103D CONGRESS

2D SESSION H. R. 2659

AMENDMENT
In the Senate of the United States,

March 24 (legislative day, February 22), 1994.

Resolved, That the bill from the House of Representatives (H.R. 2659) entitled ‘‘An Act to amend the Public

Health Service Act to revise and extend programs relating to

the transplantation of organs and of bone marrow’’, do pass

with the following

AMENDMENT:

Strike out all after the enacting clause and insert:

1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Organ Transplant Pro3 gram Reauthorization Act of 1994’’.

4 SEC. 2. ORGAN PROCUREMENT ORGANIZATIONS.

5 (a) IN GENERAL.—Subsection (a) of section 371 of the

6 Public Health Service Act (42 U.S.C. 273(a)) is amended

7 to read as follows:

8 ‘‘(a)(1) The Secretary may make grants for the consoli9 dation and expansion of qualified organ procurement orga10 nizations described in subsection (b).
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1 ‘‘(2) The Secretary may make grants to, and enter into

2 cooperative agreements and contracts with, qualified organ

3 procurement organizations described in subsection (b) and

4 other public or nonprofit private entities for the purpose

5 of increasing organ donation through—

6 ‘‘(A) the planning and conducting of programs

7 to provide information and education to the public on

8 the need for organ donations;

9 ‘‘(B) the training of individuals in requesting

10 such donations; or

11 ‘‘(C) the provision of technical assistance to

12 organ procurement organizations and other entities

13 in the health care system.

14 ‘‘(3)(A) In making awards of grants, cooperative

15 agreements and contracts under subparagraphs (A) and (B)

16 of paragraph (2), the Secretary shall give priority to carry17 ing out the purpose described in such paragraph with re18 spect to minority or other populations for which there is

19 a greater degree of organ shortages relative to the general

20 population.

21 ‘‘(B) In making awards of grants, cooperative agree22 ments and contracts under paragraph (2)(C), the Secretary

23 shall give priority to carrying out the purpose described in

24 such paragraph with respect to organ procurement organi-
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1 zations and hospitals with lower rates of procurement rel2 ative to other such organizations or hospitals.’’.

3 (b) QUALIFIED ORGAN PROCUREMENT ORGANIZA4 TIONS.—Section 371(b) of such Act (42 U.S.C. 273(b)) is

5 amended—

6 (1) in paragraph (1)—

7 (A) in the matter preceding subparagraph

8 (A), by striking ‘‘for which grants may be made

9 under subsection (a)’’ and inserting ‘‘described

10 in this section’’;

11 (B) by realigning the margin of subpara12 graph (E) so as to align with the margin of sub13 paragraph (D); and

14 (C) in subparagraph (G)—

15 (i) in the matter preceding clause (i),

16 by striking ‘‘directors or an advisory

17 board’’ and inserting ‘‘directors (or an ad18 visory board, in the case of a hospital-based

19 organ procurement organization established

20 prior to September 1, 1993)’’; and

21 (ii) in clause (i)—

22 (I) by striking ‘‘composed of’’ in

23 the matter preceding subclause (I) and

24 inserting ‘‘composed of a reasonable

25 balance of’’; and
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1 (II) by inserting before the comma

2 in subclause (II) the following: ‘‘, in3 cluding individuals who have received

4 a transplant of an organ (or trans5 plant candidates), and individuals who

6 are part of the family of an individual

7 who has donated an organ’’;

8 (2) by striking paragraph (2);

9 (3) by redesignating paragraph (3) as para10 graph (2);

11 (4) in paragraph (2) (as so redesignated)—

12 (A) by redesignating subparagraphs (B)

13 through (K) as subparagraphs (C) through (L),

14 respectively,

15 (B) by inserting after subparagraph (A) the

16 following new subparagraph:

17 ‘‘(B) conduct and participate in systematic ef18 forts, including public education, to increase the num19 ber of potential donors,’’;

20 (C) by inserting before the comma in sub21 paragraph (F) (as so redesignated) the following:

22 ‘‘, which system shall, at a minimum, allocate

23 each type of organ on the basis of—

24 ‘‘(i) a single list encompassing the entire

25 service area;
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1 ‘‘(ii) a list that encompasses at least an en2 tire State; or

3 ‘‘(iii) a list that encompasses an approved

4 alternative local unit (as defined in paragraph

5 (4)),

6 of individuals who have been medically referred to a

7 transplant center in the service area of the organiza8 tion in order to receive a transplant of the type of

9 organ with respect to which the list is maintained;’’;

10 (D) by striking subparagraph (I) (as so re11 designated) and inserting the following new sub12 paragraph:

13 ‘‘(I) be a member of and abide by the rules and

14 requirements of the Organ Procurement and Trans15 plantation Network established under section 372,’’;

16 and

17 (E) by striking subparagraph (K) (as so re18 designated) and inserting the following new sub19 paragraph:

20 ‘‘(K) evaluate annually, and report to the Organ

21 Procurement and Transplantation Network estab22 lished under section 372, on the effectiveness of the or23 ganization in acquiring potentially available organs,

24 particularly among minority populations, and the

25 variation of procurement across hospitals within the
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1 organ procurement organization region, and identify

2 a plan to increase procurement, particularly among

3 minority populations and other populations for which

4 there is a greater degree of organ shortages relative to

5 the general population, and at hospitals with low

6 rates of procurement, and’’; and

7 (5) by adding at the end thereof the following

8 new paragraphs:

9 ‘‘(3)(A) The Office of Technology Assessment shall con10 duct a study for the purpose of defining—

11 ‘‘(i) the appropriate standards by which to judge

12 the quality of performance of organ procurement or13 ganizations; and

14 ‘‘(ii) the proper criteria for a determination of

15 inadequate service from an organ procurement orga16 nization.

17 ‘‘(B) Not later than 2 years after the date of enactment

18 of this paragraph, the Office of Technology Assessment shall

19 complete the study required under subparagraph (A) and

20 prepare and submit to the Committee on Labor and Human

21 Resources of the Senate, the Committee on Energy and

22 Commerce of the House of Representatives, and the Sec23 retary, a report describing the findings made as a result

24 of the study.
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1 ‘‘(C) For purposes of this paragraph the term ‘organ’

2 means a human kidney, liver, heart, lung, pancreas, and

3 any other human organ or tissue specified by the Secretary

4 for purposes of this paragraph.

5 ‘‘(4)(A) As used in paragraph (2)(F), the term ‘alter6 native local unit’ means—

7 ‘‘(i) a unit composed of two or more contiguous

8 organ procurement organizations; or

9 ‘‘(ii) a subdivision of an organ procurement or10 ganization that operates as a distinct procurement

11 and distribution unit as a result of special geo12 graphic, rural, or minority population concerns but

13 that is not composed of any subunit of a metropolitan

14 statistical area.

15 ‘‘(B) The Organ Procurement and Transplantation

16 Network shall make recommendations to the Secretary con17 cerning the approval or denial of alternative local units.

18 The Network shall assess whether the alternative local units

19 will better promote organ donation and the equitable alloca20 tion of organs.

21 ‘‘(C) The Secretary shall approve or deny any alter22 native local unit principle or designation recommended by

23 the Network. If the Secretary does not provide otherwise

24 prior to the expiration of the 90-day period beginning on

25 the date on which the application is submitted, the rec-
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1 ommendations of the Network under subparagraph (B) with

2 respect to the application of the alternative local unit shall

3 go into effect.’’.

4 (c) EFFECTIVE DATE.—The amendments made by sub5 section (b)(5) shall apply to organ procurement organiza6 tions beginning January 1, 1995.

