MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4100.1 Rev. 3
Originating Office: Office of Management, Immediate Office
Effective Date: 12/30/14; 8/3/16; 4/21/21; 6/21/2022 Page 1 of 20
POLICY AND PROCEDURES
OFFICE OF MANAGEMENT
CDER Co-Sponsorship Agreements for Events
Table of Contents
PURPOSE ..............................................................................1
BACKGROUND ...................................................................1
POLICY .................................................................................2
RESPONSIBILITIES ...........................................................3
PROCEDURES .....................................................................9
REFERENCES ....................................................................12
DEFINITIONS ....................................................................13
EFFECTIVE DATE ............................................................14
CHANGE CONTROL TABLE ..........................................15
ATTACHMENT 1: Co-Sponsorship Timeline ..................16
ATTACHMENT 2: Instructions for Terminating a Co-
Sponsorship Agreement .....................................................17
ATTACHMENT 3: Sample Prohibited Source
Justification Memorandum ................................................18
ATTACHMENT 4: Model Co-Sponsorship Agreement ...19
PURPOSE
The purpose of this MAPP is to ensure consistency and continuity across CDER as the
Center engages in not-for-profit events (including conferences, meetings, symposia,
webinars, and workshops) co-sponsored with organization(s)
1
that provide relevant
expertise and share a mutual interest and benefit in the subject matter.
CDER co-sponsors events to share CDER’s vision, policies, current thinking, and ideas.
When resources prohibit CDER from participating in a co-sponsorship agreement, CDER
may elect to participate with an organization in a limited capacity, such as acceptance of
a speaker request invitation.
BACKGROUND
A CDER co-sponsorship provides an opportunity for CDER to share resources and
expertise to benefit both CDER and another organization. The Department of Health and
1
Non-Federal organization.
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CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4100.1 Rev. 3
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Human Services (HHS) has increasingly recognized the benefits of co-sponsored events.
Improper use of the co-sponsorship mechanism can create legal and ethical concerns.
This MAPP is to be used by program offices when planning co-sponsored events.
Co-sponsorship agreements, as discussed in this MAPP, are not to be used for financial
transactions between or among the parties of co-sponsored agreements. Any transfer of
funds or other tangible assets must be the subject of a separate instrument, such as a
contract or cooperative agreement.
Co-sponsored events help CDER achieve objectives set forth in section 406 of the FDA
Modernization Act of 1997 (Public Law 105-115), which includes working closely with
stakeholders and maximizing the availability and clarity of information to stakeholders
and the public. Co-sponsorships may also facilitate agency outreach to small business
consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public
Law 104-121).
POLICY
1. Every co-sponsored event requires a co-sponsorship agreement. The co-
sponsorship agreement allows CDER and the co-sponsors to share resources, to
plan, and to make decisions about the event.
2. Multiple co-sponsored events, or events repeated over up to three times, may be
written into a single co-sponsorship agreement if (a) all co-sposoring organiations
are consistent throughout the series, and (b) contingent upon CDER’s re-review of
the co-sponorship agreement during the 60 days following each co-sponsored
event. Multi-event co-sponsorship agreements must:
a. Specify all locations and all fees for the duration of the agreement.
b. Include a provision allowing for agreement termination, or agreement
modification, by either party, for any reason, in the 60 days following each
event.
3. When co-sponsoring an event, FDA/CDER must be listed in the title of the event.
4. An FDA.gov posting on the Meetings, Conferences, & Workshops | Drugs page is
required for each event co-sponsored by CDER, to ensure transparency.
5. For all co-sponsored events, CDER Co-Sponsorship Coordinators and CDER
Subject Matter Experts (SME) review and clear all print and electronic publicity
and marketing materials.
6. CDER engages in co-sponsored events only when CDER is offered and allowed
input and review of the event planning, agenda preparation, speaker selections,
and other event logistics.
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CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4100.1 Rev. 3
Originating Office: Office of Management, Immediate Office
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7. If CDER’s requirements for input into event planning, agenda preparation, and
speaker selections, and other event logistics are not met by the co-sponsor, the
Co-Sponsorship Coordinator or the CDER SME will terminate the co-sponsorship
agreement. (Attachment 2.)
8. Use of the FDA or CDER logos by any organization is not permitted unless
specifically included in the terms of the co-sponsorship agreement, which must
specify the parameters for use of the logos.
9. Adherence to FDA’s Staff Manual Guide (SMG) 2340.1 Acceptance of Payment
for Travel Expenses from Non-Federal Sources is to be upheld at all times.
Employees will not solicit the payment for travel expenses.
