MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH
MAPP 7500.1
PROJECT MANAGEMENT
OFFICE OF NEW DRUGS REGULATORY PROJECT MANAGEMENT
COORDINATING COMMITTEE
CONTENTS
PURPOSE
BACKGROUND
ORGANIZATION
RESPONSIBILITIES AND PROCEDURES
EFFECTIVE DATE
PURPOSE
This MAPP describes:
00The roles and responsibilities of the Regulatory Project Management Coordinating
Committee (RPMCC);
00The procedures for establishing RPMCC subcommittees;
00The structure and function of the RMPCC and its committees;
00The procedures for designating members to serve on the subcommittees; and
00The responsibilities of those designated to serve on the subcommittees.
BACKGROUND
The Office of New Drugs (OND) has formed many committees and working groups to address
various project management issues. Coordination of these committees ensures effective use of
staff resources and establishes and promotes consistent project management policy throughout
OND. To achieve these objectives, OND has established a coordinating committee, the RPMCC.
ORGANIZATION
The following descriptions and explanations apply on a general basis. There may be some
fluctuation in implementation due to workload demands:
00RPMCC - The RPMCC has two major components:
1.* RPMCC 00The RPMCC consists of the OND Associate Directors for Regulatory
Affairs (ADRAs) and all of the OND Chiefs, Project Management Staffs (CPMS)
Originator: Executive Regulatory Project Management Coordinating Committee
Effective Date: 2/26/96, 11/06/02
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MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH
MAPP 7500.1
and the Special Assistant to the Director, OND. The monthly CPMS meeting will be
used to present issues to the full RPMCC.
2.* Executive RPMCC (ERPMCC) 00The ERPMCC consists of the OND ADRAs.
The ERPMCC will manage routine matters that come before the RPMCC. At the
discretion of the ERPMCC, matters that merit broader input will be brought before
the full RPMCC for discussion.
00 Chair - The position of Chair of the RPMCC/ERPMCC will rotate among
members of the ERPMCC, with each term lasting 6 months.
00 Executive Secretary - The position of Executive Secretary will rotate among the
members of the ERPMCC, with each term lasting 6 months.
00Subcommittees
1.* Subcommittee Chairs and Vice-Chairs (or Co-Chairs) 围 For each subcommittee, the
ERPMCC will select a Chairperson and a Vice- or Co-Chair, taking into account
expertise and interest in the subject matter of the subcommittee, workload, and
organizational and management skills. Alternatively, the ERPMCC may delegate
selection of the Chairperson and Vice- or Co-Chair to the subcommittee membership.
2.* Membership 围 Subcommittee membership is not restricted to OND. Members should
be chosen by the subcommittee Chair and subcommittee Co-Chair with input from the
RPMCC, taking into account their qualifications, expertise, workload, interest in the
subject matter of the subcommittee, and the demands on their time caused by
membership on other committees. In general, no person should serve on more than two
subcommittees at one time. Membership should be distributed with the goal of achieving
broad representation within OND, provided that the individuals selected possess adequate
experience and skills to address the work of the subcommittee. Members who do not
contribute to the work of the subcommittee (i.e., do not attend meetings) will be removed
from the member roster.
To facilitate productivity of the subcommittees, use of smaller, short-term ad hoc
working groups to address specific issues is encouraged. Subcommittees may create
working groups on specific issues bringing in additional expertise as necessary.
RESPONSIBILITIES AND PROCEDURES
00RPMCC will:
1.*Provide advice to the Center, Agency, Department, and regulated industry on project
management as well as other review management issues that involve OND
2.*Develop strategies for accomplishing long-and short-term project management goals
in OND
Originator: Executive Regulatory Project Management Coordinating Committee
Effective Date: 2/26/96, 11/06/02
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MANUAL OF POLICIES AND PROCEDURES
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MAPP 7500.1
3.*Develop, recommend, and document policies and procedures (MAPPs) relating to
project management
4.*Coordinate, facilitate, and monitor the efforts of the RPMCC subcommittees. This
will include helping resolve jurisdictional issues that might affect other technical
committees (e.g., CMC CC), divisions, offices, or centers
5.*Promote and support professional development workshops and other intramural and
extramural activities related to project management
6.*Promote and support the Office of Training and Communications (OTCOM) training
in project management, team-building and related management approaches, and in
providing regulatory expertise for CDER staff
00The ERPMCC will:
1. Meet monthly to address issues that come before the RPMCC
2.*Establish new subcommittees as needed, generally in consultation with the full
RPMCC
3. Modify or disband subcommittees when they are no longer needed
4. Make decisions on routine matters, including budget and requests for speakers
5.*Determine which issues should be brought before the full RPMCC. Such issues
would normally include large budget expenditures, controversial issues, or any issue
that would have a significant impact on the project managers.
00The Chair of the RPMCC will:
1. Provide overall direction to the proceedings of the RPMCC
2. Coordinate with the ERPMCC requests for speakers on project management issues
3.*Arrange and organize monthly meetings of the RPMCC. When appropriate, issues
will be brought to the full RPMCC in a monthly CPMS meeting
4.*Communicate RPMCC activities to Center management when appropriate or when
requested
00The Executive Secretary of the RPMCC will:
1.*Document decisions made by ERPMCC and file on the PMCC shared drive
(
\\cds013\pmcc ) using the following format: pmcc\erpmcc\minutes\year-month-day
2.*Maintain on the common shared drive a current list of project management-related
subcommittees, a brief description of the issues the subcommittees are addressing,
and subcommittee members
Originator: Executive Regulatory Project Management Coordinating Committee
Effective Date: 2/26/96, 11/06/02
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MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH
MAPP 7500.1
00Subcommittees will:
1. Complete projects assigned by RPMCC within agreed-upon time frames
2.*Ensure that proposals for programs, policies, and procedures developed by the
subcommittees are submitted to ERPMCC for review and approval prior to broader
circulation for comment
3. Establish working groups, as necessary, to bring in additional expertise on specific issues
00Chairs/Co-Chairs of Subcommittees will:
1.*Report to the RPMCC at least annually to describe the status of all projects in which they
are engaged, and obtain RPMCC input and direction
2.*Schedule and conduct meetings to fulfill the subcommittee's objectives. The Vice-Chair
assumes the responsibilities of Chair in his/her absence.
3.*Ensure preparation of brief minutes of each subcommittee meeting, distribute them to
subcommittee members, and post on the PMCC shared drive using the following format:
pmcc\subcommittee name\minutes\year-month-day
4. Maintain appropriate files on committee work
5.*With assistance of the subcommittee members, create and maintain a Task List for the
subcommittee, describing major tasks the subcommittee is undertaking, projected
milestones and completion dates, and the current status of each project
6.*Obtain input from ERPMCC on documents proposing programs, policies, or procedures
prior to distribution to individuals or groups outside the Center or to CDER staff other
than the RPMCC or its subcommittees
00Members of Subcommittees will:
1.*Represent the views of their discipline, division, or office on issues considered by the
subcommittee
2.*Obtain concurrence from management for their participation on the subcommittee and
communicate with their discipline, division, or office management (whichever is
appropriate) regarding the deliberations of the subcommittee
3.*Regularly attend the meetings of the subcommittees for which they are designated
members, and contribute to the work of the committee
EFFECTIVE DATE
This MAPP is effective upon date of publication.
Originator: Executive Regulatory Project Management Coordinating Committee
Effective Date: 2/26/96, 11/06/02
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