Office of Global Health Affairs; Regulation on the Organizational Integrity of Entities That Are Implementing Programs and Activities Under the Leadership Act, 78997-79002 [E8-30686]
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Federal Register / Vol. 73, No. 248 / Wednesday, December 24, 2008 / Rules and Regulations
§ 59.501
Am I subject to this subpart?
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(c) Except as provided in paragraph
(e) of this section, the provisions of this
subpart apply to aerosol coatings
manufactured on or after July 1, 2009,
for sale or distribution in the United
States.* * *
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(f) * * *
(3) * * *
(i) You must submit an initial
notification no later than the
compliance date stated in § 59.502(a), or
on or before the date that you start
manufacturing aerosol coating products
that are sold in the United States,
whichever is later. * * *
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3. Section 59.502 is amended by
revising paragraph (a) to read as follows:
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§ 59.502 When do I have to comply with
this subpart?
(a) Except as provided in § 59.509 and
paragraphs (b) and (c) of this section,
you must be in compliance with all
provisions of this subpart by July 1,
2009.
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4. Section 59.511 is amended by
revising the first sentence of paragraph
(b) introductory text and the first
sentence of paragraph (e) introductory
text to read as follows:
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§ 59.511 What notifications and reports
must I submit?
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(b) You must submit an initial
notification no later than the
compliance date stated in § 59.502, or
on or before the date that you first
manufacture, distribute, or import
aerosol coatings, whichever is later.
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(e) If you claim the exemption under
§ 59.501(e), you must submit an initial
notification no later than the
compliance date stated in 59.502(a), or
on or before the date that you first
manufacture aerosol coatings,
whichever is later. * * *
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[FR Doc. E8–30699 Filed 12–23–08; 8:45 am]
BILLING CODE 6560–50–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 88
RIN 0991–AB46
Office of Global Health Affairs;
Regulation on the Organizational
Integrity of Entities That Are
Implementing Programs and Activities
Under the Leadership Act
AGENCY: Office of Global Health Affairs,
U.S. Department of Health and Human
Services.
ACTION: Final rule.
SUMMARY: The Office of Global Health
Affairs within the U.S. Department of
Health and Human Services (‘‘HHS’’) is
issuing this final rule to clarify that
recipients of HHS funds to implement
HIV/AIDS programs and activities under
the United States Leadership Against
HIV/AIDS, Tuberculosis and Malaria
Act of 2003 (the ‘‘Leadership Act’’),
Public Law 108–25 (May 27, 2003), that
are required to have a policy opposing
prostitution and sex trafficking, and
must submit certification of this policy
with the grant or contract application,
may, consistent with this policy
requirement, maintain an affiliation
with organizations that do not have
such a policy, provided such affiliations
do not threaten the integrity of the
government’s programs and its message
opposing prostitution and sex
trafficking. The rule describes the
separation that must exist between a
recipient of HHS HIV/AIDS funds that
has a policy opposing prostitution and
sex trafficking, as required under
section 301(f) of the Leadership Act, 22
U.S.C. 7631(f), and another organization
that engages in activities that are not
consistent with a policy opposing
prostitution and sex trafficking.
DATES: This rule is effective January 20,
2009.
FOR FURTHER INFORMATION CONTACT:
Jeanne Monahan, Office of Global
Health Affairs, Hubert H. Humphrey
Building, Room 639H, 200
Independence Avenue, SW.,
Washington, DC 20201, Tel:
202.690.6174, E-mail:
Jeanne.monahan@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The U.S. Government is opposed to
prostitution and related activities,
which are inherently harmful and
dehumanizing, and contribute to the
phenomenon of trafficking in persons. It
is critical to the effectiveness of the
Leadership Act, and to the U.S.
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78997
Government’s foreign policy that
underlies this effort, that organizations
that receive Leadership Act funds
maintain the integrity of the Leadership
Act programs and activities they
implement, and not confuse the U.S.
Government’s message opposing
prostitution and sex trafficking by
holding positions that conflict with this
policy.
On April 17, 2008, HHS published in
the Federal Register (73 FR 20900), a
Notice of Proposed Rulemaking
(‘‘NPRM’’) regarding the requirement
expressed in 22 U.S.C. 7631(f), which
provides that organizations that are
receiving Leadership Act funds must
have a policy explicitly opposing
prostitution and sex trafficking.
Specifically, the NPRM described the
legal, financial, and organizational
separation that must exist between
entities that receive grants, contracts, or
cooperative agreements from HHS under
the Leadership Act and another
organization that engages in activities
that are not consistent with a policy
opposing prostitution and sex
trafficking.
A Notice of Correction of Proposed
Rule to correct a technical error in the
NPRM was published in the Federal
Register (73 FR 29096). Although the
public comment period initially closed
on May 19, 2008, a Notice of Reopening
of the Comment Period was published
in the Federal Register (73 FR 36293),
and the final date to submit comments
on the NPRM was July 28, 2008.
This final rule is designed to provide
additional clarity for contracting and
grant officers, contracting officers’
technical representatives, program
officials and implementing partners
(e.g., grantees, contractors) of HHS
regarding the application of language in
Notices of Availability, Requests for
Proposals, and other documents
pertaining to the policy requirement
expressed in 22 U.S.C. 7631(f). This
final rule clarifies that the Government’s
organizational partners that have a
policy opposing prostitution and sex
trafficking may, consistent with this
policy requirement, maintain an
affiliation with organizations that do not
have such a policy, provided such
affiliations do not threaten the integrity
of the Government’s programs and its
message opposing prostitution and sex
trafficking, as specified in this final rule.
To maintain program integrity, adequate
separation, as outlined in this final rule,
is required between an organization that
expresses views on prostitution and sex
trafficking contrary to the Government’s
message and any federally funded
partner organization. Examples of
activities inconsistent with a policy
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opposing prostitution and sex
trafficking include, but are not limited,
to advocating for the legalization of the
institution of prostitution or organizing
or unionizing prostituted people for the
purpose of advocating for the
legalization of prostitution.
This final rule applies to funds used
by HHS to implement HIV/AIDS
programs and activities under the
Leadership Act. The rule includes
certification language that organizations
must provide to receive grants,
cooperative agreements, contracts, and
other funding instruments made
available by HHS.
All recipients that receive funds
directly from HHS (‘‘prime recipients’’)
must certify compliance with the final
rule prior to actual receipt of such
funds, in a written statement addressed
to the HHS agency’s grants or contract
officer. The certifications by prime
recipients are prerequisites to payment
by HHS of any U.S. Government funds
in connection with an award under the
Leadership Act.
All recipients must insert provisions
to implement the applicable parts of this
final rule in all sub-agreements under
their awards. These provisions must be
express terms and conditions of the subagreement, must acknowledge that
compliance with this final rule is a
prerequisite to the receipt and
expenditure of U.S. Government funds
in connection with this document, and
must acknowledge that any violation of
the provisions shall be grounds for
unilateral termination of the agreement,
prior to the end of its term.
Recipients must agree that HHS may,
at any reasonable time, inspect the
documents and materials maintained or
prepared by the recipient that relate to
the organization’s compliance with this
final rule.
Nothing in this rule is intended to
affect relevant prohibitions on Federal
Government funding under other
applicable Federal laws.
II. Discussion of the Final Rule
These sections discuss the final rule
by defining the terms relevant to this
final rule and discussing the
requirements that must be satisfied by
organizations that receive Leadership
Act funds.
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Section 88.1
Definitions
This section defines the terms that are
pertinent to this rule. Specifically, we
include the following definitions:
‘‘Commercial Sex Act’’ means any sex
act on account of which anything of
value is given to or received by any
person.
