Page:United States Statutes at Large Volume 124.djvu/556

124 STAT. 530 PUBLIC LAW 111–148—MAR. 23, 2010 providers who participate in training by Shared Decision- making Resource Centers or comparable training. ‘‘(C) LIMITATION.—Funds under this paragraph shall not be used to purchase or implement use of patient deci- sion aids other than those certified under the process identified in subsection (c). ‘‘(4) GUIDANCE.—The Secretary may issue guidance to eligible grantees under this subsection on the use of patient decision aids. ‘‘(f) FUNDING.—For purposes of carrying out this section there are authorized to be appropriated such sums as may be necessary for fiscal year 2010 and each subsequent fiscal year.’’. SEC. 3507. PRESENTATION OF PRESCRIPTION DRUG BENEFIT AND RISK INFORMATION. (a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), acting through the Commissioner of Food and Drugs, shall determine whether the addition of quantitative summaries of the benefits and risks of prescription drugs in a standardized format (such as a table or drug facts box) to the promotional labeling or print advertising of such drugs would improve health care decisionmaking by clini- cians and patients and consumers. (b) REVIEW AND CONSULTATION.—In making the determination under subsection (a), the Secretary shall review all available sci- entific evidence and research on decisionmaking and social and cognitive psychology and consult with drug manufacturers, clini- cians, patients and consumers, experts in health literacy, represent- atives of racial and ethnic minorities, and experts in women’s and pediatric health. (c) REPORT.—Not later than 1 year after the date of enactment of this Act, the Secretary shall submit to Congress a report that provides— (1) the determination by the Secretary under subsection (a); and (2) the reasoning and analysis underlying that determina- tion. (d) AUTHORITY.—If the Secretary determines under subsection (a) that the addition of quantitative summaries of the benefits and risks of prescription drugs in a standardized format (such as a table or drug facts box) to the promotional labeling or print advertising of such drugs would improve health care decisionmaking by clinicians and patients and consumers, then the Secretary, not later than 3 years after the date of submission of the report under subsection (c), shall promulgate proposed regulations as necessary to implement such format. (e) CLARIFICATION.—Nothing in this section shall be construed to restrict the existing authorities of the Secretary with respect to benefit and risk information. SEC. 3508. DEMONSTRATION PROGRAM TO INTEGRATE QUALITY IMPROVEMENT AND PATIENT SAFETY TRAINING INTO CLINICAL EDUCATION OF HEALTH PROFESSIONALS. (a) IN GENERAL.—The Secretary may award grants to eligible entities or consortia under this section to carry out demonstration projects to develop and implement academic curricula that integrates quality improvement and patient safety in the clinical 42 USC 294j. Deadline. Regulations. Determination. 21 USC 352 note.