I 

108TH CONGRESS 

2D SESSION H. R. 4354

To improve the health of women through the establishment of Offices of 

Women’s Health within the Department of Health and Human Services. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 12, 2004

Mrs. MALONEY (for herself, Ms. PRYCE of Ohio, Mr. WAXMAN, Mr. GRIJALVA, 

Mr. SERRANO, Mrs. JONES of Ohio, Ms. MILLENDER-MCDONALD, Ms. 

BALDWIN, Ms. CARSON of Indiana, Mr. GEORGE MILLER of California, 

Ms. ROYBAL-ALLARD, Ms. NORTON, Mrs. MCCARTHY of New York, Ms. 

BERKLEY, Ms. LOFGREN, Mr. FROST, Mr. GONZALEZ, Mr. KILDEE, Ms. 

SLAUGHTER, Ms. SCHAKOWSKY, Ms. DELAURO, Ms. LEE, Mr. HINCHEY, 

Mr. CASTLE, Mr. LANTOS, Mr. OWENS, Mrs. CAPITO, Ms. LINDA T. 

SA ́NCHEZ of California, Mr. BRADY of Pennsylvania, Mr. VAN HOLLEN, 

Mr. SCHIFF, Mr. CROWLEY, Mr. NETHERCUTT, Mr. FORD, Mr. 

HASTINGS of Florida, Ms. ESHOO, Mr. STARK, Mr. CONYERS, Ms. WATERS, Mr. TOWNS, Ms. BORDALLO, and Ms. SOLIS) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL

To improve the health of women through the establishment 

of Offices of Women’s Health within the Department 

of Health and Human Services.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Women’s Health Office 

3 Act of 2004’’. 

4 SEC. 2. HEALTH AND HUMAN SERVICES OFFICE ON WOM5 EN’S HEALTH. 

6 (a) ESTABLISHMENT.—Part A of title II of the Pub7 lic Health Service Act (42 U.S.C. 202 et seq.) is amended 

8 by adding at the end the following: 

9 ‘‘SEC. 229. HEALTH AND HUMAN SERVICES OFFICE ON 

10 WOMEN’S HEALTH. 

11 ‘‘(a) ESTABLISHMENT OF OFFICE.—The Secretary 

12 shall establish within the Office of the Secretary, an Office 

13 on Women’s Health (referred to in this section as the ‘Of14 fice’). The Office shall be headed by a Deputy Assistant 

15 Secretary for Women’s Health. 

16 ‘‘(b) DUTIES.—The Secretary, acting through the Of17 fice, with respect to the health concerns of women, shall—

18 ‘‘(1) establish short-range and long-range goals 

19 and objectives within the Department of Health and 

20 Human Services and, as relevant and appropriate, 

21 coordinate with other appropriate offices on activi22 ties within the Department that relate to disease 

23 prevention, health promotion, service delivery, re24 search, and public and health care professional edu25 cation, for issues of particular concern to women; 
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1 ‘‘(2) provide expert advice and consultation to 

2 the Secretary concerning scientific, legal, ethical, 

3 and policy issues relating to women’s health; 

4 ‘‘(3) monitor the Department of Health and 

5 Human Services’ offices, agencies, and regional ac6 tivities regarding women’s health and stimulate ac7 tivities and facilitate coordination of such depart8 mental and agency offices on women’s health; 

9 ‘‘(4) establish a Department of Health and 

10 Human Services Coordinating Committee on Wom11 en’s Health, which shall be chaired by the Deputy 

12 Assistant Secretary for Women’s Health and com13 posed of senior level representatives from each of the 

14 agencies and offices of the Department of Health 

15 and Human Services; 

16 ‘‘(5) establish a National Women’s Health In17 formation Center to—

18 ‘‘(A) facilitate the exchange of information 

19 regarding matters relating to health informa20 tion, health promotion, preventive health serv21 ices, research advances, and education in the 

22 appropriate use of health care; 

