[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57589-57596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22770]


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OFFICE OF SCIENCE AND TECHNOLOGY POLICY


Notice Response to Comments and Notice of Final Action Regarding 
the United States Government Policy for Institutional Oversight of Life 
Sciences Dual Use Research of Concern

SUMMARY:  On February 22, 2013, the Office of Science and Technology 
Policy (OSTP) published a 60-day public notice in the Federal Register 
(Federal Register Volume 78, Number 36, Docket No. 2013-04127) to 
invite public

[[Page 57590]]

comment on the proposed United States Government Policy for 
Institutional Oversight of Life Sciences Dual Use Research of Concern 
(hereafter, Policy for Institutional DURC Oversight or Policy). This 
Notice responds to comments received during this 60-day public notice, 
sets forth final changes to the Policy for Institutional DURC 
Oversight, and implements the final Policy for Institutional DURC 
Oversight. The Policy for Institutional DURC Oversight will be updated, 
as needed, following domestic dialogue, international engagement, and 
input from interested communities including scientists, national 
security officials, and global health specialists and announced in the 
Federal Register and at http://www.phe.gov/s3/dualuse.

DATES:  Policy release date: September 24, 2014. Effective date: 
September 24, 2015. The 12-month period between release and effective 
date will allow institutions and USG funding agencies subject to this 
Policy to establish the procedures necessary to comply with this 
Policy. Certification of compliance will be required of institutions to 
which the Policy applies, as defined in Section 6.1, at the time of 
seeking funding, but no sooner than the effective date of the Policy.

FOR FURTHER INFORMATION CONTACT:  Dr. Andrew M. Hebbeler, Assistant 
Director for Biological and Chemical Threats, Office of Science and 
Technology Policy, Eisenhower Executive Office Building, 1650 
Pennsylvania Avenue, Washington, DC 20504, [email protected].

SUPPLEMENTARY INFORMATION: The Policy for Institutional Oversight of 
Life Sciences DURC is available on the U.S. Department of Health and 
Human Services Science Safety Security (S3) Web site: http://www.phe.gov/s3/dualuse.

Background

    Life sciences research is essential to the scientific advances that 
underpin improvements in the health and safety of the public, 
agricultural crops and other plants, animals, and the environment; 
materiel\1\; and national security. While life sciences research has 
and will continue to yield benefits, no research comes without risk. 
Generally speaking, the risks associated with the conduct of life 
sciences research, such as accidental exposure of personnel or the 
environment to a pathogen or toxin, are addressed by existing and 
complementary statutes, regulations, and guidelines \2\ that ensure 
that life sciences research is conducted safely and securely.
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    \1\ Materiel includes food, water, equipment, supplies, or 
material of any kind.
    \2\ E.g., the select agent regulations (42 CFR Part 73, 9 CFR 
Part 121, and 7 CFR Part 331); NIH Guidelines on Research Involving 
Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines); 
and Biosafety in Microbiological and Biomedical Laboratories (BMBL), 
5th Edition.
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    However, despite the doubtless value and benefits of the outcomes 
of scientific research, there are certain types of legitimately-
conducted research that generate knowledge, information, products, or 
technologies that could also be intentionally utilized for harmful 
purposes. Such research is deemed to be ``dual use research.'' Within 
the life sciences, there exists a subset of dual use research that 
merits particular attention due to the magnitude of the potential 
consequences of its misuse or misapplication. This research is called 
dual use research of concern (DURC) and is defined in the Policy for 
Institutional DURC Oversight as life sciences research that, based on 
current understanding, can be reasonably anticipated to provide 
knowledge, information, products, or technologies that could be 
directly misapplied to pose a significant threat with broad potential 
consequences to public health and safety, agricultural crops and other 
plants, animals, the environment, materiel, or national security.
    Funders of life sciences research and the institutions and 
scientists who conduct this research have a shared responsibility for 
oversight of DURC and for promoting its responsible conduct and 
communication. A comprehensive oversight system for DURC includes the 
policies, practices, and procedures put in place to ensure DURC is 
identified and risk mitigation measures are implemented, where 
applicable, and such a system must include both Federal and 
institutional oversight processes. Institutional oversight of DURC is a 
critical component of a comprehensive oversight system because 
institutions are most familiar with the life sciences research 
conducted in their facilities and are in the best position to promote 
and strengthen the responsible conduct and communication of DURC.
    The Policy for Institutional DURC Oversight is one of two USG 
policies that apply to the oversight of life sciences research with 
dual use potential. The other policy is the USG Policy for Oversight of 
Life Sciences Dual Use Research of Concern, issued on March 29, 2012 
and hereafter referred to as the March 2012 DURC Policy.\3\ The March 
2012 DURC Policy sets forth a process of regular Federal review of USG-
funded or -conducted research and requires Federal agencies that fund 
or sponsor life sciences research to identify DURC and evaluate this 
research for possible risks, as well as benefits, and to ensure that 
risks are appropriately managed and benefits realized. The Policy for 
Institutional DURC Oversight complements the March 2012 DURC Policy by 
establishing review procedures and oversight requirements for the same 
scope of life sciences research at the institutions that receive 
Federal funding for such research. Together, the two policies work to 
engage the life sciences research community and the Federal departments 
and agencies that fund such research in a shared commitment to address 
the risk that knowledge, information, products, or technologies 
generated from life sciences research could be used for harm. In 
addition, the Policy for Institutional DURC Oversight and the March 
2012 DURC Policy emphasize a culture of responsibility by reminding all 
involved parties of the shared duty to uphold the integrity of science 
and prevent its misuse.\4\
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    \3\ The United States Government Policy for Oversight of Life 
Sciences Dual Use Research of Concern (March 2012 DURC Policy), 
March 29, 2012, www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf.
    \4\ The March 2012 DURC Policy and the final Policy for 
Institutional DURC Oversight are complemented by extant laws and 
treaties (e.g., United States Code Title 18 Section 175 and the 
Biological and Toxin Weapons Convention) that prohibit the 
development, production, acquisition, or stockpiling of biological 
agents or toxins of types and in quantities that have no 
justification for prophylactic, protective or other peaceful 
purposes and that prohibit the use of biological agents and toxins 
as weapons.
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Text of the Final Policy for Institutional DURC Oversight

