[No title available]

[Federal Register Volume 74, Number 233 (Monday, December 7, 2009)]

[Unknown Section]

[Pages 64257-64263]

From the Federal Register Online via the Government Publishing Office [www.gpo.gov]

[FR Doc No: X09-131207]

[[Page 64257]]

DEPARTMENT OF JUSTICE (DOJ)

Statement of Regulatory Priorities

The highest priority of the Department is to protect America against

acts of terrorism, both foreign and domestic, within the letter and

spirit of the Constitution. Without ever relaxing in the fight against

terrorism, the Department is also reinvigorating its traditional

missions by embracing its historic role in fighting crime, protecting

civil rights, preserving the environment, and ensuring fairness in the

market place. The Department is working to ensure the fair and

impartial administration of justice for all Americans, assist the

agency's state and local partners, and defend the interests of the

United States according to the law. In addition to using investigative,

prosecutorial, and other law enforcement activities, the Department is

also using the regulatory process to better carry out the Department's

wide-ranging law enforcement missions.

The Department of Justice's regulatory priorities focus in particular

on a major regulatory initiative in the area of civil rights.

Specifically, the Department is planning to revise its regulations

implementing titles II and III of the Americans With Disabilities Act

(ADA). However, in addition to this specific initiative, several other

components of the Department carry out important responsibilities

through the regulatory process. Although their regulatory efforts are

not singled out for specific attention in this regulatory plan, those

components carry out key roles in implementing the Department's anti-

terrorism and law enforcement priorities.

Civil Rights

In June 2008, the Department has published proposed rules to revise

its regulations implementing titles II and III of the ADA to amend the

ADA Standards for Accessible Design (28 CFR part 36, appendix A) to be

consistent with the revised ADA accessibility guidelines published by

the U.S. Architectural and Transportation Barriers Compliance Board

(Access Board) on July 23, 2004. During FY 2010, the Department expects

to complete its work on these regulations and to further amend the

Department's regulations to implement the ADA Amendments Act of 2008,

which took effect on January 1, 2009.

Title II of the ADA prohibits discrimination on the basis of

disability by public entities, and title III prohibits such

discrimination by places of public accommodation and requires

accessible design and construction of places of public accommodation

and commercial facilities. In implementing these provisions, the

Department of Justice is required by statute to publish regulations

that include design standards that are consistent with the guidelines

developed by the Access Board. In 2004, the Access Board revised its

Accessibility Guidelines to address issues such as unique State and

local facilities (e.g., prisons, courthouses), recreation facilities,

play areas, and building elements specifically designed for children's

use that were not addressed in the initial guidelines, to promote

greater consistency between the Federal accessibility requirements and

the model codes, and to provide greater consistency between the ADA

guidelines and the guidelines that implement the Architectural Barriers

Act. Therefore, the Department proposed to adopt revised ADA Standards

for Accessible Design that are consistent with the revised ADA

Accessibility Guidelines.

The Department has also proposed to revise its regulations

implementing title II and title III (28 CFR parts 35 and 36) to ensure

that the requirements applicable to new construction and alterations

under title II are consistent with those applicable under title III, to

update the regulations to reflect the current state of law, and to

ensure the Department's compliance with the Regulatory Flexibility Act,

as amended.

The Department's proposed rules were the second step in a three-step

process to adopt and interpret the Access Board's revised and amended

guidelines. The first step of the rulemaking process was an advance

notice of proposed rulemaking, published in the Federal Register on

September 30, 2004, at 69 FR 58768, which the Department believes

simplified and clarified the preparation of the proposed rule. In

addition to giving notice of the proposed rule that will adopt revised

ADA accessibility standards, the advance notice raised two sets of

questions for public comment, and proposed a framework for the

regulatory analysis that will accompany the proposed rule. The second

step of the rulemaking process was the publication of proposed rules

that would adopt revised ADA accessibility standards and that will

supplement the standards with specifications for prisons, jails, court

houses, legislative facilities, building elements designed for use by

children, play areas, and recreation facilities. The proposed rule also

offered proposed answers to the interpretive questions raised in the

advance notice and presented an initial regulatory assessment.

