Program Guidelines

For Project Grants 

For Family Planning Services

United States Department of Health and Human Services

Office of Public Health and Science

Office of Population Affairs

Office of Family Planning

4350 East West Highway, Suite 200

Bethesda, Maryland 20814

January 2001
Table of Contents

PART I ...................................................................... 1

1.0 Introduction to the Program Guidelines .................................. 1

1.1 Definitions ......................................................... 1

2.0 The Law, Regulations, and Guidelines ................................... 2

3.0 The Application Process .............................................. 2

3.1 Eligibility ..................................................... 2

3.2 Needs Assessment ............................................ 3

3.3 The Application ............................................... 3

3.4 Project Requirements ........................................... 4

3.5 Notice of Grant Award . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

4.0 Grant Administration ................................................. 5

5.0 Legal Issues ....................................................... 5

5.1 Voluntary Participation ......................................... 5

5.2 Confidentiality ................................................ 5

5.3 Conflict of Interest ............................................. 6

5.4 Liability Coverage ............................................. 6

5.5 Human Subjects Clearance (Research) ............................ 6

6.0 Project Management ................................................. 6

6.1 Structure of the Grantee ........................................ 6

6.2 Planning and Evaluation ........................................ 7

6.3 Financial Management ......................................... 7
6.4 Facilities and Accessibility of Services ............................. 9

6.5 Personnel .................................................... 9

6.6 Training and Technical Assistance ............................... 10

6.7 Reporting Requirements ....................................... 10

6.8 Review and Approval of Informational Educational Materials ....... 10

6.9 Community Participation, Education, and Project Promotion .......... 11

6.10 Publications and Copyright ..................................... 12

6.11 Inventories or Discoveries .................................... 12

PART II .................................................................... 13

7.0 Client Services ..................................................... 13

7.1 Service Plans and Protocols .................................... 13

7.2 Procedural Outline ............................................ 13

7.3 Emergencies ................................................. 15

7.4 Referrals and Follow-Up ....................................... 16

8.0 Required Services .................................................. 16

8.1 Client Education ............................................. 17

8.2 Counseling .................................................. 18

8.3 History, Physical Assessment, And Laboratory Testing .............. 19

8.4 Fertility Regulation .......................................... 23

8.5 Infertility Services ............................................ 24

8.6 Pregnancy Diagnosis and Counseling ............................ 24

8.7 Adolescent Services ........................................... 25
8.8 Identification of Estrogen-Exposed Offspring ...................... 26

9.0 Related Services ................................................... 26

9.1 Gynecologist Services ......................................... 26

9.2 Sexuality Transmitted Diseases (STD) and HIV/AIDS .............. 26

9.3 Special Counseling ........................................... 27

9.4 Genetic Information and Referral ............................... 27

9.5 Health Promotion/Disease Prevention ............................ 27

9.6 Postpartum Care ............................................. 27

10.0 Clinic Management ................................................ 27

10.1 Equipment and Supplies ....................................... 27

10.2 Pharmaceuticals ............................................. 28

10.3 Medical Records ............................................ 28

10.4 Quality Assurance and Audit .................................. 30

Attachments

A. The Law: Title X Population Research and Voluntary Family Planning Programs

B. Regulations: Grants for Family Planning Services under Title X of the Public Health

Service Act

C. Sterilization of Persons in Federally Assisted Family Planning Projects

D. DHHS Regional Offices- Regional Program Consultants For Family Planning

Resource Documents
PART I

1.0 Introduction to the Program Guidelines

This document, Program Guidelines for Project Grants for Family Planning Services (Guidelines),

has been developed by the Office of Population Affairs (OPA), U.S. Department of Health and Human

Services (DHHS), to assist current and prospective grantees in understanding and utilizing the family

planning services grants program authorized by Title X of the Public Health Service Act, 42 U.S.C.

300, et seq. The Office of Population Affairs also provides more detailed guidance, updated clinical

information and clarification of specific program issues in the form of periodic Program Instructions to

the Regional Offices. 

This document is organized into two parts. Part I (sections 1-6) covers project management and

administration, including the grant application and award process. Part II (sections 7-11) covers client

services and clinic management.

Reference is made throughout the document to specific sections of the Title X law and implementing

regulations, which are contained in Attachments A and B, respectively. (Reference to specific

sections of the regulations will appear in brackets, e.g., [45 CFR Part 74, Subpart C].) Federal

sterilization regulations are contained in Attachment C. The DHHS regional offices are listed in

Attachment D. Selected other materials that provide additional guidance in specific areas are

classified as Resource Documents. 

1.1 DEFINITIONS

Throughout this document, the word “must” indicates mandatory program policy. “Should” indicates

recommended program policy relating to components of family planning and project management that

the project is urged to utilize in order to fulfill the intent of Title X. The words “can” and “may” indicate

suggestions for consideration by individual projects. 

The "grantee” is the entity that receives a Federal grant and assumes legal and financial responsibility

and accountability for the awarded funds and for the performance of the activities approved for funding. 

The “project” consists of those activities described in the grant application and supported under the

approved budget. “Delegate/contract agencies” are those entities that provide family planning services

with Title X funds under a negotiated, written agreement with a grantee. “Service sites” are those

locations where services actually are provided by the grantee or delegate/contract agency. 
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2.0 The Law, Regulations, and Guidelines

To enable persons who want to obtain family planning care to have access to such services, Congress

enacted the Family Planning Services and Population Research Act of 1970 (Public Law 91-572),

which added Title X, “Population Research and Voluntary Family Planning Programs" to the Public

Health Service Act. Section 1001 of the Act (as amended) authorizes grants "to assist in the

establishment and operation of voluntary family planning projects which shall offer a broad range of

acceptable and effective family planning methods and services (including natural family planning

methods, infertility services, and services for adolescents)” (see Attachment A). The mission of Title

X is to provide individuals the information and means to exercise personal choice in determining the

number and spacing of their children. 

The regulations governing Title X [42 CFR Part 59, Subpart A] set out the requirements of the

Secretary, Department of Health and Human Services, for the provision of family planning services

funded under Title X and implement the statute as authorized under Section 1001 of the Public Health

Service Act. Prospective applicants and grantees should refer to the regulations (see Attachment B). 

This document, Program Guidelines for Project Grants for Family Planning Services, interprets

the law and regulations in operational terms and provides a general orientation to the Federal

perspective on family planning. 

3.0 The Application Process

3.1 ELIGIBILITY

Any public or nonprofit private entity located in a state (which, by definition, includes the District of

Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the U.S. Virgin

Islands, American Samoa, the U.S. Outlying Islands [Midway, Wake, et al.], the Marshall Islands, the

Federated States of Micronesia and the Republic of Palau) is eligible to apply for a Title X family

planning services project grant [59.2, 59.3].

 

To promote the purposes of Section 1001 of the Act in the most cost effective and efficient manner,

grants will be made to public and non-profit private entities to foster projects most responsive to local

needs. A non-profit private agency, institution, or organization must furnish evidence of its non-profit

status in accordance with instructions accompanying the project grant application form. Under the law,

grants cannot be made to entities that propose to offer only a single method or an unduly limited number

of family planning methods. A facility or entity offering a single method can receive assistance under

Title X by participating as a delegate/contract agency in an approvable project that offers a broad range

of acceptable and effective medically approved family planning methods and services [59.5(a)(1)].
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3.2 NEEDS ASSESSMENT

An assessment of the need for family planning services must be conducted prior to applying for a

competitive grant award. The needs assessment documents the need for family planning services for

persons in the service area and should include:

• Description of the geographic area including a discussion of potential geographic, topographic, and

other related barriers to service;

• Demographic description of the service area including objective data pertaining to individuals in

need of family planning services, maternal and infant morbidity/mortality rates, birth rates and rates

of unintended pregnancies by age groups, poverty status of the populations to be served, cultural

and linguistic barriers to services, etc.;

• Description of existing services and need for additional family planning services to meet

community/cultural needs;

• Need indicators that include rates of STDs and HIV prevalence (including perinatal infection rates)

in the grantee area;

• Identification and descriptions of linkages with other resources related to reproductive health; and

• Identification and discussion of high priority populations and target areas.

Grantees should perform periodic reassessment of service needs. Competitive grant applications must

include a full and updated needs assessment.

3.3 THE APPLICATION

The Department of Health and Human Services’ Office of Population Affairs administers the Title X

Family Planning Program through the DHHS Regional Offices. An annual announcement of the

availability of Title X service grant funds sets forth specific application requirements and evaluation

criteria. Applications must be submitted to the Office of Grants Management for Family Planning

Services on the form required by the Department. The application forms are available from the Office

of Grants Management for Family Planning Services. Assistance regarding programmatic aspects of

proposal preparation is available from the Regional Office. For assistance with administrative and

budgeting aspects of proposal preparation, contact the Office of Grants Management for Family

Planning Services. 
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Unless otherwise instructed, applicants are to respond to the standard instructions contained in the

application kit and to the PHS supplemental instructions. An application must contain: 

• a needs assessment

• a narrative description of the project and the manner in which the applicant intends to 

conduct it in order to carry out the requirements of the law and regulations; 

• a budget that includes an estimate of project income and costs, with justification for the amount

of grant funds requested [59.4(c)(2)] and which is consistent with the terms of Section 1006 of

the Act, as implemented by regulation [59.7(b)]; 

• a description of the standards and qualifications that will be required for all personnel and

facilities to be used by the project; 

• project objectives that are specific, realistic, and measurable; and

• other pertinent information as required [59.4(c)(4)]. 

