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Biennial Report of the Director

Appendix A:
Legal Mandate for This Report








Pub. L. No. 109-482: The National Institutes of Health Reform Act of 2006 (Relevant Provisions)


An Act

To amend title IV of the Public Health Service Act to revise and extend the authorities of the National Institutes of Health, and for other purposes.

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 Institutes of Health Reform Act of 2006"

TITLE I—NIH REFORM

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SEC. 102. AUTHORITY OF DIRECTOR OF NIH.

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(b) Additional Authorities.—Section 402(b) of the Public Health Service Act, as amended by subsection
(a) of this section, is amended by striking paragraphs (2) and (3) and inserting the following:

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SEC. 104. REPORTS

(a) REPORT OF DIRECTOR OF NIH.—The Public Health Service Act (42 U.S.C. 201 et seq.), as amended by section 103(a) of this Act, is amended—

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“SEC. 403. BIENNIAL REPORTS OF DIRECTOR OF NIH.

“(a) IN GENERAL.—The Director of NIH shall submit to the Congress on a biennial basis a report in accordance with this section. The first report shall be submitted not later than 1 year after the date of the enactment of the National Institutes of Health Reform Act of 2006. Each such report shall include the following information:

“(b) Requirement Regarding Disease-Specific Research Activities.— In a report under subsection (a), the Director of NIH, when reporting on research activities relating to a specific disease, disorder, or other adverse health condition, shall—

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SEC. 106. ENHANCING THE CLINICAL AND TRANSLATIONAL SCIENCE AWARD.

(a) IN GENERAL.—In administering the Clinical and Translational Science Award, the Director of NIH shall establish a mechanism to preserve independent funding and infrastructure for pediatric clinical research centers by—

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(b) Report.—As part of the biennial report under section 403 of the Public Health Service Act, the Director of NIH shall provide an evaluation and comparison of outcomes and effectiveness of training programs under subsection (a).


Public Law 110-85: The Food and Drug Administration Act of 2007 (Relevant Provisions)


An Act
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the post market authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.

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 "Food and Drug Administration Amendments Act of 2007."

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TITLE XI—OTHER PROVISIONS
Subtitle A—In General

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SEC. 1104. NIH TECHNICAL AMENDMENTS.

The Public Health Service Act (42 U.S.C. 201 et seq.) is amended—

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Public Law 110-204: The Newborn Screening Saves Lives Act of 2007 (Relevant Provisions)


An Act To amend the Public Health Service Act to establish grant programs to provide for education and outreach on newborn screening and coordinated follow-up care once newborn screening has been conducted, to reauthorize programs under part A of title XI of such Act, and for other purposes.

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 “Newborn Screening Saves Lives Act of 2007”.

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SECTION 7. CONTINGENCY PLANNING.

Part A of title XI of the Public Health Service Act (42 U.S.C. 300b-1 et seq.) as amended by section 6, is further amended by adding at the end the following:

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“SEC. 1116. HUNTER KELLY RESEARCH PROGRAM.

(a) Newborn Screening Activities. —

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