23 ‘‘(B) facilitate access to such information; 
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1 ‘‘(C) assist in the analysis of issues and 

2 problems relating to the matters described in 

3 this paragraph; and 

4 ‘‘(D) provide technical assistance with re5 spect to the exchange of information (including 

6 facilitating the development of materials for 

7 such technical assistance); 

8 ‘‘(6) coordinate efforts to promote women’s 

9 health programs and policies with the private sector; 

10 and 

11 ‘‘(7) through publications and any other means 

12 appropriate, provide for the exchange of information 

13 between the Office and recipients of grants, con14 tracts, and agreements under subsection (c), and be15 tween the Office and health professionals and the 

16 general public. 

17 ‘‘(c) GRANTS AND CONTRACTS REGARDING DU18 TIES.—

19 ‘‘(1) AUTHORITY.—In carrying out subsection 

20 (b), the Secretary may make grants to, and enter 

21 into cooperative agreements, contracts, and inter22 agency agreements with, public and private entities, 

23 agencies, and organizations. 

24 ‘‘(2) EVALUATION AND DISSEMINATION.—The 

25 Secretary shall, directly or through contracts with 
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1 public and private entities, agencies, and organiza2 tions, provide for evaluations of projects carried out 

3 with financial assistance provided under paragraph 

4 (1) and for the dissemination of information devel5 oped as a result of such projects. 

6 ‘‘(d) REPORTS.—Not later than January 31, 2006, 

7 and January 31 of each second year thereafter, the Sec8 retary shall prepare and submit to the appropriate com9 mittees of Congress a report describing the activities car10 ried out under this section during the period for which 

11 the report is being prepared. 

12 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the 

13 purpose of carrying out this section, there are authorized 

14 to be appropriated such sums as may be necessary for 

15 each of the fiscal years 2005 through 2009.’’. 

16 (b) TRANSFER OF FUNCTIONS.—There are trans17 ferred to the Office on Women’s Health (established under 

18 section 229 of the Public Health Service Act, as added 

19 by this section), all functions exercised by the Office on 

20 Women’s Health of the Public Health Service prior to the 

21 date of enactment of this section, including all personnel 

22 and compensation authority, all delegation and assign23 ment authority, and all remaining appropriations. All or24 ders, determinations, rules, regulations, permits, agree-
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1 ments, grants, contracts, certificates, licenses, registra2 tions, privileges, and other administrative actions that—

3 (1) have been issued, made, granted, or allowed 

4 to become effective by the President, any Federal 

5 agency or official thereof, or by a court of competent 

6 jurisdiction, in the performance of functions trans7 ferred under this subsection; and 

8 (2) are in effect at the time this section takes 

9 effect, or were final before the date of enactment of 

10 this section and are to become effective on or after 

11 such date; 

12 shall continue in effect according to their terms until 

13 modified, terminated, superseded, set aside, or revoked in 

14 accordance with law by the President, the Secretary, or 

15 other authorized official, a court of competent jurisdiction, 

16 or by operation of law. 

17 SEC. 3. CENTERS FOR DISEASE CONTROL AND PREVEN18 TION OFFICE OF WOMEN’S HEALTH. 

19 Part A of title III of the Public Health Service Act 

20 (42 U.S.C. 241 et seq.) is amended by adding at the end 

21 the following: 

22 ‘‘CENTERS FOR DISEASE CONTROL AND PREVENTION

23 OFFICE OF WOMEN’S HEALTH

24 ‘‘SEC. 310A. (a) ESTABLISHMENT.—The Secretary 

25 shall establish within the Office of the Director of the Cen26 ters for Disease Control and Prevention, an office to be 
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1 known as the Office of Women’s Health (referred to in 

2 this section as the ‘Office’). The Office shall be headed 

3 by a director who shall be appointed by the Director of 

4 such Centers. 

