[Federal Register Volume 68, Number 172 (Friday, September 5, 2003)]
[Notices]
[Pages 52783-52784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22626]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General


Solicitation of Information and Recommendations for Developing 
Compliance Program Guidance for Recipients of NIH Research Grants

AGENCY: Office of Inspector General (OIG), HHS.

ACTION: Notice.

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SUMMARY: This Federal Register notice seeks the input and 
recommendations of interested parties as the OIG develops compliance 
program guidance (CPG) for recipients of extramural research grant and 
cooperative agreement (grant) awards from the National Institutes of 
Health (NIH). The OIG is soliciting comments, recommendations and other 
suggestions from interested parties and organizations on the value and 
fundamental principles of compliance programs for colleges, 
universities, and other recipients of NIH grants, along with the 
specific elements that these grant recipients should consider when 
developing and implementing an effective compliance program.

DATES: To assure consideration, comments must be delivered to the 
address provided below by no later than 5 p.m. on November 4, 2003.

ADDRESSES: Please mail or deliver your written comments, 
recommendations and suggestions to the following address: Department of 
Health and Human Services, Office of Inspector General, Attention: OIG-
13-CPG, Room 5527, Cohen Building, 330 Independence Avenue, SW., 
Washington, DC 20201.
    We do not accept comments by facsimile (FAX) transmission. In 
commenting, please refer to the file code OIG-13-CPG. Comments received 
timely will be available for public inspection as they are received, 
generally beginning approximately 3 weeks after publication of a 
document, in Room 5527 of the Cohen Building at 330 Independence 
Avenue, SW., Washington, DC 20201 on Monday through Friday of each week 
from 8 a.m. to 4:30 p.m.

FOR FURTHER INFORMATION CONTACT: Richard Stern, Office of Counsel to 
the Inspector General, (202) 619-0335; or Joel Schaer, Office of 
Counsel to the Inspector General, (202) 619-0089.

SUPPLEMENTARY INFORMATION: 

1. Past CPGs

    The development of compliance program guidances is a major 
initiative of the OIG in its effort to assist participants in 
Department programs in preventing and reducing fraud and abuse and in 
complying with Federal program requirements. Over the past several 
years, the OIG has developed and issued 11 compliance program 
guidances. The suggestions contained in the guidances are not 
mandatory, nor do they represent an exclusive discussion of the 
advisable elements of a compliance program.

2. Developing Draft CPG for NIH Research Grant Recipients

    Through this Federal Register notice, the OIG is seeking input from 
interested parties as the OIG considers the development of a CPG for 
recipients of extramural research grant awards from NIH. Under its 
governing statute, the OIG's oversight responsibility extends to all 
programs and operations of the Department, and the OIG promotes 
compliance efforts by all recipients of Department funds. One community 
of paramount importance to the Government's public health efforts is 
the colleges, universities, and other recipients of public funds 
committed to furthering biomedical research. These organizations are 
largely non-profit and educational, with over 50 percent of recipients 
of NIH research grant awards in the last several years being medical 
schools. Many of these organizations have instituted health care 
compliance programs in their hospitals, and an increasing number have 
begun developing compliance programs for sponsored research.
    As with OIG's earlier CPGs, the purpose of this guidance will be to 
assist organizations in preventing fraud and abuse and in better 
complying with Federal requirements. We anticipate that the guidance 
for recipients of NIH research grants will contain seven elements that 
we consider necessary for a comprehensive compliance program. These 
seven elements include:
    [sbull] Implementing written policies and procedures that foster an 
institutional commitment to stewardship and compliance;
    [sbull] Designating a compliance officer and compliance committee;
    [sbull] Conducting effective training and education;
    [sbull] Developing effective lines of communication;
    [sbull] Conducting internal monitoring and auditing;
    [sbull] Enforcing standards through well-publicized disciplinary 
guidelines; and
    [sbull] Responding promptly to detected problems, undertaking 
corrective action, and reporting to the appropriate Federal agency.
    We are also considering an eighth element, ``Defining roles and 
responsibilities and assigning oversight responsibility,'' that would 
include a discussion of the importance of effectively delegating 
oversight authority.
    We would appreciate specific comments, recommendations and 
suggestions on aspects of these elements.
    We are also interested in comments on (a) the scope of the 
guidance, and particularly the types of activities, such as grant 
administration, that should be subject to the CPG; and (b) the risk 
areas for recipients of NIH research grants. Based on our fraud 
investigations at research institutions, we have identified internal 
control deficiencies that may warrant attention in a CPG. OIG would 
also appreciate suggestions from the public on risk areas. Risk areas 
we have tentatively identified include: (i) The proper allocation of 
charges to grant projects; (ii) ``time and effort'' reporting, 
including an accurate reporting of the commitment of effort by 
researchers; and (iii) use of program income. We would also be 
interested in comments on each of these areas.
    We will consider all comments, recommendations and suggestions 
received within the time frame

[[Page 52784]]

indicated above. Detailed justifications and empirical data supporting 
any suggestions would be appreciated. We also request that any 
comments, recommendations or suggestions be submitted in a format that 
addresses the topics outlined above in a concise manner, rather than in 
the form of comprehensive draft guidance that mirrors previous CPGs.

    Dated: August 13, 2003.
Dara Corrigan,
Acting Principal Deputy Inspector General.
[FR Doc. 03-22626 Filed 9-4-03; 8:45 am]
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