81_FR_24578 81 FR 24498 - Environmental Protection Agency Acquisition Regulation; Institutional Oversight of Life Sciences Dual Use Research of Concern

81 FR 24498 - Environmental Protection Agency Acquisition Regulation; Institutional Oversight of Life Sciences Dual Use Research of Concern

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 80 (April 26, 2016)

Page Range24498-24500
FR Document2016-09601

The Environmental Protection Agency (EPA) is issuing a direct final rule to amend the EPA Acquisition Regulation (EPAAR) to include a new solicitation provision and contract clause to implement the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (iDURC Policy). This direct final rule requires certain domestic institutions that receive contract funding from EPA to conduct or sponsor life sciences research and institutions outside of the United States that receive contract funding from EPA to conduct or sponsor research with the agents or toxins listed in the iDURC Policy, to review and communicate their research responsibly in accordance with the iDURC Policy.

Federal Register, Volume 81 Issue 80 (Tuesday, April 26, 2016)
[Federal Register Volume 81, Number 80 (Tuesday, April 26, 2016)]
[Rules and Regulations]
[Pages 24498-24500]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09601]



[[Page 24498]]

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ENVIRONMENTAL PROTECTION AGENCY

48 CFR Parts 1535 and 1552

[EPA-HQ-OARM-2016-0046; FRL 9941-86-OARM]


Environmental Protection Agency Acquisition Regulation; 
Institutional Oversight of Life Sciences Dual Use Research of Concern

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is issuing a direct 
final rule to amend the EPA Acquisition Regulation (EPAAR) to include a 
new solicitation provision and contract clause to implement the United 
States Government Policy for Institutional Oversight of Life Sciences 
Dual Use Research of Concern (iDURC Policy). This direct final rule 
requires certain domestic institutions that receive contract funding 
from EPA to conduct or sponsor life sciences research and institutions 
outside of the United States that receive contract funding from EPA to 
conduct or sponsor research with the agents or toxins listed in the 
iDURC Policy, to review and communicate their research responsibly in 
accordance with the iDURC Policy.

DATES: This rule is effective on June 27, 2016 without further notice, 
unless EPA receives adverse comment by May 26, 2016. If EPA receives 
adverse comment, we will publish a timely withdrawal in the Federal 
Register informing the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OARM-2016-0046; FRL 9941-86-OARM at http://www.regulations.gov. Follow 
the online instructions for submitting comments. Once submitted, 
comments cannot be edited or removed from Regulations.gov. The EPA may 
publish any comment received to its public docket. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. Multimedia submissions (audio, video, etc.) must be 
accompanied by a written comment. The written comment is considered the 
official comment and should include discussion of all points you wish 
to make. The EPA will generally not consider comments or comment 
contents located outside of the primary submission (i.e. on the web, 
cloud, or other file sharing system). For additional submission 
methods, the full EPA public comment policy, information about CBI or 
multimedia submissions, and general guidance on making effective 
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Holly Hubbell, Policy, Training, and 
Oversight Division (3802R), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-564-
1091; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Direct Final Rule

    EPA is publishing this rule without a prior proposed rule because 
we view this as a noncontroversial action and anticipate no adverse 
comment as this final rule amends the EPAAR to add a new solicitation 
provision and contract clause for iDURC Policy compliance. The iDURC 
policy was already published in the Federal Register for comment on 
September 25, 2014. If EPA receives adverse comment, we will publish a 
timely withdrawal in the Federal Register informing the public that the 
rule will not take effect. Any parties interested in commenting must do 
so at this time.

II. Applicability

    The EPA is promulgating a solicitation provision and contract 
clause to implement the iDURC Policy. The solicitation provision and 
contract clause notify institutions of the need to comply, and to 
ensure that institutions subject to the iDURC Policy represent that 
they shall comply with the iDURC Policy prior to or upon contract 
award. Institutions within the United States that receive funding from 
EPA to conduct or sponsor life sciences research are subject to the 
iDURC Policy if they conduct or sponsor research involving any of the 
agents or toxins listed in the iDURC Policy, regardless of the funding 
source. Institutions outside of the United States are subject to the 
iDURC Policy if they receive funding from EPA to conduct or sponsor 
research with any agents or toxins listed in the iDURC Policy. 
Institutions that are subject to the iDURC Policy have a number of 
responsibilities--at a minimum, they are advised to train laboratory 
personnel involved in such projects and maintain records of that 
training, establish an institutional review process to assess the 
research for its potential to meet the definition of dual use research 
of concern, and if it meets the definition, ensure the research is 
conducted and communicated responsibly.

