; or (B) clinical observation or expertise. (2) For purposes of this subsection, the term broad applicability means with respect to any sub-regulatory recommendation, guidance, or policy with respect to control of a communicable disease any such recommendation, guidance, or policy that is intended to influence the general public. (3) Paragraph (1) shall not apply with respect to— (A) the authority of the Secretary to carry out any provision of the Federal Food, Drug, and Cosmetic Act