    The final Policy for Institutional DURC Oversight is available on 
the U.S. Department of Health and Human Services Science Safety 
Security (S3) Web site: www.phe.gov/s3/dualuse.

Companion Guide to the USG Policies for Oversight of Life Sciences Dual 
Use Research of Concern

    The USG has developed a guide to assist in implementation of both 
the final Policy for Institutional DURC Oversight and the March 2012 
DURC Policy, entitled Tools for the Identification, Assessment, 
Management, and Responsible Communication of Dual Use Research of 
Concern: A Companion Guide to the USG Policies for Oversight of Life 
Sciences Dual Use Research of Concern (hereafter, Companion Guide). The

[[Page 57591]]

comments received in response to the proposed Policy were taken into 
consideration in developing the guidance and other information that are 
included in the Companion Guide. Use of the Companion Guide by PIs, 
institutions, and Institutional Review Entities (IREs) is voluntary. 
The Companion Guide will be considered for revisions as experience in 
implementing the final Policy for Institutional DURC Oversight and the 
March 2012 DURC Policy and in utilizing the tools included in the 
Companion Guide accumulates. This review will be carried out 
periodically as needed.
    The Companion Guide is available on the U.S. Department of Health 
and Human Services Science Safety Security (S3) Web site: http://www.phe.gov/s3/dualuse/.

Training and Education on DURC and Its Oversight

    The USG and individual Federal funding agencies are developing 
training and education resources to assist institutions and PIs in 
meeting the requirements of Sections 7.2.G and 7.1.E, respectively, of 
the final Policy for Institutional DURC Oversight. These resources will 
be made available on the U.S. Government Science Safety Security (S3) 
Web site, http://www.phe.gov/s3/dualuse/. The training and educational 
resources will be considered for revisions as experience in such 
training accumulates. This review will be carried out periodically as 
needed.
    For institutions subject to the final Policy, the USG anticipates 
that the requirements for education and training on DURC will be met by 
the effective date of the Policy or at the point of providing 
certification of compliance to a Federal funding agency or agencies, as 
described in Section 7.2.L of the final Policy. The twelve-month time 
frame between the release of the final Policy and its effective date 
was deemed sufficient to allow institutions to perform outreach and 
training for investigators whose research will now be subject to the 
Policy for Institutional DURC Oversight.

Summary of Public Comments & Revisions Reflected in the Final Policy

    On February 22, 2013, the Office of Science and Technology Policy 
(OSTP) published a 60-day public notice in the Federal Register 
(Federal Register Volume 78, Number 36, Docket No. 2013-04127) \5\ to 
invite public comment on a proposed draft of the Policy for 
Institutional DURC Oversight, and to gather specific comments on 16 
questions relating to the Policy and its possible implementation.\6\ In 
addition to assisting in the development of the final Policy, the 
comments were helpful in identifying and developing materials that are 
designed to aid institutions in the implementation of the final Policy 
for Institutional DURC Oversight and the March 2012 DURC Policy. By the 
end of the 60-day comment period, OSTP received 38 responding 
commentaries on the proposed Policy from 27 entities, described below. 
The majority of the responses (20) represented the viewpoints of 
departments and offices of 16 different research institutions: 11 
universities, three teaching hospitals, one non-profit owning two of 
the commenting teaching hospitals, and one public health reference 
laboratory. Six professional associations and one citizens' group each 
submitted one response. Eleven of the responses were submitted by 
private citizens, eight of whom identified themselves as researchers or 
scientists.
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    \5\ ``United States Government Policy for Institutional 
Oversight of Life Sciences Dual Use Research of Concern; Notice, 
Request for Comment,'' 78 Federal Register 36 (22 February 2013), pp 
12369-12372, federalregister.gov/a/2013-04127.
    \6\ United States Government Policy for Institutional Oversight 
of Life Sciences Dual Use Research of Concern (Policy for 
Institutional DURC Oversight), February 21, 2013, www.phe.gov/s3/dualuse/Documents/oversight-durc.pdf.
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    The following paragraphs review the specific comments received on 
each section of the final Policy; the USG's response to those comments; 
and the revisions and additions included in the final Policy.

