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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NamePediatrics Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee Number21515
Original Establishment Date1/7/2003Committee StatusChartered
Actual Termination Date Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*16
Current Charter Date9/27/2012Designated Fed Officer Position Title*Associate Director for Regulatory Affairs, Office of Pediatric Therapeutics
Date Of Renewal Charter Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Marieann
Exempt From Renewal*YesDesignated Federal Officer Middle NameR
Specific Termination AuthorityDesignated Federal Officer Last Name*Brill
Establishment Authority*Statutory (Congress Created)Designated Federal Officer SuffixMBA, RAC(US), MT(ASCP)
Specific Establishment Authority*Public Law 107-109, Public Law 108-155, FDAAADesignated Federal Officer Phone*(240)402-3838
Effective Date Of Authority*1/7/2003Designated Federal Officer Fax*(301)847-8640
Committee Type*ContinuingDesignated Federal Officer Email*marieann.brill@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 makes recommendations to the Commissioner of Food and Drugs in response to specific questions posed by the FDA. Recommendations for regulatory or policy decisions are reviewed by FDA staff and by the Commissioner, who then implements changes or forwards recommendations to the Department of Health and Human Services.
How is membership balanced?*Members are authorities knowledgeable in pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics. Members also include a patient-family representative , one technically qualified consumer representative, and may include one non-voting industry representative and one non-voting representative from a pediatric health organization.
How frequent & relevant are cmte mtgs?*The Pediatric Advisory Committee met two times in FY18 to cover critical regulatory and policy issues in the area of pediatric therapeutics which are essential for the agency to play a lead regulatory and policy role.
Why advice can't be obtained elsewhere?*The Pediatric Advisory Committee is mandated by law. In addition, the committee will have advisory functions for many pediatric products regulated by the FDA. The committee will provide expert advice on specific regulatory and policy areas related to pediatric therapeutics, including (1) pediatric research conducted under sections 351, 409I, and 499 of the Public Health Service Act and sections 501, 502, 505, 505A, and 505B of the Federal Food, Drug, and Cosmetic Act; (2) identification of research priorities related to pediatric therapeutics and the need for additional treatments of specific pediatric diseases or conditions, (3) the ethics, design, and analysis of clinical trials related to pediatric therapeutics, (4) pediatric labeling disputes as specified in section 3 of the Best Pharmaceuticals for Children Act (Public Law 107-109), (5) pediatric labeling changes as specified in section 5 of the Best Pharmaceuticals for Children Act (Public Law 107-109), (6) adverse event reports for drugs granted pediatric exclusivity and any safety issues that may occur as specified in section 17 of the Best Pharmaceuticals for Children Act (Public Law 107-109), (7) any other pediatric issue or pediatric labeling dispute involving FDA-regulated products, (8) research involving children as subjects as specified in 21 CFR 50.54, and (9) any other matter involving pediatrics for which FDA has regulatory responsibility. The Committee also advises and makes recommendations to the Secretary directly or to the Secretary through the Commissioner of Food and Drugs on research involving children as subjects that is conducted or supported by the Department of Health and Human Services as specified in 45 CFR 46.407.
Why close or partially close meetings?FDA is required to partially close a portion of the meeting to permit discussion of trade secrets and/or commercial information 5 U.S.C. 522b(c)(4).
Recommendation RemarksThere were no reports required for FY18. As provided in section 14(d) of the Best Pharmaceuticals for Children Act as amended by section 507 of the Food and Drug Administration Safety and Innovation Act of 2012, Pub. L. 112-144, notwithstanding section 14 of the Federal Advisory Committee Act, the Pediatric Advisory Committee will continue to operate to carry out the advisory committee’s responsibilities under sections 505A, 505B, and 520(m) of the Federal Food, Drug, and Cosmetic Act. During FY 2018, the Pediatric Advisory Committee was convened on 3 separate occasions for a total of 4 meeting days which included one day for training. The training day was added in order to educate the committee on matters pertaining to pediatric development and general administrative process. Accordingly, the Cost Section of this report reflects a total of 4 days of committee activity for FY 2018. On May 3, 2018, the Gastrointestinal Drugs Advisory Committee met jointly with the Pediatric Advisory Committee to discuss a new drug application for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.
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 CommentThe agency has made product labeling changes as a result of committee recommendations.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentNANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Pediatric Advisory Committee (and subcommittees) 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 bases rather than on a full time basis. The service of the committee resulated in advice for the improvement of the public health, for which it is difficult to assign a financial value.Grants Review CommentNA
Number Of Recommendations*359Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 359 recommendations from June of FY03 through FY18.Access Agency WebsiteYes
% of Recs Fully Implemented*90.00%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 of 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, therefore, the Agency has the option of not implementing the advice.Access OtherNo
Agency Feedback*YesAccess CommentN/A
Agency Feedback CommentWhen appropriate, information is made available to the public.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 Pediatric Advisory Committee supports FDA’s strategic priorities by providing advice and making recommendations to the Commissioner of Food and Drugs on matters relating to pediatric therapeutics, pediatric research, and any other matter involving pediatrics for which the Food and Drug Administration has regulatory responsibility. The Committee also advises and makes recommendations to the Secretary pursuant to 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services. The recommendations of this committee support the agency by improving patient and consumer safety.
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 - SUBCOMMITTEES

SUBCOMMITTEES

Committee

Subcommittees

ActionCommittee System IDSubcommittee NameFiscal Year
 COM-030481Ethics Subcommittee on the Pediatric Advisory Committee2019
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-034738Pediatrics Advisory Committee2018
 COM-001745Pediatrics Advisory Committee2017
 COM-002590Pediatrics Advisory Committee2016
 COM-004049Pediatrics Advisory Committee2015
 COM-004423Pediatrics Advisory Committee2014
 COM-006224Pediatrics Advisory Committee2013
 COM-006900Pediatrics Advisory Committee2012
 COM-008339Pediatrics Advisory Committee2011
 COM-009085Pediatrics Advisory Committee2010
 COM-010124Pediatrics Advisory Committee2009
 COM-010683Pediatrics Advisory Committee2008
 COM-012195Pediatrics Advisory Committee2007
 COM-012816Pediatrics Advisory Committee2006
 COM-014108Pediatrics Advisory Committee2005
 COM-014789Pediatrics Advisory Committee2004