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(ii) §820.30 of this chapter. Designcontrols.(iii) §820.50 of this chapter.Purchasing controls.(iv) §820.100 of this chapter.Corrective and preventive action.(v) §820.170 of this chapter.Installation.(vi) §820.200 of this chapter.Servicing.(2) If the combination productincludes a device constituent part and adrug constituent part, and the currentgood manufacturing practice operatingsystem has been shown to comply withthe QS regulation, the followingprovisions of the drug cGMPs must also be shown to have been satisfied; upondemonstration that these requirementshave been satisfied, no additionalshowing of compliance with respect tothe drug cGMPs need be made:(i) §211.84 of this chapter. Testingand approval or rejection of components, drug product containers,and closures.(ii) §211.103 of this chapter.Calculation of yield.(iii) §211.132 of this chapter. Tamper-evident packaging requirements forover-the-counter (OTC) human drugproducts.(iv) §211.137 of this chapter.Expiration dating.(v) §211.165 of this chapter. Testingand release for distribution.(vi) §211.166. of this chapter.Stability testing.(vii) §211.167 of this chapter. Specialtesting requirements.(viii) §211.170 of this chapter.Reserve samples.(3) In addition to being shown tocomply with the other applicablecurrent good manufacturing practicerequirements listed under §4.3, if thecombination product includes a biological product constituent part, thecurrent good manufacturing practiceoperation system must also be shown toimplement and comply with all currentgood manufacturing practicerequirements identified under §4.3(c)that would apply to that biologicalproduct if that constituent part were notpart of a combination product.(4) In addition to being shown tocomply with the other applicablecurrent good manufacturing practicerequirements listed under §4.3, if thecombination product includes anHCT/P, the current good manufacturingpractice operation system must also beshown to implement and comply withall current good manufacturing practicerequirements identified under §4.3(d)that would apply to that HCT/Pconstituent part if that constituent partwere not part of a combination product.(c) During any period in which themanufacture of a constituent part to beincluded in a co-packaged or single-entity combination product occurs at aseparate facility from the other type(s) of constituent part(s) to be included in thatsingle-entity or co-packagedcombination product, the current goodmanufacturing practice operatingsystem for that constituent part must bedemonstrated to comply with all currentgood manufacturing practicerequirements applicable to that type of constituent part.(d) When two or more types of constituent parts to be included in asingle-entity or co-packagedcombination product have arrived at thesame facility, or the manufacture of these constituent parts is proceeding atthe same facility, application of acurrent good manufacturing processoperating system that complies with§4.4(b) may begin, except with respectto any constituent part that remains or becomes subject to §4.4(c).(e) The current good manufacturingpractice requirements set forth in thissubpart and in parts 210, 211, 600through 680, 820, and 1271 of thischapter, supplement, and do notsupersede, each other unless theregulations explicitly provide otherwise.In the event of a conflict betweenregulations applicable under thissubpart to combination products,including their constituent parts, theregulations most specifically applicableto the constituent part in question shallsupersede the more general.

Subpart B [Reserved]

Dated: September 17, 2009.

David Horowitz,

Assistant Commissioner for Policy.

[FR Doc. E9–22850 Filed 9–22–09; 8:45 am]

BILLING CODE 4160–01–S

EQUAL EMPLOYMENT OPPORTUNITYCOMMISSION29 CFR Part 1630

RIN 3046–AA85

Regulations To Implement the EqualEmployment Provisions of theAmericans With Disabilities Act, asAmended

AGENCY

Equal EmploymentOpportunity Commission (EEOC).

ACTION

Notice of proposed rulemaking.

SUMMARY

The Equal EmploymentOpportunity Commission (theCommission or EEOC) proposes torevise its Americans with DisabilitiesAct (ADA) regulations andaccompanying interpretive guidance inorder to implement the ADAAmendments Act of 2008. TheCommission is responsible forenforcement of title I of the ADA, asamended, which prohibits employmentdiscrimination on the basis of disability.Pursuant to the ADA Amendments Actof 2008, EEOC is expressly granted theauthority to amend these regulations,and is expected to do so, in order toconform certain provisions contained inthe regulations to the Amendments Act.

DATES

Written comments on thisrulemaking must be submitted on or before November 23, 2009.

