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Drugs and Health Products

Action Plan -
Issue / Guidance and Development

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Contact: Policy Bureau Enquiries

TPD/BGTD

1. Name of Issue

2. Project Lead

Name of person/persons who drafted Action Plan and will be lead for project.

3. Lead Director/Senior Manager

Lead Director/Senior Manager responsible for the project (not necessarily the Director/Manager of the Project Lead).

4. Identification of Issue

Include the background of the issue and a brief description of issue or problem as it appears initially in "current state" terms. Include how the issue was identified, how long it has been in existence, and what has triggered the issue analysis at this time. Indicate why the issue should be considered a priority.

Background

Current State

Priority of Issue

5. Relates to Branch Goal and Key Activity or TPD Project Area

Name of goal and key activity as per Strategic Framework, or project area.

6. Relates to Program Activity Code / Internal Order Number

Identify coding if relevant to specific program activity or internal order number.

7. Impact of Issue

How does this issue impact on the operations, policies, etc. of other Bureaux/Centres/Offices, or of other Directorates, Departments, or areas of Government?

8. Project Management

Project Team and Time Required (indicate name, responsibility, and estimated time required per responsibility; these are proposed members)
Project Manager:
Project Leader:
Policy Analyst:
Regulatory Officer:
Support:

9. Resources Required (indicate estimated resources required)

FTE: (e.g. 0.1 FTE (10% of 1 FTE) x 10 working group members x 3 months)
Contracts:
Consultation:
Printing costs, miscellaneous:
Translation:

Working Group Members (indicate targeted areas from which participation is requested)

Documentation
Where will documents be filed (paper and electronically)?

10. Project Plan

Workplan Phases (general description of how project will proceed)

Use steps in SOP #1 (Issue Analysis in TPD/BGTD) and SOP #2 (Guidance Development in TPD/BGTD) as guide.

Proposed Workplan
For every phase identified under Workplan Phases section above, include a proposed list of steps sorted by proposed target date and lead for each step. Include the proposed schedule for updates to management and management approvals, the internal and external consultations to be conducted, how and when other Directorates or other regulatory agencies will be involved, anticipated communications pieces, etc.

Action Target Date By Whom Status
Phase #
Identify the specific steps to be completed Identify the proposed completion date Identify the proposed lead This will be updated as steps are completed
e.g. Form Working Group      
e.g. Draft IAS      
e.g. Consult internally      
e.g. Consult externally      
e.g. Present to DMC for approval      
e.g. Conduct international scan      
e.g. Draft guidance document      

11. Approval of Action Plan (Identify all those who need to approve the Action Plan and the proposed process)

Responsible Authority(ies) Date Approved
e.g. Lead Director/Senior Manager  
e.g. Directorate Management Committee