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‘‘Prime Recipients’’ are contractors,
grantees, applicants or awardees that
receive Leadership Act funds for HIV/
AIDS programs directly from HHS.
‘‘Prostitution’’ means procuring or
providing any commercial sex act.
‘‘Recipients’’ are contractors, grantees,
applicants or awardees that receive
Leadership Act funds for HIV/AIDS
programs directly or indirectly from
HHS. Recipients include both prime
recipients and sub-recipients.
‘‘Sex Trafficking’’ means the
recruitment, harboring, transportation,
provision, or obtaining of a person for
the purpose of a commercial sex act.
‘‘Sub-Recipients’’ are contractors,
grantees, applicants or awardees that
receive Leadership Act funds for HIV/
AIDS programs from other recipients
rather than directly from HHS.
Section 88.2 Objective Integrity of
Recipients
This section of the final rule describes
the separation that must exist between
a recipient of funds from HHS to
implement HIV/AIDS programs under
the Leadership Act and another
organization that engages in activities
that are not consistent with a policy
opposing prostitution and sex
trafficking, as required under section
301(f) of the Leadership Act.
Paragraph (a) sets forth criteria for
establishing the objective integrity and
independence that a recipient must
have from another organization that
engages in activities inconsistent with a
policy opposing prostitution and sex
trafficking.
The criteria for organizational
integrity and independence in this final
rule is modeled on criteria upheld as
facially constitutional by the U.S. Court
of Appeals for the Second Circuit in
Velazquez v. Legal Services Corp., 164
F.3d 757, 767 (2d Cir. 1999), and
Brooklyn Legal Services Corp. v. Legal
Services Corp., 462 F.3d 219, 229–33
(2d Cir. 2006), cases involving similar
organization-wide limitations applied to
recipients of Federal funding.
This final rule clarifies that an
organization affiliated with a recipient
of Leadership Act funds need not have
a policy explicitly opposing prostitution
and sex trafficking for the recipient to
maintain compliance with the policy
requirement. The affiliated
organization’s position on these issues
will have no effect on the recipient’s
eligibility for Leadership Act funds, so
long as the recipient satisfies the criteria
for objective integrity and independence
detailed in this final rule. By ensuring
adequate separation between the
recipient and affiliate, these criteria
guard against a public perception that
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the affiliate’s views on prostitution and
sex trafficking may be attributed to the
recipient, and thus to the Government,
thereby avoiding the risk of confusing
the Government’s message opposing
prostitution and sex trafficking. In
addition, the separation also guards
against a public perception that
resources between affiliate and recipient
are fungible, and thus Government
funds could inadvertently subsidize
other activities inconsistent with a
policy opposing prostitution and sex
trafficking.
Under Paragraph (b) of this section, an
organization is eligible to receive from
HHS Federal funds made available
under the Leadership Act only if it has
provided the certifications required by
section 88.3.
Section 88.3 Certifications
This section of the rule describes the
certifications required to receive
Leadership Act funding from HHS.
The certifications section contains an
Organizational Integrity Certification,
located at section 88.3(d)(1), in which a
recipient of Leadership Act funds
administered by an HHS agency certifies
it has objective integrity and
independence from any organization
that engages in activities inconsistent
with a policy opposing prostitution and
sex trafficking.
The certification section also contains
Acknowledgement and Sub-Recipient
Compliance Certifications at section
88.3(d)(2) and (3). These require each
recipient to acknowledge that its
provision of the certifications is a
prerequisite to receiving Federal funds,
that the Federal Government can stop or
withdraw those funds if HHS finds a
certification to have been inaccurate or
to have become inaccurate, and that the
prime recipient will ensure all its subrecipients provide the required
certifications. A sub-recipient must
provide the same certifications as those
provided by the prime recipient.
Paragraph (e) contains information
regarding requirements for the renewal
of the certifications. HHS requires each
recipient to provide renewed
certifications each Federal Fiscal Year,
in alignment with the award cycle.
Additionally, current recipients, as of
the effective date of the regulation, must
file a certification upon any extension,
amendment, or modification of the
funding instrument that extends the
term of such instrument or adds
additional funds to it.
III. Response to Public Comments
In response to the proposed rule, the
Office of Global Health Affairs received
five written comments from Members of
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Congress, a university law school, nongovernmental organizations involved in
public health and advocacy, and other
organizations. The following is a
summary of the comments and the
responses from the HHS Office of Global
Health Affairs:
Comment: Several commenters argue
that the proposed rule did not address
the merits of the underlying policy
requirement expressed in the
Leadership Act, which provides that
organizations that are receiving
Leadership Act funds must have a
policy explicitly opposing prostitution
and sex trafficking. They state that the
policy requirement in the Leadership
Act runs contrary to best practices in
public health efforts to stem the spread
of HIV/AIDS and human trafficking, and
the regulation appears to prohibit
organizations receiving Leadership Act
funds from participating in prevention
programs that use strategies that involve
those engaged in prostitution and sex
trafficking.
Response: The objective of the rule is
to clarify that recipients of HHS HIV/
AIDS funds that have adopted a policy
opposing prostitution and sex
trafficking may, consistent with this
policy requirement, maintain an
affiliation with other organizations that
do not have such a policy, provided
such affiliations do not threaten the
integrity of the Government’s programs
and its message opposing prostitution
and sex trafficking. In doing so, the rule
describes the legal, financial, and
organizational separation that must exist
between these recipients of HHS funds
and other organizations that engage in
activities that are not consistent with a
policy opposing prostitution and sex
trafficking. The rule is not designed to
address the merits of the policy
requirement in the Leadership Act.
Moreover, the rule does not prevent an
organization from providing prevention,
care and treatment to marginalized
populations. In fact, most Leadership
Act funds are going expressly for those
purposes. Organizations around the
world that receive Leadership Act
funds, including those with extensive
experience working directly with
prostituted people, have stated they are
in compliance with the requirement that
they must have a policy opposing
prostitution and sex trafficking.
Comment: Several commenters note
that the regulation does not define
‘‘activities inconsistent with a policy
opposing prostitution and sex
trafficking.’’ They state that the language
of the regulation is vague and that there
is confusion in the field about
permissible activities. The commenters
note that the broadness of the language
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of the rule increases the possibility that
organizations will curtail effective
programs for fear of being seen as
supporting or promoting prostitution.
Response: As stated above, the
purpose of the rule is to describe the
degree of separation that must exist
between recipients of HHS HIV/AIDS
funds, who must have a policy opposing
prostitution and sex trafficking, and
other organizations who do not have
such a policy, in order to preserve the
integrity of the Government’s message
opposing prostitution and sex
trafficking. The purpose of the rule is
not to define activities that are
inconsistent with a policy opposing
prostitution and sex trafficking. As
stated above, the rule does not prevent
recipients of Leadership Act funds from
providing prevention, care and
treatment programs to marginalized
populations, and organizations around
the world that receive Leadership Act
funds, including those with extensive
experience working directly with
prostituted people, have stated that they
have a policy opposing prostitution and
sex trafficking.
Comment: One commenter notes that
the regulation does not define
‘‘affiliate.’’ The commenter writes that
there are no limitations on organizations
that might be considered affiliates. The
commenter notes that the speech and
activities of affiliate organizations will
be scrutinized to a high degree, and that
cooperation between non-governmental
organizations (‘‘NGOs’’) will be
discouraged.
Response: The Office of Global Health
Affairs has determined that the term
‘‘affiliate’’ is not necessary to the rule,
as the objective of the rule is to describe
the degree of separation that must exist
between recipients of Leadership Act
funds and any other organizations that
do not have a policy opposing
prostitution and sex trafficking,
regardless of whether these other
organizations are technically defined as
‘‘affiliates’’ of the recipient.
