A Guide to the Rulemaking Process
Prepared by the Office of the Federal Register
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TAB LE&OF&CONTENTS&
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Before&the&Proposed&Rule&
What!gives!agencies!the!authority!to!issu e!regulati ons?
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How!does!an!agency!decid e!to!begin!rulemaking?!
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When!can!the!public!l earn!that!an!agency!plans!to!start!a!rulemaking?
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How!does!an !agency!involve!the!public!in!developing!a!proposed!rule?
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What!is!the!role!of!the!President!in!developing!a!proposed!rule?
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The&Proposed&Rule&
What!is!the!purpose!o f!the!proposed!rule?&
How!is!the!proposed!rule!struct ured?
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What!is!the!time!period!for!the!public!to !submit!comments?
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Why!do! agen cies!re‐open!comments!or!issue!multiple!proposed !rules?
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Do!agencies!have!additional!options!for! gathering !pub lic!comments?
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Why!should!you!consi der!s ubm itting!electron ic!comments?
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Before&the&Final&Rule&
How!do! public!comments!affect!the!final!rule?!
What!is!the!role!of!the!President!in!developing!a!final! rule?
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The&Final&Rule&
How!is!the!final!rule!structured?&
When!do!final!rul es!go!into!effect?
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Can !an!agency!issue!a!final!rule!with out!a!publishi ng!a!proposed!rule?
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What!are!interim!final!rules!&!direct !final!rules?
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After&the&Final&Rule&
How!are!final!rules!integrated!into!the!Code!of!Federal!Reg ulations?&
How!is!the!Congress!in!involved!in!reviewing!final!rules?
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Does!the!regulato ry!process!continue!after!rules!are!published?
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What!are!interpre tive!rules!and!policy!statements?
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When!do!the!courts!get!involve d!in!rulemaking?
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!The!material!presented!i n!this!guide!is!nece ssarily!general!in!nature!a nd!should!not!be!used!to!make!legal!dec isions.!!We!use!
the!terms!“r ule”!and!“regulation”!interchan geably !in!the!text.!!The!guide!is! adapted!from!several!major!sources:!!the!Cornell!e‐
Rulemaking!Initiative!(CeRI)!“Regulation!Room,”!hosted!by!the!Cor nell!Legal!Informat ion!Institute!(LII)!at!
http://regulationroom.o rg/lear n‐about‐rulemaking/
;!the!“Reg!Map”!created!by!ICF!Consulting!with!t he!cooperation!of!the!
General!Services!Administration's!Regulatory!Informatio n!Service!Center!at!!
http://www.regin fo.gov/public/reginfo/Regmap/index.jsp
!;!the! Office!of!the!Federal!Reg ister’s!tutorial:!“The!Federal!Reg ister:!!
What !it!Is!and!How!to!Use!It”!at!http://www.archives.gov/federal‐register/tutor ial/online‐html.html#top
;!and! !the!D epartment!
of!Transportation’ s!“The!Informal!Rulemaki ng!Process
,”!wh ich!has!more!detailed!inf ormation!and!examples! on!the!rulem aking!
process.!!In!addition,!yo u!may!wish!t o!cons ult!DOT’s!“Rulemaking!Requirements
”!(prepared! by!Nei l!Eisner,!April!2009 ),!which!
provides!hyperlinks!for! easy!access!to!the!statutes,!executive!o rders,!guidance!documents,!memoranda,!etc.!that!contain!the!
actual!legal!re quirements!or!prov ide!guidance !on!the!rulemaking!process.!!
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Before the Proposed Rule Go to Top
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What gives agencies the authority to issue regulations?
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Agencies!get!their!authority!to!issue!regulations!from!laws!(statutes)!enacted!by!Congress.!!In!
some!cases,!the!President!may!delegate!existing!Presidential!authority!to!an!agency.!!Typically,!
when!Congress!passes!a!law!to!create!an!agency,!it!grants!that!agency!general!authority!to!
regulate!certain!activities!within!our!society.!!Congress!may!also!pass!a!law!that!more!
specifically!directs!an!agency!to!solve!a!particular!problem!or!accomplish!a!certain!goal.!!!
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An!agency!must!not!take!action!that!goes!beyond!its!statutory!authority!or!violates!the!
