[Federal Register Volume 59, Number 12 (Wednesday, January 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1163]


[[Page Unknown]]

[Federal Register: January 19, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service

 

Statement of Organization, Functions, and Delegations of 
Authority; Office of the Assistant Secretary for Health

    Part H, Public Health Service (PHS), chapter HA (Office of the 
Assistant Secretary for Health), of the Statement of Organization, 
Functions, and Delegations of Authority for the Department of Health 
and Human Services (DHHS) (42 FR 61318, December 2, 1977, as amended 
most recently at 58 FR 7140-41, February 4, 1993) is amended to reflect 
changes in the Office of Research Integrity (ORI), Office of the 
Assistant Secretary for Health (OASH), as required by the National 
Institutes of Health Revitalization Act of 1993, Public Law 103-43. 
Section 161 of the law amended section 493 of the Public Health Service 
Act, 42 U.S.C. section 289B, in several respects. Specifically, section 
493, as amended, requires that the ORI be an independent entity in DHHS 
and that the Director, ORI, report to the Secretary. This revision 
accomplishes the statutory mandate while leaving ORI organizationally 
within the OASH for budget and general administrative purposes.
    This notice does not affect the authority of the Food and Drug 
Administration to conduct investigations of alleged misconduct solely 
involving regulated research.

Office of the Assistant Secretary for Health

    Under chapter HA, Office of the Assistant Secretary for Health, 
section HA-20, Functions, delete in its entirety the titles and 
statements for the Office of Research Integrity (HAG), the Division of 
Policy and Education (HAG2), and the Division of Research 
Investigations (HAG3), and add the following:

Office of Research Integrity (HAG)

    The Director reports to the Secretary and will: (1) Oversee and 
direct PHS research integrity activities on behalf of the Secretary 
with the exception of the regulatory research integrity activities of 
the Food and Drug Administration; (2) evaluate and monitor research 
integrity operations activities, including case investigations and 
evaluations, institutional assurance programs, and prevention and 
education activities; (3) coordinate the development of research 
integrity policies designed to ensure that subjects of investigations 
and whistleblowers are treated fairly, including clear specification of 
what constitutes misconduct, a fair hearing process, appropriate time 
limits on pursuing allegations, specific whistleblower protection and 
guidelines to discourage malicious allegations of misconduct; and (4) 
manage the financial resources and provide overall administrative 
guidance in carrying out the activities.

Division of Policy and Education (HAG2).

    The Director and staff: (1) Develop policies, procedures, and 
regulations for review by the Director, Office of Research Integrity, 
and recommendations to the Secretary; (2) administer, review, and 
approve institutional assurances; (3) administer the PHS ALERT system 
which provides pertinent information on research misconduct findings 
and administrative actions to PHS officials; (4) develop and implement 
research misconduct prevention and education activities for PHS 
extramural and intramural programs; (5) coordinate the dissemination of 
research integrity policies, procedures, and regulations; (6) conduct 
policy analyses and studies to improve DHHS research integrity policies 
and procedures; and (8) coordinate Freedom of Information (FOI) and 
Privacy Act responsibilities relating to research misconduct issues.

Division of Research Investigations (HAG3)

    The Director and staff: (1) Review and monitor investigations 
conducted by applicant and awardee institutions; (2) conduct 
investigations involving extramural and intramural research programs 
when necessary; (3) develop and recommend findings of misconduct and 
proposed administrative actions against those who committed misconduct; 
(4) evaluate investigations and investigatory findings of awardee and 
applicant institutions and develop and recommend findings and propose 
administrative actions; (5) assist the Office of the General Counsel 
(OGC) in preparing and presenting cases in hearings before the Research 
Integrity Adjudications Panel of the DHHS Departmental Appeals Board; 
(6) provide information on DHHS policies and procedures, as requested, 
to individuals who have made an allegation or have been accused of 
research misconduct; and (7) assure that DHHS policies and procedures 
are properly implemented in research misconduct cases.

Under Chapter HA, Section HA-30, Delegations of Authority

    All delegations and redelegations of authority to officials of the 
Office of Research Integrity that were in effect prior to the effective 
date of this reorganization shall continue in effect pending further 
redelegation.


    Dated: January 10, 1994.
Donna E. Shalala,
Secretary.
[FR Doc. 94-1163 Filed 1-18-94; 8:45 am]
BILLING CODE 4160-17-M