[Federal Register: July 3, 2000 (Volume 65, Number 128)][Rules and Regulations]
[Page 41269-41280]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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Part V
Department of Health and Human Services
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Office of Public Health and Science; Standards of Compliance for and
Provision of Abortion-Related Services in Family Planning Services
Projects; Final Rule and Notice
[[Page 41270]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 59
RIN: 0940-AA00
Standards of Compliance for Abortion-Related Services in Family
Planning Services Projects
AGENCY: Office of Population Affairs, OPHS, DHHS.
ACTION: Final rules.
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SUMMARY: The rules issued below revise the regulations that apply to
grantees under the federal family planning program by readopting the
regulations, with one revision, that applied to the program prior to
February 2, 1988. Several technical changes to the regulation are also
made to remove and/or update obsolete regulatory references. The effect
of the revisions made by the rules below is to revoke the compliance
standards, promulgated in 1988 and popularly known as the ``Gag Rule,''
that restricted family planning grantees from providing abortion-
related information in their grant-funded projects.
DATES: These rules are effective July 3, 2000.
FOR FURTHER INFORMATION CONTACT: Samuel S. Taylor, Office of Population
Affairs, (301) 594-4001.
SUPPLEMENTARY INFORMATION: The Secretary of Health and Human Services
issues below regulations establishing requirements for recipients of
family planning services grants under section 1001 of the Public Health
Service Act, 42 U.S.C. 300. The rules below adopt, with minor technical
amendments and one substantive modification, the regulations proposed
for public comment on February 5, 1993, at 58 FR 7464. They accordingly
revoke the compliance standards, known as the ``Gag Rule,'' promulgated
on February 2, 1988.
By notice published elsewhere in this issue of the Federal
Register, the Department is separately acting to reinstitute, with
minor changes, the interpretations of the statute relating to the
provision of abortion-related information and services that applied to
grantees prior to the issuance of the Gag Rule. The Secretary had
previously proposed reinstituting these interpretations in the notice
of February 5, 1993 and requested public comment on this proposed
action; the public comment period was subsequently reopened by notice
of June 23, 1993, 58 FR 34024.
I. Background
In 1988, the Secretary of Health and Human Services issued rules,
widely known as the ``Gag Rule,'' which substantially revised the
longstanding polices and interpretations defining what abortion-related
activities were permissible under Title X's statutory limitation on
abortion services. That statutory limitation, section 1008 (42 U.S.C.
300a-6), provides that ``[n]one of the funds appropriated under this
title shall be used in programs where abortion is a method of family
planning.'' The rules issued on February 2, 1988 (53 FR 2922) set out
detailed requirements that (1) Prohibited the provision to Title X
clients of nondirective counseling on all pregnancy options and
referral to abortion providers, (2) required physical and financial
separation of abortion-related activities from Title X project
activities, and (3) prohibited Title X projects from engaging in
activities that encourage, promote, or advocate abortion. These
requirements are presently codified principally at 42 CFR 59.7-59.10.
The February 2, 1988 ``Gag Rule'' was extremely controversial: The
proposed rules generated approximately 75,000 public comments, many of
which were negative. 53 FR 2922. The rules were subsequently challenged
in several district courts by a variety of providers, provider
organizations, and others. Although the requirements embodied in the
Gag Rule were upheld by the Supreme Court in 1991 as a permissible
construction of section 1008, the rules continued to be a source of
controversy, with the provider and medical communities litigating after
1991 to prevent enforcement of the rules. Following his inauguration in
1993, President Clinton ordered the Secretary to suspend the rules and
initiate a new rulemaking:
The Gag Rule endangers women's lives and health by preventing
them from receiving complete and accurate medical information and
interferes with the doctor-patient relationship by prohibiting
information that medical professionals are otherwise ethically and
legally required to provide to their patients. Furthermore, the Gag
Rule contravenes the clear intent of a majority of the members of
both the United States Senate and House of Representatives, which
twice passed legislation to block the Gag Rule's enforcement but
failed to override Presidential vetoes.
For these reasons, you have informed me that you will suspend
the Gag Rule pending the promulgation of new regulations in
accordance with the ``notice and comment'' procedures of the
Administrative Procedure Act. I hereby direct you to take that
action as soon as possible. I further direct that, within 30 days,
you publish in the Federal Register new proposed regulations for
public comment.
Presidential Memorandum of January 22, 1993, published at 58 FR 7455
(February 5, 1993). The Secretary subsequently suspended the 1988 rules
on February 5, 1993 (58 FR 7462) and issued proposed rules for public
comment (58 FR 7464).
The notice of proposed rulemaking proposed to revise the program
regulations by readopting the program regulations as they existed prior
to the adoption of the Gag Rule, which would have the effect of
revoking the Gag Rule. It also proposed that the policies and
interpretations in effect prior to the issuance of the Gag Rule be
reinstated, both in substance and in form. As noted in the proposed
rules, these policies and interpretations, which had been in effect for
a considerable time prior to 1988, were set out largely, ``in the 1981
Family Planning Guidelines and in individual policy interpretations.''
58 FR 7464. The pre-1988 interpretations had been developed during the
1970's and early 1980's in response to questions arising out of the
Department's initial interpretation that section 1008 not only
prohibited Title X projects from performing or providing abortions, but
also prohibited actions by Title X projects that ``promoted or
encouraged'' abortion as a method of family planning. Over time,
questions were raised, and answered in a series of legal opinions, as
to whether particular actions would violate the statute by promoting or
encouraging abortion as a method of family planning. As summarized in
the proposed rules, the answers that were developed were generally as
follows:
Title X projects [are] required, in the event of an unplanned
pregnancy and where the patient requests such action, to provide
nondirective counseling to the patient on all options relating to
her pregnancy, including abortion, and to refer her for abortion, if
that is the option she selects. However, consistent with the long-
standing Departmental interpretation of the statute, Title X
projects [are] not * * * permitted to promote or encourage abortion
as a method of family planning, such as by engaging in pro-choice
litigation or lobbying activities. Title X projects [are] also * * *
required to maintain a separation (that is more than a mere exercise
in bookkeeping) of their project activities from any activities that
promote or encourage abortion as a method of family planning.
Id. By notice dated June 23, 1993 (58 FR 34024), the Secretary made
available for public comment a detailed exposition of the prior
policies and interpretations.
In the public comment periods, the Secretary received 146 comments,
[[Page 41271]]
virtually all of which concerned the proposed policies and
interpretations rather than the proposed regulations themselves.
Approximately one-third of these opposed the proposed policies and
interpretations on various grounds; most of these comments were from
individuals who, in general, were opposed to any change to the Gag
Rule. The remainder of the public comments, most of which were from
providers and other health organizations, generally supported the
reinstatement of the prior policies and interpretations, although a
number of these comments suggested that they be modified in various
respects. The public comments and the Secretary's response thereto are
summarized below.
II. Public Comment and Departmental Response
The public comment generally focused on a few issues raised by the
rulemaking. As noted above, these comments generally pertained to the
proposed policies and interpretations rather than to the proposed
regulatory language itself. Accordingly, the comments on the issues
raised in the rulemaking are summarized below, and the Secretary's
response thereto is provided.
A. Lack of a Rational Basis To Revoke the Gag Rule; Necessity for
Continuation of the Gag Rule
Most of the comments in opposition to the proposed rules came from
individuals, and most objected to the proposed revocation of the Gag
Rule on the ground that abortion is wrong or that tax dollars should
not be used to provide abortion services of any kind. Several comments
also objected that the Secretary had not rational basis for revoking
the Gag Rule, as it had never gone into operation. For example, a
comment signed by fifteen members of Congress argued that--
HHS intends to discard the February 2, 1988 regulations in their
entirety * * * regardless of whether any particular portion was the
subject of court challenge or legislative action. * * * We believe
the rejection of the 1988 rule is precipitous and that each portion
of the 1988 regulations must be reviewed on its merits and
justification provided in any final regulations as to why the 1988
clarifications were or were not maintained in a new rule.
