(This measure has not been amended since it was introduced. The summary of that version is repeated here.)
National Pediatric Research Network Act of 2013 - Amends the Public Health Service Act to authorize the Director of the National Institutes of Health (NIH), in carrying out the Pediatric Research Initiative, to act through the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development to provide for the establishment of a National Pediatric Research Network.
Authorizes the Director of the Institute to award funding to public or private nonprofit entities for: (1) planning, establishing, or strengthening pediatric research consortia; and (2) providing basic operating support for such consortia, including to meet unmet needs for pediatric research through basic, clinical, behavioral, or translational research and the training of researchers in pediatric research techniques. Authorizes the Director of NIH to make awards for not more than 20 pediatric research consortia, which must be formed from a collaboration of cooperating institutions, coordinated by a lead institution, agree to disseminate scientific findings, and meet requirements prescribed by the Director of NIH. Allows such support to be for a period of five years, with additional extensions at the discretion of the Director of NIH.
Requires the Director of NIH to provide for the coordination of activities among the consortia and to require the periodic preparation and submission of reports on their activities. Requires each pediatric research consortium receiving an award to assist the Centers for Disease Control and Prevention (CDC) in the establishment or expansion of patient registries and other surveillance systems as appropriate and upon request by the CDC.
Requires the Director of NIH to ensure that an appropriate number of such awards are awarded to consortia that agree to: (1) focus primarily on pediatric rare diseases or conditions; and (2) conduct or coordinate multi-site clinical trials of therapies for, or approaches to, the prevention, diagnosis, or treatment of pediatric rare diseases or conditions.
Requires the Director of NIH to establish a data coordinating center to: (1) distribute such findings; (2) provide assistance in the design and conduct of collaborative research projects and the management, analysis, and storage of data associated with such projects; and (3) organize and conduct multi-site monitoring activities.
Requires the Director of NIH to: (1) require the data coordinating center to provide regular reports to the Director of NIH and the Commissioner of Food and Drugs (FDA) on research conducted by consortia, including information on enrollment in clinical trials and the allocation of resources with respect to such research; and (2) incorporate such information into NIH's biennial reports.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 225 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 225
To amend title IV of the Public Health Service Act to provide for a
National Pediatric Research Network, including with respect to
pediatric rare diseases or conditions.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 14, 2013
Mrs. Capps (for herself, Mrs. McMorris Rodgers, Ms. DeGette, Mr.
Harper, Ms. Matsui, and Mr. King of New York) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend title IV of the Public Health Service Act to provide for a
National Pediatric Research Network, including with respect to
pediatric rare diseases or conditions.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``National Pediatric Research Network
Act of 2013''.
SEC. 2. NATIONAL PEDIATRIC RESEARCH NETWORK.
Section 409D of the Public Health Service Act (42 U.S.C. 284h;
relating to the Pediatric Research Initiative) is amended--
(1) by redesignating subsection (d) as subsection (f); and
(2) by inserting after subsection (c) the following:
``(d) National Pediatric Research Network.--
``(1) Network.--In carrying out the Initiative, the
Director of NIH, acting through the Director of the Eunice
Kennedy Shriver National Institute of Child Health and Human
Development and in collaboration with other appropriate
national research institutes and national centers that carry
out activities involving pediatric research, may provide for
the establishment of a National Pediatric Research Network
consisting of the pediatric research consortia receiving awards
under paragraph (2).
``(2) Pediatric research consortia.--
``(A) In general.--The Director of the Institute
may award funding, including through grants, contracts,
or other mechanisms, to public or private nonprofit
entities--
``(i) for planning, establishing, or
strengthening pediatric research consortia; and
``(ii) for providing basic operating
support for such consortia, including with
respect to--
``(I) basic, clinical, behavioral,
or translational research to meet unmet
needs for pediatric research; and
``(II) training researchers in
pediatric research techniques in order
to address unmet pediatric research
needs.