5 ‘‘(b) PURPOSE.—The Director of the Office shall—

6 ‘‘(1) report to the Director of the Centers for 

7 Disease Control and Prevention on the current level 

8 of the Centers’ activity regarding women’s health 

9 conditions across, where appropriate, age, biological, 

10 and sociocultural contexts, in all aspects of the Cen11 ters’ work, including prevention programs, public 

12 and professional education, services, and treatment; 

13 ‘‘(2) establish short-range and long-range goals 

14 and objectives within the Centers for women’s health 

15 and, as relevant and appropriate, coordinate with 

16 other appropriate offices on activities within the 

17 Centers that relate to prevention, research, edu18 cation and training, service delivery, and policy de19 velopment, for issues of particular concern to 

20 women; 

21 ‘‘(3) identify projects in women’s health that 

22 should be conducted or supported by the Centers; 

23 ‘‘(4) consult with health professionals, non24 governmental organizations, consumer organizations, 

25 women’s health professionals, and other individuals 
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1 and groups, as appropriate, on the policy of the Cen2 ters with regard to women; and 

3 ‘‘(5) serve as a member of the Department of 

4 Health and Human Services Coordinating Com5 mittee on Women’s Health (established under sec6 tion 229(b)(4)). 

7 ‘‘(c) COORDINATING COMMITTEE.—

8 ‘‘(1) ESTABLISHMENT.—In carrying out sub9 section (b), the Director of the Office shall establish 

10 a committee to be known as the Coordinating Com11 mittee on Women’s Health (referred to in this sub12 section as the ‘Coordinating Committee’). 

13 ‘‘(2) COMPOSITION.—The Coordinating Com14 mittee shall be composed of the directors of the na15 tional centers and other appropriate officials of the 

16 Centers for Disease Control and Prevention. 

17 ‘‘(3) CHAIRPERSON.—The Director of the Of18 fice shall serve as the Chairperson of the Coordi19 nating Committee. 

20 ‘‘(4) DUTIES.—With respect to women’s health, 

21 the Coordinating Committee shall assist the Director 

22 of the Office in—

23 ‘‘(A) identifying the need for programs and 

24 activities that focus on women’s health; 
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1 ‘‘(B) identifying needs regarding the co2 ordination of activities, including intramural 

3 and extramural multidisciplinary activities; and 

4 ‘‘(C) making recommendations to the Di5 rector of the Centers for Disease Control and 

6 Prevention concerning findings made under 

7 subparagraphs (A) and (B). 

8 ‘‘(d) REPORTS.—Not later than January 31, 2006, 

9 and January 31 of each second year thereafter, the Direc10 tor of the Office shall prepare and submit to the appro11 priate committees of Congress a report describing the ac12 tivities carried out under this section during the period 

13 for which the report is being prepared. 

14 ‘‘(e) DEFINITION.—As used in this section, the term 

15 ‘women’s health conditions’, with respect to women of all 

16 age, ethnic, and racial groups, means diseases, disorders, 

17 and conditions—

18 ‘‘(1) unique to, significantly more serious for, 

19 or significantly more prevalent in women; and 

20 ‘‘(2) for which the factors of medical risk or 

21 type of medical intervention are different for women, 

22 or for which there is reasonable evidence that indi23 cates that such factors or types may be different for 

24 women. 
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1 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the 

2 purpose of carrying out this section, there are authorized 

3 to be appropriated such sums as may be necessary for 

4 each of the fiscal years 2005 through 2009.’’. 

5 SEC. 4. AGENCY FOR HEALTHCARE RESEARCH AND QUAL6 ITY ACTIVITIES REGARDING WOMEN’S 

7 HEALTH. 

8 Part C of title IX of the Public Health Service Act 

9 (42 U.S.C. 299c et seq.) is amended—

10 (1) by redesignating sections 927 and 928 as 

11 sections 928 and 929, respectively; 

12 (2) by inserting after section 926 the following: 

13 ‘‘SEC. 927. ACTIVITIES REGARDING WOMEN’S HEALTH. 

