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

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: Hubbell.holly@

epa.gov. 

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). 


asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 80 / Tuesday, April 26, 2016 / Rules and Regulations 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/contractoroperated 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 

■ 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). 

■ 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 ConcernRepresentation’’ 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’’. 

■ 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 


asabaliauskas on DSK3SPTVN1PROD with RULES
24500 Federal Register / Vol. 81, No. 80 / Tuesday, April 26, 2016 / Rules and Regulations 

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 

■ 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. 

■ 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 generalpurpose 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) 

■ 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 generalpurpose 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 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

48 CFR Parts 1815, 1842, and 1852 

NASA Federal Acquisition Regulation 

Supplement 

AGENCY: National Aeronautics and 

Space Administration. 

ACTION: Technical amendments. 

SUMMARY: NASA is making technical 

amendments to the NASA FAR 

Supplement (NFS) to provide needed 

editorial changes. 

DATES: Effective: April 26, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Manuel Quinones, NASA, Office of 

Procurement, Contract and Grant Policy 

Division, via email at 

manuel.quinones@nasa.gov, or 

telephone (202) 358–2143. 

SUPPLEMENTARY INFORMATION: 

I. Background 

As part NASA’s retrospective review 

of existing regulations, NASA is 

conducting periodic reviews of NASA 

FAR Supplement (NFS) to ensure the 

accuracy of information and guidance 

disseminated to the acquisition 

community This rule corrects 

typographical errors as well as 

inadvertent omissions from past 

rulemaking actions. A summary of 

changes follows: 

• Section 1815.408–70(c) is revised to 

correct a typographical error. 

• Subpart 1842.70 is revised to 

reinsert sections 1842.7002 and 

1842.7003 inadvertently removed by 

amendatory instruction 2 of final rule 80 

FR 52644 issued on September 1, 2015. 

• Sections 1852.215–79, 1852.217– 

72, 1852.223–73 (ALTERNATE I), 

1852.223–75, 1852.227–88, 1852.228– 

71, 1852.239–70, 1852.245–73, 

1852.245–82, 1852.245–83, 1852.246–73 

are revised to correct their prescription 

references. 


asabaliauskas on DSK3SPTVN1PROD with RULES