Rescission of the Regulation Entitled “Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law”; Proposal, 10207-10211 [E9-5067]
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Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Proposed Rules
after opportunity for a hearing.’’ Such
proceedings are conducted pursuant to
the provisions of 5 U.S.C. 556 and 557
and, as such, are exempt from review by
the Office of Management and Budget
pursuant to Executive Order 12866,
§ 3(d)(1).
Regulatory Flexibility Act
The Deputy Administrator, in
accordance with the Regulatory
Flexibility Act (5 U.S.C. 601–612), has
reviewed this proposed rule and by
approving it certifies that it will not
have a significant economic impact on
a substantial number of small entities.
Lacosamide products will be
prescription drugs used for the
treatment of partial-onset seizures.
Handlers of lacosamide often handle
other controlled substances used in the
treatment of central nervous system
disorders which are already subject to
the regulatory requirements of the CSA.
Executive Order 12988
This regulation meets the applicable
standards set forth in §§ 3(a) and 3(b)(2)
of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This rulemaking does not preempt or
modify any provision of state law; nor
does it impose enforcement
responsibilities on any state; nor does it
diminish the power of any state to
enforce its own laws. Accordingly, this
rulemaking does not have federalism
implications warranting the application
of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the
expenditure by state, local, and tribal
governments, in the aggregate, or by the
private sector, of $120,000,000 or more
(adjusted for inflation) in any one year,
and will not significantly or uniquely
affect small governments. Therefore, no
actions were deemed necessary under
provisions of the Unfunded Mandates
Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as
defined by § 804 of the Small Business
Regulatory Enforcement Fairness Act of
1996 (Congressional Review Act). This
rule will not result in an annual effect
on the economy of $100,000,000 or
more; a major increase in costs or prices:
or significant adverse effects on
competition, employment, investment,
productivity, innovation, or on the
ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
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List of Subjects in 21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Narcotics, Prescription drugs.
Under the authority vested in the
Attorney General by § 201(a) of the CSA
(21 U.S.C. 811(a)), and delegated to the
Administrator of DEA by Department of
Justice regulations (28 CFR 0.100), and
redelegated to the Deputy Administrator
pursuant to 28 CFR 0.104, the Deputy
Administrator hereby proposes that 21
CFR part 1308 be amended as follows:
10207
implementing the Church Amendments,
Section 245 of the Public Health Service
Act, and the Weldon Amendment.
DATES: Submit written or electronic
comment on the regulatory changes
proposed by this document by April 9,
2009.
ADDRESSES: In commenting, please refer
to ‘‘Rescission Proposal.’’ To better
manage the comment process, we will
not accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (no duplicates, please):
PART 1308—SCHEDULES OF
1. Electronically. You may submit
CONTROLLED SUBSTANCES
electronic comments on this regulation
to https://www.Regulations.gov or via e1. The authority citation for 21 CFR
mail to proposedrescission@hhs.gov. To
part 1308 continues to read as follows:
submit electronic comments to https://
Authority: 21 U.S.C. 811, 812, 871(b)
www.Regulations.gov, go to the Web site
unless otherwise noted.
and click on the link ‘‘Comment or
Submission’’ and enter the keywords
2. Section 1308.15 is amended by
‘‘Rescission Proposal.’’ [Attachments
revising paragraph (e)(1) adding a new
should be in Microsoft Word,
paragraph (e)(2) to read as follows:
WordPerfect, or Excel; however, we
§ 1308.15 Schedule V.
prefer Microsoft Word.]
*
*
*
*
*
2. By regular mail. You may mail
(e) * * *
written comments (one original and two
(1) Lacosamide [(R)-2-acetoamido-Ncopies) to the following address only:
benzyl-3-methoxy-propionamide]—2746 Office of Public Health and Science,
(2) Pregabalin [(S)-3-(aminomethyl)-5- Department of Health and Human
methylhexanoic acid]—2782
Services, Attention: Rescission Proposal
Comments, Hubert H. Humphrey
Dated: February 26, 2009.
Building, 200 Independence Avenue,
Michele M. Leonhart,
SW., Room 716G, Washington, DC
Deputy Administrator.
20201.
[FR Doc. E9–4890 Filed 3–9–09; 8:45 am]
3. By express or overnight mail. You
BILLING CODE 4410–09–P
may send written comments (one
original and two copies) to the following
address only: Office of Public Health
DEPARTMENT OF HEALTH AND
and Science, Department of Health and
HUMAN SERVICES
Human Services, Attention: Rescission
Proposal Comments, Hubert H.
45 CFR Part 88
Humphrey Building, 200 Independence
RIN 0991–AB49
Avenue, SW., Room 716G, Washington,
DC 20201.
Rescission of the Regulation Entitled
4. By hand or courier. If you prefer,
‘‘Ensuring That Department of Health
you may deliver (by hand or courier)
and Human Services Funds Do Not
your written comments (one original
Support Coercive or Discriminatory
and two copies) before the close of the
Policies or Practices in Violation of
comment period to the following
Federal Law’’; Proposal
address: Room 716G, Hubert H.
Humphrey Building, 200 Independence
AGENCY: Office of the Secretary, HHS.
Avenue, SW., Washington, DC 20201.
ACTION: Proposed rule.
(Because access to the interior of the
SUMMARY: The Department of Health and Hubert H. Humphrey Building is not
Human Services proposes to rescind the readily available to persons without
December 19, 2008 final rule entitled
federal government identification,
‘‘Ensuring That Department of Health
commenters are encouraged to leave
and Human Services Funds Do Not
their comments in the mail drop slots
Support Coercive or Discriminatory
located in the main lobby of the
Policies or Practices in Violation of
building. A stamp-in clock is available
Federal Law.’’ The Department believes for persons wishing to retain proof of
it is important to have an opportunity to filing by stamping in and retaining an
review this regulation to ensure its
extra copy of the documents being
consistency with current
filed.)
Inspection of Public Comments: All
Administration policy and to reevaluate
comments received before the close of
the necessity for regulations
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the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.Regulations.gov. Click on the link
‘‘Comment or Submission’’ on that Web
site to view public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Department of Health and Human
Services, Hubert H. Humphrey Building,
200 Independence Avenue, SW.,
Washington, DC 20201, Monday
through Friday of each week from 8:30
a.m. to 4 p.m.