``(B) Research.--The Director of NIH shall ensure
that--
``(i) each consortium receiving an award
under subparagraph (A) conducts or supports at
least one category of research described in
subparagraph (A)(ii)(I) and collectively such
consortia conduct or support all such
categories of research; and
``(ii) one or more such consortia provide
training described in subparagraph (A)(ii)(II).
``(C) Number of consortia.--The Director of NIH may
make awards under this paragraph for not more than 20
pediatric research consortia.
``(D) Organization of consortium.--Each consortium
receiving an award under subparagraph (A) shall--
``(i) be formed from a collaboration of
cooperating institutions;
``(ii) be coordinated by a lead
institution;
``(iii) agree to disseminate scientific
findings, including from clinical trials,
rapidly and efficiently; and
``(iv) meet such requirements as may be
prescribed by the Director of NIH.
``(E) Supplement, not supplant.--Any support
received by a consortium under subparagraph (A) shall
be used to supplement, and not supplant, other public
or private support for activities authorized to be
supported under this paragraph.
``(F) Duration of support.--Support of a consortium
under subparagraph (A) may be for a period of not to
exceed 5 years. Such period may be extended at the
discretion of the Director of NIH.
``(3) Coordination of consortia activities.--The Director
of NIH shall--
``(A) as appropriate, provide for the coordination
of activities (including the exchange of information
and regular communication) among the consortia
established pursuant to paragraph (2); and
``(B) require the periodic preparation and
submission to the Director of reports on the activities
of each such consortium.
``(4) Assistance with registries.--Each consortium
receiving an award under paragraph (2)(A) shall provide
assistance to the Centers for Disease Control and Prevention in
the establishment or expansion of patient registries and other
surveillance systems as appropriate and upon request by the
Director of the Centers.
``(e) Research on Pediatric Rare Diseases or Conditions.--
``(1) In general.--In making awards under subsection (d)(2)
for pediatric research consortia, the Director of NIH shall
ensure that an appropriate number of such awards are awarded to
such consortia that agree to--
``(A) focus primarily on pediatric rare diseases or
conditions (including any such diseases or conditions
that are genetic disorders (such as spinal muscular
atrophy and Duchenne muscular dystrophy) or are related
to birth defects (such as Down syndrome and fragile
X)); and
``(B) conduct or coordinate one or more multisite
clinical trials of therapies for, or approaches to, the
prevention, diagnosis, or treatment of one or more
pediatric rare diseases or conditions.
``(2) Data coordinating center.--
``(A) Establishment.--In connection with support of
consortia described in paragraph (1), the Director of
NIH shall establish a data coordinating center for the
following purposes:
``(i) To distribute the scientific findings
referred to in paragraph (1)(C).
``(ii) To provide assistance in the design
and conduct of collaborative research projects
and the management, analysis, and storage of
data associated with such projects.
``(iii) To organize and conduct multisite
monitoring activities.
``(B) Reporting.--The Director of NIH shall--
``(i) require the data coordinating center
established under subparagraph (A) to provide
regular reports to the Director of NIH and the
Commissioner of Food and Drugs on research
conducted by consortia described in paragraph
(1), including information on enrollment in
clinical trials and the allocation of resources
with respect to such research; and
``(ii) as appropriate, incorporate
information reported under clause (i) into the
Director's biennial reports under section
403.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Reported by the Committee on Energy and Commerce. H. Rept. 113-4.
Reported by the Committee on Energy and Commerce. H. Rept. 113-4.
Placed on the Union Calendar, Calendar No. 2.
Mr. Pitts moved to suspend the rules and pass the bill.
Considered under suspension of the rules. (consideration: CR H322-325)
DEBATE - The House proceeded with forty minutes of debate on H.R. 225.
At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
Considered as unfinished business. (consideration: CR H325-326)
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Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 375 - 27 (Roll no. 31).(text: CR H322)
Roll Call #31 (House)On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 375 - 27 (Roll no. 31). (text: CR H322)
Roll Call #31 (House)Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.