Page:United States Statutes at Large Volume 124.djvu/719

 124 STAT. 693 PUBLIC LAW 111–148—MAR. 23, 2010 applicable group purchasing organization, or covered recipient, respectively, for a period of not less than 45 days prior to such information being made available to the public. ‘‘(D) CLARIFICATION OF TIME PERIOD FOR REVIEW AND CORRECTIONS.—In no case may the 45-day period for review and submission of corrections to information under subparagraph (C)(ix) prevent such information from being made available to the public in accordance with the dates described in the matter preceding clause (i) in subpara- graph (C). ‘‘(E) DELAYED PUBLICATION FOR PAYMENTS MADE PURSU- ANT TO PRODUCT RESEARCH OR DEVELOPMENT AGREEMENTS AND CLINICAL INVESTIGATIONS.— ‘‘(i) IN GENERAL.—In the case of information sub- mitted under subsection (a) with respect to a payment or other transfer of value made to a covered recipient by an applicable manufacturer pursuant to a product research or development agreement for services fur- nished in connection with research on a potential new medical technology or a new application of an existing medical technology or the development of a new drug, device, biological, or medical supply, or by an applicable manufacturer in connection with a clinical investiga- tion regarding a new drug, device, biological, or medical supply, the procedures established under subparagraph (A)(ii) shall provide that such information is made available to the public on the first date described in the matter preceding clause (i) in subparagraph (C) after the earlier of the following: ‘‘(I) The date of the approval or clearance of the covered drug, device, biological, or medical supply by the Food and Drug Administration. ‘‘(II) Four calendar years after the date such payment or other transfer of value was made. ‘‘(ii) CONFIDENTIALITY OF INFORMATION PRIOR TO PUBLICATION.—Information described in clause (i) shall be considered confidential and shall not be subject to disclosure under section 552 of title 5, United States Code, or any other similar Federal, State, or local law, until on or after the date on which the information is made available to the public under such clause. ‘‘(2) CONSULTATION.—In establishing the procedures under paragraph (1), the Secretary shall consult with the Inspector General of the Department of Health and Human Services, affected industry, consumers, consumer advocates, and other interested parties in order to ensure that the information made available to the public under such paragraph is presented in the appropriate overall context. ‘‘(d) ANNUAL REPORTS AND RELATION TO STATE LAWS.— ‘‘(1) ANNUAL REPORT TO CONGRESS.—Not later than April 1 of each year beginning with 2013, the Secretary shall submit to Congress a report that includes the following: ‘‘(A) The information submitted under subsection (a) during the preceding year, aggregated for each applicable manufacturer and applicable group purchasing organiza- tion that submitted such information during such year