The final step in the process will be the publication of a final rule.

Changes mandated by the ADA Amendments Act will be addressed in a

separate rulemaking.

Other Department Initiatives

1. Prison Rape Elimination

The National Prison Rape Elimination Commission (NPREC) was created by

Congress as a bipartisan panel as part of the Prison Rape Elimination

Act of 2003 (PREA.) In June 2009, the NPREC issued its report

consisting of findings, conclusions and recommendations to the

President, Congress, the United States Attorney General, and other

Federal and State officials. The Department is in the process of

reviewing the Commission's recommendations, engaging stakeholders, and

drafting regulations to adopt national standards for the detection,

reduction, and punishment of prison rape, as provided for by the PREA.

2. Federal Habeas Corpus Review Procedures in Capital Cases

Pursuant to the USA PATRIOT Improvement and Reauthorization Act of

2005, on December 11, 2008 the Department promulgated a final rule to

implement certification procedures for states seeking to qualify for

the expedited Federal habeas corpus review procedures in capital cases

under chapter 154 of title 28 of the United States Code. On February 5,

2009, the Department published in the Federal Register a notice

soliciting further public comment on all aspects of the December 2008

final rule. The Department is presently reviewing the comments it

received in response to the February 2009 solicitation and will publish

a summary and response as appropriate.

3. Criminal Law Enforcement

In large part, the Department's criminal law enforcement components do

not rely on the rulemaking process to carry out their assigned

missions. The Federal Bureau of Investigation (FBI), for example, is

responsible for protecting and defending the United States against

terrorist and foreign intelligence threats, upholding and enforcing the

criminal laws of the United States, and providing leadership and

criminal justice services to Federal, State, municipal, and

international

[[Page 64258]]

agencies and partners. Only in very limited contexts does the FBI rely

on rulemaking. For example, the FBI is currently updating its National

Instant Criminal Background Check System regulations to allow criminal

justice agencies to conduct background checks prior to the return of

firearms.

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) issues

regulations to enforce the Federal laws relating to the manufacture and

commerce of firearms and explosives. ATF's mission and regulations are

designed to:

Curb illegal traffic in, and criminal use of, firearms, and to

assist State, local, and other Federal law enforcement

agencies in reducing crime and violence;

Facilitate investigations of violations of Federal explosives

laws and arson-for-profit schemes;

Regulate the firearms and explosives industries, including

systems for licenses and permits;

Assure the collection of all National Firearms Act (NFA)

firearms taxes and obtain a high level of voluntary

compliance with all laws governing the firearms industry;

and

Assist the States in their efforts to eliminate interstate

trafficking in, and the sale and distribution of,

cigarettes and alcohol in avoidance of Federal and State

taxes.

ATF will continue, as a priority during fiscal year 2010, to seek

modifications to its regulations governing commerce in firearms and

explosives. ATF plans to issue final regulations implementing the

provisions of the Safe Explosives Act, title XI, subtitle C, of Public

Law 107-296, the Homeland Security Act of 2002 (enacted November 25,

2002).

Combating the proliferation of methamphetamine and preventing the

diversion of prescription drugs for illicit purposes are among the

Attorney General's top drug enforcement priorities. The Drug

Enforcement Administration (DEA) is responsible for enforcing the

Controlled Substances Act and its implementing regulations to prevent

the diversion of controlled substances, while ensuring adequate

supplies for legitimate medical, scientific, and industrial purposes.

DEA accomplishes its objectives through coordination with State, local,

and other Federal officials in drug enforcement activities, development

and maintenance of drug intelligence systems, regulation of legitimate

controlled substances, and enforcement coordination and intelligence-

gathering activities with foreign government agencies. DEA continues to

develop and enhance regulatory controls relating to the diversion

control requirements for controlled substances.

One of DEA's key regulatory initiatives is its Notice of Proposed

Rulemaking ``Electronic Prescriptions for Controlled Substances'' [RIN

1117-AA61]. This regulation would provide practitioners with the option

of writing prescriptions for controlled substances electronically and

permit pharmacies to receive, dispense, and archive electronic

prescriptions for controlled substances. This regulation would provide

pharmacies, hospitals, and practitioners with the ability to use modern

technology for controlled substance prescriptions while maintaining the

closed system of controls on controlled substances.

