SUPPLEMENTARY INFORMATION:

Background: ORI oversees and directs U.S. Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services, except for the regulatory research integrity activities of the Food and Drug Administration. ORI is a program office within the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Health in the Office of the Secretary.

Core to ORI's mission are education activities for PHS-funded research institutions to teach the responsible conduct of research, promote research integrity, prevent research misconduct, and enable such institutions to respond effectively to allegations of research misconduct. (65 FR 30600, 30601 [May 12, 2000]). Co-sponsored Events contribute to this mission by providing education, training, and/or the opportunity to discuss topics such as handling allegations of research misconduct and fostering research integrity, the responsible conduct of research, and gold standard research practices. Gold standard research exemplifies the highest levels of scientific rigor, transparency, reproducibility, and adherence to ethical standards. Co-sponsored Events typically accept between 20 and 150 attendees and convene for one to three days.

Co-sponsors will work with ORI staff to jointly develop an Event. Both ORI and co-sponsors must contribute substantively to the development of the Event. Co-sponsors may charge registration fees but only at levels necessary to recover Event-related expenses. Co-sponsors are also solely responsible for collecting and handling any registration fees.

Eligibility for Co-Sponsorship: Potential co-sponsors must:

• Have demonstrated interest and experience in fostering the responsible conduct of research or handling allegations of research misconduct.
• Substantively contribute to the content of the co-sponsored Event beyond funding, logistical services, or other material support.

Expression of Interest in Co-Sponsorship: An entity may submit an expression of interest individually or jointly with other entities, describing their relative contributions. Please note that ORI may hold exploratory discussions with potential co-sponsors after initial review of submissions. Entities interested in co-sponsoring an Event with ORI should submit a one- to two-page, single-spaced document in at least 11-point font that includes the following:

1. Contact information for the entity's representative(s), including full name, role, email address, and phone number.

2. A brief summary (one to two paragraphs) detailing why ORI should select the entity, including demonstrated interest and experience in the responsible conduct of research or handling allegations of research misconduct.

3. A bullet outline addressing the eight topics listed below (roughly one paragraph each):

a. The entity's demonstration of leadership and management of matters involving research integrity.

b. The entity's prior experience and current readiness to undertake the responsibilities of co-sponsoring an Event with ORI.

c. The type of Event(s) that the entity is interested in co-sponsoring with ORI.

d. The entity must be willing to substantively contribute to the co-sponsored Event.

e. Facilities available for the Event(s), including the distance from the facilities to a major airport.

f. Any current constraints with respect to dates or facilities, and a suggested time frame of dates (at minimum, month(s) and year for the Event).

g. Whether the entity has co-sponsored an Event with ORI in the past 36 months.

h. Whether the entity has any active research misconduct proceedings (regardless of status) of which ORI is unaware.

Evaluation Criteria: After engaging in exploratory discussions with potential co-sponsors who respond to this notice, HHS will apply the following five considerations, as appropriate and relevant, to select the co-sponsor(s):

1. Qualifications and capability to fulfill co-sponsorship responsibilities.

2. Suitability of the location of the proposed Event in terms of the overall geographical distribution of recent or planned ORI Events.

3. Potential for the Event to engage an adequate number of attendees.

4. Availability and description of facilities needed to support the Event.

5. Availability of administrative support for the logistics of hosting the Event.

The duties of the co-sponsor will be outlined in a co-sponsorship agreement with ORI that will set forth details of the co-sponsored Event, including the requirement that any fees collected by the co-sponsor shall be limited to the amount necessary to cover the co-sponsor's Event-related expenses. A co-sponsorship agreement does not represent an endorsement by ORI of an individual co-sponsor's policies, positions, or activities.

91 FR 58687