14 ‘‘(a) ESTABLISHMENT.—The Director shall designate 

15 an official of the Office of Priority Populations to carry 

16 out the responsibilities described in this section for such 

17 official. 

18 ‘‘(b) PURPOSE.—The official designated under sub19 section (a) shall—

20 ‘‘(1) report to the Director on the current 

21 Agency level of activity regarding women’s health, 

22 across, where appropriate, age, biological, and 

23 sociocultural contexts, in all aspects of Agency work, 

24 including the development of evidence reports and 

25 clinical practice protocols and the conduct of re-
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1 search into patient outcomes, delivery of health care 

2 services, quality of care, and access to health care; 

3 ‘‘(2) establish short-range and long-range goals 

4 and objectives within the Agency for research impor5 tant to women’s health and, as relevant and appro6 priate, coordinate with other appropriate offices on 

7 activities within the Agency that relate to health 

8 services and medical effectiveness research, for 

9 issues of particular concern to women; 

10 ‘‘(3) identify projects in women’s health that 

11 should be conducted or supported by the Agency; 

12 ‘‘(4) consult with health professionals, non13 governmental organizations, consumer organizations, 

14 women’s health professionals, and other individuals 

15 and groups, as appropriate, on Agency policy with 

16 regard to women; and 

17 ‘‘(5) serve as a member of the Department of 

18 Health and Human Services Coordinating Com19 mittee on Women’s Health (established under sec20 tion 229(b)(4)). 

21 ‘‘(c) COORDINATING COMMITTEE.—

22 ‘‘(1) ESTABLISHMENT.—In carrying out sub23 section (b), the official designated under subsection 

24 (a) shall establish a committee to be known as the 

25 Coordinating Committee on Women’s Health (re-
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1 ferred to in this subsection as the ‘Coordinating 

2 Committee’). 

3 ‘‘(2) COMPOSITION.—The Coordinating Com4 mittee shall be composed of the official designated 

5 under subsection (a) and the directors of the centers 

6 and offices of the Agency. 

7 ‘‘(3) CHAIRPERSON.—The official designated 

8 under subsection (a) shall serve as the Chairperson 

9 of the Coordinating Committee. 

10 ‘‘(4) DUTIES.—With respect to research on 

11 women’s health, the Coordinating Committee shall 

12 assist the official designated under subsection (a) 

13 in—

14 ‘‘(A) identifying the need for such re15 search, and making an estimate each fiscal year 

16 of the funds needed to adequately support the 

17 research; 

18 ‘‘(B) identifying needs regarding the co19 ordination of research activities, including in20 tramural and extramural multidisciplinary ac21 tivities; and 

22 ‘‘(C) making recommendations to the Di23 rector of the Agency concerning findings made 

24 under subparagraphs (A) and (B). 
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1 ‘‘(d) REPORTS.—Not later than January 31, 2006, 

2 and January 31 of each second year thereafter, the official 

3 designated under subsection (a) shall prepare and submit 

4 to the appropriate committees of Congress a report de5 scribing the activities carried out under this section during 

6 the period for which the report is being prepared.’’; and 

7 (3) by adding at the end of section 928 (as re8 designated by paragraph (1)) the following: 

9 ‘‘(e) WOMEN’S HEALTH.—For the purpose of car10 rying out section 927 regarding women’s health, there are 

11 authorized to be appropriated such sums as may be nec12 essary for each of the fiscal years 2005 through 2009.’’. 

13 SEC. 5. HEALTH RESOURCES AND SERVICES ADMINISTRA14 TION OFFICE OF WOMEN’S HEALTH. 

15 Title VII of the Social Security Act (42 U.S.C. 901 

16 et seq.) is amended by adding at the end the following: 

17 ‘‘OFFICE OF WOMEN’S HEALTH

18 ‘‘SEC. 713. (a) ESTABLISHMENT.—The Secretary 

19 shall establish within the Office of the Administrator of 

20 the Health Resources and Services Administration, an of21 fice to be known as the Office of Women’s Health. The 

22 Office shall be headed by a director who shall be appointed 

23 by the Administrator. 