10. Any fees charged for attendance of the co-sponsored event will be used for event-
related expenses, including reimbursing the costs of hosting the event and travel
related expenses for invited speakers. Transcripts and educational materials may
be sold, by the outside entity, at cost, to event participants.
11. CDER staff are not permitted to disclose proprietary confidential information.
RESPONSIBILITIES
CDER Director (or designee):
• Approves all CDER co-sponsorship agreements.
• Approves the Federal Register (FR) notice at the Center level, if an FR notice will
be used to publicize the co-sponsored event.
• Sends a termination letter to the co-sponsor, if terminating a co-sponsorship
agreement.
Office of Management Director:
• Appoints the CDER Co-Sponsorship Liaison.
Super Office Director (or designee):
• Appoints one or more CDER office Co-Sponsorship Coordinator(s) to facilitate
co-sponsorship agreements and all logistics for joint events.
• Decides whether to accept or reject co-sponsorship requests.
Office Director (or designee):
• Reviews each co-sponsorship agreement. Decides to accept or decline co-
sponsorship requests before seeking the super office director’s concurrence and
clearance.
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• If the co-sponsorship is with a “prohibited source,” drafts and signs a Prohibited
Source Justification Memorandum. (Attachment 3.)
• Ensures publicity materials do not indicate endorsement by FDA or CDER.
• Approves all print and electronic outreach and publicity materials, including
quotes from CDER officials.
• Receives updates on the co-sponsorship from the CDER SME and the Co-
Sponsorship Coordinator(s).
Co-Sponsorship Liaison:
• Reports to the Office of Management Director.
• Coordinates, processes, and tracks all CDER incoming co-sponsorship requests.
• Communicates through [email protected] email address.
• Refers incoming co-sponsorship requests to the appropriate CDER office Co-
Sponsorship Coordinator.
• Ensures each event is genuinely co-sponsored, with joint development of agenda,
programs, speaker selection, and other related activities.
• Ensures all co-sponsored events reflect CDER’s public health mission.
• Provides guidelines, training, and support to the CDER office Co-Sponsorship
Coordinators on appropriate publicity materials, acceptable registration fees,
travel and related expenses, drafting and clearing FR notices, and potential
conflicts of interest.
• Ensures the CDER clearance sheet accompanies the draft co-sponsorship
agreements throughout the clearance process, and is appropriately archived.
• Provides a template for co-sponsorship agreements to the CDER office Co-
Sponsorship Coordinators, in compliance with the HHS Model Co-Sponsorship
Agreement. (Attachment 4.)
• Solicits clearance from FDA Office of the Chief Counsel (OCC) regarding ethical
or legal issues pertaining to each co-sponsorship agreement. Ensures FDA OCC
consults with HHS Office of General Counsel (OGC) Ethics Division, if
necessary.
• When multiple events are drafted into a single co-sponsorship agreement, ensures
the CDER unit, FDA/OCC, and the outside organization each review the
agreement annually, during the 60 day window following each co-sponsored
event. Receives concerns from the CDER Co-Sponsorship Coordiantors.
Communicates concerns to FDA/OCC.
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• If a co-sponsorship agreement request is from an international regulatory
counterpart, directs the request to Office of Center Director (OCD) Strategic
Initiatives / International Programs at [email protected].
• As warranted, consults with the Memorandum of Understanding (MOU) contact
in CDER’s Office of Executive Programs to ensure FDA’s Office of Regulatory
Affairs (ORA) Office of Partnership is aware of any co-sponsorship agreement
between CDER and a state or local government entity.
• Ensures that applicable MOUs are referenced in co-sponsorship agreements.
• Drafts and secures email clearance for each web announcement for every co-
sponsored event. Ensures a maximum of 60 days of pre-event posting on
FDA.gov: Meetings, Conferences & Workshops | Drugs.
• Obtains CDER Director, or designee, approval of each co-sponsorship agreement.
• Directs requests to FDA's Office of External Affairs when a co-sponsorship involves
the participation of multiple FDA Centers.
• Recommends terminating a co-sponsorship agreement in the event a co-sponsored
event appears to be for profit.
• Recommends terminating a co-sponsorship agreement if publicity materials do
not meet CDER’s requirements.
• Provides instruction on terminating co-sponsored events when necessary.
(Attachment 2.)
• Ensures copies of financial records, final co-sponsorship agreements and
Prohibited Source Justification Agreements (if any) are secured and manintained
in a FDA Electronic Record Keeping System (ERKS), satisfy the Freedom of
Information Act (FOIA) and National Archives Records Administration (NARA)
requirements, within 60 days of the completion of each co-sponsored event.