7 SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION

8 NETWORK.

9 Section 372(b) of the Public Health Service Act (42

10 U.S.C. 274(b)) is amended—

11 (1) in paragraph (1)(B)—

12 (A) in clause (i)—

13 (i) by striking ‘‘(including organiza14 tions that have received grants under sec15 tion 371)’’; and

16 (ii) by striking ‘‘; and’’ at the end

17 thereof and inserting ‘‘(including both indi18 viduals who have received a transplant of

19 an organ (or transplant candidates), and

20 individuals who are part of the family of

21 individuals who have donated an organ, the

22 number of whom shall make up not less

23 than 40 percent of the total number of

24 board members); and’’; and
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1 (B) in clause (ii), by inserting ‘‘including

2 a patient affairs committee’’ after ‘‘committees,’’;

3 and

4 (2) in paragraph (2)—

5 (A) in subparagraph (A), by striking clause

6 (i) and inserting the following new clause:

7 ‘‘(i) with respect to each type of transplant,

8 a national list of individuals who have been

9 medically referred to receive a transplant of the

10 type of organs with respect to which the list is

11 maintained (which list shall include the names

12 of all individuals included on lists in effect

13 under section 371(b)(2)(F), and’’;

14 (B) in subparagraph (B), by inserting ‘‘,

15 including requirements under section 371(b),’’

16 after ‘‘membership criteria’’;

17 (C) by redesignating subparagraphs (E)

18 through (L), as subparagraphs (F) through (M),

19 respectively;

20 (D) by inserting after subparagraph (D),

21 the following new subparagraph:

22 ‘‘(E) assist organ procurement organizations in

23 the equitable distribution of organs among transplant

24 patients,’’;
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1 (E) in subparagraph (K) (as so redesig2 nated), by striking ‘‘and’’ at the end thereof;

3 (F) in subparagraph (L) (as so redesig4 nated), by striking the period and inserting ‘‘,

5 including making recommendations to organ

6 procurements organizations and the Secretary

7 based on the annual reports required under sec8 tion 371(b)(2)(K),’’;

9 (G) in subparagraph (M) (as so redesig10 nated), by striking the period and inserting a

11 comma; and

12 (H) by adding at the end thereof the follow13 ing new subparagraphs:

14 ‘‘(N) submit to the Secretary for review and ap15 proval any change in the amount of fees imposed by

16 the Network for the registration of individuals on the

17 lists maintained under subparagraph (A)(i), such

18 change to be considered as approved if the Secretary

19 does not provide otherwise prior to the expiration of

20 the 90-day period beginning on the date on which the

21 change is submitted to the Secretary,

22 ‘‘(O) make available to the Secretary such infor23 mation, books, and records regarding the Network as

24 the Secretary may require,
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1 ‘‘(P) submit to the Secretary, on an annual

2 basis, a report on the clinical and scientific status of

3 the organ transplantations, and

4 ‘‘(Q) meet such other criteria regarding compli5 ance with this part as the Secretary may establish.’’.

6 SEC. 4. STUDY BY GENERAL ACCOUNTING OFFICE.

7 Section 377 of the Public Health Service Act (42

8 U.S.C. 274f) is amended to read as follows:

9 ‘‘SEC. 377. STUDY BY GENERAL ACCOUNTING OFFICE.

10 ‘‘(a) STUDY.—

11 ‘‘(1) IN GENERAL.—The Comptroller General of

12 the United States shall conduct a study for the pur13 pose of determining and making recommendations

14 concerning—

15 ‘‘(A) the composition of the boards of direc16 tors of organ procurement organizations and of

17 the Organ Procurement and Transplantation

18 Network on the date of enactment of this section,

19 and the effect of the Organ Transplant Program

20 Reauthorization Act of 1994 on the composition

21 and functioning of such boards;

22 ‘‘(B)(i) the number and percentage of

23 cadaveric organ transplants for foreign nationals

24 and nonresident aliens categorized by organ pro25 curement organization and by transplant center
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1 and information on any reciprocal agreements

2 between organ procurement organizations and

3 foreign countries or territories;

4 ‘‘(ii) the number and percent of the organi5 zations referred to in clause (i) above the organ

6 procurement transplant network guideline of 10

7 percent; and

8 ‘‘(III) any information on the current rate

9 of organ donation by individuals other than

10 United States citizens or legal residents;

11 ‘‘(C) organ donation rates and the impact

12 of various organ allocation systems on organ

13 procurement rates; and

14 ‘‘(D) the equitable allocation of organs na15 tionwide, including an analysis of the relative

16 probability of receiving an organ for patients

17 with similar characteristics for each category of

18 transplanted organ by organ procurement orga19 nization and recommendations for developing a

20 regional allocation system in order to ensure

21 that—

22 ‘‘(i) patients in one region have an

23 equivalent probability of receiving an organ

24 as do patients with similar characteristics

25 in another region; and
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1 ‘‘(ii) patients within a region have an

2 equivalent probability of receiving an organ

3 as do other patients with similar character4 istics in that region.

5 ‘‘(2) EQUITABLE ALLOCATION.—In carrying out

6 paragraph (1) with respect to subparagraph (D), the

7 Comptroller General shall—

8 ‘‘(A) recommend regions for allocating or9 gans to encompass as large a geographic area as

10 is practical, taking into account medical appro11 priateness, and the geographic proximity of pa12 tients with comparable priority for receiving an

13 organ;

14 ‘‘(B) take into account the impact on organ

15 donation and procurement rates; and

16 ‘‘(C) consult with experts in the area of organ al17 location and organ donations and consider their rec18 ommendations regarding the establishment of regions

19 in the country for the purpose of allocating organs.

20 ‘‘(b) REPORT.—Not later than 2 years after the date

21 of enactment of the Organ Transplant Program Reauthor22 ization Act of 1994, the Comptroller General of the United

23 States shall complete the study required under subsection

24 (a) and prepare and submit to the Committee on Energy

25 and Commerce of the House of Representatives, and to the
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1 Committee on Labor and Human Resources of the Senate,

2 a report describing the findings made as a result of the

3 study.’’.

4 SEC. 5. GENERAL PROVISIONS.

5 (a) LIMITATION.—Section 374(b) of the Public Health

6 Service Act (42 U.S.C. 274b(b)) is amended—

7 (1) by striking paragraph (2);

8 (2) by redesignating paragraph (3) as para9 graph (2); and

10 (3) in paragraph (2) (as so redesignated), by

11 striking ‘‘371(a)(3)’’ and inserting ‘‘371(a)(2)’’.

12 (b) REPEAL.—Section 376 of the Public Health Service

13 Act (42 U.S.C. 274d) is repealed.

14 (c) TRANSFER.—Section 378 of the Public Health

15 Service Act (42 U.S.C. 274g) is amended—

16 (1) by transferring such section to part H of title

17 III; and

18 (2) by inserting such section after section 377.

19 (d) AUTHORIZATION OF APPROPRIATIONS.—Section

20 378 of the Public Health Service Act (42 U.S.C. 274g) is

21 amended by striking ‘‘1991’’ and all that follows through

22 the period and inserting ‘‘1994, and such sums as may be

23 necessary for each of the fiscal years 1995 and 1996.’’.

24 SEC. 6. COMPREHENSIVE CHILD IMMUNIZATION.

25 (a) SHORT TITLE; REFERENCES AND PURPOSE.—
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1 (1) SHORT TITLE.—This section may be cited as

2 the ‘‘Comprehensive Child Immunization Act of

3 1994’’.

4 (2) REFERENCES.—Except as otherwise expressly

5 provided, whenever in this section an amendment or

6 repeal is expressed in terms of an amendment to, or

7 repeal of, a section or other provision, the reference

8 shall be considered to be made to a section or other

9 provision of the Public Health Service Act (42 U.S.C.

10 201 et seq.).

11 (3) PURPOSE.—It is the purpose of this section

12 to ensure that children in the United States are ap13 propriately immunized against vaccine preventable

14 infectious diseases at the earliest appropriate age.