In the past, drug traffickers have been able to easily obtain large

quantities of the List I chemicals ephedrine, pseudoephedrine, and

phenylpropanolamine, and others used in the clandestine production of

methamphetamine from both foreign and domestic sources. One of DEA's

key regulatory initiatives has been implementation of the Combat

Methamphetamine Epidemic Act of 2005 (CMEA), which further regulates

the importation, manufacture, and retail sale of ephedrine,

pseudoephedrine, and phenylpropanolamine and drug products containing

these three chemicals. CMEA imposes sales and purchase limits for over-

the-counter ephedrine, pseudoephedrine, and phenylpropanolamine

products at the retail level; provides for the establishment of

aggregate and individual company import and manufacturing quotas; and

limits importation to that which is necessary to provide for medical,

scientific, and other legitimate purposes. CMEA also provides

investigators with necessary identifying information regarding

manufacturers and importers of these chemicals. Regulations pertaining

to implementation of CMEA include, but are not limited to:

``Retail Sales of Scheduled Listed Chemical Products; Self-

Certification of Regulated Sellers of Scheduled Listed

Chemical Products'' [RIN 1117-AB05]

``Implementation of the Combat Methamphetamine Epidemic Act of

2005; Notice of Transfers Following Importation or

Exportation'' [RIN 1117-AB06]

``Elimination of Exemptions for Chemical Mixtures Containing

the List I Chemicals Ephedrine and/or Pseudoephedrine''

[RIN 1117-AB11]

``Registration Requirements for Importers and Manufacturers of

Prescription Drug Products Containing Ephedrine,

Pseudoephedrine, or Phenylpropanolamine'' [RIN 1117-AB09]

``Removal of Thresholds for the List I Chemicals

Pseudoephedrine and Phenylpropanolamine'' [RIN 1117-AB10]

The Federal Bureau of Prisons issues regulations to enforce the

Federal laws relating to its mission: To protect society by confining

offenders in the controlled environments of prisons and community-based

facilities that are safe, humane, cost-efficient, and appropriately

secure, and that provide work and other self-improvement opportunities

to assist offenders in becoming law-abiding citizens. During the next

12 months, in addition to other regulatory objectives aimed at

accomplishing its mission, the Bureau will continue its ongoing efforts

to: streamline regulations, eliminating unnecessary language and

improving readability; improve disciplinary procedures through a

revision of the subpart relating to the disciplinary process; reduce

the introduction of contraband through various means, such as

clarifying drug and alcohol surveillance testing programs and protect

the public from continuing criminal activity committed within prison;

and enhance the Bureau's ability to more closely monitor the

communications of high-risk inmates.

4. Immigration Matters

On March 1, 2003, pursuant to the Homeland Security Act of 2002 (HSA),

the responsibility for immigration enforcement and for providing

immigration-related services and benefits such as naturalization and

work authorization was transferred from the Justice Department's

Immigration and Naturalization Service (INS) to the Department of

Homeland Security (DHS). However, the immigration judges and the Board

of Immigration Appeals in the Executive Office for Immigration Review

(EOIR)) remain part of the Department of Justice; the immigration

judges adjudicate approximately 300,000 cases each year to determine

whether the aliens should be ordered

[[Page 64259]]

removed or should be granted some form of relief from removal, and the

Board has jurisdiction over appeals from those decisions, as well as

other matters. Accordingly, the Attorney General has a continuing role

in the conduct of removal hearings, the granting of relief from

removal, and the detention or release of aliens pending completion of

removal proceedings. The Attorney General also is responsible for civil

litigation and criminal prosecutions relating to the immigration laws.

In several pending rulemaking actions, the Department is working to

revise and update the regulations relating to removal proceedings in

order to improve the efficiency and effectiveness of the hearings in

resolving issues relating to removal of aliens and the granting of

relief from removal.

