Strategic_Planning_SOW_-_Revised_.pdf

STATEMENT OF WORK

1. Title: Strategic Planning Support for NIOSH’s National Personal Protective

Technology Laboratory

2. Period of Performance: Three years after award of the task order. Contract is for one year base, with two option years. This is a firm fixed price type contract.

3. Purpose:

The purpose of this contract is to provide strategic planning support services to the

National Personal Protective Technology Laboratory (NPPTL), including its Personal

Protective Technologies and Public Safety Programs, and other activities in furtherance of its mission. The National Institute for Occupational Safety and Health (NIOSH) undertakes initiatives to strategically position its programs and activities to better protect the health and safety of American workers.

4. Background:

NPPTL is a division of NIOSH, within CDC that has as its mission: to prevent work-related injury, illness, and death by advancing the state of knowledge and application of personal protective technologies (PPT).

The Laboratory is responsible for (1) conducting work site surveillance of hazards for which protective technologies and equipment are used to protect workers, and studies patterns of personal protective technology (PPT) use; (2) conducting a variety of laboratory and field research relating to the development and evaluation of innovative personal protective technologies and equipment; (3) researching and developing criteria, standards and guidelines relating to PPT performance, quality, reliability and efficacy; (4) directing and performing the NIOSH respirator approval program and related laboratory, field, quality, and records activities; (5) producing and disseminating research findings, technical information, training materials, performance criteria, and recommendations for using personal protective equipment to improve protection of workers; and (6) developing, studying and assessing the effectiveness of communications and training approaches and technologies relating to PPT.

These initiatives and activities include:

Building a New Institute (BNI) across NIOSH - an Institute-wide activity to improve the quality of all scientific activities, including prioritization methodologies and metrics

PPE Policy Group (PPG) – an Institute-wide activity to coordinate all respirator and non-respirator PPE Policy efforts, including the expansion of post-certification responsibilities

Various program analysis and review efforts, including:

PPT and Public Safety Review efforts, PPT and Public Safety Strategic Planning activities and Institute-wide congressional and external inquiries.

Annual NIOSH Director’s Goal activities

NRC activities involving the Institute of Medicine’s Committee on Personal

Protective Equipment (COPPE)

NPPTL’s Mid-Year Review, reviewing all NPPTL program and administrative functions

PPT Program Healthcare worker action plans, Public safety action plans, and Mine escape policy development issues.

NPPTL Program/Project and Budget Formulation Process, - a revision to the annual process used to define all program and supporting projects and NPPTL-wide budgets for the up-coming fiscal year

PPT Program Professional Judgment Budget, - revisions, as requested, to a comprehensive definition, analysis, and justification of the PPT Program and funding

NIOSH integration of FDA and NIOSH clearance and approval processes for respirators used in Healthcare.

In the performance of its activities, NPPTL produces many types of technical outputs primarily aimed at the technical communities researching, manufacturing, using, and regulating the various types of personal protective technologies and equipment. These outputs include technical papers and peer-reviewed manuscripts, presentations at technical meetings and conferences, and various types of guidance, recommendations, and policy documents.

5. Specific Requirements:

The following services shall be provided in support of NIOSH and NPPTL roles stated in

Section 4:

a. NPPTL is responsible for implementing the requirements of 42 CFR 84 pertaining to the certification of respirators for use in American workplaces. This responsibility includes the periodic updating of these regulations. NPPTL is undertaking a major effort to evaluate the potential use of national and international consensus standards to supplement the CFR implementing mechanism. Additionally, NPPTL is considering making additional changes to its rule for updating the fee schedule used to support the activities of the certification application process.

