Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices In Violation of Federal Law, 50274-50285 [E8-19744]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 166 (Tuesday, August 26, 2008)]
[Proposed Rules]
[Pages 50274-50285]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19744]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 88

RIN 0991-AB48


Ensuring That Department of Health and Human Services Funds Do 
Not Support Coercive or Discriminatory Policies or Practices In 
Violation of Federal Law

AGENCY: Office of the Secretary, HHS.

ACTION: Proposed rule.

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SUMMARY: The Department of Health and Human Services proposes to 
promulgate regulations to ensure that Department funds do not support 
morally coercive or discriminatory practices or policies in violation 
of federal law, pursuant to the Church Amendments (42 U.S.C. 300a-7), 
Public Health Service (PHS) Act Sec.  245 (42 U.S.C. 238n), and the 
Weldon Amendment (Consolidated Appropriations Act, 2008, Pub. L. 110-
161, Sec.  508(d), 121 Stat. 1844, 2209). This notice of proposed 
rulemaking proposes to define certain key terms. Furthermore, in order 
to ensure that recipients of Department funds know about their legal 
obligations under these nondiscrimination provisions, the Department 
proposes to require written certification by certain recipients that 
they will comply with all three statutes, as applicable.

DATES: Submit written or electronic comment on the regulations proposed 
by this document by September 25, 2008.

ADDRESSES: In commenting, please refer to ``Provider Conscience 
Regulation''. Because of staff and resource limitations, we cannot 
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 
consciencecomment@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 ``provider conscience''. 
(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: Brenda 
Destro, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Room 
728E, 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: Brenda Destro, Hubert H. Humphrey Building, 200 Independence 
Avenue, SW., Room 728E, 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 728E, 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 and extra copy of the documents being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    Submitting Comments: We welcome comments from the public on all 
issues set forth in this proposed rule to assist us in fully 
considering issues and developing policies. For all comments submitted, 
you should specify the subject as ``Provider Conscience Regulation''.
    Inspection of Public Comments: All comments received before the 
close of 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

[[Page 50275]]

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 Server (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 used communications software and modem 
to call (202) 512-1661; type swais, then login as guest (no password 
required).

FOR FURTHER INFORMATION CONTACT: Brenda Destro, (202) 401-2305, Office 
of Public Health and Science, Department of Health and Human Services, 
Room 728E, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201.

SUPPLEMENTARY INFORMATION:

I. Background

    Religious liberty and freedom of conscience have long been 
protected in the Constitution and laws of the United States. Workers in 
all sectors of the economy enjoy legal protection of their consciences 
and religious liberties. In federal law, there are several provisions 
that prohibit recipients of certain federal funds from coercing 
individuals in the health care field into participating in actions they 
find religiously or morally objectionable. These same provisions also 
prohibit discrimination on the basis of one's objection to, 
participation in, or refusal to participate in, specific medical 
procedures, including abortion or sterilization. In addition, there is 
a provision that prohibits the federal governments and state and local 
governments from discriminating against individual and institutional 
providers who refuse, among other things, to receive training in 
abortions, require or provide such training, perform abortions, or 
refer for or make arrangements for abortions or training in abortions. 
More recently, an appropriations provision has been enacted that 
prohibits certain federal agencies and programs and State and local 
governments that receive certain federal funds from discriminating 
against individuals and institutions that refuse to, among other 
things, provide, refer for, pay for, or cover, abortion.

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 
provide 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 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 which 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 either 
``performed or assisted in the performance of a lawful sterilization 
procedure or abortion,'' or ``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 which 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,'' or ``because he refused to perform or assist in the 
performance of any such service or activity on the grounds that his 
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, or loan guarantee under certain Departmentally 
implemented statutes from denying admission to, or otherwise 
discriminating against, ``any applicant (including 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 receive 
training in the performance of 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 training program in the health 
professions that does not (or did not) perform abortions or require, 
provide, or refer for training in the performance of abortions or make

[[Page 50276]]

arrangements for the provision of such training. In addition, PHS Act 
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 such as a medical license), the 
federal government and any State or local government receiving federal 
financial assistance deem accredited any post-graduate physician 
training program that otherwise would be accredited but for the 
reliance on an accrediting standard that 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 [Consolidated Appropriations Act, 2008, Public Law No. 
110-161, Div. G, Sec.  508(d), 121 Stat. 1844, 2209 (Dec. 26, 2007)]

    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 (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; Revised Continuing 
Appropriations Resolution of 2007, Public Law 110-5, Sec.  2, 121 Stat. 
8, 9; Consolidated Appropriations Act, 2008, Public Law No. 110-161, 
Div. G, Sec.  508(d), 121 Stat. 1844, 2209. The Weldon Amendment 
provides that ``[n]one of the funds made available under 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.''