III. Submitting Comments

    A. Do not submit CBI to EPA through the Web site http://www.regulations.gov or by email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI, and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    B. Tips for Preparing Your Comments. When submitting comments, see 
the commenting tips at: http://www2.epa.gov/dockets/commenting-epa-dockets and remember to:
     Identify the rulemaking by docket number and other 
identifying information (subject heading, Federal Register date and 
page number).
     Follow directions--The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) Part or section number.
     Explain why you agree or disagree, suggest alternatives, 
and substitute language for your requested changes.
     Describe any assumptions and provide any technical 
information and/or data that you used.
     If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
     Provide specific examples to illustrate your concerns, and 
suggest alternatives.
     Explain your views as clearly as possible, avoiding the 
use of profanity or personal threats.
    C. Make sure to submit your comments by the comment period deadline 
identified.

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' under the 
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and 
is therefore not subject to review under the EO 12866 and 13563 (76 FR 
3821, January 21, 2011).

[[Page 24499]]

B. Paperwork Reduction Act

    The information collection activities in this rule have been 
submitted for approval to the Office of Management and Budget (OMB) 
under the PRA. The Information Collection Request (ICR) document that 
the EPA prepared has been assigned EPA ICR number 2530.01. You can find 
a copy of the ICR in the docket for this rule, and it is briefly 
summarized here. The information collection requirements are not 
enforceable until OMB approves them.
    The iDURC Policy instructs institutions subject to the Policy train 
individuals within their institution that are conducting research 
involving any of the agents or toxins identified in the Policy. 
Additionally, institutions are to maintain records of that training. 
EPA is submitting an information collection request for these 
recordkeeping requirements. EPA may collect the training records to 
ensure EPA is in compliance with the Policy, and that institutions 
receiving EPA funding are appropriately complying as well. EPA does not 
expect any issues of confidentiality to be relevant to this information 
collection.
    Respondents/affected entities: Private Industry; Federal Government 
(in the form of government-owned/contractor-operated laboratories).
    Respondent's obligation to respond: Mandatory (48 CFR Chapter 15, 
Part 52 and Part 35).
    Estimated number of respondents: 12 to 24.
    Frequency of response: Only once, or as necessary.
    Total estimated burden: 36 to 64 hours per year.
    Total estimated cost: $1,440 to $4,320.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number.

C. Regulatory Flexibility Act (RFA), as Amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et. 
seq.

    This action is not subject to the RFA. The RFA applies only to 
rules subject to notice and comment rulemaking requirements under the 
Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. 
This rule pertains to contracts, which the APA expressly exempts from 
notice and comment rulemaking requirements under 5 U.S.C. 553(a)(2).

D. Unfunded Mandates Reform Act

    This action does not contain any unfunded mandates as described in 
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect 
small governments. The action imposes no enforceable duty on any State, 
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government, as 
specified in Executive Order 13132.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications, as specified in 
Executive Order 13175. No substantial compliance costs are expected. 
There will be no impact on the relationship between the federal 
government and Indian tribes, or on the distribution of power and 
responsibilities between the federal government and Indian tribes. 
Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that concern environmental health or safety risks 
that the EPA has reason to believe may disproportionately affect 
children, per the definition of ``covered regulatory action'' in 
section 2-202 of the Executive Order. This action is not subject to 
Executive Order 13045 because it does not concern an environmental 
health risk or safety risk.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28335 
(May 22, 2001), because it is not a significant regulatory action under 
Executive Order 12866.

I. National Technology Transfer and Advancement Act of 1995 (NTTAA)

    This action does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    EPA has determined that this final rule will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations because it does not 
affect the level of protection provided to human health or the 
environment in the general public.

K. Congressional Review Act

    This action is subject to the CRA, and the EPA will submit a rule 
report to each House of the Congress and to the Comptroller General of 
the United States. This action is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects

48 CFR Part 1535

    Environmental protection, Dual use research, Institutional 
oversight, Life sciences, Research and development.

48 CFR Part 1552

    Environmental protection, Dual use research, Institutional 
oversight, Life sciences, Research and development.

    Dated: April 19, 2016.
John R. Bashista,
Director, Office of Acquisition Management.

    For the reasons stated in the preamble, 48 CFR parts 1535 and 1552 
are amended as set forth below:

PART 1535--RESEARCH AND DEVELOMENT CONTRACTING

0
1. The authority citation for part 1535 continues to read as follows:

    Authority:  Sec. 205(c), 63 Stat. 390, as amended, 40 U.S.C. 
486(c).


0
2. Amend section 1535.007 by adding paragraph (c) to read as follows:


1535.007  Solicitations.

* * * * *
    (c) Contracting officers shall insert 48 CFR 1552.235-81--``Notice 
of Institutional Oversight of Life Sciences Dual Use Research of 
Concern-Representation'' when notified in the Advance Procurement Plan 
(APP) or by an EPA funding/requesting office, in accordance with the 
Institutional Oversight of Life Sciences Dual Use Research of Concern 
(iDURC) EPA Order 1000.19--``Policy and Procedures for Managing Dual 
Use Research of Concern,'' in solicitations that will result in a 
contract under which EPA funding will be used by the recipient to 
conduct or sponsor ``life sciences research''.