24 ‘‘(b) PURPOSE.—The Director of the Office shall—

25 ‘‘(1) report to the Administrator on the current 

26 Administration level of activity regarding women’s 
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1 health across, where appropriate, age, biological, and 

2 sociocultural contexts; 

3 ‘‘(2) establish short-range and long-range goals 

4 and objectives within the Health Resources and 

5 Services Administration for women’s health and, as 

6 relevant and appropriate, coordinate with other ap7 propriate offices on activities within the Administra8 tion that relate to health care provider training, 

9 health service delivery, research, and demonstration 

10 projects, for issues of particular concern to women; 

11 ‘‘(3) identify projects in women’s health that 

12 should be conducted or supported by the bureaus of 

13 the Administration; 

14 ‘‘(4) consult with health professionals, non15 governmental organizations, consumer organizations, 

16 women’s health professionals, and other individuals 

17 and groups, as appropriate, on Administration policy 

18 with regard to women; and 

19 ‘‘(5) serve as a member of the Department of 

20 Health and Human Services Coordinating Com21 mittee on Women’s Health (established under sec22 tion 229(b)(4) of the Public Health Service Act). 

23 ‘‘(c) COORDINATING COMMITTEE.—

24 ‘‘(1) ESTABLISHMENT.—In carrying out sub25 section (b), the Director of the Office shall establish 
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1 a committee to be known as the Coordinating Com2 mittee on Women’s Health (referred to in this sub3 section as the ‘Coordinating Committee’). 

4 ‘‘(2) COMPOSITION.—The Coordinating Com5 mittee shall be composed of the directors of the bu6 reaus of the Administration. 

7 ‘‘(3) CHAIRPERSON.—The Director of the Of8 fice shall serve as the Chairperson of the Coordi9 nating Committee. 

10 ‘‘(4) DUTIES.—With respect to women’s health, 

11 the Coordinating Committee shall assist the Director 

12 of the Office in—

13 ‘‘(A) identifying the need for programs and 

14 activities that focus on women’s health; 

15 ‘‘(B) identifying needs regarding the co16 ordination of activities, including intramural 

17 and extramural multidisciplinary activities; and 

18 ‘‘(C) making recommendations to the Ad19 ministrator concerning findings made under 

20 subparagraphs (A) and (B). 

21 ‘‘(d) REPORTS.—Not later than January 31, 2006, 

22 and January 31 of each second year thereafter, the Direc23 tor of the Office shall prepare and submit to the appro24 priate committees of Congress a report describing the ac-
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1 tivities carried out under this section during the period 

2 for which the report is being prepared. 

3 ‘‘(e) DEFINITIONS.—For purposes of this section: 

4 ‘‘(1) ADMINISTRATION.—The term ‘Administra5 tion’ means the Health Resources and Services Ad6 ministration. 

7 ‘‘(2) ADMINISTRATOR.—The term ‘Adminis8 trator’ means the Administrator of the Health Re9 sources and Services Administration. 

10 ‘‘(3) OFFICE.—The term ‘Office’ means the Of11 fice of Women’s Health established under this sec12 tion in the Administration. 

13 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the 

14 purpose of carrying out this section, there are authorized 

15 to be appropriated such sums as may be necessary for 

16 each of the fiscal years 2005 through 2010.’’. 

17 SEC. 6. FOOD AND DRUG ADMINISTRATION OFFICE OF 

18 WOMEN’S HEALTH. 

19 Chapter IX of the Federal Food, Drug, and Cosmetic 

20 Act (21 U.S.C. 391 et seq.) is amended by adding at the 

21 end the following: 

22 ‘‘SEC. 910. OFFICE OF WOMEN’S HEALTH. 