15 (b) MONITORING OF CHILDHOOD IMMUNIZATIONS.—

16 Title XXI of the Public Health Service Act (42 U.S.C.

17 300aa–1 et seq.) is amended by adding at the end thereof

18 the following new subtitle:

19 ‘‘Subtitle 3—Improved Immuniza20 tion Delivery and Monitoring

21 Systems

22 ‘‘Part A—List of Vaccines and Administration

23 ‘‘SEC. 2141. LIST OF PEDIATRIC VACCINES; SCHEDULE FOR

24 ADMINISTRATION.

25 ‘‘(a) RECOMMENDED PEDIATRIC VACCINES.—
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1 ‘‘(1) IN GENERAL.—The Secretary shall establish

2 a list of the vaccines that the Secretary recommends

3 for administration to all children for the purpose of

4 immunizing the children, subject to such contra5 indications for particular medical categories of chil6 dren as the Secretary may establish under subsection

7 (b)(1)(D). The Secretary shall periodically review the

8 list, and shall revise the list as appropriate.

9 ‘‘(2) RULE OF CONSTRUCTION.—

10 ‘‘(A) The list of vaccines specified in sub11 paragraph (B) is deemed to be the list of vac12 cines maintained under paragraph (1).

13 ‘‘(B) The list of vaccines specified in this

14 subparagraph is the list of vaccines that, for pur15 poses of paragraph (1), is established (and peri16 odically reviewed and as appropriate revised) by

17 the Advisory Committee on Immunization Prac18 tices, an advisory committee established by the

19 Secretary, acting through the Director of the

20 Centers for Disease Control and Prevention.

21 ‘‘(b) RECOMMENDED SCHEDULE FOR ADMINISTRA22 TION.—

23 ‘‘(1) IN GENERAL.—Subject to paragraph (2), in

24 the case of a pediatric vaccine, the Secretary shall es25 tablish (and periodically review and as appropriate
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1 revise) a schedule of nonbinding recommendations for

2 the following:

3 ‘‘(A) The number of immunizations with

4 the vaccine that children should receive.

5 ‘‘(B) The ages at which children should re6 ceive the immunizations.

7 ‘‘(C) The dose of vaccine that should be ad8 ministered in the immunizations.

9 ‘‘(D) Any contraindications regarding ad10 ministration of the vaccine.

11 ‘‘(E) Such other guidelines as the Secretary

12 determines to be appropriate with respect to ad13 ministering the vaccine to children.

14 ‘‘(2) VARIATIONS IN MEDICAL PRACTICE.—In es15 tablishing and revising a schedule under paragraph

16 (1), the Secretary shall ensure that, in the case of the

17 pediatric vaccine involved, the schedule provides for

18 the full range of variations in medical judgment re19 garding the administration of the vaccine, subject to

20 remaining within medical norms.

21 ‘‘(3) RULE OF CONSTRUCTION.—

22 ‘‘(A) The schedule specified in subparagraph

23 (B) is deemed to be the schedule maintained

24 under paragraph (1).
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1 ‘‘(B) The schedule specified in this

2 subparagraph is the schedule that, for purposes

3 of paragraph (1), is established (and periodi4 cally reviewed and as appropriate revised) by

5 the advisory committee specified in subsection

6 (a)(2)(B).

7 ‘‘(c) GENERALLY APPLICABLE RULES OF CONSTRUC8 TION.—This section does not supersede any State law or

9 requirements with respect to receiving immunizations (in10 cluding any such law relating to religious exemptions or

11 other exemptions under such State laws).

12 ‘‘(d) ISSUANCE OF LIST AND SCHEDULES.— Not later

13 than 180 days after the date of the enactment of this section,

14 the Secretary shall establish the initial list required in sub15 section (a) and the schedule required in subsection (b).

16 ‘‘Part B—State Registry System for Immunization

17 Information

18 ‘‘SEC. 2145. PURPOSE.

19 ‘‘It is the purpose of this part to authorize the Sec20 retary, in consultation with State public health officials,

21 to establish State registry systems to monitor the immuni22 zation status of all children.

23 ‘‘SEC. 2146. GRANTS FOR IMMUNIZATION REGISTRIES.

24 ‘‘(a) IN GENERAL.—For the purpose described in sec25 tion 2145, the Secretary, acting through the Director of the
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1 Centers for Disease Control and Prevention, shall make an

2 allotment each fiscal year for each State in an amount de3 termined in accordance with section 2151. The Secretary

4 shall make a grant to the State of the allotment made for

5 the State for the fiscal year if the State submits to the Sec6 retary an application in accordance with section 2150 on

7 behalf of the chief executive officer of such State.

8 ‘‘(b) DESIGN OF STATE REGISTRIES.—To carry out

9 the purpose described in section 2145, a State registry es10 tablished under this part shall be designed to—

11 ‘‘(1) provide accurate and up to date surveil12 lance data regarding immunization rates at the State

13 and local levels;

14 ‘‘(2) assist in identifying localities with inad15 equate immunization rates to target for necessary re16 medial assistance;

17 ‘‘(3) assist in the effective administration and

18 management of immunization programs at State and

19 local levels by providing data to guide immunization

20 program efforts;

21 ‘‘(4) assist the State in providing and receiving

22 information on the immunization status of children

23 who move across geographic boundaries that are cov24 ered by different State or local registries; and
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1 ‘‘(5) facilitate the linkage of vaccine dosage in2 formation to adverse events reported to the Centers for

3 Disease Control and Prevention under section 2125(b)

4 and disease outbreak patterns, for the purpose of mon5 itoring vaccine safety and effectiveness.

6 ‘‘(c) ELIGIBLE USE OF FUNDS.—The Secretary may

7 make a grant under subsection (a) only if the State agrees

8 to expend the grant for the purpose of—

9 ‘‘(1) collecting the data described in section 2147;

10 ‘‘(2) operating registries to maintain the data

11 (and establishing such registries, in the case of a

12 State that is not operating such a registry);

13 ‘‘(3) utilizing the data to monitor the extent to

14 which children have received immunizations in ac15 cordance with the schedule established under section

16 2141;

17 ‘‘(4) notifying parents, as appropriate, if chil18 dren have not received immunizations in accordance

19 with such schedule;

20 ‘‘(5) coordinating and exchanging information

21 with other State registries to allow the monitoring of

22 the immunization status of children changing State of

23 residence; and

24 ‘‘(6) such other activities as the Secretary may

25 authorize with respect to achieving the objectives es-
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1 tablished by the Secretary for the year 2000 for the

2 immunization status of children in the United States.

3 ‘‘(d) RE QUIREMENT REGARDING STATE LAW.—

4 ‘‘(1) IN GENERAL.—The Secretary may make a

5 grant under subsection (a) only if the State in6 volved—

7 ‘‘(A) provides assurances satisfactory to the

8 Secretary that, not later than October 1, 1996,

9 the State will be operating a registry in accord10 ance with this part, including having in effect

11 such laws and regulations as may be necessary

12 to so operate such a registry;

13 ‘‘(B) agrees that, prior to such date, the

14 State will make such efforts to operate a registry

15 in accordance with this part as may be author16 ized in the law and regulations of the State; and

17 ‘‘(C) has in effect such laws and regulations

18 as may be necessary to ensure the following safe19 guards for the rights of parents:

20 ‘‘(i) An exemption for the parent, upon

21 the request of the parent, from the require22 ments established by the State, pursuant to

23 this part, for the collection of data described

24 in subsections (b) and (c) of section 2147, or

25 the collection of any other data regarding
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1 any child of the parent that the State may

2 require for incorporation in the State im3 munization registry.

4 ‘‘(ii) Restrictions ensuring that no in5 formation relating to a child or to the par6 ent or guardian of a child that is collected

7 or maintained by the State immunization

8 registry pursuant to this part, or the na9 tional immunization surveillance program

10 established under section 2153, will be used

11 as a basis for the criminal prosecution or

12 the commencement of a criminal investiga13 tion of a parent or guardian.

14 ‘‘(2) RULES OF CONSTRUCTION.—

15 ‘‘(A) With respect to the agreements made

16 by a State under this part, other than para17 graph (1)(B), the Secretary may require compli18 ance with the agreements only to the extent con19 sistent with such paragraph.

20 ‘‘(B) The provisions of this part do not au21 thorize the Secretary, as a condition of the re22 ceipt of a grant under subsection (a) by a State,

23 to prohibit the State from pr oviding any parent,

24 upon the request of the parent, with an exemp25 tion from the requirements established by the
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1 State pursuant to this part for the collection of

2 data regarding any child of the parent.

