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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 June 30, 2014.

Fiscal Year - 2012

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TimeTargetNumber of Activities
Oct 2011N/A255
Nov 2011N/A318
Dec 2011N/A320
Jan 2012N/A376
Feb 2012N/A439
Mar 2012N/A552
Apr 2012N/A538
May 2012N/A398
Jun 2012N/A361
Jul 2012N/A477
Aug 2012N/A582
Sep 2012N/A577

FY 2012 YTD: 5,193

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A34
Nov 2011N/A80
Dec 2011N/A52
Jan 2012N/A32
Feb 2012N/A69
Mar 2012N/A203
Apr 2012N/A158
May 2012N/A52
Jun 2012N/A112
Jul 2012N/A127
Aug 2012N/A105
Sep 2012N/A65

FY 2012 Total: 1,089

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A1
Nov 2011N/A0
Dec 2011N/A1
Jan 2012N/A0
Feb 2012N/A0
Mar 2012N/A1
Apr 2012N/A2
May 2012N/A2
Jun 2012N/A0
Jul 2012N/A1
Aug 2012N/A1
Sep 2012N/A0

FY 2012 Total: 9

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A98
Nov 2011N/A103
Dec 2011N/A212
Jan 2012N/A164
Feb 2012N/A132
Mar 2012N/A219
Apr 2012N/A286
May 2012N/A209
Jun 2012N/A156
Jul 2012N/A197
Aug 2012N/A242
Sep 2012N/A264

FY 2012 Total: 2,282

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 - 2012
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TimeTargetNumber
Oct 2011N/A80
Nov 2011N/A60
Dec 2011N/A15
Jan 2012N/A43
Feb 2012N/A46
Mar 2012N/A90
Apr 2012N/A45
May 2012N/A68
Jun 2012N/A60
Jul 2012N/A85
Aug 2012N/A137
Sep 2012N/A71

FY 2012 Total: 800

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 - 2012
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TimeTargetNumber
Oct 2011N/A42
Nov 2011N/A75
Dec 2011N/A40
Jan 2012N/A180
Feb 2012N/A192
Mar 2012N/A39
Apr 2012N/A47
May 2012N/A66
Jun 2012N/A33
Jul 2012N/A67
Aug 2012N/A97
Sep 2012N/A177

FY 2012 YTD: 1,055

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A0
Dec 2011N/A0
Jan 2012N/A1
Feb 2012N/A0
Mar 2012N/A0
Apr 2012N/A0
May 2012N/A1
Jun 2012N/A0
Jul 2012N/A0
Aug 2012N/A0
Sep 2012N/A1

FY 2012 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.