[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2659 Engrossed Amendment Senate (EAS)]
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:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Organ Transplant Program
Reauthorization Act of 1994''.
SEC. 2. ORGAN PROCUREMENT ORGANIZATIONS.
(a) In General.--Subsection (a) of section 371 of the Public Health
Service Act (42 U.S.C. 273(a)) is amended to read as follows:
``(a)(1) The Secretary may make grants for the consolidation and
expansion of qualified organ procurement organizations described in
subsection (b).
``(2) The Secretary may make grants to, and enter into cooperative
agreements and contracts with, qualified organ procurement
organizations described in subsection (b) and other public or nonprofit
private entities for the purpose of increasing organ donation through--
``(A) the planning and conducting of programs to provide
information and education to the public on the need for organ
donations;
``(B) the training of individuals in requesting such
donations; or
``(C) the provision of technical assistance to organ
procurement organizations and other entities in the health care
system.
``(3)(A) In making awards of grants, cooperative agreements and
contracts under subparagraphs (A) and (B) of paragraph (2), the
Secretary shall give priority to carrying out the purpose described in
such paragraph with respect to minority or other populations for which
there is a greater degree of organ shortages relative to the general
population.
``(B) In making awards of grants, cooperative agreements and
contracts under paragraph (2)(C), the Secretary shall give priority to
carrying out the purpose described in such paragraph with respect to
organ procurement organizations and hospitals with lower rates of
procurement relative to other such organizations or hospitals.''.
(b) Qualified Organ Procurement Organizations.--Section 371(b) of
such Act (42 U.S.C. 273(b)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A), by
striking ``for which grants may be made under
subsection (a)'' and inserting ``described in this
section'';
(B) by realigning the margin of subparagraph (E) so
as to align with the margin of subparagraph (D); and
(C) in subparagraph (G)--
(i) in the matter preceding clause (i), by
striking ``directors or an advisory board'' and
inserting ``directors (or an advisory board, in
the case of a hospital-based organ procurement
organization established prior to September 1,
1993)''; and
(ii) in clause (i)--
(I) by striking ``composed of'' in
the matter preceding subclause (I) and
inserting ``composed of a reasonable
balance of''; and
(II) by inserting before the comma
in subclause (II) the following: ``,
including individuals who have received
a transplant of an organ (or transplant
candidates), and individuals who are
part of the family of an individual who
has donated an organ'';
(2) by striking paragraph (2);
(3) by redesignating paragraph (3) as paragraph (2);
(4) in paragraph (2) (as so redesignated)--
(A) by redesignating subparagraphs (B) through (K)
as subparagraphs (C) through (L), respectively,
(B) by inserting after subparagraph (A) the
following new subparagraph:
``(B) conduct and participate in systematic efforts,
including public education, to increase the number of potential
donors,'';
(C) by inserting before the comma in subparagraph
(F) (as so redesignated) the following: ``, which
system shall, at a minimum, allocate each type of organ
on the basis of--
``(i) a single list encompassing the entire service
area;
``(ii) a list that encompasses at least an entire
State; or
``(iii) a list that encompasses an approved
alternative local unit (as defined in paragraph (4)),
of individuals who have been medically referred to a transplant
center in the service area of the organization in order to
receive a transplant of the type of organ with respect to which
the list is maintained;'';
(D) by striking subparagraph (I) (as so
redesignated) and inserting the following new
subparagraph:
``(I) be a member of and abide by the rules and
requirements of the Organ Procurement and Transplantation
Network established under section 372,''; and
(E) by striking subparagraph (K) (as so
redesignated) and inserting the following new
subparagraph:
``(K) evaluate annually, and report to the Organ
Procurement and Transplantation Network established under
section 372, on the effectiveness of the organization in
acquiring potentially available organs, particularly among
minority populations, and the variation of procurement across
hospitals within the organ procurement organization region, and
identify a plan to increase procurement, particularly among
minority populations and other populations for which there is a
greater degree of organ shortages relative to the general
population, and at hospitals with low rates of procurement,
and''; and
(5) by adding at the end thereof the following new
paragraphs:
``(3)(A) The Office of Technology Assessment shall conduct a study
for the purpose of defining--
``(i) the appropriate standards by which to judge the
quality of performance of organ procurement organizations; and
``(ii) the proper criteria for a determination of
inadequate service from an organ procurement organization.
``(B) Not later than 2 years after the date of enactment of this
paragraph, the Office of Technology Assessment shall complete the study
required under subparagraph (A) and prepare and submit to the Committee
on Labor and Human Resources of the Senate, the Committee on Energy and
Commerce of the House of Representatives, and the Secretary, a report
describing the findings made as a result of the study.
``(C) For purposes of this paragraph the term `organ' means a human
kidney, liver, heart, lung, pancreas, and any other human organ or
tissue specified by the Secretary for purposes of this paragraph.
``(4)(A) As used in paragraph (2)(F), the term `alternative local
unit' means--
``(i) a unit composed of two or more contiguous organ
procurement organizations; or
``(ii) a subdivision of an organ procurement organization
that operates as a distinct procurement and distribution unit
as a result of special geographic, rural, or minority
population concerns but that is not composed of any subunit of
a metropolitan statistical area.
``(B) The Organ Procurement and Transplantation Network shall make
recommendations to the Secretary concerning the approval or denial of
alternative local units. The Network shall assess whether the
alternative local units will better promote organ donation and the
equitable allocation of organs.
``(C) The Secretary shall approve or deny any alternative local
unit principle or designation recommended by the Network. If the
Secretary does not provide otherwise prior to the expiration of the 90-
day period beginning on the date on which the application is submitted,
the recommendations of the Network under subparagraph (B) with respect
to the application of the alternative local unit shall go into
effect.''.
(c) Effective Date.--The amendments made by subsection (b)(5) shall
apply to organ procurement organizations beginning January 1, 1995.
SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.