Section 1. Introduction

    The introductory text of the final Policy for Institutional DURC 
Oversight states that the USG will update the Policy, as warranted, 
based on feedback on implementation of the final Policy, evaluation of 
the Policy's impact, and assessment of the advantages and disadvantages 
of expanding the scope of the Policy. In the final Policy, the 
introductory statement was revised to include that the USG will update 
the components outlined in the final Policy and the March 2012 DURC 
Policy, as needed, following domestic dialogue, international 
engagement, and input from interested communities including scientists, 
national security officials, and global health specialists.
    The introduction in the final Policy, as well as a short statement 
in Section 6.1 (Applicability), include revisions to clarify that while 
institutions may, as they deem appropriate, expand their internal 
oversight to life sciences research outside the scope of the final 
Policy, such an expansion of scope by the institution would not be 
subject to oversight as articulated in the final Policy.

Section 4. Definitions

    Two new definitions are provided in the final Policy for 
Institutional DURC Oversight. The first, a definition of ``to 
certify,'' which means to attest to the USG that an institution subject 
to this Policy will comply with all aspects of this Policy. A 
definition has also been provided for ``Principal Investigator'' (PI). 
For the purposes of the Policy, a PI is an individual who is designated 
by the research institution to direct a project or program and who is 
responsible to the funding agency or the research institution for the 
scientific and technical direction of that project or program. There 
may be more than one PI on a research grant or project within a single 
or multiple institutions.
    Two definitions have been modified. The definition for the 
Institutional Contact for Dual Use Research (ICDUR) was revised to 
clarify that the person serving in this capacity should function as an 
institutional point of contact for questions regarding compliance with 
and implementation of the requirements for the oversight of DURC as 
well as the liaison (as necessary) between the institution and the 
relevant USG funding agency. The definition of ``life sciences'' was 
also revised to align with the definition of the same term in the March 
2012 DURC Policy, i.e., for the purposes of the final Policy, ``life 
sciences'' includes the discipline of aerobiology.

Section 5. Policy Statement

    Section 5.A of the final Policy for Institutional DURC Oversight 
includes slight revisions that clarify that life sciences research that 
meets the scope specified in Section 6.2 of the final Policy is subject 
to Federal oversight through the March 2012 DURC Policy as well as the 
institutional oversight set forth in the final Policy.

Section 6.1 Applicability

    In the final Policy for Institutional DURC Oversight, the last 
paragraph of the applicability section was revised to clarify that life 
sciences research institutions that conduct or sponsor research that is 
within the scope of the Policy but receive no USG funds in support of 
life sciences research are not required to adhere to the oversight 
requirements of the final Policy. These institutions are, however, 
strongly encouraged to implement internal

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oversight procedures consistent with the culture of shared 
responsibility underpinning the Policy. As noted in the Introduction to 
the final Policy, institutions may also, as they deem appropriate, 
expand their internal oversight to life sciences research outside the 
scope of the final Policy; however such an expansion of scope by the 
institution would not be subject to oversight as articulated in the 
final Policy.
    The final Policy also reflects the relocation of the paragraph 
regarding compliance with the Policy from this section to a new 
section, Section 6.3.

Section 6.2. Scope of Research Requiring Oversight

    The scope of the proposed Policy for Institutional DURC Oversight 
includes research that directly involves non-attenuated forms of the 15 
agents or toxins listed in Section 6.2.1 of the final Policy, including 
the use of botulinum toxin at any quantity, and which also produces, 
aims to produce, or can be reasonably anticipated to produce one or 
more of the effects listed in Section 6.2.2 of the final Policy. 
Comments on the proposed Policy were specifically requested regarding 
the appropriateness of the scope of the Policy, including whether the 
scope should be expanded to all select agents, microbes, or all life 
sciences; what factors should be considered in determining a final or 
revised scope; what criteria might be used to determine what research 
should or should not be subject to oversight; and what effects such an 
expansion might have on the ability to conduct research. In addition, 
comments were invited on whether the scope of the proposed Policy 
should be expanded to include the use of any of the listed 15 agents or 
toxins in attenuated forms; the use of the genes from any of the listed 
15 agents or toxins; in silico experiments (e.g., modeling experiments, 
bioinformatics approaches) involving the biology of the listed 15 
agents or toxins; or research related to the public, animal, and 
agricultural health impact of any of the 15 listed agents or toxins 
(e.g., modeling the effects of a toxin, developing new methods to 
deliver a vaccine, developing surveillance mechanisms for a listed 
agent).
    Eighteen comments were received on the topic of expanding the scope 
of the proposed Policy. Eleven comments favored the proposed scope or 
narrowing the proposed scope, while seven comments favored expansion of 
the proposed scope. Eight of the comments cited a negative impact on 
research should the scope be expanded, while nine comments made no 
mention of effects on the ability to conduct the research. One 
institution that already conducts DURC reviews of all recombinant DNA 
and BSL-3 research cited no additional burden as a result of an 
expanded scope for its review process. In general, those in favor of 
scope expansion expressed satisfaction with the current scope, with the 
understanding that expansion may occur in the future.
    Thirteen comments were received in response to the more specific 
question on modifications to the scope. Three comments recommended no 
expansion or modification to the scope of the Policy, while two 
considered the scope appropriate at the current time but acknowledged 
that future developments may warrant changes. Five comments suggested 
that attenuated forms of agents should be considered for inclusion in 
the scope of the Policy if there is sufficient justification. Three 
comments expressed support for expanding the scope to include genes 
known to increase pathogenicity, virulence, or infectivity; however, 
one of these comments proposed limiting the source of these genes to 
any of the listed agents, while the other two comments noted that any 
genes known to increase these characteristics should be included in the 
scope. Two comments supported expansion of the scope to include 
consideration of in silico experiments. Two other comments received on 
this topic requested additional guidance on review of these types of 
studies in the event of an expansion of the Policy's scope. One comment 
suggested that the scope of the Policy could permit flexibility beyond 
a specific list of pathogens by limiting the scope to only the seven 
identified categories of experimental effects (Sec. 6.2.2) and thus the 
review process would involve evaluating the dual use implications of 
all research meeting one or more of these seven categories.
    Because institutional oversight of DURC will be a new undertaking 
for many institutions, the USG has maintained the scope of the final 
Policy as a well-defined subset of life sciences research that involves 
15 agents \7\ and seven categories of experiments. Of note, the final 
Policy is intended to apply only to research that directly involves 
non-attenuated \8\ forms of the 15 agents. After implementation of the 
final Policy, the USG will assess the advantages and disadvantages of 
expanding the scope of the Policy to encompass additional agents and/or 
categories of experiments and will update the Policy, as warranted.
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    \7\ The 15 agents and toxins listed in the Policy for 
Institutional DURC Oversight are subject to the select agent 
regulations (42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121), 
which set forth the requirements for possession, use, and transfer 
of select agents and toxins, and have the potential to pose a severe 
threat to human, animal, or plant health, or to animal or plant 
products. It is important to note, however, that the Federal Select 
Agent Program does not oversee the implementation of the Policy for 
Institutional DURC Oversight or the March 2012 DURC Policy.
    \8\ The only forms of the agents or toxins listed in Section 
6.2.1 of the final Policy for Institutional DURC Oversight that, for 
the purposes of the Policy, are considered by the USG to be 
attenuated and therefore not subject to the requirements of the 
Policy, can be found on the Select Agent and Toxin Exclusions list 
under ``Attenuated Strains of HHS and USDA Select Agents and 
Toxins'' at: http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Exclusions.html.
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Section 6.3. Compliance