Electronic Access
This Federal Register document is
also available from the Federal Register
online database through GPO Access, a
service of the U.S. Government Printing
Office. Free public access is available on
a Wide Area Information Service
(WAIS) through the Internet and via
asynchronous dial-in. Internet users can
access the database by using the World
Wide Web (the Superintendent of
Documents’ home page address is
https://www.gpoaccess.gov/), by using
local WAIS client software, or by telnet
to swais.access.gpo.gov, then login as
guest (no password required). Dial-in
users should use communications
software and modem to call (202) 512–
1661; type swais, then login as guest (no
password required).
FOR FURTHER INFORMATION CONTACT:
Mahak Nayyar, (240) 276–9866, Office
of Public Health and Science,
Department of Health and Human
Services, Room 716G, Hubert E.
Humphrey Building, 200 Independence
Avenue, SW., Washington, DC 20201.
SUPPLEMENTARY INFORMATION:
I. Background
Statutory Background
Several provisions of federal law
prohibit recipients of certain federal
funds from coercing individuals in the
health care field into participating in
actions they find religiously or morally
objectionable.
Conscience Clauses/Church
Amendments [42 U.S.C. 300a–7]
The conscience provisions contained
in 42 U.S.C. 300a–7 (collectively known
as the ‘‘Church Amendments’’) were
enacted at various times during the
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1970s in response to debates over
whether receipt of federal funds
required the recipients of such funds to
perform abortions or sterilizations. The
first conscience provision in the Church
Amendments, 42 U.S.C. 300a–7(b),
provides that ‘‘[t]he receipt of any grant,
contract, loan, or loan guarantee under
[certain statutes implemented by the
Department of Health and Human
Services] by any individual or entity
does not authorize any court or any
public official or other public authority
to require’’ (1) The individual to
perform or assist in a sterilization
procedure or an abortion, if it would be
contrary to his/her religious beliefs or
moral convictions; (2) the entity to make
its facilities available for sterilization
procedures or abortions, if the
performance of sterilization procedures
or abortions in the facilities is
prohibited by the entity on the basis of
religious beliefs or moral convictions; or
(3) the entity to provide personnel for
the performance or assistance in the
performance of sterilization procedures
or abortions, if it would be contrary to
the religious beliefs or moral
convictions of such personnel.
The second conscience provision in
the Church Amendments, 42 U.S.C.
300a–7(c)(1), prohibits any entity that
receives a grant, contract, loan, or loan
guarantee under certain Departmentimplemented statutes from
discriminating against any physician or
other health care personnel in
employment, promotion, termination of
employment, or the extension of staff or
other privileges because the individual
‘‘performed or assisted in the
performance of a lawful sterilization
procedure or abortion, because he
refused to perform or assist in the
performance of such a procedure or
abortion on the grounds that his
performance or assistance in the
performance of the procedure or
abortion would be contrary to his
religious beliefs or moral convictions, or
because of his religious beliefs or moral
convictions respecting sterilization
procedures or abortions.’’
The third conscience provision,
contained in 42 U.S.C. 300a–7(c)(2),
prohibits any entity that receives a grant
or contract for biomedical or behavioral
research under any program
administered by the Department from
discriminating against any physician or
other health care personnel in
employment, promotion, termination of
employment, or extension of staff or
other privileges ‘‘because he performed
or assisted in the performance of any
lawful health service or research
activity, because he refused to perform
or assist in the performance of any such
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service or activity on the grounds that
his performance or assistance in the
performance of such service or activity
would be contrary to his religious
beliefs or moral convictions, or because
of his religious beliefs or moral
convictions respecting any such service
or activity.’’
The fourth conscience provision, 42
U.S.C. 300a–7(d), provides that ‘‘[n]o
individual shall be required to perform
or assist in the performance of any part
of a health service program or research
activity funded in whole or in part
under a program administered by [the
Department] if his performance or
assistance in the performance of such
part of such program or activity would
be contrary to his religious beliefs or
moral convictions.’’
The final conscience provision
contained in the Church Amendments,
42 U.S.C. 300a–7(e), prohibits any entity
that receives a grant, contract, loan, loan
guarantee, or interest subsidy under
certain Departmentally implemented
statutes from denying admission to, or
otherwise discriminating against, ‘‘any
applicant (including applicants for
internships and residencies) for training
or study because of the applicant’s
reluctance, or willingness, to counsel,
suggest, recommend, assist, or in any
way participate in the performance of
abortions or sterilizations contrary to or
consistent with the applicant’s religious
beliefs or moral convictions.’’
Public Health Service Act Sec. 245 [42
U.S.C. 238n]
Enacted in 1996, section 245 of the
Public Health Service Act (PHS Act)
prohibits the federal government and
any State or local government receiving
federal financial assistance from
discriminating against any health care
entity on the basis that the entity (1)
‘‘Refuses to undergo training in the
performance of induced abortions, to
require or provide such training, to
perform such abortions, or to provide
referrals for such training or such
abortions;’’ (2) refuses to make
arrangements for such activities; or (3)
‘‘attends (or attended) a post-graduate
physician training program, or any other
program of training in the health
professions, that does not (or did not)
perform induced abortions or require,
provide, or refer for training in the
performance of induced abortions, or
make arrangements for the provision of
such training.’’ For the purposes of this
protection, the statute defines ‘‘financial
assistance’’ as including, ‘‘with respect
to a government program,’’
‘‘governmental payments provided as
reimbursement for carrying out healthrelated activities.’’ In addition, PHS Act
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Sec. 245 requires that, in determining
whether to grant legal status to a health
care entity (including a State’s
determination of whether to issue a
license or certificate), the federal
government and any State or local
government receiving federal financial
assistance shall deem accredited any
post-graduate physician training
program that would be accredited, but
for the reliance on an accrediting
standard that, regardless of whether
such standard provides exceptions or
exemptions, requires an entity: (1) to
perform induced abortions; or (2) to
require, provide, or refer for training in
the performance of induced abortions,
or make arrangements for such training.