Section 372(b) of the Public Health Service Act (42 U.S.C. 274(b))
is amended--
(1) in paragraph (1)(B)--
(A) in clause (i)--
(i) by striking ``(including organizations
that have received grants under section 371)'';
and
(ii) by striking ``; and'' at the end
thereof and inserting ``(including both
individuals who have received a transplant of
an organ (or transplant candidates), and
individuals who are part of the family of
individuals who have donated an organ, the
number of whom shall make up not less than 40
percent of the total number of board members);
and''; and
(B) in clause (ii), by inserting ``including a
patient affairs committee'' after ``committees,''; and
(2) in paragraph (2)--
(A) in subparagraph (A), by striking clause (i) and
inserting the following new clause:
``(i) with respect to each type of transplant, a
national list of individuals who have been medically
referred to receive a transplant of the type of organs
with respect to which the list is maintained (which
list shall include the names of all individuals
included on lists in effect under section 371(b)(2)(F),
and'';
(B) in subparagraph (B), by inserting ``, including
requirements under section 371(b),'' after ``membership
criteria'';
(C) by redesignating subparagraphs (E) through (L),
as subparagraphs (F) through (M), respectively;
(D) by inserting after subparagraph (D), the
following new subparagraph:
``(E) assist organ procurement organizations in the
equitable distribution of organs among transplant patients,'';
(E) in subparagraph (K) (as so redesignated), by
striking ``and'' at the end thereof;
(F) in subparagraph (L) (as so redesignated), by
striking the period and inserting ``, including making
recommendations to organ procurements organizations and
the Secretary based on the annual reports required
under section 371(b)(2)(K),'';
(G) in subparagraph (M) (as so redesignated), by
striking the period and inserting a comma; and
(H) by adding at the end thereof the following new
subparagraphs:
``(N) submit to the Secretary for review and approval any
change in the amount of fees imposed by the Network for the
registration of individuals on the lists maintained under
subparagraph (A)(i), such change to be considered as approved
if the Secretary does not provide otherwise prior to the
expiration of the 90-day period beginning on the date on which
the change is submitted to the Secretary,
``(O) make available to the Secretary such information,
books, and records regarding the Network as the Secretary may
require,
``(P) submit to the Secretary, on an annual basis, a report
on the clinical and scientific status of the organ
transplantations, and
``(Q) meet such other criteria regarding compliance with
this part as the Secretary may establish.''.
SEC. 4. STUDY BY GENERAL ACCOUNTING OFFICE.
Section 377 of the Public Health Service Act (42 U.S.C. 274f) is
amended to read as follows:
``SEC. 377. STUDY BY GENERAL ACCOUNTING OFFICE.
``(a) Study.--
``(1) In general.--The Comptroller General of the United
States shall conduct a study for the purpose of determining and
making recommendations concerning--
``(A) the composition of the boards of directors of
organ procurement organizations and of the Organ
Procurement and Transplantation Network on the date of
enactment of this section, and the effect of the Organ
Transplant Program Reauthorization Act of 1994 on the
composition and functioning of such boards;
``(B)(i) the number and percentage of cadaveric
organ transplants for foreign nationals and nonresident
aliens categorized by organ procurement organization
and by transplant center and information on any
reciprocal agreements between organ procurement
organizations and foreign countries or territories;
``(ii) the number and percent of the organizations
referred to in clause (i) above the organ procurement
transplant network guideline of 10 percent; and
``(III) any information on the current rate of
organ donation by individuals other than United States
citizens or legal residents;
``(C) organ donation rates and the impact of
various organ allocation systems on organ procurement
rates; and
``(D) the equitable allocation of organs
nationwide, including an analysis of the relative
probability of receiving an organ for patients with
similar characteristics for each category of
transplanted organ by organ procurement organization
and recommendations for developing a regional
allocation system in order to ensure that--
``(i) patients in one region have an
equivalent probability of receiving an organ as
do patients with similar characteristics in
another region; and
``(ii) patients within a region have an
equivalent probability of receiving an organ as
do other patients with similar characteristics
in that region.
``(2) Equitable allocation.--In carrying out paragraph (1)
with respect to subparagraph (D), the Comptroller General
shall--
``(A) recommend regions for allocating organs to
encompass as large a geographic area as is practical,
taking into account medical appropriateness, and the
geographic proximity of patients with comparable
priority for receiving an organ;
``(B) take into account the impact on organ
donation and procurement rates; and
``(C) consult with experts in the area of organ allocation
and organ donations and consider their recommendations
regarding the establishment of regions in the country for the
purpose of allocating organs.
``(b) Report.--Not later than 2 years after the date of enactment
of the Organ Transplant Program Reauthorization Act of 1994, the
Comptroller General of the United States shall complete the study
required under subsection (a) and prepare and submit to the Committee
on Energy and Commerce of the House of Representatives, and to the
Committee on Labor and Human Resources of the Senate, a report
describing the findings made as a result of the study.''.
SEC. 5. GENERAL PROVISIONS.
(a) Limitation.--Section 374(b) of the Public Health Service Act
(42 U.S.C. 274b(b)) is amended--
(1) by striking paragraph (2);
(2) by redesignating paragraph (3) as paragraph (2); and
(3) in paragraph (2) (as so redesignated), by striking
``371(a)(3)'' and inserting ``371(a)(2)''.
(b) Repeal.--Section 376 of the Public Health Service Act (42
U.S.C. 274d) is repealed.
(c) Transfer.--Section 378 of the Public Health Service Act (42
U.S.C. 274g) is amended--
(1) by transferring such section to part H of title III;
and
(2) by inserting such section after section 377.
(d) Authorization of Appropriations.--Section 378 of the Public
Health Service Act (42 U.S.C. 274g) is amended by striking ``1991'' and
all that follows through the period and inserting ``1994, and such sums
as may be necessary for each of the fiscal years 1995 and 1996.''.
SEC. 6. COMPREHENSIVE CHILD IMMUNIZATION.
(a) Short Title; References and Purpose.--
(1) Short title.--This section may be cited as the
``Comprehensive Child Immunization Act of 1994''.
(2) References.--Except as otherwise expressly provided,
whenever in this section an amendment or repeal is expressed in
terms of an amendment to, or repeal of, a section or other
provision, the reference shall be considered to be made to a
section or other provision of the Public Health Service Act (42
U.S.C. 201 et seq.).
(3) Purpose.--It is the purpose of this section to ensure
that children in the United States are appropriately immunized
against vaccine preventable infectious diseases at the earliest
appropriate age.
(b) Monitoring of Childhood Immunizations.--Title XXI of the Public
Health Service Act (42 U.S.C. 300aa-1 et seq.) is amended by adding at
the end thereof the following new subtitle:
``Subtitle 3--Improved Immunization Delivery and Monitoring Systems
``Part A--List of Vaccines and Administration
``SEC. 2141. LIST OF PEDIATRIC VACCINES; SCHEDULE FOR ADMINISTRATION.