Consequently, the HHS Office of Global
Health Affairs has deleted the term
‘‘affiliate’’ from the rule. Further, the
separation requirements are designed to
ensure the U.S. Government’s message
opposing prostitution and sex
trafficking is not confused or diluted.
Organizations may still cooperate with
each other, provided that, if they receive
Leadership Act funds for HIV/AIDS
programs, they also have a policy
opposing sex trafficking and
prostitution, and remain sufficiently
separate from organizations that do not
have such a policy.
Comment: Several commenters note
that the level of separation required by
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the rule is unnecessary. The
commenters state that the level of
separation currently applied to faithbased organizations would be sufficient
for recipients of HIV/AIDS funding. The
commenters also claim that the rule is
inconsistent with HHS’s previous
conclusion that, in the context of faithbased organizations, separation
requirements of this sort are excessive.
Response: The policy requirement in
the Leadership Act is not analogous to
the Federal Government’s partnership
with faith-based organizations. The
Constitution of the United States
requires the Government to be neutral
on matters of faith and religion.
However, the Constitution does not
require the Government to be neutral on
prostitution and sex trafficking. The
United States is free to adopt policies
that favor or disfavor activities related to
prostitution and sex trafficking. In the
Leadership Act, Congress chose to
establish a policy that requires funding
recipients to have a policy against
prostitution and sex trafficking, which
is inherently different from the
neutrality the U.S. Government must
exhibit towards faith-based
organizations. The U.S. Government has
found prostitution and sex trafficking to
be degrading and harmful to those
involved, and therefore a stronger
separation standard is required than is
established for faith-based
organizations.
This clearer form of separation is
necessary to ensure that the U.S.
Government policy against prostitution
and sex trafficking is clear and not
confused with a contrary policy held by
a grantee or contractor.
Comment: Several commenters argue
that the regulation requires recipients to
achieve a level of separation from
affiliates that will be an undue burden
on NGOs, and defies Congress’ intent to
promote efficiency in foreign aid. The
commenters note that the level of
separation required for recipients of
HIV/AIDS funding is so stringent that
recipients will not be able to set up
affiliates. They note that having separate
personnel and management factors will
create lengthy delays in working in
developing countries. They also claim
that the separation requirements will
harm the recipients’ ability to raise
money.
Response: The burden and cost of the
rule is unlikely to be significant for
organizations that are receiving
Leadership Act funds because the policy
requirement has been in place for a
number of years. Since 2004, over 18
billion dollars have supported HIV/
AIDS prevention, care, and treatment
programs, and these groups have stated
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their compliance with section 301(f) of
the Leadership Act. The rule does not
alter the policy requirement. Rather, it
clarifies that a recipient of Leadership
Act funds may maintain an affiliation
with an organization that does not have
a policy opposing prostitution and sex
trafficking if the two organizations are
sufficiently separate.
Comment: One commenter states that
the policy undermines Congress’ desire
to promote public/private partnerships
in the delivery of HIV/AIDS services.
The commenter claims that recipients
will find it dangerous, and in some
cases illegal, to work with other NGOs.
The commenter notes that the
separation requirements will force
recipients to increase administrative
costs, and will undercut organizations’
ability to raise funds both from the
Government and from the private sector.
Response: The intent of the rule is not
to prevent public/private partnerships,
but to more clearly define the
organizations that can enter into those
partnerships and receive funding under
the Leadership Act. The cost of the rule
is unlikely to be significant for
organizations receiving Leadership Act
funds. Since 2004, HHS has required
recipients of Leadership Act funds to
certify their compliance with section
301(f) of the Leadership Act, and on July
23, 2007, the Office of Global Health
Affairs issued a ‘‘Guidance on
Organizational Integrity,’’ similar to this
final regulation. The Office of Global
Health Affairs instructed HHS agencies
to disseminate the guidance to their
contractors and grantees that receive
funding under the Leadership Act, and
provided means for the public to
comment on the guidance, including
whether the guidance is economically
significant under definitions provided
by the Office of Management and
Budget (‘‘OMB’’). The Office of Global
Health Affairs has received no
comments on the guidance.
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Regulatory Flexibility Act
The Secretary certifies under 5 U.S.C.
605(b), as enacted by the Regulatory
Flexibility Act (Pub. L. 96–354), that
this rule will not result in a significant
impact on a substantial number of small
entities. Since enactment of the policy
requirement in the Leadership Act, HHS
has required its contract solicitations
and grant announcements for
Leadership Act funding to include a
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section regarding ‘‘Prostitution and
Related Activities.’’
Executive Order 12866—Regulatory
Planning and Review
HHS has drafted and reviewed this
regulation in accordance with Executive
Order 12866, section 1(b), Principles of
Regulation. HHS has determined this
rule is a ‘‘significant regulatory action’’
under Executive Order 12866, section
3(f)(4), Regulatory Planning and Review,
because it raises novel legal or policy
issues that arise out of legal mandates
and the President’s priorities, and,
accordingly, the Office of Management
and Budget has reviewed it.
The benefits of this rule are that the
limitations on promoting or advocating
the legalization or the practice of
prostitution and sex trafficking will (1)
help further the U.S. Government’s
strategy to reduce sexual exploitation
that fuels the spread of HIV/AIDS and
opportunistic infections, such as
tuberculosis and malaria, and (2)
demonstrate the U.S. Government’s
opposition to prostitution and sex
trafficking.
The cost of this rule is unlikely to be
significant, according to cost
estimations, approximately $7337.10 in
total. Since 2004, HHS has required
recipients of Leadership Act funds to
certify their compliance with section
301(f) of the Leadership Act. Further,
the Office of Global Health Affairs
issued a guidance, similar to this final
rule, on July 23, 2007. The Office of
Global Health Affairs instructed HHS
agencies to disseminate the guidance to
their contractors and grantees that
receive funding under the Leadership
Act, and provided means for the public
to comment on the guidance, including
whether the guidance is economically
significant under definitions provided
by OMB. The Office of Global Health
Affairs has received no comments on
the guidance.
Executive Order 13132—Federalism
Executive Order 13132 on Federalism
requires Federal Departments and
agencies to consult with State and local
Government officials in the
development of regulatory policies with
implications for Federalism. This rule
does not have Federalism implications
for State or local Governments, as
defined in the Executive Order.
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Unfunded Mandates Reform Act of 1995
Section 202 of the Unfunded
Mandates Reform Act of 1995 requires
that a covered Federal Department or
agency prepare a budgetary impact
statement before promulgating a rule
that includes any Federal mandate that
could result in the expenditure by State,
local, and tribal Governments, in the
aggregate, or by the private sector, of
$100 million or more in any one year.
HHS has determined that this rule
would not impose a mandate that will
result in the expenditure by State, local,
and Tribal Governments, in the
aggregate, or by the private sector, of
more than $100 million in any one year.
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 final 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 rule will not
have an impact on family well-being, as
defined in this legislation.
Paperwork Reduction Act
To obtain or retain Leadership Act
funding, HHS will require recipients to
submit certifications. The title of the
information collection is ‘‘Certification
Regarding the Organizational Integrity
of Entities Implementing Leadership Act
Programs and Activities.’’ The
documents are necessary to ensure that
recipients of Leadership Act funding
have objective integrity and
independence from any organizations
that engage in activities inconsistent
with a policy opposing prostitution and
sex trafficking.
HHS estimates that 555 respondents
will prepare documents to validate that
recipients have objective integrity and
independence from organizations that
engage in activities inconsistent with
policies opposing prostitution and sex
trafficking. HHS also estimates that the
average cost per hour will be $26.44,
with 1⁄2 hour estimated time burden per
response. In total, the estimated burden
cost is approximately $7337.10.