The Laws in the Courts

    The federal courts have recognized the breadth and importance of 
statutory and other conscience protections for health care 
professionals and workers. Shortly after its passage, a federal 
appellate court decision characterized the importance of conscience 
protections contained in the Church Amendments. Faced with the question 
of a denominational hospital's right to refuse to perform sterilization 
procedures, the Ninth Circuit affirmed a lower court decision 
protecting the hospital's right to refuse to perform sterilizations and 
abortions on religious or moral grounds: ``If [a] hospital's refusal to 
perform sterilization [or, by implication, abortion] infringes upon any 
constitutionally cognizable right to privacy, such infringement is 
outweighed by the need to protect the freedom of religion of 
denominational hospitals `with religious or moral scruples against 
sterilizations and abortions.' '' Taylor v. St. Vincent's Hospital, 523 
F.2d 75, 77 (9th Cir. 1975) (citations omitted).

The Problem

    There appears to be an attitude toward the health care professions 
that health care professionals and institutions should be required to 
provide or assist in the provision of medicine or procedures to which 
they object, or else risk being subjected to discrimination. Reflecting 
this attitude, in some instances the standards of professional 
organizations have been used to define the exercise of conscience to be 
unprofessional, forcing health care professionals to choose between 
their capacity to practice in good standing and their right of 
conscience.\1\
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    \1\ ``HHS Secretary Calls on Certification Group to Protect 
Conscience Rights,'' March 14, 2008. Available at https://
www.hhs.gov/news/press/2008pres/03/20080314a.html.
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    Despite the fact that several conscience statutes protecting health 
care entities from discrimination have been in existence for decades, 
the Department is concerned that the public and many health care 
providers are largely uninformed of the protections afforded to 
individuals and institutions under these provisions. This lack of 
knowledge within the health professions can be detrimental to 
conscience and other rights, particularly for individuals and entities 
with moral objections to abortion and other medical procedures.

The Department's Response

    In general, the Department is concerned 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. Such developments 
also promote the mistaken beliefs that rights of conscience and self-
determination extend to all persons, except health care providers. 
Additionally, religious and faith-based organizations have a long 
tradition of providing medical care in the United States, and they 
continue to do so today--some of these are among the largest providers 
of health care in this nation. A trend that isolates and excludes some 
among various religious, cultural, and/or ethnic groups from 
participating in the delivery of health care is especially troublesome 
when considering current and anticipated shortages of health care 
professionals in many medical disciplines facing the country.
    The Department also notes that, while many recipients of Department 
funds currently must certify compliance with federal nondiscrimination 
laws, federal conscience protections are not mentioned in existing 
forms. For example, Form PHS-5161-1, required as part of Public Health 
Service grant applications, requires applicants to certify compliance 
with all federal nondiscrimination laws, including laws prohibiting 
discrimination on the basis of race, color, national origin, religion, 
sex, handicap, age, drug abuse, and alcohol abuse or alcoholism. The 
Department seeks to raise awareness of federal conscience laws by 
specifically including 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.
    Toward these ends, the Department has concluded that regulations 
and related efforts are 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 morally 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

[[Page 50277]]

inclusive, tolerant environment in the health care industry than may 
currently exist.
    This regulation does not limit patient access to health care, but 
rather protects any individual health care provider or institution from 
being compelled to participate in, or from being punished for refusal 
to participate in, a service that, for example, violates their 
conscience.
    These proposed actions are consistent with the Administration's 
current efforts to ensure that community and faith-based organizations 
are able to participate in federal programs on a level playing field 
with other organizations.

II. Summary of the Proposed Rule

    This proposed rule sets out, and provides further definition of, 
the rights and responsibilities created by the federal 
nondiscrimination provisions. It clarifies the scope of 
nondiscrimination protections to applicable members of the Department's 
workforce, as well as and health care entities and members of the 
workforces of entities receiving Department funds. This proposed rule 
would also require certain recipients of Department funds to certify 
compliance with these requirements. In order to ensure proper 
enforcement, this proposed rule would define certain terms for the 
purposes of this proposed regulation.
    The Office for Civil Rights of the Department of Health and Human 
Services has been designated to receive complaints of discrimination 
based on the nondiscrimination statutes and this proposed regulation. 
It will coordinate handling of complaints with the staff of the 
Departmental programs from which the entity with respect to whom a 
complaint has been filed receives funding. Enforcement of the 
requirements set forth in this proposed regulation will be conducted 
through the usual and ordinary program mechanisms. Compliance with the 
requirements proposed herein would likely be examined as part of any 
broader compliance review conducted by Department staff. If the 
Department becomes aware that a State or local government or an entity 
may be in violation of the requirements or prohibitions proposed 
herein, the Department would work with such government or entity to 
assist such government or entity to come into compliance with such 
requirements or prohibitions. If, despite the Department's assistance, 
compliance is not achieved, the Department will consider all legal 
options, including termination of funding, return of funds paid out in 
violation of nondiscrimination provisions under 45 CFR 74, and other 
measures.

