US Code
Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–6. Risk communication

(a) Advisory Committee on Risk Communication(1) In generalThe Secretary shall establish an advisory committee to be known as the “Advisory Committee on Risk Communication” (referred to in this section as the “Committee”).
(2) Duties of CommitteeThe Committee shall advise the Commissioner on methods to effectively communicate risks associated with the products regulated by the Food and Drug Administration.
(3) MembersThe Secretary shall ensure that the Committee is composed of experts on risk communication, experts on the risks described in subsection (b), and representatives of patient, consumer, and health professional organizations.
(4) Permanence of CommitteeSection 1013 of title 5 shall not apply to the Committee established under this subsection.
(b) Partnerships for risk communication(1) In generalThe Secretary shall partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted systems for communication to health care providers about emerging postmarket drug risks.
(2) PartnershipsThe systems developed under paragraph (1) shall—(A) account for the diversity among physicians in terms of practice, willingness to adopt technology, and medical specialty; and
(B) include the use of existing communication channels, including electronic communications, in place at the Food and Drug Administration.

Structure US Code

US Code

Title 21— FOOD AND DRUGS

CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER V— DRUGS AND DEVICES

Part E— General Provisions Relating to Drugs and Devices

§ 360bbb. Expanded access to unapproved therapies and diagnostics

§ 360bbb–0. Expanded access policy required for investigational drugs

§ 360bbb–0a. Investigational drugs for use by eligible patients

§ 360bbb–1. Dispute resolution

§ 360bbb–2. Classification of products

§ 360bbb–3. Authorization for medical products for use in emergencies

§ 360bbb–3a. Emergency use of medical products

§ 360bbb–3b. Products held for emergency use

§ 360bbb–3c. Expedited development and review of medical products for emergency uses

§ 360bbb–4. Countermeasure development, review, and technical assistance

§ 360bbb–4a. Priority review to encourage treatments for agents that present national security threats

§ 360bbb–4b. Medical countermeasure master files

§ 360bbb–5. Critical Path Public-Private Partnerships

§ 360bbb–5a. Emerging technology program

§ 360bbb–6. Risk communication

§ 360bbb–7. Notification

§ 360bbb–8. Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments

§ 360bbb–8a. Optimizing global clinical trials

§ 360bbb–8b. Use of clinical investigation data from outside the United States

§ 360bbb–8c. Patient participation in medical product discussion

§ 360bbb–8d. Notification, nondistribution, and recall of controlled substances