``(a) Recommended Pediatric Vaccines.--
``(1) In general.--The Secretary shall establish a list of
the vaccines that the Secretary recommends for administration
to all children for the purpose of immunizing the children,
subject to such contraindications for particular medical
categories of children as the Secretary may establish under
subsection (b)(1)(D). The Secretary shall periodically review
the list, and shall revise the list as appropriate.
``(2) Rule of construction.--
``(A) The list of vaccines specified in
subparagraph (B) is deemed to be the list of vaccines
maintained under paragraph (1).
``(B) The list of vaccines specified in this
subparagraph is the list of vaccines that, for purposes
of paragraph (1), is established (and periodically
reviewed and as appropriate revised) by the Advisory
Committee on Immunization Practices, an advisory
committee established by the Secretary, acting through
the Director of the Centers for Disease Control and
Prevention.
``(b) Recommended Schedule for Administration.--
``(1) In general.--Subject to paragraph (2), in the case of
a pediatric vaccine, the Secretary shall establish (and
periodically review and as appropriate revise) a schedule of
nonbinding recommendations for the following:
``(A) The number of immunizations with the vaccine
that children should receive.
``(B) The ages at which children should receive the
immunizations.
``(C) The dose of vaccine that should be
administered in the immunizations.
``(D) Any contraindications regarding
administration of the vaccine.
``(E) Such other guidelines as the Secretary
determines to be appropriate with respect to
administering the vaccine to children.
``(2) Variations in medical practice.--In establishing and
revising a schedule under paragraph (1), the Secretary shall
ensure that, in the case of the pediatric vaccine involved, the
schedule provides for the full range of variations in medical
judgment regarding the administration of the vaccine, subject
to remaining within medical norms.
``(3) Rule of construction.--
``(A) The schedule specified in subparagraph (B) is
deemed to be the schedule maintained under paragraph
(1).
``(B) The schedule specified in this subparagraph
is the schedule that, for purposes of paragraph (1), is
established (and periodically reviewed and as
appropriate revised) by the advisory committee
specified in subsection (a)(2)(B).
``(c) Generally Applicable Rules of Construction.--This section
does not supersede any State law or requirements with respect to
receiving immunizations (including any such law relating to religious
exemptions or other exemptions under such State laws).
``(d) Issuance of List and Schedules.--Not later than 180 days
after the date of the enactment of this section, the Secretary shall
establish the initial list required in subsection (a) and the schedule
required in subsection (b).
``Part B--State Registry System for Immunization Information
``SEC. 2145. PURPOSE.
``It is the purpose of this part to authorize the Secretary, in
consultation with State public health officials, to establish State
registry systems to monitor the immunization status of all children.
``SEC. 2146. GRANTS FOR IMMUNIZATION REGISTRIES.
``(a) In general.--For the purpose described in section 2145, the
Secretary, acting through the Director of the Centers for Disease
Control and Prevention, shall make an allotment each fiscal year for
each State in an amount determined in accordance with section 2151. The
Secretary shall make a grant to the State of the allotment made for the
State for the fiscal year if the State submits to the Secretary an
application in accordance with section 2150 on behalf of the chief
executive officer of such State.
``(b) Design of State Registries.--To carry out the purpose
described in section 2145, a State registry established under this part
shall be designed to--
``(1) provide accurate and up to date surveillance data
regarding immunization rates at the State and local levels;
``(2) assist in identifying localities with inadequate
immunization rates to target for necessary remedial assistance;
``(3) assist in the effective administration and management
of immunization programs at State and local levels by providing
data to guide immunization program efforts;
``(4) assist the State in providing and receiving
information on the immunization status of children who move
across geographic boundaries that are covered by different
State or local registries; and
``(5) facilitate the linkage of vaccine dosage information
to adverse events reported to the Centers for Disease Control
and Prevention under section 2125(b) and disease outbreak
patterns, for the purpose of monitoring vaccine safety and
effectiveness.
``(c) Eligible Use of Funds.--The Secretary may make a grant under
subsection (a) only if the State agrees to expend the grant for the
purpose of--
``(1) collecting the data described in section 2147;
``(2) operating registries to maintain the data (and
establishing such registries, in the case of a State that is
not operating such a registry);
``(3) utilizing the data to monitor the extent to which
children have received immunizations in accordance with the
schedule established under section 2141;
``(4) notifying parents, as appropriate, if children have
not received immunizations in accordance with such schedule;
``(5) coordinating and exchanging information with other
State registries to allow the monitoring of the immunization
status of children changing State of residence; and
``(6) such other activities as the Secretary may authorize
with respect to achieving the objectives established by the
Secretary for the year 2000 for the immunization status of
children in the United States.
``(d) Requirement Regarding State Law.--
``(1) In general.--The Secretary may make a grant under
subsection (a) only if the State involved--
``(A) provides assurances satisfactory to the
Secretary that, not later than October 1, 1996, the
State will be operating a registry in accordance with
this part, including having in effect such laws and
regulations as may be necessary to so operate such a
registry;
``(B) agrees that, prior to such date, the State
will make such efforts to operate a registry in
accordance with this part as may be authorized in the
law and regulations of the State; and
``(C) has in effect such laws and regulations as
may be necessary to ensure the following safeguards for
the rights of parents:
``(i) An exemption for the parent, upon the
request of the parent, from the requirements
established by the State, pursuant to this
part, for the collection of data described in
subsections (b) and (c) of section 2147, or the
collection of any other data regarding any
child of the parent that the State may require
for incorporation in the State immunization
registry.
``(ii) Restrictions ensuring that no
information relating to a child or to the
parent or guardian of a child that is collected
or maintained by the State immunization
registry pursuant to this part, or the national
immunization surveillance program established
under section 2153, will be used as a basis for
the criminal prosecution or the commencement of
a criminal investigation of a parent or
guardian.
``(2) Rules of construction.--
``(A) With respect to the agreements made by a
State under this part, other than paragraph (1)(B), the
Secretary may require compliance with the agreements
only to the extent consistent with such paragraph.
``(B) The provisions of this part do not authorize
the Secretary, as a condition of the receipt of a grant
under subsection (a) by a State, to prohibit the State
from providing any parent, upon the request of the
parent, with an exemption from the requirements
established by the State pursuant to this part for the
collection of data regarding any child of the parent.