0
3. Amend section 1535.007-70 by adding paragraph (h) to read as 
follows:


1535.007-70  Contract clauses.

* * * * *
    (h) Contracting officers shall insert 48 CFR 1552.235-82--
``Institutional

[[Page 24500]]

Oversight of Life Sciences Dual Use Research of Concern'' into all 
solicitations containing 48 CFR 1552.235-81 and in existing contracts 
that are bilaterally modified at the request of an EPA funding/
requesting office in accordance with EPA Order 1000.19.

PART 1552--SOLICITATION PROVISIONS AND CONTRACT CLAUSES

0
4. The authority citation for part 1552 continues to read as follows:

    Authority:  5 U.S.C. 301 as amended, 40 U.S.C. 486(c); and 41 
U.S.C. 418b.


0
5. Add section 1552.235-81 to read as follows:


1552.235-81  Institutional oversight of life Sciences dual use research 
of concern--representation.

    As prescribed in 1535.007(c), insert the following solicitation 
provision:

Institutional Oversight of Life Sciences Dual Use Research of Concern--
Representation (JUNE 2016)

    (a) Definitions. As used in this provision--
    Institution means any government agency (Federal, State, tribal, 
or local), academic institution, corporation, company, partnership, 
society, association, firm, sole proprietorship, or other legal 
entity conducting research.
    Life Sciences research means a systematic investigation designed 
to develop or contribute to generalizable knowledge involving living 
organisms (e.g., microbes, human beings, animals, and plants) and 
their products, including all disciplines and methodologies of 
biology such as aerobiology, agricultural science, plant science, 
animal science, bioinformatics, genomics, proteomics, microbiology, 
synthetic biology, virology, molecular biology, environmental 
science, public health, modeling, engineering of living systems, and 
all applications of the biological sciences. The term is meant to 
encompass the diverse approaches to understanding life at the level 
of ecosystems, populations, organisms, organs, tissues, cells, and 
molecules. Life sciences research does not include routine product 
testing, quality control, mapping, collection of general-purpose 
statistics, routine monitoring and evaluation of an operational 
program, observational studies, and the training of scientific and 
technical personnel.
    (b) Representation. By submission of its offer or quotation, the 
Offeror represents that if it is:
    (1) An institution within the United States that conducts or 
sponsors life sciences research that involves one or more of the 
agents or toxins listed in section 6.2.1 of the ``United States 
Government Policy for Institutional Oversight of Life Sciences Dual 
Use Research of Concern'' (iDURC Policy), even if the research is 
not supported by United States Government funds; or
    (2) An institution outside of the United States that receives 
funds to conduct or sponsor research that involves one or more of 
the agents or toxins listed in section 6.2.1 of the iDURC Policy; 
then the Offeror will comply with the iDURC Policy.
    (c) Resources. Information about dual use research in the life 
sciences, as well as specific details on the iDURC Policy can be 
found on the U.S. Department of Health and Human Services Dual Use 
Research of Concern page: http://www.phe.gov/s3/dualuse/Pages/default.aspx.

    (End of Provision)

0
6. Add 1552.235-82 to read as follows:


1552.235-82  Institutional oversight of life sciences dual use research 
of concern.

    As prescribed in 1535.007-70(h), insert the following contract 
clause:

Institutional Oversight Of Life Sciences Dual Use Research Of Concern 
(JUNE 2016)

    (a) Definitions. As used in this clause--
    Institution means any government agency (Federal, State, tribal, 
or local), academic institution, corporation, company, partnership, 
society, association, firm, sole proprietorship, or other legal 
entity conducting research.
    Life Sciences research means a systematic investigation designed 
to develop or contribute to generalizable knowledge involving living 
organisms (e.g., microbes, human beings, animals, and plants) and 
their products, including all disciplines and methodologies of 
biology such as aerobiology, agricultural science, plant science, 
animal science, bioinformatics, genomics, proteomics, microbiology, 
synthetic biology, virology, molecular biology, environmental 
science, public health, modeling, engineering of living systems, and 
all applications of the biological sciences. The term is meant to 
encompass the diverse approaches to understanding life at the level 
of ecosystems, populations, organisms, organs, tissues, cells, and 
molecules. Life sciences research does not include routine product 
testing, quality control, mapping, collection of general-purpose 
statistics, routine monitoring and evaluation of an operational 
program, observational studies, and the training of scientific and 
technical personnel.
    (b) Compliance. The Contractor agrees that it shall comply with 
the ``United States Government Policy for Institutional Oversight of 
Life Sciences Dual Use Research of Concern'' (iDURC Policy) during 
the period of performance of this contract, including all option 
periods or other extensions, if the Contractor:
    (1) Is an institution within the United States that conducts or 
sponsors, or begins to conduct or sponsor life sciences research 
that involves one or more of the agents or toxins listed in Section 
6.2.1 of the iDURC Policy, even if the research is not supported by 
United States Government funds; or
    (2) Is an institution outside the United States that receives 
funds through this contract to conduct or sponsor research that 
involves one or more of the agents or toxins listed in Section 6.2.1 
of the iDURC Policy.
    (c) Resources. Information about dual use research in the life 
sciences as well as specific details on the iDURC Policy can be 
found on the U.S. Department of Health and Human Services Dual Use 
Research of Concern page: http://www.phe.gov/s3/dualuse/Pages/default.aspx.