    Ten comments were received regarding the issue of compliance with 
the proposed Policy for Institutional DURC Oversight. Six of these 
comments noted that the proposed Policy contained limited information 
on compliance or its implementation or enforcement at institutions and 
Federal agencies. In addition, three of the comments indicated 
confusion regarding the role of the Institutional Review Entity (IRE) 
in ensuring compliance with the Policy. To address confusion and 
concerns over the responsibilities for compliance on both the part of 
the institution and the Federal funding agency, language regarding 
compliance with the Policy has been moved to a separate section 
(Section 6.3) and reflects revisions that clarify that any suspension, 
limitation, or termination of USG funding or loss of future USG funding 
opportunities due to noncompliance with the final Policy will be 
consistent with existing regulations and policies governing USG-funded 
research and may subject the institution to other potential penalties 
under applicable laws and regulations.
    Regarding the role of the IRE in ensuring compliance at the 
institution, Section 7.2.H of the final Policy includes revisions 
intended to clarify that it is the institution, not the IRE, that is 
responsible for institutional compliance with the Policy.

Section 7. Organizational Framework for Oversight of DURC

    The figure in Section 7 has been modified to correspond to changes 
and revisions described below.

Section 7.1. Responsibilities of Principal Investigators

    The proposed Policy for Institutional DURC Oversight required PIs 
to refer any research involving one or more of

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the 15 listed agents to an IRE, which would then determine whether the 
research can be reasonably anticipated to produce any of the seven 
effects, and if so, whether that research meets the definition of DURC.
    Comments were solicited on whether it is preferable to require PIs 
to determine whether their research involves one or more of the listed 
agents as well as determine whether any of his or her research 
involving one or more of the listed agents can be reasonably 
anticipated to produce any of the listed effects before referring the 
research to the IRE. Fourteen comments were received on this topic. 
Nine of the comments were supportive of a review process that would 
require the PI to assess his or her research for both use of one or 
more the listed agents and the applicability of the listed experiments. 
Furthermore, nine comments indicated that the assessment of the 
applicability of the listed experimental effects should be conducted by 
both the PIs and the IRE.
    Comments from two institutions with extant review systems for dual 
use research indicated that their review processes already require that 
PIs assess their research for the listed experimental effects and 
participate in discussions of the risks and benefits of the research. 
These institutions noted that the increased involvement of the PI in 
the review process is beneficial for both the PI and the institution 
because it promotes a common understanding of DURC, informs the 
institution of instances when training on DURC might be needed, 
strengthens the review, enhances collaboration, and improves 
compliance. Two other comments in support of the expansion of the PI's 
role noted that because of the Policy's requirements for ongoing review 
by PIs, the expectation of PIs to assess the applicability of the 
listed effects at the outset of the research is both reasonable and 
beneficial. Four comments opposed expanding the PI's role regarding 
review of research for experimental effects. These comments cited 
concerns about the subjective nature of the determination, and that PIs 
did not have sufficient expertise for the assessment. In response to 
these comments, Section 7.1.A of the final Policy includes revisions 
that require PIs initiating or conducting research with one or more of 
the listed agents to also review the research for the presence or 
anticipation of any of the listed experimental effects. Section 7.1.B 
also includes revisions that indicate that the PI must work with the 
IRE to assess the risks and benefits of the research as well as to 
develop the risk mitigation measures for any research determined to be 
DURC. For consistency, similar changes were made to the description of 
the responsibilities of institutions (Section 7.2.B.iii).
    Comments were also solicited on whether research that has undergone 
institutional dual use review, but has been determined by the IRE to 
not meet the definition of DURC, should be monitored for emerging DURC 
issues. While the proposed Policy for Institutional DURC Oversight did 
not place any periodicity or time requirements for the identification 
of research that meets the scope of the Policy, comments indicated that 
it was not clear whether and how a PI should continue to consider the 
dual use potential of his or her work or whether a PI should ever re-
examine work that has been previously determined by the IRE to not meet 
the definition of DURC. Twelve of the 16 comments addressing this topic 
agreed that some form of ongoing review by the PI and/or the dual use 
review entity was reasonable. However, there were concerns regarding 
the increased burden that ongoing or periodic review would have on 
institutions, in particular the interpretations that this ongoing 
review would involve monitoring in perpetuity all research that meets 
the scope of the Policy. In response to these comments, Section 7.1.A 
of the final Policy includes revisions that require PIs to notify the 
IRE as soon as, (1) his or her research involves one or more of the 
agents or toxins listed in Section 6.2.1; (2) his or her research with 
one or more of the agents or toxins listed in Section 6.2.1 of the 
Policy also produces, aims to produce, or can be reasonably anticipated 
to produce one or more of the seven effects listed in Section 6.2.2 of 
the Policy; or (3) his or her research that is within the scope of 
Section 6.2 of the Policy may meet the definition of DURC (as defined 
in Section 4 of the Policy).

