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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.

Details on agency responses to committee recommendations can be found under the Performance Measures section for each committee in the fields “Agency Feedback” and “Agency Feedback Comment.”


HHS - 990 - Peripheral and Central Nervous System Drugs Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NamePeripheral and Central Nervous System Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2022Committee Number990
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*10
Current Charter Date6/4/2020Designated Fed Officer Position Title*Designated Federal Officer
Date Of Renewal Charter6/4/2022Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Jessica
Exempt From Renewal*NoDesignated Federal Officer Middle Name
Specific Termination AuthorityDesignated Federal Officer Last Name*Seo
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharm.D., M.P.H
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(301) 796-7699
Effective Date Of Authority*11/28/1990Designated Federal Officer Fax*301-847-8533
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*jessica.seo@fda.hhs.gov
Committee Type*Continuing
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 data on the safety and effectiveness of marketed and investigational human drugs for use in the treatment of neurological diseases and makes appropriate recommendations to the Commissioner of the Food and Drugs.
How is membership balanced?*Members are experts in the fields of neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology, statistics or related specialties. The Committee has one technically qualified member identified with consumer interests. In addition to the voting members, the Committee includes one non-voting member who is identified with industry interests.
How frequent & relevant are cmte mtgs?*In FY-22, the Committee held one meeting.

On March 30, 2022, the Peripheral and Central Nervous System Drugs Advisory Committee met to discuss new drug application (NDA) 216660, for sodium phenylbutyrate/taurursodiol (AMX0035) powder for oral suspension, submitted by Amylyx Pharmaceuticals, Inc., for the treatment of amyotrophic lateral sclerosis (ALS). The Committee members were asked to discuss whether the data from the single randomized, controlled trial and the open-label extension study established a conclusion that sodium phenylbutyrate/taurursodiol is effective in the treatment of patients with amyotrophic lateral sclerosis (ALS). The Committee voted 6 to 4 (with 0 abstentions) that the data submitted by the Applicant did not establish a conclusion that sodium phenylbutyrate/taurursodiol is effective in the treatment of ALS. Agency Action: The Agency is still reviewing the recommendations made at the meeting.

It is expected the Committee will meet one to two times during FY-23.
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 decisions. The Committee helps the regulatory decisions withstand intense public scrutiny. The means of obtaining this advice would involve the recruitment of large numbers of scientists on a full-time basis at maximum rates of compensation.
Why close or partially close meetings?The Committee held no closed meetings during FY-22.
Recommendation RemarksThere were no reports required for this Committee in FY-22.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesYes
Outcome Major Policy ChangesYesAction Issued New RegulationsYes
Outcome Advance In Scientific ResearchYesAction Proposed LegislationYes
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 Peripheral and Central Nervous System 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*28Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 28 recommendations from FY-03 through FY-22.

See Committee website for specific accomplishments: https://www.fda.gov/advisory-committees/human-drug-advisory-committees/peripheral-and-central-nervous-system-drugs-advisory-committee
Access Agency WebsiteYes
% of Recs Fully Implemented*84.00%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, therefore, the Agency has the option of not implementing the advice. This number represents an approximation of the percentage of recommendations that the agency has fully implemented or plans to fully implement.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 Comment*It 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 Peripheral and Central Nervous System Drugs Advisory Committee supports FDA's strategic priorities by reviewing and evaluating data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of neurologic diseases and makes appropriate recommendations to the Commissioner of Food and Drugs. This supports 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 the 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
Date Cost Last Modified4/18/2022 2:21 PMEst. Fed Staff Support Next FY* 
Federal Staff Support (FTE)* Est Cost Remarks
Cost Remarks  
Hide Section - Interest Areas

Interest Areas

Category
Area
Food and Drugs
Food and Drugs
Health
Health Care
Safety
Treatment
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-040254Peripheral and Central Nervous System Drugs Advisory Committee2021
 COM-038530Peripheral and Central Nervous System Drugs Advisory Committee2020
 COM-036402Peripheral and Central Nervous System Drugs Advisory Committee2019
 COM-034605Peripheral and Central Nervous System Drugs Advisory Committee2018
 COM-001997Peripheral and Central Nervous System Drugs Advisory Committee2017
 COM-002381Peripheral and Central Nervous System Drugs Advisory Committee2016
 COM-003839Peripheral and Central Nervous System Drugs Advisory Committee2015
 COM-004396Peripheral and Central Nervous System Drugs Advisory Committee2014
 COM-006262Peripheral and Central Nervous System Drugs Advisory Committee2013
 COM-006533Peripheral and Central Nervous System Drugs Advisory Committee2012
 COM-008389Peripheral and Central Nervous System Drugs Advisory Committee2011
 COM-008744Peripheral and Central Nervous System Drugs Advisory Committee2010
 COM-010035Peripheral and Central Nervous System Drugs Advisory Committee2009
 COM-010682Peripheral and Central Nervous System Drugs Advisory Committee2008
 COM-012213Peripheral and Central Nervous System Drugs Advisory Committee2007
 COM-012581Peripheral and Central Nervous System Drugs Advisory Committee2006
 COM-013771Peripheral and Central Nervous System Drugs Advisory Committee2005
 COM-014509Peripheral and Central Nervous System Drugs Advisory Committee2004
 COM-015913Peripheral and Central Nervous System Drugs Advisory Committee2003
 COM-016725Peripheral and Central Nervous System Drugs Advisory Committee2002
 COM-017665Peripheral and Central Nervous System Drugs Advisory Committee2001
 COM-018476Peripheral and Central Nervous System Drugs Advisory Committee2000
 COM-019580Peripheral and Central Nervous System Drugs Advisory Committee1999
 COM-020588Peripheral and Central Nervous System Drugs Advisory Committee1998
 COM-021486Peripheral and Central Nervous System Drugs Advisory Committee1997