• If two or three events are drafted into a single co-sponsorship agreement:
o Ensures the office director (or designee), and OCC both review the co-
sponsorship agreement immediately after each co-sponsored event.
o Communicates any office director concerns to OCC.
o Secures re-clearance of the agreement during the 60-day window
following each co-sponsored event, or based on concerns, arranges for
withdrawal from the co-sponsorship agreement.
CDER Office Co-Sponsorship Coordinator:
• Represents a specific CDER office or super office.
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• Coordinates with the CDER SME to draft a letter informing the organization of
the office director’s decision to accept or decline the request to co-sponsor an
event.
• Works with the organization and the CDER SME to develop the co-sponsorship
agreement. Ensures that all organizations are identified and represented in the
agreement. The co-sponsorship agreement includes the agenda, speakers,
logistics, communications plan, and other elements of the joint event.
• Coordinates with the office and super office to ensure the CDER SMEs are
appropriately involved with preparation of the co-sponsorship agreement and
planning of the co-sponsored event.
• If two or three events are drafted into a single co-sponsorship agreement:
o Collaborates with the Co-Sponsorship Liaison to ensures the office
director (or designee), and OCC both review the co-sponsorship
agreement immediately after each co-sponsored event.
o Communicates any office director concerns to the Co-Sponsorship
Liaison.
o Secures office director re-clearance of the agreement during the 60-day
window following each co-sponsored event, or based on CDER concerns,
arranges for withdrawal from the co-sponsorship agreement.
o Collaborates with the outside organization. If the outside organization
wishes to withdraw from, or to modify the co-sponsorship agreement,
ensures the organization’s plans are communicated to and cleared by the
Co-Sponsorship Liaison, the office director (or designee), and OCC,
during the 60-day window following each co-sponsored event.
• Maintains communications with the CDER super office director or designee.
• Coordinates with the CDER Co-Sponsorship Liaison to ensure the co-sponsorship
agreement(s) comply with relevant statutes, regulations, and policies.
• Coordinates with the CDER SME to draft a Prohibited Source Justification
Memorandum, if necessary.
• Tracks and secures co-sponsorship agreement clearance from the organization.
• Ensures compliance with travel restrictions dictated by form 348 Travel (SMG
2340.1, Acceptance of Payment for Travel Expenses from Non-Federal Sources).
• Reviews and tracks fees for all co-sponsored events. If attendee fees appear
higher than necessary to cover the cost of the event, consults with the CDER Co-
Sponsorship Liaison to evaluate if it is appropriate to terminate the co-sponsored
event.
• Ensures the co-sponsor does not use HHS, FDA, or CDER images or logos
inappropriately. Ensures compliance with the FDA Logo Policy.
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• Maintains copies of all cleared publicity materials, including printed brochures
and Web pages.
• Ensures publicity materials using FDA’s or CDER’s logo, or biography
information of any FDA employees, are not available until all required signatures
are obtained for the co-sponsorship agreement and the agreement is fully
executed. Directs publicity materials to the office director, or designee, for
approval.
• Ensures the organization does not use quotes or endorsements from CDER staff
unless prior approval of quotes or endorsements is obtained from the appropriate
CDER office director or designee.
• Ensures no quotes or endorsements appear in electronic or print media, in advance
of the co-sponsorship agreement being fully cleared.
• If quotes or endorsements appear in electronic or print media in advance of the
co-sponsorship agreement being fully cleared, or without prior approval of the
office director, contacts the outside organization, and ensures the quote or
endorsement is removed or retracted.
• If the outside organization refuses to remove or retract unauthorized quotes,
endorsements, advertisements, or marketing in electronic or print media, engages
in the steps necessary to terminate the co-sponsorship agreement. (See
Attachment 2.)
• In less than 45 days after each co-sponsored event, receives an accounting of
financial records from the outside organization, and forwards this accounting to
the Co-Sponsorship Liaison.
• Approves the web announcement of the co-sponsored event.
Subject Matter Expert:
• Works with the assigned CDER office Co-Sponsorship Coordinator.
• Coordinates with the CDER office Co-Sponsorship Coordinator to share the
office director’s approval or denial of the request to co-sponsor an event.
• Coordinates with the CDER office Co-Sponsorship Coordinator to draft a
Prohibited Source Justification Memorandum, if necessary.
• Provides updates to the CDER office director (or designee).
• Works with the co-sponsor and the CDER office Co-Sponsorship Coordinator to
draft and finalize the co-sponsorship agreement.
• Ensures publicity materials are appropriate.
• Shares all print and electronic publicity materials with the CDER office Co-
Sponsorship Coordinator.
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• Ensures all co-sponsored events reflect CDER’s public health mission.
• Works with the co-sponsor and the CDER office Co-Sponsorship Coordinator on
the event planning, agenda preparation, speaker selections, and other event
logistics.
