, 64257-64263 [X09-131207]

[Federal Register Volume 74, Number 233 (Monday, December 7, 2009)]
[Unknown Section]
[Pages 64257-64263]
From the Federal Register Online via the Government Printing 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)

                              -----------

                            FINAL RULE STAGE

                              -----------




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: dea.diversion.policy@usdoj.gov
RIN: 1117-AA61
BILLING CODE 4410-BP-S