Weldon Amendment
The Weldon Amendment, originally
adopted as section 508(d) of the LaborHHS Division (Division F) of the 2005
Consolidated Appropriations Act,
Public Law 108–447, 118 Stat. 2809,
3163 (Dec. 8, 2004), has been readopted
(or incorporated by reference) in each
subsequent HHS appropriations act.
Title V of the Departments of Labor,
Health and Human Services, and
Education, and Related Agencies
Appropriations Act, 2006, Public Law
109–149, Sec. 508(d), 119 Stat. 2833,
2879–80 (Dec. 30, 2005); Revised
Continuing Appropriations Resolution
of 2007, Public Law 110–5, Sec. 2, 121
Stat. 8, 9 (Feb. 15, 2007); Consolidated
Appropriations Act, 2008, Public Law
110–161, Div. G, Sec. 508(d), 121 Stat.
1844, 2209 (Dec. 26, 2007);
Consolidated Security, Disaster
Assistance, and Continuing
Appropriations Act, 2009, Public Law
110–329, Div. A, Sec. 101, 122 Stat.
3574, 3575 (Sept. 30, 2008). The Weldon
Amendment provides that ‘‘[n]one of
the funds made available in this Act
[making appropriations for the
Departments of Labor, Health and
Human Services, and Education] may be
made available to a Federal agency or
program, or to a State or local
government, if such agency, program, or
government subjects any institutional or
individual health care entity to
discrimination on the basis that the
health care entity does not provide, pay
for, provide coverage of, or refer for
abortions.’’ It also defines ‘‘health care
entity’’ to include ‘‘an individual
physician or other health care
professional, a hospital, a providersponsored organization, a health
maintenance organization, a health
insurance plan, or any other kind of
health care facility, organization, or
plan.’’
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Rulemaking
No statutory provision requires the
promulgation of rules to implement the
requirements of the Church
Amendments, Public Health Service
(PHS) Act Sec. 245, and the Weldon
Amendment. Nevertheless, on August
26, 2008, the Department exercised its
discretion and issued a proposed rule
entitled ‘‘Ensuring that Department of
Health and Human Services Funds Do
Not Support Coercive or Discriminatory
Policies or Practices in Violation of
Federal Law’’ (73 FR 50274). Citing
concerns that the development of an
environment in the health care field that
is intolerant of individual conscience,
certain religious beliefs, ethnic and
cultural traditions, and moral
convictions may discourage individuals
from diverse backgrounds from entering
health care professions, the Department
concluded that regulations were
necessary in order to (1) Educate the
public and health care providers on the
obligations imposed, and protections
afforded, by federal law; (2) work with
State and local governments and other
recipients of funds from the Department
to ensure compliance with the
nondiscrimination requirements
embodied in the Church Amendments,
PHS Act Sec. 245, and the Weldon
Amendment; (3) when such compliance
efforts prove unsuccessful, enforce these
nondiscrimination laws through the
various Department mechanisms, to
ensure that Department funds do not
support coercive or discriminatory
practices, or policies in violation of
federal law; and (4) otherwise take an
active role in promoting open
communication within the healthcare
industry, and between providers and
patients, fostering a more inclusive,
tolerant environment in the health care
industry than may currently exist.
A wide variety of individuals and
organizations, including private
citizens, individual and institutional
health care providers, religious
organizations, patient advocacy groups,
professional organizations, universities
and research institutions, consumer
organizations, and State and federal
agencies and representatives,
commented on the proposed rule.
Comments dealt with a range of issues
surrounding the proposed rule,
including the need for the rule, what
kinds of workers would be protected by
the proposed rule, the rule’s
relationship to Title VII of the Civil
Rights Act and other statutes and
protections, what services are covered
by the rule, whether health care workers
might use the regulation to discriminate
against patients, what significant
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implementation issues could be
associated with the rule, legal
arguments, the cost impacts and the
public health consequences of the rule.
On December 19, 2008, the
Department issued a final rule (73 FR
78072). The Department saw a need to
balance the rights of patients in
obtaining legal health care services
against the statutory rights of providers
in the context of federally funded
entities not to be discriminated against
based on a refusal to participate in a
service to which they have objections.
Thus, the Department imposed an
additional certification requirement by
specifically including a reference to the
nondiscrimination provisions contained
in the Church Amendments, PHS Act
Sec. 245, and the Weldon Amendment
in certifications currently required of
most existing and potential recipients of
Department funds. The final rule went
into effect on January 20, 2009, except
that Department components have been
given discretion to phase in the written
certification requirement by no later
than the beginning of the next federal
fiscal year following the effective date of
the regulation. Furthermore, the
certification requirement is not effective
pending completion of the information
collection process under the Paperwork
Reduction Act. The 60-day comment
period on the information collection
expired on February 27, 2009, and OMB
approval for the information collection
has not yet been sought.
II. Proposed Rule
The Department is proposing to
rescind in its entirety the final rule
entitled ‘‘Ensuring That Department of
Health and Human Services Funds Do
Not Support Coercive or Discriminatory
Policies or Practices in Violation of
Federal Law,’’ published in the Federal
Register on December 19, 2008 (73 FR
78072, 45 CFR Part 88). Commenters
asserted that the rule would limit access
to patient care and raised concerns that
individuals could be denied access to
services, with effects felt
disproportionately by those in rural
areas or otherwise underserved. The
Department believes that the comments
on the August 2008 proposed rule raised
a number of questions that warrant
further careful consideration. It is
important that the Department have the
opportunity to review this regulation to
ensure its consistency with current
Administration policy. Accordingly, we
believe it would benefit the Department
to review this rule, accept further
comments, and reevaluate the necessity
for regulations implementing the
statutory requirements. Thus, the
Department is proposing to rescind the
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December 19, 2008 final rule, and we
are soliciting public comment to aid our
consideration of the many complex
questions surrounding the issue and the
need for regulation in this area.