The application must address all points contained in section 59.7(a) of the regulations, which are the

criteria DHHS Regional Offices will use to decide which family planning projects to fund and in what

amount. The application shall not include activities that cannot be funded under Title X, such as

abortion, fundraising, or lobbying activities.

3.4 PROJECT REQUIREMENTS

Projects must adhere to:

C Section 59.5 and all other applicable provisions of the regulations, which list the requirements to

be met by each project supported by Title X.

C The applicable requirements of these Program Guidelines for Project Grants for Family

Planning Services.

C Other Federal regulations which apply to grants made under Title X [59.10]. For assistance in

identifying other relevant regulations, contact the Regional Office.
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3.5 NOTICE OF GRANT AWARD

The notice of grant award will inform the grantee how long DHHS intends to support the project

without requiring it to recompete for funds [59.8]. This period of funding is called the “project period.” 

The project will be funded in increments called “budget periods.” The budget period is normally twelve

months, although shorter or longer budget periods may be established for compelling administrative or

programmatic reasons.

4.0 Grant Administration

All grantees must comply with the applicable legislative, regulatory and administrative requirements

described in the Public Health Service Grants Policy Statement. A copy of the Public Health

Service Grants Policy Statement may be obtained from the Office of Grants Management for Family

Planning Services. 

5.0 Legal Issues 

5.1 VOLUNTARY PARTICIPATION

Use by any individual of project services must be solely on a voluntary basis. Individuals must not be

subjected to coercion to receive services or to use or not to use any particular method of family

planning. Acceptance of family planning services must not be a prerequisite to eligibility for, or receipt

of, any other service or assistance from or participation in any other programs of the applicant

[59.5(a)(2)].

Project personnel must be informed that they may be subject to prosecution under Federal law if they

coerce or endeavor to coerce any person to undergo an abortion or sterilization procedure.

5.2 CONFIDENTIALITY

Every project must assure client confidentiality and provide safeguards for individuals against the

invasion of personal privacy, as required by the Privacy Act. No information obtained by the project

staff about individuals receiving services may be disclosed without the individual’s written consent,

except as required by law or as necessary to provide services to the individual, with appropriate

safeguards for confidentiality. Information may otherwise be disclosed only in summary, statistical, or

other form that does not identify the individual [59.11]. 
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5.3 CONFLICT OF INTEREST

Grantees must establish policies to prevent employees, consultants, or members of governing or

advisory bodies from using their positions for purposes of private gain for themselves or for others.

5.4 LIABILITY COVERAGE

Grantees and/or delegates/contractors should ensure the existence of adequate liability coverage for all

segments of the project funded under the grant, including all individuals providing services. Governing

boards should obtain liability coverage for their members. 

5.5 HUMAN SUBJECTS CLEARANCE (RESEARCH)

Grantees considering clinical or sociological research using Title X clients as subjects must adhere to the

legal requirements governing human subjects research at 45 CFR Part 46, as applicable. A copy of

these regulations may be obtained from the Regional Office. Grantees must advise the Regional Office

in writing of research projects involving Title X clients or resources in any segment of the project.

6.0 Project Management

6.1 STRUCTURE OF THE GRANTEE

Family planning services under Title X grant authority may be offered by grantees directly and/or by

delegate/contract agencies operating under the umbrella of the grantee. However, the grantee is

responsible for the quality, cost, accessibility, acceptability, reporting, and performance of the grantfunded activities provided by delegate/contract agencies. Grantees must therefore have a negotiated,

written agreement with each delegate/contract agency and establish written standards and guidelines for

all delegated project activities consistent with the appropriate section(s) of the Program Guidelines for

Project Grants for Family Planning Services, as well as other applicable requirements such as

Subpart C of 45 CFR Part 74, or Subpart C of 45 CFR Part 92. If a delegate/contract agency wishes

to subcontract any of its responsibilities or services, a written negotiated agreement that is consistent

with Title X requirements and approved by the grantee must be maintained by the delegate/contractor. 

Delegate/contract agencies should be invited to participate in the establishment of grantee standards and

guidelines. 
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6.2 PLANNING AND EVALUATION

All projects receiving Title X funds must provide services of high quality and be competently and

efficiently administered. To meet these requirements, each competitive application must include a plan

which identifies overall goals and specific measurable objectives for the project period. The objectives

may be directed to all clients or to specific groups of clients and must be consistent with Title X

objectives. The plan must include an evaluation component that addresses and defines indicators by

which the project intends to evaluate itself. 

6.3 FINANCIAL MANAGEMENT

Grantees must maintain a financial management system that meets the standards specified in Subpart C

of 45 CFR Part 74 or Subpart C of 45 CFR Part 92, as applicable, as well as any other requirements

imposed by the Notice of Grant Award, and which complies with Federal standards to safeguard the

use of funds. Documentation and records of all income and expenditures must be maintained as

required.

! Charges, Billing, and Collections

A grantee is responsible for the implementation of policies and procedures for charging, billing,

and collecting funds for the services provided by the project. The policies and procedures

should be approved by the governing authority or board of the grantee and the Regional Office.

Clients must not be denied project services or be subjected to any variation in quality of

services because of the inability to pay. Billing and collection procedures must have the

following characteristics: 

(1) Charges must be based on a cost analysis of all services provided by the project. At the

time of services, clients who are responsible for paying any fee for their services must

be given bills directly. In cases where a third party is responsible, bills must be

submitted to that party.

(2) A schedule of discounts must be developed and implemented with sufficient

proportional increments so that inability to pay is never a barrier to service. A schedule

of discounts is required for individuals with family incomes between 101% and 250% of

the Federal poverty level. Fees must be waived for individuals with family incomes

above this amount who, as determined by the service site project director, are unable,

for good cause, to pay for family planning services. 

(3) Clients whose documented income is at or below 100% of the Federal poverty 
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level must not be charged, although projects must bill all third parties authorized or

legally obligated to pay for services. 

(4) Individual eligibility for a discount must be documented in the client’s financial record. 

(5) Bills to third parties must show total charges without applying any discount. 

(6) Where reimbursement is available from Title XIX or Title XX of the Social Security

Act, a written agreement with the Title XIX or the Title XX state agency at either the

grantee level or delegate/contract agency level is required.

(7) Bills to clients must show total charges less any allowable discounts. 

(8) Eligibility for discounts for minors who receive confidential services must be based on

the income of the minor. 

(9) Reasonable efforts to collect charges without jeopardizing client confidentiality must be

made. 

(10) A method for the “aging” of outstanding accounts must be established. 

(11) Voluntary donations from clients are permissible. However, clients must not be

pressured to make donations, and donations must not be a prerequisite to the provision

of services or supplies. Donations from clients do not waive the billing/charging

requirements set out above. 

(12) Client income should be re-evaluated at least annually.

Effective financial management will assure the short and long term viability of the project, including the

efficient use of grant funds. Technical assistance in achieving this objective is available from the

Regional Office. Title X projects offering services that are not required by the statute, regulations or

these Guidelines should whenever possible seek other sources of funding for such services before

applying Title X funds to those activities.

! Financial Audit

Audits of grantees and delegate/contract agencies must be conducted in accordance with the

provisions of 45 CFR Part 74, Subpart C, and 45 CFR Part 92, Subpart C, as applicable. The

audits must be conducted by auditors meeting established criteria for qualifications and

independence. 
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6.4 FACILITIES AND ACCESSIBILITY OF SERVICES

Facilities in which project services are provided should be geographically accessible to the population

served and should be available at times convenient to those seeking services, i.e., they should have

evening and/or weekend hours in addition to daytime hours. The facilities should be adequate to

provide the necessary services and should be designed to ensure comfort and privacy for clients and to

expedite the work of the staff. Facilities must meet applicable standards established by the Federal,

state and local governments (e.g., local fire, building and licensing codes). 

Projects must comply with 45 CFR Part 84, which prohibits discrimination on the basis of handicap in

Federally assisted programs and activities, and which requires, among other things, that recipients of

Federal funds operate their Federally assisted programs so that, when viewed in their entirety, they are

readily accessible to people with disabilities. A copy of Part 84 may be obtained from the Regional

office. Projects must also comply with any applicable provisions of the Americans With Disabilities Act

(Public Law 101-336).

Emergency situations may occur at any time. All projects must therefore have written plans and

procedures for the management of emergencies.

6.5 PERSONNEL

Grantees and delegate/contract agencies are reminded of their obligation to establish and maintain

personnel policies that comply with applicable Federal and state requirements, including Title VI of the

Civil Rights Act, Section 504 of the Rehabilitation Act of 1973, and Title I of the Americans With

Disabilities Act. These policies should include, but need not be limited to, staff recruitment, selection,

performance evaluation, promotion, termination, compensation, benefits, and grievance procedures. 

Project staff should be broadly representative of all significant elements of the population to be served

by the project, and should be sensitive to and able to deal effectively with the cultural and other

characteristics of the client population [59.5 (b)(10)].

Grantees must also ensure that: 

• Projects are administered by a qualified project director;

• The clinical care component of the project operates under the responsibility of a medical director

who is a licensed and qualified physician with special training or experience in family planning;

• Protocols exist that provide all project personnel with guidelines for client care;
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• Personnel records are kept confidential;

• Licenses of applicants for positions requiring licensure are verified prior to employment and that

there is documentation that licenses are kept current.

