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U.S. Department of Health and Human Services

About FDA

Number of Pediatric Advisory Committee (PAC) related activities in the month

Dictionary:
The Office of Pediatric Therapeutics plans and coordinates all aspects of FDA’s Pediatric Advisory Committee (PAC) meetings. This effort includes meeting management, recruitment and maintenance of PAC members and Special Government Employees (SGE) experts, conflict of interest (COI) analysis and logistics.


Pediatric Advisory Committee meetings are announced in the Federal Register and are open to the public, unless otherwise stated. The Pediatric Advisory Committee advises and makes recommendations to the Commissioner of Food and Drugs on matters relating to pediatric therapeutics (including drugs and biological products) and medical devices, pediatric research, pediatric ethical issues and any other matter involving pediatrics for which the Food and Drug Administration has regulatory responsibility. The committees are established to provide functions which support the FDA's mission of protecting and promoting the public health and safety of children.


Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics. The core of voting members shall also include one representative from a relevant patient or patient-family organization and 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 and one non-voting member who represents a pediatric health organization.


In advance of each meeting, the Office of Pediatric Therapeutics, in accordance with the Federal Advisory Committee Act, coordinates all aspects of the Pediatric Advisory Committee. This effort includes the recruitment, identification, selection and appointment of well-qualified committee members and consulting experts. In addition, the Office of Pediatric Therapeutics coordinates all logistical matters associated with the meeting (e.g. member availability, travel, lodging, etc).


In order to participate in a meeting, members of the committee and other required experts are screened to identify potential conflicts of interest to all matters to be discussed at the meeting.A Federal employee may not participate personally and substantially in a particular matter in which, to his knowledge, he, his spouse, minor child, general partner, organization in which he is serving as officer, director, trustee, general partner or employee, or any person or organization with whom he is negotiating or has any arrangement concerning prospective employment, has a financial interest.

Information is current as of March 31, 2014.

Fiscal Year - 2013

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TimeTargetNumber of Activities
Oct 2012N/A441
Nov 2012N/A403
Dec 2012N/A300
Jan 2013N/A418
Feb 2013N/A465
Mar 2013N/A435
Apr 2013N/A323
May 2013N/A305
Jun 2013N/A367
Jul 2013N/A434
Aug 2013N/A571
Sep 2013N/A578

FY 2013 Total: 5,040

Conflict of Interest (COI) matters (includes screening forms for financial interests, discussion, analysis, meetings, waiver determination)

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A12
Nov 2012N/A74
Dec 2012N/A31
Jan 2013N/A67
Feb 2013N/A55
Mar 2013N/A74
Apr 2013N/A77
May 2013N/A166
Jun 2013N/A147
Jul 2013N/A206
Aug 2013N/A242
Sep 2013N/A141

FY 2013 Total: 1,292

Federal Register (FR) Notices (includes document development, clearance, publication and communications)

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A2
Mar 2013N/A0
Apr 2013N/A0
May 2013N/A0
Jun 2013N/A0
Jul 2013N/A0
Aug 2013N/A2
Sep 2013N/A0

FY 2013 Total: 4

Logistical (includes contract development, communications with committee members, orientation, travel, hotel, budget, and records maintenance)

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A207
Nov 2012N/A120
Dec 2012N/A94
Jan 2013N/A148
Feb 2013N/A318
Mar 2013N/A303
Apr 2013N/A127
May 2013N/A26
Jun 2013N/A112
Jul 2013N/A171
Aug 2013N/A246
Sep 2013N/A324

FY 2013 Total: 2,196

Special Government Employee (SGE) matters (includes evaluation and maintenance of all CVs, academic and scientific qualifications, personnel action files, nomination packets, communications, recruitment, polling, and award materials)

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A100
Nov 2012N/A65
Dec 2012N/A87
Jan 2013N/A146
Feb 2013N/A47
Mar 2013N/A33
Apr 2013N/A108
May 2013N/A101
Jun 2013N/A94
Jul 2013N/A32
Aug 2013N/A41
Sep 2013N/A40

FY 2013 Total: 894

Advisory Committee Member matters (includes evaluation and maintenance of personnel action files in accord with FACA requirements, communications, nomination packages, recruitment, polling, term extensions)

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A122
Nov 2012N/A144
Dec 2012N/A88
Jan 2013N/A57
Feb 2013N/A43
Mar 2013N/A23
Apr 2013N/A11
May 2013N/A12
Jun 2013N/A14
Jul 2013N/A25
Aug 2013N/A40
Sep 2013N/A73

FY 2013 Total: 652

Advisory Committee meetings held (including Pac interaction with other Advisory Committee meetings)

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A2
Apr 2013N/A0
May 2013N/A0
Jun 2013N/A0
Jul 2013N/A0
Aug 2013N/A0
Sep 2013N/A2

FY 2013 Total:4

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.