III. Statutory Authority
The Secretary proposes to rescind the
December 19, 2008 final rule entitled
‘‘Ensuring That Department of Health
and Human Services Funds Do Not
Support Coercive or Discriminatory
Policies or Practices in Violation of
Federal Law.’’ As discussed above, the
Church Amendments, section 245 of the
PHS Act, and the Weldon Amendment
require, among other things, that the
Department and recipients of
Department funds (including State and
local governments) refrain from
discriminating against institutional and
individual health care entities for their
participation in certain medical
procedures or services, including
certain health services, or research
activities funded in whole or in part by
the federal government. No statutory
provision, however, requires
promulgation of a rule such as that
published on December 19, 2008. This
proposed rule is being issued pursuant
to the authority of 5 U.S.C. 301, which
empowers the head of an Executive
department to prescribe regulations ‘‘for
the government of his department, the
conduct of his employees, the
distribution and performance of its
business, and the custody, use, and
preservation of its records, papers, and
property.’’
IV. Request for Comment
The Department, in order to
determine whether or not to rescind the
final rule in part or in its entirety, seeks
comments. In particular, the Department
seeks the following:
1. Information, including specific
examples where feasible, addressing the
scope and nature of the problems giving
rise to the need for federal rulemaking
and how the current rule would resolve
those problems;
2. Information, including specific
examples where feasible, supporting or
refuting allegations that the December
19, 2008 final rule reduces access to
information and health care services,
particularly by low-income women;
3. Comment on whether the December
19, 2008 final rule provides sufficient
clarity to minimize the potential for
harm resulting from any ambiguity and
confusion that may exist because of the
rule; and
4. Comment on whether the objectives
of the December 19, 2008 final rule
might also be accomplished through
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non-regulatory means, such as outreach
and education.
V. Impact Analysis
Executive Order 12866—Regulatory
Planning and Review
HHS has examined the economic
implications of this proposed rule as
required by Executive Order 12866.
Executive Order 12866 directs agencies
to assess all costs and benefits of
available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity).
Executive Order 12866 classifies a rule
as significant if it meets any one of a
number of specified conditions,
including: having an annual effect on
the economy of $100 million, adversely
affecting a single sector of the economy
in a material way, adversely affecting
competition, or adversely affecting jobs.
This proposed rule is not significant
under these economic standards.
However, under Executive Order 12866,
a regulation is also considered a
significant regulatory action if it raises
novel legal or policy issues. Because
HHS previously determined that the
December 19, 2008 final rule was a
significant regulatory action under this
standard, HHS will assume that the
proposed rescission of the December 19,
2008 final rule is also a significant
regulatory action.
The December 19, 2008 final rule
estimated the quantifiable costs
associated with the certification
requirements of the proposed regulation
to be $43.6 million each year.
Rescinding the rule would therefore
result in a cost savings of $43.6 million
each year to the health care industry.
Regulatory Flexibility Act
HHS has examined the economic
implications of this proposed rule as
required by the Regulatory Flexibility
Act (RFA). If a rule has a significant
economic burden on a substantial
number of small entities, the RFA
requires agencies to analyze regulatory
options that would lessen the economic
effect of the rule on small entities. For
purposes of the RFA, small entities
include small businesses, nonprofit
organizations, and small governmental
jurisdictions. Most hospitals and most
other providers and suppliers are small
entities by virtue of either nonprofit
status or having revenues of $6 million
to $29 million in any 1 year. Individuals
and States are not included in the
definition of a small entity. The position
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of the Department has long been that the
RFA requirements for regulatory
flexibility analysis only apply to rules
that create significant adverse impacts
on small entities. Rescission of the final
rule may create positive impacts on
small entities by removing any burdens
imposed by that rule. Accordingly, we
certify that this proposed rule will not
have a significant effect on a substantial
number of small entities.
Executive Order 13132—Federalism
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on state and local
governments, preempts State law, or
otherwise has federalism implications.
This proposed rule would not require
additional steps to meet the
requirements of Executive Order 13132
because it removes any burden imposed
by the December 19, 2008 final rule.
Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4)
requires cost-benefit and other analysis
before any rulemaking if the rule
includes a ‘‘Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any 1 year.’’ The current inflationadjusted statutory threshold is
approximately $130 million. The
Department has determined that this
proposed rule would not constitute a
significant rule under the Unfunded
Mandates Reform Act, because it would
rescind rather than impose mandates.
Assessment of Federal Regulation and
Policies on Families
Section 654 of the Treasury and
General Government Appropriations
Act of 1999 requires federal
departments and agencies to determine
whether a proposed policy or regulation
could affect family well-being. If the
determination is affirmative, then the
Department or agency must prepare an
impact assessment to address criteria
specified in the law. This regulation
will not have an impact on family wellbeing, as defined in the Act, because it
affects only regulated entities and
eliminates costs that would otherwise
be imposed on those entities.
Paperwork Reduction Act of 1995
This proposed rule does not create
any new requirements under the
Paperwork Reduction Act of 1995.
Instead, it proposes to eliminate
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requirements that would be imposed by
the final rule issued on December 19,
2008. The 60-day comment period on
the information collection requirements
of the December 19, 2008 final rule
expired on February 27, 2009, and OMB
approval for the information collection
requirements has not yet been sought.
List of Subjects in 45 CFR Part 88
Abortion, Civil rights, Colleges and
universities, Employment, Government
contracts, Government employees, Grant
programs, Grants administration, Health
care, Health insurance, Health
professions, Hospitals, Insurance
companies, Laboratories, Medicaid,
Medical and dental schools, Medical
research, Medicare, Mental health
programs, Nursing homes, Public
health, Religious discrimination,
Religious liberties, Reporting and
recordkeeping requirements, Rights of
conscience, Scientists, State and local
governments, Sterilization, Students.
Dated: March 5, 2009.
Charles E. Johnson,
Acting Secretary.
PART 88—[REMOVED AND
RESERVED]
Therefore, under 5 U.S.C. 301, the
Department of Health and Human
Services proposes to remove and reserve
45 CFR part 88.
[FR Doc. E9–5067 Filed 3–6–09; 11:15 am]
BILLING CODE 4150–28–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
[FWS–R8–ES–2008–0078; 92210–1117–
0000–B4]
RIN 1018–AV03
Endangered and Threatened Wildlife
and Plants; Designation of Critical
Habitat for Cirsium loncholepis (La
Graciosa thistle)
AGENCY:
Interior.
ACTION: Proposed rule; reopening of
comment period, notice of availability
of draft economic analysis, and
amended required determinations.
SUMMARY: We, the U.S. Fish and
Wildlife Service (Service), announce the
reopening of the comment period on the
proposed revised designation of critical
habitat for Cirsium loncholepis
(common name La Graciosa thistle)
under the Endangered Species Act of
14:40 Mar 09, 2009
Jkt 217001
DATES: We will accept public comments
received or postmarked on or before
April 9, 2009.
ADDRESSES: You may submit comments
by one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• U.S. mail or hand-delivery: Public
Comments Processing, Attn: RIN 1018–
AV03; Division of Policy and Directives
Management; U.S. Fish and Wildlife
Service; 4401 N. Fairfax Drive, Suite
222; Arlington, VA 22203.
We will not accept e-mail or faxes. We
will post all comments on https://
www.regulations.gov. This generally
means that we will post any personal
information you provide us (see the
Public Comments section below for
more information).
FOR FURTHER INFORMATION CONTACT:
Diane K. Noda, Field Supervisor,
Ventura Fish and Wildlife Office, 2493
Portola Road, Suite B, Ventura, CA
93003, (telephone 805–644–1766;
facsimile 805–644–3958). If you use a
telecommunications device for the deaf
(TDD), call the Federal Information
Relay Service (FIRS) at 800–877–8339.
SUPPLEMENTARY INFORMATION:
Public Comments
Fish and Wildlife Service,
VerDate Nov<24>2008
1973, as amended (Act). We also
announce the availability of the January
16, 2009, draft economic analysis (DEA)
of the proposed revised designation of
critical habitat for C. loncholepis and
announce an amended required
determinations section of the proposal.
We are reopening the comment period
to allow all interested parties an
opportunity to comment simultaneously
on the proposed revised designation of
critical habitat for C. loncholepis, the
associated DEA, and the amended
required determinations section.
Comments previously submitted on this
rulemaking do not need to be
resubmitted. These comments have
already been incorporated into the
public record and will be fully
considered in preparation of the final
rule.
We will accept written comments and
information during this reopened
comment period on the proposed
revised designation of critical habitat for
Cirsium loncholepis published in the
Federal Register on August 6, 2008 (73
FR 45805), the DEA of the proposed
revised designation of critical habitat for
Cirsium loncholepis, and the amended
required determinations provided in
this document. We will consider
information and recommendations from
all interested parties. We are
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
10211
particularly interested in comments
concerning:
1. The reasons why we should or
should not designate habitat as critical
habitat under section 4 of the Act (16
U.S.C. 1533), including whether the
benefit of designation would outweigh
threats to the species caused by the
designation, such that the designation of
critical habitat is prudent.
2. Specific information on:
• The amount and distribution of
Cirsium loncholepis habitat,
• The importance of including habitat
that provides connectivity between
extant populations of Cirsium
loncholepis to the species’ conservation
and recovery, and the amount and
distribution of such habitat,
• What areas occupied at the time of
listing and that contain features
essential for the conservation of the
species should be included in the
designation and why, and
• What areas not occupied at the time
of listing are essential to the
conservation of the species and why.
3. Land use designations and current
or planned activities in the subject areas
and their possible impacts on proposed
revised designation of critical habitat for
Cirsium loncholepis.
4. Probable economic, national
security, or other impacts from
designating particular areas as critical
habitat. We are particularly interested in
any impacts on small entities and
specific impacts on national security,
and the benefits of including or
excluding areas that exhibit these
impacts.
5. Any proposed critical habitat areas
covered by existing or proposed
conservation or management plans that
we should consider for exclusion from
the designation under section 4(b)(2) of
the Act. We specifically request
information on any final or draft habitat
conservation plans that include Cirsium
loncholepis as a covered species that
have been prepared under section
10(a)(1)(B) of the Act, or any other
management plan, conservation plan, or
agreement that benefits this plant or its
primary constituent elements.
6. Land use designations and current
or planned activities in the subject areas
and their possible impacts on the
proposed revised designation of critical
habitat for Cirsium loncholepis.
7. Additional scientific information
that will help us to better delineate
areas that contain the primary
constituent elements.
8. Any foreseeable environmental
impacts directly or indirectly resulting
from the proposed revised designation
of critical habitat for Cirsium
loncholepis.
E:\FR\FM\10MRP1.SGM
10MRP1
]]>Agencies
[Federal Register Volume 74, Number 45 (Tuesday, March 10, 2009)]
[Proposed Rules]
[Pages 10207-10211]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5067]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 88
RIN 0991-AB49
Rescission of the Regulation Entitled ``Ensuring That Department
of Health and Human Services Funds Do Not Support Coercive or
Discriminatory Policies or Practices in Violation of Federal Law'';
Proposal
AGENCY: Office of the Secretary, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services proposes to
rescind the December 19, 2008 final rule entitled ``Ensuring That
Department of Health and Human Services Funds Do Not Support Coercive
or Discriminatory Policies or Practices in Violation of Federal Law.''
The Department believes it is important to have an opportunity to
review this regulation to ensure its consistency with current
Administration policy and to reevaluate the necessity for regulations
implementing the Church Amendments, Section 245 of the Public Health
Service Act, and the Weldon Amendment.
DATES: Submit written or electronic comment on the regulatory changes
proposed by this document by April 9, 2009.
ADDRESSES: In commenting, please refer to ``Rescission Proposal.'' To
better manage the comment process, we will not accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on this
regulation to https://www.Regulations.gov or via e-mail to
proposedrescission@hhs.gov. To submit electronic comments to https://
www.Regulations.gov, go to the Web site and click on the link ``Comment
or Submission'' and enter the keywords ``Rescission Proposal.''
[Attachments should be in Microsoft Word, WordPerfect, or Excel;
however, we prefer Microsoft Word.]