• Reviews and clears the FDA.gov announcement for the co-sponsored event.
• If an FR notice will be published, drafts, reviews, clears and processes the FR
notice in accordance with Office of Regulatory Policy’s (ORP) requirements.
• If two or three events are drafted into a single co-sponsorship agreement:
o Collaborates with the Co-Sponsorship Coordiantor to ensures the office
director (or designee), and OCC both review the co-sponsorship
agreement immediately after each co-sponsored event. Communicates any
concerns about future co-sponsored events to the Co-Sponsorship Liaison.
o Collaborates with the outside organization. If the outside organization
wishes to withdraw from, or to modify the co-sponsorship agreement,
ensures the organization’s plans are communicated to and cleared by the
Co-Sponsorship Coordiantor, the office director (or designee), and OCC,
during the 60-day window following each co-sponsored event.
FDA Office of the Chief Counsel (FDA OCC):
• Evaluates and clears draft co-sponsorship agreements for programmatic issues.
• When multiple events are drafted into a single co-sponsorship agreement, re-
reviews the agreement during the 60 day window following each co-sponsored
event. Communicates concerns to the Co-Sponsorship Liaison.
• Evaluates each draft co-sponsorship for prohibited sources.
• If a prohibited source is apparent, and the decision is made to continue to include
the prohibited source in the co-sponsorship, requires a signed Prohibited Source
Justification Memorandum from the sponsoring CDER office director before
clearance. (Attachment 3.)
• Signs the electronic clearance sheet. Returns this sheet to the CDER Co-
Sponsorship Liaison at [email protected].
• Provides advice to the Co-Sponsorship Liaison and the CDER office Co-
Sponsorship Coordinator if a co-sponsor is not following FDA’s requirements.
Terminating the co-sponsorship agreement may be necessary.
• Evaluates if HHS OGC Ethics Division should review the draft co-sponsorship
agreements. Collaborates with OGC, if appropriate.
• Receives comments from HHS OGC. Shares any comments, as appropriate, with
the CDER Co-Sponsorship Liaison.
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HHS Office of General Counsel (OGC) Ethics Division:
• Evaluates draft co-sponsorship agreements for ethics issues, if requested, by FDA
OCC.
• Coordinates the review of the draft co-sponsorship agreements with FDA OCC.
• Forwards reviewed CDER draft co-sponsorships, with comments, to FDA OCC.
CDER Office of Regulatory Policy (ORP):
• Reviews and approves FR notices for any co-sponsored events publishing an FR
notice. Obtains CDER Director clearance of the FR notice on behalf of the
requestor.
• If a controversial or novel issue is presented, determines whether FDA OCC
should review the FR notice, then informs FDA OCC that their review is
necessary, and obtains FDA OCC clearance of the FR notice.
• Upon final clearance of the FR notice, submits the notice to the FDA Regulations
Policy and Management Staff (RPMS) system for processing on behalf of the
requesting office.
Office of the Commissioner, Office of Policy and Planning, Office of Policy,
Regulations, Policy and Management Staff:
• Processes and prepares FR notices for publication, if applicable.
OCD Strategic Initiatives / International Programs:
• When notified of a cleared co-sponsorship agreement involving an international
regulatory counterpart, communicates with the CDER office Co-Sponsorship
Coordinator and the CDER SME to provide appropriate guidance and feedback.
PROCEDURES
2
1. An organization contacts a CDER office with a co-sponsorship request.
2. The CDER office Co-Sponsorship Coordinator forwards the requesting
documents to the office director, or designee, for clearance.
3. The CDER office director, or designee, accepts or declines the co-sponsorship
request based on the following considerations:
2
See Attachment 1, Co-Sponsorship Timeline.
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a. Is the organization requesting the co-sponsorship agreement a prohibited
source?
• If the organization is a prohibited source, the benefits to the Department of
Health and Human Services must clearly outweigh any potential
appearance of undue influence or preferential treatment for a co-
sponsorship to move forward.
b. Is there a potential conflict of interest?
c. Does the requesting organization have substantive expertise in the subject
matter of the event?
d. How will the co-sponsorship agreement benefit CDER?
e. Do CDER and the requesting organization have a mutual interest and benefit
in the proposed co-sponsored event?
f. Will the proposed co-sponsorship agreement advance CDER’s mission and
priorities?
g. Will the proposed event allow CDER an opportunity to deliver a message to
an appropriate audience?
h. Does CDER have the resources and staff available to dedicate to the co-
sponsored event?
i. Is there enough time to effectively complete this co-sponsorship request? A
minimum of 3 months is preferred to plan a co-sponsored event. This allows
adequate time to draft and clear the co-sponsorship agreement and to ensure
adequate planning, speaker selection, and appropriate publicity for the event.
