; and (3) the need for updated safe harbor rules under section 1001.952 of title 42, Code of Federal Regulations (or successor regulations) and section 1128B of the Social Security Act (commonly referred to as the Federal Anti-Kickback Statute ( 42 U.S.C. 1320a–7b )) with respect to the assistance provided under this section. 4. Public awareness and education campaign (a) National campaign The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health and the Commissioner of Food and Drugs (referred to in this section as the Secretary ) and in consultation with the stakeholders specified in subsection (e), shall carry out a national campaign to increase the awareness and knowledge of individuals in the United States, including healthcare professionals, patients, and others, with respect to the need for diverse clinical trials among the demographic groups identified pursuant to section 2(a)(1). (b) Requirements The national campaign conducted under this section shall include— (1) (A) the development and distribution of written educational materials; (B) the development and placing of public service announcements that are intended to encourage individuals who are members of the demographic groups identified pursuant to section 2(b)(1)(A)(I) to seek to participate in clinical trials; and (C) the development of curricula for health care professionals on— (i) how to participate in clinical trials as an investigator; and (ii) how such professionals can enroll patients in trials; (2) such efforts as are reasonable and necessary to ensure meaningful access by consumers with limited English proficiency; (3) the development and distribution of best practices and training for recruiting underrepresented study populations, including a method for sharing such best practices among clinical trial sponsors, providers, community-based organizations who assist with recruitment, and with the public