[Federal Register Volume 75, Number 139 (Wednesday, July 21, 2010)]
[Proposed Rules]
[Pages 42362-42363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17739]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 50

45 CFR Part 94

[Docket Number NIH-2010-0001]
RIN 0925-AA53


Responsibility of Applicants for Promoting Objectivity in 
Research for Which Public Health Service Funding Is Sought and 
Responsible Prospective Contractors

AGENCY: Department of Health and Human Services.

ACTION: Proposed rule; extension of comment period; request for 
comments.

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SUMMARY: The Department of Health and Human Services (HHS or the 
Department), including the HHS Public Health Service (PHS), is 
extending the comment period for a proposed rule that would amend the 
regulations on the Responsibility of Applicants for Promoting 
Objectivity in Research for which PHS Funding is Sought and Responsible 
Prospective Contractors, and is clarifying certain elements of the 
proposed rule for which we are seeking additional comment. The proposed 
rule was published in the Federal Register on May 21, 2010 (75 FR 
28688). The comment period is extended by 30 days and thus will end on 
August 19, 2010.

DATES: Comments must be received on or before August 19, 2010 in order 
to ensure we will be able to consider the comments when preparing the 
final rule.

ADDRESSES: Individuals, organizations and institutions interested in 
submitting comments identified by RIN 0925-AA53 and Docket Number [NIH-
2010-0001] may do so by any of the following methods:

Electronic Submissions

    You may submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     To ensure timely processing of comments, NIH is no longer 
accepting comments submitted to the agency by e-mail.

Written Submissions

    You may submit written comments in the following ways:
     Fax: 301-402-0169.
     Mail: Jerry Moore, NIH Regulations Officer, Office of 
Management Assessment, National Institutes of Health, 6011 Executive 
Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669.
     Hand Delivery/Courier (for paper, disk, or CD-ROM 
submissions). Attention: Jerry Moore, 6011 Executive Boulevard, Suite 
601, Rockville, MD 20852-7669.
    Instructions: All submissions received must include the agency name 
and Regulatory Information Number (RIN) [0925-AA53] and docket number 
[NIH-2010-0001] for this rulemaking action. All comments may be posted 
without change, including any personal information provided.
    Docket: For access to the docket to read background documents or 
comments received concerning this rulemaking action, go to the 
eRulemaking.gov Portal: http://www.regulations.gov and follow the 
instructions provided for conducting a search, using the docket number 
[NIH-2010-0001].

FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, 
Office of Management Assessment, National Institutes of Health, 6011 
Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669, 
telephone 301-496-4607, fax 301-402-0169, e-mail [email protected], 
concerning questions about the rulemaking process and Dr. Sally Rockey, 
NIH Deputy Director for Extramural Research, concerning substantive 
questions about the proposed rule, e-mail [email protected].

SUPPLEMENTARY INFORMATION: HHS published a Notice of Proposed 
Rulemaking (NPRM) in the Federal Register on May 21, 2010 (75 FR 
28688), with a deadline for written comments of July 20, 2010. The NPRM 
proposed changes to 42 CFR Part 50, Subpart F, and 45 CFR Part 94 (the 
regulations) to expand and add transparency to Investigator disclosure 
of significant financial interests (SFIs) to Institutions, as well as 
enhance regulatory compliance and effective oversight of financial 
conflicts of interest (FCOIs). The current regulations at 42 CFR Part 
50, Subpart F, are applicable to each Institution that applies for PHS 
grants or cooperative agreements for research and, through 
implementation of the regulations by each Institution, to each 
Investigator participating in such research.\1\ The current PHS 
contracting regulations at 45 Part 94 similarly apply to each 
Institution that seeks PHS funding for research and, through 
implementation of the regulations, to each Investigator who 
participates in such research.\2\
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    \1\ In those few cases where an individual, rather than an 
institution, is an applicant for PHS grants or cooperative 
agreements for research, PHS Awarding Components will make case-by-
case determinations on the steps to be taken to ensure that the 
design, conduct, and reporting of the research will not be biased by 
any conflicting financial interest of the individual.
    \2\ In neither case do the regulations currently apply to Small 
Business Innovation Research (SBIR)/Small Business Technology 
Transfer Research (STTR) Phase I applications.
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    Since the NPRM was published, the Department has received questions 
concerning the authorities that exist under the current regulations and 
the proposed revisions to enable the PHS to enforce compliance by 
Institutions and Investigators with the regulations. In addition, the 
Department has considered whether, as part of the proposed revisions, 
it should clarify how the regulations apply in circumstances in which 
an Investigator or a PHS-funded research project transfers from one 
Institution to another, or in which a new Institution, and 
Investigators at the new Institution, become involved in an ongoing 
PHS-funded research project (e.g., where the new Institution becomes a 
subgrantee on the project). The Department recognizes that scientific 
discovery is a fluid process, and sometimes necessitates the movement 
of people and projects between Institutions. Under most ordinary 
circumstances, this type of movement presents no concerns. However, the 
Department is fully committed to protecting the objectivity of PHS-
funded research and wants to be sure that the transfer of an 
Investigator or research project from one Institution to another does 
not compromise the integrity of PHS-funded research. As a result, we 
are seeking comment whether the recently-published proposed rule should 
be