The contractor shall develop strategies and implementing mechanisms, including approaches utilizing consensus standards, to provide for timelier updating of respirator regulatory requirements and for the incorporation of technological improvements that will provide higher levels for the protection for the American workforce. The contactor will also provide technical and legal support to updating rule-making efforts involving additional changes to the certification fee structure and other areas, as requested.

b. NIOSH has a leadership role in a multi-agency review of the preparedness of the

United States in the event of a near-future influenza pandemic. A focus has been on ensuring the appropriate level of respiratory protection and protective clothing for health care workers so that they will be able to continue to perform their needed duties during a pandemic. A White Paper concerning the demand for respiratory protective devices during such an event, including surgical masks, N95 industrial and N95 surgical FFRs, and elastomerics has been prepared; it details six priority areas. Additional strategies, implementing processes, and pre-pandemic training, testing and simulations will be required to ensure the Nation’s preparedness.

The contractor shall support all aspects of NPPTL participation on pandemic preparedness and emergency response activities, including the development of strategies in support of harmonizing the approval and clearance responsibilities of

NIOSH and the FDA and efforts with the CDC’s Division of the Strategic

National Stockpile optimizing PPE supply and distribution efforts during emergency preparedness scenarios.

c. Several comprehensive reviews of NIOSH and its management of the PPT

Program have been conducted by the National Research Council (and its Institute of Medicine). These reports present a series of strategic recommendations as to how NIOSH can accomplish its mission of preventing disease, injury, and death for the millions of American workers who rely upon personal protective equipment. Specific emphasis was placed on expanding NIOSH activities beyond respirators to cover all types of PPE.

The contractor shall prepare revisions to the PPT and Public Safety Program strategic initiatives, plans and activities, including those mentioned above, and others as they are defined and requested, to keep each current.

d. The contractor shall develop strategies for identifying and pursuing alternative sources of funding for NIOSH and the PPT Program (e.g. increasing certification fees, partnering with other government agencies, Cooperative Research and

Development Agreements [CRADAs] between industry and the laboratory, etc.)

e. The contractor shall prepare White Papers and PowerPoint presentations containing strategic approaches that analyze specific activities, including emerging issues, of importance to the mission of NIOSH.

f. The contractor shall be provided with written Task Orders for each specific effort requested under this contract.

6. Deliverables:

Technical guidance will be provided in consultation with the NPPTL senior leadership in consultation with the NPPTL director to identify specific tasks and deliverables related to the requirements listed in Section 5.

7. Staffing:

To perform the services in this task order, the Contractor Project Director shall have:

a) Demonstrated professional skills in administering Federal research and development programs;

b) Knowledge of the NIOSH organization and the management approaches used to further its mission and disseminate its outputs to improve the health and safety protections for American workers

c) Knowledge of the requirements of 42 CFR 84 and other personal protective technology regulatory and consensus standards; and,

d) Direct experience with the mission of NPPTL and its research, standards development, and conformity assessment program activities.

8. Management Requirements:

a) Project Schedule – Project schedules shall be established in consultation with the NPPTL Director.

b) Quarterly Progress Report – A Quarterly Progress Report shall be provided and is the responsibility of the Contractor Project Director. The report shall include: 1) Summary of activity progress and accomplishments during the last quarter, 2) Activities Planned for the next quarter, and 3) Issues, Concerns, Questions. The Contractor Project Director shall send the completed Quarterly

Activity Report to the NPPTL Project Officer no later than the 10th of the first month of the following quarter.

c) Meetings – Participate in 1) a kick-off meeting and final closeout meeting as may be required by NPPTL, 2) webinars, and 3) as required by NPPTL, attend meetings that may require travel. Participation in meetings requiring travel shall be at NPPTL expense.

9. Invoicing:

It is suggested that the vendor submit a quarterly invoice concurrent with the quarterly progress report. Payment of said invoice is contingent on acceptance of the quarterly report by the NPPTL Project Officer, Maryann D’Alessandro and the Contracting Officer. For each period the total price will be broken into quarterly payments based on the work conducted. If the vendor wishes to invoice differently please include this request in your proposal. This is a firm fixed priced contract.

10. Location:

NIOSH NPPTL is located at 626 Cochrans Mill Road, Pittsburgh, PA 15236. Services will be performed at the facility of the Contractor and at the NPPTL facilities in consultation with the NPPTL director.

11. Travel:

Travel will be determined in consultation with the NPPTL Director and travel costs shall be reimbursed at the Federal Travel reimbursement rates.