With respect to the comments objecting to the revocation of the Gag
Rule or the use of tax dollars for abortion on moral grounds, the
Secretary notes that, under the interpretations adopted in conjunction
with the regulations below, the funding of abortion or activities that
promote or encourage abortion with Title X funds has been and will
continue to be prohibited. Rather, what changes under the
interpretations reinstated in conjunction with the regulations below is
which activities are considered to ``promote or encourage'' abortion.
In contrast to the position taken under the Gag Rule, under the present
view (which was also the Department's view of the statute prior to
1988), the provision of neutral and factual information about abortion
is not considered to promote or encourage abortion as a method of
family planning. Indeed, the rule itself, now requires the provision to
pregnant women, on request, of neutral, factual information and non-
directive counseling on each of three options. The basic statutory
interpretation underlying both the Gag Rule and the specific policies
that governed the Title X program prior to 1988--that section 1008
prohibits activities that promote or encourage abortion as a method of
family planning--remains unchanged.
With respect to the contentions that the Secretary lacks a rational
basis for revoking the Gag Rule and that she must justify each separate
part of the Gag Rule being discarded, we do not agree. The pre-1988
interpretation of the statute represents a permissible exercise of
administrative discretion. The crucial difference between this approach
and the Gag Rule is one of experience. Because of ongoing litigation,
the Gag Rule was never implemented on a nationwide basis, so that its
proponents can point to no evidence that it can and will work
operationally on a national basis in the Title X program. The policies
reflected in, and interpretations reinstituted in conjunction with, the
regulations below, on the other hand, have been used by the program for
virtually its entire history; indeed, they have been in effect during
the pendency of this rulemaking. Both the program managers and the
Title X grantee community are well-versed in these policies and
interpretations, and the grantees have in the past generally been able
to operate in compliance with them. Further, as evidenced by the public
comment received, the reinstituted policies and interpretations are
generally acceptable to the grantee community, in contrast to the
compliance standards in the Gag Rule, which were generally unacceptable
to the grantee community. This factor likewise favors their adoption,
as it suggests a far greater likelihood of voluntary compliance by
grantees. Finally, the suggestion that the Gag Rule provisions should
be accepted or rejected separately is rejected as unsound. The
provisions of the Gag Rule were an interrelated set of requirements
that depended on several underlying assumptions about how the Title X
program should work; moreover, they depended in part on several
definitions that applied to all the major provisions of the Gag Rule.
See, in this regard, 53 FR 2923, 2925; see also, the discussion of
definitions at 53 FR 2926-2927.
B. Failure To Comply With the Administrative Procedure Act; Vagueness
of Standards
A number of comments, from both proponents of and opponents to the
proposed rules, objected to the failure to publish the actual policies
and interpretations as part of the proposed rule on the ground that
this violated the public comment requirements of the Administrative
Procedure Act (APA); several comments argued that it was impossible to
comment on policies that had never been published. A related criticism
was that several of the interpretations described in the preamble to
the notice of proposed rulemaking, particularly the interpretation
relating to physical separation, were too vague.
The Secretary agreed that the provision of further information on
the specific details of the pre-1988 policies and interpretations would
promote more helpful public comment. Accordingly, by notice dated June
23, 1993 (58 FR 34024), the Department made available on request a
summary of the policies and interpretations in existence prior to 1988.
The June notice also extended the public comment period for 45 days, to
permit further substantive comment on the prior policies and
interpretations. Over a third of the public comments, including the
majority of the comments from individuals, were received during the re-
opened and comment period. The Secretary has thus addressed the concern
about notice of the content of the policies and interpretations
expressed by these comments.
As is further discussed below, the Secretary has incorporated in
the regulatory text the policies relating to nondirective counseling
and referral of the 1981 Program Guidelines for Project Grants for
Family Planning Services (1981 Guidelines). The comments urging that
these Guidelines requirements be reflected in the regulations have thus
been accepted. With respect to the longstanding program
interpretations, however, the Secretary does not agree that the
Department is required to set out those
[[Page 41272]]
interpretations in the regulations promulgated below and accordingly,
has not accepted the comments suggesting that it do so. As noted above,
the interpretations themselves were developed in the classic way in
which statutory interpretations are done: That is, they have generally
been developed in legal opinions written to answer questions about how
the statutory prohibition, as initially interpreted by the Department,
applied to particular situations. This is not an unusual approach
within the program as a whole: Interpretive guidance has been provided
on a number of issues (e.g., fee schedules, use of certain methods)
over the years, as particular questions have arisen in the course of
the program. While the program could incorporate those interpretations
in the legislative rules below, the Secretary has decided not to do so.
With respect to the areas that continue to be covered by guidance, the
Secretary believes that incorporating the guidance into the regulations
below would be inadvisable and unnecessary. The Secretary has thus
chosen to preserve the program's flexibility to address new issues that
may arise in this area.
Moreover, the Title X program grantees have operated on the basis
of the policies of the 1981 Guidelines and the interpretations
summarized in the notice published elsewhere in this issue of the
Federal Register for virtually the entire history of the program and in
general compliance with them. As the comment of one State agency
grantee stated with regard to this issue:
The [State] Family Planning Program has been a participant in
the nation's Title X program since the early 1970's. The rules and
1981 Family Planning Guidelines in place prior to the ``Gag Rule''
were adequate guidance to the state for program operation and for
compliance with the statutory prohibition related to abortions.
These guidelines and directives have been used successfully for many
years in providing quality medical care, education and counseling to
clients in the program.
The audits of 14 Title X grantees conducted by the GAO and of 31 Title
X grantees conducted by the Department's Office of the Inspector
General in the 1980's showed only minor compliance problems. Indeed,
the principal recommendation of both audit reports was that the
Department provide more specific guidance to its grantees than that
previously available in the program guidelines and prior legal
opinions, not that the Department undertake major disallowances,
require major corrective actions, or develop new interpretations of the
law such as that embodied in the Gag Rule. See, e.g., Comp. Gen. Rep.
No GAO/HARD-HRD-82-106 (1982), at 14-15. The Secretary is addressing
this recommendation through the specific guidance in the notice
published elsewhere in this edition of the Federal Register and believe
that the notice will provide grantees with sufficient guidance to
reduce or eliminate potential variations in grantee practice.
The Secretary views this final rule, the principal purposes of
which are to revoke the Gag Rule and adopt the counseling and referral
requirements noted, as separate and severable from the Notice. The
interpretations set out in the Notice are being set out in order to
clarify the Department's view of the statute and its operation in
practical terms, and because so much of the public comment received was
directed at the interpretations reflected in the Notice rather than at
the revision of the regulation itself. Were the policies set forth in
the Notice to be challenged or invalidated, it is our view that the
Title X program could still be administered under the rules below in
compliance with the statute, in that grantees would be prohibited by
Sec. 59.5(a)(5) below from providing abortions as part of the Title X
family project and from engaging in counseling and referral practices
inconsistent with the regulatory requirements adopted in that section.
Such an outcome would be consistent with a permissible interpretation
of the statute.
C. Amend, or Adopt a More Restrictive Reading of, the Statute
Fifteen of the comments that stated support for the proposed
policies and interpretations suggested, however, that the prior
limitations in the policies and interpretations with respect to what
abortion-related activities a Title X project could engage in be
eliminated. A few of these comments suggested that the statutory
prohibition of section 1008 be repealed outright. Most of the comments
suggested in essence that the statute be read strictly to prohibit only
the use of funds for abortions, thereby permitting Title X projects to
engage in a number of abortion-related activities that would not be
permitted under the pre-1988 interpretations.