Constitution.!!!Agencies!must!follow!an!open!public!process!when!they!issue!regulations,!
according!to!the!Administrative!Procedure!Act!(APA).!!This!includes!publishing!a!statement!of!
rulemaking!authority!in!the!Federal'Register!for!all!proposed!and!final!rules.!!
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How does an agency decide to begin rulemaking?
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Congress!may!pass!a!law!that!directs!an!agency!to!take!action!on!a!certain!subject!and!set!a!
schedule!for!the!agency!to!follow!in!issuing!rules.!!More!often,!an!agency!surveys!its!area!of!
legal!responsibility,!and!then!decides!which!issues!or!goals!have!priority!for!rulemaking.!!!
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These!are!a!few!of!the!many!factors!that!an!agency!may!consider:!!!
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●!!New!technologies!or!new!data!on!existing!issues;!
●!!Concerns!arising!from!accidents!or!various!problems!affecting!society;!!
●!!Recommendations!from!Congressional!committees!or!federal!advisory!committees;!
●!!Petitions!from!interest!groups,!corporations,!and!members!of!the!public;!
●!!Lawsuits!filed!by!interest!groups,!corporations,!States,!and!members!of!the!public;!
●!!Presidential!directives;!
●!!“Prompt!letters”!from!the!Office!of!Management!and!Budget!(OMB);!
●!!Requests!from!other!agencies;!
●!!Studies!and!recommendations!of!agency!staff.!
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Go to Top
When can the public learn that an agency plans to start a rulemaking?
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Agencies!are!required!to!publish!a!“Regulatory!Plan”!once!a!year!in!the!fall!and!an!“Agenda!of!
Regulatory!and!Deregulatory!Actions”!in!the!spring!and!fall.!!The!Regulatory!Plan!and!the!
Regulatory!Agenda!are!often!referred!to!as!the!“Unified!Agenda.”!The!Unified!Agenda!is!how!
agencies!announce!future!rulemaking!activities!update!the!public!on!pending!and!completed!
regulatory!actions.!!!
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The!Unified!Agenda!is!posted!on!RegInfo.gov!and!Regulations.gov.!!Agencies!also!publish!most!
of!this!material!(their!regulatory!plans)!in!the!Federal'Register.!!The!Federal'Register!version!
and!a!separate!Unified!Agenda!collection!are!available!on!the!Government!Printing!Office’s!
(GPO)!Federal!Digital!system!(FDsys.gov).!!!
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How does an agency involve the public in developing a proposed rule?
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An!agency!may!take!some!preliminary!steps!before!issuing!a!proposed!rule.!!They!gather!
information!through!unstructured!processes!and!informal!conversations!with!people!and!
organizations!interested!in!the!issues.!!If!an!agency!receives!a!“Petition!for!Rulemaking”!from!a!
member!of!the!public,!it!may!decide!to!announce!the!petition!in!the!Federal'Register'and!
accept!public!comments!on!the!issue.!!!
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An!agency!that!is!in!the!preliminary!stages!of!rulemaking!may!publish!an!“Advance!Notice!of!
Proposed!Rulemaking”!in!the!Federal'Register!to!get!more!information.!!The!Advance!Notice!is!
a!formal!invitation!to!participate!in!shaping!the!proposed!rule!and!starts!the!notice‐and‐
comment!process!in!motion.!!!
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Anyone!interested!(individuals!and!groups)!may!respond!to!the!Advance!Notice!by!submitting!
comments!aimed!at!developing!and!improving!the!draft!proposal!or!by!recommending!against!
issuing!a!rule.!!Some!agencies!develop!proposed!rules!through!a!negotiated!rulemaking.!!In!this!
process,!an!agency!invites!members!of!interested!groups!to!meetings!where!they!attempt!to!
reach!a!consensus!on!the!terms!of!the!proposed!rule.!!If!the!participants!reach!agreement,!the!
agency!may!endorse!their!ideas!and!use!them!as!the!basis!for!the!proposed!rule.!
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What is the role of the President in developing a proposed rule?