6.6 TRAINING AND TECHNICAL ASSISTANCE

Projects must provide for the orientation and in-service training of all project personnel, including the

staffs of delegate agencies and service sites. All project personnel should participate in continuing

education related to their activities. Documentation of continuing education should be maintained and

used in evaluating the scope and effectiveness of the staff training program. 

Training through regional training centers is available to all projects under the Title X program. In

addition to training, grantees may receive technical assistance for specific project activities. Technical

assistance is provided by contract from the OPA and administered through the Regional Office. 

Information on training and technical assistance is available from the Regional Office.

6.7 REPORTING REQUIREMENTS

Grantees must:

 (1) comply with the financial and other reporting requirements of 45 CFR Part 74 or 45 CFR Part

92, as applicable; and 

 (2) comply with other reporting requirements as required by DHHS.

6.8 REVIEW AND APPROVAL OF INFORMATIONAL AND EDUCATIONAL 

 MATERIALS 

An advisory committee of five to nine members (the size of the committee can differ from these limits

with written documentation and approval from the Regional Office) who are broadly representative of

the community must review and approve all informational and educational (I&E) materials developed or

made available under the project prior to their distribution to assure that the materials are suitable for

the population and community for which they are intended and to assure their consistency with the

purposes of Title X. Oversight responsibility for the I&E committee(s) rests with the grantee. The

grantee may delegate the I & E operations for the review and approval of materials to delegate/contract

agencies.
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The I&E committee(s) must:

• Consider the educational and cultural backgrounds of the individuals to whom the materials are

addressed;

• Consider the standards of the population or community to be served with respect to such

materials;

• Review the content of the material to assure that the information is factually correct; 

• Determine whether the material is suitable for the population or community to which it is to be

made available; and 

• Establish a written record of its determinations [59.6]. 

The committee(s) may delegate responsibility for the review of the factual, technical, and clinical

accuracy to appropriate project staff. However, final approval of the I& E material rests with the

committee(s). 

6.9 COMMUNITY PARTICIPATION, EDUCATION, AND PROJECT PROMOTION

Boards and advisory committees for family planning services should be broadly representative of the

population served.

! Community Participation

Title X grantees and delegate/contract agencies must provide an opportunity for participation in

the development, implementation, and evaluation of the project (1) by persons broadly

representative of all significant elements of the population to be served, and (2) by persons in

the community knowledgeable about the community’s needs for family planning services

[59.5(b)(10)]. 

The I& E advisory committee may serve the community participation function if it meets the

above requirements, or a separate group may be identified. In either case, the grantee project

plan must include a plan for community participation. The community participation committee

must meet annually or more often as appropriate.
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! Community Education

Each family planning project must provide for community education programs [59.5(b)(3)]. 

This should be based on an assessment of the needs of the community and should contain an

implementation and evaluation strategy. 

Community education should serve to enhance community understanding of the objectives of

the project, make known the availability of services to potential clients, and encourage

continued participation by persons to whom family planning may be beneficial. 

! Project Promotion

To facilitate community awareness of and access to family planning services, projects must

establish and implement planned activities whereby their services are made known to the

community [59.5(b)(3)]. Projects should review a range of strategies and assess the availability

of existing resources and materials. Promotion activities should be reviewed annually and be

responsive to the changing needs of the community. For more information, contact the

Regional Offices.

6.10 PUBLICATIONS AND COPYRIGHT

Unless otherwise stipulated, publications resulting from activities conducted under the grant need not be

submitted to DHHS for prior approval. The word "publication" is defined to include computer software. 

Grantees should ensure that publications developed under Title X do not contain information which is

contrary to program requirements or to accepted clinical practice. Federal grant support must be

acknowledged in any publication. Except as otherwise provided in the conditions of the grant award,

the author is free to arrange for copyright without DHHS approval of publications, films, or similar

materials developed from work supported by DHHS. Restrictions on motion picture film production are

outlined in the Public Health Service Grants Policy Statement. Any such copyrighted materials shall

be subject to a royalty-free, non-exclusive, and irrevocable right of the Government to reproduce,

publish, or otherwise use such materials for Federal purposes and to authorize others to do so [45 CFR

74.36][45 CFR 92.34 ].

6.11 INVENTIONS OR DISCOVERIES

Family planning projects must comply with Government-wide regulations, 37 CFR Part 401, which

apply to the rights to inventions made under government grants, contracts and cooperative agreements.
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PART II

7.0 Client Services

Projects funded under Title X must provide clinical, informational, educational, social and referral

services relating to family planning to clients who want such services. All projects must offer a broad

range of acceptable and effective medically approved family planning methods and services either onsite or by referral [59.5(a)(1)]. Projects should make available to clients all methods of contraception

approved by the Federal Food and Drug Administration.

Part II of this document has been developed to assist grantees in determining those services which will

be provided to fulfill the mission of Title X. 

C Projects must provide services stipulated in the law or regulations, or which are required by

these Guidelines for the provision of high quality family planning services. 

C Projects may also provide those services that are intended to promote the reproductive and

general health care of the family planning client population. 

7.1 SERVICE PLANS AND PROTOCOLS 

The service plan is the component of the grantee's project plan, as set forth in the competitive

application, which identifies those services to be provided to clients under Title X by the project. As

part of the project plan, all grantees must assure that delegate/contractors have written clinical protocols

and plans for client education, approved by the grantee and signed by the service site Medical Director,

which outline procedures for the provision of each service offered and which are in accordance with

state laws. Clinical protocols must be consistent with the requirements of these Guidelines.

 

Under exceptional circumstances, a waiver from a particular requirement may be obtained from the

Regional Office upon written request from a grantee. In submitting a request for an exception, the

grantee must provide epidemiologic, clinical, and other supportive data to justify the request and the

duration of the waiver. 

7.2 PROCEDURAL OUTLINE

The services provided to family planning clients, and the sequence in which they are provided, will

depend upon the type of visit and the nature of the service requested. However, the following

components must be offered to and documented on all clients at the initial visit: 
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Education

C Presentation of relevant information and educational materials, based upon client needs and

knowledge;

Counseling

C Interactive process in which a client is assisted in making an informed choice;

Informed Consent

C Explanation of all procedures and obtaining a general consent covering examination and treatment

and, where applicable, a method specific informed consent form; 

History

C Obtaining of a personal and family medical and social history; 

Examination

C Performance of a physical examination and any necessary clinical procedures, as indicated;

Laboratory Testing

C Performance of routine and other indicated laboratory tests; 

Follow-up & Referrals

C Planned mechanism for client follow-up; 

• Performance of any necessary clinical procedures; 

C Provision of medications and/or supplies as needed; and

C Provision of referrals as needed.
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Return visits, with the exception of routine supply visits, should include an assessment of the client’s

health status, current complaints, and evaluation of birth control method, as well as an opportunity to

change methods. The following components must be offered to and documented on all clients at the

return visit:

History

C Updating a personal and family medical and social history; 

Examination

C Performance of a physical examination and any necessary clinical procedures, as indicated; 

Laboratory Testing

C Performance of routine and other indicated laboratory tests; 

Follow-up & Referrals

C Planned mechanism for client follow-up; 

• Performance of any necessary clinical procedures; 

C Provision of medications and/or supplies as needed; and

C Provision of referrals as needed.

7.3 EMERGENCIES

Emergency situations involving clients and/or staff may occur at any time. All projects must therefore

have written plans for the management of on-site medical emergencies. At a minimum, written

protocols must address vaso-vagal reactions, anaphylaxis, syncope, cardiac arrest, shock, hemorrhage,

and respiratory difficulties. Protocols must also be in place for emergencies requiring transport, afterhours management of contraceptive emergencies, and clinic emergencies. All project staff must be

familiar with these plans. Appropriate training, including training in CPR, should be available to staff. 
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7.4 REFERRALS AND FOLLOW-UP

Grantees must assure that delegate/contract agencies provide all family planning services listed in

Section 8.0 under “Required Services,” either on-site or by referral. When required services are to be

provided by referral, the grantee must establish formal arrangements with a referral agency for the

provision of services and reimbursement of costs, as appropriate. 

Agencies must have written policies/procedures for follow-up on referrals that are made as a result of

abnormal physical examination or laboratory test findings. These policies must be sensitive to clients’

concerns for confidentiality and privacy.

For services determined to be necessary but which are beyond the scope of the project, clients must be

referred to other providers for care. When a client is referred for non-family planning or emergency

clinical care, agencies must:

• Make arrangements for the provision of pertinent client information to the referral provider. 

Agencies must obtain client’s consent to such arrangements, except as may be necessary to

provide services to the patient or as required by law, with appropriate safeguards for

confidentiality;

• Advise client on their responsibility in complying with the referral; and

• Counsel client on the importance of such referral and the agreed upon method of follow-up.

Efforts may be made to aid the client in identifying potential resources for reimbursement of the referral

provider, but projects are not responsible for the cost of this care. Agencies must maintain a current list

of health care providers, local health and human services departments, hospitals, voluntary agencies,

and health services projects supported by other Federal programs to be used for referral purposes. 

Whenever possible, clients should be given a choice of providers from which to select.

8.0 Required Services

The services contained in this section must be provided by all projects funded under Title X. 