With respect to the suggestion that section 1008 be repealed, such
an action is obviously outside the scope of what can be accomplished
through rulemaking and thus cannot be accepted in this context. With
respect to the remaining comments, while the Secretary agrees that the
statute could on its face be read only to proscribe the use of Title X
funds for the provisions of abortion, this is not considered to be the
better reading of the statutory language. Rather, the legislative
history of section 1008 indicates that that section was intended to
restrict the permissible scope of abortion-related services provided
under Title X. Conf. Rep. No. 1667, 97th Cong., 2d Sess. 8-9 (1970).
The floor statements by the section's principal sponsor, Rep. Dingell,
indicated that the section's restrictions on the ``use'' of Title X
funds should be read as having a broader scope that is urged by these
comments:
Mr. Speaker, I support the legislation before this body. I set
forth in my extended remarks the reasons why I offered to the
amendment which prohibited abortion as a method of family planning *
* *. With the ``prohibition of abortion'' the committee members
clearly intended that abortion is not to be encouraged or promoted
in any way through this legislation. Programs which include abortion
as a method of family planning are not eligible for funds allocated
through this Act.
116 Cong. Rec. 37375 (1970). The Department has consistently, since
1972, read section 1008 as incorporating this legislation on activities
that ``promote or encourage'' abortion as a method of family planning.
This interpretation is well-known to Congress, which has not, to date
amended section 1008. Thus, there is legal support for this
longstanding interpretation of the statute. Moreover, there is nothing
in the rulemaking record that suggests that this fundamental reading of
the statute, as it was administered before the Gag Rule, presented
major operational problems for Title X projects. Accordingly, the
Secretary has not accepted the suggestions made by this group of
comments that section 1008 be read only to prohibit the provision of,
or payment for, abortions.
D. Abortion Information and Counseling
The Gag Rule prohibited the provision of information other than
information directed at protecting maternal and fetal health to women
determined to be pregnant; thus, it prohibited what is generally known
as ``options counseling'', i.e., the provision to pregnant women in a
nondirective fashion of neutral, factual information about all options
for the management of a pregnancy, including abortion. See, 42 CFR 59.8
(1989 ed.). The pre-1988 policies, in contrast, required options
counseling, if requested. As stated in the 1981 ``Title X Guidelines'':
Pregnant women should be offered information and counseling
regarding their pregnancies. Those requesting information on options
for the management of an
[[Page 41273]]
unintended pregnancy are to be given non-directive counseling on the
following alternative courses of action, and referral upon requests:
- Prenatal care and delivery
- Infant care, foster care, or adoption
- Pregnancy termination.
The June, 1993 summary of the pre-1988 interpretations also stated that
Title X projects were not permitted to provide options counseling that
promoted abortion or encouraged patients to obtain abortion, but could
advise patients of all medical options and accompanying risks.
Most of those comments supporting adoption of the proposed rules
appeared to agree with the pre-1988 policies and interpretations.
However, there appeared to be some confusion among those who agreed
with the pre-1988 requirement for options counseling as to how much
information and counseling could be provided. Several of these comments
also suggested that the ``on request'' limitation be deleted,
particularly where State law requires the provision of information
about abortion to women considering that option.
Several comments opposing adoption of the proposed rules and
revocation of the Gag Rule also specifically addressed the issue of
counseling. Several of these comments suggested that counseling on
``all options'' include the option of keeping the baby, and two
comments suggested that the rules should contain an exception for
grantees or individuals who object to providing such information and
counseling on moral grounds.
A number of comments argued that the regulatory text should reflect
the requirement for nondirective counseling and referral. These
comments recommended that the final regulations include specific
language providing for options counseling as a necessary component of
quality reproductive health care services. Some cited medical ethics
and good medical care as requiring that patients receive full and
complete information to enable them to make informed decisions. For
example, a leading medical organization commented that all women,
regardless of their income level, have a right to full and accurate
information about all options for managing an unwanted pregnancy. The
organization pointed out that it is essential that the program
regulations contain specific language about the counseling and referral
requirements, and recommended the incorporation of sections of the 1981
Title X program guidelines into the regulations so as to be absolutely
clear that pregnancy counseling and referral must be provided to
patients facing an unwanted pregnancy upon request. Congress has also
repeatedly indicated that it considers this requirement to be an
important one: the program's four most recent appropriations, Pub. L.
104-208 (110 Stat. 300-243), Pub. L. 105-78 (111 Stat. 1478), Pub. L.
105-277 (112 Stat. 2681), and Pub. L. 106-113 (113 Stat. 1501-225),
required that pregnancy counseling in the Title X program be
``nondirective.'' Consequently, the Secretary has decided to reflect
this fundamental program policy in the regulatory text. See,
Sec. 59.5(a)(5) below. The interpretive summary has also been revised
to reflect this change to the regulation. However, in response to the
apparent confusion as to the amount of counseling permitted to be
provided under the pre-1988 interpretations, the interpretive summary
clarifies that Title X grantees are not restricted as to the
completeness of the factual information they may provide relating to
all options, including the option of pregnancy termination. It should
be noted, though, that the previous restriction as to the ``type'' of
information that may be provided about abortion continues: Information
and counseling provided by Title X projects on all options for
pregnancy management, including pregnancy termination, must be
nondirective. Thus, grantees may provide as much factual, neutral
information about any option, including abortion, as they consider
warranted by the circumstances, but may not steer or direct clients
toward selecting any option, including abortion, in providing options
counseling.
The Secretary is retaining the ``on request'' policy in the
regulatory language adopted below, on the ground that it properly
implements the requirement for nondirective counseling. If projects
were to counsel on an option even where a client indicated that she did
not want to consider that option, there would be a real question as to
whether the counseling was truly nondirective or whether the client was
being steered to choose a particular option. We note that under the
``on request'' policy a Title X grantee is not prohibited from offering
to a pregnant client information and counseling on all options for
pregnancy management, including pregnancy termination; indeed, such an
offer is required under Sec. 59.5(a)(5) below. However, if the client
indicates that she does not want information and counseling on any
particular option, that decision must be respected. The regulatory
language below reflects this policy. Also, consistent with longstanding
program practice and sound public health policy (see the discussion in
the following paragraphs) and to avoid ambiguity in when the offer of
pregnancy options counseling must be made, the rule has been clarified
to require the offer of pregnancy options counseling to be made
whenever a pregnant client presents, not just when the pregnancy is
``unintended.''
With respect to the suggestion that counseling on ``keeping the
baby'' be provided, the Secretary views that suggestion as co-extensive
with the requirement for the provision of counseling on prenatal care
and delivery, as the remaining counseling option set out in the 1981
``Title X Guidelines'' and the regulatory language adopted below
relates to foster care and adoption. If a more directive form of
counseling is meant by this suggestion, it is rejected as inconsistent
with the underlying interpretation, recently reinforced by Congress,
that counseling on pregnancy options should be nondirective.
Finally, the Secretary rejects the suggestion that an exception to
the requirement for options counseling be carved out for those
organizations that object to providing such counseling on religious or
moral grounds. First, totally omitting information on a legal option or
removing an option from the client's consideration necessarily steers
her toward the options presented and is a directive form of counseling.
Second, the Secretary is unaware of any current grantees that object to
the requirement for nondirective options counseling, so this suggestion
appears to be based on more of a hypothetical than an actual concern.
Third, the requirement for nondirective options counseling has existed
in the Title X program for many years, and, with the exception of the
period 1988-1992, it has always been considered to be a necessary and
basic health service of Title X projects. Indeed, pregnancy testing is
a common and frequent reason for women coming to visit a Title X
clinic: in 1995, an estimated 1.1 million women obtained pregnancy
tests in Title X clinics. (National Survey of Family Growth, 1995
cycle, special table.) Clearly, a significant number of Title X clients
have a need for information and counseling relating to pregnancy.