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Before!a!proposed!rule!is!published!in!the!Federal'Register!for!public!comment,!the!President,!
as!head!of!the!Executive!branch,!may!take!the!opportunity!to!review!the!rule.!!The!President!is!
assisted!by!the!Office!of!Information!&!Regulatory!Affairs!(OIRA),!which!analyzes!draft!proposed!
rules!when!they!are!“significant”!due!to!economic!effects!or!because!they!raise!important!
policy!issues.!!For!significant!rules,!the!agency!must!estimate!the!costs!and!benefits!of!the!rule!
and!consider!alternate!solutions.!!!
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If!the!proposed!rule!requires!the!public!to!provide!information!to!the!government,!the!agency!
must!estimate!the!paperwork!burden!on!the!public!and!obtain!permission!to!proceed!from!
OIRA.!In!addition,!the!agency!may!be!required!to!analyze!a!proposed!rule’s!impact!on:!small!
businesses;!state,!local!and!tribal!governments;!families;!federalism.!It!may!also!need!to!analyze!
issues!of!just!compensation!and!unfunded!mandates.!
The Proposed Rule Go to Top
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What is the purpose of the proposed rule?
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The!proposed!rule,!or!Notice!of!Proposed!Rulemaking!(NPRM),!is!the!official!document!that!
announces!and!explains!the!agency’s!plan!to!address!a!problem!or!accomplish!a!goal.!!All!
proposed!rules!must!be!published!in!the!Federal'Register!to!notify!the!public!and!to!give!them!
an!opportunity!to!submit!comments.!!The!proposed!rule!and!the!public!comments!received!on!
it!form!the!basis!of!the!final!rule.!!!
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How is the proposed rule structured?
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Proposed!rules!have!preambles!which!contain!a!summary,!date!and!contact!information,!and!
supplementary!information.!!A!proposed!rule!begins!with!a!“Summary”!of!the!issues!and!
actions!under!consideration;!it!also!states!why!the!rule!is!necessary.!!Under!the!“Dates”!and!
“Addresses”!captions,!the!agency!invites!everyone!to!comment!on!the!proposed!rule,!sets!a!
date!for!comments!to!be!submitted,!and!specifies!various!methods!for!conveying!comments.!!
Many!agencies!give!several!options!for!submitting!comments,!including!U.S.!mail,!private!
courier,!email,!and!the!official!federal!electronic!comment!portal:!Regulations.gov.!!!
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In!the!“Supplementary!Information”!portion,!the!agency!discusses!the!merits!of!the!proposed!
solution,!cites!important!data!and!other!information!used!to!develop!the!action,!and!details!its!
choices!and!reasoning.!!The!agency!must!also!identify!the!legal!authority!for!issuing!the!rule.!!!
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Following!the!preamble,!the!agency!usually!publishes!the!regulatory!text!of!the!proposal!in!full.!!
The!regulatory!text!sets!out!amendments!to!the!standing!body!of!law!in!the!Code!of!Federal!
Regulations.!!If!the!amendments!are!not!set!out!in!full!text,!the!agency!must!describe!the!
proposed!action!in!a!narrative!form.!!!
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Go to Top
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What is the time period for the public to submit comments?
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In!general,!agencies!will!specify!a!comment!period!ranging!from!30!to!60!days!in!the!“Dates”!
section!of!the!Federal'Register'document,!but!the!time!period!can!vary.!!For!complex!
rulemakings,!agencies!may!provide!for!longer!time!periods,!such!as!180!days!or!more.!!Agencies!
may!also!use!shorter!comment!periods!when!that!can!be!justified.!!!
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Members!of!the!public!may!request!that!the!agency!allow!more!time!to!submit!comments,!and!
agencies!may!consider!late‐filed!comments,!if!their!decision‐making!schedule!permits!it.!!
Commentors!should!be!aware!that!agencies!generally!are!not!legally!required!to!consider!late‐
filed!comments.!!Agencies!usually!provide!information!in!the!proposed!rule!and/or!their!
procedural!rules!indicating!whether!they!will!consider!late‐filed!comments.!!
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Why do agencies re-open comments or issue multiple proposed rules?
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An!agency!may!extend!or!re‐open!a!comment!period!when!it!is!not!satisfied!that!it!has!enough!
high!quality!comments!or!when!the!public!comments!make!a!good!case!for!adding!more!time.!!!!!
