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21 U.S.C. § 399b — Office of Women’s Health
Federal law — U.S. Code and appendices · legal_authorities
**(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 objectives 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 protocols and policies;
(3) provide information to women and health care providers 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 issues, consumer organizations, and women’s health professionals on Administration policy with regard to women;
(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
(6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under [section 237a(b)(4) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section237a/b/4&
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Stable record: federal_law:legal_authorities:record_usc_705230d9d3f1f233dec7229f
Source file: Laws/federal/codes/united-states-code/title-21/section-399b-office-of-womens-health--0f0428ab4f.md
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Source location: Title 21, Chapter 9, § 399b; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(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 objectives 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 protocols and policies;
(3) provide information to women and health care providers 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 issues, consumer organizations, and women’s health professionals on Administration policy with regard to women;
(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
(6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under [section 237a(b)(4) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section237a/b/4&num=0&edition=prelim)).
**(c) 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.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Training** The Secretary shall set standards and administer training and education programs for the employees of State, local, territorial, and tribal food safety officials relating to the regulatory responsibilities and policies established by this chapter, including programs for—
(1) scientific training;
(2) training to improve the skill of officers and employees authorized to conduct inspections under sections 372 and 374 of this title;
(3) training to achieve advanced product or process specialization in such inspections;
(4) training that addresses best practices;
(5) training in administrative process and procedure and integrity issues;
(6) training in appropriate sampling and laboratory analysis methodology; and
(7) training in building enforcement actions following inspections, examinations, testing, and investigations.
**(b) Partnerships with State and local officials**
(1) **In general** — The Secretary, pursuant to a contract or memorandum of understanding between the Secretary and the head of a State, local, territorial, or tribal department or agency, is authorized and encouraged to conduct examinations, testing, and investigations for the purposes of determining compliance with the food safety provisions of this chapter through the officers and employees of such State, local, territorial, or tribal department or agency.
(2) **Content** — A contract or memorandum described under paragraph (1) shall include provisions to ensure adequate training of such officers and employees to conduct such examinations, testing, and investigations. The contract or memorandum shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part,
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 399c
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment of Office** There is established within the Office of the Secretary, an Office on Women’s Health (referred to in this section as the “Office”). The Office shall be headed by a Deputy Assistant Secretary for Women’s Health who may report to the Secretary.
**(b) Duties** The Secretary, acting through the Office, with respect to the health concerns of women, shall—
(1) establish short-range and long-range goals and objectives within the Department of Health and Human Services and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Department that relate to disease prevention, health promotion, service delivery, research, and public and health care professional education, for issues of particular concern to women throughout their lifespan; 11 So in original. Probably should be “lifespans;”.
(2) provide expert advice and consultation to the Secretary concerning scientific, legal, ethical, and policy issues relating to women’s health;
(3) monitor the Department of Health and Human Services’ offices, agencies, and regional activities regarding women’s health and identify needs regarding the coordination of activities, including intramural and extramural multidisciplinary activities;
(4) establish a Department of Health and Human Services Coordinating Committee on Women’s Health, which shall be chaired by the Deputy Assistant Secretary for Women’s Health and composed of senior level representatives from each of the agencies and offices of the Department of Health and Human Services;
(5) establish a National Women’s Health Information Center to—
(A) facilitate the exchange of information regarding matters relating to health information, health promotion, preventive health services, research advances, and e
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 238
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** The Secretary shall award grants under this section to carry out the competitive grant program established under section 399c(d) 11 See References in Text note below. of title 21, pursuant to any memoranda of understanding entered into under such section.
**(b) Integrated approach** The grant program described under subsection (a) shall be carried out under this section in a manner that facilitates the integration of food safety standards and guidance with the variety of agricultural production systems, encompassing conventional, sustainable, organic, and conservation and environmental practices.
**(c) Priority** In awarding grants under this section, the Secretary shall give priority to projects that target small and medium-sized farms, beginning farmers, socially disadvantaged farmers, veteran farmers or ranchers (as defined in [section 2279(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section2279/a&num=0&edition=prelim)), small processors, or small fresh fruit and vegetable merchant wholesalers.
**(d) Program coordination**
(1) **In general** — The Secretary shall coordinate implementation of the grant program under this section with the National Integrated Food Safety Initiative.
(2) **Interaction** — The Secretary shall—
(A) in carrying out the grant program under this section, take into consideration applied research, education, and extension results obtained from the National Integrated Food Safety Initiative; and
(B) in determining the applied research agenda for the National Integrated Food Safety Initiative, take into consideration the needs articulated by participants in projects funded by the program under this section.
**(e) Grants**
(1) **In general** — In carrying out this section, t
Source: Supplied U.S. Code snapshot — release unconfirmed · 7 U.S.C. § 7626
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Federal law — U.S. Code and appendices · legal_authorities
Page 709
TITLE 21—FOOD AND DRUGS
§ 399b
(e) Duration of awards
The Secretary may award grants to an indi-
vidual grant recipient under this section for pe-
riods of not more than 3 years. In the event the
Secretary conducts a program evaluation, fund-
ing in the second year or third year of the grant,
where applicable, shall be contingent on a suc-
cessful program evaluation by the Secretary
after the first year.
(f) Progress and evaluation
(1) In general
The Secretary shall measure the status and
success of each grant program authorized
under the FDA Food Safety Modernization Act
(and any amendment made by such Act), in-
cluding the grant program under this section.
A recipient of a grant described in the pre-
ceding sentence shall, at the end of each grant
year, provide the Secretary with information
on how grant funds were spent and the status
of the efforts by such recipient to enhance
food safety. To the extent practicable, the
Secretary shall take the performance of such
a grant recipient into account when deter-
mining whether to continue funding for such
recipient.
(2) No duplication
In carrying out paragraph (1), the Secretary
shall not duplicate the efforts of the Secretary
under other provisions of this chapter or the
FDA Food Safety Modernization Act that re-
quire measurement and review of the activi-
ties of grant recipients under either this chap-
ter or such Act.
(g) Supplement not supplant
Grant funds received under this section shall
be used to supplement, and not supplant, non-
Federal funds and any other Federal funds avail-
able to carry out the activities described in this
section.
(h) Authorization of appropriations
For the purpose of making grants under this
section, there are authorized to be appropriated
such sum
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 399b
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