121 STAT. 958
PUBLIC LAW 110–85—SEPT. 27, 2007 ‘‘(v) publicly available information about implemented RiskMAPs and risk evaluation and mitigation strategies under subsection (o); ‘‘(vi) guidance documents and regulations related to drug safety; and ‘‘(vii) other material determined appropriate by the Secretary; ‘‘(C) providing access to summaries of the assessed and aggregated data collected from the active surveillance infrastructure under subsection (k)(3) to provide information of known and serious side-effects for drugs approved under this section or licensed under such section 351; ‘‘(D) preparing, by 18 months after approval of a drug or after use of the drug by 10,000 individuals, whichever is later, a summary analysis of the adverse drug reaction reports received for the drug, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number; ‘‘(E) enabling patients, providers, and drug sponsors to submit adverse event reports through the Internet Web site; ‘‘(F) providing educational materials for patients and providers about the appropriate means of disposing of expired, damaged, or unusable medications; and ‘‘(G) supporting initiatives that the Secretary determines to be useful to fulfill the purposes of the Internet Web site. ‘‘(3) POSTING OF DRUG LABELING.—The Secretary shall post on the Internet Web site established under paragraph (1) the approved professional labeling and any required patient labeling of a drug approved under this section or licensed under such section 351 not later than 21 days after the date the drug is approved or licensed, including in a supplemental application with respect to a labeling change. ‘‘(4) PRIVATE SECTOR RESOURCES.—To ensure development of the Internet Web site by the date described in paragraph (1), the Secretary may, on a temporary or permanent basis, implement systems or products developed by private entities. ‘‘(5) AUTHORITY FOR CONTRACTS.—The Secretary may enter into contracts with public and private entities to fulfill the requirements of this subsection. ‘‘(6) REVIEW.—The Advisory Committee on Risk Communication under section 567 shall, on a regular basis, perform a comprehensive review and evaluation of the types of risk communication information provided on the Internet Web site established under paragraph (1) and, through other means, shall identify, clarify, and define the purposes and types of information available to facilitate the efficient flow of information to patients and providers, and shall recommend ways for the Food and Drug Administration to work with outside entities to help facilitate the dispensing of risk communication information to patients and providers.’’.
Reports.
Reports.
Deadline.
SEC. 916. ACTION PACKAGE FOR APPROVAL.
dkrause on GSDDPC44 with PUBLAW
Section 505(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(l)) is amended by—
VerDate Aug 31 2005
13:52 Jan 23, 2009
Jkt 059194
PO 00001
Frm 00956
Fmt 6580
Sfmt 6581
M:\STATUTES\2007\59194PT1.001
APPS10
PsN: 59194PT1
�
