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