3 ‘‘SEC. 2147. REGISTRY DATA.

4 ‘‘(a) IN GENERAL.—For purposes of section

5 2146(c)(1), the data described in this section are the data

6 described in subsection (b) and the data described in sub7 section (c).

8 ‘‘(b) DATA REGARDING BIRTH OF CHILD.—With re9 spect to the birth of a child, the data described in this sub10 section is as follows:

11 ‘‘(1) The name of each child born in the State

12 involved after the date of the implementation of the

13 registry (in no event shall such date be later than Oc14 tober 1, 1996).

15 ‘‘(2) Demographic data on the child.

16 ‘‘(3) The name of one or both of the parents of

17 the child. If the child has been given up for adoption,

18 any information regarding the identity of the birth

19 parent or parents of the child may not be entered into

20 the registry, or if entered, shall be deleted.

21 ‘‘(4) The address, as of the date of the birth of

22 the child, of each parent whose name is received in

23 the registry pursuant to paragraph (3).

24 ‘‘(c) DATA REGARDING INDIVIDUAL IMMUNIZA25 TIONS.—With respect to a child to whom a pediatric vac-
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1 cine is administered in the State involved, the data de2 scribed in this subsection is as follows:

3 ‘‘(1) The name, age, and address of the child.

4 ‘‘(2) The date on which the vaccine was adminis5 tered to the child.

6 ‘‘(3) The name and business address of the health

7 care provider that administered the vaccine.

8 ‘‘(4) The address of the facility at which the vac9 cine was administered.

10 ‘‘(5) The name and address of one or both par11 ents of the child as of the date on which the vaccine

12 was administered, if such information is available to

13 the health care provider.

14 ‘‘(6) The type of vaccine.

15 ‘‘(7) The lot number or other information identi16 fying the particular manufacturing batch of the vac17 cine.

18 ‘‘(8) The dose of vaccine that was administered.

19 ‘‘(9) A notation of the presence of any adverse

20 medical reactions that the child experienced in rela21 tion to the vaccine and of which the health care pro22 vider is aware, in accordance with section 2125.

23 ‘‘(10) The presence of contraindications noted by

24 the health care provider with respect to administra25 tion of the vaccine to the child.
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1 ‘‘(11) Such other data regarding immunizations

2 for the child, including identifying data, as the Sec3 retary, in consultation with State public health offi4 cials, may require consistent with applicable law (in5 cluding social security account numbers furnished

6 pursuant to section 205(c)(2)(E) of the Social Secu7 rity Act).

8 ‘‘(d) LIMITATION.—The Secretary may not establish

9 information reporting requirements in addition to those de10 scribed in subsection (c) if such requirements are unduly

11 burdensome.

12 ‘‘(e) DATE CERTAIN FOR SUBMISSION TO REGISTRY.—

13 The Secretary may make a grant under section 2146 only

14 if the State involved agrees to ensure that, with respect to

15 a child—

16 ‘‘(1) the data described in subsection (b) are sub17 mitted to the registry under such section as soon as

18 possible but in no event later than 8 weeks after the

19 date on which the child is born; and

20 ‘‘(2) the data described in subsection (c) with re21 spect to a vaccine are submitted to such registry as

22 soon as possible but in no event later than 4 weeks

23 after the date on which the vaccine is administered to

24 the child.
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1 ‘‘(f) UNIFORMITY IN METHODOLOGIES.—The Secretary

2 shall, in consultation with State public health officials, es3 tablish standards regarding the methodologies used in estab4 lishing and operating registries under section 2146, and

5 may make a grant under such section only if the State

6 agrees to comply with the standards. The Secretary shall

7 provide maximum flexibility to the States while also retain8 ing a reasonable degree of uniformity among the States in

9 such methodologies for the purpose of ensuring the utility,

10 comparability, and exchange of the data maintained in

11 such registries.

12 ‘‘(g) COORDINATION AMONG STATES.—The Secretary

13 may make a grant under section 2146 to a State only if,

14 with respect to the operation of the registry of the State

15 under such section, the State agrees to transfer that infor16 mation contained in the State registry pursuant to section

17 2146 to other States upon the request of such States for such

18 information.

19 ‘‘SEC. 2148. FEDERAL STANDARDS ON CONFIDENTIALITY.

20 ‘‘(a) ESTABLISHMENT.—

21 ‘‘(1) IN GENERAL.—The Secretary, in consulta22 tion with the States, shall by regulation establish

23 standards providing for maintaining the confidential24 ity of the identity of individuals with respect to

25 whom data are maintained in registries under section
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1 2146. Such standards shall, with respect to a State,

2 provide that the State is to have in effect laws or reg3 ulations regarding such confidentiality, including ap4 propriate penalties for violation of the laws. The Sec5 retary may make a grant under such section only if

6 the State involved agrees to comply with the stand7 ards.

8 ‘‘(2) USE OF DISCLOSURE.—

9 ‘‘(A) No personally identifiable information

10 relating to a child or to the parent or guardian

11 of such child that is collected or maintained by

12 the State registry may be used or disclosed by

13 any holder of such information except as per14 mitted for—

15 ‘‘(i) the monitoring of a child’s immu16 nization status;

17 ‘‘(ii) oversight, audit, and evaluation

18 of the immunization delivery and registry

19 systems;

20 ‘‘(iii) activities relating to establishing

21 and maintaining a safe and effective supply

22 of recommended childhood vaccine;

23 ‘‘(iv) processing of insurance claims for

24 payment for vaccine administration (but
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1 only to the extent necessary for processing

2 claims); and

3 ‘‘(v) administration of the National

4 Vaccine Injury Compensation Program

5 under subtitle 2.

6 ‘‘(B) Information regarding immunizations

7 provided as described in subparagraph (A)(i)

8 may be used or disclosed only with the written

9 authorization of the individual to whom it refers

10 or to the parent with custody of such individual.

11 ‘‘(b) USE OF SOCIAL SECURITY ACCOUNT NUMBERS.—

12 Any usage or disclosure of data in registries under section

13 2146 that consists of social security account numbers and

14 related information which is otherwise permitted under this

15 part may be exercised only to the extent permitted under

16 section 205(c)(2)(E) of the Social Security Act. For pur17 poses of the preceding sentence, the term ‘related informa18 tion’ has the meaning given such term in clause (iv)(II)

19 of such section.

20 ‘‘SEC. 2149. PROVIDER PARTICIPATION.

21 ‘‘(a) IN GENERAL.—The State shall monitor and en22 force compliance by health care providers with the require23 ments of sections 2147 and 2148 and section 2155(b) for

24 all doses of pediatric vaccine administered in the State. The

25 State shall establish procedures satisfactory to the Secretary
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1 for discontinuing the distribution of federally purchased or

2 State purchased vaccine for any health care provider who

3 fails to comply with the requirements of section 2147 and

4 for reinstating such vaccine supply to such provider upon

5 receiving from such provider—

6 ‘‘(1) the reports necessary to make current and

7 complete the information that would have been fur8 nished to the State registry between the dates of the

9 provider’s termination and reinstatement; and

10 ‘‘(2) satisfactory assurances regarding the pro11 vider’s future compliance.

12 ‘‘(b) REPORTS TO SECRETARY.—The Secretary may

13 make a grant under section 2146 only if the State involved

14 agrees to submit to the Secretary such reports as the Sec15 retary determines to be appropriate with respect to the ac16 tivities of the State under this part.

17 ‘‘SEC. 2150. APPLICATION FOR GRANT.

18 ‘‘An application by a State for a grant under section

19 2146 is in accordance with this section if the application—

20 ‘‘(1) is submitted not later than the date speci21 fied by the Secretary;

22 ‘‘(2) contains each agreement required in this

23 part;

24 ‘‘(3) contains any information required in this

25 part to be submitted to the Secretary; and
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1 ‘‘(4) is in such form, is made in such manner,

2 and contains such agreements, assurances, and infor3 mation as the Secretary determines to be necessary to

4 carry out this part.