[[Page 42363]]

further enhanced for clarity in protecting research integrity.
    With regard to enforcement authorities, the current regulations 
include in 42 CFR 50.606 and 45 CFR 94.6 a description of remedies 
available to HHS and a PHS Awarding Component when identifying concerns 
regarding FCOI or compliance with the regulations. In addition, 42 CFR 
50.607 identifies other HHS regulations that apply, including uniform 
administrative requirements, as well as debarment and suspension 
procedures. The NPRM includes proposed revisions to all three of these 
sections. Among the proposed changes, with regard to matters determined 
to require corrective action under the regulations, we proposed 
revising paragraph 50.606(b) to incorporate by reference 45 CFR 74.14 
(special award conditions), and proposed revising paragraph 94.6(b) to 
reference ``other enforcement action'' in addition to, or in lieu of, a 
Stop Work Order by the Contracting Officer. In section 50.607, we 
proposed minor revisions to update the CFR location or title of the 
existing references, but also specifically requested comment with 
regard to the necessity of this section.
    In conjunction with the comment period extension, we seek public 
comment on whether the proposed changes to the regulations' references 
to the enforcement authorities available to the PHS, including those 
discussed above, should be further revised and clarified in the 
regulations. This includes comment on whether the regulations should 
include one or more descriptions of specific measures that the 
Department, including a PHS Awarding Component, may initiate as a 
result of particular types of identified FCOI or non-compliance under 
the regulations. As one example, the regulations potentially could 
describe situations in which an Investigator's identified FCOI or an 
Investigator's failure to comply with an Institution's FCOI policy or 
FCOI management plan necessitates notification to other Institutions 
(e.g., when the Investigator, or the PHS-funded research project on 
which he or she is working, transfers from one Institution to another).
    In addition to possible clarification of enforcement authorities, 
the Department also seeks comment as to whether it should clarify how 
the regulations apply in circumstances in which an Investigator or a 
PHS-funded research project transfers from one Institution to another, 
or in which a new Institution, and Investigators at the new 
Institution, become involved in an ongoing PHS-funded research project 
(e.g., where the new Institution becomes a subgrantee on the project). 
As one example, we proposed in the NPRM to revise substantially 42 CFR 
50.604(f) and 45 CFR 94.4(f) such that these paragraphs would require 
an Institution, through its designated officials, to determine whether 
an Investigator's SFI is related to PHS-funded research and, if so 
related, whether the SFI is a FCOI. We request comment as to whether 
the regulations should further clarify that, as part of the 
Institution's FCOI determination process, institutional officials must 
consider whether an Investigator's SFI was previously determined to be 
a FCOI and subject to a management plan with regard to other PHS-funded 
research project(s). Such consideration could be based on information 
in the Institution's own records or from publicly accessible sources 
(e.g., the Web site of an Institution that previously employed the 
Investigator). We welcome additional public comment on alternative 
approaches or additional clarifications that may be incorporated into 
the regulations to protect further the objectivity of PHS-funded 
research in situations involving a transfer of an Investigator or PHS-
funded project between Institutions, or the introduction of a new 
Institution and Investigators to an existing PHS-funded project.

    Dated: June 22, 2010.
Francis S. Collins,
Director, National Institutes of Health.
    Approved: July 6, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010-17739 Filed 7-20-10; 8:45 am]
BILLING CODE 4140-01-P