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Similarly,!an!agency!may!find!that!people!have!raised!new!issues!in!their!comments!that!were!
not!discussed!in!the!initial!proposed!rule.!!As!new!issues!or!additional!complexity!arises,!the!
agency!may!publish!a!series!of!proposed!rules!in!the!Federal'Register.!!!
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Do agencies have additional options for gathering public comments?
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During!the!comment!period,!an!agency!may!also!hold!public!hearings!where!people!can!make!
statements!and!submit!data.!!Some!agencies!operate!under!laws!that!require!rulemaking!
hearings.!!Others!may!hold!public!meetings!to!collect!more!information!or!to!help!affected!
groups!get!a!better!understanding!of!the!proposed!rule.!!Many!agencies!are!beginning!to!use!
webcasts!and!interactive!Internet!sessions!to!broaden!the!audience!attending!public!meetings.!!!
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After!the!comment!period!closes,!an!agency!may!establish!a!second!period!for!reply!comments!
(comments!that!respond!to!prior!comments).!!A!reply!period!is!not!required!by!law.!!The!reply!
comment!period!enables!people!to!respond!to!comments!that!agencies!received!at!the!end!of!
comment!period,!creating!more!of!a!public!dialog.!!
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Why should you consider submitting electronic comments?
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Most!agencies!now!prefer!to!receive!comments!electronically!so!that!your!input!on!a!proposed!
rule!or!other!document!is!more!easily!available!to!the!public.!!Having!electronic!data!helps!
agencies!organize!the!comments!by!subject!or!in!other!ways!to!help!the!public!and!the!agency!
make!more!effective!use!of!them.!!!
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You!can!submit!electronic!comments!to!the!agency!docket!site!by!following!the!instructions!in!
the!Federal'Register.!!Many!of!the!proposed!rules!and!other!documents!on!this!site!display!a!
special!button!for!submitting!comments!directly!to!the!official!electronic!docket.!!For!
information!on!using!the!federal!eRulemaking!portal!to!submit!comments,!go!to!the!
Regulations.gov!“Help”!pages!on!submitting!a!comment.!!
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Before the Final Rule Go to Top
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How do public comments affect the final rule?
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The!notice‐and‐comment!process!enables!anyone!to!submit!a!comment!on!any!part!of!the!
proposed!rule.!This!process!is!not!like!a!ballot!initiative!or!an!up‐or‐down!vote!in!a!legislature.!!
An!agency!is!not!permitted!to!base!its!final!rule!on!the!number!of!comments!in!support!of!the!
rule!over!those!in!opposition!to!it.!!!At!the!end!of!the!process,!the!agency!must!base!its!
reasoning!and!conclusions!on!the!rulemaking!record,!consisting!of!the!comments,!scientific!
data,!expert!opinions,!and!facts!accumulated!during!the!pre‐rule!and!proposed!rule!stages.!!!
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To!move!forward!with!a!final!rule,!the!agency!must!conclude!that!its!proposed!solution!will!help!
accomplish!the!goals!or!solve!the!problems!identified.!!It!must!also!consider!whether!alternate!
solutions!would!be!more!effective!or!cost!less.!!!
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If!the!rulemaking!record!contains!persuasive!new!data!or!policy!arguments,!or!poses!difficult!
questions!or!criticisms,!the!agency!may!decide!to!terminate!the!rulemaking.!!Or,!the!agency!
may!decide!to!continue!the!rulemaking!but!change!aspects!of!the!rule!to!reflect!these!new!
issues.!!If!the!changes!are!major,!the!agency!may!publish!a!supplemental!proposed!rule.!!If!the!
changes!are!minor,!or!a!logical!outgrowth!of!the!issues!and!solutions!discussed!in!the!proposed!
rules,!the!agency!may!proceed!with!a!final!rule.!!!!
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What is the role of the President in developing a final rule?
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In!the!same!way!that!the!President!and!the!Office!of!Information!&!Regulatory!Affairs!(OIRA)!
review!draft!proposed!rules!prior!to!publication,!the!President!and!OIRA!analyze!draft!final!
rules!when!they!are!“significant”!due!to!economic!effects!or!because!they!raise!important!
policy!issues.!!The!Presidential!level!review!takes!place!before!the!final!rule!is!published!in!the!