On June 3, 2009, the Attorney General announced his intention to

initiate a new rulemaking proceeding for regulations to govern claims

of ineffective assistance of counsel in immigration proceedings. The

Department is currently drafting regulations to further this goal. The

Department is also drafting regulations pursuant to the William

Wilberforce Trafficking Victims Protection Reauthorization Act of 2008

to take into account the specialized needs of unaccompanied alien

children in removal proceedings.

_______________________________________________________________________

DOJ--Civil Rights Division (CRT)

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FINAL RULE STAGE

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89. NONDISCRIMINATION ON THE BASIS OF DISABILITY IN PUBLIC

ACCOMMODATIONS AND COMMERCIAL FACILITIES (SECTION 610 REVIEW)

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority:

5 USC 301; 28 USC 509; 28 USC 510; 42 USC 12186(b)

CFR Citation:

28 CFR 36

Legal Deadline:

None

Abstract:

In 1991, the Department of Justice published regulations to implement

title III of the Americans With Disabilities Act of 1990 (ADA). Those

regulations include the ADA Standards for Accessible Design, which

establish requirements for the design and construction of accessible

facilities that are consistent with the ADA Accessibility Guidelines

(ADAAG) published by the U.S. Architectural and Transportation Barriers

Compliance Board (Access Board). In the time since the regulations

became effective, the Department of Justice and the Access Board have

each gathered a great deal of information regarding the implementation

of the Standards. The Access Board began the process of revising ADAAG

a number of years ago. It published new ADAAG in final form on July 23,

2004, after having published guidelines in proposed form in November

1999 and in draft final form in April 2002. In order to maintain

consistency between ADAAG and the ADA Standards, the Department is

reviewing its title III regulations and expects to propose, in one or

more stages, to adopt revised ADA Standards consistent with the final

revised ADAAG and to make related revisions to the Department's title

III regulations. In addition to maintaining consistency between ADAAG

and the Standards, the purpose of this review and these revisions is to

more closely coordinate with voluntary standards; to clarify areas

which, through inquiries and comments to the Department's technical

assistance phone lines, have been shown to cause confusion; to reflect

evolving technologies in areas affected by the Standards; and to comply

with section 610 of the Regulatory Flexibility Act, which requires

agencies once every 10 years to review rules that have a significant

economic impact upon a substantial number of small entities.

The first step in adopting revised Standards was an advance notice of

proposed rulemaking that was published in the Federal Register on

September 30, 2004, at 69 FR 58768, issued under both title II and

title III. The Department believes that the advance notice simplified

and clarified the preparation of the proposed rule. In addition to

giving notice that the proposed rule will adopt revised ADA

accessibility standards, the advance notice raised questions for public

comment and proposed a framework for the regulatory analysis that

accompanied the proposed rule.

The adoption of revised ADAAG will also serve to address changes to the

ADA Standards previously proposed in RIN 1190-AA26, RIN 1190-AA38, RIN

1190-AA47, and RIN 1190-AA50, all of which have now been withdrawn from

the Unified Agenda. These changes include technical specifications for

facilities designed for use by children, accessibility standards for

State and local government facilities, play areas, and recreation

facilities, all of which had previously been published by the Access

Board.

The timetable set forth below refers to the notice of proposed

rulemaking that the Department issued as the second step of the above

described title III rulemaking. This notice proposed to adopt revised

ADA Standards for Accessible Design consistent with the minimum

guidelines of the revised ADAAG, and initiated the review of the

regulation in accordance with the requirements of section 610 of the

Regulatory Flexibility Act, as amended by the Small Business Regulatory

Enforcement Fairness Act of 1996 (SBREFA).

Statement of Need:

Section 504 of the ADA requires the Access Board to issue supplemental

minimum guidelines and requirements for accessible design of buildings

and facilities subject to the ADA, including title III. Section 306(c)

of the ADA requires the Attorney General to promulgate regulations

implementing title III that are consistent with the Access Board's ADA

guidelines. Because this rule will adopt standards that are consistent

with the minimum guidelines issued by the Access Board, this rule is

required by statute. Similarly, the Department's review of its title

III regulation is being undertaken to comply with the requirements of

the Regulatory Flexibility Act, as amended by SBREFA.