Fourth, this policy is also consistent with the prevailing medical
standards recommended by national medical groups such as the American
College of Obstetricians and Gynecologists and the American Medical
Association. ``Guidelines for Women's Health Care,'' American College
of Obstetricians and
[[Page 41274]]
Gynecologists, 1996 ed., at 65; ``Pregnancy Choices: Raising the Baby,
Adoption, and Abortion,'' American College of Obstetricians and
Gynecologists, September, 1993, reviewed December, 1995; ``Code of
Medical Ethics: Current Opinions with Annotations,'' American Medical
Association, 199-1997 ed. Accordingly, the Secretary has not accepted
this suggestion.
The corollary suggestion, that the requirement to provide options
counseling should not apply to employees of a grantee who object to
providing such counseling on moral or religious grounds, is likewise
rejected. In addition to the foregoing considerations, such 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. However, in such cases the grantees must make other
arrangements to ensure that the service is available to Title X clients
who desire it.
E. Referral for abortion
The Gag Rule specifically prohibited referral for abortion as a
method of family planning and required grantees to give women
determined to be pregnant a list of providers of prenatal care, which
list could not include providers ``whose principal business is the
provision of abortion.'' 42 CFR 59.8(a) (1989 ed.). The Gag Rule
permitted referral to an abortion provider only where there was a
medical emergency. 42 CFR 59.8(a)(2) (1989 ed.). By contrast, the 1981
Guidelines required appropriate referral on request, while the pre-1988
interpretations permitted Title X projects to make what was known as a
``mere referral'' for abortion; a ``mere referral'' was considered to
be the provision to the client of the name and address and/or telephone
number of an abortion provider. Affirmative actions, such as obtaining
a consent for the abortion, arranging for transportation, negotiating a
reduction in the fee for an abortion or arranging for or scheduling the
procedure, were considered to be prohibited by section 1008. The pre-
1988 rules (Sec. 59.5(b)(1)) were interpreted by the agency to require
referral for abortion where medically indicated. See, Valley Family
Planning v. State of North Dakota, 489 F.Supp. 238 (D.N.D. 1980),
aff'd., 661 F.2d 99 (8th Cir. 1981).
A number of comments, mostly from individuals and organizations
supporting revocation of the Gag Rule, suggested modifications of the
proposed referral policies and interpretations. Most of these comments
suggested that the content limitations on referrals be broadened, with
Title X grantees being permitted to provide other relevant information,
such as comparative charges, stage of pregnancy up to which referral
providers may under State law or will provide abortion, the number of
weeks of estimated gestation, etc. These comments argued that the
provision of such factual information does not ``promote or encourage''
abortion any more than does the provision of the abortion providers'
names and addresses and/or telephone numbers. One comment also
suggested that the restriction on negotiating fees for clients referred
for abortion conflicts with the requirement to refer for abortion where
medically indicated.
Several comments opposing revocation of the Gag Rule also expressed
problems with the proposed referral policies and interpretations. A few
comments urged that referrals to agencies that can assist clients who
choose the ``keeping the baby'' or adoption options should be required.
Another comment criticized the requirement for referral where
``medically indicated'' as confusing. Revisions suggested were that
``self-referrals'' for abortion be specifically prohibited, to reduce
commercialization and profiteering by Title X grantees who are also
abortion providers and that grantees who objected to abortion on moral
or religious grounds be permitted not to make abortion referrals.
The Secretary agrees with the comments advocating expanding the
content of what information may be provided in the course of an
abortion referral. The content (as opposed to action) restrictions of
the ``mere referral'' policy proceeded from an assumption that the
provision of information other than the name and address and/or
telephone number of an abortion provider might encourage or promote
abortion as a method of family planning. The Secretary now agrees,
based on experience and the comments of several providers on this
point, that the provision of the types of additional neutral, factual
information about particular providers described above is likely to do
little, if anything, to encourage or promote the selection of abortion
as a method of family planning over and above the provision of the
information previously considered permissible; at most, such
information would seem likely to assist clients in making a rational
selection among abortion providers, if abortion is being considered.
Moreover, it does not seem rational to restrict the provision of
factual information in the referral context, when no similar
restriction applies in the counseling context. Accordingly, the
Secretary has revised the interpretations summarized in the notice
section to clarify that grantees are not restricted from providing
neutral, factual information about abortion providers in the course of
providing an abortion referral, when one is requested by a pregnant
Title X client.
Consistent with the incorporation of the requirement for
nondirective counseling in the regulations, the regulations below also
include the remaining requirement from the 1981 Guidelines, the
requirement to provide a referral, if requested by the client. As
referenced previously, a number of comments argued that the regulatory
text should reflect the requirement for nondirective counseling and
referral. One comment described the provision of factual information
and referral as requested as both a necessary and significant component
of the Title X program for many years. Another comment pointed out that
the program guideline requirements regarding pregnancy options
counseling and referral have been used for many years, are well
understood and accepted in the Title X provider community, and should
be required services in Title X family planning clinics. Since the
services about which pregnancy options counseling is provided are not
ones which a Title X project typically provides, the provision of a
referral is the logical and appropriate outcome of the counseling
process.
The Secretary is not accepting the remainder of the comments on
this issue, as they either proceed from a misunderstanding of, or do
not raise valid objections to, the regulations and the proposed
policies and interpretations. The comment arguing that the restriction
on negotiating fees conflicts with the requirement to refer for
abortion where medically indicated is based on a misunderstanding of
that requirement: in such circumstances, the referral is not for
abortion ``as a method of family planning'' (i.e., to determine the
number and/or space of one's children) but is rather for the treatment
of a medical condition; thus, the statutory prohibition does not apply,
so there is no restriction on negotiating fees and similar actions. The
suggestion that referrals to agencies that can assist clients who
choose the options of ``keeping the baby'' or adoption be required is
likewise rejected as unnecessary. Under the regulatory language adopted
below, the options of prenatal care and delivery and adoption are
options that are required to be part of the options counseling process,
so an
[[Page 41275]]
appropriate referral for one or the other option would be required, if
the client chose one of those options and requested a referral.
However, requiring a referral for prenatal care and delivery or
adoption where the client rejected those options would seem coercive
and inconsistent with the concerns underlying the ``nondirective''
counseling requirement. The Secretary also rejects the criticism that
the provision requiring referral for abortion where medically indicated
is undefined and confusing. The meaning of the regulatory requirement
for referrals where medically indicated (which applies to all medical
services not provided by the project, not just abortion services) has
not in the past been a source of confusion for providers, and the
Secretary believes that Title X medical personnel are able to make the
medical judgments this requirement calls for.
The Secretary likewise rejects the suggestion that ``self-
referrals'' for abortion be banned. Very few current Title X providers
are also abortion providers: it is estimated that, over the past
decade, the percentage of Title X providers located with or near
abortion providers has been at or below five percent, with
approximately half of these providers consisting of hospitals. Thus,
the issue this comment raises is irrelevant to the vast majority of
Title X grantees and the program as a whole. Moreover, with respect to
those few grantees that are also abortion providers, some may be the
only or one of only a few abortion providers in their service area,
making ``self-referrals'' a necessity in such situations. The
Department has no evidence that commercialization and profiteering are
occurring in these circumstances; absent such evidence, the Secretary
sees no reason to limit or cut off a legal service option for those
Title X clients who freely select it. However, the Department will
continue to monitor the issue of self-referrals in the Title X program,
to forestall the type of problem suggested by these commenters.
Finally, the Secretary rejects the suggestion that the referral
requirement not apply to providers that object to it on moral or
religious grounds for the same reasons it objected to the same
suggestion with respect to counseling.