III. Statutory Authority

    On the basis of the above-mentioned statutory authority, the 
Secretary proposes to promulgate these regulations, requiring 
certification of compliance with the anti-discrimination statutes.
    The statutory provisions discussed above require 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 or refusal 
to participate in certain medical procedures or services, including 
certain health services, or research activities funded in whole or in 
part by the Federal Government. The Department has authority to 
promulgate regulations to enforce these prohibitions. Finally, the 
Department also has the legal authority to require that recipients 
certify their compliance with these proposed requirements and to 
require their sub-recipients to likewise certify their compliance with 
these proposed requirements. In addition, 5 U.S.C. 301 empowers the 
head of an Executive department to prescribe regulations ``for the 
government of his department, the conduct of its employees, the 
distribution and performance of its business, and the custody, use, and 
preservation of its records, papers, and property.''

IV. Provisions of the Proposed Rule

Section 88.1 Purpose

    The ``Purpose'' section of the regulation sets forth the objective 
that the proposed regulation would, when finalized, provide for the 
implementation and enforcement of federal nondiscrimination statutes 
protecting the conscience rights of health care entities. It also 
states that the statutory provisions and regulations contained in this 
Part are to be interpreted and implemented broadly to effectuate these 
protections.

Section 88.2 Definitions

    Assist in the Performance: The Department, in considering how to 
interpret the term ``assist in the performance,'' seeks to provide 
broad protection for individuals' consciences. The Department seeks to 
avoid judging whether a particular action is genuinely offensive to an 
individual. At the same time, the Department wishes to guard against 
potential abuses of these protections by limiting the definition of 
``assist in performance'' only to those actors who have a reasonable 
connection to the procedure, health service or health service program, 
or research activity to which they object.
    Therefore, the Department proposes to interpret this term broadly, 
as encompassing individuals who are members of the workforce of the 
Department-funded entity performing the objectionable procedure. When 
applying the term ``assist in the performance'' to members of an 
entity's workforce, the Department proposes to include participation in 
any activity with a reasonable connection to the objectionable 
procedure, including referrals, training, and other arrangements for 
offending procedures. For example, an operating room nurse would assist 
in the performance of surgical procedures, and an employee whose task 
it is to clean the instruments used in a particular procedure would be 
considered to assist in the performance of the particular procedure.
    Health Care Entity/Entity: While both PHS Act Sec.  245 and the 
Weldon Amendment provide examples of specific types of protected 
individuals and health care organizations, neither statute provides an 
exhaustive list of such health care entities. PHS Act Sec.  245 defines 
``health care entity'' as ``includ[ing] an individual physician, a 
postgraduate physician training program, and a participant in a program 
of training in the health professions.'' As the Department has 
previously indicated, the definition of ``health care entity'' in PHS 
Act Sec.  245 also encompasses institutional entities, such as 
hospitals and other entities.\2\ The Weldon Amendment defines the term 
``health care entity'' as ``includ[ing] 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.'' The Church Amendment does not define the term ``entity,'' and 
does not use the term ``health care entity.''
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    \2\ See Letter from Secretary Tommy G. Thompson to Hon. W.F. 
Tauzin, September 24, 2002.
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    In keeping with the definitions in PHS Act Sec.  245 and the Weldon 
Amendment, the Department proposes to define ``health care entity'' to 
include the specifically mentioned organizations from the two statutes, 
as well as other types of entities referenced in the Church Amendments. 
It is important to note that the Department does not intend for this to 
be a comprehensive list of relevant organizations for

[[Page 50278]]

purposes of the regulation, but merely a list of examples.
    Health Service/Health Service Program: One of the provisions in the 
Church Amendments uses the term ``health service,'' another uses the 
term, ``health service program.'' Neither define the terms, nor does 
the PHS Act define ``health service program.'' In developing an 
appropriate definition for ``health service program,'' we have looked 
at the Social Security Act. Section 1128B(f)(1) of the Social Security 
Act, 42 U.S.C. 1320a-7b(f)(1), defines a similar term, ``federal health 
care program'', as ``any plan or program that provides health benefits, 
whether directly, through insurance, or otherwise, which is funded 
directly, in whole or in part, by the United States Government.''
    Building on this broad definition, we propose that the term 
``health service program'' should be understood to include an activity 
related in any way to providing medicine, health care, or any other 
service related to health or wellness, including programs where the 
Department provides care directly (e.g., Indian Health Service); 
programs where grants pay for the provision of health services (e.g., 
Administration for Children and Families programs such as the 
Unaccompanied Refugee Minor and the Division of Unaccompanied Children 
Services programs and HRSA programs such as community health centers); 
programs where the Department reimburses another entity that provides 
care (e.g., Medicare); and health insurance programs where federal 
funds are used to provide access to health coverage (e.g., SCHIP, 
Medicaid, and Medicare Advantage). Similarly, we propose that the term 
``health service'' means any service so provided.
    Individual: For the purposes of this part, the Department proposes 
to define ``individual'' to mean a member of the workforce (see 
definition of ``workforce'' below) of an entity or health care entity. 
One conscience clause of the Church Amendments, 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 
Secretary of Health, Education and Welfare [Secretary of Health and 
Human Services] 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 (emphasis added).''
    Instrument: We propose to use ``instrument'' to mean the variety of 
means by which the Department conveys funding and resources to 
organizations, including: grants, cooperative agreements, contracts, 
grants under a contract, and memoranda of understanding. The definition 
of ``instrument'' is intended to include all means by which the 
Department conveys funding and resources.
    Recipient: This term is used to encompass any entity that receives 
Department funds directly.
    Sub-recipient: This term is used to encompass any entity that 
receives Department funds indirectly through a recipient or sub-
recipient.
    Workforce: We propose to define ``workforce'' as including 
employees, volunteers, trainees, and other persons whose conduct, in 
the performance of work for an entity, is under the control or 
authority of such entity, whether or not they are paid by the 
Department-funded entity. The definition is drawn from the 
``Administrative Data Standards and Related Requirements'' rules 
implementing Health Insurance Portability and Accountability Act 
(HIPAA), 45 CFR Parts 160, 162, and 164 (2006) at 45 CFR 160.103. In 
keeping with this definition, persons and organizations under contract 
with an entity, if they are under the control or authority of the 
entity, would be considered members of the entity's workforce.
    In defining both ``individual'' and ``workforce,'' the Department 
proposes definitions that provide a reasonable scope for the natural 
persons protected by 42 U.S.C. 300a-7(d) and the corresponding 
provisions of these regulations. By limiting the scope of persons 
protected by these regulations to those who are under the control or 
authority of an entity that implements a health service program or 
research activity funded in whole or in part under a program 
administered by the Department, we propose to provide the bright line 
necessary for Department-funded entities subject to the applicable 
Church Amendment provisions to set policies or otherwise take steps to 
secure conscience protections within the workplace and, thus, to comply 
with the Church Amendment and these regulations.