• If travel is required for the event, an additional 3 months are
recommended.
• If an FR notice will be published for a co-sponsored event, an additional 2
months are recommended.
4. The office director informs the super office director of the request for approval of
the co-sponsorship. The office director and super office director must be in
concurrence.
5. The office director communicates the conditional decision to accept or to decline
the co-sponsorship request to the CDER office Co-Sponsorship Coordinator.
6. The CDER office Co-Sponsorship Coordinator forwards the office director’s
decision to accept or decline the request to the CDER Co-Sponsorship Liaison.
7. The CDER office Co-Sponsorship Coordinator or the CDER SME informs the
requesting organization whether the request is conditionally accepted or declined.
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Writing and Clearing the Co-Sponsorship Agreement:
1. All co-sponsorship requests are conditionally accepted until the co-sponsor’s
representative, the CDER office Co-Sponsorship Coordinator, and the CDER
SME negotiate the terms of the co-sponsorship agreement using the template
provided by the CDER Co-Sponsorship Liaison. The agreement outlines the
responsibilities of CDER and each co-sponsor.
2. The CDER office Co-Sponsorship Coordinator works with the co-sponsor, and
the CDER SME, to draft a co-sponsorship agreement.
3. The CDER office Co-Sponsorship Coordinator and the CDER SME share the
draft co-sponsorship agreement with the office director, or designee, for
clearance.
4. The CDER office Co-Sponsorship Coordinator forwards the draft co-sponsorship
agreement, and the tracking sheet, to the CDER Co-Sponsorship Liaison at
[email protected], for FDA OCC clearance.
5. The CDER Co-Sponsorship Liaison solicits FDA OCC clearance from the
[email protected] email address.
6. If HHS OGC clearance is required, FDA OCC alerts the CDER Co-Sponsorship
Liaison, and obtains the HHS OGC clearance or comments.
7. FDA OCC shares FDA OCC and HHS OGC comments or clearance, via email,
with the CDER Co-Sponsorship Liaison. The CDER Co-Sponsorship Liaison
forwards comments or clearance to the CDER office Co-Sponsorship Coordinator
and the CDER SME.
8. If FDA OCC or HHS OGC comments require reconciliation, the CDER office
Co-Sponsorship Coordinator, or the CDER SME, incorporates the comments into
a resvision of the draft co-sponsorship agreement. This revised draft is returned to
the CDER Co-Sponsorship Liaison, for FDA OCC clearance.
9. After FDA OCC clearance is received, the CDER office Co-Sponsorship
Coordinator obtains an electronic signature from the co-sponsor’s executive. This
signed agreement is forwarded to the CDER Co-Sponsorship Liaison.
10. The CDER Co-Sponsorship Liaison obtains the CDER Director’s signature on the
draft co-sponsorship agreement signed by the co-sponsor’s executive.
11. The CDER Co-Sponsorship Liaison shares the approved co-sponsorship
agreement with the CDER office Co-Sponsorship Coordinator. The CDER office
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Co-Sponsorship Coordinator shares the approved co-sponsorship agreement with
the co-sponsor.
12. If this is an international event, the CDER Co-Sponsorship Liaison also notifies
OCD Strategic Initiatives / International Programs at
The Web Notice:
1. The CDER Co-Sponsorship Liaison, or designee, drafts the web notice to be
posted on the FDA.gov Meetings, Conferences & Workshops | Drugs page.
2. The CDER SME reviews and approves the CDER web notice.
3. The CDER Co-Sponsorship Liaison ensures appropriate posting of the web notice
a maximum of 60 days before the event.
Speakers:
1. Speaker requests for CDER staff are not automatically approved. Each speaker
request must be processed and officially cleared by CDER’s Speaker Liaison as
outlined in CDER MAPP 4510.1, CDER Authorization and Tracking of Outside
Speaker Clearance.
2. CDER staff who present at co-sponsored events must have their speeches
reviewed and cleared before the co-sponsored event, as outlined in CDER MAPP
4510.2, Clearance of Speeches, Articles, and Other Communication Materials.
REFERENCES
1. FDA Modernization Act of 1997.
2. Small Business Regulatory Enforcement Fairness Act of 1996.
3. Freedom of Information Act, as amended, 1996.
4. Legal memorandum of August 8, 2002, entitled "Co-Sponsorship Guidance,"
issued by the HHS Designated Agency Ethics Official.
5. HHS, 2012, HHS Travel Manual.
6. FDA, 1991. Staff Manual Guide 2150.2, Grants and Cooperative Agreements.
7. FDA, 2017. Staff Manual Guide 2128.2, FDA Visual Identity Program. (Ref. sec.
5, Visual Identity Logo Policy.)