F. Physical and Financial Separation
The Gag Rule required Title X projects to be organized so as to
have a physical and financial separation from prohibited abortion
activities, determined by whether there was ``objective integrity and
independence [of the Title X project] from prohibited activities.'' 42
CFR 59.9 (1989 ed.). This determination was to be based on a case-by-
case review of facts and circumstances. Factors relevant to this
determination included, but were not limited to, the existence of
separate accounting records, the degree of separation from facilities
(such as treatment, consultation, examination, and waiting room) in
which prohibited activities occurred and the extent of such prohibited
activities, the existence of separate personnel, and the extent of the
presence of evidence of identification of the Title X project and the
absence of identification of material promoting abortion. Id.
The pre-1988 interpretations required Title X grantees to maintain
physical and financial separation between the Title X project and any
abortion-related activities they conducted, in that a Title X grantee
was required to ensure that the Title X-supported project was separate
and distinguishable from those activities. This requirement was held to
go beyond a requirement for the technical allocation of funds between
Title X project activities and impermissible abortion activities.
However, it was considered permissible for a hospital grantee to
provide abortions, as long as ``sufficient separation'' was maintained,
and common waiting rooms were also permissible, as long as no
impermissible materials were present. Common staff and unitary filing
systems were also permissible, so long as costs were properly allocated
and, with respect to staff members, their abortion-relation activities
were performed in a program that was itself separate from the Title X
project. The test, as articulated in the summary made available for
comment by the June 23, 1993 notice, was ``whether the abortion element
in a program of family planning services bulks so large and is so
intimately related to all aspects of the program as to make it
difficult or impossible to separate the eligible and non-eligible items
of cost.''
These interpretations received by far the most specific and
extensive public comment. The vast majority of this public comment was
from providers and provider organizations and was negative. Although it
was generally agreed that the financial separation of Title X project
activities from abortion-related activities was required by statute
and, in the words of one comment, ``absolutely necessary,'' many of
these comments objected that requiring additional types of separation
would be unnecessary, costly, and medically unwise. The argument was
made that the requirement for physical separation is unnecessary, as it
is not required by the statute which, on its face, requires financial
separation only. Further, it was argued that since Title X grantees are
subject to rigorous financial audits, it can be determined whether
program funds have been spent on permissible family planning services,
without additional requirements being necessary. With respect to the
issue of cost, it was generally objected that requiring separation of
staff and facilities would be inefficient and cost ineffective. For
example, one comment argued that--
The wastefulness and inefficiency of the separation requirements
is * * * illustrated by the policy which allows common waiting
rooms, but disallows ``impermissible materials'' in them. This puts
grantees in the position of having to continuously monitor health
information for undefined ``permissibility'' or to build a separate
waiting room just to be able to utilize those materials * * *.
It was argued that these concerns were particularly important for small
and rural clinics ``that may be the only accessible Title X family
planning and/or abortion providers for a large population of low-income
women.'' Of particular concern for such clinics was the duplication of
costs inherent in the separation requirements, as they--
cannot afford to operate separate facilities or to employ separate
staff for these services without substantially increasing the prices
of * * * services. Nor can they offer different services on
different days of the week because so many of their patients * * *
are only able to travel to the clinic on one day.
Many providers also pointed out that requiring complete physical
separation of services would be inconsistent with public health
principles, which recommend integrated health care, and would impact
negatively on continuity of care. As one comment stated, ``women's
reproductive health needs are not artificially separated between
services: a woman who needs an abortion may also need contraceptive
services, and may at another time require parental care.'' Several
providers objected in particular that such a separation would, in the
words of one comment, ``remove * * * one of the most opportune time[s]
to facilitate the entry of the abortion patent into family planning
counseling, which is at the post-abortion check-up.'' it was also
pointed out that separation of services would burden women, by making
them ``make multiple appointments or trips to visit different staff or
facilities.'' Finally, the separation policy was objected to by several
of the comments that otherwise generally supported the proposed rule
[[Page 41276]]
as unnecessarily broad, ambiguous, and vague.
Several of the comments opposing the revocation of the Gag Rule and
the adoption of the proposed rules likewise objected specifically to
the separation requirements, generally on the ground that the pre-1988
policies were vague and unenforceable. Two comments also argued that,
if the pre-1988 requirement of physical separation was to be
reinstituted, it made no sense to revoke Sec. 59.9 of the Gag Rule in
its entirety, as that section of the Gag Rule contained specific
standards to implement this requirement; alternatively, it was argued
that if the Secretary is going to use different standards to determine
whether the requisite physical separation existed, those should be
published for public comment.
The Secretary agrees that the comments on both sides of this issue
have identified substantial concerns with the pre-1988 interpretations
with respect to the issue of how much physical separation should be
required between a grantee's Title X project activities and abortion-
related activities. The Secretary agrees with the comments that the
pre-1988 interpretation that some physical separation was required was
unenforceable. Indeed, since the pre-1988 interpretations had held that
it was permissible to provide abortions on a Title X clinic site and to
have common waiting areas, records, and staff (subject largely to
proper allocation of costs), it was difficult to tell just what degree
and kind of physical separation were prohibited. As a consequence, the
agency attempted to enforce this requirement on only a few occasions
prior to 1988. The Secretary does not agree with opponents of the
proposed rules, however, who argued that the ``physical separation''
requirements in Sec. 59.9 of the Gag Rule should be retained on the
ground that they provide a necessary clarification of this issue.
Although Sec. 59.9 provided ostensibly more specific standards, the
fundamental measure of compliance under that section remained
ambiguous: ``the degree of separation from facilities [in which
prohibited activities occurred] and the extent of such prohibited
activities,'' and ``[t]he extent to which'' certain materials were
present or absent. Furthermore, since under Sec. 59.9 compliance was to
be determined on a ``facts and circumstances'' basis, this section of
the Gag Rule provided grantees with less specific advance notice of the
compliance standards than did the pre-1988 policies and
interpretations. Moreover, the change in policy from the more concrete
policies proposed during the Gag Rule rulemaking to the less concrete
``facts and circumstances'' standard ultimately adopted in the final
Gag Rule as a result of the public comment suggests the practical
difficulties of line-drawing in this area. In fact, since the Gag Rule
was never implemented on a national basis, the precise contours of the
compliance standards of Sec. 59.9 were never determined. The Secretary
has accordingly not accepted the suggestion from several opponents of
the proposed rule that the policies of Sec. 59.9 be retained.
As noted by many of the comments from groups that generally
supported the revocation of the Gag Rule, the statute does not on its
face require physical separation; rather, by its terms it is addressed
to the use of ``funds.'' While the interpretation of the statute by
agency counsel on which the requirement for physical separation is
based was reasonable, it is not the only possible reading of the
statute. Rather, the fundamental question under the statute is, as the
agency sees it, whether Title X funds are used by Title X grantees to
promote or encourage abortions as a method of family planning in the
Title X-assisted project. The Department has traditionally viewed a
grant project as consisting of an identified set of activities
supported in whole or in part by grant funds. If a Title X grantee can
demonstrate by its financial records, counseling and service protocols,
administrative procedures, and other means that--within the identified
set of Title X-supported activities--promotion or encouragement of
abortion as a method of family planning does not occur, then it is hard
to see what additional statutory protection is afforded by the
imposition of a requirement for ``physical'' separation. Indeed, in the
light of the enforcement history noted above, it is not unreasonable to
say that the standard of ``physical'' separation has, as a practical
matter, had little relevance or applicability in the Title X program to
date. Moreover, the practical difficulty of drawing lines in this area,
both as experienced prior to 1988 and as evident in the history of the
Gag Rule itself, suggests that this legal interpretation is not likely
ever to result in an enforceable compliance policy that is consistent
with the efficient and cost-effective delivery of family planning
services. Accordingly, the Secretary has accepted the suggestion of a
number of the comments that the requirement for physical separation be
dropped; the interpretations summarized in the notice published in the
notices section of this edition of the Federal Register are revised
accordingly. This decision makes it unnecessary to respond to the
remaining comments on the issue.