Section 88.3 Applicability

    The proposed ``Applicability'' section of the regulation outlines 
the certifications various entities must provide in order to receive 
Department funds. This section would direct entities to the appropriate 
sections that contain the relevant requirements from the three statutes 
that form the basis of this regulation.

Section 88.4 Requirements and Prohibitions

    The ``Requirements and Prohibitions'' section explains the 
obligations that the Church Amendments, PHS Act Sec.  245, and the 
Weldon Amendment impose on entities which receive funding from the 
Department. These provisions are taken from the relevant statutory 
language and make up the elements of the certification provided by the 
entities. We intend for the proposed requirements and prohibitions to 
be interpreted using the definitions proposed in section 88.2.

Section 88.5 Written Certification of Compliance

    In the ``Written Certification of Compliance'' section of the 
regulation, the Department seeks to require certain recipients and sub-
recipients of Department funds to certify compliance with the Church 
Amendments, PHS Act Sec.  245, and the Weldon Amendment, as applicable, 
and to provide for the affected recipients and sub-recipients 
requirements for collecting, maintaining, and submitting written 
certifications.
    We are concerned that there is a lack of knowledge on the part of 
States, local governments, and the health care industry of the rights 
of health care entities created by, and the corresponding obligations 
imposed on the recipients of certain federal funding by, the non-
discrimination provisions. Under this proposed rule, recipients of 
federal funds would be required to submit their certifications directly 
to the Department as part of the instrument or in a separate writing 
signed by the recipients' officer or other person authorized to bind 
the recipient. They would also be required to collect and maintain 
certifications by sub-recipients who receive Department funds through 
them.
    The proposed regulation requires that entities certify in writing 
that they will operate in compliance with the Church Amendments, PHS 
Act Sec.  245, and the Weldon Amendment as applicable. Certification 
provides a demonstrable way of ensuring that the recipients of such 
funding know of, and attest that they will comply with, the applicable 
nondiscrimination provisions. Sub-recipients of federal funds--entities 
that will receive federal funds indirectly through another entity (a 
recipient or other sub-recipient)--are required to provide 
certification as set out in the ``Sub-recipient'' subsection of the 
``Certification of Compliance'' section, and submit them to the 
recipients

[[Page 50279]]

through which they receive Department funds for maintenance.
    Although it is collected and maintained by the recipient, this 
certification by sub-recipients is a certification addressed to the 
Department, not to the recipients collecting the certification. 
Recipients are expected to comply with requirements for retention of 
and access to records set forth in 45 CFR 74.53.
    While all recipients and sub-recipients of Department funds are 
required to comply with the Church Amendments, PHS Act Sec.  245, and 
the Weldon Amendment, as applicable, section 88.5(e) contains three 
important exceptions from the requirement to provide the written 
certification: (1) Physicians, physician offices, and other health care 
practitioners participating in Part B of the Medicare program; (2) 
physicians, physician offices, or other health care practitioners which 
participates in Part B of the Medicare program, when such individuals 
or organizations are sub-recipients of Department funds through a 
Medicare Advantage plan; and (3) sub-recipients of state Medicaid 
programs (i.e., any entity that is paid for services by the state 
Medicaid program). While other providers participating in the Medicare 
program as well as state Medicaid programs would be required to submit 
written certification of compliance to the Department, the large number 
of entities included in these three categories poses significant 
implementation hurdles for Departmental components and programs. 
Furthermore, the Department believes that, due primarily to their 
generally smaller size, the excepted categories of recipients and sub-
recipients of Department funds are less likely to encounter the types 
of issues sought to be addressed in this regulation. However, excepted 
providers may become subject to the written certification requirement 
by nature of their receiving Department funds under a separate agency 
or program. For example, a physician office participating in Medicare 
Part B may become subject to the written certification requirement by 
receiving Department funds to conduct clinical research. We note, 
however, that the State Medicaid programs are responsible for ensuring 
the compliance of their sub-recipients as part of ensuring that the 
State Medicaid program is operated consistently with applicable 
nondiscrimination provisions. The Department is considering whether 
other recipients of Department funds from programs that do not involve 
the provision of health care should also be excepted from the 
certification requirement and we seek comment on this issue.
    When finalized, individual Department components will be tasked 
with determining how best to implement the written certification 
requirements set out in this regulation in a way that ensures efficient 
program operation. To this end, Department components will be 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.