``SEC. 2147. REGISTRY DATA.
``(a) In General.--For purposes of section 2146(c)(1), the data
described in this section are the data described in subsection (b) and
the data described in subsection (c).
``(b) Data Regarding Birth of Child.--With respect to the birth of
a child, the data described in this subsection is as follows:
``(1) The name of each child born in the State involved
after the date of the implementation of the registry (in no
event shall such date be later than October 1, 1996).
``(2) Demographic data on the child.
``(3) The name of one or both of the parents of the child.
If the child has been given up for adoption, any information
regarding the identity of the birth parent or parents of the
child may not be entered into the registry, or if entered,
shall be deleted.
``(4) The address, as of the date of the birth of the
child, of each parent whose name is received in the registry
pursuant to paragraph (3).
``(c) Data Regarding Individual Immunizations.--With respect to a
child to whom a pediatric vaccine is administered in the State
involved, the data described in this subsection is as follows:
``(1) The name, age, and address of the child.
``(2) The date on which the vaccine was administered to the
child.
``(3) The name and business address of the health care
provider that administered the vaccine.
``(4) The address of the facility at which the vaccine was
administered.
``(5) The name and address of one or both parents of the
child as of the date on which the vaccine was administered, if
such information is available to the health care provider.
``(6) The type of vaccine.
``(7) The lot number or other information identifying the
particular manufacturing batch of the vaccine.
``(8) The dose of vaccine that was administered.
``(9) A notation of the presence of any adverse medical
reactions that the child experienced in relation to the vaccine
and of which the health care provider is aware, in accordance
with section 2125.
``(10) The presence of contraindications noted by the
health care provider with respect to administration of the
vaccine to the child.
``(11) Such other data regarding immunizations for the
child, including identifying data, as the Secretary, in
consultation with State public health officials, may require
consistent with applicable law (including social security
account numbers furnished pursuant to section 205(c)(2)(E) of
the Social Security Act).
``(d) Limitation.--The Secretary may not establish information
reporting requirements in addition to those described in subsection (c)
if such requirements are unduly burdensome.
``(e) Date Certain for Submission to Registry.--The Secretary may
make a grant under section 2146 only if the State involved agrees to
ensure that, with respect to a child--
``(1) the data described in subsection (b) are submitted to
the registry under such section as soon as possible but in no
event later than 8 weeks after the date on which the child is
born; and
``(2) the data described in subsection (c) with respect to
a vaccine are submitted to such registry as soon as possible
but in no event later than 4 weeks after the date on which the
vaccine is administered to the child.
``(f) Uniformity in Methodologies.--The Secretary shall, in
consultation with State public health officials, establish standards
regarding the methodologies used in establishing and operating
registries under section 2146, and may make a grant under such section
only if the State agrees to comply with the standards. The Secretary
shall provide maximum flexibility to the States while also retaining a
reasonable degree of uniformity among the States in such methodologies
for the purpose of ensuring the utility, comparability, and exchange of
the data maintained in such registries.
``(g) Coordination Among States.--The Secretary may make a grant
under section 2146 to a State only if, with respect to the operation of
the registry of the State under such section, the State agrees to
transfer that information contained in the State registry pursuant to
section 2146 to other States upon the request of such States for such
information.
``SEC. 2148. FEDERAL STANDARDS ON CONFIDENTIALITY.
``(a) Establishment.--
``(1) In general.--The Secretary, in consultation with the
States, shall by regulation establish standards providing for
maintaining the confidentiality of the identity of individuals
with respect to whom data are maintained in registries under
section 2146. Such standards shall, with respect to a State,
provide that the State is to have in effect laws or regulations
regarding such confidentiality, including appropriate penalties
for violation of the laws. The Secretary may make a grant under
such section only if the State involved agrees to comply with
the standards.
``(2) Use of disclosure.--
``(A) No personally identifiable information
relating to a child or to the parent or guardian of
such child that is collected or maintained by the State
registry may be used or disclosed by any holder of such
information except as permitted for--
``(i) the monitoring of a child's
immunization status;
``(ii) oversight, audit, and evaluation of
the immunization delivery and registry systems;
``(iii) activities relating to establishing
and maintaining a safe and effective supply of
recommended childhood vaccine;
``(iv) processing of insurance claims for
payment for vaccine administration (but only to
the extent necessary for processing claims);
and
``(v) administration of the National
Vaccine Injury Compensation Program under
subtitle 2.
``(B) Information regarding immunizations provided
as described in subparagraph (A)(i) may be used or
disclosed only with the written authorization of the
individual to whom it refers or to the parent with
custody of such individual.
``(b) Use of Social Security Account Numbers.--Any usage or
disclosure of data in registries under section 2146 that consists of
social security account numbers and related information which is
otherwise permitted under this part may be exercised only to the extent
permitted under section 205(c)(2)(E) of the Social Security Act. For
purposes of the preceding sentence, the term `related information' has
the meaning given such term in clause (iv)(II) of such section.
``SEC. 2149. PROVIDER PARTICIPATION.
``(a) In General.--The State shall monitor and enforce compliance
by health care providers with the requirements of sections 2147 and
2148 and section 2155(b) for all doses of pediatric vaccine
administered in the State. The State shall establish procedures
satisfactory to the Secretary for discontinuing the distribution of
federally purchased or State purchased vaccine for any health care
provider who fails to comply with the requirements of section 2147 and
for reinstating such vaccine supply to such provider upon receiving
from such provider--
``(1) the reports necessary to make current and complete
the information that would have been furnished to the State
registry between the dates of the provider's termination and
reinstatement; and
``(2) satisfactory assurances regarding the provider's
future compliance.
``(b) Reports to Secretary.--The Secretary may make a grant under
section 2146 only if the State involved agrees to submit to the
Secretary such reports as the Secretary determines to be appropriate
with respect to the activities of the State under this part.
``SEC. 2150. APPLICATION FOR GRANT.
``An application by a State for a grant under section 2146 is in
accordance with this section if the application--
``(1) is submitted not later than the date specified by the
Secretary;
``(2) contains each agreement required in this part;
``(3) contains any information required in this part to be
submitted to the Secretary; and
``(4) is in such form, is made in such manner, and contains
such agreements, assurances, and information as the Secretary
determines to be necessary to carry out this part.
