2010-17739. 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.

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: [phone].
• 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 [phone], fax [phone], e-mail [e-mail], 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 [e-mail].

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]

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 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.

Footnotes

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.