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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 - 2011

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TimeTargetNumber of Activities
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/AN/A
Feb 2011N/A458
Mar 2011N/A911
Apr 2011N/A958
May 2011N/A400
Jun 2011N/A386
Jul 2011N/A377
Aug 2011N/A445
Sep 2011N/A414

FY 2011 Total: 4,349

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/AN/A
Feb 2011N/A94
Mar 2011N/A230
Apr 2011N/A169
May 2011N/A101
Jun 2011N/A77
Jul 2011N/A102
Aug 2011N/A93
Sep 2011N/A79

FY 2011 Total: 945

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/AN/A
Feb 2011N/A2
Mar 2011N/A2
Apr 2011N/A3
May 2011N/A0
Jun 2011N/A0
Jul 2011N/A1
Aug 2011N/A0
Sep 2011N/A0

FY 2011 Total: 8

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/AN/A
Feb 2011N/A101
Mar 2011N/A304
Apr 2011N/A533
May 2011N/A187
Jun 2011N/A102
Jul 2011N/A162
Aug 2011N/A148
Sep 2011N/A198

FY 2011 Total: 1,735

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 - 2011
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TimeTargetNumber
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/AN/A
Feb 2011N/A204
Mar 2011N/A208
Apr 2011N/A104
May 2011N/A68
Jun 2011N/A115
Jul 2011N/A64
Aug 2011N/A174
Sep 2011N/A121

FY 2011 Total: 1,058

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 - 2011
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TimeTargetNumber
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/AN/A
Feb 2011N/A57
Mar 2011N/A167
Apr 2011N/A149
May 2011N/A42
Jun 2011N/A92
Jul 2011N/A48
Aug 2011N/A30
Sep 2011N/A15

FY 2011 Total: 600

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/AN/A
Feb 2011N/AN/A
Mar 2011N/AN/A
Apr 2011N/AN/A
May 2011N/A2
Jun 2011N/A0
Jul 2011N/A0
Aug 2011N/A0
Sep 2011N/A1

FY 2011 Total: 3

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.