2. By regular mail. You may mail written comments (one original and
two copies) to the following address only: Office of Public Health and
Science, Department of Health and Human Services, Attention: Rescission
Proposal Comments, Hubert H. Humphrey Building, 200 Independence
Avenue, SW., Room 716G, Washington, DC 20201.
3. By express or overnight mail. You may send written comments (one
original and two copies) to the following address only: Office of
Public Health and Science, Department of Health and Human Services,
Attention: Rescission Proposal Comments, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Room 716G, Washington, DC 20201.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to the following address: Room 716G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201. (Because access to the interior of the Hubert H. Humphrey
Building is not readily available to persons without federal government
identification, commenters are encouraged to leave their comments in
the mail drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain proof of filing by
stamping in and retaining an extra copy of the documents being filed.)
Inspection of Public Comments: All comments received before the
close of
[[Page 10208]]
the comment period are available for viewing by the public, including
any personally identifiable or confidential business information that
is included in a comment. We post all comments received before the
close of the comment period on the following Web site as soon as
possible after they have been received: https://www.Regulations.gov.
Click on the link ``Comment or Submission'' on that Web site to view
public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Department of Health and Human Services, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201, Monday through
Friday of each week from 8:30 a.m. to 4 p.m.
Electronic Access
This Federal Register document is also available from the Federal
Register online database through GPO Access, a service of the U.S.
Government Printing Office. Free public access is available on a Wide
Area Information Service (WAIS) through the Internet and via
asynchronous dial-in. Internet users can access the database by using
the World Wide Web (the Superintendent of Documents' home page address
is https://www.gpoaccess.gov/), by using local WAIS client software, or
by telnet to swais.access.gpo.gov, then login as guest (no password
required). Dial-in users should use communications software and modem
to call (202) 512-1661; type swais, then login as guest (no password
required).
FOR FURTHER INFORMATION CONTACT: Mahak Nayyar, (240) 276-9866, Office
of Public Health and Science, Department of Health and Human Services,
Room 716G, Hubert E. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201.
SUPPLEMENTARY INFORMATION:
I. Background
Statutory Background
Several provisions of federal law prohibit recipients of certain
federal funds from coercing individuals in the health care field into
participating in actions they find religiously or morally
objectionable.
Conscience Clauses/Church Amendments [42 U.S.C. 300a-7]
The conscience provisions contained in 42 U.S.C. 300a-7
(collectively known as the ``Church Amendments'') were enacted at
various times during the 1970s in response to debates over whether
receipt of federal funds required the recipients of such funds to
perform abortions or sterilizations. The first conscience provision in
the Church Amendments, 42 U.S.C. 300a-7(b), provides that ``[t]he
receipt of any grant, contract, loan, or loan guarantee under [certain
statutes implemented by the Department of Health and Human Services] by
any individual or entity does not authorize any court or any public
official or other public authority to require'' (1) The individual to
perform or assist in a sterilization procedure or an abortion, if it
would be contrary to his/her religious beliefs or moral convictions;
(2) the entity to make its facilities available for sterilization
procedures or abortions, if the performance of sterilization procedures
or abortions in the facilities is prohibited by the entity on the basis
of religious beliefs or moral convictions; or (3) the entity to provide
personnel for the performance or assistance in the performance of
sterilization procedures or abortions, if it would be contrary to the
religious beliefs or moral convictions of such personnel.
The second conscience provision in the Church Amendments, 42 U.S.C.
300a-7(c)(1), prohibits any entity that receives a grant, contract,
loan, or loan guarantee under certain Department-implemented statutes
from discriminating against any physician or other health care
personnel in employment, promotion, termination of employment, or the
extension of staff or other privileges because the individual
``performed or assisted in the performance of a lawful sterilization
procedure or abortion, because he refused to perform or assist in the
performance of such a procedure or abortion on the grounds that his
performance or assistance in the performance of the procedure or
abortion would be contrary to his religious beliefs or moral
convictions, or because of his religious beliefs or moral convictions
respecting sterilization procedures or abortions.''
The third conscience provision, contained in 42 U.S.C. 300a-
7(c)(2), prohibits any entity that receives a grant or contract for
biomedical or behavioral research under any program administered by the
Department from discriminating against any physician or other health
care personnel in employment, promotion, termination of employment, or
extension of staff or other privileges ``because he performed or
assisted in the performance of any lawful health service or research
activity, because he refused to perform or assist in the performance of
any such service or activity on the grounds that his performance or
assistance in the performance of such service or activity would be
contrary to his religious beliefs or moral convictions, or because of
his religious beliefs or moral convictions respecting any such service
or activity.''
The fourth conscience provision, 42 U.S.C. 300a-7(d), provides that
``[n]o individual shall be required to perform or assist in the
performance of any part of a health service program or research
activity funded in whole or in part under a program administered by
[the Department] if his performance or assistance in the performance of
such part of such program or activity would be contrary to his
religious beliefs or moral convictions.''
The final conscience provision contained in the Church Amendments,
42 U.S.C. 300a-7(e), prohibits any entity that receives a grant,
contract, loan, loan guarantee, or interest subsidy under certain
Departmentally implemented statutes from denying admission to, or
otherwise discriminating against, ``any applicant (including applicants
for internships and residencies) for training or study because of the
applicant's reluctance, or willingness, to counsel, suggest, recommend,
assist, or in any way participate in the performance of abortions or
sterilizations contrary to or consistent with the applicant's religious
beliefs or moral convictions.''