    (End of clause)

[FR Doc. 2016-09601 Filed 4-25-16; 8:45 am]
 BILLING CODE 6560-50-P



                                                  24498               Federal Register / Vol. 81, No. 80 / Tuesday, April 26, 2016 / Rules and Regulations

                                                  ENVIRONMENTAL PROTECTION                                information about CBI or multimedia                   III. Submitting Comments
                                                  AGENCY                                                  submissions, and general guidance on                     A. Do not submit CBI to EPA through
                                                                                                          making effective comments, please visit               the Web site http://www.regulations.gov
                                                  48 CFR Parts 1535 and 1552                              http://www2.epa.gov/dockets/                          or by email. Clearly mark the part or all
                                                  [EPA–HQ–OARM–2016–0046; FRL 9941–86–                    commenting-epa-dockets.                               of the information that you claim to be
                                                  OARM]                                                   FOR FURTHER INFORMATION CONTACT:                      CBI. For CBI information in a disk or
                                                                                                          Holly Hubbell, Policy, Training, and                  CD–ROM that you mail to EPA, mark
                                                  Environmental Protection Agency                         Oversight Division (3802R),                           the outside of the disk or CD–ROM as
                                                  Acquisition Regulation; Institutional                   Environmental Protection Agency, 1200                 CBI, and then identify electronically
                                                  Oversight of Life Sciences Dual Use                     Pennsylvania Ave. NW., Washington,                    within the disk or CD–ROM the specific
                                                  Research of Concern                                     DC 20460; telephone number: 202–564–                  information that is claimed as CBI. In
                                                  AGENCY: Environmental Protection                        1091; email address: Hubbell.holly@                   addition to one complete version of the
                                                  Agency (EPA).                                           epa.gov.                                              comment that includes information
                                                  ACTION: Direct final rule.                              SUPPLEMENTARY INFORMATION:                            claimed as CBI, a copy of the comment
                                                                                                                                                                that does not contain the information
                                                  SUMMARY:   The Environmental Protection                 I. Direct Final Rule                                  claimed as CBI must be submitted for
                                                  Agency (EPA) is issuing a direct final                     EPA is publishing this rule without a              inclusion in the public docket.
                                                  rule to amend the EPA Acquisition                       prior proposed rule because we view                   Information so marked will not be
                                                  Regulation (EPAAR) to include a new                     this as a noncontroversial action and                 disclosed except in accordance with
                                                  solicitation provision and contract                     anticipate no adverse comment as this                 procedures set forth in 40 CFR part 2.
                                                  clause to implement the United States                   final rule amends the EPAAR to add a                     B. Tips for Preparing Your Comments.
                                                  Government Policy for Institutional                     new solicitation provision and contract               When submitting comments, see the
                                                  Oversight of Life Sciences Dual Use                     clause for iDURC Policy compliance.                   commenting tips at: http://www2.epa.
                                                  Research of Concern (iDURC Policy).                     The iDURC policy was already                          gov/dockets/commenting-epa-dockets
                                                  This direct final rule requires certain                 published in the Federal Register for                 and remember to:
                                                  domestic institutions that receive                      comment on September 25, 2014. If EPA                    • Identify the rulemaking by docket
                                                  contract funding from EPA to conduct                    receives adverse comment, we will                     number and other identifying
                                                  or sponsor life sciences research and                   publish a timely withdrawal in the                    information (subject heading, Federal
                                                  institutions outside of the United States               Federal Register informing the public                 Register date and page number).
                                                  that receive contract funding from EPA                  that the rule will not take effect. Any                  • Follow directions—The Agency
                                                  to conduct or sponsor research with the                 parties interested in commenting must                 may ask you to respond to specific
                                                  agents or toxins listed in the iDURC                    do so at this time.                                   questions or organize comments by
                                                  Policy, to review and communicate their                                                                       referencing a Code of Federal
                                                  research responsibly in accordance with                 II. Applicability                                     Regulations (CFR) Part or section
                                                  the iDURC Policy.                                          The EPA is promulgating a                          number.
                                                  DATES: This rule is effective on June 27,               solicitation provision and contract                      • Explain why you agree or disagree,
                                                  2016 without further notice, unless EPA                 clause to implement the iDURC Policy.                 suggest alternatives, and substitute
                                                  receives adverse comment by May 26,                     The solicitation provision and contract               language for your requested changes.
                                                  2016. If EPA receives adverse comment,                  clause notify institutions of the need to                • Describe any assumptions and
                                                  we will publish a timely withdrawal in                  comply, and to ensure that institutions               provide any technical information and/
                                                  the Federal Register informing the                      subject to the iDURC Policy represent                 or data that you used.
                                                  public that the rule will not take effect.              that they shall comply with the iDURC                    • If you estimate potential costs or
                                                  ADDRESSES: Submit your comments,                        Policy prior to or upon contract award.               burdens, explain how you arrived at
                                                  identified by Docket ID No. EPA–HQ–                     Institutions within the United States                 your estimate in sufficient detail to
                                                  OARM–2016–0046; FRL 9941–86–                            that receive funding from EPA to                      allow for it to be reproduced.
                                                  OARM at http://www.regulations.gov.                     conduct or sponsor life sciences                         • Provide specific examples to
                                                  Follow the online instructions for                      research are subject to the iDURC Policy              illustrate your concerns, and suggest
                                                  submitting comments. Once submitted,                    if they conduct or sponsor research                   alternatives.
                                                  comments cannot be edited or removed                    involving any of the agents or toxins                    • Explain your views as clearly as
                                                  from Regulations.gov. The EPA may                       listed in the iDURC Policy, regardless of             possible, avoiding the use of profanity
                                                  publish any comment received to its                     the funding source. Institutions outside              or personal threats.
                                                  public docket. Do not submit                            of the United States are subject to the                  C. Make sure to submit your
                                                  electronically any information you                      iDURC Policy if they receive funding                  comments by the comment period
                                                  consider to be Confidential Business                    from EPA to conduct or sponsor                        deadline identified.
                                                  Information (CBI) or other information                  research with any agents or toxins listed             IV. Statutory and Executive Order
                                                  whose disclosure is restricted by statute.              in the iDURC Policy. Institutions that                Reviews
                                                  Multimedia submissions (audio, video,                   are subject to the iDURC Policy have a
                                                  etc.) must be accompanied by a written                  number of responsibilities—at a                       A. Executive Order 12866: Regulatory
                                                  comment. The written comment is                         minimum, they are advised to train                    Planning and Review and Executive
                                                  considered the official comment and                     laboratory personnel involved in such                 Order 13563: Improving Regulation and
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  should include discussion of all points                 projects and maintain records of that                 Regulatory Review
                                                  you wish to make. The EPA will                          training, establish an institutional                    This action is not a ‘‘significant
                                                  generally not consider comments or                      review process to assess the research for             regulatory action’’ under the terms of
                                                  comment contents located outside of the                 its potential to meet the definition of               Executive Order (EO) 12866 (58 FR
                                                  primary submission (i.e. on the web,                    dual use research of concern, and if it               51735, October 4, 1993) and is therefore
                                                  cloud, or other file sharing system). For               meets the definition, ensure the research             not subject to review under the EO
                                                  additional submission methods, the full                 is conducted and communicated                         12866 and 13563 (76 FR 3821, January
                                                  EPA public comment policy,                              responsibly.                                          21, 2011).


