‘‘(5) An explanation of the manner in which the 
significant regulatory action is consistent with a 
statutory mandate and avoids undue interference 
with State, local, and tribal government functions. 
‘‘(6) For an economically significant regulatory 
action, if any of the following was developed during 
the decisionmaking process of the agency: 
‘‘(A) An assessment of and quantification 
of costs and benefits of the significant regu-
latory action. 
‘‘(B) An assessment of and quantification 
of costs and benefits of potentially effective and 
feasible alternatives, including any underlying 
analysis. 
‘‘(C) An explanation of why the planned 
significant regulatory action is preferable to any 
identified potential alternatives. 
‘‘(d) DEADLINES FOR REVIEW.— 
‘‘(1) REVIEW
COORDINATION.—To the extent 
practicable, the head of each agency shall work with 
the Administrator to establish a mutually agreeable 
date on which to submit a significant regulatory ac-
tion for review. 
‘‘(2) EXPEDITED REVIEW.—When an agency is 
obligated by law to issue a significant regulatory ac-
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tion before complying with the provisions of this sec-
tion, the head of the agency shall notify the Admin-
istrator as soon as possible. To the extent prac-
ticable, OIRA and the agency shall comply with the 
provisions of this section. 
‘‘(3) 10-DAY REVIEW.—In the case of a signifi-
cant regulatory action that is a notice of inquiry, ad-
vance notice of proposed rulemaking, or other pre-
liminary regulatory action prior to a notice of pro-
posed rulemaking, within 10 business days after the 
date of submission of the such action to the Admin-
istrator, OIRA shall complete the review. 
‘‘(4) 90-DAY REVIEW.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), for any other significant reg-
ulatory action not described in paragraph (3), 
within 90 days after the date of submission of 
the action, OIRA shall complete the review. 
‘‘(B) 
EXCEPTION
45-DAY
REVIEW.—If 
OIRA has previously reviewed the significant 
regulatory action described in subparagraph (A) 
and, since that review, there has been no mate-
rial change in the facts and circumstances upon 
which the significant regulatory action is based, 
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OIRA shall complete the review within 45 days 
after submission of the action. 
‘‘(5) EXTENSION.—Any review described under 
this subsection may be extended for any number of 
additional 30-day periods upon written request by 
the Administrator or the head of the agency. Such 
request shall be granted unless the nonrequesting 
party denies the request in writing within 5 days 
after receipt of the request for extension. 
‘‘(6) RETURN.—If the Administrator deter-
mines OIRA is unable to complete a review within 
the time period described under this subsection, the 
Administrator may return the draft of the signifi-
cant regulatory action to the agency with a written 
explanation of why OIRA was unable to complete 
the review and what additional information, re-
sources, or time OIRA would need to complete the 
review. 
‘‘(7) WITHDRAWAL.—An agency may withdraw 
the regulatory action from OIRA review at any time 
prior to the completion of the review. 
‘‘(e) COMPLIANCE
REVIEW.—The Administrator 
shall review any significant regulatory action submitted 
under subsection (c) to determine the extent to which the 
agency— 
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‘‘(1) identified the problem that the significant 
regulatory action is designed to address (including, 
where applicable, the failures of private markets or 
public institutions that warrant new agency action); 
‘‘(2) assessed the significance of the problem 
the regulatory action is designed to address; 
‘‘(3) examined whether existing regulations or 
laws have created or contributed to the problem that 
the regulatory action is designed to correct and 
whether those regulations or laws should be modified 
to achieve the intended goal more effectively; 
‘‘(4) identified and assessed available alter-
natives to direct regulation, including providing eco-
nomic incentives to encourage desired behaviors, 
such as user fees or marketable permits, or pro-
viding information upon which choices can be made 
by the public; 
‘‘(5) considered, to the extent reasonable, the 
degree and nature of the risks posed by various sub-
stances or activities within the jurisdiction of the 
agency; 
‘‘(6) designed the regulatory action to be the 
most cost-effective manner to achieve the regulatory 
objective; 
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‘‘(7) considered incentives for innovation, con-
sistency, predictability, flexibility, distributive im-
pacts, equity, and the costs of enforcement and com-
pliance by the Government, regulated entities, and 
the public; 
‘‘(8) assessed costs and benefits of the regu-
latory action and made a reasoned determination 
that the benefits justify the costs; 
‘‘(9) used the best reasonably obtainable sci-
entific, technical, economic, and other information 
concerning the need for and consequences of the reg-
ulatory action; 
‘‘(10) identified and assessed alternative forms 
of regulation and, to the extent feasible, specified 
performance objectives rather than behavior or man-
ner of compliance; 
‘‘(11) sought comments and suggestions from 
appropriate State, local, and tribal officials on any 
aspect of the regulatory action that might signifi-
cantly or uniquely affect those governmental entities; 
‘‘(12) assessed the effects of the regulatory ac-
tion on State, local, and tribal governments, includ-
ing specifically the availability of resources to carry 
out the regulatory action, and minimized the bur-
dens that uniquely or significantly affect such gov-
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ernmental entities, consistent with achieving regu-
latory objectives; 
‘‘(13) harmonized the regulatory action with 
the regulatory and other functions of State, local, 
and tribal governments; 
‘‘(14) avoided conflicts with or duplication of 
other existing regulations; 
‘‘(15) tailored the regulatory action to impose 
the least burden on society, including individuals, 
businesses of differing sizes, and other entities (in-
cluding small communities and governmental enti-
ties), consistent with obtaining the regulatory objec-
tives, and taking into account, among other things 
and to the extent practicable, the costs of cumulative 
regulations; 
‘‘(16) drafted the regulatory action to be simple 
and easy to understand, and minimized the potential 
for uncertainty and litigation arising from such un-
certainty; 
‘‘(17) met all applicable Executive order re-
quirements; 
‘‘(18) met all applicable statutory requirements; 
and 
‘‘(19) complied with all applicable guidance. 
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