Section 7.2. Responsibilities of USG-Funded Research Institutions

    Section 7.2.B. Section 7.2 of the final Policy details the 
oversight process and the roles and responsibilities of research 
institutions (Federal and non-Federal) that receive USG funds for life 
sciences research and that conduct or sponsor research with any of the 
15 agents or toxins listed in Section 6.2.1 of the final Policy. Public 
comment was requested on ways to optimize the relationship between the 
March 2012 DURC Policy and the proposed Policy for Institutional DURC 
Oversight. Nine comments were received related to the requirements in 
both policies to review research for DURC potential and develop and 
implement risk mitigation plans for any identified DURC. Four of these 
comments noted the potential for duplicate reviews for research that is 
found to be DURC by both the IRE (per the final Policy for 
Institutional DURC Oversight) and the Federal funding agency (per the 
March 2012 DURC Policy). Likewise, four of these comments noted that 
both policies require the development of risk mitigation plans for any 
identified DURC and that this could lead to a single DURC project with 
two risk mitigation plans.
    In an effort to reduce burden for the implementing institutions, 
the final Policy includes revisions that indicate that research that 
has already been determined to be DURC under the March 2012 DURC Policy 
and is already being conducted under a risk mitigation plan does not 
require the development of a new risk mitigation plan. In addition, any 
research that has already been determined to be DURC under the March 
2012 DURC Policy, and for which a risk mitigation plan has already been 
developed, is not required to undergo the review steps outlined in 
Sections 7.2.B.i-vi. However, the institutions will remain responsible 
for ensuring that the risk mitigation plan is implemented and kept up-
to-date, that the PIs continue to conduct ongoing assessments of their 
research, and that the risk mitigation plan undergoes annual review by 
the IRE (described below).
    Section 7.2.B.iii of the final Policy includes revisions to clarify 
that the IRE should include the PI in its review activities, as 
appropriate, and that any research that has been determined by an 
institution to be DURC should not be conducted until an approved risk 
mitigation plan has been implemented.
    Section 7.2.B.iv of the final Policy describes the first reporting 
requirement of institutions regarding oversight of DURC: Within 30 
calendar days of the institutional review of the research for DURC 
potential, the institution must notify the USG of any research that 
falls within the scope of 6.2, including whether the research meets or 
does not meet the definition of DURC. Revisions included in the final 
Policy also detail the necessary information to include in this initial 
30-day notification: The grant or contract number related to the 
research (if the research is funded by the USG); the name(s) of PI(s); 
the name(s) of the applicable agent(s) listed in Section 6.2.1 of the 
Policy; and a description of why the research is deemed to produce one 
or more of the experimental effects listed in Section 6.2.2 of the 
Policy. For research that is