G. Advocacy Restrictions
The Gag Rule, at 42 CFR 59.10 (1989 ed.), prohibited Title X
projects from encouraging, promoting, or advocating abortion as a
method of family planning. This section prohibited Title X projects
from engaging in actions to ``assist women to obtain abortions or
increase the availability or accessibility of abortion for family
planning purposes,'' including actions such as lobbying for the passage
of legislation to increase the availability of abortion as a method of
family planning, providing speakers to promote the use of abortion as a
method of family planning, paying dues to any group that as a
significant part of its activities advocated abortion as a method of
family planning, using legal action to make abortion available as a
method of family planning, and developing or disseminating materials
advocating abortion as a method of family planning. The pre-1988
interpretations likewise prohibited the promotion or encouragement of
abortion as a method of family planning through advocacy activities
such as providing speakers, bringing legal action to liberalize
statutes relating to abortion, and producing and/or showing films that
tend to encourage or promote abortion as a method of family planning.
However, under those prior interpretations, it was considered
permissible for Title X grantees to be dues-paying members of abortion
advocacy groups, so long as there were other legitimate program-related
reasons for the affiliation.
Very few comments were received concerning these proposed
interpretations. Those received from persons and entities that
generally supported the proposed rules generally argued against the
restriction on showing films advocating abortion, on the ground that it
was possible to violate this restriction by showing a film that was
purely factual and detailed relative risks. The few comments on this
part of the policies and interpretations received from those who
generally opposed revoking the Gag Rule pointed out the similarity
between the advocacy policies articulated in the proposed
interpretations and Sec. 59.10 of the Gag Rule and argued that
Sec. 59.10 should accordingly be reinstated.
As set out above, the Secretary is of the view the Gag Rule cannot
and should not be adopted piecemeal, as recommended by these comments.
Moreover, the Secretary is of the view
[[Page 41277]]
that the prohibition against dues paying contained in Sec. 59.10 is not
required by the statute and does not represent sound public policy.
Accordingly, the suggestion that Sec. 59.10 be reinstated has not been
adopted. With respect to the criticism of the prohibition against Title
X grantees showing films advocating abortion as a method of family
planning, it is recognized that the prohibition should not encompass
the kind of neutral, factual information that grantees are permitted to
provide in the counseling context; the interpretations have been
clarified accordingly. To the extent that these comments seek to
further liberalize the advocacy restrictions, however, they are
rejected as inconsistent with the Secretary's basic interpretation of
section 1008.
H. Miscellaneous
A number of comments were received on miscellaneous issues. Those
comments, and the Secretary's responses thereto, are summarized below.
1. Changes outside the scope of the rulemaking
Several comments were received advocating changes to other sections
of the regulations on issues other than the issue of compliance with
section 1008. These comments included the following suggestions: that
the regulations be revised to permit natural family planning providers
to be Title X grantees; that the regulations be revised to prohibit
single method providers from participating in Title X projects; that
the footnote in the regulation addressing Pub. L. 94-63 be revised to
state that the law also forbids coercion to carry a pregnancy to term;
that the regulations be revised to deal with recent medical
developments, such as HIV or Norplant. All of these suggestions are
rejected on the ground that they exceed the scope of the rulemaking
because these issues were not the subject of the Notice of Proposed
Rulemaking.
2. Audit standards
Several providers urged that the OMB audit standards for Title X
projects be revised to reflect the change in the regulations. While
this comment is likewise outside the scope of the rulemaking, the
Department intends to work with the Office of Management and Budget to
revise the program audit standards to reflect the regulations below and
the policies and interpretations also being reinstituted.
3. Separation of Powers
Two comments, including one from four members of Congress, argued
that the suspension of the Gag Rule violated the separation of powers
insofar as it misspent federal tax dollars without amendment to the
statute or compliance with the APA. The Secretary disagrees that
suspension of the Gag Rule violated either the statute or the APA. The
Gag Rule was, in the Secretary's view, a permissible interpretation of
the statute, but not the only permissible interpretation of the
statute; thus, suspension of those rules (and reinstitution of the
Department's longstanding policies and interpretations of the statute)
is not inconsistent with the statute. Nor was the suspension action
inconsistent with the APA, as the findings which the APA requires be
made in such circumstances were made. Finally, the Secretary notes that
this issues is now moot, with the publication of the regulations below.
I. Technical Amendments
Because the proposed rules proposed the reissuance of the program
regulations that were issued in 1980, it was recognized that--
some of the other regulations cross-referenced in the rules below
may no longer be operative or citations may need to be updated.
However, such housekeeping details will be addressed in the final
rules.
58 FR 7464. Further review of the proposed regulations has established
that this is indeed the case. Accordingly, a number of technical
amendments have been made to the regulations, to delete obsolete
statutory or regulatory references or to clarify the existing
provisions or incorporate new regulatory or other references made
relevant by subsequent changes in the law. A summary of the technical
amendments, and the reasons therefor, follows:
1. Sec. 59.2 (definition of ``low income family''): The reference
to ``Community Services Administration Income Poverty Guidelines (45
CFR 1060.2)'' is changed to ``Poverty Guidelines issued pursuant to 42
U.S.C. 9902(2).'' This change reflects a change in the law, effected by
Pub. L. 97-35, Sec. 673.
2. Sec. 59.2 (definition of ``State''): The definition of this term
is changed to reflect statutory changes regarding the Trust Territories
of the Pacific Islands effected by Pub. L. 99-239 (relating to the
Federated States of Micronesia, the Marshall Islands, and the Republic
of Palau).
3. Sec. 59.5(a)(8): The reference to the ``CSA Income Poverty
Guidelines'' is changed, consistent with and for the reason set out
above with respect to Sec. 59.2 (definition of ``low income family'').
4. Sec. 59.9: The reference to ``Subpart Q'' of 45 CFR Part 74 has
been deleted, as that subpart has been revoked. A reference to 45 CFR
Part 92 has been added, to reflect the requirements at that part that
apply by their terms of State and local governments.
5. Sec. 59.10: The references to 42 CFR Part 122 and 45 CFR Part 19
have been deleted, as those parts have been revoked. A reference to 37
CFR Part 401, which applies by its terms, has been added, reflecting a
change in the law. The description of 45 CFR Part 74 has been changed,
to reflect accurately the current title of that part. A reference to 45
CFR Part 92 has been added, to reflect the requirements at that part
that apply by their terms to State and local governments.
6. Sec. 59.11: The word ``documented'' has been inserted before the
word ``consent'' in this section to clarify what was implicit in this
section, that the consent for disclosure must be documented by the
project.
7. Sec. 59.12 (proposed): The proposed section (which was the prior
section relating to inventions and discoveries) has been deleted, as it
has been superseded by the government-wide regulations at 37 CFR Part
401, a reference to which has been added to Sec. 59.10. This change has
also occasioned the renumbering of the proposed Sec. 59.13.
The above changes are all technical in nature and simply bring the
regulations issued below into conformity with current law. They are
thus essentially housekeeping in nature, as noted in the proposed
rules. Accordingly, and for the reasons set out above, the Secretary
finds that public comment on these changes would be impracticable,
unnecessary, and contrary to the public interest and that good cause
therefore exists for omitting public comment thereon.
III. Effective Date
These regulations are adopted effective upon publication, as they
meet the conditions for exception from the requirement for a 30-day
delay in effective date under 5 U.S.C. 553(d). First, by revoking the
Gag Rule, the regulations below relieve the restrictions imposed on
grantees' conduct of their Title X projects by the Gag Rule. Second,
the policies adopted in the regulations below and the interpretations
adopted in conjunction with them are already largely in effect, by
virtue of the suspension of the Gag Rule and the reinstitution of the
pre-
[[Page 41278]]
1988 policies and interpretations effected by the interim rules of
February 5, 1993. To the extent this status quo is changed by the
revision of the policies and interpretations in question, the effect of
those revisions is to clarify and simplify certain of the present
restrictions, which should make complying with the policies and
interpretations easier for grantees than is presently the case. Thus,
no useful purpose would be served by delaying the effective date of
these regulations, and the Secretary accordingly finds that good cause
exists for making them effective upon publication.