``SEC. 2151. DETERMINATION OF AMOUNT OF ALLOTMENT.
``The Secretary shall determine the amount of the allotments
required in section 2146 for States for a fiscal year in accordance
with a formula established by the Secretary that allots the amounts
appropriated under section 2152 for the fiscal year on the basis of the
costs of the States in establishing and operating registries under
section 2146.
``SEC. 2152. AUTHORIZATION OF APPROPRIATIONS.
``For the purpose of carrying out this part, other than section
2153, there are authorized to be appropriated $152,000,000 for fiscal
year 1994, $125,000,000 for fiscal year 1995, and $35,000,000 for each
of the fiscal years 1996 through 1999.
``SEC. 2153. NATIONAL IMMUNIZATION SURVEILLANCE PROGRAM.
``(a) In General.--The Secretary shall establish a national
immunization surveillance program for the purpose of assessing the
effects of the programs and activities provided for in this subtitle
towards appropriately immunizing children and facilitating State
immunization registries. The national immunization surveillance program
shall--
``(1) provide technical assistance to States for the
development of vaccination registries and monitoring systems;
and
``(2) receive aggregate epidemiologic data (that is in a
format that is not person specific) collected by States as
provided for in section 2147 at intervals determined
appropriate by the Secretary for the purpose of--
``(A) compiling accurate and up-to-date
surveillance data regarding immunization rates at the
State level in order to assess the progress made
towards achieving nationally established immunization
goals;
``(B) assisting in the effective administration and
management of immunization programs at the State level
by providing technical assistance to guide immunization
program efforts at the request of the State;
``(C) providing technical assistance to States and
localities to facilitate monitoring the immunization
status of children who move across geographic
boundaries that are covered by different State or local
registries at the request of such States or localities;
and
``(D) monitoring the safety and effectiveness of
vaccines by linking vaccine dosage information with
adverse events reporting under section 2125(b) and
disease outbreak patterns.
``(b) Rule of Construction.--Nothing in this subtitle shall be
construed to authorize the release of person specific information to
the Secretary for the purpose of immunization surveillance.
``(c) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary to carry out this section in
each of the fiscal years 1994 through 1999.
``SEC. 2154. REPORT.
``Not later than January 1, 1995, and biennially thereafter, the
Secretary shall prepare and submit to the appropriate committees of
Congress a report concerning the planning, development, operation and
effectiveness of the national immunization surveillance program and the
State immunization registries.
``Part C--Distribution of Vaccines, Public Outreach and Education
``SEC. 2155. DISTRIBUTION OF VACCINES.
``(a) In General.--
``(1) Health care providers.--The Secretary shall provide
for the distribution, without charge, of recommended pediatric
vaccines (in accordance with section 2141) purchased by the
Secretary to health care providers who serve children and who--
``(A) are members of a uniformed service, or are
officers or employees of the United States;
``(B) are health centers (as defined in section
2163); or
``(C) provide services under section 503 of the
Indian Health Care Improvement Act or pursuant to a
contract under section 102 of the Indian Self
Determination Act.
``(2) States.--The Secretary shall provide for the
distribution, without charge, of those recommended pediatric
vaccines that are purchased by the Secretary and provided to
States for the purposes of immunizing medicaid-eligible
children, and additional vaccines that may be purchased by the
Secretary for children within those States.
``(b) Duties of Health Care Providers.--
``(1) Free provision to children.--A health care provider
or entity receiving vaccine under this section may use such
vaccine only for administration to children and may not impose
a charge for such vaccine. A provider or health care entity may
impose a fee that reflects actual regional costs as determined
by the Secretary for the administration of such vaccine, except
that a provider may not deny a child a vaccination due to the
inability of the child's parent to pay an administration fee.
``(2) Reporting requirements.--A health care provider
receiving vaccine under this section shall report the
information required under section 2147 to the applicable State
registry operated pursuant to a grant under section 2146 if
such State registry exists. The provider shall additionally
report to such State registry any occurrence reported to the
Secretary pursuant to section 2125(b). The provider shall also
provide regular and periodic estimates to the State of the
provider's future dosage needs for recommended childhood
vaccines distributed under this section. All reports shall be
made with such frequency and in such detail as the Secretary,
in consultation with State public health officials, may
prescribe.
``SEC. 2156. IMPROVED IMMUNIZATION DELIVERY, OUTREACH AND EDUCATION.
``(a) Federal Efforts.--The Secretary, acting through the Centers
for Disease Control and Prevention and in conjunction with State health
officials and other appropriate public and private organizations, shall
conduct the following activities to improve Federal, State and local
vaccine delivery systems and immunization outreach and education
efforts:
``(1) National public awareness campaign.--
``(A) In general.--The Secretary, in conjunction
with State health officials and other appropriate
public and private organizations, shall develop and
implement a National Immunization Public Awareness
Campaign to assist families (through bilingual means if
necessary) of children under the age of 2 years, and
expectant parents, in obtaining knowledge concerning
the importance of having their children immunized and
in identifying the vaccines, schedules for
immunization, and vaccine provider locations,
appropriate with respect to their children.
``(B) Implementation.--In implementing the Campaign
under subparagraph (A), the Secretary shall ensure
that--
``(i) new and innovative methods are
developed and utilized to publicly advertise
the need to have children immunized in a timely
manner;
``(ii) print, radio and television media
are utilized to convey immunization information
to the public; and
``(iii) with respect to immunization
information, efforts are made to target
pregnant women and the parents of children
under the age of 2.
``(2) Interagency committee on immunization.--The
Secretary, in conjunction with the Secretary of Agriculture,
the Secretary of Housing and Urban Development, and the
Secretary of Education, shall carry out activities through the
Interagency Committee on Immunization to incorporate
immunization status assessments and referral services as an
integral part of the process by which individuals apply for
assistance under--
``(A) the food stamp program under the Food Stamp
Act of 1977;
``(B) section 17 of the Child Nutrition Act of
1966;
``(C) the Head Start Act;
``(D) part A of title IV of the Social Security
Act;
``(E) title XIX of the Social Security Act;
``(F) any of the housing assistance laws of the
United States; and
``(G) other programs determined appropriate by any
of the Secretaries described in this paragraph.
