaking a New Large U.S. Population Cohort Study of Genes, Environment, and Disease that called for the HHS Secretary to assess the public’s willingness to participate in a large population cohort study in advance of any funding decision. NIH funded studies to assess public opinions and expectations of a large genetic cohort study. Two papers were published reporting results of these studies: Kaufman D, Murphy J, Scott J, Hudson K. Subjects matter: a survey of public opinions about a large genetic cohort study. Genetics in Medicine. 2008 Nov;10(11):831-9.Murphy J, Scott J, Kaufman D, Geller G, LeRoy L, Hudson K. Public expectations for return of results from large-cohort genetic research. American Journal of Bioethics. 2008 Nov;8(11):36-43.Access OtherNo
Agency Feedback*YesAccess CommentNIH website: http://oba.od.nih.gov/SACGHS/sacghs_home.htmlThis committee's information is listed here such as the committee charter, minutes, agenda and future meeting dates.
Agency Feedback CommentDHHS provided feedback in writing and orally through the HHS ex officios serving on SACGHS about its plans to implement the Committee’s recommendations. Key staff in the Secretary’s immediate office provided updates on the status of the Committee’s recommendations as well as information about Secretarial programs and priorities. Staff level discussions also provided feedback on the work of the Committee and helped identify additional areas in which the Committee could work synergistically with the Department.Narrative Description*In FY 2011, the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) completed its work on behalf of the Secretary of Health and Human Services (HHS). Its mandate related to the HHS mission of enhancing the health and well-being of Americans and, more specifically, to HHS strategic goals of improving the safety, quality, affordability and accessibility of health care and advancing scientific and biomedical research and development related to health.SACGHS explored, analyzed, and deliberated on the broad range of policy needs associated with the scientific, clinical, public health, ethical, economic, legal and social issues raised by the development, use, and potential misuse of genetic and genomic technologies and made recommendations to the HHS Secretary and others upon request. The following topics were SACGHS priorities: the clinical utility of genetic and genomic technologies; consumer-initiated genomic services; coverage and reimbursement of genetic tests and services; genetics education and training; genetics and the future of the health care system; informed consent, privacy, and discrimination related to genomic data sharing; and public health genomics. Health disparities were considered across all of the other priority topics, and genetic discrimination, oversight of genetic testing, and gene patents and licensing were of ongoing interest.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$4,800.00Est Payments to Non-Fed Members Next FY*$0.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$48,477.00Estimated Payments to Federal Staff*$0.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$12,917.00Est Travel Reimb Non-Fed Members nextFY*$0.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$0.00Est Travel Reimb to Consultants Next FY*$0.00
Other Costs$23,131.00Est. Other Costs Next FY*$0.00
Total Costs$89,325.00Est. Total Next FY*$0.00
Federal Staff Support (FTE)*0.30Est. Fed Staff Support Next FY*0.00
Hide Section - Custom Links

Custom Links

     Committee Level Reports               
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

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Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

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Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-009088Secretary's Advisory Committee on Genetics, Health, and Society2010
 COM-010033Secretary's Advisory Committee on Genetics, Health, and Society2009
 COM-010734Secretary's Advisory Committee on Genetics, Health, and Society2008
 COM-011972Secretary's Advisory Committee on Genetics, Health, and Society2007
 COM-012565Secretary's Advisory Committee on Genetics, Health, and Society2006
 COM-014025Secretary's Advisory Committee on Genetics, Health, and Society2005
 COM-014465Secretary's Advisory Committee on Genetics, Health, and Society2004
 COM-016021Secretary's Advisory Committee on Genetics, Health, and Society2003