HHS therefore estimates annual
aggregate burden to collect the
information as follows:
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79001
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden
hours
per response
Average cost
per hour
Total burden
hours
Total burden
cost
Certifications ............................................
555
1
.5
$26.44
277.5
$7,337.10
During the Notice of Revised
Rulemaking (NPRM) process, HHS
accepted comments from the public, in
accordance with the Paperwork
Reduction Act of 1995. HHS will submit
this information collection to the Office
of Management and Budget (OMB) for
regular approval.
Affected parties do not have to
comply with the information collection
requirements in the final rule until the
Department of Health and Human
Services publishes in the Federal
Register the control numbers assigned
by the Office of Management and
Budget (OMB). Publication of the
control numbers notifies the public that
OMB has approved these information
collection requirements under the
Paperwork Reduction Act of 1995.
Prime Recipients are contractors,
grantees, applicants or awardees who
receive Leadership Act funds for HIV/
AIDS programs directly from HHS.
Prostitution means procuring or
providing any commercial sex act.
Recipients are contractors, grantees,
applicants or awardees who receive
Leadership Act funds for HIV/AIDS
programs directly or indirectly from
HHS. Recipients include both prime
recipients and sub-recipients.
Sex Trafficking means the
recruitment, harboring, transportation,
provision, or obtaining of a person for
the purpose of a commercial sex act.
Sub-Recipients are contractors,
grantees, applicants or awardees, other
than prime recipients, who receive
Leadership Act funds for HIV/AIDS
programs from other recipients rather
than directly from HHS.
List of Subjects in 45 CFR Part 88
Administrative practice and
procedure, Federal aid programs, Grant
programs, Grants administration.
Dated: September 26, 2008.
William R. Steiger,
Director, Office of Global Health Affairs.
Approved: October 22, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.
Editorial Note: This document was
received in the Office of the Federal Register
on Friday, December 19, 2008.
For the reasons stated in the preamble,
the Office of Global Health Affairs
amends 45 CFR subtitle A to add Part
88 as follows:
■
PART 88–ORGANIZATIONAL
INTEGRITY OF ENTITIES
IMPLEMENTING PROGRAMS AND
ACTIVITIES UNDER THE LEADERSHIP
ACT
Sec.
88.1
88.2
88.3
Definitions.
Organizational integrity of recipients.
Certifications.
Authority: 22 U.S.C. 7631(f) and 5 U.S.C.
301.
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§ 88.1
Definitions.
For the purposes of this part:
Commercial Sex Act means any sex
act on account of which anything of
value is given to or received by any
person.
■
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§ 88.2 Organizational integrity of
recipients.
(a) A recipient must have objective
integrity and independence from any
organization that engages in activities
inconsistent with a policy opposing
prostitution and sex trafficking. A
recipient will be found to have objective
integrity and independence from such
an organization if:
(1) The organization is a legally
separate entity;
(2) The organization receives no
transfer of Leadership Act funds, and
Leadership Act funds do not subsidize
activities inconsistent with a policy
opposing prostitution and sex
trafficking; and
(3) The recipient is physically and
financially separate from the
organization. Mere bookkeeping
separation of Leadership Act funds from
other funds is not sufficient. HHS will
determine, on a case-by-case basis and
based on the totality of the facts,
whether sufficient physical and
financial separation exists. The presence
or absence of any one or more factors
will not be determinative. Factors
relevant to this determination shall
include, but will not be limited to, the
following:
(i) The existence of separate
personnel, management, and
governance;
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(ii) The existence of separate
accounts, accounting records, and
timekeeping records;
(iii) The degree of separation from
facilities, equipment and supplies used
by the organization to conduct activities
inconsistent with a policy opposing
prostitution and sex trafficking, and the
extent of such activities by the
organization;
(iv) The extent to which signs and
other forms of identification that
distinguish the recipient from the
organization are present, and signs and
materials that could be associated with
the organization or activities
inconsistent with a policy opposing
prostitution and sex trafficking are
absent; and
(v) The extent to which HHS, the U.S.
Government and the project name are
protected from public association with
the organization and its activities
inconsistent with a policy opposing
prostitution and sex trafficking in
materials such as publications,
conferences and press or public
statements.
(b) An organization is ineligible to
receive any Leadership Act funds unless
it has provided the certifications
required by § 88.3.
§ 88.3
Certifications.
(a) HHS agencies shall include the
certification requirements for any grant,
cooperative agreement, contract, or
other funding instrument in the public
announcement of the availability of the
grant, cooperative agreement, contract,
or other funding instrument.
(b) Unless the recipient is otherwise
excepted, a person authorized to bind
the recipient shall execute the
certifications for the grant, cooperative
agreement, contract, or other funding
instrument.
(c) A prime recipient must submit its
certifications to the grant or contract
officer of the HHS agency that will
award funds. A sub-recipient must
provide its certifications to the prime
recipient. The prime recipient will
submit certifications from its subrecipients when requested to do so by
the HHS grant or contract officer.
(d) The certifications shall state as
follows:
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[FR Doc. E8–30686 Filed 12–19–08; 4:15 pm]
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PHMSA published a Notice of
Proposed Rulemaking (NPRM) (73 FR
1307; January 8, 2008) proposing to
increase the design factor and
corresponding operating pressure
limitations for natural gas pipelines
made from new Polyamide–11 (PA–11)
thermoplastic pipe. PHMSA initiated
this rulemaking in response to several
petitions submitted by Arkema, Inc.
(Arkema), a manufacturer of PA–11
pipe. In October 2004, Arkema
submitted two petitions to PHMSA
requesting we revise 49 CFR 192.121
and 192.123. The first petition requested
an increase in the design factor from
0.32 to 0.40 in the plastic pipe design
formula in § 192.121 for new PA–11
plastic pipe. The second petition
requested an increase in the design
pressure limitation in § 192.123 from
100 psig (689 kPa) to 200 psig (1379
kPa) for new 2-inch IPS 1 PA–11 plastic
pipe. The design factor and design
pressure limitations for all other plastic
pipe would remain unchanged.
On June 22, 2005, PHMSA published
a notice in the Federal Register (70 FR
36093) seeking comments on the
Arkema petitions. Following public
comments and recommendations from
PHMSA staff, on April 6, 2006, Arkema
submitted amended petitions proposing
various additional requirements and
safety controls on the use of PA–11
pipe. Arkema again proposed an
increase in the design factor in
§ 192.121 from 0.32 to 0.40 for new PA–
11 pipe, but proposed two new
conditions: (1) The minimum wall
thickness for pipe of a given diameter
must be SDR 2–11 or thicker; and (2) the
rapid crack propagation (RCP)
characteristics of each new pipe design
involving a new diameter or thicker
wall must be measured using accepted
industry standard test methods.
Likewise, Arkema proposed that we
amend § 192.123 to allow the use of PA–
11 pipe at a maximum design pressure
of up to 200 psig (1379 kPa) for SDR–
11 pipe, but broadened its request to
include pipe at diameters of up to 4inch IPS. This request was based on the
availability of complete PA–11 piping
systems; results from a three-year
research program by the Gas Technology
Institute; and the successful testing of
exhumed samples of PA–11 pipe that
had been installed and operated under
Federal and State waivers. Finally,
Arkema supported a commenter’s
recommendation to reduce the risk of
excavation-related damage by requiring
that PA–11 pipe be buried with warning
tapes or other devices designed to alert
excavators to the presence of a high
pressure gas line.
PHMSA is adopting the amendments
as proposed in the NPRM with four
exceptions:
(1) We are adding the term ‘‘copper
tubing size (CTS)’’ to clarify that
pipeline operators may use copper tube
size pipe as well as iron pipe size pipe.