ADDRESSES

Written comments should be submitted to Stephen Llewellyn,Executive Officer, Executive Secretariat,Equal Employment OpportunityCommission, 131 M Street, NE., Suite4NW08R, Room 6NE03F, Washington,DC 20507. As a convenience tocommenters, the Executive Secretariatwill accept comments transmitted byfacsimile (‘‘FAX’’) machine. Thetelephone number of the FAX receiveris (202) 663–4114. (This is not a toll-freenumber.) Only comments of six or fewerpages will be accepted via FAXtransmittal to ensure access to theequipment. Receipt of FAX transmittalswill not be acknowledged, except thatthe sender may request confirmation of receipt by calling the ExecutiveSecretariat staff at (202) 663–4070(voice) or (202) 663–4074 (TTY). (Theseare not toll-free telephone numbers.)You may also submit comments andattachments electronically at

http:// www.regulations.gov

, which is theFederal eRulemaking Portal. Follow theinstructions online for submittingcomments. Copies of commentssubmitted by the public will beavailable for review at the Commission’slibrary, 131 M Street, NE., Suite4NW08R, Washington, DC 20507, between the hours of 9:30 a.m. and5p.m. or can be reviewed at

http:// www.regulations.gov

FOR FURTHER INFORMATION CONTACT

Christopher Kuczynski, Assistant LegalCounsel, or Jeanne Goldberg, SeniorAttorney Advisor, Office of LegalCounsel, U.S. Equal EmploymentOpportunity Commission at (202) 663–4638 (voice) or (202) 663–7026 (TTY).These are not toll-free-telephonenumbers. This document is alsoavailable in the following formats: largeprint, Braille, audio tape, and electronicfile on computer disk. Requests for thisdocument in an alternative formatshould be made to the Office of Communications and Legislative Affairsat (202) 663–4191 (voice) or (202) 663–

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4494 (TTY) or to the PublicationsInformation Center at 1–800–669–3362.

SUPPLEMENTARY INFORMATION

The ADAAmendments Act of 2008 (‘‘theAmendments Act’’) was signed into law by President George W. Bush onSeptember 25, 2008, with a statutoryeffective date of January 1, 2009.Pursuant to the 2008 amendments, thedefinition of disability under the ADA,42 U.S.C. 12101,

et seq.,

shall beconstrued in favor of broad coverage tothe maximum extent permitted by theterms of the ADA as amended, and thedetermination of whether an individualhas a disability should not demandextensive analysis. The AmendmentsAct makes important changes to thedefinition of the term ‘‘disability’’ byrejecting the holdings in severalSupreme Court decisions and portionsof EEOC’s ADA regulations. The effectof these changes is to make it easier foran individual seeking protection underthe ADA to establish that he or she hasa disability within the meaning of theADA. Statement of the Managers toAccompany S. 3406, The Americanswith Disabilities Act Amendments Actof 2008 (hereinafter 2008 SenateManagers’ Statement); Committee onEducation and Labor Report togetherwith Minority Views (to accompanyH.R. 3195), H.R. Rep. No. 110–730 part1, 110th Cong., 2d Sess. (June 23, 2008)(hereinafter 2008 House Comm. onEduc. and Labor Report); Committee onthe Judiciary Report together withAdditional Views (to accompany H.R.3195), H.R. Rep. No. 110–730 part 2,110th Cong., 2d Sess. (June 23, 2008)(hereinafter 2008 House JudiciaryCommittee Report).The Amendments Act retains theADA’s basic definition of ‘‘disability’’ asan impairment that substantially limitsone or more major life activities, arecord of such an impairment, or beingregarded as having such an impairment.However, it changes the way that thesestatutory terms should be interpreted inseveral ways, therefore necessitatingrevision of the existing regulations andinterpretive guidance contained in theaccompanying ‘‘Appendix to Part1630—Interpretive Guidance on Title Iof the Americans with Disabilities Act,’’which are published at 29 CFR part1630.Consistent with the provisions of theAmendments Act and Congress’sexpressed expectation therein, theproposed rule:—Provides that the definition of ‘‘disability’’ shall be interpreted broadly;—Revises that portion of the regulationsdefining the term ‘‘substantiallylimits’’ as directed in theAmendments Act by providing that alimitation need not ‘‘significantly’’ or‘‘severely’’ restrict a major life activityin order to meet the standard, and bydeleting reference to the terms‘‘condition, manner, or duration’’under which a major life activity isperformed, in order to effectuateCongress’s clear instruction that‘‘substantially limits’’ is not to bemisconstrued to require the ‘‘level of limitation, and the intensity of focus’’applied by the Supreme Court in