The client’s written informed voluntary consent to receive services must be obtained prior to the client

receiving any clinical services. In addition, if a client chooses a prescription method of contraception, a

method-specific consent form must be obtained and updated routinely at subsequent visits to reflect

current information about that method.
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8.1 CLIENT EDUCATION 

Grantees and/or delegate/contract agencies must have written plans for client education that include

goals and content outlines to ensure consistency and accuracy of information provided. Client

education must be documented in the client record. The education provided should be appropriate to

the client’s age, level of knowledge, language, and socio-cultural background and be presented in an

unbiased manner. A mechanism to determine that the information provided has been understood

should be established. 

Education services must provide clients with the information needed to:

• Make informed decisions about family planning; 

• Use specific methods of contraception and identify adverse effects; 

• Perform breast/testicular self examination; 

• Reduce risk of transmission of sexually transmitted diseases and Human 

Immunodeficiency Virus (HIV); 

• Understand the range of available services and the purpose and sequence of clinic procedures;

and 

• Understand the importance of recommended screening tests and other procedures involved in

the family planning visit. 

Clients should be offered information about basic female and male reproductive anatomy and 

physiology, and the value of fertility regulation in maintaining individual and family health. Additional

education should include information on reproductive health and health promotion/disease prevention,

including nutrition, exercise, smoking cessation, alcohol and drug abuse, domestic violence and sexual

abuse.

! Method-Specific Informed Consent

Written informed consent, specific to the contraceptive method, must be signed before a

prescription contraceptive method is provided. Prior to implementation, informed consent forms

should be approved by the service site Medical Director. 

The consent forms must be written in a language understood by the client or translated and

witnessed by an interpreter. To provide informed consent for contraception, the client must receive

information on the benefits and risks, effectiveness, potential side effects, complications,

discontinuation issues and danger signs of the contraceptive method chosen. Specific education

and consent forms for the contraceptive method provided must be part of 
-18-

the project’s service plan. 

The signed informed consent form must be a part of the client’s record. All consent forms should

contain a statement that the client has been counseled, provided with the appropriate informational

material, and understands the content of both. The method-specific consent form should be

renewed and updated when there is a major change in the client's health status or a change to a

different prescriptive contraceptive method.

Federal sterilization regulations [42 CFR Part 50, Subpart B], which address informed consent

requirements, must be complied with when a sterilization procedure is performed or arranged for

by the project (see Attachment C). 

8.2 COUNSELING

The primary purpose of counseling in the family planning setting is to assist clients in reaching an

informed decision regarding their reproductive health and the choice and continued use of family

planning methods and services. The counseling process is designed to help clients resolve uncertainty,

ambivalence, and anxiety about reproductive issues and to enhance their capacity to arrive at a decision

that reflects their considered self-interest. 

The counseling process involves mutual sharing of information. Persons who provide counseling should

be knowledgeable, objective, nonjudgmental, sensitive to the rights and differences of clients as

individuals, culturally aware and able to create an environment in which the client feels comfortable

discussing personal information. The counselor must be sufficiently knowledgeable to provide accurate

information regarding the benefits and risk, safety, effectiveness, potential side effects, complications,

discontinuation issues and danger signs of the various contraceptive methods. Additionally, the

counselor should be knowledgeable about the other services offered by the agency. Documentation of

counseling must be included in the client’s record. 

! Method Counseling

Method counseling refers to an individualized dialogue with a client that covers the following:

• Results of physical exam and lab studies;

• Effective use of contraceptive methods, including natural family planning (NFP), and the

benefit and efficacy of the methods;

• Possible side effects/complications;

• How to discontinue the method selected and information regarding back-up 
-19-

method use, including the use of certain oral contraceptives as post-coital emergency

contraception;

• Planned return schedule;

• Emergency 24-hour telephone number;

• Location where emergency services can be obtained; and

• Appropriate referral for additional services as needed.

! Sexually Transmitted Disease (STD) and HIV Counseling

All clients must receive thorough and accurate counseling on STDs and HIV. STD/HIV counseling

refers to an individualized dialogue with a client in which there is discussion of personal risks for

STDs/HIV, and the steps to be taken by the individual to reduce risk, if necessary. Persons found

to have behaviors which currently put them at risk for STD/HIV must be given advice regarding

risk reduction and must be advised whether clinical evaluation is indicated. All projects must offer,

at a minimum, education about HIV infection and AIDS, information on risks and infection

prevention, and referral services. On an optional basis, clinics may also provide HIV risk

assessment, counseling and testing by specially trained staff. When the project does not offer these

optional services, the project must provide the client with a list of health care providers who can

provide these services.

8.3 HISTORY, PHYSICAL ASSESSMENT, AND LABORATORY TESTING

! History

At the initial comprehensive clinical visit, a complete medical history must be obtained on all female

and male clients. Pertinent history must be updated at subsequent clinical visits. The comprehensive

medical history must address at least the following areas: 

• Significant illnesses; hospitalizations; surgery; blood transfusion or exposure to blood

products; and chronic or acute medical conditions;

• Allergies; 

• Current use of prescription and over-the-counter medications; 

• Extent of use of tobacco, alcohol, and other drugs;
-20-

• Immunization and Rubella status;

• Review of systems; 

• Pertinent history of immediate family members; and 

• Partner history

- injectable drug use

- multiple partners

- risk history for STDs and HIV

- bisexuality.

Histories of reproductive function in female clients must include at least the following: 

• Contraceptive use past and current (including adverse effects);

• Menstrual history; 

• Sexual history;

• Obstetrical history;

• Gynecological conditions;

• Sexually transmitted diseases, including HBV;

• HIV;

• Pap smear history (date of last Pap, any abnormal Pap, treatment); and

• In utero exposure to diethylstilbestrol (DES).

Histories of reproductive function in male clients must include at least the following: 

• Sexual history;

• Sexually transmitted diseases (including HBV);
-21-

• HIV; and 

• Urological conditions.

! Physical Assessment (female)

For many clients, family planning programs are their only continuing source of health information

and clinical care. Therefore, an initial complete physical examination, including height and weight,

examination of the thyroid, heart, lungs, extremities, breasts, abdomen, pelvis, and rectum, should

be performed.

While most client services will necessarily relate to fertility regulation, family planning clinics must

provide and encourage clients to use health maintenance screening procedures, initially and as

indicated. Clinics must provide and stress the importance of the following to all clients:

C Blood pressure evaluation;

C Breast exam; 

C Pelvic examination which includes vulvar evaluation and bimanual exam;

C Pap smear;

C Colo-rectal cancer screening in individuals over 40; and

C STD and HIVscreening, as indicated. 

Following counseling about the importance of the above preventive services, if a client chooses to

decline or defer a service, this should be documented in their record. Counseling must include

information about the possible health risks associated with declining or delaying preventive

screening tests or procedures.

All physical examination and laboratory test requirements stipulated in the prescribing information

for specific methods of contraception must be followed. Physical examination and related

prevention services should not be deferred beyond 3 months after the initial visit, and in no case

may be deferred beyond 6 months, unless if in the clinician’s judgment there is a compelling reason

for extending the deferral. All deferrals, including the reason(s) for deferral, must be documented in

the client record. Project protocols should be developed accordingly.
-22-

! Physical Assessment (male)

Family planning clinics also may be an important source of reproductive health care for male 

clients. Physical examination should be made available to male clients, including height and weight,

examination of the thyroid, heart, lungs, breasts, abdomen, extremities, genitals and rectum. 

Examination should also include palpation of the prostate, as appropriate, and instructions in selfexamination of the testes. Clinics should stress the importance of the following to male clients:

C Blood pressure evaluation;

C Colo-rectal cancer screening in individuals over 40; and

C STD and HIVscreening, as indicated. 

! Laboratory Testing

Specific laboratory tests are required for the provision of specific methods of contraception.

Laboratory tests can also be important indicators of client health status and useful for diagnostic

purposes. Pregnancy testing must be provided onsite. The following laboratory procedures must

be provided to clients if required in the provision of a contraceptive method, and may be provided

for the maintenance of health status and/or diagnostic purposes, either on-site or by referral: 

- Anemia assessment

- Gonorrhea and chlamydia test 

- Vaginal wetmount 

- Diabetes testing

- Cholesterol and lipids 

- Hepatitis B testing

- Syphilis serology (VDRL, RPR)

- Rubella titer

- Urinalysis
-23-

- HIV testing

• Notification of Abnormal Lab Results

A procedure which addresses client confidentiality must be established to allow for client

notification and adequate follow-up of abnormal laboratory results. 

• Other Laboratory Services or Procedures

Other procedures and lab tests may be indicated for some clients and may be provided on-site or

by referral. 

! Revisits 

Revisit schedules must be individualized based upon the client’s need for education, counseling, and

clinical care beyond that provided at the initial and annual visit. 

Clients selecting hormonal contraceptives, intrauterine devices ( IUDs), cervical caps, or

diaphragms for the first time should be scheduled for a revisit as appropriate after initiation of the

method to reinforce its proper use, to check for possible side effects, and to provide additional

information or clarification. A new or established client who chooses to continue a method already

in use need not return for this early revisit unless a need for reevaluation is determined on the basis

of the findings at the initial visit.