(2) We are adding the term ‘‘thicker
pipe wall’’ to clarify that ‘‘SDR–11 or
greater’’ means pipe with thicker pipe
wall.
(3) We are clarifying that the use of
arithmetic interpolation to determine a
design pressure rating at a specified
temperature (i.e., ‘‘S’’ in the plastic pipe
design formula in § 192.121) will not be
allowed for PA–11 pipe. Arkema did not
request that we permit such an
1 IPS means Iron Pipe Size, while CTS means
copper tube size. These are recognized pipe size
standards that refer to a nominal pipe diameter, not
to the actual inside diameter (ID) or outside
diameter (OD) of a pipe. IPS is generally used for
pipe sizes 2 inches or greater; CTS is generally used
for pipe sizes 2 inches or less.
(1) Organizational Integrity
Certification: ‘‘I hereby certify that
[name of recipient], a recipient of the
funds made available through this
[grant, cooperative agreement, contract,
or other funding instrument], has
objective integrity and independence
from any organization that engages in
activities inconsistent with a policy
opposing prostitution and sex
trafficking.’’
(2) Acknowledgement Certification: ‘‘I
further certify that the recipient
acknowledges that these certifications
are a prerequisite to receipt of U.S.
Government funds in connection with
this [grant, cooperative agreement,
contract, or other funding instrument],
and that any violation of these
certifications shall be grounds for
termination by HHS in accordance with
the Federal Acquisition Regulations,
Part 49 for contracts, 45 CFR Parts 74 or
92 for grants and cooperative
agreements, as well as any other
remedies as provided by law.’’
(3) Sub-Recipient Compliance
Certification: ‘‘I further certify that the
recipient will include these identical
certification requirements in any [grant,
cooperative agreement, contract, or
other funding instrument] to a subrecipient of funds made available under
this [grant, cooperative agreement,
contract, or other funding instrument],
and will require such sub-recipient to
provide the same certifications that the
recipient provided.’’
(e) Prime recipients and subrecipients of funds must file a renewed
certification each Fiscal Year, in
alignment with the award cycle. Prime
recipients and sub-recipients that are
already recipients as of the effective
date of this regulation must file a
certification upon any extension,
amendment, or modification of the
grant, cooperative agreement, contract,
or other funding instrument that
extends the term of such instrument, or
adds additional funds to it.
2 SDR (standard dimension ratio) means the ratio
of a pipe’s average specified outside diameter to the
minimum specified wall thickness of the pipe. For
any given pipe diameter, the higher the SDR, the
thinner the pipe wall. Typical SDRs are specified
in industry standards developed by the American
National Standards Institute (ANSI).
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials
Safety Administration
49 CFR Part 192
[Docket No. PHMSA–2005–21305]
RIN 2137–AE26
Pipeline Safety: Polyamide–11 (PA–11)
Plastic Pipe Design Pressures
AGENCY: Pipeline and Hazardous
Materials Safety Administration
(PHMSA); DOT.
ACTION: Final rule.
SUMMARY: This final rule amends the
design factor and design pressure limits
for natural gas pipelines made from new
Polyamide–11 (PA–11) thermoplastic
pipe. Together, these two changes in the
regulations allow pipeline operators to
operate certain pipelines constructed of
new PA–11 pipe at higher operating
pressures than is currently allowed for
other plastic pipe materials.
DATES: This final rule takes effect
January 23, 2009.
FOR FURTHER INFORMATION CONTACT:
Richard Sanders at (405) 954–7214, or
by e-mail at Richard.Sanders@dot.gov.
SUPPLEMENTARY INFORMATION:
Background
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]]>Agencies
[Federal Register Volume 73, Number 248 (Wednesday, December 24, 2008)]
[Rules and Regulations]
[Pages 78997-79002]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30686]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 88
RIN 0991-AB46
Office of Global Health Affairs; Regulation on the Organizational
Integrity of Entities That Are Implementing Programs and Activities
Under the Leadership Act
AGENCY: Office of Global Health Affairs, U.S. Department of Health and
Human Services.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Office of Global Health Affairs within the U.S. Department
of Health and Human Services (``HHS'') is issuing this final rule to
clarify that recipients of HHS funds to implement HIV/AIDS programs and
activities under the United States Leadership Against HIV/AIDS,
Tuberculosis and Malaria Act of 2003 (the ``Leadership Act''), Public
Law 108-25 (May 27, 2003), that are required to have a policy opposing
prostitution and sex trafficking, and must submit certification of this
policy with the grant or contract application, may, consistent with
this policy requirement, maintain an affiliation with organizations
that do not have such a policy, provided such affiliations do not
threaten the integrity of the government's programs and its message
opposing prostitution and sex trafficking. The rule describes the
separation that must exist between a recipient of HHS HIV/AIDS funds
that has a policy opposing prostitution and sex trafficking, as
required under section 301(f) of the Leadership Act, 22 U.S.C. 7631(f),
and another organization that engages in activities that are not
consistent with a policy opposing prostitution and sex trafficking.
DATES: This rule is effective January 20, 2009.
FOR FURTHER INFORMATION CONTACT: Jeanne Monahan, Office of Global
Health Affairs, Hubert H. Humphrey Building, Room 639H, 200
Independence Avenue, SW., Washington, DC 20201, Tel: 202.690.6174, E-
mail: Jeanne.monahan@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The U.S. Government is opposed to prostitution and related
activities, which are inherently harmful and dehumanizing, and
contribute to the phenomenon of trafficking in persons. It is critical
to the effectiveness of the Leadership Act, and to the U.S.
Government's foreign policy that underlies this effort, that
organizations that receive Leadership Act funds maintain the integrity
of the Leadership Act programs and activities they implement, and not
confuse the U.S. Government's message opposing prostitution and sex
trafficking by holding positions that conflict with this policy.
On April 17, 2008, HHS published in the Federal Register (73 FR
20900), a Notice of Proposed Rulemaking (``NPRM'') regarding the
requirement expressed in 22 U.S.C. 7631(f), which provides that
organizations that are receiving Leadership Act funds must have a
policy explicitly opposing prostitution and sex trafficking.
Specifically, the NPRM described the legal, financial, and
organizational separation that must exist between entities that receive
grants, contracts, or cooperative agreements from HHS under the
Leadership Act and another organization that engages in activities that
are not consistent with a policy opposing prostitution and sex
trafficking.
A Notice of Correction of Proposed Rule to correct a technical
error in the NPRM was published in the Federal Register (73 FR 29096).
Although the public comment period initially closed on May 19, 2008, a
Notice of Reopening of the Comment Period was published in the Federal
Register (73 FR 36293), and the final date to submit comments on the
NPRM was July 28, 2008.
This final rule is designed to provide additional clarity for
contracting and grant officers, contracting officers' technical
representatives, program officials and implementing partners (e.g.,
grantees, contractors) of HHS regarding the application of language in
Notices of Availability, Requests for Proposals, and other documents
pertaining to the policy requirement expressed in 22 U.S.C. 7631(f).
This final rule clarifies that the Government's organizational partners
that have a policy opposing prostitution and sex trafficking may,
consistent with this policy requirement, maintain an affiliation with
organizations that do not have such a policy, provided such
affiliations do not threaten the integrity of the Government's programs
and its message opposing prostitution and sex trafficking, as specified
in this final rule. To maintain program integrity, adequate separation,
as outlined in this final rule, is required between an organization
that expresses views on prostitution and sex trafficking contrary to
the Government's message and any federally funded partner organization.
