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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameNonprescription Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee Number984
Original Establishment Date11/28/1990Committee StatusChartered
Actual Termination Date Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*11
Current Charter Date8/27/2017Designated Fed Officer Position Title*DFO
Date Of Renewal Charter8/27/2019Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Moon Hee
Exempt From Renewal*NoDesignated Federal Officer Middle NameVeronica
Specific Termination AuthorityDesignated Federal Officer Last Name*Choi
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharm.D.
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(301) 796-9001
Effective Date Of Authority*11/28/1990Designated Federal Officer Fax*301-847-8533
Committee Type*ContinuingDesignated Federal Officer Email*moonhee.choi@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 Committee reviews and evaluates available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products, or any other FDA-regulated product, for use in the treatment of a broad spectrum of human symptoms and diseases and advises the Commissioner either on the promulgation of monographs establishing conditions under which these drugs are generally recognized as safe and effective and not misbranded or on the approval of new drug applications for such drugs.
How is membership balanced?*Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of internal medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests.
How frequent & relevant are cmte mtgs?*The committee did not meet during FY-18. It is expected that this committee will meet two to four times in FY-19.
Why advice can't be obtained elsewhere?*Members of the committee are drawn from academia, research and/or clinical practice. Their advice and input lends credibility to regulatory decision made and helps those decisions withstand intense public scrutiny. The alternate means of obtaining this advice would involve the recruitment of large number of scientists on a full-time basis at maximum rates of compensations.
Why close or partially close meetings?The committee held no closed meetings during FY-18.
Recommendation RemarksThe committee is not required to do any reporting for FY-18. Although this committee did not meet in the first quarter of FY-18, considerable time was devoted to broadening the recruitment effort of new members, screening individuals for conflicts of interest, maintaining associated records for these activities per the requirements of FDASIA, and streamlining paper processes within FDA. In addition, time was spent in the routine care and maintenance of the committee: the development of a financial report for this website; updating the roster and number of vacancies on our website; completing the annual ethics report; reviewing financial disclosures of current members and providing ethics training; and assisting other committees by providing experts from the Nonprescription Drugs Advisory Committee.
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 RegulationsYes
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 CommentFDA approves or chooses not to approve new medical products.
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 Non-Prescription Drugs Advisory Committee enabled the Agency to obtain required and frequently scarce professional services from medical and scientific 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*17Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 17 recommendations from FY-03 through FY-18.Access Agency WebsiteYes
% of Recs Fully Implemented*80.00%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*10.00%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 CommentIt usually does. Product approval issues are first released to the sponsor. 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 Nonprescription Drugs Advisory Committee supports FDA's strategic priorities by reviewing and evaluating available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products, or any other FDA-regulated product, for use in the treatment of a broad spectrum of human symptoms and diseases and advises the Commissioner of Food and Drugs either on the promulgation of monographs establishing conditions under which these drugs are generally recognized as safe and effective and not misbranded or on the approval of new drug applications for such drugs. The Committee will serve as a forum for the exchange of views regarding the prescription and nonprescription status, including switches from one status to another, of these various drug products and combinations thereof. The Committee may also conduct peer review of agency sponsored intramural and extramural scientific biomedical programs in support of FDA’s mission and regulatory responsibilities. This support the development of safe and effective new medical technologies, and advances the status of the Agency as a science-based and science-led regulatory agency, providing global leadership in the protection of public health.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members* Est Payments to Non-Fed Members Next FY* 
Payments to Federal Members* Est. Payments to Fed Members Next FY* 
Payments to Federal Staff* Estimated Payments to Federal Staff* 
Payments to Consultants* Est. Payments to Consultants Next FY* 
Travel Reimb. For Non-Federal Members* Est Travel Reimb Non-Fed Members nextFY* 
Travel Reimb. For Federal Members* Est Travel Reimb For Fed Members* 
Travel Reimb. For Federal Staff* Est. Travel Reimb to Fed Staff Next FY* 
Travel Reimb. For Consultants* Est Travel Reimb to Consultants Next FY* 
Other Costs Est. Other Costs Next FY* 
Total Costs$0.00Est. Total Next FY*$0.00
Federal Staff Support (FTE)* Est. Fed Staff Support Next FY* 
Hide Section - Custom Links

Custom Links

     Committee Level Reports               
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-001952Nonprescription Drugs Advisory Committee2017
 COM-002305Nonprescription Drugs Advisory Committee2016
 COM-003996Nonprescription Drugs Advisory Committee2015
 COM-004775Nonprescription Drugs Advisory Committee2014
 COM-006166Nonprescription Drugs Advisory Committee2013
 COM-006940Nonprescription Drugs Advisory Committee2012
 COM-008383Nonprescription Drugs Advisory Committee2011
 COM-009132Nonprescription Drugs Advisory Committee2010
 COM-010110Nonprescription Drugs Advisory Committee2009
 COM-011022Nonprescription Drugs Advisory Committee2008
 COM-012113Nonprescription Drugs Advisory Committee2007
 COM-012670Nonprescription Drugs Advisory Committee2006
 COM-013782Nonprescription Drugs Advisory Committee2005
 COM-014497Nonprescription Drugs Advisory Committee2004
 COM-015983Nonprescription Drugs Advisory Committee2003
 COM-016625Nonprescription Drugs Advisory Committee2002
 COM-017612Nonprescription Drugs Advisory Committee2001
 COM-018347Nonprescription Drugs Advisory Committee2000
 COM-019558Nonprescription Drugs Advisory Committee1999
 COM-020309Nonprescription Drugs Advisory Committee1998
 COM-021733Nonprescription Drugs Advisory Committee1997
 COM-034687Nonprescription Drugs Advisory Committee2018