5 ‘‘SEC. 2151. DETERMINATION OF AMOUNT OF ALLOTMENT.

6 ‘‘The Secretary shall determine the amount of the allot7 ments required in section 2146 for States for a fiscal year

8 in accordance with a formula established by the Secretary

9 that allots the amounts appropriated under section 2152

10 for the fiscal year on the basis of the costs of the States

11 in establishing and operating registries under section 2146.

12 ‘‘SEC. 2152. AUTHORIZATION OF APPROPRIATIONS.

13 ‘‘For the purpose of carrying out this part, other than

14 section 2153, there are authorized to be appropriated

15 $152,000,000 for fiscal year 1994, $125,000,000 for fiscal

16 year 1995, and $35,000,000 for each of the fiscal years 1996

17 through 1999.

18 ‘‘SEC. 2153. NATIONAL IMMUNIZATION SURVEILLANCE PRO19 GRAM.

20 ‘‘(a) IN GENERAL.—The Secretary shall establish a na21 tional immunization surveillance program for the purpose

22 of assessing the effects of the programs and activities pro23 vided for in this subtitle towards appropriately immuniz24 ing children and facilitating State immunization registries.

25 The national immunization surveillance program shall—
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1 ‘‘(1) provide technical assistance to States for the

2 development of vaccination registries and monitoring

3 systems; and

4 ‘‘(2) receive aggregate epidemiologic data (that is

5 in a format that is not person specific) collected by

6 States as provided for in section 2147 at intervals de7 termined appropriate by the Secretary for the purpose

8 of—

9 ‘‘(A) compiling accurate and up-to-date

10 surveillance data regarding immunization rates

11 at the State level in order to assess the progress

12 made towards achieving nationally established

13 immunization goals;

14 ‘‘(B) assisting in the effective administra15 tion and management of immunization pro16 grams at the State level by providing technical

17 assistance to guide immunization program ef18 forts at the request of the State;

19 ‘‘(C) providing technical assistance to

20 States and localities to facilitate monitoring the

21 immunization status of children who move across

22 geographic boundaries that are covered by dif23 ferent State or local registries at the request of

24 such States or localities; and
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1 ‘‘(D) monitoring the safety and effectiveness

2 of vaccines by linking vaccine dosage informa3 tion with adverse events reporting under section

4 2125(b) and disease outbreak patterns.

5 ‘‘(b) RULE OF CONSTRUCTION.—Nothing in this sub6 title shall be construed to authorize the release of person

7 specific information to the Secretary for the purpose of im8 munization surveillance.

9 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There are

10 authorized to be appropriated such sums as may be nec11 essary to carry out this section in each of the fiscal years

12 1994 through 1999.

13 ‘‘SEC. 2154. REPORT.

14 ‘‘Not later than January 1, 1995, and biennially there15 after, the Secretary shall prepare and submit to the appro16 priate committees of Congress a report concerning the plan17 ning, development, operation and effectiveness of the na18 tional immunization surveillance program and the State

19 immunization registries.

20 ‘‘Part C—Distribution of Vaccines, Public Outreach

21 and Education

22 ‘‘SEC. 2155. DISTRIBUTION OF VACCINES.

23 ‘‘(a) IN GENERAL.—

24 ‘‘(1) HEALTH CARE PROVIDERS.—The Secretary

25 shall provide for the distribution, without charge, of
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1 recommended pediatric vaccines (in accordance with

2 section 2141) purchased by the Secretary to health

3 care providers who serve children and who—

4 ‘‘(A) are members of a uniformed service, or

5 are officers or employees of the United States;

6 ‘‘(B) are health centers (as defined in sec7 tion 2163); or

8 ‘‘(C) provide services under section 503 of

9 the Indian Health Care Improvement Act or

10 pursuant to a contract under section 102 of the

11 Indian Self Determination Act.

12 ‘‘(2) STATES.—The Secretary shall provide for

13 the distribution, without charge, of those rec14 ommended pediatric vaccines that are purchased by

15 the Secretary and provided to States for the purposes

16 of immunizing medicaid-eligible children, and addi17 tional vaccines that may be purchased by the Sec18 retary for children within those States.

19 ‘‘(b) DUTIES OF HEALTH CARE PROVIDERS.—

20 ‘‘(1) FREE PROVISION TO CHILDREN.—A health

21 care provider or entity receiving vaccine under this

22 section may use such vaccine only for administration

23 to children and may not impose a charge for such

24 vaccine. A provider or health care entity may impose

25 a fee that reflects actual regional costs as determined
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1 by the Secretary for the administration of such vac2 cine, except that a provider may not deny a child a

3 vaccination due to the inability of the child’s parent

4 to pay an administration fee.

5 ‘‘(2) REPORTING REQUIREMENTS.—A health care

6 provider receiving vaccine under this section shall re7 port the information required under section 2147 to

8 the applicable State registry operated pursuant to a

9 grant under section 2146 if such State registry exists.

10 The provider shall additionally report to such State

11 registry any occurrence reported to the Secretary pur12 suant to section 2125(b). The provider shall also pro13 vide regular and periodic estimates to the State of the

14 provider’s future dosage needs for recommended child15 hood vaccines distributed under this section. All re16 ports shall be made with such frequency and in such

17 detail as the Secretary, in consultation with State

18 public health officials, may prescribe.

19 ‘‘SEC. 2156. IMPROVED IMMUNIZATION DELIVERY, OUT20 REACH AND EDUCATION.

21 ‘‘(a) FEDERAL EFFORTS.—The Secretary, acting

22 through the Centers for Disease Control and Prevention and

23 in conjunction with State health officials and other appro24 priate public and private organizations, shall conduct the

25 following activities to improve Federal, State and local vac-
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1 cine delivery systems and immunization outreach and edu2 cation efforts:

3 ‘‘(1) NATIONAL PUBLIC AWARENESS CAMPAIGN.—

4 ‘‘(A) IN GENERAL.—The Secretary, in con5 junction with State health officials and other ap6 propriate public and private organizations, shall

7 develop and implement a National Immuniza8 tion Public Awareness Campaign to assist fami9 lies (through bilingual means if necessary) of

10 children under the age of 2 years, and expectant

11 parents, in obtaining knowledge concerning the

12 importance of having their children immunized

13 and in identifying the vaccines, schedules for im14 munization, and vaccine provider locations, ap15 propriate with respect to their children.

16 ‘‘(B) IMPLEMENTATION.—In implementing

17 the Campaign under subparagraph (A), the Sec18 retary shall ensure that—

19 ‘‘(i) new and innovative methods are

20 developed and utilized to publicly advertise

21 the need to have children immunized in a

22 timely manner;

23 ‘‘(ii) print, radio and television media

24 are utilized to convey immunization infor25 mation to the public; and
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1 ‘‘(iii) with respect to immunization in2 formation, efforts are made to target preg3 nant women and the parents of children

4 under the age of 2.

5 ‘‘(2) INTERAGENCY COMMITTEE ON IMMUNIZA6 TION.—The Secretary, in conjunction with the Sec7 retary of Agriculture, the Secretary of Housing and

8 Urban Development, and the Secretary of Education,

9 shall carry out activities through the Interagency

10 Committee on Immunization to incorporate immuni11 zation status assessments and referral services as an

12 integral part of the process by which individuals

13 apply for assistance under—

14 ‘‘(A) the food stamp program under the

15 Food Stamp Act of 1977;

16 ‘‘(B) section 17 of the Child Nutrition Act

17 of 1966;

18 ‘‘(C) the Head Start Act;

19 ‘‘(D) part A of title IV of the Social Secu20 rity Act;

21 ‘‘(E) title XIX of the Social Security Act;

22 ‘‘(F) any of the housing assistance laws of

23 the United States; and
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1 ‘‘(G) other programs determined appro2 priate by any of the Secretaries described in this

3 paragraph.

4 ‘‘(3) EXPANDED OPPORTUNITY FOR NATIONAL

5 SERVICE.—The Secretary, in conjunction with the

6 Commission on National and Community Service

7 and other independent agencies, is encouraged to de8 velop opportunities for participants in national and

9 community service programs to contribute to local

10 initiatives for the improvement of immunization serv11 ices, including public outreach and education efforts.