V. Request for Comment

    The Department, in order to craft its final rule to best reflect 
the environment within the health care field, seeks comment on this 
Proposed Rule. In particular, the Department seeks the following:
     Comment on all issues raised by the proposed regulation.
     Information with regard to general knowledge or lack 
thereof of the protections established by these nondiscrimination 
provisions, including any facts, surveys, audits, reports, or any other 
evidence of knowledge or lack of knowledge on these matters in the 
general public, as well as within the healthcare industry and 
educational institutions.
     In the past, there has been some confusion about whether 
the receipt of federal funds permitted public officials to require 
entities to provide abortions or perform sterilizations. The debate was 
resolved, and statutory provisions like section (b) of the Church 
Amendments [42 U.S.C. 300a-7(b)] were promulgated to protect entities 
from public authorities who would claim that the receipt of federal 
funds creates a legal obligation for the entity to provide abortions or 
sterilization procedures. The Department seeks information, including 
any facts, surveys, audits, or reports on whether this remains an 
issue, that is, do public authorities continue to claim that the 
receipt of federal funds is sufficient basis for entities to be 
required to provide abortions or perform sterilizations? If so, how 
should the Department address this problem?
     Comment on whether written certification of compliance 
with nondiscrimination provisions should contain language specifying 
that the certification is a material prerequisite to the payment of 
Department funds.
     The Department also seeks comment on what constitutes the 
most effective methods of educating recipients of Department funds, 
their employees, and participants of the protections against 
discrimination found in the Church Amendments, PHS Act Sec.  245, and 
the Weldon Amendment. What is the best method for communicating to the 
public the protections afforded by these statutes, and any regulation 
implementing them?
    [cir] One option is to require the physical posting of notices of 
nondiscrimination protections in conspicuous places within the 
buildings of recipients of funds, and on applications to educational 
programs that are recipients of funds. Have notices been effective 
educational tools with respect to individuals' rights under federal 
law?
    [cir] Another option is to require inclusion of nondiscrimination 
protections in notice of applications for training, residency, and 
educational programs.
    [cir] Another option is requiring notice of nondiscrimination 
protections on websites and in employee/volunteer handbooks of 
recipients.
    The Department seeks further comment on this matter--both on the 
merit of the options mentioned, and on any other means of educating the 
public with respect to the nondiscrimination protections under federal 
law.
     Comment on whether there are recipients of Department 
funds that should be excepted from the proposed certification 
requirement, for example because the program under which such 
recipients receive Department funds is unrelated to the provision of 
health care or medical research.

VI. 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 sector of the economy in a material way, 
adversely affecting competition, or adversely affecting jobs. A 
regulation is also considered a significant regulatory action if it 
raises novel legal or policy issues. HHS has

[[Page 50280]]

determined that this proposed rule is a significant regulatory action 
as defined by Executive Order 12866.
    An underlying assumption of this regulation is that the health care 
industry, including entities receiving Department funds, will benefit 
from more diverse and inclusive workforces by informing health care 
workers of their rights and fostering an environment in which 
individuals and organizations from many different faiths, cultures, and 
philosophical backgrounds are encouraged to participate. As a result, 
we cannot accurately account for all of the regulation's future 
benefits, but the Department believes the future benefits will exceed 
the costs of complying with the regulation.
    The statutes mandating the requirements for protecting health care 
entities and individuals in the health care industry as discussed in 
this rule have been in effect for a number of years and the proposed 
regulations are consistent with prior Departmental interpretations of 
these nondiscrimination statutes; \3\ therefore, the regulatory burden 
associated with this rule, if finalized, is largely associated with the 
incremental costs of a recipient certifying compliance to the federal 
government and the cost of collecting and maintaining records of 
certification statements from sub-recipients. We estimate the universe 
and number of entities that would be required to certify to be, at 
most, 584,294 (see Table I). We do not distinguish between recipients 
and sub-recipients of HHS funding. Each entity could be a recipient, a 
sub-recipient, or both. In accordance with subsection 88.5(e) below, 
physicians, physician offices, and other health care practitioners 
participating in Medicare Part B or who are sub-recipients assisting in 
the implementation of a State Medicaid program are not subject to the 
written certification requirement; however, a high estimate of the 
number of physician offices and offices of other health care 
practitioners who may be required to certify as recipients or sub-
recipients of Department funds through other programs, instruments, or 
mechanisms is included.
---------------------------------------------------------------------------

    \3\ The [* * *] suggestion that the requirement to provide 
options counseling [including abortion counseling] should not apply 
to employees of a grantee who object to providing such counseling on 
moral or religious grounds, is likewise rejected [* * *] [S]uch a 
requirement is not necessary: under 42 U.S.C. 300a-7(d), grantees 
may not require individual employees who have such objections to 
provide such counseling (emphasis added). 65 FR 41270 (July 3, 2000) 
[codified at 42 CFR 59 (2008)]; see also Letter from Secretary Tommy 
G. Thompson to Hon. W.F. Tauzin, September 24, 2002.