23 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab24 lish within the Office of the Commissioner, an office to 

25 be known as the Office of Women’s Health (referred to 
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1 in this section as the ‘Office’). The Office shall be headed 

2 by a director who shall be appointed by the Commissioner 

3 of Food and Drugs. 

4 ‘‘(b) PURPOSE.—The Director of the Office shall—

5 ‘‘(1) report to the Commissioner of Food and 

6 Drugs on current Food and Drug Administration 

7 (referred to in this section as the ‘Administration’) 

8 levels of activity regarding women’s participation in 

9 clinical trials and the analysis of data by sex in the 

10 testing of drugs, medical devices, and biological 

11 products across, where appropriate, age, biological, 

12 and sociocultural contexts; 

13 ‘‘(2) establish short-range and long-range goals 

14 and objectives within the Administration for issues 

15 of particular concern to women’s health within the 

16 jurisdiction of the Administration, including, where 

17 relevant and appropriate, adequate inclusion of 

18 women and analysis of data by sex in Administration 

19 protocols and policies; 

20 ‘‘(3) provide information to women and health 

21 care providers on those areas in which differences 

22 between men and women exist; 

23 ‘‘(4) consult with pharmaceutical, biologics, and 

24 device manufacturers, health professionals with ex25 pertise in women’s issues, consumer organizations, 
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1 and women’s health professionals on Administration 

2 policy with regard to women; 

3 ‘‘(5) make annual estimates of funds needed to 

4 monitor clinical trials and analysis of data by sex in 

5 accordance with needs that are identified; and 

6 ‘‘(6) serve as a member of the Department of 

7 Health and Human Services Coordinating Com8 mittee on Women’s Health (established under sec9 tion 229(b)(4) of the Public Health Service Act). 

10 ‘‘(c) COORDINATING COMMITTEE.—

11 ‘‘(1) ESTABLISHMENT.—In carrying out sub12 section (b), the Director of the Office shall establish 

13 a committee to be known as the Coordinating Com14 mittee on Women’s Health (referred to in this sub15 section as the ‘Coordinating Committee’). 

16 ‘‘(2) COMPOSITION.—The Coordinating Com17 mittee shall be composed of the directors of the cen18 ters of the Administration. 

19 ‘‘(3) CHAIRPERSON.—The Director of the Of20 fice shall serve as the Chairperson of the Coordi21 nating Committee. 

22 ‘‘(4) DUTIES.—With respect to women’s health, 

23 the Coordinating Committee shall assist the Director 

24 of the Office in—
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1 ‘‘(A) identifying whether there is a need 

2 for further studies and, if so, developing strate3 gies to foster such studies; 

4 ‘‘(B) identifying issues in specific areas of 

5 women’s health that fall within the mission of 

6 the Administration; 

7 ‘‘(C) identifying whether any need exists 

8 for the coordination of Administration activi9 ties, including internal and external activities; 

10 ‘‘(D) maintaining the Administration’s 

11 focus in areas of importance to women; 

12 ‘‘(E) supporting the development of meth13 odologies to determine how to obtain data spe14 cific to women (including data relating to the 

15 age of women and the membership of women in 

16 ethnic or racial groups); and 

17 ‘‘(F) supporting the development and ex18 pansion of clinical trials of treatments and 

19 therapies for which obtaining such data has 

20 been determined to be an appropriate function. 

21 ‘‘(d) REPORTS.—Not later than January 31, 2006, 

22 and January 31 of each second year thereafter, the Direc23 tor of the Office shall prepare and submit to the appro24 priate committees of Congress a report describing the ac-
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1 tivities carried out under this section during the period 

2 for which the report is being prepared. 

3 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the 

4 purpose of carrying out this section, there are authorized 

5 to be appropriated such sums as may be necessary for 

6 each of the fiscal years 2005 through 2009.’’. 

7 SEC. 7. NO NEW REGULATORY AUTHORITY. 

8 Nothing in this Act and the amendments made by 

9 this Act may be construed as establishing regulatory au10 thority or modifying any existing regulatory authority.

Æ