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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 - 2014

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TimeTargetNumber of Activities
Oct 2013N/A109
Nov 2013N/A423
Dec 2013N/A317
Jan 2014N/A455
Feb 2014N/A408
Mar 2014N/A452
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 2,164

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

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A38
Nov 2013N/A184
Dec 2013N/A111
Jan 2014N/A81
Feb 2014N/A138
Mar 2014N/A36
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 588

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

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A0
Nov 2013N/A0
Dec 2013N/A4
Jan 2014N/A0
Feb 2014N/A0
Mar 2014N/A1
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 5

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

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A36
Nov 2013N/A79
Dec 2013N/A42
Jan 2014N/A177
Feb 2014N/A224
Mar 2014N/A273
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 831

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 - 2014
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TimeTargetNumber
Oct 2013N/A11
Nov 2013N/A100
Dec 2013N/A65
Jan 2014N/A62
Feb 2014N/A15
Mar 2014N/A42
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 295

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 - 2014
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TimeTargetNumber
Oct 2013N/A24
Nov 2013N/A60
Dec 2013N/A95
Jan 2014N/A135
Feb 2014N/A31
Mar 2014N/A100
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 445

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

Fiscal Year - 2014
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TimeTargetNumber
Oct 2013N/A0
Nov 2013N/A0
Dec 2013N/A0
Jan 2014N/A0
Feb 2014N/A0
Mar 2014N/A0
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 0

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.