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determined by the IRE to meet the definition of DURC, the notification 
should also include: The name of the investigator (if different from 
the PI) responsible for the performance of the DURC; and a description 
of the IRE's basis for its determination.
    Section 7.2.B.v-vi. These sections of the final Policy regard the 
institution working together with the USG funding agency to develop a 
risk mitigation plan for research that has been determined by the 
institution to be DURC. In order to clarify this process, the final 
Policy includes revisions that require the institution to submit a 
draft risk mitigation plan to the USG funding agency within 90 calendar 
days of the IRE's determination that the research is DURC. In turn, the 
USG funding agency is required to finalize and approve the risk 
mitigation plan within 60 calendar days of receipt of the draft plan.
    Section 7.2.B.viii-ix. In order to clarify and streamline the 
requirements for periodic review by IREs of the risk mitigation plans 
developed in response to determinations of DURC, the final Policy for 
Institutional DURC Oversight includes revisions that require IREs to 
review, at least annually, all active risk mitigation plans and modify 
them, as needed. This annual review should apply to all risk mitigation 
plans for DURC taking place at the institution, regardless of whether 
the DURC was identified per the final Policy for Institutional DURC 
Oversight or the March 2012 DURC Policy. The review of risk mitigation 
plans would likely include a review of the DURC itself, and may result 
in a change in the DURC status of the research (e.g., the research no 
longer meets the definition of DURC). Therefore, the final Policy also 
includes revisions that require IREs to notify, within 30 calendar 
days, the appropriate USG agency of any change in the status of a DURC-
designated project at the institution, and details of any changes to 
risk mitigation plans, which need to be approved by the funding agency.
    Review of research proposals. Thirteen comments were received in 
response to the request for feedback on whether research institutions 
should review life sciences research proposals for DURC issues prior to 
their submission to a funding agency. Eight of the comments noted that 
fewer proposals are funded than are submitted, and thus a requirement 
for institutional reviews of proposals before funding is secured could 
result in a waste in effort and an unnecessary burden upon the 
institution.
    In response to these comments, references to the institutional or 
IRE review of research proposals for DURC concerns prior to submission 
to a funding agency have been removed. However, it should be noted that 
institutions that conduct Federally-funded life sciences research are 
required, at the time of application for USG funds for life sciences 
research, to provide certification to the USG funding agency or 
agencies that the institution is in full compliance with all aspects of 
the Policy or will be at the time the research is initiated. In 
addition, the Policy for Institutional DURC Oversight requires PIs to 
identify any and all research involving one or more of the 15 listed 
agents and refer such research to the IRE, along with the PIs 
assessment of the applicability of the listed experimental effects. 
Thus, institutions will have a process in place for reviewing research 
for dual use concerns before the research is initiated, and this review 
must be done by the time this research begins.
    Comments on the proposed Policy also indicated that guidance was 
needed for institutions and IREs to meet the review and reporting 
requirements set forth in Section 7.2.B. To assist institutions and 
their IREs, Section C of the Companion Guide contains more information 
on the reporting requirements for institutions with respect to findings 
of DURC. Also, Section D of the Companion Guide contains guidance and 
tools to assist IRE's in the drafting of risk mitigation plans for 
DURC.
    Section 7.2.D. The proposed Policy for Institutional DURC Oversight 
described the role of an Institutional Contact for Dual Use Research 
(ICDUR), who is designated by the institution to serve as a point of 
contact for questions regarding compliance with and implementation of 
the requirements for the oversight of research that falls within the 
scope of and/or meets the definition of DURC. When questions arise 
regarding compliance or implementation of the final Policy or the March 
2012 DURC Policy, the assessment of DURC, or the development of risk 
mitigation plans, the ICDUR also serves as the liaison (as necessary) 
between the institution and the relevant program officers at the 
Federal agencies.
    Comments were solicited regarding the feasibility of a single 
individual serving in the capacity of the ICDUR. Nine of the thirteen 
comments were supportive of the ICDUR's role, with two comments voicing 
concerns about the expertise and training needed for performing the 
role of the ICDUR. Based on the comments received concerning the role 
and expertise of the ICDUR, the final Policy clarifies that the ICDUR 
is not expected to be able to answer all DURC-related questions, but 
rather would serve as the institutional point of contact for questions 
and would ensure that all questions are adequately addressed by the 
appropriate subject matter experts. Furthermore, it is at the 
discretion of the institution to decide whether the position of ICDUR 
should be a new full-time position or whether the responsibilities of 
the ICDUR should be assigned to an extant institutional staff member or 
official.
    Section 7.2.E. The final Policy for Institutional DURC Oversight 
details the responsibility of institutions subject to the Policy to 
establish an IRE, describes the range of mechanisms available to 
institutions in meeting this requirement, and details the required 
attributes of an IRE. Comments were requested on how DURC oversight 
could be usefully integrated with other existing institutional 
oversight processes in order to reduce duplication and burdens on 
institutions, as well as the feasibility, benefits, and limitations of 
using an institution's Institutional Biosafety Committee (IBC) to 
conduct the DURC institutional review process.
    Twelve of the nineteen comments received on the topic of utilizing 
extant IBCs for dual use reviews posited that integration of DURC 
review with existing IBC processes would be less of a burden for the 
institution than establishing a new entity for the sole purpose of 
conducting DURC reviews. These institutions noted that, because some 
IBCs already conduct some form of review for dual use concerns, they 
are familiar with the concept already. In addition, the commenting 
institutions noted that using an extant body would eliminate a 
duplicative process of standing up yet another entity for a similar 
submission and review process. A few (four) of the respondents either 
opposed the use of the IBC for DURC review or requested more 
information on the process. These comments described potential 
challenges to using the IBC for dual use reviews, including that review 
of research for dual use concerns would be an entirely new role for the 
IBC and that committee members may not have the expertise to conduct 
such reviews. Also, the time required to review research projects could 
increase significantly for IBCs, reducing the efficiency of both the 
recombinant DNA and dual use reviews. Many comments were also concerned 
with the ability of IREs to recognize and assess the risks associated 
with DURC. A few comments noted that institutions may not have the 
expertise required to identify DURC and that the consistency of DURC 
reviews