                       Table I--Affected Entities
------------------------------------------------------------------------
                                                              Number of
                     Health care entity                        entities
------------------------------------------------------------------------
Hospitals (less than 100 beds) \1\.........................        2,403
Hospitals (100-200 beds) \4\...............................        1,129
Hospitals (200-500 beds) \4\...............................        1,160
Hospitals (more than 500 beds) \4\.........................          244
Nursing Homes (less than 50 beds) \2\......................        2,388
Nursing Homes (50-99 beds) \5\.............................        5,819
Nursing Homes (99-199 beds) \5\............................        6,877
Nursing Homes (more than 200 beds) \5\.....................        1,037
Physicians Offices \3\.....................................      234,200
Offices of Other Health CarePractitioners \6\ \4\..........      115,378
Outpatient Care Centers \6\ \5\............................       26,901
Medical and Diagnostic Laboratories \6\....................       11,856
Home Health Care Services \6\..............................       20,184
Pharmacies (chain and independent) \6\.....................       58,109
Dental Schools \7\.........................................           56
Medical Schools (Allopathic) \4\...........................          125
Medical Schools (Osteopathic) \4\..........................           20
Nursing Schools (Licensed practical) \8\...................        1,138
Nursing Schools (Baccalaureate) \11\.......................          550
Nursing Schools (Associate degree) \11\....................          885
Nursing Schools (Diploma) \11\.............................           78
Occupational Therapy Schools \4\...........................          142
Optometry Schools \4\......................................           17
Pharmacy Schools \4\.......................................           92
Podiatry Schools \4\.......................................            7
Public Health Schools \4\..................................           37
Residency Programs (accredited) \9\........................        8,494
Health Insurance Carriers and 3rd-Party Administrators \10\        4,578
Grant awards \11\..........................................       76,088
Contractors \12\...........................................        4,245
State and territorial governments..........................           57
                                                            ------------
    Total..................................................      584,294
------------------------------------------------------------------------
\1\ Health, United States, 2007. U.S. Dept. of Health and Human
  Services, Centers for Disease Control and Prevention, National Center
  for Health Statistics. Nov. 2007.
\2\ Nursing Home Data Compendium, 2007 edition. U.S. Dept. of Health and
  Human Services, Centers for Medicaid and Medicare Services.
\3\ NPRM: Modification to Medical Data Code Set Standards to Adopt ICD-
  10-CM and ICD-10-PCS.
\4\ From the NAICS Code 6213--Office of Other Health Care Practitioners
  (including Chiropractors, Optometrists, non-Physician Mental Health
  Practitioners, Physical Occupational and Speech Therapists,
  Podiatrists, and all other Miscellaneous Health Care Practitioners).
\5\ From the NAICS Code 6214--Outpatient Care Centers (including Family
  Planning Centers, Outpatient Mental Health and Substance Abuse
  Centers, Other Outpatient Care Centers, HMO Medical Centers, Kidney
  Dialysis Centers, Freestanding Ambulatory Surgical and Emergency
  Centers, and all Other Outpatient Care Centers).

[[Page 50281]]

 
\6\ 2005 NCPA-Pfizer Digest: Total, Prescription Sales Increase At
  Nation's Independent Pharmacies. National Community Pharmacies
  Association Press Release, May 12, 2005.
\7\ Dental Education At-A-Glance, 2004. American Dental Education
  Association. Available at: https://www.adea.org/CEPR/Documents/2004_
Dental_Ed_At_A_Glance.pdf.
\8\ National Center for Health Workforce Analysis: U.S. Health Workforce
  Personnel Factbook. U.S. Dept. of Health and Human Services, Health
  Resources and Services Administration.
\9\ Number of Accredited Programs by Academic Year (7/1/2007--6/30/
  2008). Accreditation Council for Graduate Medical Education. Available
  at: https://www.acgme.org/adspublic/reports/accredited_programs.asp.
\10\ U.S. Department of Labor, Bureau of Labor Statistics, National
  Occupational Employment and Wage Estimates, May 2007.
\11\ HHS Grants Statistics, 2007. Available at https://www.hhs.gov/
 grantsnet.
\12\ General Services Administration (estimated).