                                             VerDate Sep<11>2014   17:40 Apr 25, 2016   Jkt 238001   PO 00000   Frm 00044   Fmt 4700   Sfmt 4700   E:\FR\FM\26APR1.SGM   26APR1


                                                                      Federal Register / Vol. 81, No. 80 / Tuesday, April 26, 2016 / Rules and Regulations                                            24499

                                                  B. Paperwork Reduction Act                              UMRA, 2 U.S.C. 1531–1538, and does                    environmental effects on minority or
                                                     The information collection activities                not significantly or uniquely affect small            low-income populations because it does
                                                  in this rule have been submitted for                    governments. The action imposes no                    not affect the level of protection
                                                  approval to the Office of Management                    enforceable duty on any State, local or               provided to human health or the
                                                  and Budget (OMB) under the PRA. The                     tribal governments or the private sector.             environment in the general public.
                                                  Information Collection Request (ICR)                    E. Executive Order 13132: Federalism                  K. Congressional Review Act
                                                  document that the EPA prepared has
                                                                                                            This action does not have federalism                  This action is subject to the CRA, and
                                                  been assigned EPA ICR number 2530.01.
                                                                                                          implications. It will not have substantial            the EPA will submit a rule report to
                                                  You can find a copy of the ICR in the
                                                                                                          direct effects on the States, on the                  each House of the Congress and to the
                                                  docket for this rule, and it is briefly
                                                                                                          relationship between the national                     Comptroller General of the United
                                                  summarized here. The information
                                                                                                          government and the States, or on the                  States. This action is not a ‘‘major rule’’
                                                  collection requirements are not
                                                                                                          distribution of power and                             as defined by 5 U.S.C. 804(2).
                                                  enforceable until OMB approves them.
                                                                                                          responsibilities among the various
                                                     The iDURC Policy instructs                                                                                 List of Subjects
                                                                                                          levels of government, as specified in
                                                  institutions subject to the Policy train
                                                                                                          Executive Order 13132.                                48 CFR Part 1535
                                                  individuals within their institution that
                                                  are conducting research involving any                   F. Executive Order 13175: Consultation                  Environmental protection, Dual use
                                                  of the agents or toxins identified in the               and Coordination With Indian Tribal                   research, Institutional oversight, Life
                                                  Policy. Additionally, institutions are to               Governments                                           sciences, Research and development.
                                                  maintain records of that training. EPA is                 This action does not have tribal                    48 CFR Part 1552
                                                  submitting an information collection                    implications, as specified in Executive
                                                  request for these recordkeeping                                                                                 Environmental protection, Dual use
                                                                                                          Order 13175. No substantial compliance                research, Institutional oversight, Life
                                                  requirements. EPA may collect the                       costs are expected. There will be no
                                                  training records to ensure EPA is in                                                                          sciences, Research and development.
                                                                                                          impact on the relationship between the
                                                  compliance with the Policy, and that                    federal government and Indian tribes, or                Dated: April 19, 2016.
                                                  institutions receiving EPA funding are                  on the distribution of power and                      John R. Bashista,
                                                  appropriately complying as well. EPA                    responsibilities between the federal                  Director, Office of Acquisition Management.
                                                  does not expect any issues of                           government and Indian tribes. Thus,
                                                  confidentiality to be relevant to this                                                                          For the reasons stated in the
                                                                                                          Executive Order 13175 does not apply                  preamble, 48 CFR parts 1535 and 1552
                                                  information collection.                                 to this action.
                                                     Respondents/affected entities: Private                                                                     are amended as set forth below:
                                                  Industry; Federal Government (in the                    G. Executive Order 13045: Protection of
                                                                                                          Children From Environmental Health                    PART 1535—RESEARCH AND