Examples of activities inconsistent with a policy
[[Page 78998]]
opposing prostitution and sex trafficking include, but are not limited,
to advocating for the legalization of the institution of prostitution
or organizing or unionizing prostituted people for the purpose of
advocating for the legalization of prostitution.
This final rule applies to funds used by HHS to implement HIV/AIDS
programs and activities under the Leadership Act. The rule includes
certification language that organizations must provide to receive
grants, cooperative agreements, contracts, and other funding
instruments made available by HHS.
All recipients that receive funds directly from HHS (``prime
recipients'') must certify compliance with the final rule prior to
actual receipt of such funds, in a written statement addressed to the
HHS agency's grants or contract officer. The certifications by prime
recipients are prerequisites to payment by HHS of any U.S. Government
funds in connection with an award under the Leadership Act.
All recipients must insert provisions to implement the applicable
parts of this final rule in all sub-agreements under their awards.
These provisions must be express terms and conditions of the sub-
agreement, must acknowledge that compliance with this final rule is a
prerequisite to the receipt and expenditure of U.S. Government funds in
connection with this document, and must acknowledge that any violation
of the provisions shall be grounds for unilateral termination of the
agreement, prior to the end of its term.
Recipients must agree that HHS may, at any reasonable time, inspect
the documents and materials maintained or prepared by the recipient
that relate to the organization's compliance with this final rule.
Nothing in this rule is intended to affect relevant prohibitions on
Federal Government funding under other applicable Federal laws.
II. Discussion of the Final Rule
These sections discuss the final rule by defining the terms
relevant to this final rule and discussing the requirements that must
be satisfied by organizations that receive Leadership Act funds.
Section 88.1 Definitions
This section defines the terms that are pertinent to this rule.
Specifically, we include the following definitions:
``Commercial Sex Act'' means any sex act on account of which
anything of value is given to or received by any person.
``Prime Recipients'' are contractors, grantees, applicants or
awardees that receive Leadership Act funds for HIV/AIDS programs
directly from HHS.
``Prostitution'' means procuring or providing any commercial sex
act.
``Recipients'' are contractors, grantees, applicants or awardees
that receive Leadership Act funds for HIV/AIDS programs directly or
indirectly from HHS. Recipients include both prime recipients and sub-
recipients.
``Sex Trafficking'' means the recruitment, harboring,
transportation, provision, or obtaining of a person for the purpose of
a commercial sex act.
``Sub-Recipients'' are contractors, grantees, applicants or
awardees that receive Leadership Act funds for HIV/AIDS programs from
other recipients rather than directly from HHS.
Section 88.2 Objective Integrity of Recipients
This section of the final rule describes the separation that must
exist between a recipient of funds from HHS to implement HIV/AIDS
programs under the Leadership Act and another organization that engages
in activities that are not consistent with a policy opposing
prostitution and sex trafficking, as required under section 301(f) of
the Leadership Act.
Paragraph (a) sets forth criteria for establishing the objective
integrity and independence that a recipient must have from another
organization that engages in activities inconsistent with a policy
opposing prostitution and sex trafficking.
The criteria for organizational integrity and independence in this
final rule is modeled on criteria upheld as facially constitutional by
the U.S. Court of Appeals for the Second Circuit in Velazquez v. Legal
Services Corp., 164 F.3d 757, 767 (2d Cir. 1999), and Brooklyn Legal
Services Corp. v. Legal Services Corp., 462 F.3d 219, 229-33 (2d Cir.
2006), cases involving similar organization-wide limitations applied to
recipients of Federal funding.
This final rule clarifies that an organization affiliated with a
recipient of Leadership Act funds need not have a policy explicitly
opposing prostitution and sex trafficking for the recipient to maintain
compliance with the policy requirement. The affiliated organization's
position on these issues will have no effect on the recipient's
eligibility for Leadership Act funds, so long as the recipient
satisfies the criteria for objective integrity and independence
detailed in this final rule. By ensuring adequate separation between
the recipient and affiliate, these criteria guard against a public
perception that the affiliate's views on prostitution and sex
trafficking may be attributed to the recipient, and thus to the
Government, thereby avoiding the risk of confusing the Government's
message opposing prostitution and sex trafficking. In addition, the
separation also guards against a public perception that resources
between affiliate and recipient are fungible, and thus Government funds
could inadvertently subsidize other activities inconsistent with a
policy opposing prostitution and sex trafficking.
Under Paragraph (b) of this section, an organization is eligible to
receive from HHS Federal funds made available under the Leadership Act
only if it has provided the certifications required by section 88.3.
Section 88.3 Certifications
This section of the rule describes the certifications required to
receive Leadership Act funding from HHS.
The certifications section contains an Organizational Integrity
Certification, located at section 88.3(d)(1), in which a recipient of
Leadership Act funds administered by an HHS agency certifies it has
objective integrity and independence from any organization that engages
in activities inconsistent with a policy opposing prostitution and sex
trafficking.
The certification section also contains Acknowledgement and Sub-
Recipient Compliance Certifications at section 88.3(d)(2) and (3).
These require each recipient to acknowledge that its provision of the
certifications is a prerequisite to receiving Federal funds, that the
Federal Government can stop or withdraw those funds if HHS finds a
certification to have been inaccurate or to have become inaccurate, and
that the prime recipient will ensure all its sub-recipients provide the
required certifications. A sub-recipient must provide the same
certifications as those provided by the prime recipient. Paragraph (e)
contains information regarding requirements for the renewal of the
certifications. HHS requires each recipient to provide renewed
certifications each Federal Fiscal Year, in alignment with the award
cycle. Additionally, current recipients, as of the effective date of
the regulation, must file a certification upon any extension,
amendment, or modification of the funding instrument that extends the
term of such instrument or adds additional funds to it.
III. Response to Public Comments
In response to the proposed rule, the Office of Global Health
Affairs received five written comments from Members of
[[Page 78999]]
Congress, a university law school, non-governmental organizations
involved in public health and advocacy, and other organizations. The
following is a summary of the comments and the responses from the HHS
Office of Global Health Affairs:
Comment: Several commenters argue that the proposed rule did not
address the merits of the underlying policy requirement expressed in
the Leadership Act, which provides that organizations that are
receiving Leadership Act funds must have a policy explicitly opposing
prostitution and sex trafficking. They state that the policy
requirement in the Leadership Act runs contrary to best practices in
public health efforts to stem the spread of HIV/AIDS and human
trafficking, and the regulation appears to prohibit organizations
receiving Leadership Act funds from participating in prevention
programs that use strategies that involve those engaged in prostitution
and sex trafficking.
Response: The objective of the rule is to clarify that recipients
of HHS HIV/AIDS funds that have adopted a policy opposing prostitution
and sex trafficking may, consistent with this policy requirement,
maintain an affiliation with other organizations that do not have such
a policy, provided such affiliations do not threaten the integrity of
the Government's programs and its message opposing prostitution and sex
trafficking. In doing so, the rule describes the legal, financial, and
organizational separation that must exist between these recipients of
HHS funds and other organizations that engage in activities that are
not consistent with a policy opposing prostitution and sex trafficking.
The rule is not designed to address the merits of the policy
requirement in the Leadership Act. Moreover, the rule does not prevent
an organization from providing prevention, care and treatment to
marginalized populations. In fact, most Leadership Act funds are going
expressly for those purposes. Organizations around the world that
receive Leadership Act funds, including those with extensive experience
working directly with prostituted people, have stated they are in
compliance with the requirement that they must have a policy opposing
prostitution and sex trafficking.
Comment: Several commenters note that the regulation does not
define ``activities inconsistent with a policy opposing prostitution
and sex trafficking.'' They state that the language of the regulation
is vague and that there is confusion in the field about permissible
activities. The commenters note that the broadness of the language of
the rule increases the possibility that organizations will curtail
effective programs for fear of being seen as supporting or promoting
prostitution.