    The Department envisions three sub-categories of potential costs 
for recipients and sub-recipients of Department funds: (1) Direct costs 
associated with the act of certification; (2) direct costs associated 
with collecting and maintaining certifications made by sub-recipients, 
and (3) indirect costs associated with certification.
    The direct cost of certification is the cost of reviewing the 
certification language, reviewing relevant entity policies and 
procedures, and reviewing files before signing. We estimate that each 
of the 584,294 entities will spend an average of 30 minutes on these 
activities. Although some entities may need to sign a certification 
statement more than once, we assume that the entity will only carefully 
review the language, procedures and their files before signing the 
initial statement each year. We assume the cost of signing subsequent 
statements to be small. Some existing HHS certification forms specify 
the certification statement should be signed by the CEO, CFO, direct 
owner, or Chairman of the Board. According to Bureau of Labor 
Statistics wage data, the mean hourly wage for occupation code 11-1011, 
Chief Executives, is $72.77. We estimate the loaded rate to be $145.54. 
Thus, assuming that the recipient chooses to have a high-level employee 
such as a Chief Executive certify on its behalf, the cost associated 
with the act of certification is $42.5 million (584,294 x .5 x 
$145.54).
    The direct cost of collecting and maintaining certifications made 
by sub-recipients is estimated as the labor cost. We assume that each 
of the 73,088 grant awards and 4,245 contractors doing business with 
HHS have at least one sub-recipient. We also assume that, on average, 
each grant awardee and contractor will spend one hour collecting and 
maintaining certifications made by sub-recipients. The mean hourly wage 
for office and administrative support occupations, occupation code 43-
0000, is $15.00, or $30 loaded. Thus, the cost of collecting and 
maintaining records is estimated to be $2 million (77,333 entities x 1 
hour x $30).
    Indirect costs associated with the certification requirement might 
include costs for such actions as staffing/scheduling changes and 
internal reviews to assess compliance. There is insufficient data to 
estimate the number of funding recipients not currently compliant with 
the Church Amendments, PHS Act Sec.  245, or the Weldon Amendment. 
However, because together these three federal statutes have been in 
existence for many years, we expect the incremental and indirect costs 
of certification to be minimal for Department funding recipients. We 
specifically request comment on this assumption.
    The total quantifiable costs of the proposed regulation, if 
finalized, are estimated to be $44.5 million each year.

Regulatory Flexibility Act

    HHS has examined the economic implications of this proposed rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act (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. While the 
proposed rule will affect a number of small entities, we preliminarily 
conclude that the costs of compliance are not economically significant 
(see discussion above). Moreover, in accordance with subsection 88.5(e) 
below, physicians, physician offices, and other health care 
practitioners participating in Medicare Part B or who are sub-
recipients assisting in the implementation of a State Medicaid program 
are not subject to the written certification requirement. Thus, we 
conclude that this proposal, if finalized, will not impose significant 
costs on small entities. Therefore, the Secretary certifies that this 
rule will not result in a significant impact 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.
    All three acts enforced in this proposed regulation--the Church 
Amendments, PHS Act Sec.  245, and the Weldon Amendment--impose 
restrictions on States, local governments, and public entities 
receiving funds from the Department, including under certain 
Department-implemented statutes. Insofar as these regulations impact 
State and local governments, they do so only to the extent that States 
and local governments would be required to submit certifications of 
compliance with the statutes and these regulations, as applicable. 
Since we expect the recipients of Department funds to comply with 
existing federal law, we anticipate the impact on States and local 
governments of the proposed certification requirement to be negligible.
    The Department will consult with States and local governments to 
seek ways to minimize any burden imposed on the States and local 
governments by these proposed regulations, consistent with meeting the 
Department's objectives of ensuring: (1) Knowledge of the obligations 
imposed, and the rights and protections afforded, by these federal 
nondiscrimination provisions; and (2) compliance with the 
nondiscrimination provisions.

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 analyses before any rulemaking if 
the rule would

[[Page 50282]]

include 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.

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. 
These regulations will not have an impact on family well-being, as 
defined in the Act.

Paperwork Reduction Act of 1995

    This proposed rule does not create any new requirements under the 
Paperwork Reduction Act of 1995.

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.

    Therefore, under the Church Amendments, 42 U.S.C. 300a-7, Public 
Health Service Act Sec.  245, 42 U.S.C. 238n, and the Weldon Amendment, 
Consolidated Appropriations Act, 2008, Pub. L. No. 110-161, Div. G, 
Sec.  508(d), 121 Stat. 1844, 2209, the Department of Health and Human 
Services proposes to add 45 CFR Part 88 to read as follows:

PART 88--ENSURING THAT DEPARTMENT OF HEALTH AND HUMAN SERVICES 
FUNDS DO NOT SUPPORT COERCIVE OR DISCRIMINATORY POLICIES OR 
PRACTICES

Sec.
88.1 Purpose.
88.2 Definitions.
88.3 Applicability.
88.4 Requirements and prohibitions.
88.5 Written certification of compliance.

    Authority: 42 U.S.C. 300a-7, 42 U.S.C. 238n, Pub. L. 120-161, 
Div. G, section 508(d), 121 Stat. 1884, 2209, 31 U.S.C. 6306, 41 
U.S.C. 253, 40 U.S.C. 471, 42 U.S.C. 1395w-22(j)(3)(B), and 42 
U.S.C. 1396u-2(b)(3).