[[Page 57595]]

among institutions may vary considerably. Other comments requested more 
guidance and tools for the institution and its IRE to assist in the 
review and oversight processes.
    To address the comments and concerns on the composition and 
expertise of the IRE, the final Policy clarifies that: the IRE is to be 
composed of no fewer than five members; the IRE membership should be 
empowered by the institution to execute the actions listed in Sections 
7.2.B.i-iii, v, and viii, of the final Policy; the IRE should include 
members that understand biosafety and biosecurity considerations; and 
the IRE may include as a member or as a consultant at least one 
individual knowledgeable of the institution's policies and procedures. 
No changes were made regarding the range of mechanisms available to 
institutions in fulfilling the requirement to establish an IRE; the 
final Policy retains the flexibility for institutions to create or 
designate the review entity best suited for their needs, as long as the 
review entity is appropriately constituted (per Section 7.2.E.ii-iv) to 
meet the requirements of the final Policy. In addition, guidance on the 
establishment of an IRE has been provided in the Companion Guide and 
training materials have been developed to assist institutions and their 
IREs in implementing the requirements of the final Policy.
    Of note, the final Policy identifies resources for institutions 
with questions regarding DURC reviews or oversight. The final Policy 
describes the USG's responsibility to provide guidance to institutions 
on the sharing of DURC research products and on the communication of 
DURC, as well as convene advisory bodies such as the National Science 
Advisory Board for Biosecurity (NSABB), when necessary, to develop 
recommendations on particularly complex cases of DURC. In addition, per 
Section 8.B, institutions may, with the participation of the designated 
ICDUR, consult with the USG department or agency that is funding the 
research (or in the case of non-USG funded research, with the NIH or 
with the USG funding agency designated by the NIH) for advice on 
matters related to DURC.
    Section 7.2.F. Retention of records. The proposed Policy for 
Institutional DURC Oversight required institutions to maintain records 
of institutional DURC reviews, risk mitigation plans, and personnel 
training on dual use research for three years. Comments were solicited 
regarding the appropriate amount of time that institutions should be 
required to retain such records. Twelve comments were received on this 
topic. Nine recommended that records be retained for or beyond the 
period of time of the research grant or contract. Five of the comments 
indicated that records should be retained, at a minimum, for the length 
of the grant or contract period and then three additional years 
following project termination or completion. Two comments indicated 
that indefinite records retention was too burdensome for institutions. 
The comments also indicated that while research institutions may have 
different records retention requirements, these requirements are 
generally record-specific; that is, each type of record may have its 
own retention schedule and requirement. Three comments considered the 
records retention requirements of the Policy for Institutional DURC 
Oversight to be repetitive and unnecessary considering that the 
laboratories conducting research subject to the Policy for 
Institutional DURC Oversight are also complying with biological select 
agents and toxins (BSAT) related record-keeping requirements, 
Occupational Safety and Health Administration regulations, 
Environmental Protection Agency regulations, and biosafety-related 
requirements--some of which have record retention requirements that 
exceed the length of time indicated in the proposed Policy. These 
comments recommended that the USG harmonize the recordkeeping 
requirements.
    The final Policy includes revisions that require institutions to 
maintain records of institutional DURC reviews and completed risk 
mitigation plans for the term of the research grant or contract plus 
three years after its completion, but no less than eight years, unless 
a shorter period is required by law or regulation. This revision 
accommodates the period of performance for most life sciences research 
grants and contracts.
    Section 7.2.H. The final Policy for Institutional DURC Oversight 
includes revisions to clarify that it is the institution, not the IRE, 
that is responsible for institutional compliance with the final Policy. 
While institutions are required to empower their IRE to execute the 
requirements listed in Section 7.2.B.i-iii, v, and viii, the 
responsibility to ensure compliance with the final Policy and with 
approved risk mitigation plans, as well as report instances of non-
compliance, rests with the institution. The final Policy incorporates 
revisions to clarify these points. As noted earlier, language regarding 
compliance with the final Policy has been moved to a new section 
(Section 6.3).
    Section 7.2.K. Accessibility of Institutional Review Procedures. 
The proposed Policy for Institutional DURC Oversight required IREs to 
make their procedures for reviewing life sciences research for dual use 
potential accessible to the public. Further, it stipulated that the 
posted policies of the institution should include an overview of the 
institution's procedures or review process, but should not include 
details of particular cases or the minutes of the DURC review entity's 
proceedings. The final Policy includes revisions to clarify that 
institutions should make documentation of their DURC review process 
available to the public upon request, as consistent with applicable 
law. In addition, the final Policy has been updated to indicate that 
the provision of DURC review procedures is an institutional 
responsibility that may be delegated to IREs.
    7.2.L. Certification of compliance. The proposed Policy for 
Institutional DURC Oversight required institutions to provide, on an 
annual basis, a formal assurance to the appropriate Federal funding 
agency or agencies that the institution is in compliance with all 
aspects of the Policy. Two comments addressed the process for providing 
institutional assurances of compliance with the Policy. Suggestions for 
reducing burden associated with providing assurances included 
lengthening the period of time between assurances and allowing 
institutions to file a single assurance with a single entity (as is the 
case for the Common Rule) rather than requiring institutions to provide 
an assurance to each Federal funding agency that they work with.
    The final Policy contains revisions clarifying that certification 
of compliance must be provided by an institution at the time of seeking 
funding for life sciences research, but no sooner than the effective 
date of the final Policy. Each USG funding agency will be implementing 
the certification requirement for applicants and grantees according to 
their own agency policies. More information and guidance on meeting the 
institutional requirement to provide certification of compliance with 
the Policy for Institutional DURC Oversight can be obtained in the 
grants and contracting policies of the funding agency.