Summary of Legal Basis:

The summary of the legal basis of authority for this regulation is set

forth above under Legal Authority and Statement of Need.

Alternatives:

The Department is required by the ADA to issue this regulation.

Pursuant to SBREFA, the Department's title III regulation will consider

whether alternatives to the currently published requirements are

appropriate.

Anticipated Cost and Benefits:

The Access Board has analyzed the effect of applying its proposed

amendments to ADAAG to entities covered by titles II and III of the ADA

and has determined that they constitute

[[Page 64260]]

a significant regulatory action for purposes of Executive Order 12866.

The Access Board's determination will apply as well to the revised ADA

standards published by the Department.

As part of its revised ADAAG, the Access Board made available in

summary form an updated regulatory assessment to accompany the final

revised ADAAG. The Department prepared an initial Regulatory Impact

Analysis (RIA), pursuant to E.O. 12866, of the combined economic impact

of changes contained in this proposed rule and in the companion NPRM to

amend the Department's title II regulation (RIN 1190-AA46). The RIA

incorporates the elements required for the Initial Regulatory

Flexibility Analysis (IRFA) required by the Regulatory Flexibility Act,

as amended. A summary of this RIA was published in the Federal Register

at 73 FR 37009, 37042 (June 30, 2008). The full analysis is available

for public review on www.regulations.gov and on the Department's ADA

Home Page, www.ada.gov. A revised RIA will be made available to the

public when the final rules are published.

The preliminary RIA indicates that the proposed rules will have a net

positive public benefit, i.e., the benefits will exceed the costs over

the life of the rule. This concept is expressed as the discounted net

present value (NPV) The RIA projects that the NPV will be between $7.5

billion (at a 7% discount rate) and $ 31.1 billion (at a 3% discount

rate). The RIA also concludes that the combined effect of the proposed

rules would not have a significant economic impact on a substantial

number of small entities.

Section 4(2) of the Unfunded Mandates Reform Act of 1995, 2 U.S.C.

1503(2), excludes from coverage under that Act any proposed or final

Federal regulation that ``establishes or enforces any statutory rights

that prohibit discrimination on the basis of race, color, religion,

sex, national origin, age, handicap, or disability.`` Accordingly, this

rulemaking is not subject to the provisions of the Unfunded Mandates

Reform Act.

Risks:

Without the proposed changes to the Department's title III regulation,

the ADA Standards will fail to be consistent with the ADAAG.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

ANPRM 09/30/04 69 FR 58768

ANPRM Comment Period End 01/28/05

ANPRM Comment Period

Extended 01/19/05 70 FR 2992

ANPRM Comment Period End 05/31/05

NPRM 06/17/08 73 FR 34508

NPRM Comment Period End 08/18/08

NPRM Correction 06/30/08 73 FR 37009

Final Action 03/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses, Organizations

Government Levels Affected:

None

Additional Information:

RIN 1190-AA44, which will effect changes to 28 CFR 36 (the Department's

regulation implementing title III of the ADA), is related to another

rulemaking of the Civil Rights Division, RIN 1190-AA46, which will

effect changes to 28 CFR 35 (the Department's regulation implementing

title II of the ADA).

Agency Contact:

John L. Wodatch

Chief, Disability Rights Section

Department of Justice

Civil Rights Division

950 Pennsylvania Avenue NW

Washington, DC 20030

Phone: 800 514-0301

TDD Phone: 800 514-0383

Fax: 202 307-1198

RIN: 1190-AA44

_______________________________________________________________________

DOJ--CRT

90. NONDISCRIMINATION ON THE BASIS OF DISABILITY IN STATE AND LOCAL

GOVERNMENT SERVICES (SECTION 610 REVIEW)

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority:

5 USC 301; 28 USC 509 to 510; 42 USC 12134; PL 101-336

CFR Citation:

28 CFR 35

Legal Deadline:

None

Abstract:

On July 26, 1991, the Department published its final rule implementing

title II of the Americans With Disabilities Act (ADA). On November 16,

1999, the U.S. Architectural and Transportation Barriers Compliance

Board (Access Board) issued its first comprehensive review of the ADA

Accessibility Guidelines (ADAAG), which form the basis of the

Department's ADA Standards for Accessible Design. The Access Board

published an Availability of Draft Final Guidelines on April 2, 2002,

and published the ADA Accessibility Guidelines in final form on July

23, 2004. The ADA (section 204(c)) requires the Department's standards

to be consistent with the Access Board's guidelines. In order to

maintain consistency between ADAAG and the Standards, the Department is

reviewing its title II regulations and expects to propose, in one or

more stages, to adopt revised standards consistent with new ADAAG. The

Department will also, in one or more stages, review its title II

regulations for purposes of section 610 of the Regulatory Flexibility

Act and make related changes to its title II regulations.

In addition to the statutory requirement for the rule, the social and

economic realities faced by Americans with disabilities dictate the

need for the rule. Individuals with disabilities cannot participate in

the social and economic activities of the Nation without being able to

access the programs and services of State and local governments.

Further, amending the Department's ADA regulations will improve the

format and usability of the ADA Standards for Accessible Design;

harmonize the differences between the ADA Standards and national

consensus standards and model codes; update the ADA Standards to

reflect technological developments that meet the needs of persons with

disabilities; and coordinate future ADA Standards revisions with

national standards and model code organizations. As a result, the

overarching goal of improving access for persons with disabilities so

that they can benefit from the goods, services, and activities provided

to the public by covered entities will be met.

The first part of the rulemaking process was an advance notice of

proposed rulemaking, published in the Federal Register on September 30,

2004, at 69 FR 58768, issued under both title II and title III. The

Department believes the advance notice simplified and clarified the

preparation of the proposed rule to

[[Page 64261]]

follow. In addition to giving notice of the proposed rule that will

adopt revised ADA accessibility standards, the advance notice raised

questions for public comment and proposed a framework for the

regulatory analysis that accompanied the proposed rule.

The adoption of revised ADA Standards consistent with revised ADAAG

will also serve to address changes to the ADA Standards previously

proposed under RIN 1190-AA26, RIN 1190-AA38, RIN 1190-AA47, and RIN

1190-AA50, all of which have now been withdrawn from the Unified

Agenda. These changes include technical specifications for facilities

designed for use by children, accessibility standards for State and

local government facilities, play areas, and recreation facilities, all

of which had previously been published by the Access Board.

The timetable set forth below refers to the notice of proposed

rulemaking that the Department issued as the second step of the above-

described title III rulemaking. This notice also proposed to eliminate

the Uniform Federal Accessibility Standards (UFAS) as an alternative to

the ADA Standards for Accessible Design.

Statement of Need:

Section 504 of the ADA requires the Access Board to issue supplemental

minimum guidelines and requirements for accessible design of buildings

and facilities subject to the ADA, including title II. Section 204(c)

of the ADA requires the Attorney General to promulgate regulations

implementing title II that are consistent with the Access Board's ADA

guidelines. Because this rule will adopt standards that are consistent

with the minimum guidelines issued by the Access Board, this rule is

required by statute. Similarly, the Department's review of its title II

regulations is being undertaken to comply with the requirements of the

Regulatory Flexibility Act, as amended by the Small Business Regulatory

Enforcement Fairness Act (SBREFA).

Summary of Legal Basis:

The summary of the legal basis of authority for this regulation is set

forth above under Legal Authority and Statement of Need.

Alternatives:

The Department is required by the ADA to issue this regulation as

described in the Statement of Need above. Pursuant to SBREFA, the

Department's title II regulation will consider whether alternatives to

the currently published requirements are appropriate.

Anticipated Cost and Benefits:

The Administration is deeply committed to ensuring that the goals of

the ADA are met. Promulgating this amendment to the Department's ADA

regulations will ensure that entities subject to the ADA will have one

comprehensive design standard to follow. Currently, entities subject to

title II of the ADA (State and local governments) have a choice between

following the Department's ADA Standards for title III, which were

adopted for places of public accommodation and commercial facilities

and which do not contain standards for common State and local

government buildings (such as courthouses and prisons), or the Uniform

Federal Accessibility Standards (UFAS). By developing one comprehensive

standard, the Department will eliminate the confusion that arises when

governments try to mesh two different standards. As a result, the

overarching goal of improving access to persons with disabilities will

be better served.