Federal'Register.!!OIRA’s!final!analysis!of!estimated!costs!and!benefits!may!take!into!
consideration!any!comments!and!alternate!solutions!suggested!in!public!comments.!!!
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Agencies!may!also!use!this!review!and!analysis!phase!to!consult!with!other!agencies!who!share!
responsibility!for!issues!covered!by!the!rule.!!In!some!cases,!interagency!review!is!mandatory.!
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The Final Rule Go to Top
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How is the final rule structured?
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Final!rules!also!have!preambles,!including!the!summary,!effective!date,!and!supplementary!
information.!!The!final!rule!published!in!the!Federal'Register!begins!with!a!“Summary”!of!the!
societal!problems!and!regulatory!goals!and!explains!why!the!rule!is!necessary.!!!
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Every!final!rule!must!have!an!“Effective!Date.”!However,!any!portions!that!are!subject!to!later!
approval!under!the!Paperwork!Reduction!Act!or!are!subject!to!Congressional!approval!may!be!
excepted!from!that!effective!date.!!The!“Dates”!caption!in!the!Federal'Register!may!also!contain!
compliance!or!applicability!dates.!!
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The!agency!must!state!the!“basis!and!purpose”!of!the!rule!in!the!“Supplementary!Information”!
part!of!the!preamble.!!This!statement!!sets!out!the!goals!or!problems!the!rule!addresses,!
describes!the!facts!and!data!the!agency!relies!on,!responds!to!major!criticisms!in!the!proposed!
rule!comments,!and!explains!why!the!agency!did!not!choose!other!alternatives.!!!
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The!agency!must!identify!its!legal!authority!for!issuing!the!rule!and!publish!the!regulatory!text!
in!full.!!The!regulatory!text!sets!out!amendments!to!the!Code!of!Federal!Regulations!(CFR).!!
Each!amendment!begins!with!instructions!for!changing!the!CFR.!!!!!!!!
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When do final rules go into effect?
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When!an!agency!publishes!a!final!rule,!generally!the!rule!is!effective!no!less!than!thirty!days!
after!the!date!of!publication!in!the!Federal'Register.!!If!the!agency!wants!to!make!the!rule!
effective!sooner,!it!must!cite!“good!cause”!(persuasive!reasons)!as!to!why!this!is!in!the!public!
interest.!!!
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Significant!rules!(defined!by!Executive!Order!12866)!and!major!rules!(defined!by!the!Small!
Business!Regulatory!Enforcement!Fairness!Act)!are!required!to!have!a!60!day!delayed!effective!
date.!
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Can an agency issue a final rule without a publishing a proposed rule?
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Yes,!the!Administrative!Procedure!Act!(APA)!permits!agencies!to!finalize!some!rules!without!
first!publishing!a!proposed!rule!in!the!Federal'Register.!!This!exception!is!limited!to!cases!where!
the!agency!has!“good!cause”!to!find!that!the!notice‐and‐!comment!process!would!be!
“impracticable,!unnecessary,!or!contrary!to!the!public!interest.”!!These!situations!may!include!
emergencies!where!problems!must!be!addressed!immediately!to!avert!threats!to!public!health!
and!safety,!minor!technical!amendments!and!corrections!where!there!is!no!substantive!issue,!
and!some!instances!where!an!agency!has!no!discretion!to!propose!a!rule!because!Congress!has!
already!directed!a!specific!regulatory!outcome!in!a!law.!!!The!agency!must!state!its!reasoning!
for!finding!good!cause!in!the!preamble!of!the!final!rule!published!in!the!Federal'Register.!
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There!are!other!exceptions!to!conventional!notice‐and‐comment!rulemaking.!!An!agency!may!
go!straight!to!final!rulemaking!without!a!proposed!rule!when!they!issue!internal!agency!
procedures,!rules!that!affect!only!federal!employees,!and!rules!that!manage!federal!property!
and!real!estate.!!Even!these!types!of!rules!can!be!subject!to!proposed!rulemaking!because!of!a!
special!statutory!requirement!or!because!an!internal!agency!rule!also!has!a!substantial!effect!on!
the!public.!!!
