[Federal Register Volume 65, Number 93 (Friday, May 12, 2000)]
[Notices]
[Pages 30600-30601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11958]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary; Office of Public Health and Science


Statement of Organization, Functions, and Delegations of 
Authority

    Part A, (Office of the Secretary) of the Statement of Organization, 
Functions, and Delegations of Authority for the Department of Health 
and Human Services, Chapter AC, Office of Public Health and Science 
(OPHS), paragraph ACA, Immediate Office, as last amended at 62 FR 5009-
10, 2/3/97; and paragraph ACF, Office of Research Integrity (ORI), as 
last amended at 60 FR 56606-06,

[[Page 30601]]

dated November 9, 1995, are being amended to make policy changes 
approved by the Secretary. Specifically, the Notice is to reflect that 
the Assistant Secretary for Health (ASH) will make proposed findings of 
research misconduct and administrative actions in response to 
allegations of research misconduct involving research conducted or 
supported by components of the Public Health Service (PHS); that direct 
investigations, previously conducted by ORI, will be conducted by 
components of the PHS for intramural research and by the Office of 
Inspector General for extramural research; and that role and structure 
of ORI will be changed to focus more on preventing misconduct and 
promoting research integrity through expanded education programs. The 
changes are as follows:
    I. Amend Chapter AC.20 Functions, paragraph A. ``Office of Public 
Health and Science,'' paragraph titled, ``The Immediate Office (ACA)'' 
by adding the following new clause:
    (1) Proposes findings of research misconduct and administrative 
actions in response to allegations of research misconduct involving 
research conducted or supported by the Public Health Service (PHS) 
OPDIVs, including reversal of an institution's no misconduct finding or 
opening of a new investigation.
    II. Under Section AC.20 Function, delete, paragraph E. ``Office of 
Research Integrity (ACF)'' in its entirety, and replace with the 
following:
    E. Office of Research Integrity (ACF)--The Director reports to the 
Secretary and will: (1) Oversee and direct Public Health Service (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) recommend to the Assistant Secretary for 
Health for decision, findings of research misconduct and administrative 
actions in connection with research conducted or supported by the PHS; 
(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, and specific whistleblower protections; (4) manage the 
financial resources and provide overall administrative guidance in 
carrying out the activities; and (5) oversee and direct the research 
misconduct and integrity activities of the office, including the 
oversight of research misconduct inquiries and investigations, 
education and training in the responsible conduct of research, 
activities designed to promote research integrity and prevent 
misconduct, and research and evaluation programs.
    1. Division of Education and Integrity (ACF2)--The Director and 
staff: (1) develop and implement, in consultation with the PHS OPDIVs, 
activities and programs for PHS intramural and extramural research to 
teach the responsible conduct of research, promote research integrity, 
prevent research misconduct, and to enable the extramural institutions 
and PHS OPDIVs to respond effectively to allegations of research 
misconduct; (2) coordinate the dissemination of research integrity 
policies, procedures, and regulations; (3) conduct policy analyses, 
evaluations, and research to improve DHHS research integrity policies 
and procedures and build the knowledge base in research misconduct, 
research integrity, and prevention; (4) develop (in consultation with 
the PHS OPDIVs) policies, procedures, and regulations for review by the 
Director, Office of Research Integrity, and recommendations to the 
Secretary; (5) administer programs for: approval of institutional 
assurances; response to Freedom of Information Act and Privacy Act 
requests; review and approval of intramural and extramural policies and 
procedures; and response to allegations of whistleblower retaliation.
    2. Division of Investigative Oversight (ACF3)--The Director and 
staff: (1) review and monitor investigations conducted by applicant and 
awardee institutions and intramural research programs; (2) evaluate 
investigations and investigatory findings of awardee and applicant 
institutions, intramural research programs, and the Office of Inspector 
General and develop and recommend to the ORI Director, findings of 
research misconduct and proposal administrative actions against those 
who committed misconduct; (3) assist the Office of the General Counsel 
(OGC) in preparing and presenting cases in hearings before the Research 
Integrity Adjudications Panel of the DHHS Department Appeals Board; (4) 
provide information on DHHS policies and procedures, as requested, to 
individuals who have made an allegation or have been accused of 
research misconduct; and (5) establish and implement a program of 
advice and technical assistance to entities that conduct inquiries and 
investigations, or otherwise respond to allegations of research 
misconduct.
    III. Under Chapter AC, Section ACF-30, Delegations of Authority--
All delegations and redelegations of authority to the Assistant 
Secretary for Health and 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: April 14, 2000.
Betsy D'Jamos,
Acting Assistant Secretary for Management and Budget.
[FR Doc. 00-11958 Filed 5-11-00; 8:45 am]
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