8.4 FERTILITY REGULATION 

! Reversible Contraception

Currently, the reversible methods of contraception include barrier methods (female and male),

IUDs, fertility awareness methods, natural family planning, and hormonal methods (injectables,

implants, orals). Certain oral contraceptive regimens have been found by the Federal Food and

Drug Administration to be safe and effective for use as postcoital emergency contraception when

initiated within 72 hours after unprotected intercourse. More than one method of contraception can

be used simultaneously by a client and may be particularly indicated to minimize the risks of

STDs/HIV and pregnancy. Consistent and correct use of condoms should be encouraged for all

persons at risk for STDs/HIV. 
-24-

! Permanent Contraception

The counseling and consent process must assure that the client's decision to undergo sterilization is

completely voluntary and made with full knowledge of the permanence, risks, and benefits

associated with female and male sterilization procedures. Federal sterilization regulations, which

address informed consent requirements, must be complied with when a sterilization procedure is

performed or arranged for by the project (see Attachment C). 

8.5 INFERTILITY SERVICES

Grantees must make basic infertility services available to women and men desiring such services.

Infertility services are categorized as follows:

• Level I Includes initial infertility interview, education, physical examination, 

counseling, and appropriate referral. 

• Level II Includes such testing as semen analysis, assessment of ovulatory function and

postcoital testing. 

• Level III More sophisticated and complex than Level I and Level II services. 

Grantees must provide Level I infertility services as a minimum. Level II infertility services may be

offered in projects with clinicians who have special training in infertility. Level III services are

considered to be beyond the scope of Title X program.

8.6 PREGNANCY DIAGNOSIS AND COUNSELING 

Projects must provide pregnancy diagnosis and counseling to all clients in need of this service.

Pregnancy testing is one of the most common reasons for a first visit to the family planning facility. It is

therefore important to use this occasion as an entry point for providing education and counseling about

family planning. 

Pregnancy cannot be accurately diagnosed and staged through laboratory testing alone. Pregnancy

diagnosis consists of a history, pregnancy test, and physical assessment, including pelvic examination. 

Projects should have available a pregnancy test of high sensitivity. If the medical examination cannot be

performed in conjunction with the laboratory testing, the client must be counseled as to the importance

of receiving a physical assessment as soon as possible, preferably within 15 days. This can be done

on-site, by a provider selected by the client, or by a provider to which the client has been referred by

the project. For those clients with positive pregnancy test results who elect to continue the pregnancy,

referral for early initiation of prenatal care should be made. Clients planning to carry their pregnancies
-25-

to term should be given information about good health practices during early pregnancy, especially

those which serve to protect the fetus during the first three months (e.g., good nutrition, avoidance of

smoking, drugs, and exposure to x-rays). For clients with a negative pregnancy diagnosis, the cause of

delayed menses should be investigated. If ectopic pregnancy is suspected, the client must be referred

for immediate diagnosis and therapy. 

Projects must offer pregnant women the opportunity to be provided information and counseling

regarding each of the following options:

• Prenatal care and delivery;

• Infant care, foster care, or adoption; and

• Pregnancy termination.

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 [59.5(a)(5)].

Clients who are found not to be pregnant should be given information about the availability of

contraceptive and infertility services, as appropriate.

8.7 ADOLESCENT SERVICES

Adolescent clients require skilled counseling and age-appropriate information. Appointments should be

available to them for counseling and clinical services as soon as possible. 

Adolescents seeking contraceptive services must be informed about all methods of contraception.

Abstinence as well as contraceptive and safer sex practice options to reduce risks for STD/HIV and

pregnancy must be discussed with all adolescents. It is important not to assume that adolescents are

sexually active simply because they have come for family planning services. As the contraceptive needs

of adolescents frequently change, counseling should prepare them to use a variety of methods

effectively. 

Adolescents must be assured that the counseling sessions are confidential and, if follow-up is necessary,

every attempt will be made to assure the privacy of the individual. However, counselors should

encourage family participation in the decision of minors to seek family planning services and provide

counseling to minors on resisting attempts to coerce minors into engaging in sexual activities. Title X

projects may not require written consent of parents or guardians for the provision of services to minors. 

Nor can the project notify parents or guardians before or after a minor has requested and received Title

X family planning services. 
-26-

8.8 IDENTIFICATION OF ESTROGEN-EXPOSED OFFSPRING 

The children of women who received DES or similar hormones during pregnancy may have

abnormalities of their reproductive systems or other fertility related risks. As part of the medical

history, clients born between 1940 and 1970 should be asked if their mothers took estrogens during

pregnancy. Clients prenatally exposed to exogenous estrogens should receive information/education

and special screening either on-site or by referral. 

9.0 Related Services

The following related health services, which can improve quality of care, may be offered if skilled

personnel and equipment are available.

9.1 GYNECOLOGIC SERVICES

Family planning programs should provide for the diagnosis and treatment of minor gynecologic

problems so as to avoid fragmentation or lack of health care for clients with these conditions. Problems

such as vaginitis or urinary tract infection may be amenable to on-the-spot diagnosis and treatment,

following microscopic examination of vaginal secretions or urine. More complex procedures, such as

colposcopy, may be offered, provided that clinicians performing these services have specialized

training. 

9.2 SEXUALLY TRANSMITTED DISEASES (STD) AND HIV/AIDS

The increasing incidence and prevalence of STDs, particularly among adolescents, requires that family

planning projects increase their efforts to provide education and information about the more common

STDs and HIV/AIDS. Projects should make available detection and treatment of the more common

STDs. At-risk clients should be urged to undergo examination and treatment as indicated, either

directly or by referral. When treatment is provided on-site, appropriate follow-up measures must be

undertaken. 

Gonorrhea and chlamydia tests must be available for clients requesting IUD insertion. Tests for

gonorrhea, syphilis, chlamydia and HIV should be provided as indicated by client request or evidence

of increased risk for infection. 

Grantees and/or delegate contract agencies must comply with state and local STD reporting

requirements. 
-27-

9.3 SPECIAL COUNSELING

Clients should be offered appropriate counseling and referral as indicated regarding future planned

pregnancies, management of a current pregnancy, and other individual concerns (e.g., substance use

and abuse, sexual abuse, domestic violence, genetic issues, nutrition, sexual concerns, etc.) as

indicated. Preconceptional counseling should be provided if the client's history indicates a desired

pregnancy in the future. 

9.4 GENETIC INFORMATION AND REFERRAL

Basic information regarding genetic conditions should be offered to family planning clients who request

or are in need of such services. Extensive genetic counseling and evaluation is beyond the scope of the

Title X program. Referral systems should be in place for those who require further genetic counseling

and evaluation

9.5 HEALTH PROMOTION/DISEASE PREVENTION 

Family planning programs should, whenever possible, provide or coordinate access to services

intended to promote health and prevent disease. Programs are encouraged to assess the health

problems prevalent in the populations they serve and to develop strategies to address them.

9.6 POSTPARTUM CARE

Family planning programs may provide postpartum care in collaboration with local agencies or

institutions which provide prenatal and/or intrapartum care. If a family planning program undertakes

responsibility for postpartum care, such care should be directed toward assessment of the woman's

physical health, initiation of contraception if desired, and counseling and education related to parenting,

breast feeding, infant care, and family adjustment.

10.0 Clinic Management

10.1 EQUIPMENT AND SUPPLIES

Equipment and supplies must be appropriate to the type of care offered by the project. Projects are

expected to follow applicable Federal and state regulations regarding infection control.
-28-

10.2 PHARMACEUTICALS

Agencies must be operated in accordance with Federal and state laws relating to security and record

keeping for drugs and devices. The inventory, supply, and provision of pharmaceuticals must be

conducted in accordance with state pharmacy laws and professional practice regulations.

It is essential that each facility maintain an adequate supply and variety of drugs and devices to

effectively manage the contraceptive needs of its clients. Projects should also ensure access to other

drugs or devices that are necessary for the provision of other medical services included within the scope

of the Title X project. 

10.3 MEDICAL RECORDS

Projects must establish a medical record for every client who obtains clinical services. These records

must be maintained in accordance with accepted medical standards and State laws with regard to

record retention. Records must be: 

• Complete, legible and accurate, including documentation of telephone encounters of a clinical

nature; 

• Signed by the clinician and other appropriately trained health professionals making

entries, including name, title and date; 

• Readily accessible;

• Systematically organized to facilitate prompt retrieval and compilation of information; 

• Confidential; 

• Safeguarded against loss or use by unauthorized persons; 

• Secured by lock when not in use; and

• Available upon request to the client.

! Content of the Client Record

The client’s medical record must contain sufficient information to identify the client, indicate where

and how the client can be contacted, justify the clinical impression or diagnosis, and warrant the

treatment and end results. The required content of the medical record includes: 
-29-

C Personal data;

C Medical history, physical exam, laboratory test orders, results, and follow-up; 

C Treatment and special instructions; 

C Scheduled revisits; 

C Informed consents; 

C Refusal of services; and 

C Allergies and untoward reactions to drug(s) recorded in a prominent and specific

location.

The record must also contain reports of clinical findings, diagnostic and therapeutic orders, and

documentation of continuing care, referral, and follow-up. The record must allow for entries by 

counseling and social service staff. Projects should maintain a problem list at the front of each chart

listing identified problems to facilitate continuing evaluation and follow-up. Client financial

information should be kept separate from the client medical record. If included in the medical

record, client financial information should not be a barrier to client services.

