41270 Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

42 CFR Part 59

RIN: 0940–AA00

Standards of Compliance for AbortionRelated Services in Family Planning

Services Projects

AGENCY: Office of Population Affairs,

OPHS, DHHS.

ACTION: Final rules.

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 abortionrelated 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,

Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Rules and Regulations 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

41272 Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Rules and Regulations

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 § 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

Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Rules and Regulations 41273

unintended pregnancy are to be given nondirective 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, § 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 § 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

41274 Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Rules and Regulations

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 pre1988 rules (§ 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 ‘‘selfreferrals’’ 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

Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Rules and Regulations 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 abortionrelated 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

41276 Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Rules and Regulations

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

§ 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

§ 59.9 of the Gag Rule should be

retained on the ground that they provide

a necessary clarification of this issue.

Although § 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 § 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 § 59.9 were never

determined. The Secretary has

accordingly not accepted the suggestion

from several opponents of the proposed

rule that the policies of § 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 Xsupported 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 § 59.10 of the Gag

Rule and argued that § 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

Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Rules and Regulations 41277

that the prohibition against dues paying

contained in § 59.10 is not required by

the statute and does not represent sound

public policy. Accordingly, the

suggestion that § 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 crossreferenced 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. § 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, § 673.

2. § 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. § 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

§ 59.2 (definition of ‘‘low income

family’’).

4. § 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. § 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. § 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. § 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

§ 59.10. This change has also occasioned

the renumbering of the proposed

§ 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 preVerDate 11<MAY>2000 22:54 Jun 30, 2000 Jkt 190000 PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 E:\FR\FM\03JYR3.SGM pfrm08 PsN: 03JYR3
41278 Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Rules and Regulations

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.

§ 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.

§ 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.

§ 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.

§ 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.

§ 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

Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Rules and Regulations 41279

1Section 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.’’

(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

(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 § 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 inservice 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.

§ 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

41280 Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Rules and Regulations

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.

§ 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 nonfederal 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.

§ 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.

§ 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.

§ 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

§ 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.

§ 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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