Public Health Service Act Sec. 245 [42 U.S.C. 238n]
Enacted in 1996, section 245 of the Public Health Service Act (PHS
Act) prohibits the federal government and any State or local government
receiving federal financial assistance from discriminating against any
health care entity on the basis that the entity (1) ``Refuses to
undergo training in the performance of induced abortions, to require or
provide such training, to perform such abortions, or to provide
referrals for such training or such abortions;'' (2) refuses to make
arrangements for such activities; or (3) ``attends (or attended) a
post-graduate physician training program, or any other program of
training in the health professions, that does not (or did not) perform
induced abortions or require, provide, or refer for training in the
performance of induced abortions, or make arrangements for the
provision of such training.'' For the purposes of this protection, the
statute defines ``financial assistance'' as including, ``with respect
to a government program,'' ``governmental payments provided as
reimbursement for carrying out health-related activities.'' In
addition, PHS Act
[[Page 10209]]
Sec. 245 requires that, in determining whether to grant legal status to
a health care entity (including a State's determination of whether to
issue a license or certificate), the federal government and any State
or local government receiving federal financial assistance shall deem
accredited any post-graduate physician training program that would be
accredited, but for the reliance on an accrediting standard that,
regardless of whether such standard provides exceptions or exemptions,
requires an entity: (1) to perform induced abortions; or (2) to
require, provide, or refer for training in the performance of induced
abortions, or make arrangements for such training.
Weldon Amendment
The Weldon Amendment, originally adopted as section 508(d) of the
Labor-HHS Division (Division F) of the 2005 Consolidated Appropriations
Act, Public Law 108-447, 118 Stat. 2809, 3163 (Dec. 8, 2004), has been
readopted (or incorporated by reference) in each subsequent HHS
appropriations act. Title V of the Departments of Labor, Health and
Human Services, and Education, and Related Agencies Appropriations Act,
2006, Public Law 109-149, Sec. 508(d), 119 Stat. 2833, 2879-80 (Dec.
30, 2005); Revised Continuing Appropriations Resolution of 2007, Public
Law 110-5, Sec. 2, 121 Stat. 8, 9 (Feb. 15, 2007); Consolidated
Appropriations Act, 2008, Public Law 110-161, Div. G, Sec. 508(d), 121
Stat. 1844, 2209 (Dec. 26, 2007); Consolidated Security, Disaster
Assistance, and Continuing Appropriations Act, 2009, Public Law 110-
329, Div. A, Sec. 101, 122 Stat. 3574, 3575 (Sept. 30, 2008). The
Weldon Amendment provides that ``[n]one of the funds made available in
this Act [making appropriations for the Departments of Labor, Health
and Human Services, and Education] may be made available to a Federal
agency or program, or to a State or local government, if such agency,
program, or government subjects any institutional or individual health
care entity to discrimination on the basis that the health care entity
does not provide, pay for, provide coverage of, or refer for
abortions.'' It also defines ``health care entity'' to include ``an
individual physician or other health care professional, a hospital, a
provider-sponsored organization, a health maintenance organization, a
health insurance plan, or any other kind of health care facility,
organization, or plan.''
Rulemaking
No statutory provision requires the promulgation of rules to
implement the requirements of the Church Amendments, Public Health
Service (PHS) Act Sec. 245, and the Weldon Amendment. Nevertheless, on
August 26, 2008, the Department exercised its discretion and issued a
proposed rule entitled ``Ensuring that Department of Health and Human
Services Funds Do Not Support Coercive or Discriminatory Policies or
Practices in Violation of Federal Law'' (73 FR 50274). Citing concerns
that the development of an environment in the health care field that is
intolerant of individual conscience, certain religious beliefs, ethnic
and cultural traditions, and moral convictions may discourage
individuals from diverse backgrounds from entering health care
professions, the Department concluded that regulations were necessary
in order to (1) Educate the public and health care providers on the
obligations imposed, and protections afforded, by federal law; (2) work
with State and local governments and other recipients of funds from the
Department to ensure compliance with the nondiscrimination requirements
embodied in the Church Amendments, PHS Act Sec. 245, and the Weldon
Amendment; (3) when such compliance efforts prove unsuccessful, enforce
these nondiscrimination laws through the various Department mechanisms,
to ensure that Department funds do not support coercive or
discriminatory practices, or policies in violation of federal law; and
(4) otherwise take an active role in promoting open communication
within the healthcare industry, and between providers and patients,
fostering a more inclusive, tolerant environment in the health care
industry than may currently exist.
A wide variety of individuals and organizations, including private
citizens, individual and institutional health care providers, religious
organizations, patient advocacy groups, professional organizations,
universities and research institutions, consumer organizations, and
State and federal agencies and representatives, commented on the
proposed rule. Comments dealt with a range of issues surrounding the
proposed rule, including the need for the rule, what kinds of workers
would be protected by the proposed rule, the rule's relationship to
Title VII of the Civil Rights Act and other statutes and protections,
what services are covered by the rule, whether health care workers
might use the regulation to discriminate against patients, what
significant implementation issues could be associated with the rule,
legal arguments, the cost impacts and the public health consequences of
the rule.
On December 19, 2008, the Department issued a final rule (73 FR
78072). The Department saw a need to balance the rights of patients in
obtaining legal health care services against the statutory rights of
providers in the context of federally funded entities not to be
discriminated against based on a refusal to participate in a service to
which they have objections. Thus, the Department imposed an additional
certification requirement by specifically including a reference to the
nondiscrimination provisions contained in the Church Amendments, PHS
Act Sec. 245, and the Weldon Amendment in certifications currently
required of most existing and potential recipients of Department funds.
The final rule went into effect on January 20, 2009, except that
Department components have been given discretion to phase in the
written certification requirement by no later than the beginning of the
next federal fiscal year following the effective date of the
regulation. Furthermore, the certification requirement is not effective
pending completion of the information collection process under the
Paperwork Reduction Act. The 60-day comment period on the information
collection expired on February 27, 2009, and OMB approval for the
information collection has not yet been sought.
II. Proposed Rule
The Department is proposing to rescind in its entirety the final
rule entitled ``Ensuring That Department of Health and Human Services
Funds Do Not Support Coercive or Discriminatory Policies or Practices
in Violation of Federal Law,'' published in the Federal Register on
December 19, 2008 (73 FR 78072, 45 CFR Part 88). Commenters asserted
that the rule would limit access to patient care and raised concerns
that individuals could be denied access to services, with effects felt
disproportionately by those in rural areas or otherwise underserved.
The Department believes that the comments on the August 2008 proposed
rule raised a number of questions that warrant further careful
consideration. It is important that the Department have the opportunity
to review this regulation to ensure its consistency with current
Administration policy. Accordingly, we believe it would benefit the
Department to review this rule, accept further comments, and reevaluate
the necessity for regulations implementing the statutory requirements.