! Confidentiality and Release of Records

A confidentiality assurance statement must appear in the client’s record. The written consent of the

client is required for the release of personally identifiable information, except as may be necessary

to provide services to the client or as required by law, with appropriate safeguards for

confidentiality [59.11]. HIV information should be handled according to law, and kept separate

whenever possible. When information is requested, agencies should release only the specific

information requested. Information collected for reporting purposes may be disclosed only in

summary, statistical, or other form which does not identify particular individuals. Upon request,

clients transferring to other providers must be provided with a copy or summary of their record to

expedite continuity of care.
-30-

10.4 QUALITY ASSURANCE AND AUDIT 

A quality assurance system must be in place that provides for ongoing evaluation of project personnel

and services. The quality assurance system should include: 

• An established set of clinical, administrative and programmatic standards by which conformity

would be maintained;

• A tracking system to identify clients in need of follow-up and/or continuing care; 

• Ongoing medical audits to determine conformity with agency protocols;

• Peer review procedures to evaluate individual clinician performance, to provide feedback to

providers, and to initiate corrective action when deficiencies are noted; 

• Periodic review of medical protocols to insure maintenance of current standards of care; 

• A process to elicit consumer feedback; and 

• Ongoing and systematic documentation of quality assurance activities.
TITLE X - POPULATION RESEARCH AND VOLUNTARY

FAMILY PLANNING PROGRAMS

PROJECT GRANTS AND CONTRACTS FOR FAMILY PLANNING SERVICES

SEC. 1001 [300]

(a)The Secretary is authorized to make grants to and enter into contracts with public or nonprofit

private entities to assist in the establishment and operation of voluntary family planning projects which shall

offer a broad range of acceptable and effective family planning methods and services (including natural

family planning methods, infertility services, and services for adolescents). To the extent practicable, entities

which receive grants or contracts under this subsection shall encourage family 1 participation in projects

assisted under this subsection. 

(b)In making grants and contracts under this section the Secretary shall take into account the number

of patients to be served, the extent to which family planning services are needed locally, the relative need

of the applicant, and its capacity to make rapid and effective use of such assistance. Local and regional

entities shall be assured the right to apply for direct grants and contracts under this section, and the

Secretary shall by regulation fully provide for and protect such right. 

 (c)The Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount

of such grant by the fair market value of any supplies or equipment furnished the grant recipient by the

Secretary. The amount by which any such grant is so reduced shall be available for payment by the

Secretary of the costs incurred in furnishing the supplies or equipment on which the reduction of such grant

is based. Such amount shall be deemed as part of the grant and shall be deemed to have been paid to the

grant recipient. 

 (d)For the purpose of making grants and contracts under this section, there are authorized to be

appropriated $30,000,000 for the fiscal year ending June 30, 1971; $60,000,000 for the fiscal year ending

June 30, 1972; $111,500,000 for the fiscal year ending June 30, 1973, $111,500,000 each for the fiscal

years ending June 30, 1974, and June 30, 1975; $115,000,000 for fiscal year 1976; 

$115,000,000 for the fiscal year ending September 30, 1977;

$136,400,000 for the fiscal year ending September 30, 1978; 

$200,000,000 for the fiscal year ending September 30, 1979; 

$230,000,000 for the fiscal year ending September 30, 1980; 

$264,500,000 for the fiscal year ending September 30, 1981; 

$126,510,000 for the fiscal year ending September 30, 1982; 

$139,200,000 for the fiscal year ending September 30, 1983; 

$150,030,000 for the fiscal year ending September 30, 1984; and 

$158,400,000 for the fiscal year ending September 30, 1985. 

1

So in law. See section 931(b)(I) of Public Law 97-35 (95 Stat. 570). Probably should be “family”.
FORMULA GRANTS TO STATES FOR FAMILY PLANNING SERVICES

SEC. 1002 [300a] 

(a)The Secretary is authorized to make grants, from allotments made under subsection (b), to State

health authorities to assist in planning, establishing, maintaining, coordinating, and evaluating family planning

services. No grant may be made to a State health authority under this section unless such authority has

submitted, and had approved by the Secretary, a State plan for a coordinated and comprehensive program

of family planning services. 

(b)The sums appropriated to carry out the provisions of this section shall be allotted to the States by

the Secretary on the basis of the population and the financial need of the respective States.

(c)For the purposes of this section, the term ''State'' includes the Commonwealth of Puerto Rico, the

Northern Mariana Islands, Guam, American Samoa, the Virgin Islands, the District of Columbia, and the

Trust Territory of the Pacific Islands. 

(d)For the purpose of making grants under this section, there are authorized to be appropriated

$10,000,000 for the fiscal year ending June 30, 1971; $15,000,000 for the fiscal year ending June 30,

1972; and $20,000,000 for the fiscal year ending June 30, 1973.

TRAINING GRANTS AND CONTRACTS; AUTHORIZATION OF APPROPRIATIONS

SEC. 1003 [300a-1]

(a) The Secretary is authorized to make grants to public or nonprofit private entities and to enter into

contracts with public or private entities and individuals to provide the training for personnel to carry out

family planning service programs described in section 1001 or 1002 of this title. 

(b) For the purpose of making payments pursuant to grants and contracts under this section, there are

authorized to be appropriated $2,000,000 for the fiscal year ending June 30, 1971; $3,000,000 for the

fiscal year ending June 30, 1972; $4,000,000 for the fiscal year ending June 30, 1973; $3,000,000 each

for the fiscal years ending June 30, 1974 and June 30, 1975; $4,000,000 for fiscal year ending 1976;

$5,000,000 for the fiscal year ending September 30, 1977; $3,000,000 for the fiscal year ending

September 30, 1978; $3,100,000 for the fiscal year ending September 30, 1979; $3,600,000 for the fiscal

year ending September 30, 1980; $4,100,000 for the fiscal year ending September 30, 1981; $2,920,000

for the fiscal year ending September 30, 1982; $3,200,000 for the fiscal year ending September 30, 1983;

$3,500,000 for the fiscal year ending September 30, 1984; and $3,500,000 for the fiscal year ending

September 30, 1985. 

RESEARCH

SEC. 1004 [300a-2] 

The Secretary may - 

(1) conduct, and 

(2) make grants to public or nonprofit private entities and enter into contracts with public or private

entities and individuals for projects for, research in the biomedical, contraceptive development, behavioral,

and program implementation fields related to family planning and population. 
INFORMATIONAL AND EDUCATIONAL MATERIALS

SEC. 1005 [300a-3]

(a) The Secretary is authorized to make grants to public or nonprofit private entities and to enter into

contracts with public or private entities and individuals to assist in developing and making available family

planning and population growth information (including educational materials) to all persons desiring such

information (or materials). 

(b) For the purpose of making payments pursuant to grants and contracts under this section, there are

authorized to be appropriated $750,000 for the fiscal year ending June 30, 1971; $1,000,000 for the fiscal

year ending June 30, 1972; $1,250,000 for the fiscal year ending June 30, 1973; $909,000 each for the

fiscal years ending June 30, 1974, and June 30, 1975; $2,000,000 for fiscal year 1976; $2,500,000 for

the fiscal year ending September 30, 1977; $600,000 for the fiscal year ending September 30, 1978;

$700,000 for the fiscal year ending September 30, 1979; $805,000 for the fiscal year ending September

30, 1980; $926,000 for the fiscal year ending September 30, 1981; $570,000 for the fiscal year ending

September 30, 1982; $600,000 for the fiscal year ending September 30, 1983; $670,000 for the fiscal

year ending September 30, 1984; and $700,000 for the fiscal year ending September 30, 1985.

REGULATIONS AND PAYMENTS

SEC. 1006 [300a-4] 

(a)Grants and contracts made under this subchapter shall be made in accordance with such regulations

as the Secretary may promulgate. The amount of any grant under any section of this title shall be determined

by the Secretary; except that no grant under any such section for any program or project for a fiscal year

beginning after June 30, 1975, may be made for less than 90 per centum of its costs (as determined under

regulations of the Secretary) unless the grant is to be made for a program or project for which a grant was

made (under the same section) for the fiscal year ending June 30, 1975, for less than 90 per centum of its

costs (as so determined), in which case a grant under such section for that program or project for a fiscal

year beginning after that date may be made for a percentage which shall not be less than the percentage

of its costs for which the fiscal year 1975 grant was made. 

(b)Grants under this title shall be payable in such installments and subject to such conditions as the

Secretary may determine to be appropriate to assure that such grants will be effectively utilized for the

purposes for which made.

(c)A grant may be made or contract entered into under section 1001 or 1002 for a family planning

service project or program only upon assurances satisfactory to the Secretary that-- 

(1) priority will be given in such project or program to the furnishing of such services to persons

from low-income families; and 

(2) no charge will be made in such project or program for services provided to any person 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 or is under legal obligation to pay such charge. 

For purposes of this subsection, the term ''low-income family'' shall be defined by the Secretary in
accordance with such criteria as he may prescribe so as to insure that economic status shall not be a

deterrent to participation in the programs assisted under this title.

(d)(1) A grant may be made or a contract entered into under section 1001 or 1005 only upon

assurances satisfactory to the Secretary that informational or educational materials developed or made

available under the grant or contract will be suitable for the purposes of this title and for the population or

community to which they are to be made available, taking into account the educational and cultural

background of the individuals to whom such materials are addressed and the standards of such population

or community with respect to such materials. 