8. FDA, 2008. Staff Manual Guide 2340.1, Acceptance of Payment for Travel
Expenses from Non-Federal Sources. (Ref. sec. 348 Travel.)
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9. FDA, 2020. Staff Manual Guide 2830.3, Agreements With Other Government
Agencies – International Arrangements with Foreign Government Agencies and
International Organizations.
10. FDA, 2017, MAPP 4100.2, CDER Participation in Public Private Partnerships
and Consortia.
11. FDA, 2002, MAPP 4140.5, Submitting Issues and Documents to the Office of the
Chief Counsel for Legal Review, Comment, or Clearance.
12. FDA, 2013, MAPP 4510.1 Rev. 1: CDER Authorization and Tracking of Outside
Speaker Clearance.
13. FDA, 2013, MAPP 4510.2. Clearance of Speeches, Articles, and Other
Communication Materials.
14. 21 USC 331(j). Prohibited Acts.
15. 18 USC 1905. Disclosure of Confidential Information Generally.
DEFINITIONS
Co-Sponsorship Agreement – The official document, signed by the CDER Director and
the executive of a co-sponsor, that itemizes responsibilities for a co-sponsored event.
FDA and CDER logos and biographical information on FDA employees may not be used
in publicity or outreach efforts until the co-sponsorship agreement establishing the
parameters for such use has been signed by all parties.
Co-Sponsorship Event – A joint conference, seminar, symposium, educational program,
public information campaign, or similar event related to the mission of CDER. This
single event involves CDER and one or more co-sponsors who provide relevant expertise
and share a mutual interest and benefit in the subject matter. These events may not
generate monetary profit for any of the co-sponsors involved.
Co-Sponsorship Request – A specific request received from an organization interested
in engaging in a co-sponsorship agreement with CDER. Co-sponsorship requests are to
be directed to the CDER Co-Sponsorship Liaison, who determines the appropriate CDER
office and notifies the CDER office Co-Sponsorship Coordinator. The appropriate CDER
super office director or office director will accept or deny the co-sponsorship request.
Co-Sponsor – A private, non-Federal organization (e.g., an association, corporation,
foundation, or university).
Prohibited Source – Any person or entity that: (a) is seeking official action by the
agency planning the event; (b) does business or seeks to do business with that agency; (c)
conducts activities regulated by that agency; (d) has interests that may be substantially
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CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4100.1 Rev. 3
Originating Office: Office of Management, Immediate Office
Effective Date: 12/30/14; 8/3/16; 4/21/21; 6/21/2022 Page 14 of 20
affected by the performance or nonperformance of the official duties of an employee of
that agency; or (e) is an organization the majority of whose members are described in (a)
through (d) above.
Prohibited Source Justification Memorandum – A memorandum, signed by a CDER
office director, presented with the draft co-sponsorship agreement, for FDA OCC to
review. This memorandum is appropriate when the prohibited source has a special
expertise or status, making them the preferred partner in a co-sponsored event.
Public Private Partnership (PPP) – As per CDER MAPP 4100.2, PPP or consortium is
an on-going collaborative group managed by a convening or coordinating organization
involving multiple stakeholder organizations including at least one non-profit or 501(c)
(3) organization (e.g., academia, government, or foundation) and at least one for-profit
organization (e.g., pharmaceutical, biotechnology, or medical device company). The PPP
or consortium is an on-going effort that typically involves multiple meetings, committees,
and working groups aimed at addressing scientific or regulatory issues over an extended
period of time through an exchange of views, experience, or expertise and, as
appropriate, a commitment of resources to scientific research and analysis. CDER staff
are required to follow the clearance process outlined in MAPP 4100.2 to participate in a
PPP or consortium activity.
Speaker – Any CDER employee invited, as a speaker or a panelist, to present at an event
of any outside organization or CDER co-sponsorship. Speakers are required to follow the
speaker clearance process outlined in CDER MAPP 4510.1 for each speaker request. A
co-sponsored event may have multiple speakers. Each speaker requires clearance from
the employees’ speaker clearing official. A speaker contract does not require a co-
sponsorship agreement.
Subject Matter Expert (SME) – An FDA employee with expert knowledge of the
subject who is involved in planning the meeting (e.g., a project specialist, project
manager, medical officer, or consumer safety officer) and communicates with the CDER
Co-Sponsorship Liaison, CDER office Co-Sponsorship Coordinator, and the co-sponsors
to write the co-sponsorship agreement.
EFFECTIVE DATE
This MAPP is effective upon publication.
MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4100.1 Rev. 3
Originating Office: Office of Management, Immediate Office
Effective Date: 12/30/14; 8/3/16; 4/21/21; 6/21/2022 Page 15 of 20
CHANGE CONTROL TABLE
Effective
Date
Revision
Number
Revisions
12/30/2014
Initial
n/a
8/3/2016
Rev. 1
• Removed FR Notice Requirement.
• Removed FDA Ethics involvement.
• Inserted HHS OGC involvement.
• Minor edits for clarity. Edited graphics to
reflect the change in text.
4/21/2021
Rev. 2
• Inserted Prohibited Source Justification
Memorandum instruction and template.
• Minor edits to reflect change of process in
coordinating with FDA OCC, HHS OGC, and
CDER’s Web Team.
• Removed FR Notice instructions.
• Removed HHS Co-Sponsorship Guidance
Memorandum, dated August 8, 2002.
6/21/2022
Rev. 3
• Allows for two or three co-sponsored events to
be drafted into a single CDER co-sponsorship
agreement.
• Describes additional clearances and
contingencies for multi-event agreements.
MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4100.1 Rev. 3
Originating Office: Office of Management, Immediate Office
Effective Date: 12/30/14; 8/3/16; 4/21/21; 6/21/2022 Page 16 of 20
ATTACHMENT 1: Co-Sponsorship Timeline
MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4100.1 Rev. 3
Originating Office: Office of Management, Immediate Office
Effective Date: 12/30/14; 8/3/16; 4/21/21; 6/21/2022 Page 17 of 20
ATTACHMENT 2: Instructions for Terminating a Co-Sponsorship Agreement
1. CDER office Co-Sponsorship Coordinators will monitor the co-sponsorship
actions of co-sponsors to ensure:
a. Fees are reasonable to cover the cost of hosting the event, but co-sponsors will
not profit from the event.
b. Images and logos are used appropriately.
c. Publicity materials using FDA’s or CDER’s logo, and biographical
information of any FDA employees, are not distributed until the co-
sponsorship agreement is signed.
2. In the event that a co-sponsored event appears to have attendee fees higher than
necessary to cover the cost of the event, images or logos are used inappropriately,
or marketing materials are released prematurely, the CDER office Co-
Sponsorship Coordinator will ask the co-sponsor to address the concern and
provide corrective action.
3. In the event that the co-sponsor refuses to adequately address the concern, or does
not take enough corrective action to satisfy the CDER office Co-Sponsorship
Coordinator, the CDER office Co-Sponsorship Coordinator will alert the CDER
Co-Sponsorship Liaison.
4. If the CDER Co-Sponsorship Liaison concurs that the co-sponsor is not following
CDER’s requirements, the CDER Co-Sponsorship Liaison will consult with FDA
OCC.
5. FDA OCC will advise the CDER Co-Sponsorship Liaison and CDER office Co-
Sponsorship Coordinator of actions necessary for CDER to continue with the co-
sponsorship agreement.
6. If, after consultation with FDA OCC, CDER determines the co-sponsor is unable
to satisfy and resolve CDER’s concerns and the co-sponsorship agreement has not
been finalized, further clearance of the co-sponsorship agreement will cease. If
the co-sponsorship agreement has been signed by all parties, the CDER Director
will send a letter terminating the agreement to the co-sponsor.
7. CDER Co-Sponsorship Liaison will alert the appropriate CDER office Co-
Sponsorship Coordinator, CDER Subject Matter Expert (SME) and CDER office
director (or designee) when the co-sponsorship agreement termination letter has
been delivered.
MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4100.1 Rev. 3
Originating Office: Office of Management, Immediate Office
Effective Date: 12/30/14; 8/3/16; 4/21/21; 6/21/2022 Page 18 of 20
ATTACHMENT 3: Sample Prohibited Source Justification Memorandum
JUSTIFICATION FOR USING A PROHIBITIED SOURCE
{Insert tentative name and date of co-sponsored event}
Co-Sponsored by CDER and {Insert name of outside organization}
1. Is the event one which serves an important mission of the Department? {1 – 2
paragraph response.}
2. Is there another available co-sponsor that is not a prohibited source, or do the
prohibited sources have a special expertise or status that would make them the
preferred co-sponsors of the event? {1 – 2 paragraph response.}
3. What would be the nature of the prohibited sources’ involvement in the event? To
what extent will the prohibited sources take an active role in the development of
the substantive portions of the event? {1 – 2 paragraph response.}
4. Would co-sponsoring an event with these prohibited sources create the
appearance of partiality toward the source, or the appearance of an endorsement
of that source, with respect to other matters that it has pending before the
government? {1 – 2 paragraph response.}
5. Does the prohibited source regularly apply for contracts, grants or other financial
relationships with CDER? Do grants, contracts, or other financial relationships
with CDER represent a significant percentage of the source’s overall budget? {1 –
2 paragraph response.}
6. Are significant activities of the prohibited sources regulated by the HHS
component co-sponsoring the event? If so, the HHS component may not co-
sponsor an event with the prohibited sources unless the benefits to the Department
clearly outweigh any potential appearance of undue influence or preferential
treatment.{1 – 2 paragraph response.}
MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4100.1 Rev. 3
Originating Office: Office of Management, Immediate Office
Effective Date: 12/30/14; 8/3/16; 4/21/21; 6/21/2022 Page 19 of 20
ATTACHMENT 4: Model Co-Sponsorship Agreement
Note: The following template is also posted on the FDA Ethics page of Inside FDA.