Notes at the End of 7.2

    DURC research at multiple institutions. The proposed Policy for 
Institutional DURC Oversight noted that there will be situations where 
a PI is conducting potential DURC at multiple institutions and proposed 
that it should be the purview of each institution to

[[Page 57596]]

review these projects and, if appropriate, develop and implement a risk 
mitigation plan. Examples of DURC projects involving more than one 
institution include cases where the DURC is a collaboration between PIs 
at different institutions or when the DURC is undertaken by a single PI 
who maintains laboratories at more than one institution. Comments were 
requested regarding whether each institution participating in a multi-
site DURC project should have oversight of their portion of the 
projects and, if DURC is being conducted at their institution, develop 
and implement their own risk mitigation plans, or whether the primary 
institution should have the responsibility for meeting the requirements 
for oversight of DURC.
    Twelve comments were received related to the oversight of DURC 
taking place at multiple institutions. Seven of the comments expressed 
the view that each institution conducting DURC should be responsible 
for the assessment of its research for DURC potential, and, in cases 
where DURC is determined, develop and implement a risk mitigation plan. 
Comments differed, however, on how institutions should work together to 
coordinate the oversight responsibilities of the DURC. Two comments 
suggested that in cases of multiple PIs (and their institutions) 
collaborating on a single DURC project, the institutions of the 
collaborating investigators should report any findings of DURC to a 
single, primary institution. Conversely, another comment stated that 
DURC assessment should be a responsibility of the primary or lead 
institution in the DURC collaboration, but that the individual 
collaborating institutions should be responsible for risk mitigation 
plan development and implementation of their portion of the project. 
Some (five) of the comments were concerned with how differences in 
institutional DURC assessments and mitigation plans should be handled, 
how these differences are arbitrated, and how the risk mitigation 
plan(s) should be implemented in cases of differing institutional 
resources and capabilities.
    The oversight of research that falls within the scope and 
applicability of the final Policy should be consistent, regardless of 
whether the research is undertaken by a single investigator at a single 
institution, by a single investigator holding multiple research 
positions at different institutions, or by multiple investigators 
collaborating across institutions. When DURC research is undertaken at 
multiple institutions, these institutions should work together to 
ensure that DURC oversight, including the DURC reviews and any 
resulting risk mitigation plans, is implemented consistently across the 
collaborating entities. Consequently, in the final Policy, the note at 
the conclusion of Section 7.2 includes revisions to clarify that in the 
case of DURC collaborations involving multiple institutions, the 
primary institution (i.e., the institution in receipt of the grant or 
contract from the USG funding agency) is responsible for notifying the 
funding agency of research that falls within the scope of the Policy 
and, if that research is determined to be DURC, providing copies of 
each collaborating institution's risk mitigation plan. Furthermore, the 
primary institution should ensure that DURC oversight is consistently 
applied by all entities participating in the collaboration.
    The final Policy includes an additional note in this section 
regarding cases in which a Federal department or agency simply passes 
through funding from another Federal department or agency to support 
life sciences research at an institution that conducts or sponsors 
research involving any of the agents listed in Section 6.2.1. In such 
cases, the agency originally providing the funding shall be considered 
the USG funding agency, and the ultimate recipient of the funds shall 
be considered the institution, and respectively shall fulfill the 
requirements expected of each under this Policy.

Section 7.3. Responsibilities of USG Funding Agencies

    In order to facilitate timely finalization of risk mitigation plans 
drafted by the IRE (per Section 7.2.B.v) and submitted by institutions 
(per Section 7.2.B.vi), the final Policy for Institutional DURC 
Oversight requires the appropriate USG agencies to provide an initial 
response to institutions within 30 calendar days and finalize the plan 
within 60 calendar days of receipt of the draft plan. This change is, 
in part, due to two comments received that suggested a specified time 
frame for USG funding agencies to respond.

Section 8. Resources for Institutional Oversight of DURC

    The final Policy contains no revisions to Section 8. However, as 
referenced in Section III of this Notice, Section 8.A of the Policy 
describes an implementation guide (i.e., a ``compendium of tools'') for 
use with both the Policy for Institutional DURC Oversight and the March 
2012 DURC Policy. Comments were requested on the sufficiency of the 
tools and guidance material, and approximately one-third of the 26 
comments received indicated the list to be sufficient. However, many 
more comments included suggestions of additional tools and how tools 
should be developed. These suggestions include provision of real or 
hypothetical case studies illustrating the DURC assessment process, 
provision of example or template risk mitigation plans, and additional 
guidance for interpreting the seven experimental effects enumerated in 
the Policy. Comments received in response to the proposed Policy were 
helpful in developing and revising the guide's components, including: A 
tool to assist PIs and IREs in assessing the applicability of the 
listed experimental effects; points to consider in the assessment of 
risks and benefits; guidance on developing a risk mitigation plan for 
IRE-identified DURC; and guidance regarding the responsible 
communication of DURC.
    The compendium of implementation tools is titled Tools for the 
Identification, Assessment, Management, and Responsible Communication 
of Dual Use Research of Concern: Companion Guide to the USG Policies 
for Oversight of Life Sciences Dual Use Research of Concern (Companion 
Guide), and is posted on the U.S. Department of Health and Human 
Services Science Safety Security (S3) Web site: http://www.phe.gov/s3/dualuse. Use of the Companion Guide by PIs, institutions, and 
Institutional Review Entities (IREs) is, however, not a requirement of 
the Policy for Institutional DURC Oversight or the March 2012 DURC 
Policy.

Cristin A. Dorgelo,
Chief of Staff, Office of Science and Technology Policy.
[FR Doc. 2014-22770 Filed 9-24-14; 8:45 am]
BILLING CODE 3270-F4-P