(2) In the case of any grant or contract under section 1001, such assurances shall provide for the

review and approval of the suitability of such materials, prior to their distribution, by an advisory committee

established by the grantee or contractor in accordance with the Secretary's regulations. Such a committee

shall include individuals broadly representative of the population or community to which the materials are

to be made available.

VOLUNTARY PARTICIPATION

SEC. 1007 [300a-5] 

The acceptance by any individual of family planning services or family planning or population growth

information (including educational materials) provided through financial assistance under this title (whether

by grant or contract) shall be voluntary and shall not be a prerequisite to eligibility for or receipt of any other

service or assistance from, or to participation in, any other program of the entity or individual that provided

such service or information. 

PROHIBITION OF ABORTION

SEC. 1008 1 [300a-6] 

None of the funds appropriated under this title shall be used in programs where abortion is a method of

family planning.

1

Section 1009 was repealed by section 601(a)(1)(G) of Public Law 105-362 (112 Stat. 3285).
407

Public Health Service, HHS Pt. 59

(2) The trainee is not eligible or able

to continue in attendance in accordance with its standards and practices.

[45 FR 73658, Nov. 6, 1980. Redesignated at 61

FR 6131, Feb. 16, 1996]

§ 58.232 What additional Department

regulations apply to grantees?

Several other Department regulations apply to grantees. They include,

but are not limited to:

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 46—Protection of human subjects

45 CFR part 74—Administration of grants

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 83—Regulation for the administration and enforcement of sections 794 and

855 of the Public Health Service Act

45 CFR part 84—Nondiscrimination on the

basis of handicap in programs and activities receiving or benefiting from Federal

financial assistance

45 CFR part 86—Nondiscrimination on the

basis of sex in education programs and activities receiving or benefiting 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 93—New restrictions on lobbying

[49 FR 38116, Sept. 27, 1984. Redesignated and

amended at 61 FR 6131, Feb. 16, 1996]

§ 58.233 What other audit and inspection requirements apply to grantees?

Each entity which receives a grant

under this subpart must meet the requirements of 45 CFR part 74 concerning audit and inspection.

[61 FR 6131, Feb. 16, 1996; 61 FR 51020, Sept.

30, 1996]

§ 58.234 Additional conditions.

The Secretary may impose additional

conditions in the grant award before or

at the time of the award if he or she determines that these conditions are necessary to assure or protect the advancement of the approved activity,

the interest of the public health, or the

conservation of grant funds.

[45 FR 73658, Nov. 6, 1980. Redesignated at 61

FR 6131, Feb. 16, 1996]

Subparts E–F [Reserved]

PART 59—GRANTS FOR FAMILY

PLANNING SERVICES

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 B [Reserved]

Subpart C—Grants for Family Planning

Service Training

59.201 Applicability.

59.202 Definitions.

59.203 Eligibility.

59.204 Application for a grant.

59.205 Project requirements.

59.206 Evaluation and grant award.

59.207 Payments.

59.208 Use of project funds.

59.209 Civil rights.

59.210 Inventions or discoveries.

59.211 Publications and copyright.

59.212 Grantee accountability.

59.213 [Reserved]

59.214 Additional conditions.

59.215 Applicability of 45 CFR part 74.

Subpart A—Project Grants for

Family Planning Services

AUTHORITY: 42 U.S.C. 300a–4.

408

§ 59.1 42 CFR Ch. I (10–1–00 Edition)

SOURCE: 65 FR 41278, July 3, 2000, unless

otherwise noted.

§ 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. 300) 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.

[65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10,

2000]

§ 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. Outlying Islands (Midway, Wake, et al.), the Marshall Islands, the Federated State of Micronesia and the Republic of Palau.

[65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10,

2000]

§ 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 (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 participate

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

409

Public Health Service, HHS § 59.5

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.’’

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 to

religion, race, color, national origin,

handicapping condition, age, sex, number of pregnancies, or marital status.

(5) Not provide abortion as a method

of family planning. A project must:

(i) Offer pregnant women the opportunity to be 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

410

§ 59.6 42 CFR Ch. I (10–1–00 Edition)

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.

[65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10,

2000]

§ 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 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

411

Public Health Service, HHS § 59.10

(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

412

§ 59.11 42 CFR Ch. I (10–1–00 Edition)

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 or protect advancement of the

approved program, the interests of public health, or the proper use of grant

funds.

[65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10,

2000]

Subpart B [Reserved]

Subpart C—Grants for Family

Planning Service Training

AUTHORITY: Sec. 6(c), 84 Stat. 1507, 42

U.S.C. 300a–4; sec. 6(c), 84 Stat. 1507, 42 U.S.C.

300a–1.

SOURCE: 37 FR 7093, Apr. 8, 1972, unless otherwise noted.

§ 59.201 Applicability.

The regulations in this subpart are

applicable to the award of grants pursuant to section 1003 of the Public

Health Service Act (42 U.S.C. 300a–1) to

provide the training for personnel to

carry out family planning service programs described in sections 1001 and

1002 of the Public Health Service Act

(42 U.S.C. 300, 300a).

§ 59.202 Definitions.

As used in this subpart:

(a) Act means the Public Health Service Act.

(b) State means one of the 50 States,

the District of Columbia, Puerto Rico,

Guam, the Virgin Islands, American

Samoa, or the Trust Territory of the

Pacific Islands.

(c) Nonprofit private entity means a

private entity no part of the net earnings of which inures, or may lawfully

inure, to the benefit of any private

shareholder or individual.

(d) 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.

(e) Training means job-specific skill

development, the purpose of which is to

promote and improve the delivery of

family planning services.

§ 59.203 Eligibility.

(a) Eligible applicants. Any public or

nonprofit private entity located in a

State is eligible to apply for a grant

under this subpart.

(b) Eligible projects. Grants pursuant

to section 1003 of the Act and this subpart may be made to eligible applicants for the purpose of providing programs, not to exceed three months in

duration, for training family planning

or other health services delivery personnel in the skills, knowledge, and attitudes necessary for the effective delivery of family planning services: Provided, That the Secretary may in particular cases approve support of a program whose duration is longer than

three months where he determines (1)

that such program is consistent with

the purposes of this subpart and (2)

that the program’s objectives cannot

be accomplished within three months

because of the unusually complex or

specialized nature of the training to be

undertaken.

[37 FR 7093, Apr. 8, 1972, as amended at 40 FR

17991, Apr. 24, 1975]

413

Public Health Service, HHS § 59.206

1 Applications and instructions may be obtained from the Program Director, Family

Planning Services, at the Regional Office of

the Department of Health and Human Services for the region in which the project is to

be conducted, or the Office of Family Planning, Office of the Assistant Secretary for

Health, Washington, DC 20201.

§ 59.204 Application for a grant.

(a) An application for a grant under

this subpart shall be submitted to the

Secretary at such time and in such

form and manner as the Secretary may

prescribe. 1 The application shall contain a full and adequate description of

the project and of the manner in which

the applicant intends to conduct the

project and carry out the requirements

of this subpart, and a budget and justification of the amount of grant funds

requested, and such other pertinent information as the Secretary may require.

(b) The application shall be executed

by an individual authorized to act for

the applicant and to assume for the applicant the obligations imposed by the

regulations of this subpart and any additional conditions of the grant.

(Sec. 6(c), Public Health Service Act, 84 Stat.

1506 and 1507 (42 U.S.C. 300, 300a–1, and 300a–

4))

[37 FR 7093, Apr. 8, 1972, as amended at 49 FR

38116, Sept. 27, 1984]

§ 59.205 Project requirements.

An approvable application must contain each of the following unless the

Secretary determines that the applicant has established good cause for its

omission:

(a) Assurances that:

(1) No portion of the Federal funds

will be used to train personnel for programs where abortion is a method of

family planning.

(2) No portion of the Federal funds

will be used to provide professional

training to any student as part of his

education in pursuit of an academic degree.

(3) No project personnel or trainees

shall on the grounds of sex, religion, or

creed be excluded from participation

in, be denied the benefits of, or be subjected to discrimination under the

project.

(b) Provision of a methodology to assess the particular training (e.g., skills,

attitudes, or knowledge) that prospective trainees in the area to be served

need to improve their delivery of family planning services.

(c) Provision of a methodology to define the objectives of the training program in light of the particular needs of

trainees defined pursuant to paragraph

(b) of this section.

(d) Provision of a method for development of the training curriculum and

any attendant training materials and

resources.

(e) Provision of a method for implementation of the needed training.

(f) Provision of an evaluation methodology, including the manner in

which such methodology will be employed, to measure the achievement of

the objectives of the training program.

(g) Provision of a method and criteria

by which trainees will be selected.

§ 59.206 Evaluation and grant award.

(a) Within the limits of funds available for such purpose, the Secretary

may award grants to assist in the establishment and operation of those

projects which will in his judgment

best promote the purposes of section

1003 of the Act, taking into account:

(1) The extent to which a training

program will increase the delivery of

services to people, particularly low-income groups, with a high percentage of

unmet need for family planning services;

(2) The extent to which the training

program promises to fulfill the family

planning services delivery needs of the

area to be served, which may include,

among other things:

(i) Development of a capability within family planning service projects to

provide pre- and in-service training to

their own staffs;

(ii) Improvement of the family planning services delivery skills of family

planning and health services personnel;

(iii) Improvement in the utilization

and career development of paraprofessional and paramedical manpower in

family planning services;

(iv) Expansion of family planning

services, particularly in rural areas,

through new or improved approaches to

414

§ 59.207 42 CFR Ch. I (10–1–00 Edition)

program planning and deployment of

resources;

(3) The capacity of the applicant to

make rapid and effective use of such

assistance;

(4) The administrative and management capability and competence of the

applicant;

(5) The competence of the project

staff in relation to the services to be

provided; and

(6) The degree to which the project

plan adequately provides for the requirements set forth in §59.205.