                                                  form of government-owned/contractor-
                                                                                                          and Safety Risks                                      DEVELOMENT CONTRACTING
                                                  operated laboratories).
                                                     Respondent’s obligation to respond:                    The EPA interprets Executive Order                  ■ 1. The authority citation for part 1535
                                                  Mandatory (48 CFR Chapter 15, Part 52                   13045 as applying only to those                       continues to read as follows:
                                                  and Part 35).                                           regulatory actions that concern                         Authority: Sec. 205(c), 63 Stat. 390, as
                                                     Estimated number of respondents: 12                  environmental health or safety risks that             amended, 40 U.S.C. 486(c).
                                                  to 24.                                                  the EPA has reason to believe may
                                                     Frequency of response: Only once, or                 disproportionately affect children, per               ■ 2. Amend section 1535.007 by adding
                                                  as necessary.                                           the definition of ‘‘covered regulatory                paragraph (c) to read as follows:
                                                     Total estimated burden: 36 to 64                     action’’ in section 2–202 of the
                                                  hours per year.                                                                                               1535.007    Solicitations.
                                                                                                          Executive Order. This action is not
                                                     Total estimated cost: $1,440 to $4,320.              subject to Executive Order 13045                      *     *     *     *     *
                                                     An agency may not conduct or                         because it does not concern an                          (c) Contracting officers shall insert 48
                                                  sponsor, and a person is not required to                environmental health risk or safety risk.             CFR 1552.235–81—‘‘Notice of
                                                  respond to, a collection of information                                                                       Institutional Oversight of Life Sciences
                                                  unless it displays a currently valid OMB                H. Executive Order 13211: Actions That                Dual Use Research of Concern-
                                                  control number.                                         Significantly Affect Energy Supply,                   Representation’’ when notified in the
                                                                                                          Distribution, or Use                                  Advance Procurement Plan (APP) or by
                                                  C. Regulatory Flexibility Act (RFA), as                                                                       an EPA funding/requesting office, in
                                                  Amended by the Small Business                             This action is not subject to Executive
                                                                                                          Order 13211 (66 FR 28335 (May 22,                     accordance with the Institutional
                                                  Regulatory Enforcement Fairness Act of                                                                        Oversight of Life Sciences Dual Use
                                                  1996 (SBREFA), 5 U.S.C. 601 et. seq.                    2001), because it is not a significant
                                                                                                          regulatory action under Executive Order               Research of Concern (iDURC) EPA
                                                    This action is not subject to the RFA.                12866.                                                Order 1000.19—‘‘Policy and Procedures
                                                  The RFA applies only to rules subject to                                                                      for Managing Dual Use Research of
                                                  notice and comment rulemaking                           I. National Technology Transfer and                   Concern,’’ in solicitations that will
                                                  requirements under the Administrative                   Advancement Act of 1995 (NTTAA)                       result in a contract under which EPA
                                                  Procedure Act (APA), 5 U.S.C. 553, or                     This action does not involve technical              funding will be used by the recipient to
                                                  any other statute. This rule pertains to                standards.                                            conduct or sponsor ‘‘life sciences
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                                                  contracts, which the APA expressly                                                                            research’’.
                                                                                                          J. Executive Order 12898: Federal
                                                  exempts from notice and comment                                                                               ■ 3. Amend section 1535.007–70 by
                                                                                                          Actions To Address Environmental
                                                  rulemaking requirements under 5 U.S.C.                                                                        adding paragraph (h) to read as follows:
                                                                                                          Justice in Minority Populations and
                                                  553(a)(2).
                                                                                                          Low-Income Populations                                1535.007–70       Contract clauses.
                                                  D. Unfunded Mandates Reform Act                           EPA has determined that this final                  *     *    *    *      *
                                                    This action does not contain any                      rule will not have disproportionately                   (h) Contracting officers shall insert 48
                                                  unfunded mandates as described in                       high and adverse human health or                      CFR 1552.235–82—‘‘Institutional


