; or (bb) the subject of an enforcement action in a court of the United States or by an agency. (D) Consultation The advisory committee shall consult, as necessary, with physicians who are specialists in treating the disease for which a drug is being considered. (E) Request for studies The advisory committee may request the Agency for Healthcare Research and Quality or an academic or research institution to study and make a report on a petition described in subparagraph (A)(i) in order to assess cost-effectiveness, clinical effectiveness, comparative effectiveness, safety, and compliance with a drug regimen. (F) Recommendations The advisory committee shall make recommendations to the Director of the Agency for Healthcare Research and Quality regarding the appropriate price at which to begin negotiations on a part D drug pursuant to this section. (G) Limitations on review of manufacturer petitions The advisory committee shall not review a petition of a drug manufacturer under subparagraph (A)(i) with respect to a covered part D drug unless the petition is accompanied by the following: (i) Raw data from clinical trials on the safety and effectiveness of the drug. (ii) Any data from clinical trials conducted using active controls on the drug or drugs that are the current standard of care. (iii) Any available data on comparative effectiveness of the drug. (iv) Any other information the Secretary requires for the advisory committee to complete its review. (g) Informing beneficiaries The Secretary shall take steps to inform part D eligible individuals not previously enrolled in a Medicare operated drug plan (including such individuals who are newly eligible to enroll under this part) regarding the enrollment of such individual in a Medicare operated drug plan in accordance with this section, including providing information in the annual handbook and adding information to the official public Medicare website related to prescription drug coverage available through this part. (h) Application of all other requirements for