``(3) Expanded opportunity for national service.--The
Secretary, in conjunction with the Commission on National and
Community Service and other independent agencies, is encouraged
to develop opportunities for participants in national and
community service programs to contribute to local initiatives
for the improvement of immunization services, including public
outreach and education efforts.
``(b) Grants to States.--
``(1) In general.--
``(A) The Secretary may award grants to States to
enable such State to develop, revise and implement
immunization improvement plans as described in
paragraph (2).
``(B) To be eligible to receive a grant under
subparagraph (A), a State shall prepare and submit to
the Secretary an application at such time, in such
manner, and containing such information as the
Secretary may require.
``(2) Design.--A State immunization improvement plan shall
be designed to improve immunization delivery, outreach,
education and coordination within the State. Such plan shall
provide for the creation of--
``(A) a vaccine provider education campaign and the
distribution of any other materials determined to be
appropriate by State health officials--
``(i) to enable such providers to make the
best use of vaccination opportunities; and
``(ii) to educate such providers concerning
their obligation to report immunization
information with respect to their patients to
State registries;
``(B) expanded capacity for the delivery of
immunizations through--
``(i) increasing the number or type of
facilities through which vaccines may be made
available and the capacity of such facilities
to immunize more children;
``(ii) developing alternative methods of
delivering vaccines, such as mobile health
clinics;
``(iii) increasing the number of hours
during which vaccines are made available by
providers within the State; or
``(iv) coordinating with federally
qualified health centers to reach and immunize
underserved children through education,
outreach, tracking, and the provision of
services;
except that, the Secretary may waive any specific
requirement of this subparagraph if the Secretary
determines that State immunization delivery efforts are
sufficient without the imposition of such requirement;
``(C) population-based assessment criteria through
which the State is able to assess the effectiveness of
immunization activities in the State, which may be
fulfilled through the implementation of a State
immunization registry under section 2146;
``(D) a public awareness campaign, in conjunction
with the National Campaign established under subsection
(a)(1), to provide parents with information about the
importance of immunization, the types and schedules for
the administration of vaccines, and the locations of
vaccines providers;
``(E) coordinated community outreach activities
among public or private health programs, including
local health departments and health centers, and other
public or private entities, to encourage and facilitate
the ability of parents to obtain immunization services
for their children; and
``(F) other activities that are not inconsistent
with the purposes of this subtitle, subject to the
approval of the Secretary.
``(3) Immunization improvement plan approval.--
``(A) Goals.--As part of the immunization
improvement plan of a State, the State shall establish
immunization rate goals for children residing within
the State.
``(B) Approval.--The immunization improvement plan
developed by a State under this subsection shall be
submitted to the Secretary for approval prior to the
distribution of grant funds to the States under this
subsection. The Secretary shall periodically review the
progress that the State has made under such plan in
achieving the goals established under subparagraph (A).
``(C) Distribution of grants.--In awarding grants
under this section, the Secretary shall ensure that
grant awards will be equitably distributed between
rural and urban areas. In determining such
distribution, the Secretary shall take into account the
added costs of supporting the health care delivery
infrastructure in sparsely populated areas. The
Secretary shall give special consideration to those
States that have low childhood immunization rates and
that submit plans that demonstrate the State's
substantial effort and commitment to improving such
rates.
``(D) Reporting.--A State shall annually prepare
and submit to the Director of the Centers for Disease
Control and Prevention a report concerning the
implementation of the State immunization improvement
plan.
``(c) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $250,000,000 for fiscal year
1994, and such sums as may be necessary for each of the fiscal years
1995 through 1999.
``SEC. 2157. PERFORMANCE BASED GRANT PROGRAM.
``(a) Annual Report.--Not later than July 1 of each year, a State
shall prepare and submit to the Director of the Centers for Disease
Control and Prevention a report that contains an estimate (based on a
base population sample) of the percentage of 2 year old residents of
the State who have been fully immunized as described in subsection (c).
``(b) Payments to States.--
``(1) In general.--Subject to the availability of
appropriations, the Secretary shall provide to a State that has
submitted an annual report under subsection (a) that
demonstrates that the State has fully immunized at least 50
percent of the 2 year old residents of that State, with respect
to the year for which the report was prepared, a payment in an
amount equal to--
``(A) with respect to a State that has demonstrated
the full immunization of at least 50 and less than 64
percent of all 2 year old residents of the State, $50
multiplied by the number of fully immunized 2 year old
resident children in excess of the number of children
equaling such 50 percent amount;
``(B) with respect to a State that has demonstrated
the full immunization of at least 65 and less than 70
percent of all 2 year old residents of the State, $75
multiplied by the number of fully immunized 2 year old
resident children in excess of the number of children
equaling such 65 percent amount; and
``(C) with respect to a State that has demonstrated
the full immunization of at least 70 and less than 91
percent of all 2 year old residents of the State, $100
multiplied by the number of fully immunized 2 year old
resident children in excess of the number of children
equaling such 70 percent amount.
``(2) Use of funds.--
``(A) Condition.--As a condition of receiving
amounts under this section a State that uses a
combination of Federal and State funds in achieving the
immunization goals described in paragraph (1) shall
agree to reinvest, in activities related to improving
immunization services, that percentage of the payments
to the State under paragraph (1) that is equal to the
amount of Federal contributions to immunization
services in the State as compared to the amount of the
State contributions to such services.
``(B) Discretionary use.--A State that has
demonstrated that the use of State-only funds was
responsible for the increase in the immunization rate
which qualified such State for payments under paragraph
(1), may use amounts awarded under this section for
other purposes, at the discretion of the State.
``(3) Verification.--Prior to making a payment to a State
under this subsection, the Secretary shall, in collaboration
with the Centers for Disease Control and Prevention, verify the
accuracy of the State report involved.
``(c) Definition.--For purposes of this section, the term `fully
immunized' means a 2 year old child that has received four doses of DTP
vaccine (diphtheria, tetanus, pertussis), three doses of polio vaccine,
and one dose of MMR (measles, mumps, rubella) vaccine.
``Part D--General Provisions
``SEC. 2161. REPORT.
``Not later than October 1, 1995, and biennially thereafter, the
Secretary shall prepare and submit to the appropriate committees of
Congress a report concerning the costs, efficiency, and effectiveness
of procedures established to deliver vaccine to health care providers.
``SEC. 2162. NATIONAL VACCINE PROGRAM.