The Department of Health and Human Services (HHS) [or name of subcomponent] and
[name of co-sponsor] agree to co-sponsor [name of event], according to the terms
expressed below:
Background: [Provide the following information: (a) the nature and purpose of the
event; (b) the identity and background of the co-sponsor(s); (c) the importance of the
event to both HHS and the co-sponsor; (d) the substantive interest and special expertise
of the co-sponsor in the subject matter of the event; (e) any other relevant background
information that may explain the mutual interest of HHS and the co-sponsor in working
together on the event.]
Responsibilities for Developing the Event: [Provide the following information: (a) the
respective responsibilities of HHS and the co-sponsor for developing the substantive
aspects of the event, such as the agenda and speakers; (b) the respective responsibilities
of HHS and the co-sponsor for logistics and finances, such as arranging and paying for
conference facilities, advertising, food, and any other event expenses. Note: this is the
core paragraph of the co-sponsorship agreement, and it should reflect as much detail as
HHS and the co-sponsor reasonably can provide.]
Registration Fees and Other Charges: [Provide the following information: (a) state
whether the co-sponsor intends to charge registration fees, and, if so, state that the co-
sponsor agrees to set a fee no higher than necessary to recover its share of the costs of the
event; (b) state whether HHS and the co-sponsor agree that HHS employees will be
allowed free attendance at the event; (c) state whether the co-sponsor intends to sell
educational materials pertaining to the event or transcripts or recordings of the event, and,
if so, state that the co-sponsor agrees to sell such items at cost.]
Independently Sponsored Portions of Event: [Provide the following information: (a)
state whether either HHS or the co-sponsor intends to sponsor any discrete portion of the
event independently; (b) describe any separately sponsored portion; (c) state that HHS
resources, including staff, will not be used to develop, promote or otherwise support a
portion of the event that is independently sponsored by the co-sponsor, although official
announcements and brochures may contain factual references to the schedule of the entire
event, including portions sponsored solely by the co-sponsor.]
Fundraising: [Name of co-sponsor] will make clear, in any solicitation for funds to
cover its share of the event costs, that it, not HHS, is asking for the funds. [Name of co-
sponsor] will not imply that HHS endorses any fundraising activities in connection with
the event. [Name of co-sponsor] will make clear to donors that any gift will go solely
toward defraying the expenses of [name of co-sponsor], not HHS.
MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4100.1 Rev. 3
Originating Office: Office of Management, Immediate Office
Effective Date: 12/30/14; 8/3/16; 4/21/21; 6/21/2022 Page 20 of 20
Promotional Activity: [Name of co-sponsor] will not use the event primarily as a
vehicle to sell or promote products or services. [Name of co-sponsor] will ensure that any
incidental promotional activity does not imply that HHS endorses any products or
services. [Name of co-sponsor] will make reasonable efforts, subject to HHS review, to
segregate any incidental promotional activity from the main activities of the event.
Event Publicity and Endorsements: [Name of co-sponsor] will not use the name of
HHS or any of its components, except in factual publicity for the specific event. Factual
publicity includes dates, times, locations, purposes, agendas, fees, and speakers involved
with the event. Such factual publicity shall not imply that the involvement of HHS in the
event serves as an endorsement of the general policies, activities, or products of [name of
co-sponsor]; where confusion could result, publicity should be accompanied by a
disclaimer to the effect that no endorsement is intended. [Name of co-sponsor] will clear
all publicity materials for the event with HHS to ensure compliance with this paragraph.
Records: Records concerning the event shall account fully and accurately for the
financial commitments and expenditures of HHS and [name of co-sponsor]. Such records
shall reflect, at a minimum, the amounts, sources, and uses of all funds.
Public Availability: This co-sponsorship agreement, as well as the financial records
described in the paragraph above, shall be publicly available.
Co-Sponsorship Guidance: HHS and [name of co-sponsor] will abide by the legal
memorandum of August 8, 2002, entitled "Co-Sponsorship Guidance," issued by the
HHS Designated Agency Ethics Official.