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                                                  24500               Federal Register / Vol. 81, No. 80 / Tuesday, April 26, 2016 / Rules and Regulations

                                                  Oversight of Life Sciences Dual Use                       (2) An institution outside of the United              (c) Resources. Information about dual use
                                                  Research of Concern’’ into all                          States that receives funds to conduct or              research in the life sciences as well as
                                                  solicitations containing 48 CFR                         sponsor research that involves one or more            specific details on the iDURC Policy can be
                                                                                                          of the agents or toxins listed in section 6.2.1       found on the U.S. Department of Health and
                                                  1552.235–81 and in existing contracts                   of the iDURC Policy; then the Offeror will
                                                  that are bilaterally modified at the                                                                          Human Services Dual Use Research of
                                                                                                          comply with the iDURC Policy.
                                                  request of an EPA funding/requesting                      (c) Resources. Information about dual use           Concern page: http://www.phe.gov/s3/
                                                  office in accordance with EPA Order                     research in the life sciences, as well as             dualuse/Pages/default.aspx.
                                                  1000.19.                                                specific details on the iDURC Policy can be
                                                                                                          found on the U.S. Department of Health and               (End of clause)
                                                  PART 1552—SOLICITATION                                  Human Services Dual Use Research of                   [FR Doc. 2016–09601 Filed 4–25–16; 8:45 am]
                                                  PROVISIONS AND CONTRACT                                 Concern page: http://www.phe.gov/s3/                  BILLING CODE 6560–50–P
                                                  CLAUSES                                                 dualuse/Pages/default.aspx.
                                                                                                            (End of Provision)
                                                  ■ 4. The authority citation for part 1552               ■ 6. Add 1552.235–82 to read as
                                                  continues to read as follows:                           follows:                                              NATIONAL AERONAUTICS AND
                                                    Authority: 5 U.S.C. 301 as amended, 40                                                                      SPACE ADMINISTRATION
                                                  U.S.C. 486(c); and 41 U.S.C. 418b.                      1552.235–82 Institutional oversight of life
                                                                                                          sciences dual use research of concern.                48 CFR Parts 1815, 1842, and 1852
                                                  ■ 5. Add section 1552.235–81 to read as                   As prescribed in 1535.007–70(h),
                                                  follows:                                                insert the following contract clause:                 NASA Federal Acquisition Regulation
                                                  1552.235–81 Institutional oversight of life             Institutional Oversight Of Life Sciences Dual         Supplement
                                                  Sciences dual use research of concern—                  Use Research Of Concern (JUNE 2016)
                                                  representation.                                            (a) Definitions. As used in this clause—
                                                                                                                                                                AGENCY:National Aeronautics and
                                                    As prescribed in 1535.007(c), insert                     Institution means any government agency            Space Administration.
                                                  the following solicitation provision:                   (Federal, State, tribal, or local), academic          ACTION:   Technical amendments.
                                                                                                          institution, corporation, company,
                                                  Institutional Oversight of Life Sciences Dual           partnership, society, association, firm, sole
                                                  Use Research of Concern—Representation                  proprietorship, or other legal entity                 SUMMARY:   NASA is making technical
                                                  (JUNE 2016)                                             conducting research.                                  amendments to the NASA FAR
                                                     (a) Definitions. As used in this provision—             Life Sciences research means a systematic          Supplement (NFS) to provide needed
                                                     Institution means any government agency              investigation designed to develop or                  editorial changes.
                                                                                                          contribute to generalizable knowledge
                                                  (Federal, State, tribal, or local), academic
                                                  institution, corporation, company,
                                                                                                          involving living organisms (e.g., microbes,           DATES:    Effective: April 26, 2016.
                                                                                                          human beings, animals, and plants) and their
                                                  partnership, society, association, firm, sole                                                                 FOR FURTHER INFORMATION CONTACT:
                                                                                                          products, including all disciplines and
                                                  proprietorship, or other legal entity                                                                         Manuel Quinones, NASA, Office of
                                                                                                          methodologies of biology such as
                                                  conducting research.                                    aerobiology, agricultural science, plant              Procurement, Contract and Grant Policy
                                                     Life Sciences research means a systematic            science, animal science, bioinformatics,
                                                  investigation designed to develop or                                                                          Division, via email at
                                                                                                          genomics, proteomics, microbiology,                   manuel.quinones@nasa.gov, or