``The Secretary shall authorize a report to be prepared by the
National Academy of Sciences concerning the role of the National
Vaccine Program established under this title in achieving progress
towards the nationally established immunization goals for the year
2000, and recommendations with respect to the changes in such Program
that would facilitate greater progress towards achieving such goals.
``SEC. 2163. DEFINITIONS.
``For purposes of this subtitle--
``(1) Health care provider.--The term `health care
provider', with respect to the administration of vaccines to
children, means an entity that is licensed or otherwise
authorized for such administration under the law of the State
in which the entity administers the vaccine, subject to section
333(e).
``(2) Health center.--The term `health center' means--
``(A) a federally-qualified health center, as
defined in section 1905(l)(2) of the Social Security
Act; or
``(B) a public or nonprofit private entity
receiving Federal funds under--
``(i) section 329, 330 or 340;
``(ii) section 340A (relating to grants for
health services for residents of public
housing); or
``(iii) section 501(a)(2) of the Social
Security Act (relating to special projects of
regional and national significance).
``(3) Immunization.--The term `immunization' means an
immunization against a vaccine-preventable disease.
``(4) Parent.--The term `parent', with respect to a child,
means a legal guardian of the child.
``(5) Pediatric vaccine.--The term `pediatric vaccine'
means a vaccine included on the list established under section
2141.
``(6) State.--The term `State' means the 50 States, the
District of Columbia, the Commonwealth of Puerto Rico, Guam,
American Samoa, the U.S. Virgin Islands, the Republic of the
Marshall Islands, Micronesia, the Northern Mariana Islands, and
Palau.''.
(c) National Vaccine Injury Compensation Program Amendments.--
(1) Amendment of vaccine injury table.--
(A) Addition of vaccines.--Section 2114 (42 U.S.C.
300aa-14) is amended by adding at the end thereof the
following new subsection:
``(f) Addition of Vaccines to Table.--
``(1) In general.--The Vaccine Injury table contained in
subsection (a) shall also include any recommended childhood
vaccine included in the list promulgated by the Secretary under
section 2141.
``(2) Review of information and revision.--Not later than 2
years after the addition of a new vaccine to the table
contained in subsection (a), and on a regular basis thereafter,
the Secretary shall review information obtained under sections
2125 and part B of subtitle 3, and based on such review (and
other relevant information) shall, as appropriate, develop with
respect to such new vaccine--
``(A) revisions with respect to illnesses,
disabilities, injuries or conditions covered by such
table;
``(B) appropriate specifications of the time period
for the first symptom or manifestation of onset or of
significant aggravation of such illnesses,
disabilities, injuries or condition after vaccine
administration, for purposes of receiving compensation
under the Program; and
``(C) recommendations as to the amount of tax that
should be imposed under section 4131 of the Internal
Revenue Code of 1986 for each dose of vaccine.
``(3) Limitation.--The Secretary may modify the table
contained in subsection (a) pursuant to paragraphs (1) and (2)
only in accordance with subsection (c).
``(4) Revision.--For purposes of section 2116(b), the
addition of vaccine to the table contained in subsection (a) by
operation of this subsection shall constitute a revision of the
table.''.
(B) Attorneys fees.--Section 2115(e) (42 U.S.C.
300aa-15(e)) is amended by adding at the end thereof
the following new paragraph:
``(4) The special master may award reasonable attorneys
fees whether or not an election has been made under section
2121(a) to file a civil action concerning such petition.''.
(C) Consent for annuity.--Subparagraphs (A) and (B)
of section 2115(f)(4) are amended by striking ``, with
the consent of the petitioner,'' each place that such
appears.
(C) Time periods for fees and costs.--
(i) In general.--Section 2115(e) (42 U.S.C.
300aa-15(e)) (as amended by paragraph (3)) is
further amended by adding at the end thereof
the following new paragraph:
``(5) With respect to a petitioners' application for
attorneys' fees and costs--
``(A) if the respondent enters no objection to such
application within 21 days of the date on which the
application was filed (unless such time period is
extended by the special master with the consent of the
petitioner) the special master shall enter a decision
on such application within 30 days of such filing;
``(B) if the respondent files an objection to such
application and the special master does not enter a
decision with respect to the application within 60 days
after the date on which the objection is filed, the
special master involved shall, upon the written request
of the petitioner, enter a decision within 15 days
after the filing of such request; and
``(C) if the respondent files an objection to such
application and the petitioner moves to reduce costs
and fees as provided for in the objection, the special
master shall enter a decision within 5 days after the
receipt of the petitioner's motion.
The chief special master, upon the request of a special master,
may waive the time limitations applicable to the special master
under this paragraph if the special master demonstrates that
complicating factors exist with respect to the issues involved
to which the time limitation applies.''.
(B) Application.--The amendment made by
subparagraph (A) shall apply to all petitioners'
applications for attorneys' fees and costs filed under
section 2115(e) of the Public Health Service Act which
are pending on the date of enactment of this Act.
(E) Authorization of appropriations.--Section
2115(j) (42 U.S.C. 300aa-15(j)) is amended by striking
``$80,000,000 for each succeeding fiscal year'' and
inserting in lieu thereof ``$110,000,000 for each
succeeding fiscal year''.
(F) Limitation of actions.--Section 2116(b) (42
U.S.C. 300aa-16(b)) is amended by striking ``such
person may file'' and inserting ``or to significantly
increase the likelihood of obtaining compensation, such
person may, notwithstanding section 2111(b)(2), file''.
(2) Extension of time for decision.--
(A) Jurisdiction.--Section 2112(d)(3)(D) (42 U.S.C.
300aa-12(d)(3)(D)) is amended by striking ``540 days''
and inserting ``30 months (but for not more than 6
months at a time)''.
(B) Report on collections.--Section 2117 (42 U.S.C.
300aa-17) is amended by adding at the end thereof the
following new subsection:
``(c) Report.--The Attorney General shall, on January 1 of each
year, prepare and submit to the appropriate committees of Congress a
report concerning amounts collected under this section.''.
(C) Increased responsibilities of commission.--
Section 2119(f) (42 U.S.C. 300aa-19(f)) is amended--
(i) by striking ``and'' at the end of
paragraph (4);
(ii) by striking the period at the end of
paragraph (5) and inserting ``, and''; and
(iii) by adding at the end thereof the
following new paragraph:
``(6) monitor the balance of the Vaccine Injury Trust Fund
established by section 9510 of the Internal Revenue Code and,
as appropriate, recommend changes in the tax per dose of
vaccine imposed under section 4131 of such Code.''.