IV. Analysis of Impacts
The Secretary has examined the impacts of the final rule under the
Regulatory Flexibility Act (5 U.S.C. 601-612), and certifies that this
final rule will not have a significant impact on a substantial number
of small entities.
Section 202 of the Unfunded Mandates Reform Act (the Act) requires
that agencies prepare an assessment of anticipated costs and benefits
before proposing any rule that may result in an expenditure by State,
local, and tribal governments, in the aggregate, or by the private
sector, of $100,000,000 (adjusted for inflation) in any year. This rule
will not result in such an expenditure; consequently, it is not covered
by Section 202 of the Act.
Executive Order 13132 requires that a Federalism Assessment be
prepared in any cases in which policies have significant federalism
implications as defined in the Executive Order. The Department does not
intend or interpret this final rule as imposing additional costs or
burdens on the States. The Department has evaluated the public
comments. Public comments from State and local health departments
indicate support for the Title X policies contained in the final rule
and the interpretations to ensure the provision of quality medical care
and patients' rights to comprehensive services. In the interest of
consistent program operation and uniform understanding of the policy,
the final rule codifies what has been longstanding program policy and
is consistent with current program practice.
The Office of Management and Budget has reviewed this rule pursuant
to Executive Order 12866.
List of Subjects in 42 CFR Part 59.
Family planning--birth control; Grant programs--health; Health
facilities.
Dated: June 28, 2000.
David Satcher,
Assistant Secretary for Health and Surgeon General.
Approved: June 28, 2000.
Donna E. Shalala,
Secretary.
PART 59--GRANTS FOR FAMILY PLANNING
For the reasons set out in the preamble, subpart A of part 59 of
title 42, Code of Federal Regulations, is hereby revised to read as
follows:
Subpart A--Project Grants for Family Planning Services
Sec.
59.1 To what programs do these regulations apply?
59.2 Definitions.
59.3 Who is eligible to apply for a family planning services
grant?
59.4 How does one apply for a family planning services grant?
59.5 What requirements must be met by a family planning project?
59.6 What procedures apply to assure the suitability of
informational and educational material?
59.7 What criteria will the Department of Health and Human
Services use to decide which family planning services projects to
fund and in what amount?
59.8 How is a grant awarded?
59.9 For what purposes may grant funds be used?
59.10 What other HHS regulations apply to grants under this
subpart?
59.11 Confidentiality.
59.12 Additional conditions.
Subpart A--Project Grants for Family Planning Services
Authority: 42 U.S.C. 300a-4.
Sec. 59.1 To what programs do these regulations apply?
The regulations of this subpart are applicable to the award of
grants under section 1001 of the Public Health Service Act (42 U.S.C.
3200) to assist in the establishment and operation of voluntary family
planning projects. These projects shall consist of the educational,
comprehensive medical, and social services necessary to aid individuals
to determine freely the number and spacing of their children.
Sec. 59.2 Definitions.
As used in this subpart:
Act means the Public Health Service Act, as amended.
Family means a social unit composed of one person, or two or more
persons living together, as a household.
Low income family means a family whose total annual income does not
exceed 100 percent of the most recent Poverty Guidelines issued
pursuant to 42 U.S.C. 9902(2). ``Low-income family'' also includes
members of families whose annual family income exceeds this amount, but
who, as determined by the project director, are unable, for good
reasons, to pay for family planning services. For example,
unemancipated minors who wish to receive services on a confidential
basis must be considered on the basis of their own resources.
Nonprofit, as applied to any private agency, institution, or
organization, means that no part of the entity's net earnings benefit,
or may lawfully benefit, any private shareholder or individual.
Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
State includes, in addition to the several States, the District of
Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana
Islands, the U.S. Virgin Islands, American Samoa, the U.S. Outlaying
Islands (Midway, Wage, et al.), the Marshall Islands, the Federated
State of Micronesia and the Republic of Palau.
Sec. 59.3 Who is eligible to apply for a family planning services
grant?
Any public or nonprofit private entity in a State may apply for a
grant under this subpart.
Sec. 59.4 How does one apply for a family planning services grant?
(a) Application for a grant under this subpart shall be made on an
authorized form.
(b) An individual authorized to act for the applicant and to assume
on behalf of the applicant the obligations imposed by the terms and
conditions of the grant, including the regulations of this subpart,
must sign the application.
(c) The application shall contain--
(1) A description, satisfactory to the Secretary, of the project
and how it will meet the requirements of this subpart;
(2) A budget and justification of the amount of grant funds
requested;
(3) A description of the standards and qualifications which will be
required for all personnel and for all facilities to be used by the
project; and
(4) Such other pertinent information as the Secretary may require.
Sec. 59.5 What requirements must be met by a family planning project?
(a) Each project supported under this part must:
(1) Provide a broad range of acceptable and effective medically
approved family planning methods
[[Page 41279]]
(including natural family planning methods) and services (including
infertility services and services for adolescents). If an organization
offers only a single method of family planning, it may participated as
part of a project as long as the entire project offers a broad range of
family planning services.
(2) Provide services without subjecting individuals to any coercion
to accept services or to employ or not to employ any particular methods
of family planning. Acceptance of services must be solely on a
voluntary basis and may not be made a prerequisite to eligibility for,
or receipt of, any other services, assistance from or participation in
any other program of the applicant.\1\
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\1\ Section 205 of Pub. L. 94-63 states: ``Any (1) officer or
employee of the United States, (2) officer or employee of any State,
political subdivision of a State, or any other entity, which
administers or supervises the administration of any program
receiving Federal financial assistance, or (3) person who receives,
under any program receiving Federal assistance, compensation for
services, who coerces or endeavors to coerce any person to undergo
an abortion or sterilization procedure by threatening such person
with the loss of, or disqualification for the receipt of, any
benefit or service under a program receiving Federal financial
assistance shall be fined not more than $1,000 or imprisoned for not
more than one year, or both.''
---------------------------------------------------------------------------
(3) Provide services in a manner which protects the dignity of the
individual.
(4) Provide services without regard of religion, race, color,
national origin, handicapping condition, age, sex, number of
pregnancies, or martial status.
(5) Not provide abortion a method of family planning. A project
must:
(i) Offer pregnant women the opportunity to provided information
and counseling regarding each of the following options:
(A) Prenatal care and delivery;
(B) Infant care, foster care, or adoption; and
(C) Pregnancy termination.
(ii) If requested to provide such information and counseling,
provide neutral, factual information and nondirective counseling on
each of the options, and referral upon request, except with respect to
any option(s) about which the pregnant woman indicates she does not
wish to receive such information and counseling.
(6) Provide that priority in the provision of services will be
given to persons from low-income families.
(7) Provide that no charge will be made for services provided to
any persons from a low-income family except to the extent that payment
will be made by a third party (including a government agency) which is
authorized to or is under legal obligation to pay this charge.
(8) Provide that charges will be made for services to persons other
than those from low-income families in accordance with a schedule of
discounts based on ability to pay, except that charges to persons from
families whose annual income exceeds 250 percent of the levels set
forth in the most recent Poverty Guidelines issued pursuant to 42
U.S.C. 9902(2) will be made in accordance with a schedule of fees
designed to recover the reasonable cost of providing services.
(9) If a third party (including a Government agency) is authorized
or legally obligated to pay for services, all reasonable efforts must
be made to obtain the third-party payment without application of any
discounts. Where the cost of services is to be reimbursed under title
XIX, XX, or XXI of the Social Security Act, a written agreement with
the title XIX, XX or XXI agency is required.