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Agencies!can!also!issue!and!enforce!rules!by!using!“actual!notice,”!which!requires!direct!
notification!of!all!affected!persons!and!entities.!!Because!it!is!difficult!to!pinpoint!every!person!
and!entity!affected!by!a!rulemaking,!this!option!is!used!mostly!for!rules!that!have!a!very!narrow!
effect!on!known!or!readily!definable!persons!or!corporations.&
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Go to Top
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What are interim final rules & direct final rules?
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Interim!Final!Rule:!!When!an!agency!finds!that!it!has!good!cause!to!issue!a!final!rule!without!
first!publishing!a!proposed!rule,!it!often!characterizes!the!rule!as!an!“interim!final!rule,”!or!
“interim!rule.”!!This!type!of!rule!becomes!effective!immediately!upon!publication.!!In!most!
cases,!the!agency!stipulates!that!it!will!alter!the!interim!rule!if!warranted!by!public!comments.!!!
If!the!agency!decides!not!to!make!changes!to!the!interim!rule,!it!generally!will!publish!a!brief!
final!rule!in!the!Federal'Register!confirming!that!decision.!!!
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Direct!Final!Rule:!!When!an!agency!decides!that!a!proposed!rule!is!unnecessary!because!it!
would!only!relate!to!routine!or!uncontroversial!matters,!it!may!publish!a!direct!final!rule!in!the!
Federal'Register.!In!a!direct!final!rule,!the!agency!states!that!the!rule!will!go!into!effect!on!a!
certain!date,!unless!it!gets!substantive!adverse!comments!during!the!comment!period.!An!
agency!may!finalize!this!process!by!publishing!in!the!Federal'Register!a!confirmation!that!it!
received!no!adverse!comments.!!If!adverse!comments!are!submitted,!the!agency!is!required!to!
withdraw!the!direct!final!rule!before!the!effective!date.!!The!agency!may!re‐start!the!process!by!
publishing!a!conventional!proposed!rule!or!decide!to!end!the!rulemaking!process!entirely.!!!
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After the Final Rule Go to Top
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How are final rules integrated into the Code of Federal Regulations?
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Agencies!must!publish!the!changes!to!the!Code!of!Federal!Regulations!(CFR)!in!the!final!rule,!
instructing!how!amendments!add,!revise,!remove,!or!re‐designate!regulatory!text.!!The!CFR!
contains!all!of!the!generally!applicable!rules!of!the!Federal!government!with!current!or!future!
effect.!!!
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On!the!day!a!final!rule!is!published!in!the!Federal'Register,!Office!of!the!Federal!Register!and!
GPO!staff!being!processing!the!material!for!codification!into!the!CFR.!!Rules!that!are!
immediately!effective!are!integrated!into!the!“Electronic!Code!of!Federal!Regulations”!(e‐CFR)!
database!(ecfr.gpoaccess.gov).!!Rules!with!delayed!effective!dates!are!placed!in!amendment!
files!and!linked!from!the!main!e‐CFR!database.!The!e‐CFR!is!an!unofficial,!but!authoritative!
editorial!compilation!published!by!the!Office!of!the!Federal'Register!and!GPO.!!Users!can!check!
the!update!status!of!the!e‐CFR!by!consulting!the!home!page.!!!
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The!official!annual!editions!of!the!CFR!are!assembled!from!the!material!published!in!the!e‐CFR.!!
Each!of!the!50!subject!matter!titles!are!republished!each!year!on!a!staggered,!quarterly!basis,!
and!appear!in!print!and!online!
(http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR).!!!!!
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How is the Congress in involved in reviewing final rules?
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Under!the!Small!Business!Regulatory!Enforcement!Fairness!Act!(also!known!as!the!
Congressional!Review!Act),!new!final!rules!must!be!sent!to!Congress!and!the!Government!
Accountability!Office!for!review!before!they!can!take!effect.!“Major!rules”!(ones!that!are!
economically!significant!and!require!OIRA!review)!must!be!made!effective!at!least!60!days!after!
the!date!of!publication!in!the!Federal'Register,!allowing!time!for!Congressional!review.!!In!
emergency!situations,!a!major!rule!can!be!made!effective!before!60!days.!!!