Sec.  88.1  Purpose.

    The purpose of this part is to provide for the implementation and 
enforcement of the Church Amendments, 42 U.S.C. 300a-7, section 245 of 
the Public Health Service Act, 42 U.S.C. 238n, and the Weldon 
Amendment, Consolidated Appropriations Act, 2008, Public Law No. 110-
161, Div. G, section 508(d), 121 Stat. 1844, 2209. These statutory 
provisions protect the rights of health care entities/entities, both 
individuals and institutions, to refuse to perform health care services 
to which they may object for religious, moral, ethical, or other 
reasons. Consistent with this objective to protect the conscience 
rights of health care entities/entities, the provisions in the Church 
Amendments, section 245 of the Public Health Service Act and the Weldon 
Amendment, and the implementing regulations contained in this Part are 
to be interpreted and implemented broadly to effectuate their 
protective purposes.


Sec.  88.2  Definitions

    For the purposes of this part:
    Assist in the Performance means to participate in any activity with 
a reasonable connection to a procedure, health service or health 
service program, or research activity, so long as the individual 
involved is a part of the workforce of a Department-funded entity. This 
includes counseling, referral, training, and other arrangements for the 
procedure, health service, or research activity.
    Entity includes an individual physician or other health care 
professional, health care personnel, a participant in a program of 
training in the health professions, an applicant for training or study, 
a post graduate physician training program, a hospital, a provider-
sponsored organization, a health maintenance organization, a health 
insurance plan, laboratory or any other kind of health care 
organization or facility. It may also include components of State or 
local governments.
    Health Care Entity includes an individual physician or other health 
care professional, health care personnel, a participant in a program of 
training in the health professions, an applicant for training or study 
in the health professions, a post graduate physician training program, 
a hospital, a provider-sponsored organization, a health maintenance 
organization, a health insurance plan, laboratory or any other kind of 
health care organization or facility. It may also include components of 
State or local governments.
    Health Service/Health Service Program includes any plan or program 
that provides health benefits, whether directly, through insurance, or 
otherwise, which is funded, in whole or in part, by the Department. It 
may also include components of State or local governments.
    Individual means a member of the workforce of an entity/health care 
entity.
    Instrument is the means by which federal funds are conveyed to a 
recipient, and includes grants, cooperative agreements, contracts, 
grants under a contract, memoranda of understanding, and any other 
funding or employment instrument or contract.
    Recipient means an organization or individual receiving funds 
directly from the Department or component of the Department to carry 
out a project or program. The term includes State and local 
governments, public and private institutions of higher education, 
public and private hospitals, commercial organizations, and other 
quasi-public and private nonprofit organizations such as, but not 
limited to, community action agencies, research institutes, educational 
associations, and health centers. The term may include foreign or 
international organizations (such as agencies of the United Nations) 
which are recipients, sub-recipients, or contractors or subcontractors 
of recipients or sub-recipients at the discretion of the Department 
awarding agency.
    Sub-recipient means an organization or individual receiving funds 
indirectly from the Department or component of the Department through a 
recipient or another sub-recipient to carry out a project or program. 
The term includes State and local governments, public and private 
institutions of higher education, public and private hospitals, 
commercial organizations, and other quasi-public and private nonprofit 
organizations such as, but not limited to, community action agencies, 
research institutes, educational associations, and health centers. The 
term may include foreign or international organizations (such as 
agencies of the United Nations) which are recipients, sub-recipients, 
or contractors or subcontractors of recipients or sub-recipients at the 
discretion of the Department awarding agency.
    Workforce includes employees, volunteers, trainees, and other 
persons whose conduct, in the performance of

[[Page 50283]]

work for a Department-funded entity, is under the control or authority 
of such entity, whether or not they are paid by the Department-funded 
entity.


Sec.  88.3  Applicability.

    (a) The Department of Health and Human Services is required to 
comply with Sec.  88.4(a), (b)(1), and (d)(1).
    (b) Any State or local government that receives federal funds 
appropriated through the appropriations act for the Department of 
Health and Human Services is required to comply with Sec. Sec.  
88.4(b)(1) and 88.5.
    (c) Any entity that receives federal funds appropriated through the 
appropriations act for the Department of Health and Human Services to 
implement any part of any federal program is required to comply with 
Sec. Sec.  88.4(b)(2) and 88.5.
    (d) Any State or local government that receives federal financial 
assistance is required to comply with Sec. Sec.  88.4(a) and 88.5.
    (e) Any State or local government, any part of any State or local 
government, or any other public entity must comply with Sec.  88.4(e).
    (f)(1) Any entity, including a State or local government, that 
receives a grant, contract, loan, or loan guarantee under the Public 
Health Service Act, the Community Mental Health Centers Act, or the 
Developmental Disabilities Assistance and Bill of Rights Act of 2000, 
must comply with Sec. Sec.  88.4(c)(1) and 88.5.
    (2) In addition to complying with the provisions set forth in Sec.  
88.4(c)(1), any such entity that is an educational institution, 
teaching hospital, or program for the training of health care 
professionals or health care workers shall also compl