Page:United States Statutes at Large Volume 124.djvu/1040

124 STAT. 1014 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(1) HEALTH CARE SERVICES.—The term ‘health care serv- ices’ means any services provided by a health care provider, or by any individual working under the supervision of a health care provider, that relate to— ‘‘(A) the diagnosis, prevention, or treatment of any human disease or impairment; or ‘‘(B) the assessment of the health of human beings. ‘‘(2) HEALTH CARE ORGANIZATION.—The term ‘health care organization’ means any individual or entity which is obligated to provide, pay for, or administer health benefits under any health plan. ‘‘(3) HEALTH CARE PROVIDER.—The term ‘health care pro- vider’ means any individual or entity— ‘‘(A) licensed, registered, or certified under Federal or State laws or regulations to provide health care services; or ‘‘(B) required to be so licensed, registered, or certified but that is exempted by other statute or regulation. ‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section, $50,000,000 for the 5-fiscal year period beginning with fiscal year 2011. ‘‘(l) CURRENT STATE EFFORTS TO ESTABLISH ALTERNATIVE TO TORT LITIGATION.—Nothing in this section shall be construed to limit any prior, current, or future efforts of any State to establish any alternative to tort litigation. ‘‘(m) RULE OF CONSTRUCTION.—Nothing in this section shall be construed as limiting states’ authority over or responsibility for their state justice systems.’’. SEC. 10608. EXTENSION OF MEDICAL MALPRACTICE COVERAGE TO FREE CLINICS. (a) IN GENERAL.—Section 224(o)(1) of the Public Health Service Act (42 U.S.C. 233(o)(1)) is amended by inserting after ‘‘to an individual’’ the following: ‘‘, or an officer, governing board member, employee, or contractor of a free clinic shall in providing services for the free clinic,’’. (b) EFFECTIVE DATE.—The amendment made by this section shall take effect on the date of enactment of this Act and apply to any act or omission which occurs on or after that date. SEC. 10609. LABELING CHANGES. Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended by adding at the end the following: ‘‘(10)(A) If the proposed labeling of a drug that is the subject of an application under this subsection differs from the listed drug due to a labeling revision described under clause (i), the drug that is the subject of such application shall, notwithstanding any other provision of this Act, be eligible for approval and shall not be considered misbranded under section 502 if— ‘‘(i) the application is otherwise eligible for approval under this subsection but for expiration of patent, an exclusivity period, or of a delay in approval described in paragraph (5)(B)(iii), and a revision to the labeling of the listed drug has been approved by the Secretary within 60 days of such expiration; ‘‘(ii) the labeling revision described under clause (i) does not include a change to the ‘Warnings’ section of the labeling; Deadlines. Drugs and drug abuse. 42 USC 233 note.