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Committee Detail

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.


HHS - 830 - Clinical Trials Review Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameClinical Trials Review CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2003Committee Number830
Original Establishment Date11/20/1985Committee StatusTerminated
Actual Termination Date9/30/2003Committee URL 
New Committee This FYNoPresidential Appointments*No
Terminated This FYYesMax Number of Members*15
Current Charter Date7/1/1987Designated Fed Officer Position Title*SCIENTIFIC REVIEW ADMINISTRATOR
Date Of Renewal Charter Designated Federal Officer Prefix
Projected Termination Date9/30/2003Designated Federal Officer First Name*VALERIE
Exempt From Renewal*YesDesignated Federal Officer Middle NameL.
Specific Termination AuthorityDepartmental DeterminationDesignated Federal Officer Last Name*PRENGER
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPHD
Specific Establishment Authority*42 U.S.C. 282(b)(6)Designated Federal Officer Phone*301-435-0288
Effective Date Of Authority*11/20/1985Designated Federal Officer Fax*
Exempt From EO 13875 Discretionary Cmte Designated Federal Officer Email* 
Committee Type*Continuing
Presidential*No
Committee Function*Grant Review Committee
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Terminate
Legislation to Terminate RequiredNo
Legislation Status 
How does cmte accomplish its purpose?*Section 492 of the PHS Act states that The Secretary... shall by regulation require appropriate technical and scientific peer review - A) applications...; and B) biomedical and behavioral research and development contracts... This Committee is composed of recognized biomedical and/or behavioral research authorities who represent the forefront of research and technical knowledge and who provide first-level merit review of highly scientific and technical research grant applications of investigator initiated funding of single and/or multi-center clinical trials and registries involving caradiovascular, pulmonary, and blood diseases. During this reporting period, the Committee reviewed 45 applications requesting $113,609,519.
How is membership balanced?*The members of this Committee are authorities knowledgeable in the fields of fundamental and clinical research in disciplines related to cardiovascular, lung, and blood diseases, as well as epidemiology, biostatistics, and clinical trial design.
How frequent & relevant are cmte mtgs?*The Committee met 3 times during this reporting period.
Why advice can't be obtained elsewhere?*The Committee is composed of recognized biomedical and behavioral research authorities who represent the forefront of research and technical knowledge and who provide first-level merit review of highly scientific and technical research grant applications. These evaluations and recommendations cannot be obtained from other sources because the specialized, complex nature of the applications require a unique balance and breadth of expertise not available on the NIH staff or from other established sources.
Why close or partially close meetings?The meetings of the Committee were closed to the public for the review of grant applications. Sections 552b(c)(4) and 552b(c)(6) of the Government in the Sunshine Act permit the closing of meetings where discussion could reveal confidential trade secrets or commercial property such as patentable material and personal information, the disclosure of which would consitute a clearly unwarranted invasion of personal privacy.
Recommendation Remarks
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*NoAction Reorganize Priorities*No
Outcome Trust In GovernmentNoAction Reallocate ResourcesNo
Outcome Major Policy ChangesNoAction Issued New RegulationsNo
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
Outcome Effective Grant MakingYesAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionNoAction CommentInitial Review Groups only provide advice.
Outcome Implement Laws/Reg RequirementsYesGrants Review*Yes
Outcome OtherNoNumber Of Grants Reviewed45
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 CommentNIH does not currently collect this data.
Number Of Recommendations*45Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentGrant ReviewAccess Agency WebsiteYes
% of Recs Fully Implemented*0.00%Access Committee WebsiteNo
% of Recs Fully Implemented CommentSection 9(b) of the Federal Advisory Committee Act states that unless otherwise specifically provided by statute or Presidential directive, advisory committees shall be utilized solely for advisory functions. Determinations of action to be taken and policy to be expressed with respect to matters upon which an advisory committee reports or makes recommendations shall be made solely by the President or an officer of the Federal Government. NIH does not currently track this information.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*0.00%Access PublicationsNo
% of Recs Partially Implemented CommentSection 9(b) of the Federal Advisory Committee Act states that unless otherwise specifically provided by statute or Presidential directive, advisory committees shall be utilized solely for advisory functions. Determinations of action to be taken and policy to be expressed with respect to matters upon which an advisory committee reports or makes recommendations shall be made solely by the President or an officer of the Federal Government. NIH does not currently track this information.Access OtherNo
Agency Feedback*Not ApplicableAccess CommentNA
Agency Feedback Comment*NANarrative Description*The goal of NIH research is to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability, from the rarest genetic disorder to the common cold. The NIH mission is to uncover new knowledge that will lead to better health for everyone. NIH works toward that mission by supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad. Section 492 of the PHS Act states that The Secretary ...shall by regulation require appropriate technical and scientific peer review of -(A) applications...; (B) biomedical and behavioral research and development contracts... During this reporting period, the Committee reviewed 45 applications requesting $113,609,519.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$15,500.00Est 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*$146,682.00Estimated Payments to Federal Staff*$0.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$37,245.00Est 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$6,808.00Est. Other Costs Next FY*$0.00
Total Costs$206,235.00Est. Total Next FY*$0.00
Federal Staff Support (FTE)*1.90Est. Fed Staff Support Next FY*0.00
Cost RemarksEst Cost Remarks
Hide Section - Interest Areas

Interest Areas

No interest areas selected for this committee.
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-016570Clinical Trials Review Committee2002
 COM-017885Clinical Trials Review Committee2001
 COM-018424Clinical Trials Review Committee2000
 COM-019826Clinical Trials Review Committee1999
 COM-020451Clinical Trials Review Committee1998
 COM-021495Clinical Trials Review Committee1997