124 STAT. 536 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(4) consult with health professionals, nongovernmental organizations, consumer organizations, women’s health profes- sionals, and other individuals and groups, as appropriate, on Administration policy with regard to women; and ‘‘(5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 229(b)(4) of the Public Health Service Act). ‘‘(c) CONTINUED ADMINISTRATION OF EXISTING PROGRAMS.—The Director of the Office shall assume the authority for the develop- ment, implementation, administration, and evaluation of any projects carried out through the Health Resources and Services Administration relating to women’s health on the date of enactment of this section. ‘‘(d) DEFINITIONS.—For purposes of this section: ‘‘(1) ADMINISTRATION.—The term ‘Administration’ means the Health Resources and Services Administration. ‘‘(2) ADMINISTRATOR.—The term ‘Administrator’ means the Administrator of the Health Resources and Services Adminis- tration. ‘‘(3) OFFICE.—The term ‘Office’ means the Office of Women’s Health established under this section in the Administration. ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.’’. (g) FOOD AND DRUG ADMINISTRATION OFFICE OF WOMEN’S HEALTH.—Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following: ‘‘SEC. 1011. OFFICE OF WOMEN’S HEALTH. ‘‘(a) ESTABLISHMENT.—There is established within the Office of the Commissioner, an office to be known as the Office of Women’s Health (referred to in this section as the ‘Office’). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs. ‘‘(b) PURPOSE.—The Director of the Office shall— ‘‘(1) report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the ‘Administration’) levels of activity regarding women’s participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts; ‘‘(2) establish short-range and long-range goals and objec- tives within the Administration for issues of particular concern to women’s health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration proto- cols and policies; ‘‘(3) provide information to women and health care pro- viders on those areas in which differences between men and women exist; ‘‘(4) consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women’s 21 USC 399b.