12 ‘‘(b) GRANTS TO STATES.—

13 ‘‘(1) IN GENERAL.—

14 ‘‘(A) The Secretary may award grants to

15 States to enable such State to develop, revise and

16 implement immunization improvement plans as

17 described in paragraph (2).

18 ‘‘(B) To be eligible to receive a grant under

19 subparagraph (A), a State shall prepare and

20 submit to the Secretary an application at such

21 time, in such manner, and containing such in22 formation as the Secretary may require.

23 ‘‘(2) DESIGN.—A State immunization improve24 ment plan shall be designed to improve immunization

25 delivery, outreach, education and coordination within
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1 the State. Such plan shall provide for the creation

2 of—

3 ‘‘(A) a vaccine provider education cam4 paign and the distribution of any other mate5 rials determined to be appropriate by State

6 health officials—

7 ‘‘(i) to enable such providers to make

8 the best use of vaccination opportunities;

9 and

10 ‘‘(ii) to educate such providers concern11 ing their obligation to report immunization

12 information with respect to their patients to

13 State registries;

14 ‘‘(B) expanded capacity for the delivery of

15 immunizations through—

16 ‘‘(i) increasing the number or type of

17 facilities through which vaccines may be

18 made available and the capacity of such fa19 cilities to immunize more children;

20 ‘‘(ii) developing alternative methods of

21 delivering vaccines, such as mobile health

22 clinics;

23 ‘‘(iii) increasing the number of hours

24 during which vaccines are made available

25 by providers within the State; or
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1 ‘‘(iv) coordinating with federally quali2 fied health centers to reach and immunize

3 underserved children through education,

4 outreach, tracking, and the provision of

5 services;

6 except that, the Secretary may waive any spe7 cific requirement of this subparagraph if the Sec8 retary determines that State immunization de9 livery efforts are sufficient without the imposi10 tion of such requirement;

11 ‘‘(C) population-based assessment criteria

12 through which the State is able to assess the ef13 fectiveness of immunization activities in the

14 State, which may be fulfilled through the imple15 mentation of a State immunization registry

16 under section 2146;

17 ‘‘(D) a public awareness campaign, in con18 junction with the National Campaign established

19 under subsection (a)(1), to provide parents with

20 information about the importance of immuniza21 tion, the types and schedules for the administra22 tion of vaccines, and the locations of vaccines

23 providers;

24 ‘‘(E) coordinated community outreach ac25 tivities among public or private health pro-
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1 grams, including local health departments and

2 health centers, and other public or private enti3 ties, to encourage and facilitate the ability of

4 parents to obtain immunization services for their

5 children; and

6 ‘‘(F) other activities that are not inconsist7 ent with the purposes of this subtitle, subject to

8 the approval of the Secretary.

9 ‘‘(3) IMMUNIZATION IMPROVEMENT PLAN AP10 PROVAL.—

11 ‘‘(A) GOALS.—As part of the immunization

12 improvement plan of a State, the State shall es13 tablish immunization rate goals for children re14 siding within the State.

15 ‘‘(B) APPROVAL.—The immunization im16 provement plan developed by a State under this

17 subsection shall be submitted to the Secretary for

18 approval prior to the distribution of grant funds

19 to the States under this subsection. The Secretary

20 shall periodically review the progress that the

21 State has made under such plan in achieving the

22 goals established under subparagraph (A).

23 ‘‘(C) DISTRIBUTION OF GRANTS.—In

24 awarding grants under this section, the Sec25 retary shall ensure that grant awards will be eq-
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1 uitably distributed between rural and urban

2 areas. In determining such distribution, the Sec3 retary shall take into account the added costs of

4 supporting the health care delivery infrastruc5 ture in sparsely populated areas. The Secretary

6 shall give special consideration to those States

7 that have low childhood immunization rates and

8 that submit plans that demonstrate the State’s

9 substantial effort and commitment to improving

10 such rates.

11 ‘‘(D) REPORTING.—A State shall annually

12 prepare and submit to the Director of the Cen13 ters for Disease Control and Prevention a report

14 concerning the implementation of the State im15 munization improvement plan.

16 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There are

17 authorized to be appropriated to carry out this section,

18 $250,000,000 for fiscal year 1994, and such sums as may

19 be necessary for each of the fiscal years 1995 through 1999.

20 ‘‘SEC. 2157. PERFORMANCE BASED GRANT PROGRAM.

21 ‘‘(a) ANNUAL REPORT.—Not later than July 1 of each

22 year, a State shall prepare and submit to the Director of

23 the Centers for Disease Control and Prevention a report

24 that contains an estimate (based on a base population sam25 ple) of the percentage of 2 year old residents of the State
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1 who have been fully immunized as described in subsection

2 (c).

3 ‘‘(b) PAYMENTS TO STATES.—

4 ‘‘(1) IN GENERAL.—Subject to the availability of

5 appropriations, the Secretary shall provide to a State

6 that has submitted an annual report under subsection

7 (a) that demonstrates that the State has fully immu8 nized at least 50 percent of the 2 year old residents

9 of that State, with respect to the year for which the

10 report was prepared, a payment in an amount equal

11 to—

12 ‘‘(A) with respect to a State that has dem13 onstrated the full immunization of at least 50

14 and less than 64 percent of all 2 year old resi15 dents of the State, $50 multiplied by the number

16 of fully immunized 2 year old resident children

17 in excess of the number of children equaling such

18 50 percent amount;

19 ‘‘(B) with respect to a State that has dem20 onstrated the full immunization of at least 65

21 and less than 70 percent of all 2 year old resi22 dents of the State, $75 multiplied by the number

23 of fully immunized 2 year old resident children

24 in excess of the number of children equaling such

25 65 percent amount; and
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1 ‘‘(C) with respect to a State that has dem2 onstrated the full immunization of at least 70

3 and less than 91 percent of all 2 year old resi4 dents of the State, $100 multiplied by the num5 ber of fully immunized 2 year old resident chil6 dren in excess of the number of children equaling

7 such 70 percent amount.

8 ‘‘(2) USE OF FUNDS.—

9 ‘‘(A) CONDITION.—As a condition of receiv10 ing amounts under this section a State that uses

11 a combination of Federal and State funds in

12 achieving the immunization goals described in

13 paragraph (1) shall agree to reinvest, in activi14 ties related to improving immunization services,

15 that percentage of the payments to the State

16 under paragraph (1) that is equal to the amount

17 of Federal contributions to immunization serv18 ices in the State as compared to the amount of

19 the State contributions to such services.

20 ‘‘(B) DISCRETIONARY USE.—A State that

21 has demonstrated that the use of State-only

22 funds was responsible for the increase in the im23 munization rate which qualified such State for

24 payments under paragraph (1), may use
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1 amounts awarded under this section for other

2 purposes, at the discretion of the State.

3 ‘‘(3) VERIFICATION.—Prior to making a pay4 ment to a State under this subsection, the Secretary

5 shall, in collaboration with the Centers for Disease

6 Control and Prevention, verify the accuracy of the

7 State report involved.

8 ‘‘(c) DEFINITION.—For purposes of this section, the

9 term ‘fully immunized’ means a 2 year old child that has

10 received four doses of DTP vaccine (diphtheria, tetanus,

11 pertussis), three doses of polio vaccine, and one dose of

12 MMR (measles, mumps, rubella) vaccine.

13 ‘‘Part D—General Provisions

14 ‘‘SEC. 2161. REPORT.

15 ‘‘Not later than October 1, 1995, and biennially there16 after, the Secretary shall prepare and submit to the appro17 priate committees of Congress a report concerning the costs,

18 efficiency, and effectiveness of procedures established to de19 liver vaccine to health care providers.

20 ‘‘SEC. 2162. NATIONAL VACCINE PROGRAM.