Toyota Motor Mfg., Ky

Williams,

534 U.S. 134 (2002) (2008 SenateManagers’ Statement at 6);—Expands the definition of ‘‘major lifeactivities’’ through two non-exhaustive lists:—The first list includes activities suchas caring for oneself, performingmanual tasks, seeing, hearing, eating,sleeping, walking, standing, sitting,reaching, lifting, bending, speaking, breathing, learning, reading,concentrating, thinking,communicating, interacting withothers, and working, some of whichthe EEOC previously identified inregulations and sub-regulatoryguidance, and some of whichCongress additionally included in theAmendments Act;—The second list includes major bodilyfunctions, such as functions of theimmune system, special sense organs,and skin; normal cell growth; anddigestive, genitourinary, bowel, bladder, neurological, brain,respiratory, circulatory,cardiovascular, endocrine, hemic,lymphatic, musculoskeletal, andreproductive functions, many of which were included by Congress inthe Amendments Act, and some of which have been added by theCommission as further illustrativeexamples;—Provides that mitigating measuresother than ‘‘ordinary eyeglasses orcontact lenses’’ shall not beconsidered in assessing whether anindividual has a ‘‘disability’’;—Provides that an impairment that isepisodic or in remission is a disabilityif it would substantially limit a majorlife activity when active;—Provides that the definition of ‘‘regarded as’’ is changed so that it nolonger requires a showing that theemployer perceived the individual to be substantially limited in a major lifeactivity, and instead provides that anapplicant or employee who issubjected to an action prohibited bythe ADA (

e.g.,

failure to hire, denialof promotion, or termination) becauseof an actual or perceived impairmentwill meet the ‘‘regarded as’’ definitionof disability, unless the impairment is both transitory and minor;—The proposed rule provides thatactions based on an impairmentinclude actions based on symptoms of an impairment, and the Commissioninvites public comment on this point;—Provides that individuals coveredonly under the ‘‘regarded as’’ prongare not entitled to reasonableaccommodation; and,—Provides that qualification standards,employment tests, or other selectioncriteria based on an individual’suncorrected vision shall not be usedunless shown to be job-related for theposition in question and consistentwith business necessity.To effectuate these changes, theproposed rule revises the followingsections of 29 CFR part 1630 and theaccompanying provisions of theaccompanying Appendix:—§1630.1 (adds subsections (3) and(4));—§1630.2(g)(3) (adds cross-reference to1630.2(

));—§1630.2 (h) (replaces the term‘‘mental retardation’’ with the term‘‘intellectual disability’’);—§1630.2(i) (revises definition of ‘‘major life activities’’ and providesexamples)—§1630.2(j) (revises definition of ‘‘substantially limits’’ and providesexamples)—§1630.2(k) (provides examples of ‘‘record of’’ a disability)—§1630.2(

) (revises definition of ‘‘regarded as’’ having a disability andprovides examples)—§1630.2(m) (revises terminology)—§1630.2(o) (adds subsection (4)stating that reasonableaccommodations are not available toindividuals who are only ‘‘regardedas’’ individuals with disabilities)—§1630.4 (renumbers section and addssubsection (b) regarding ‘‘claims of nodisability’’)—§1630.9 (revises terminology insubsection (c) and adds subsection (e)stating that an individual coveredonly under the ‘‘regarded as’’definition of disability is not entitledto reasonable accommodation)—§1630.10 (revises to add provision onqualification standards and testsrelated to uncorrected vision)—§1630.16(a) (revises terminology).These regulatory revisions areexplained in the revised Part 1630Appendix containing the interpretiveguidance which would be issued andpublished in the Code of FederalRegulations with the final rule. TheCommission originally issued the

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interpretive guidance concurrent withthe issuance of the original Part 1630ADA regulations in order to ensure thatindividuals with disabilities understandtheir rights under these regulations andto facilitate and encourage compliance by covered entities. The Appendixaddresses the major provisions of theregulations and explains the majorconcepts. The Appendix as revisedwould continue to represent theCommission’s interpretation of theissues discussed, and the Commissionwill be guided by it when resolvingcharges of employment discriminationunder the ADA.

Regulatory Procedures

Executive Order 12866

The rule has been drafted andreviewed in accordance with ExecutiveOrder 12866, 58 FR 51735 (Sept. 30,1993), section 1(b), Principles of Regulation. It is considered to be a‘‘significant regulatory action’’ pursuantto section 3(f)(4) of Executive Order12866 in that it arises out of theCommission’s legal mandate to enforcethe ADA, and therefore was circulatedto the Office of Management and Budgetfor review. These revisions arenecessary to bring the Commission’sregulations into compliance with theADA Amendments Act of 2008, which became effective January 1, 2009, andexplicitly invalidated certain provisionsof the regulations. The proposedrevisions to the title I regulations andAppendix are intended to add to thepredictability and consistency betweenjudicial interpretations and executiveenforcement of the ADA as nowamended by Congress.

