; (3) reflect information that existing clinical guidelines or leading professional organizations and agencies with relevant expertise in the field recognize as accurate, objective, and complete; or (4) demonstrate the effectiveness of a specific therapy in practice. . (b) Regulations Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate final regulations to carry out section 399V–7 of the Public Health Service Act, as added by subsection (a). (c) Applicability Section 399V–7 of the Public Health Service Act, as added by subsection (a), applies to any application for a grant, cooperative agreement, loan, or loan guarantee described in such section 399V–7 that is submitted to the Department of Health and Human Services on or after the date that is 1 year after the date of enactment of this Act.