(10)(i) Provide that if an application relates to consolidation of
service areas or health resources or would otherwise affect the
operations of local or regional entities, the applicant must document
that these entities have been given, to the maximum feasible extent, an
opportunity to participate in the development of the application. Local
and regional entities include existing or potential subgrantees which
have previously provided or propose to provide family planning services
to the area proposed to be served by the applicant.
(ii) Provide an opportunity for maximum participation by existing
or potential subgrantees in the ongoing policy decisionmaking of the
project.
(11) Provide for an Advisory Committee as required by Sec. 59.6.
(b) In addition to the requirements of paragraph (a) of this
section, each project must meet each of the following requirements
unless the Secretary determines that the project has established good
cause for its omission. Each project must:
(1) Provide for medical services related to family planning
(including physician's consultation, examination prescription, and
continuing supervision, laboratory examination, contraceptive supplies)
and necessary referral to other medical facilities when medically
indicated, and provide for the effective usage of contraceptive devices
and practices.
(2) Provide for social services related to family planning,
including counseling, referral to and from other social and medical
services agencies, and any ancillary services which may be necessary to
facilitate clinic attendance.
(3) Provide for informational and educational programs designed
to--
(i) Achieve community understanding of the objectives of the
program;
(ii) Inform the community of the availability of services; and
(iii) Promote continued participation in the project by persons to
whom family planning services may be beneficial.
(4) Provide for orientation and in-service training for all project
personnel.
(5) Provide services without the imposition of any durational
residency requirement or requirement that the patient be referred by a
physician.
(6) Provide that family planning medical services will be performed
under the direction of a physician with special training or experience
in family planning.
(7) Provide that all services purchased for project participants
will be authorized by the project director or his designee on the
project staff.
(8) Provide for coordination and use of referral arrangements with
other providers of health care services, local health and welfare
departments, hospitals, voluntary agencies, and health services
projects supported by other federal programs.
(9) Provide that if family planning services are provided by
contract or other similar arrangements with actual providers of
services, services will be provided in accordance with a plan which
establishes rates and method of payment for medical care. These
payments must be made under agreements with a schedule of rates and
payment procedures maintained by the grantee. The grantee must be
prepared to substantiate, that these rates are reasonable and
necessary.
(10) Provide, to the maximum feasible extent, an opportunity for
participation in the development, implementation, and evaluation of the
project by persons broadly representative of all significant elements
of the population to be served, and by others in the community
knowledgeable about the community's needs for family planning services.
Sec. 59.6 What procedures apply to assure the suitability of
informational and educational material?
(a) A grant under this section may be made only upon assurance
satisfactory to the Secretary that the project shall provide for the
review and approval of informational and educational materials
developed or made available under the project by an Advisory Committee
prior to their distribution, to assure that the materials are suitable
for the population
[[Page 41280]]
or community to which they are to be made available and the purposes of
title X of the Act. The project shall not disseminate any such
materials which are not approved by the Advisory Committee.
(b) The Advisory Committee referred to in paragraph (a) of this
section shall be established as follows:
(1) Size. The Committee shall consist of no fewer than five but not
more than nine members, except that this provision may be waived by the
Secretary for good cause shown.
(2) Composition. The Committee shall include individuals broadly
representative (in terms of demographic factors such as race, color,
national origin, handicapped condition, sex, and age) of the population
or community for which the materials are intended.
(3) Function. In reviewing materials, the Advisory Committee shall:
(i) Consider the educational and cultural backgrounds of
individuals to whom the materials are addressed;
(ii) Consider the standards of the population or community to be
served with respect to such materials;
(iii) Review the content of the material to assure that the
information is factually correct;
(iv) Determine whether the material is suitable for the population
or community to which is to be made available; and
(v) Establish a written record of its determinations.
Sec. 59.7 What criteria will the Department of Health and Human
Services use to decide which family planning services projects to fund
and in what amount?
(a) Within the limits of funds available for these purposes, the
Secretary may award grants for the establishment and operation of those
projects which will in the Department's judgment best promote the
purposes of section 1001 of the Act, taking into account:
(1) The number of patients, and, in particular, the number of low-
income patients to be served;
(2) The extent to which family planning services are needed
locally;
(3) The relative need of the applicant;
(4) The capacity of the applicant to make rapid and effective use
of the federal assistance;
(5) The adequacy of the applicant's facilities and staff;
(6) The relative availability of non-federal resources within the
community to be served and the degree to which those resources are
committed to the project; and
(7) The degree to which the project plan adequately provides for
the requirements set forth in these regulations.
(b) The Secretary shall determine the amount of any award on the
basis of his estimate of the sum necessary for the performance of the
project. No grant may be made for less than 90 percent of the project's
costs, as so estimated, unless the grant is to be made for a project
which was supported, under section 1001, for less than 90 percent of
its costs in fiscal year 1975. In that case, the grant shall not be for
less than the percentage of costs covered by the grant in fiscal year
1975.
(c) No grant may be made for an amount equal to 100 percent for the
project's estimated costs.
Sec. 59.8 How is a grant awarded?
(a) The notice of grant award specifies how long HHS intends to
support the project without requiring the project to recompete for
funds. This period, called the project period, will usually be for
three to five years.
(b) Generally the grant will initially be for one year and
subsequent continuation awards will also be for one year at a time. A
grantee must submit a separate application to have the support
continued for each subsequent year. Decisions regarding continuation
awards and the funding level of such awards will be made after
consideration of such factors as the grantee's progress and management
practices, and the availability of funds. In all cases, continuation
awards require a determination by HHS that continued funding is in the
best interest of the government.
(c) Neither the approval of any application nor the award of any
grant commits or obligates the United States in any way to make any
additional, supplemental, continuation, or other award with respect to
any approved application or portion of an approved application.
Sec. 59.9 For what purpose may grant funds be used?
Any funds granted under this subpart shall be expended solely for
the purpose for which the funds were granted in accordance with the
approved application and budget, the regulations of this subpart, the
terms and conditions of the award, and the applicable cost principles
prescribed in 45 CFR Part 74 or Part 92, as applicable.
Sec. 59.10 What other HHS regulations apply to grants under this
subpart?
Attention is drawn to the following HHS Department-wide regulations
which apply to grants under this subpart. These include:
37 CFR Part 401--Rights to inventions made by nonprofit
organizations and small business firms under government grants,
contracts, and cooperative agreements
42 CFR Part 50, Subpart D--Public Health Service grant appeals
procedure
45 CFR Part 16--Procedures of the Departmental Grant Appeals Board
45 CFR Part 74--Uniform administrative requirements for awards and
subawards to institutions of higher education, hospitals, other
nonprofit organizations, and commercial organizations; and certain
grants and agreements with states, local governments and Indian
tribal governments
45 CFR Part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and Human Services
effectuation of Title VI of the Civil Rights Act of 1964
45 CFR Part 81--Practice and procedure for hearings under Part 80 of
this Title
45 CFR Part 84--Nondiscrimination on the basis of handicap in
programs and activities receiving or benefitting from Federal
financial assistance
45 CFR Part 91--Nondiscrimination on the basis of age in HHS
programs or activities receiving Federal financial assistance
45 CFR Part 92--Uniform administrative requirements for grants and
cooperative agreements to state and local governments
Sec. 59.11 Confidentiality.
All information as to personal facts and circumstances obtained by
the project staff about individuals receiving services must be held
confidential and must not be disclosed without the individual's
documented consent, except as may be necessary to provide services to
the patient or as required by law, with appropriate safeguards for
confidentiality. Otherwise, information may be disclosed only in
summary, statistical, or other form which does not identify particular
individuals.
Sec. 59.12 Additional conditions.
The Secretary may, with respect to any grant, impose additional
conditions prior to or at the time of any award, when in the
Department's judgment these conditions are necessary to assure orb
protect advancement of the approved program, the interests of public
health, or the proper use of grant funds.
[FR Doc. 00-16758 Filed 6-30-00; 8:45 am]
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