[Federal Register: July 21, 2010 (Volume 75, Number 139)]
[Proposed Rules]
[Page 42362-42363]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy10-21]
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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 jm40z@nih.gov,
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 FCOI-NPRM@mail.nih.gov.
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