{"identifier":"/us/usc/t21/s399b","title":21,"num":"\u00a7\u202f399b.","heading":"Office of Women\u2019s Health","text":"\u00a7\u202f399b.\nOffice of Women\u2019s Health\n(a)\nEstablishment\nThere is established within the Office of the Commissioner, an office to be known as the Office of Women\u2019s Health (referred to in this section as the \u201cOffice\u201d). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs.\n(b)\nPurpose\nThe Director of the Office shall\u2014\n(1) report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the \u201cAdministration\u201d) levels of activity regarding women\u2019s 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;\n(2) establish short-range and long-range goals and objectives within the Administration for issues of particular concern to women\u2019s health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration protocols and policies;\n(3) provide information to women and health care providers on those areas in which differences between men and women exist;\n(4) consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women\u2019s issues, consumer organizations, and women\u2019s health professionals on Administration policy with regard to women;\n(5) make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and\n(6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women\u2019s Health (established under\nsection 237a(b)(4) of title 42\n(c)\nAuthorization of appropriations\nFor 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.","url":"https://projectusc.org/usc/t21/s399b.html","content":[{"t":"sec","id":"/us/usc/t21/s399b","children":[{"t":"num","text":"\u00a7\u202f399b."},{"t":"heading","text":"Office of Women\u2019s Health"},{"t":"subsec","id":"/us/usc/t21/s399b/a","children":[{"t":"num","text":"(a)"},{"t":"heading","text":"Establishment"},{"t":"content","children":[{"t":"p","text":"There is established within the Office of the Commissioner, an office to be known as the Office of Women\u2019s Health (referred to in this section as the \u201cOffice\u201d). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s399b/b","children":[{"t":"num","text":"(b)"},{"t":"heading","text":"Purpose"},{"t":"chapeau","text":"The Director of the Office shall\u2014"},{"t":"para","id":"/us/usc/t21/s399b/b/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the \u201cAdministration\u201d) levels of activity regarding women\u2019s 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;","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s399b/b/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" establish short-range and long-range goals and objectives within the Administration for issues of particular concern to women\u2019s health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration protocols and policies;","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s399b/b/3","children":[{"t":"num","text":"(3)"},{"t":"content","text":" provide information to women and health care providers on those areas in which differences between men and women exist;","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s399b/b/4","children":[{"t":"num","text":"(4)"},{"t":"content","text":" consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women\u2019s issues, consumer organizations, and women\u2019s health professionals on Administration policy with regard to women;","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s399b/b/5","children":[{"t":"num","text":"(5)"},{"t":"content","text":" make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s399b/b/6","children":[{"t":"num","text":"(6)"},{"t":"content","text":" serve as a member of the Department of Health and Human Services Coordinating Committee on Women\u2019s Health (established under ","children":[{"t":"ref","text":"section 237a(b)(4) of title 42","href":"/us/usc/t42/s237a/b/4","tail":")."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s399b/c","children":[{"t":"num","text":"(c)"},{"t":"heading","text":"Authorization of appropriations"},{"t":"content","children":[{"t":"p","text":"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.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}