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If!the!House!and!Senate!pass!a!resolution!of!disapproval!and!the!President!signs!it!(or!if!both!
houses!override!a!presidential!veto),!the!rule!becomes!void!and!cannot!be!republished!by!an!
agency!in!the!same!form!without!Congressional!approval.!!Since!1996,!when!this!process!
started,!Congress!has!disapproved!only!one!rule.!
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Congress!may!also!exercise!its!oversight!in!other!ways,!by!holding!hearings!and!posing!
questions!to!agency!heads,!by!enacting!new!legislation,!or!by!imposing!funding!restrictions.!
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Does the regulatory process continue after rules are published?
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The!regulatory!process!enters!the!compliance,!interpretation,!and!review!phase!after!a!final!
rule!is!published.!!Individuals!and!industries!affected!by!a!rule,!and!the!agency!compliance!
officers!and!inspectors!who!must!enforce!a!rule,!may!need!guidance!to!better!understand!the!
regulatory!requirements.!!Agencies!may!write!compliance!materials!and!technical!assistance!
manuals!to!distribute!to!the!public.!!These!guidance!materials!may!be!posted!on!a!website!or!
published!in!the!Federal'Register!as!interpretive!rules.!!See!more!about!interpretive!rules!and!
policy!statements!below.!!!
Based!on!its!experience!in!enforcing!a!rule,!an!agency!may!decide!to!change!a!rule,!remove!it!
from!the!CFR!entirely,!or!let!it!stand.!!A!law!or!a!Presidential!directive!may!require!a!formal!
review!process!every!few!years.!!An!agency!may!undertake!a!review!based!on!a!petition!from!
the!public.!!Its!own!experts!may!also!begin!a!review!process!when!conditions!change!and!rules!
seem!outdated.!If!an!agency!decides!to!amend!or!revoke!a!rule,!it!must!use!the!notice‐and‐
comment!process!to!make!the!change.!
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What are interpretive rules and policy statements?
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Interpretive!rules,!policy!statements,!and!other!guidance!documents!may!be!issued!anytime!
after!a!final!rule!is!published!to!help!the!public!understand!to!how!a!regulation!applies!to!them!
and!affects!their!interests.!!!An!agency!may!explain!how!it!interprets!an!existing!regulation!or!
statute,!how!a!rule!may!apply!in!a!given!instance,!and!what!things!a!person!or!corporation!must!
do!to!comply.!!!
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There!is!a!key!distinction!between!an!interpretive!rule!and!a!final!“legislative”!or!“substantive”!
rule.!The!interpretive!rule!or!policy!statement!must!not!set!new!legal!standards!or!impose!new!
requirements.!!Guidance!documents!do!not!contain!amendments!to!the!CFR!and!are!not!
subject!to!the!notice!and!comment!process.!!!But!in!some!cases,!agencies!choose!to!request!
comments!on!interpretive!rules!and!other!guidance!documents!to!improve!the!quality!and!
clarity!of!the!material.!!!Interpretive!rules!and!policy!statements!that!have!broad!applicability!
are!often!published!in!the!Federal'Register,!but!some!may!only!appear!on!agency!websites.!!!
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When do the courts get involved in rulemaking?
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Individuals!and!corporate!entities!may!go!into!the!courts!to!make!a!claim!that!they!have!been,!
or!will!be,!damaged!or!adversely!affected!in!some!manner!by!a!regulation.!!The!reviewing!court!
can!consider!whether!a!rule:!is!unconstitutional;!goes!beyond!the!agency’s!legal!authority;!was!
made!without!following!the!notice‐and‐comment!process!required!by!the!Administrative!
Procedure!Act!or!other!law;!or!was!arbitrary,!capricious,!or!an!abuse!of!discretion.!!An!agency!
head!can!also!be!sued!for!failing!to!act!in!a!timely!manner!in!certain!cases.!!!!!
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If!a!court!sets!aside!(vacates)!all!or!part!of!a!rule,!it!usually!sends!the!rule!back!to!the!agency!to!
correct!the!deficiencies.!!!The!agency!may!have!to!reopen!the!comment!period,!publish!a!new!
statement!of!basis!and!purpose!in!the!Federal'Register!to!explain!and!justify!its!decisions,!or!re‐
start!the!rulemaking!process!from!the!beginning!by!issuing!a!new!proposed!rule.!
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