Appendix A

APPENDIX A

42 U.S.C. § 289b : US Code - Notes

42 U.S.C. § 289b : US Code

SUBTITLE C – RESEARCH INTEGRITY

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Secs. 161, 163, June 10, 1993, 107 Stat. 140, 142.)

CODIFICATION

June 10, 1993, referred to in subsec. (a)(1), was in the original

"the date of enactment of this section" which was translated as

meaning the date of enactment of Pub. L. 103-43, which amended this

section generally, to reflect the probable intent of Congress.

AMENDMENTS

1993 - Pub. L. 103-43, Sec. 161, amended section generally. Prior

to amendment, section read as follows:

"(a) The Secretary shall by regulation require that each entity

which applies for a grant, contract, or cooperative agreement under

this chapter for any project or program which involves the conduct

of biomedical or behavioral research submit in or with its

application for such grant, contract, or cooperative agreement

assurances satisfactory to the Secretary that such entity -

"(1) has established (in accordance with regulations which the

Secretary shall prescribe) an administrative process to review

reports of scientific fraud in connection with biomedical and

behavioral research conducted at or sponsored by such entity; and

"(2) will report to the Secretary any investigation of alleged

scientific fraud which appears substantial.

"(b) The Director of NIH shall establish a process for the prompt

and appropriate response to information provided the Director of

NIH respecting scientific fraud in connection with projects for

which funds have been made available under this chapter. The

process shall include procedures for the receiving of reports of

such information from recipients of funds under this chapter and

taking appropriate action with respect to such fraud."

Subsec. (e). Pub. L. 103-43, Sec. 163, added subsec. (e).

REGULATIONS

Section 165 of Pub. L. 103-43 provided that:

"(a) Issuance of Final Rules. -

"(1) In general. - Not later than 180 days after the date of

the enactment of this Act [June 10, 1993], the Secretary shall,

subject to paragraph (2), issue the final rule for each

regulation required in section 493 or 493A of the Public Health

Service Act [this section and section 289b-1 of this title].

"(2) Definition of research misconduct. - Not later than 90

days after the date on which the report required in section

162(e) [107 Stat. 142] is submitted to the Secretary, the

Secretary shall issue the final rule for the regulations required

in section 493 of the Public Health Service Act with respect to

the definition of the term 'research misconduct'.

"(b) Applicability to Ongoing Investigations. - The final rule

issued pursuant to subsection (a) for investigations under section

493 of the Public Health Service Act [this section] does not apply

to investigations commenced before the date of the enactment of

this Act [June 10, 1993] under authority of such section as in

effect before such date.

"(c) Definitions. - For purposes of this section:

"(1) The term 'section 493 of the Public Health Service Act'

means such section as amended by sections 161 and 163 of this Act

[this section], except as indicated otherwise in subsection (b).

"(2) The term 'section 493A of the Public Health Service Act'

means such section as added by section 164 of this Act [section

289b-1 of this title].

"(3) The term 'Secretary' means the Secretary of Health and

Human Services."

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