21 ‘‘The Secretary shall authorize a report to be prepared

22 by the National Academy of Sciences concerning the role

23 of the National Vaccine Program established under this title

24 in achieving progress towards the nationally established im25 munization goals for the year 2000, and recommendations
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1 with respect to the changes in such Program that would

2 facilitate greater progress towards achieving such goals.

3 ‘‘SEC. 2163. DEFINITIONS.

4 ‘‘For purposes of this subtitle—

5 ‘‘(1) HEALTH CARE PROVIDER.—The term

6 ‘health care provider’, with respect to the administra7 tion of vaccines to children, means an entity that is

8 licensed or otherwise authorized for such administra9 tion under the law of the State in which the entity

10 administers the vaccine, subject to section 333(e).

11 ‘‘(2) HEALTH CENTER.—The term ‘health center’

12 means—

13 ‘‘(A) a federally-qualified health center, as

14 defined in section 1905(l)(2) of the Social Secu15 rity Act; or

16 ‘‘(B) a public or nonprofit private entity

17 receiving Federal funds under—

18 ‘‘(i) section 329, 330 or 340;

19 ‘‘(ii) section 340A (relating to grants

20 for health services for residents of public

21 housing); or

22 ‘‘(iii) section 501(a)(2) of the Social

23 Security Act (relating to special projects of

24 regional and national significance).
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1 ‘‘(3) IMMUNIZATION.—The term ‘immunization’

2 means an immunization against a vaccine-prevent3 able disease.

4 ‘‘(4) PARENT.—The term ‘parent’, with respect

5 to a child, means a legal guardian of the child.

6 ‘‘(5) PEDIATRIC VACCINE.—The term ‘pediatric

7 vaccine’ means a vaccine included on the list estab8 lished under section 2141.

9 ‘‘(6) STATE.—The term ‘State’ means the 50

10 States, the District of Columbia, the Commonwealth

11 of Puerto Rico, Guam, American Samoa, the U.S.

12 Virgin Islands, the Republic of the Marshall Islands,

13 Micronesia, the Northern Mariana Islands, and

14 Palau.’’.

15 (c) NATIONAL VACCINE INJURY COMPENSATION PRO16 GRAM AMENDMENTS.—

17 (1) AMENDMENT OF VACCINE INJURY TABLE.—

18 (A) ADDITION OF VACCINES.—Section 2114

19 (42 U.S.C. 300aa–14) is amended by adding at

20 the end thereof the following new subsection:

21 ‘‘(f) ADDITION OF VACCINES TO TABLE.—

22 ‘‘(1) IN GENERAL.—The Vaccine Injury table

23 contained in subsection (a) shall also include any rec24 ommended childhood vaccine included in the list pro25 mulgated by the Secretary under section 2141.
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1 ‘‘(2) REVIEW OF INFORMATION AND REVISION.—

2 Not later than 2 years after the addition of a new

3 vaccine to the table contained in subsection (a), and

4 on a regular basis thereafter, the Secretary shall re5 view information obtained under sections 2125 and

6 part B of subtitle 3, and based on such review (and

7 other relevant information) shall, as appropriate, de8 velop with respect to such new vaccine—

9 ‘‘(A) revisions with respect to illnesses, dis10 abilities, injuries or conditions covered by such

11 table;

12 ‘‘(B) appropriate specifications of the time

13 period for the first symptom or manifestation of

14 onset or of significant aggravation of such ill15 nesses, disabilities, injuries or condition after

16 vaccine administration, for purposes of receiving

17 compensation under the Program; and

18 ‘‘(C) recommendations as to the amount of

19 tax that should be imposed under section 4131 of

20 the Internal Revenue Code of 1986 for each dose

21 of vaccine.

22 ‘‘(3) LIMITATION.—The Secretary may modify

23 the table contained in subsection (a) pursuant to

24 paragraphs (1) and (2) only in accordance with sub25 section (c).
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1 ‘‘(4) REVISION.—For purposes of section

2 2116(b), the addition of vaccine to the table contained

3 in subsection (a) by operation of this subsection shall

4 constitute a revision of the table.’’.

5 (B) ATTORNEYS FEES.—Section 2115(e) (42

6 U.S.C. 300aa-15(e)) is amended by adding at the

7 end thereof the following new paragraph:

8 ‘‘(4) The special master may award reasonable

9 attorneys fees whether or not an election has been

10 made under section 2121(a) to file a civil action con11 cerning such petition.’’.

12 (C) CONSENT FOR ANNUITY.—Subpara13 graphs (A) and (B) of section 2115(f)(4) are

14 amended by striking ‘‘, with the consent of the

15 petitioner,’’ each place that such appears.

16 (C) TIME PERIODS FOR FEES AND COSTS.—

17 (i) IN GENERAL.—Section 2115(e) (42

18 U.S.C. 300aa–15(e)) (as amended by para19 graph (3)) is further amended by adding at

20 the end thereof the following new para21 graph:

22 ‘‘(5) With respect to a petitioners’ application

23 for attorneys’ fees and costs—

24 ‘‘(A) if the respondent enters no objection to

25 such application within 21 days of the date on
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1 which the application was filed (unless such time

2 period is extended by the special master with the

3 consent of the petitioner) the special master shall

4 enter a decision on such application within 30

5 days of such filing;

6 ‘‘(B) if the respondent files an objection to

7 such application and the special master does not

8 enter a decision with respect to the application

9 within 60 days after the date on which the objec10 tion is filed, the special master involved shall,

11 upon the written request of the petitioner, enter

12 a decision within 15 days after the filing of such

13 request; and

14 ‘‘(C) if the respondent files an objection to

15 such application and the petitioner moves to re16 duce costs and fees as provided for in the objec17 tion, the special master shall enter a decision

18 within 5 days after the receipt of the petitioner’s

19 motion.

20 The chief special master, upon the request of a special

21 master, may waive the time limitations applicable to

22 the special master under this paragraph if the special

23 master demonstrates that complicating factors exist

24 with respect to the issues involved to which the time

25 limitation applies.’’.
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1 (B) APPLICATION.—The amendment made

2 by subparagraph (A) shall apply to all petition3 ers’ applications for attorneys’ fees and costs

4 filed under section 2115(e) of the Public Health

5 Service Act which are pending on the date of en6 actment of this Act.

7 (E) AUTHORIZATION OF APPROPRIA8 TIONS.—Section 2115(j) (42 U.S.C. 300aa-15(j))

9 is amended by striking ‘‘$80,000,000 for each

10 succeeding fiscal year’’ and inserting in lieu

11 thereof ‘‘$110,000,000 for each succeeding fiscal

12 year’’.

13 (F) LIMITATION OF ACTIONS.—Section

14 2116(b) (42 U.S.C. 300aa–16(b)) is amended by

15 striking ‘‘such person may file’’ and inserting

16 ‘‘or to significantly increase the likelihood of ob17 taining compensation, such person may, not18 withstanding section 2111(b)(2), file’’.

19 (2) EXTENSION OF TIME FOR DECISION.—

20 (A) JURISDICTION.—Section 2112(d)(3)(D)

21 (42 U.S.C. 300aa–12(d)(3)(D)) is amended by

22 striking ‘‘540 days’’ and inserting ‘‘30 months

23 (but for not more than 6 months at a time)’’.

24 (B) REPORT ON COLLECTIONS.—Section

25 2117 (42 U.S.C. 300aa–17) is amended by add-
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1 ing at the end thereof the following new sub2 section:

3 ‘‘(c) REPORT.—The Attorney General shall, on Janu4 ary 1 of each year, prepare and submit to the appropriate

5 committees of Congress a report concerning amounts col6 lected under this section.’’.

7 (C) INCREASED RESPONSIBILITIES OF COM8 MISSION.—Section 2119(f) (42 U.S.C. 300aa–

9 19(f)) is amended—

10 (i) by striking ‘‘and’’ at the end of

11 paragraph (4);

12 (ii) by striking the period at the end of

13 paragraph (5) and inserting ‘‘, and’’; and

14 (iii) by adding at the end thereof the

15 following new paragraph:

16 ‘‘(6) monitor the balance of the Vaccine Injury

17 Trust Fund established by section 9510 of the Inter18 nal Revenue Code and, as appropriate, recommend

19 changes in the tax per dose of vaccine imposed under

20 section 4131 of such Code.’’.