The Access Board has analyzed the effect of applying its proposed

amendments to ADAAG to entities covered by titles II and III of the ADA

and has determined that they constitute a significant regulatory action

for purposes of Executive Order 12866. The Access Board's determination

will apply as well to the revised ADA Standards published by the

Department.

As part of its revised ADAAG, the Access Board made available in

summary form an updated regulatory assessment to accompany the final

revised ADAAG. The Department prepared an initial Regulatory Impact

Analysis (RIA), pursuant to E.O. 12866, of the combined economic impact

of changes contained in this proposed rule and in the companion NPRM to

amend the Department's title III regulation (RIN 1190-AA44). The RIA

incorporates the elements required for the Initial Regulatory

Flexibility Analysis (IRFA) required by the Regulatory Flexibility Act,

as amended. A summary of this RIA was published in the Federal Register

at 73 FR 36964, 36996 (June 30, 2008). The full analysis is available

for public review on www.regulations.gov and on the Department's ADA

Home Page, www.ada.gov. A revised RIA will be made available to the

public when the final rules are published.

The preliminary RIA indicates that the proposed rules will have a net

positive public benefit; i.e., the benefits will exceed the costs over

the life of the rule. This concept is expressed as the discounted net

present value (NPV) The RIA projects that the NPV will be between $ 7.5

billion (at a 7% discount rate) and $ 31.1 billion (at a 3% discount

rate). The RIA also concludes that the combined effect of the proposed

rules would not have a significant economic impact on a substantial

number of small entities.

The Access Board has made every effort to lessen the impact of its

proposed guidelines on State and local governments but recognizes that

the guidelines will have some federalism effects. These effects are

discussed in the Access Board's regulatory assessment, which also

applies to the Department's proposed rule. Section 4(2) of the Unfunded

Mandates Reform Act of 1995, 2 U.S.C. 1503(2), excludes from coverage

under that Act any proposed or final Federal regulation that

``establishes or enforces any statutory rights that prohibit

discrimination on the basis of race, color, religion, sex, national

origin, age, handicap, or disability.'' Accordingly, this rulemaking is

not subject to the provisions of the Unfunded Mandates Reform Act.

Risks:

Without this amendment to the Department's ADA regulations, regulated

entities will be subject to confusion and delay as they attempt to sort

out the requirements of conflicting design standards. This amendment

should eliminate the costs and risks associated with that process.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

ANPRM 09/30/04 69 FR 58768

ANPRM Comment Period End 01/28/05

ANPRM Comment Period

Extended 01/19/05 70 FR 2992

ANPRM Comment Period End 05/31/05

NPRM 06/17/08 73 FR 34466

NPRM Comment Period End 08/18/08

NPRM Correction 06/30/08 73 FR 36964

Final Action 03/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Governmental Jurisdictions

[[Page 64262]]

Government Levels Affected:

Local, State

Federalism:

This action may have federalism implications as defined in EO 13132.

Additional Information:

RIN 1190-AA46, which will effect changes to 28 CFR 35 (the Department's

regulation implementing title II of the ADA), is related to another

rulemaking of the Civil Rights Division, RIN 1190-AA44, which will

effect changes to 28 CFR 36 (the Department's regulation implementing

title III of the ADA). By adopting revised ADAAG, this rulemaking will,

among other things, address changes to the ADA Standards previously

proposed in RINs 1190-AA26, 1190-AA36, and 1190-AA38, which have been

withdrawn and merged into this rulemaking. These changes include

accessibility standards for State and local government facilities that

had been previously published by the Access Board (RIN 1190-AA26) and

the timing for the compliance of State and local governments with the

curb-cut requirements of the title II regulation (RIN 1190-AA36). In

order to consolidate regulatory actions implementing title II of the

ADA, on February 15, 2000, RINs 1190-AA26 and 1190-AA38 were merged

into this rulemaking and on March 5, 2002, RIN 1190-AA36 was merged

into this rulemaking.