Thus, the Department is proposing to rescind the
[[Page 10210]]
December 19, 2008 final rule, and we are soliciting public comment to
aid our consideration of the many complex questions surrounding the
issue and the need for regulation in this area.
III. Statutory Authority
The Secretary proposes to rescind the December 19, 2008 final rule
entitled ``Ensuring That Department of Health and Human Services Funds
Do Not Support Coercive or Discriminatory Policies or Practices in
Violation of Federal Law.'' As discussed above, the Church Amendments,
section 245 of the PHS Act, and the Weldon Amendment require, among
other things, that the Department and recipients of Department funds
(including State and local governments) refrain from discriminating
against institutional and individual health care entities for their
participation in certain medical procedures or services, including
certain health services, or research activities funded in whole or in
part by the federal government. No statutory provision, however,
requires promulgation of a rule such as that published on December 19,
2008. This proposed rule is being issued pursuant to the authority of 5
U.S.C. 301, which empowers the head of an Executive department to
prescribe regulations ``for the government of his department, the
conduct of his employees, the distribution and performance of its
business, and the custody, use, and preservation of its records,
papers, and property.''
IV. Request for Comment
The Department, in order to determine whether or not to rescind the
final rule in part or in its entirety, seeks comments. In particular,
the Department seeks the following:
1. Information, including specific examples where feasible,
addressing the scope and nature of the problems giving rise to the need
for federal rulemaking and how the current rule would resolve those
problems;
2. Information, including specific examples where feasible,
supporting or refuting allegations that the December 19, 2008 final
rule reduces access to information and health care services,
particularly by low-income women;
3. Comment on whether the December 19, 2008 final rule provides
sufficient clarity to minimize the potential for harm resulting from
any ambiguity and confusion that may exist because of the rule; and
4. Comment on whether the objectives of the December 19, 2008 final
rule might also be accomplished through non-regulatory means, such as
outreach and education.
V. Impact Analysis
Executive Order 12866--Regulatory Planning and Review
HHS has examined the economic implications of this proposed rule as
required by Executive Order 12866. Executive Order 12866 directs
agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). Executive Order 12866 classifies a
rule as significant if it meets any one of a number of specified
conditions, including: having an annual effect on the economy of $100
million, adversely affecting a single sector of the economy in a
material way, adversely affecting competition, or adversely affecting
jobs. This proposed rule is not significant under these economic
standards. However, under Executive Order 12866, a regulation is also
considered a significant regulatory action if it raises novel legal or
policy issues. Because HHS previously determined that the December 19,
2008 final rule was a significant regulatory action under this
standard, HHS will assume that the proposed rescission of the December
19, 2008 final rule is also a significant regulatory action.
The December 19, 2008 final rule estimated the quantifiable costs
associated with the certification requirements of the proposed
regulation to be $43.6 million each year. Rescinding the rule would
therefore result in a cost savings of $43.6 million each year to the
health care industry.
Regulatory Flexibility Act
HHS has examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act (RFA). If a rule has a
significant economic burden on a substantial number of small entities,
the RFA requires agencies to analyze regulatory options that would
lessen the economic effect of the rule on small entities. For purposes
of the RFA, small entities include small businesses, nonprofit
organizations, and small governmental jurisdictions. Most hospitals and
most other providers and suppliers are small entities by virtue of
either nonprofit status or having revenues of $6 million to $29 million
in any 1 year. Individuals and States are not included in the
definition of a small entity. The position of the Department has long
been that the RFA requirements for regulatory flexibility analysis only
apply to rules that create significant adverse impacts on small
entities. Rescission of the final rule may create positive impacts on
small entities by removing any burdens imposed by that rule.
Accordingly, we certify that this proposed rule will not have a
significant effect on a substantial number of small entities.
Executive Order 13132--Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts State law, or otherwise has federalism
implications. This proposed rule would not require additional steps to
meet the requirements of Executive Order 13132 because it removes any
burden imposed by the December 19, 2008 final rule.
Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires cost-benefit and other analysis before any rulemaking if
the rule includes a ``Federal mandate that may result in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any 1 year.'' The current inflation-adjusted
statutory threshold is approximately $130 million. The Department has
determined that this proposed rule would not constitute a significant
rule under the Unfunded Mandates Reform Act, because it would rescind
rather than impose mandates.
Assessment of Federal Regulation and Policies on Families
Section 654 of the Treasury and General Government Appropriations
Act of 1999 requires federal departments and agencies to determine
whether a proposed policy or regulation could affect family well-being.
If the determination is affirmative, then the Department or agency must
prepare an impact assessment to address criteria specified in the law.
This regulation will not have an impact on family well-being, as
defined in the Act, because it affects only regulated entities and
eliminates costs that would otherwise be imposed on those entities.
Paperwork Reduction Act of 1995
This proposed rule does not create any new requirements under the
Paperwork Reduction Act of 1995. Instead, it proposes to eliminate
[[Page 10211]]
requirements that would be imposed by the final rule issued on December
19, 2008. The 60-day comment period on the information collection
requirements of the December 19, 2008 final rule expired on February
27, 2009, and OMB approval for the information collection requirements
has not yet been sought.
List of Subjects in 45 CFR Part 88
Abortion, Civil rights, Colleges and universities, Employment,
Government contracts, Government employees, Grant programs, Grants
administration, Health care, Health insurance, Health professions,
Hospitals, Insurance companies, Laboratories, Medicaid, Medical and
dental schools, Medical research, Medicare, Mental health programs,
Nursing homes, Public health, Religious discrimination, Religious
liberties, Reporting and recordkeeping requirements, Rights of
conscience, Scientists, State and local governments, Sterilization,
Students.
Dated: March 5, 2009.
Charles E. Johnson,
Acting Secretary.
PART 88--[REMOVED AND RESERVED]
Therefore, under 5 U.S.C. 301, the Department of Health and Human
Services proposes to remove and reserve 45 CFR part 88.
[FR Doc. E9-5067 Filed 3-6-09; 11:15 am]
BILLING CODE 4150-28-P