Preliminary Regulatory Impact Analysis

The following preliminary review of existing research highlights the costsand benefits of providing reasonableaccommodation under the ADA andsuggests that the effect on the economyof the changes to EEOC’s regulation asa result of the ADA Amendments Actwill very likely be below the $100million threshold for ‘‘economicallysignificant’’ regulations. Focusing on thecosts of reasonable accommodationsrequired by the regulationsimplementing the ADA Amendments,this preliminary review considersestimates of the cost of accommodation,the prevalence of accommodationalready in the workplace, the number of additional accommodation requests thatthe ADA Amendments Act would needto generate to reach the $100 millionthreshold for a economically significantregulatory impact, and the reported benefits to employers of providingreasonable accommodations. Since theexisting research measuring the relevantcosts and benefits is limited, however,the Commission seeks public commenton this issue in order to determinewhether further regulatory impactanalysis will be required.

Preliminary Discussion of Assumptions

Although this review is based on dataregarding how many people will benefitfrom the changes in the ADA and whatthe anticipated costs will be, it isimportant to take note of the followingunique factors bearing on any inquiryinto the increased costs imposed by theADA Amendments Act and EEOC’sproposed rule:—The fact that prior to the AmendmentsAct many plaintiffs lost reasonableaccommodation cases in litigation based on coverage does not meanemployers denied the underlyingaccommodation requests because theyconcluded that individuals did notmeet the definition of ‘‘disability.’’Many pre-Amendments Act courtdecisions, including those cited byCongress in the legislative history of the Amendments Act, held thatsomeone was not an individual witha disability in cases where theemployer’s denial of accommodationhad nothing to do with coverage.Rather, coverage was raised as a legaldefense after-the-fact against theasserted violation of the ADA. Thissuggests that costs associated with theAmendments and implementingregulations are not newly imposedand in many instances have already been expended under the ADA.—It is incorrect to assume that cancer,epilepsy, diabetes, or otherimpairments addressed in section1630.2(j)(5) of the NPRM were notcovered, in absolute terms, under theprior definition, but now are. Manypeople with the types of impairmentsidentified in section (j)(5) that willconsistently meet the new definitionof disability were already coveredunder EEOC’s prior interpretation of the law and by those employers whovoluntarily complied with it.—Many of the individuals actually brought within the new definition of ‘‘disability’’ are likely to have lesssevere limitations needing lessextensive accommodations. Moreover,those brought within the new‘‘regarded as’’ definition of ‘‘disability’’ are not entitled toaccommodation at all.—Of those newly covered under theamended definition who do bothrequest and need accommodation,employers will sometimes providewhatever is requested based onexisting employer policies andprocedures (

e.g.,

use of accruedannual or sick leave or employerunpaid leave policy, employer short-or long-term disability benefits,employer flexible schedule optionsguaranteed by a CBA, voluntarytransfer programs, ‘‘early return towork’’ programs, etc.), or underanother statute (

e.g.,

FMLA, workers’compensation, etc.).—Moreover, of those individuals withdisabilities who do requestaccommodation, not all will beentitled to it under the ADA because,for example, they do not need theaccommodation requested, there is noreasonable accommodation that can be provided absent undue hardship,or they would not be ‘‘qualified’’ orwould pose a ‘‘direct threat to safety,even with an accommodation.’’—EEOC fully expects to issue a new orrevised small business handbook aspart of revisions made to all of ourADA publications, which includedozens of enforcement guidances andtechnical assistance documents, someof which are specifically gearedtoward small business (

e.g.,

‘‘TheADA: A Primer for Small Business,’’

http://www.eeoc.gov/ada/ adahandbook.html)

.—An emphasis on the anticipated‘‘difference’’ in compliance costs between smaller and larger entitiesmay overlook some offsets to costsincurred by smaller entities. Forexample, EEOC makes available evenmore free outreach and trainingmaterials than it does paid trainings.Moreover, smaller entities are lesslikely to have detailed reasonableaccommodation procedurescontaining information relating to thedefinition of disability that must berevised or deleted.—The under-utilization of taxincentives available to encourageemployers to provide reasonableaccommodation, the lag time inreceipt of the offsets, and the fact thatthe offsets are only partial, do notnecessarily support greater costs,since the incentives typically apply toaccommodations that would relate tomore severe disabilities covered priorto the ADA Amendments Act.

Reasonable Accommodation

We note at the outset that extensivedata on the costs of providingreasonable accommodations forapplicants and employees withdisabilities does not exist, and thatmuch of the data that has been collectedwas obtained through either limitedsample surveys or surveys that collectedvery little information.