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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameRisk Communication Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2018Committee Number31951
Original Establishment Date Committee StatusChartered
Actual Termination Date Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*15
Current Charter Date7/17/2009Designated Fed Officer Position Title*DFO
Date Of Renewal Charter Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Russell
Exempt From Renewal*YesDesignated Federal Officer Middle NameT.
Specific Termination AuthorityDesignated Federal Officer Last Name*Fortney
Establishment Authority*Statutory (Congress Created)Designated Federal Officer Suffix
Specific Establishment Authority*21 U.S.C. 360bbb-6Designated Federal Officer Phone*(301) 796-1068
Effective Date Of Authority*9/27/2007Designated Federal Officer Fax*301-847-3640
Committee Type*ContinuingDesignated Federal Officer Email*russell.fortney@fda.hhs.gov
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The RCAC meets up to four times per year. Members' comments and discussion provide advice to the Agency on improving communications practices, from both a basis of scientific research and practical experience, in matters ranging from specific types of agency communications to more general strategies and research needs, in order to help the agency accomplish its goal of improving patient and consumer safety by providing risk-benefit information that is clear, timely, and usable by the audience. The meetings also facilitate the RCAC purpose of interactive sharing of information between the FDA and the public.
How is membership balanced?*The RCAC consists of 15 voting members including the Chair. Members are selected among authorities in fields such as risk communication, social marketing, health literacy, and other relevant areas. Some members will be selected to provide experiential insight on the communications needs of various groups who use FDA-regulated products such as patients, healthcare professionals, consumer or patient advocacy organizations. Depending on the topic, the commissioner or designee may select from a group of individuals nominated by industry to serve temporarily as nonvoting members who are identified with industry interests. FDA will give close attention to distribution with respect to members' geographic region, minority status, and sex, so long as the effectiveness of the Committee is not impaired.
How frequent & relevant are cmte mtgs?*Approximately 2 meetings per year are projected; 1 meeting was held in the current fiscal year.
Why advice can't be obtained elsewhere?*FDA strives to communicate with many audiences using many instruments, but in the past not all were developed or evaluated in ways consistent with established best practices in risk communication. The RCAC is necessary in order to bring expertise on current research and established best practices to the Agency, to help the agency interact with the public for more effective risk communication. This need was recognized both in the Congress (HR 3580) and the National Academies' Institute of Medicine (The Future of Drug Safety, recommendation 6.1).
Why close or partially close meetings?There were no closed meetings to report in FY-18.
Recommendation RemarksIn FY-18, the RCAC held one meeting, March 5-6, 2018. The committee met to discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule. The Pregnancy and Lactation Labeling Rule was implemented in June 2015, and required changes to labeling of information in prescription drug and biological products to better communicate clinically relevant information to health care providers on risks associated with medication exposure during pregnancy and lactation.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction 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 SatisfactionYesAction CommentThe committee does not advise on resource allocation, but prioritization may be reflected in resource allocation. The other actions boxes above that are checked applicable are showing that the Agency is actively engaged in developing internal strategy, process, and capacity to implement recommendations more fully, but none of this is complete at this time. The boxes above that are blank are, to date, inapplicable.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentN/ANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Risk Communication Advisory Committee enables the Agency to obtain required and frequently scarce professional services from medical, scientific and communications experts not otherwise available to the Agency and to obtain the services of these experts only on an as needed basis rather than on a full time basis. The service of the committee resulted in advice for the improvement of the public health, for which it is difficult to assign a financial value.Grants Review CommentN/A
Number Of Recommendations*188Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 188 recommendations from FY03 through FY18, following the convention 1 topic = 1 recommendationAccess Agency WebsiteYes
% of Recs Fully Implemented*20.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*70.00%Access PublicationsYes
% of Recs Partially Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.Access OtherNo
Agency Feedback*YesAccess CommentN/A
Agency Feedback CommentFeedback is usually provided. When appropriate, information is made available to the public. Actions related to guidance documents or other general matters issues are available publicly when implemented.Narrative Description*FDA’s strategic priorities in responding to the public health challenges of the 21st century are to advance regulatory science and innovation; strengthen the safety and integrity of the global supply chain; strengthen compliance and enforcement activities to support public health; expand efforts to meet the needs of special populations; advance medical countermeasures and emergency preparedness; advance food safety and nutrition; promote public health by advancing the safety and effectiveness of medical products; establish an effective tobacco regulation, prevention, and control program; and manage for organizational excellence and accountability. The Risk Communication Advisory Committee supports FDA's strategic priorities by providing expert advice on FDA strategies and programs designed to communicate with the public about the risks and benefits of FDA-regulated products, review and evaluate scientific research relevant to risk communication, and facilitate the interactive sharing between FDA and the public of information on risks and benefits of FDA-regulated products.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$17,693.00Est Payments to Non-Fed Members Next FY*$16,304.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$347,080.00Estimated Payments to Federal Staff*$354,768.00
Payments to Consultants*$15,965.00Est. Payments to Consultants Next FY*$17,000.00
Travel Reimb. For Non-Federal Members*$15,199.00Est Travel Reimb Non-Fed Members nextFY*$30,931.00
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$90,703.00Est. Other Costs Next FY*$96,715.00
Total Costs$486,640.00Est. Total Next FY*$515,718.00
Federal Staff Support (FTE)*2.35Est. Fed Staff Support Next FY*2.35
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-001991Risk Communication Advisory Committee2017
 COM-002311Risk Communication Advisory Committee2016
 COM-003828Risk Communication Advisory Committee2015
 COM-004515Risk Communication Advisory Committee2014
 COM-006174Risk Communication Advisory Committee2013
 COM-006524Risk Communication Advisory Committee2012
 COM-008334Risk Communication Advisory Committee2011
 COM-008728Risk Communication Advisory Committee2010
 COM-010391Risk Communication Advisory Committee2009
 COM-011009Risk Communication Advisory Committee2008
 COM-012239Risk Communication Advisory Committee2007