Chapter 3: Roles and Responsibilities

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Contact: Policy Bureau Enquiries

The primary responsibility for issue analysis and guidance development rests with the Project Lead (i). The Lead Director (ii), and Directorate Management Committee (DMC) Members (iii) provide support, and review and approve documents throughout the process. The Publications Unit, Therapeutic Products Directorate (TPD) or Website Coordinator, Biologics and Genetic Therapies Directorate (BGTD) (iv) provides support prior to publication of the documents. Once a document has been published, the Contact (v) assumes ongoing responsibility for the process.

(i) Project Lead

The Project Lead is responsible for:

• discussing the need for issue analysis and/or guidance development with the Lead Director;
• determining if work has been or is currently being undertaken on the issue (in Canada or in other jurisdictions), and incorporating it into the issue analysis and/or guidance development as appropriate;
• preparing the Action Plan;
• presenting to DMC with Lead Director at key points in process;
• leading the Working Group if one is formed;
• writing the Issue Analysis Summary (IAS);
• writing the Guidance Document (if applicable);
• conducting internal and external consultations, reviewing comments received, revising documents as appropriate, and documenting the analysis of comments;
• ensuring translations are verified;
• liaising with other bureaux/centres/offices on content issues;
• ensuring Corporate Memory records for assigned issue analysis and guidance development processes are complete and filed appropriately; and
• responding to any requests received on the issue analysis and guidance development processes for a particular issue under the Access to Information Act.

The Project Lead will manage the project and will have overall responsibility and accountability. The Project Lead will not necessarily complete all steps his/herself, but will be responsible for ensuring each task is completed, as well as coordinating the activities of others in the process. Note that one or more of these responsibilities (particularly the drafting of the IAS and Guidance Document) may be contracted to an external party; in this situation, the Project Lead is responsible for managing the contract and its deliverables.

Note that the Project Lead can be identified from anywhere in the relevant Directorate; however, the relevant policy areas must be kept informed of developing issues.

(ii) Lead Director/ Senior Manager

The Director or Senior Manager of the Lead Bureau/Centre/Office (referred to as the Lead Director) is not necessarily the Project Lead's Director, but is responsible for:

• approving the development of Action Plans;
• ensuring deliverables are produced in a timely manner;
• ensuring the issue analysis and guidance development processes are being followed;
• serving as the link between the Project Lead and DMC;
• approving draft documents prior to internal consultation and prior to presentation to DMC;
• signing off on both process and content for issue analysis and guidance development; and
• assigning ongoing responsibility for a guidance document to a Contact, and ensuring the Contact is aware and appropriately resourced to fulfil that role.

(iii) Directorate Management Committee (DMC) Members

The members of the TPD and BGTD Management Committees are responsible for:

• ensuring a Lead Bureau/Centre/Office has been identified for each issue brought to its attention;
• ensuring adequate resources are available within each of their respective Bureaux/Centres/Offices for issue analysis and guidance development;
• encouraging staff within each of their respective Bureaux/Centres/Offices to provide input into issue analysis and guidance development;
• approving Action Plans, implementation plans, training plans, draft documents prior to external consultations, final versions of documents, etc.;
• providing feedback to the Project Lead as requested throughout the process; and
• keeping staff of their respective Bureau/Centre/Office informed of the progress of issue analysis and guidance development, of documents being distributed for comment internally, and of those being implemented.

(iv) Publications Unit/Website Coordinator

The Publications Unit, TPD or Website Coordinator, BGTD is responsible for:

• providing assistance regarding templates, formatting, etc.;
• maintaining the Metatag Database;
• ensuring publications are in accordance with Treasury Board and Health Canada policies related to publications;
• disseminating published documents internally from a generic e-mail account;
• arranging for posting of documents on the Health Canada web site;
• maintaining lists of Contacts for published documents;
• setting up a standard review cycle for each published document; and
• informing the Contact when each published document is to be reviewed.

(v) Contact

When the issue analysis and guidance development processes are completed and final documents are posted, a position or unit will be assigned ongoing responsibility for each published document. This position or unit, called the Contact, will be assigned by the Lead Director/Senior Manager and is responsible for:

• receiving, reviewing and responding to comments on the document(s) from internal and external sources;
• deciding whether to initiate review/revision outside of the regular cycle;
• ensuring resources (money, human resources) are available in the budget for periodic review/revision according to set cycle;
• working with the Lead Director identify a Project Lead when review/revision is initiated; and
• conducting an evaluation of the document(s) in accordance with the Evaluation Plan.