Response: As stated above, the purpose of the rule is to describe
the degree of separation that must exist between recipients of HHS HIV/
AIDS funds, who must have a policy opposing prostitution and sex
trafficking, and other organizations who do not have such a policy, in
order to preserve the integrity of the Government's message opposing
prostitution and sex trafficking. The purpose of the rule is not to
define activities that are inconsistent with a policy opposing
prostitution and sex trafficking. As stated above, the rule does not
prevent recipients of Leadership Act funds from providing prevention,
care and treatment programs to marginalized populations, and
organizations around the world that receive Leadership Act funds,
including those with extensive experience working directly with
prostituted people, have stated that they have a policy opposing
prostitution and sex trafficking.
Comment: One commenter notes that the regulation does not define
``affiliate.'' The commenter writes that there are no limitations on
organizations that might be considered affiliates. The commenter notes
that the speech and activities of affiliate organizations will be
scrutinized to a high degree, and that cooperation between non-
governmental organizations (``NGOs'') will be discouraged.
Response: The Office of Global Health Affairs has determined that
the term ``affiliate'' is not necessary to the rule, as the objective
of the rule is to describe the degree of separation that must exist
between recipients of Leadership Act funds and any other organizations
that do not have a policy opposing prostitution and sex trafficking,
regardless of whether these other organizations are technically defined
as ``affiliates'' of the recipient. Consequently, the HHS Office of
Global Health Affairs has deleted the term ``affiliate'' from the rule.
Further, the separation requirements are designed to ensure the U.S.
Government's message opposing prostitution and sex trafficking is not
confused or diluted. Organizations may still cooperate with each other,
provided that, if they receive Leadership Act funds for HIV/AIDS
programs, they also have a policy opposing sex trafficking and
prostitution, and remain sufficiently separate from organizations that
do not have such a policy.
Comment: Several commenters note that the level of separation
required by the rule is unnecessary. The commenters state that the
level of separation currently applied to faith-based organizations
would be sufficient for recipients of HIV/AIDS funding. The commenters
also claim that the rule is inconsistent with HHS's previous conclusion
that, in the context of faith-based organizations, separation
requirements of this sort are excessive.
Response: The policy requirement in the Leadership Act is not
analogous to the Federal Government's partnership with faith-based
organizations. The Constitution of the United States requires the
Government to be neutral on matters of faith and religion. However, the
Constitution does not require the Government to be neutral on
prostitution and sex trafficking. The United States is free to adopt
policies that favor or disfavor activities related to prostitution and
sex trafficking. In the Leadership Act, Congress chose to establish a
policy that requires funding recipients to have a policy against
prostitution and sex trafficking, which is inherently different from
the neutrality the U.S. Government must exhibit towards faith-based
organizations. The U.S. Government has found prostitution and sex
trafficking to be degrading and harmful to those involved, and
therefore a stronger separation standard is required than is
established for faith-based organizations.
This clearer form of separation is necessary to ensure that the
U.S. Government policy against prostitution and sex trafficking is
clear and not confused with a contrary policy held by a grantee or
contractor.
Comment: Several commenters argue that the regulation requires
recipients to achieve a level of separation from affiliates that will
be an undue burden on NGOs, and defies Congress' intent to promote
efficiency in foreign aid. The commenters note that the level of
separation required for recipients of HIV/AIDS funding is so stringent
that recipients will not be able to set up affiliates. They note that
having separate personnel and management factors will create lengthy
delays in working in developing countries. They also claim that the
separation requirements will harm the recipients' ability to raise
money.
Response: The burden and cost of the rule is unlikely to be
significant for organizations that are receiving Leadership Act funds
because the policy requirement has been in place for a number of years.
Since 2004, over 18 billion dollars have supported HIV/AIDS prevention,
care, and treatment programs, and these groups have stated
[[Page 79000]]
their compliance with section 301(f) of the Leadership Act. The rule
does not alter the policy requirement. Rather, it clarifies that a
recipient of Leadership Act funds may maintain an affiliation with an
organization that does not have a policy opposing prostitution and sex
trafficking if the two organizations are sufficiently separate.
Comment: One commenter states that the policy undermines Congress'
desire to promote public/private partnerships in the delivery of HIV/
AIDS services. The commenter claims that recipients will find it
dangerous, and in some cases illegal, to work with other NGOs. The
commenter notes that the separation requirements will force recipients
to increase administrative costs, and will undercut organizations'
ability to raise funds both from the Government and from the private
sector.
Response: The intent of the rule is not to prevent public/private
partnerships, but to more clearly define the organizations that can
enter into those partnerships and receive funding under the Leadership
Act. The cost of the rule is unlikely to be significant for
organizations receiving Leadership Act funds. Since 2004, HHS has
required recipients of Leadership Act funds to certify their compliance
with section 301(f) of the Leadership Act, and on July 23, 2007, the
Office of Global Health Affairs issued a ``Guidance on Organizational
Integrity,'' similar to this final regulation. The Office of Global
Health Affairs instructed HHS agencies to disseminate the guidance to
their contractors and grantees that receive funding under the
Leadership Act, and provided means for the public to comment on the
guidance, including whether the guidance is economically significant
under definitions provided by the Office of Management and Budget
(``OMB''). The Office of Global Health Affairs has received no comments
on the guidance.
Regulatory Flexibility Act
The Secretary certifies under 5 U.S.C. 605(b), as enacted by the
Regulatory Flexibility Act (Pub. L. 96-354), that this rule will not
result in a significant impact on a substantial number of small
entities. Since enactment of the policy requirement in the Leadership
Act, HHS has required its contract solicitations and grant
announcements for Leadership Act funding to include a section regarding
``Prostitution and Related Activities.''
Executive Order 12866--Regulatory Planning and Review
HHS has drafted and reviewed this regulation in accordance with
Executive Order 12866, section 1(b), Principles of Regulation. HHS has
determined this rule is a ``significant regulatory action'' under
Executive Order 12866, section 3(f)(4), Regulatory Planning and Review,
because it raises novel legal or policy issues that arise out of legal
mandates and the President's priorities, and, accordingly, the Office
of Management and Budget has reviewed it.
The benefits of this rule are that the limitations on promoting or
advocating the legalization or the practice of prostitution and sex
trafficking will (1) help further the U.S. Government's strategy to
reduce sexual exploitation that fuels the spread of HIV/AIDS and
opportunistic infections, such as tuberculosis and malaria, and (2)
demonstrate the U.S. Government's opposition to prostitution and sex
trafficking.
The cost of this rule is unlikely to be significant, according to
cost estimations, approximately $7337.10 in total. Since 2004, HHS has
required recipients of Leadership Act funds to certify their compliance
with section 301(f) of the Leadership Act. Further, the Office of
Global Health Affairs issued a guidance, similar to this final rule, on
July 23, 2007. The Office of Global Health Affairs instructed HHS
agencies to disseminate the guidance to their contractors and grantees
that receive funding under the Leadership Act, and provided means for
the public to comment on the guidance, including whether the guidance
is economically significant under definitions provided by OMB. The
Office of Global Health Affairs has received no comments on the
guidance.
Executive Order 13132--Federalism
Executive Order 13132 on Federalism requires Federal Departments
and agencies to consult with State and local Government officials in
the development of regulatory policies with implications for
Federalism. This rule does not have Federalism implications for State
or local Governments, as defined in the Executive Order.