(3) Simplification of vaccine information materials.--
(A) Information.--Section 2126(b) (42 U.S.C. 300aa-
26(b)) is amended--
(i) by striking ``by rule'' in the matter
preceding paragraph (1);
(ii) in paragraph (1), by striking ``90''
and inserting ``30''; and
(iii) in paragraph (2), by striking ``,
appropriate health care providers and parent
organizations''.
(B) Requirements.--Section 2126(c) (42 U.S.C.
300aa-26(c)) is amended--
(i) in the matter preceding paragraph (1),
by inserting ``shall be based on available data
and information,'' after ``such materials'';
and
(ii) by striking out paragraphs (1) through
(10) and inserting in lieu thereof the
following new paragraphs:
``(1) a concise description of the benefits of the vaccine;
``(2) a concise description of the risks associated with
the vaccine;
``(3) a statement of the availability of the National
Vaccine Injury Compensation Program;
``(4) a statement of the availability from the Secretary of
more detailed written information concerning the information
required under paragraphs (1), (2), and (3), that shall be made
available to the parent, legal guardian, or other responsible
person upon request; and
``(5) such other relevant information as determined
appropriate by the Secretary.''.
(C) Other individuals.--Subsections (a) and (d) of
section 2126 (42 U.S.C. 300aa-26(a) and (d)) are
amended by inserting ``or to any other individual''
immediately after ``to the legal representative of any
child'' each place that such occurs.
(D) Provider duties.--Subsection (d) of section
2126 (42 U.S.C. 300aa-26(d)) is amended--
(i) by striking all after ``subsection
(a),'' the second place it appears in the first
sentence and inserting ``supplemented with
visual presentations or oral explanations, in
appropriate cases.''; and
(ii) by striking ``or other information''
in the last sentence.
(4) Authorization of appropriations.--Part A of subtitle 2
of title XXI (42 U.S.C. 300aa-10 et seq.) is amended by adding
at the end thereof the following new section:
``authorization of appropriations
``Sec. 2120. (a) Secretary.--For purposes of administering this
part, there are authorized to be appropriated from the Vaccine Injury
Compensation Trust Fund established under section 9510(c) of the
Internal Revenue Code of 1986, to the Secretary, $3,000,000 for each of
the fiscal years 1994, 1995 and 1996.
``(b) Attorney General.--For purposes of administering this part,
there are authorized to be appropriated from the Vaccine Injury
Compensation Trust Fund described in subsection (a), to the Attorney
General, $3,000,000 for each of the fiscal years 1994, 1995 and 1996.
``(c) Court of Federal Claims.--For purposes of administering this
part, there are authorized to be appropriated from the Vaccine Injury
Compensation Trust Fund described in subsection (a), to the Court of
Federal Claims, $3,000,000 for each of the fiscal years 1994, 1995 and
1996.''.
(d) Miscellaneous Provisions.--Section 317(k) (42 U.S.C. 247b(k))
is amended--
(1) by striking out paragraph (1); and
(2) by redesignating paragraphs (2) through (5) as
paragraphs (1) and (4), respectively.
(e) Amendments to the Federally Supported Health Centers Assistance
Act of 1992.--
(1) Clarification of coverage of officers and employees of
clinics.--The first sentence of section 224(g)(1) of the Public
Health Service Act (42 U.S.C. 233(g)(1)) is amended by striking
``officer, employee, or contractor'' and inserting the
following: ``officer or employee of such an entity, and any
contractor''.
(2) Coverage for services furnished to individuals other
than patients of clinic.--Section 224(g) of such Act (42 U.S.C.
233(g)(1)), as amended by paragraph (1), is further amended--
(A) in the first sentence of paragraph (1), by
inserting after ``Service'' the following: ``with
respect to services provided to patients of the entity
and (subject to paragraph (7)) to certain other
individuals''; and
(B) by adding at the end the following new
paragraph:
``(7) For purposes of paragraph (1), an officer, employee, or
contractor described in such paragraph may be deemed to be an employee
of the Public Health Service with respect to services provided to
individuals who are not patients of an entity described in paragraph
(4) only if the Secretary determines--
``(A) that the provision of the services to such
individuals benefits health center patients and general
populations that could be served by the health center through
community-wide intervention efforts within the communities
served by such health center, and facilitates the provision of
services to health center patients; or
``(B) that such services are otherwise required to be
provided to such individuals under an employment contract (or
other similar arrangement) between the individual and the
entity.''.
(3) Determining compliance of entity with requirements for
coverage.--
(A) In general.--Section 224(h) of such Act (42
U.S.C. 233(h)), as added by section 2(b) of the
Federally Supported Health Centers Assistance Act of
1992, is amended by striking ``the entity--'' and
inserting the following: ``the Secretary, after
receiving such assurances and conducting such
investigation as the Secretary considers necessary,
finds that the entity--''.
(B) Finding.--Section 224 of such Act (42 U.S.C.
233) is amended by adding at the end thereof the
following new subsection:
``(l) With respect to subsection (h), the finding of the Secretary
that an entity meets all of the requirements under such subsection
shall apply for the period specified by the Secretary, and shall be
binding for all parties unless the Secretary reverses such finding for
good cause shown at a later date.''.
(4) Payment of judgments.--Section 224(k)(2) of such Act
(42 U.S.C. 233(k)(2)), as added by section 4 of the Federally
Supported Health Centers Assistance Act of 1992, is amended by
adding at the end thereof the following new sentence:
``Appropriations for purposes of this paragraph shall be made
separate from appropriations made for purposes of sections 329,
330, 340 and 340A.''.
(5) Effective date.--The amendments made by this section
shall take effect as if included in the enactment of the
Federally Supported Health Centers Assistance Act of 1992.
SEC. 7. EFFECTIVE DATES.
(a) In General.--Except as provided in subsection (b), the
amendments made by this Act shall become effective on the date of
enactment of this Act.
(b) Exception.--The amendments made by section 2(b)(4)(C) shall
become effective 9 months after the date of enactment of this Act.
Prior to such date, section 371(b)(3)(E) of the Public Health Service
Act, as in effect on the day before the date of the enactment of this
Act, shall remain in effect.
Attest:
Secretary.
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