21 (3) SIMPLIFICATION OF VACCINE INFORMATION

22 MATERIALS.—

23 (A) INFORMATION.—Section 2126(b) (42

24 U.S.C. 300aa–26(b)) is amended—
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1 (i) by striking ‘‘by rule’’ in the matter

2 preceding paragraph (1);

3 (ii) in paragraph (1), by striking ‘‘90’’

4 and inserting ‘‘30’’; and

5 (iii) in paragraph (2), by striking ‘‘,

6 appropriate health care providers and par7 ent organizations’’.

8 (B) REQUIREMENTS.—Section 2126(c) (42

9 U.S.C. 300aa–26(c)) is amended—

10 (i) in the matter preceding paragraph

11 (1), by inserting ‘‘shall be based on avail12 able data and information,’’ after ‘‘such

13 materials’’; and

14 (ii) by striking out paragraphs (1)

15 through (10) and inserting in lieu thereof

16 the following new paragraphs:

17 ‘‘(1) a concise description of the benefits of the

18 vaccine;

19 ‘‘(2) a concise description of the risks associated

20 with the vaccine;

21 ‘‘(3) a statement of the availability of the Na22 tional Vaccine Injury Compensation Program;

23 ‘‘(4) a statement of the availability from the Sec24 retary of more detailed written information concern25 ing the information required under paragraphs (1),
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1 (2), and (3), that shall be made available to the par2 ent, legal guardian, or other responsible person upon

3 request; and

4 ‘‘(5) such other relevant information as deter5 mined appropriate by the Secretary.’’.

6 (C) OTHER INDIVIDUALS.—Subsections (a)

7 and (d) of section 2126 (42 U.S.C. 300aa–26(a)

8 and (d)) are amended by inserting ‘‘or to any

9 other individual’’ immediately after ‘‘to the legal

10 representative of any child’’ each place that such

11 occurs.

12 (D) PROVIDER DUTIES.—Subsection (d) of

13 section 2126 (42 U.S.C. 300aa–26(d)) is amend14 ed—

15 (i) by striking all after ‘‘subsection

16 (a),’’ the second place it appears in the first

17 sentence and inserting ‘‘supplemented with

18 visual presentations or oral explanations, in

19 appropriate cases.’’; and

20 (ii) by striking ‘‘or other information’’

21 in the last sentence.

22 (4) AUTHORIZATION OF APPROPRIATIONS.—Part

23 A of subtitle 2 of title XXI (42 U.S.C. 300aa-10 et

24 seq.) is amended by adding at the end thereof the fol25 lowing new section:
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1 ‘‘AUTHORIZATION OF APPROPRIATIONS

2 ‘‘SEC. 2120. (a) SECRETARY.—For purposes of admin3 istering this part, there are authorized to be appropriated

4 from the Vaccine Injury Compensation Trust Fund estab5 lished under section 9510(c) of the Internal Revenue Code

6 of 1986, to the Secretary, $3,000,000 for each of the fiscal

7 years 1994, 1995 and 1996.

8 ‘‘(b) ATTORNEY GENERAL.—For purposes of admin9 istering this part, there are authorized to be appropriated

10 from the Vaccine Injury Compensation Trust Fund de11 scribed in subsection (a), to the Attorney General,

12 $3,000,000 for each of the fiscal years 1994, 1995 and 1996.

13 ‘‘(c) COURT OF FEDERAL CLAIMS.—For purposes of

14 administering this part, there are authorized to be appro15 priated from the Vaccine Injury Compensation Trust Fund

16 described in subsection (a), to the Court of Federal Claims,

17 $3,000,000 for each of the fiscal years 1994, 1995 and

18 1996.’’.

19 (d) MISCELLANEOUS PROVISIONS.—Section 317(k) (42

20 U.S.C. 247b(k)) is amended—

21 (1) by striking out paragraph (1); and

22 (2) by redesignating paragraphs (2) through (5)

23 as paragraphs (1) and (4), respectively.

24 (e) AMENDMENTS TO THE FEDERALLY SUPPORTED

25 HEALTH CENTERS ASSISTANCE ACT OF 1992.—
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1 (1) CLARIFICATION OF COVERAGE OF OFFICERS

2 AND EMPLOYEES OF CLINICS.—The first sentence of

3 section 224(g)(1) of the Public Health Service Act (42

4 U.S.C. 233(g)(1)) is amended by striking ‘‘officer, em5 ployee, or contractor’’ and inserting the following:

6 ‘‘officer or employee of such an entity, and any con7 tractor’’.

8 (2) COVERAGE FOR SERVICES FURNISHED TO IN9 DIVIDUALS OTHER THAN PATIENTS OF CLINIC.—Sec10 tion 224(g) of such Act (42 U.S.C. 233(g)(1)), as

11 amended by paragraph (1), is further amended—

12 (A) in the first sentence of paragraph (1),

13 by inserting after ‘‘Service’’ the following: ‘‘with

14 respect to services provided to patients of the en15 tity and (subject to paragraph (7)) to certain

16 other individuals’’; and

17 (B) by adding at the end the following new

18 paragraph:

19 ‘‘(7) For purposes of paragraph (1), an officer, em20 ployee, or contractor described in such paragraph may be

21 deemed to be an employee of the Public Health Service with

22 respect to services provided to individuals who are not pa23 tients of an entity described in paragraph (4) only if the

24 Secretary determines—
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1 ‘‘(A) that the provision of the services to such in2 dividuals benefits health center patients and general

3 populations that could be served by the health center

4 through community-wide intervention efforts within

5 the communities served by such health center, and fa6 cilitates the provision of services to health center pa7 tients; or

8 ‘‘(B) that such services are otherwise required to

9 be provided to such individuals under an employment

10 contract (or other similar arrangement) between the

11 individual and the entity.’’.

12 (3) DETERMINING COMPLIANCE OF ENTITY WITH

13 REQUIREMENTS FOR COVERAGE.—

14 (A) IN GENERAL.—Section 224(h) of such

15 Act (42 U.S.C. 233(h)), as added by section 2(b)

16 of the Federally Supported Health Centers As17 sistance Act of 1992, is amended by striking ‘‘the

18 entity—’’ and inserting the following: ‘‘the Sec19 retary, after receiving such assurances and con20 ducting such investigation as the Secretary con21 siders necessary, finds that the entity—’’.

22 (B) FINDING.—Section 224 of such Act (42

23 U.S.C. 233) is amended by adding at the end

24 thereof the following new subsection:
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1 ‘‘(l) With respect to subsection (h), the finding of the

2 Secretary that an entity meets all of the requirements under

3 such subsection shall apply for the period specified by the

4 Secretary, and shall be binding for all parties unless the

5 Secretary reverses such finding for good cause shown at a

6 later date.’’.

7 (4) PAYMENT OF JUDGMENTS.—Section

8 224(k)(2) of such Act (42 U.S.C. 233(k)(2)), as added

9 by section 4 of the Federally Supported Health Cen10 ters Assistance Act of 1992, is amended by adding at

11 the end thereof the following new sentence: ‘‘Appro12 priations for purposes of this paragraph shall be

13 made separate from appropriations made for pur14 poses of sections 329, 330, 340 and 340A.’’.

15 (5) EFFECTIVE DATE.—The amendments made

16 by this section shall take effect as if included in the

17 enactment of the Federally Supported Health Centers

18 Assistance Act of 1992.

19 SEC. 7. EFFECTIVE DATES.

20 (a) IN GENERAL.—Except as provided in subsection

21 (b), the amendments made by this Act shall become effective

22 on the date of enactment of this Act.

23 (b) EXCEPTION.—The amendments made by section

24 2(b)(4)(C) shall become effective 9 months after the date of

25 enactment of this Act. Prior to such date, section
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1 371(b)(3)(E) of the Public Health Service Act, as in effect

2 on the day before the date of the enactment of this Act, shall

3 remain in effect.

Attest:

Secretary.
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