Unfunded Mandates Reform Act of 1995
Section 202 of the Unfunded Mandates Reform Act of 1995 requires
that a covered Federal Department or agency prepare a budgetary impact
statement before promulgating a rule that includes any Federal mandate
that could result in the expenditure by State, local, and tribal
Governments, in the aggregate, or by the private sector, of $100
million or more in any one year. HHS has determined that this rule
would not impose a mandate that will result in the expenditure by
State, local, and Tribal Governments, in the aggregate, or by the
private sector, of more than $100 million in any one year.
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 final 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 rule will not have an impact on family well-being, as defined in
this legislation.
Paperwork Reduction Act
To obtain or retain Leadership Act funding, HHS will require
recipients to submit certifications. The title of the information
collection is ``Certification Regarding the Organizational Integrity of
Entities Implementing Leadership Act Programs and Activities.'' The
documents are necessary to ensure that recipients of Leadership Act
funding have objective integrity and independence from any
organizations that engage in activities inconsistent with a policy
opposing prostitution and sex trafficking.
HHS estimates that 555 respondents will prepare documents to
validate that recipients have objective integrity and independence from
organizations that engage in activities inconsistent with policies
opposing prostitution and sex trafficking. HHS also estimates that the
average cost per hour will be $26.44, with \1/2\ hour estimated time
burden per response. In total, the estimated burden cost is
approximately $7337.10.
HHS therefore estimates annual aggregate burden to collect the
information as follows:
[[Page 79001]]
Annual Burden Estimates
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Average cost Total burden Total burden
respondents respondent response per hour hours cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certifications.................................... 555 1 .5 $26.44 277.5 $7,337.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
During the Notice of Revised Rulemaking (NPRM) process, HHS
accepted comments from the public, in accordance with the Paperwork
Reduction Act of 1995. HHS will submit this information collection to
the Office of Management and Budget (OMB) for regular approval.
Affected parties do not have to comply with the information
collection requirements in the final rule until the Department of
Health and Human Services publishes in the Federal Register the control
numbers assigned by the Office of Management and Budget (OMB).
Publication of the control numbers notifies the public that OMB has
approved these information collection requirements under the Paperwork
Reduction Act of 1995.
List of Subjects in 45 CFR Part 88
Administrative practice and procedure, Federal aid programs, Grant
programs, Grants administration.
Dated: September 26, 2008.
William R. Steiger,
Director, Office of Global Health Affairs.
Approved: October 22, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.
Editorial Note: This document was received in the Office of the
Federal Register on Friday, December 19, 2008.
0
For the reasons stated in the preamble, the Office of Global Health
Affairs amends 45 CFR subtitle A to add Part 88 as follows:
PART 88-ORGANIZATIONAL INTEGRITY OF ENTITIES IMPLEMENTING PROGRAMS
AND ACTIVITIES UNDER THE LEADERSHIP ACT
Sec.
88.1 Definitions.
88.2 Organizational integrity of recipients.
88.3 Certifications.
Authority: 22 U.S.C. 7631(f) and 5 U.S.C. 301.
Sec. 88.1 Definitions.
0
For the purposes of this part:
Commercial Sex Act means any sex act on account of which anything
of value is given to or received by any person.
Prime Recipients are contractors, grantees, applicants or awardees
who receive Leadership Act funds for HIV/AIDS programs directly from
HHS.
Prostitution means procuring or providing any commercial sex act.
Recipients are contractors, grantees, applicants or awardees who
receive Leadership Act funds for HIV/AIDS programs directly or
indirectly from HHS. Recipients include both prime recipients and sub-
recipients.
Sex Trafficking means the recruitment, harboring, transportation,
provision, or obtaining of a person for the purpose of a commercial sex
act.
Sub-Recipients are contractors, grantees, applicants or awardees,
other than prime recipients, who receive Leadership Act funds for HIV/
AIDS programs from other recipients rather than directly from HHS.
Sec. 88.2 Organizational integrity of recipients.
(a) A recipient must have objective integrity and independence from
any organization that engages in activities inconsistent with a policy
opposing prostitution and sex trafficking. A recipient will be found to
have objective integrity and independence from such an organization if:
(1) The organization is a legally separate entity;
(2) The organization receives no transfer of Leadership Act funds,
and Leadership Act funds do not subsidize activities inconsistent with
a policy opposing prostitution and sex trafficking; and
(3) The recipient is physically and financially separate from the
organization. Mere bookkeeping separation of Leadership Act funds from
other funds is not sufficient. HHS will determine, on a case-by-case
basis and based on the totality of the facts, whether sufficient
physical and financial separation exists. The presence or absence of
any one or more factors will not be determinative. Factors relevant to
this determination shall include, but will not be limited to, the
following:
(i) The existence of separate personnel, management, and
governance;
(ii) The existence of separate accounts, accounting records, and
timekeeping records;
(iii) The degree of separation from facilities, equipment and
supplies used by the organization to conduct activities inconsistent
with a policy opposing prostitution and sex trafficking, and the extent
of such activities by the organization;
(iv) The extent to which signs and other forms of identification
that distinguish the recipient from the organization are present, and
signs and materials that could be associated with the organization or
activities inconsistent with a policy opposing prostitution and sex
trafficking are absent; and
(v) The extent to which HHS, the U.S. Government and the project
name are protected from public association with the organization and
its activities inconsistent with a policy opposing prostitution and sex
trafficking in materials such as publications, conferences and press or
public statements.
(b) An organization is ineligible to receive any Leadership Act funds
unless it has provided the certifications required by Sec. 88.3.
Sec. 88.3 Certifications.
(a) HHS agencies shall include the certification requirements for
any grant, cooperative agreement, contract, or other funding instrument
in the public announcement of the availability of the grant,
cooperative agreement, contract, or other funding instrument.
(b) Unless the recipient is otherwise excepted, a person authorized
to bind the recipient shall execute the certifications for the grant,
cooperative agreement, contract, or other funding instrument.
(c) A prime recipient must submit its certifications to the grant
or contract officer of the HHS agency that will award funds. A sub-
recipient must provide its certifications to the prime recipient. The
prime recipient will submit certifications from its sub-recipients when
requested to do so by the HHS grant or contract officer.
(d) The certifications shall state as follows:
[[Page 79002]]
(1) Organizational Integrity Certification: ``I hereby certify that
[name of recipient], a recipient of the funds made available through
this [grant, cooperative agreement, contract, or other funding
instrument], has objective integrity and independence from any
organization that engages in activities inconsistent with a policy
opposing prostitution and sex trafficking.''
(2) Acknowledgement Certification: ``I further certify that the
recipient acknowledges that these certifications are a prerequisite to
receipt of U.S. Government funds in connection with this [grant,
cooperative agreement, contract, or other funding instrument], and that
any violation of these certifications shall be grounds for termination
by HHS in accordance with the Federal Acquisition Regulations, Part 49
for contracts, 45 CFR Parts 74 or 92 for grants and cooperative
agreements, as well as any other remedies as provided by law.''
(3) Sub-Recipient Compliance Certification: ``I further certify
that the recipient will include these identical certification
requirements in any [grant, cooperative agreement, contract, or other
funding instrument] to a sub-recipient of funds made available under
this [grant, cooperative agreement, contract, or other funding
instrument], and will require such sub-recipient to provide the same
certifications that the recipient provided.''
(e) Prime recipients and sub-recipients of funds must file a
renewed certification each Fiscal Year, in alignment with the award
cycle. Prime recipients and sub-recipients that are already recipients
as of the effective date of this regulation must file a certification
upon any extension, amendment, or modification of the grant,
cooperative agreement, contract, or other funding instrument that
extends the term of such instrument, or adds additional funds to it.
[FR Doc. E8-30686 Filed 12-19-08; 4:15 pm]
BILLING CODE 4150-28-P