Agency Contact:

John L. Wodatch

Chief, Disability Rights Section

Department of Justice

Civil Rights Division

950 Pennsylvania Avenue NW

Washington, DC 20030

Phone: 800 514-0301

TDD Phone: 800 514-0383

Fax: 202 307-1198

RIN: 1190-AA46

_______________________________________________________________________

DOJ--Drug Enforcement Administration (DEA)

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FINAL RULE STAGE

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91. ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority:

21 USC 802; 21 USC 821; 21 USC 827; 21 USC 829; 21 USC 871(b)

CFR Citation:

21 CFR 1300; 21 CFR 1306; 21 CFR 1311

Legal Deadline:

None

Abstract:

DEA is revising its regulations to establish the criteria that will

allow DEA-registered practitioners to sign and transmit controlled

substances prescriptions electronically. The regulations will also

permit pharmacies to receive, dispense, and archive these electronic

prescriptions. These regulations would not mandate the use of

electronic prescriptions, but would establish the requirements that

must be met by any registrant that wishes to issue or receive

electronic prescriptions for controlled substances. The regulations

would establish requirements that practitioners must meet when issuing

electronic prescriptions, including requirements for the software

applications used to issue those prescriptions; registrants would have

to use only those software applications that meet the security

requirements if they intend to sign, transmit, or process electronic

prescriptions for controlled substances. The regulations would not

apply to software used to create a prescription that is then printed

and manually signed. These revised regulations would be in addition to,

not a replacement of, the existing rules.

Statement of Need:

These regulations are needed to give pharmacies, hospitals, and

practitioners the ability to use modern technology for controlled

substance prescriptions, while maintaining the closed system of

distribution of controlled substances dispensing. The regulations are

required to ensure, to the extent possible, that non-registrants cannot

gain access to electronic prescription software applications to issue

illegal prescriptions and that legitimate prescriptions, once written,

cannot be altered or repudiated.

Summary of Legal Basis:

The Controlled Substances Act (21 U.S.C. 871(b) provides that the

Attorney General, DEA by delegation, may promulgate and enforce any

rules, regulations, and procedures deemed necessary for the efficient

execution of the Attorney General's functions, including general

enforcement of the Controlled Substances Act. Specific legal authority

for this regulation is provided above.

Alternatives:

DEA solicited comments on all aspects of its Notice of Proposed

Rulemaking regarding this matter, and also sought specific information

on a number of issues and topics. All comments received have been

considered. DEA has addressed comments in its Final Rule.

Anticipated Cost and Benefits:

The estimated annualized cost of the Final Rule is $34 million (7

percent net present value), which covers the costs for practitioners,

pharmacies, and application providers.

Electronic prescriptions provide potential benefits in terms of reduced

processing time, reduced callbacks, and fewer medication errors. These

benefits of electronic prescriptions are not directly attributable to

this rule except to the extent the rule facilitates implementation of

electronic prescribing of controlled substances. Pharmacies will

directly benefit from the rule as they will not be required to maintain

paper copies of electronic prescriptions. Electronic prescriptions for

controlled substances will also provide benefits as certain types of

forgery or alteration of prescriptions may be less likely to occur.

Risks:

Were DEA not to promulgate these regulations, prescribing practitioners

would not be permitted to sign and transmit electronic controlled

substances prescriptions. Pharmacies would not be permitted to receive,

dispense, and archive these electronic prescriptions.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

ANPRM 03/05/01 66 FR 13274

NPRM 06/27/08 73 FR 36722

NPRM Comment Period End 09/25/08

Final Rule 03/00/10

Final Action Effective 05/00/10

Regulatory Flexibility Analysis Required:

No

Government Levels Affected:

None

Additional Information:

DEA-218

[[Page 64263]]

URL For Public Comments:

www.deadiversion.usdoj.gov

Agency Contact:

Mark W. Caverly

Chief, Liaison and Policy Section

Department of Justice

Drug Enforcement Administration

8701 Morrissette Drive

Springfield, VA 22152

Phone: 202 307-7297

Email: [email protected]

RIN: 1117-AA61

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