                                                  contribute to generalizable knowledge                   synthetic biology, virology, molecular
                                                  involving living organisms (e.g., microbes,                                                                   telephone (202) 358–2143.
                                                                                                          biology, environmental science, public
                                                  human beings, animals, and plants) and their            health, modeling, engineering of living               SUPPLEMENTARY INFORMATION:
                                                  products, including all disciplines and                 systems, and all applications of the biological
                                                  methodologies of biology such as                        sciences. The term is meant to encompass the          I. Background
                                                  aerobiology, agricultural science, plant                diverse approaches to understanding life at
                                                  science, animal science, bioinformatics,                the level of ecosystems, populations,                   As part NASA’s retrospective review
                                                  genomics, proteomics, microbiology,                     organisms, organs, tissues, cells, and                of existing regulations, NASA is
                                                  synthetic biology, virology, molecular                  molecules. Life sciences research does not            conducting periodic reviews of NASA
                                                  biology, environmental science, public                  include routine product testing, quality
                                                  health, modeling, engineering of living
                                                                                                                                                                FAR Supplement (NFS) to ensure the
                                                                                                          control, mapping, collection of general-              accuracy of information and guidance
                                                  systems, and all applications of the biological         purpose statistics, routine monitoring and
                                                  sciences. The term is meant to encompass the            evaluation of an operational program,
                                                                                                                                                                disseminated to the acquisition
                                                  diverse approaches to understanding life at             observational studies, and the training of            community This rule corrects
                                                  the level of ecosystems, populations,                   scientific and technical personnel.                   typographical errors as well as
                                                  organisms, organs, tissues, cells, and                     (b) Compliance. The Contractor agrees that         inadvertent omissions from past
                                                  molecules. Life sciences research does not              it shall comply with the ‘‘United States              rulemaking actions. A summary of
                                                  include routine product testing, quality                Government Policy for Institutional                   changes follows:
                                                  control, mapping, collection of general-                Oversight of Life Sciences Dual Use Research
                                                  purpose statistics, routine monitoring and              of Concern’’ (iDURC Policy) during the                  • Section 1815.408–70(c) is revised to
                                                  evaluation of an operational program,                   period of performance of this contract,               correct a typographical error.
                                                  observational studies, and the training of              including all option periods or other                   • Subpart 1842.70 is revised to
                                                  scientific and technical personnel.                     extensions, if the Contractor:
                                                     (b) Representation. By submission of its
                                                                                                                                                                reinsert sections 1842.7002 and
                                                                                                             (1) Is an institution within the United
                                                  offer or quotation, the Offeror represents that         States that conducts or sponsors, or begins to
                                                                                                                                                                1842.7003 inadvertently removed by
                                                  if it is:                                               conduct or sponsor life sciences research that        amendatory instruction 2 of final rule 80
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                                                     (1) An institution within the United States          involves one or more of the agents or toxins          FR 52644 issued on September 1, 2015.
                                                  that conducts or sponsors life sciences                 listed in Section 6.2.1 of the iDURC Policy,            • Sections 1852.215–79, 1852.217–
                                                  research that involves one or more of the               even if the research is not supported by              72, 1852.223–73 (ALTERNATE I),
                                                  agents or toxins listed in section 6.2.1 of the         United States Government funds; or
                                                  ‘‘United States Government Policy for                      (2) Is an institution outside the United
                                                                                                                                                                1852.223–75, 1852.227–88, 1852.228–
                                                  Institutional Oversight of Life Sciences Dual           States that receives funds through this               71, 1852.239–70, 1852.245–73,
                                                  Use Research of Concern’’ (iDURC Policy),               contract to conduct or sponsor research that          1852.245–82, 1852.245–83, 1852.246–73
                                                  even if the research is not supported by                involves one or more of the agents or toxins          are revised to correct their prescription
                                                  United States Government funds; or                      listed in Section 6.2.1 of the iDURC Policy.          references.


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Document Created: 2016-04-26 01:36:45
Document Modified: 2016-04-26 01:36:45
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionDirect final rule.
DatesThis rule is effective on June 27, 2016 without further notice, unless EPA receives adverse comment by May 26, 2016. If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect.
ContactHolly Hubbell, Policy, Training, and Oversight Division (3802R), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-564-
FR Citation81 FR 24498 
CFR Citation48 CFR 1535
48 CFR 1552
CFR AssociatedEnvironmental Protection; Dual Use Research; Institutional Oversight; Life Sciences and Research and Development

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