(b) The amount of any award shall be

determined by the Secretary on the

basis of his estimate of the sum necessary for all or a designated portion of

direct project costs plus an additional

amount for indirect costs, if any, which

will be calculated by the Secretary either: (1) On the basis of his estimate of

the actual indirect costs reasonably related to the project, or (2) on the basis

of a percentage of all, or a portion of,

the estimated direct costs of the

project when there are reasonable assurances that the use of such percentage will not exceed the approximate

actual indirect costs. Such award may

include an estimated provisional

amount for indirect costs or for designated direct costs (such as travel or

supply costs) subject to upward (within

the limits of available funds) as well as

downward adjustments to actual costs

when the amount properly expended by

the grantee for provisional items has

been determined by the Secretary.

(c) Allowability of costs shall be in

conformance with the applicable cost

principles prescribed by Subpart Q of 35

CFR part 74.

(d) All grant awards shall be in writing, shall set forth the amount of funds

granted and the period for which support is recommended.

(e) Neither the approval of any project nor any grant award shall commit

or obligate the United States in any

way to make any additional, supplemental, continuation, or other award

with respect to any approved project or

portion thereof. For continuation support, grantees must make separate application annually at such times and in

such form as the Secretary may direct.

[37 FR 7093, Apr. 8, 1972, as amended at 38 FR

26199, Sept. 19, 1973]

§ 59.207 Payments.

The Secretary shall from time to

time make payments to a grantee of all

or a portion of any grant award, either

in advance or by way of reimbursement

for expenses incurred or to be incurred

in the performance of the project to

the extent he determines such payments necessary to promote prompt

initiation and advancement of the approved project.

§ 59.208 Use of project funds.

(a) Any funds granted pursuant to

this subpart as well as other funds to

be used in performance of the approved

project shall be expended solely for

carrying out the approved project in

accordance with the statute, the regulations of this subpart, the terms and

conditions of the award, and, except as

may otherwise be provided in this subpart, the applicable cost principles prescribed by subpart Q of 45 CFR part 74.

(b) Prior approval by the Secretary of

revision of the budget and project plan

is required whenever there is to be a

significant change in the scope or nature of project activities.

(c) The Secretary may approve the

payment of grant funds to trainees for:

(1) Return travel to the trainee’s

point of origin.

(2) Per diem during the training program, and during travel to and from

the program, at the prevailing institutional or governmental rate, whichever

is lower.

[37 FR 7093, Apr. 8, 1972, as amended at 38 FR

26199, Sept. 19, 1973]

§ 59.209 Civil rights.

Attention is called to the requirements of Title VI of the Civil Rights

Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d

et seq.) and in particular section 601 of

such Act which provides that no person

in the United States shall, on the

grounds of race, color, or national origin be excluded from participation in,

be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. A regulation

impelmenting such title VI, which applies to grants made under this part,

has been issued by the Secretary of

Health and Human Services with the

415

Public Health Service, HHS § 59.212

approval of the President (45 CFR part

80).

§ 59.210 Inventions or discoveries.

Any grant award pursuant to §59.206

is subject to the regulations of the Department of Health and Human Services as set forth in 45 CFR parts 6 and

8, as amended. Such regulations shall

apply to any activity for which grant

funds are in fact used whether within

the scope of the project as approved or

otherwise. Appropriate measures shall

be taken by the grantee and by the

Secretary to assure that no contracts,

assignments or other arrangements inconsistent with the grant obligation

are continued or entered into and that

all personnel involved in the supported

activity are aware of and comply with

such obligations. Laboratory notes, related technical data, and information

pertaining to inventions and discoveries shall be maintained for such periods, and filed with or otherwise made

available to the Secretary, or those he

may designate at such times and in

such manner, as he may determine necessary to carry out such Department

regulations.

§ 59.211 Publications and copyright.

Except as may otherwise be provided

under the terms and conditions of the

award, the grantee may copyright

without prior approval any publications, films or similar materials developed or resulting from a project supported by a grant under this part, subject, however, to a royalty-free, nonexclusive, and irrevocable license or

right in the Government to reproduce,

translate, publish, use, disseminate,

and dispose of such materials and to

authorize others to do so.

§ 59.212 Grantee accountability.

(a) Accounting for grant award payments. All payments made by the Secretary shall be recorded by the grantee

in accounting records separate from

the records of all other grant funds, including funds derived from other grant

awards. With respect to each approved

project the grantee shall account for

the sum total of all amounts paid by

presenting or otherwise making available evidence satisfactory to the Secretary of expenditures for direct and

indirect costs meeting the requirements of this part: Provided, however,

That when the amount awarded for indirect costs was based on a predetermined fixed-percentage of estimated direct costs, the amount allowed for indirect costs shall be computed on the

basis of such predetermined fixed-percentage rates applied to the total, or a

selected element thereof, of the reimbursable direct costs incurred.

(b) [Reserved]

(c) Accounting for grant-related income—(1) Interest. Pursuant to section

203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 4213), a State

will not be held accountable for interest earned on grant funds, pending

their disbursement for grant purposes.

A State, as defined in section 102 of the

Intergovernmental Cooperation Act,

means any one of the several States,

the District of Columbia, Puerto Rico,

any territory or possession of the

United States, or any agency or instrumentality of a State, but does not include the governments of the political

subdivisions of the State. All grantees

other than a State, as defined in this

subsection, must return all interest

earned on grant funds to the Federal

Government.

(d) Grant closeout—(1) Date of final accounting. A grantee shall render, with

respect to each approved project, a full

account, as provided herein, as of the

date of the termination of grant support. The Secretary may require other

special and periodic accounting.

(2) Final settlement. There shall be

payable to the Federal Government as

final settlement with respect to each

approved project the total sum of:

(i) Any amount not accounted for

pursuant to paragraph (a) of this section;

(ii) Any credits for earned interest

pursuant to paragraph (c)(1) of this section;

(iii) Any other amounts due pursuant

to subparts F, M, and O of 45 CFR part

74.

Such total sum shall constitute a debt

owed by the grantee to the Federal

Government and shall be recovered

from the grantee or its successors or

416

§ 59.213 42 CFR Ch. I (10–1–00 Edition)

assignees by setoff or other action as

provided by law.

[36 FR 18465, Sept. 15, 1971, as amended at 38

FR 26199, Sept. 19, 1973]

§ 59.213 [Reserved]

§ 59.214 Additional conditions.

The Secretary may with respect to

any grant award impose additional

conditions prior to or at the time of

any award when in his judgment such

conditions are necessary to assure or

protect advancement of the approved

project, the interests of public health,

or the conservation of grant funds.

§ 59.215 Applicability of 45 CFR part

74.

The provisions of 45 CFR part 74, establishing uniform administrative requirements and cost principles, shall

apply to all grants under this subpart

to State and local governments as

those terms are defined in subpart A of

that part 74. The relevant provisions of

the following subparts of part 74 shall

also apply to grants to all other grantee organizations under this subpart.

45 CFR PART 74

Subpart:

A General.

B Cash Depositories.

C Bonding and Insurance.

D Retention and Custodial Requirements

for Records.

F Grant-Related Income.

G Matching and Cost Sharing.

K Grant Payment Requirements.

L Budget Revision Procedures.

M Grant Closeout, Suspension, and Termination.

O Property.

Q Cost Principles.

[38 FR 26199, Sept. 19, 1973]

PART 59a—NATIONAL LIBRARY OF

MEDICINE GRANTS

Subpart A—Grants for Establishing, Expanding, and Improving Basic Resources

Sec.

59a.1 Programs to which these regulations

apply.

59a.2 Definitions.

59a.3 Who is eligible for a grant?

59a.4 How are grant applications evaluated?

59a.5 Awards.

59a.6 How may funds or materials be used?

59a.7 Other HHS regulations that apply.

Subpart B—Establishment of Regional

Medical Libraries

59a.11 Programs to which these regulations

apply.

59a.12 Definitions.

59a.13 Who is eligible for a grant?

59a.14 How to apply.

59a.15 Awards.

59a.16 What other conditions apply?

59a.17 Other HHS regulations that apply.

SOURCE: 56 FR 29189, June 26, 1991, unless

otherwise noted.

Subpart A—Grants for Establishing,

Expanding, and Improving

Basic Resources

AUTHORITY: 42 U.S.C. 286b–2, 286b–5.

§ 59a.1 Programs to which these regulations apply.

(a) The regulations of this subpart

apply to grants of funds, materials, or

both, for establishing, expanding, and

improving basic medical library resources as authorized by section 474 of

the Act (42 U.S.C. 286b–5).

(b) This subpart also applies to cooperative agreements awarded for this

purpose. In these circumstances, references to ‘‘grant(s)’’ shall include ‘‘cooperative agreements(s).’’

§ 59a.2 Definitions.

Undefined terms have the same

meaning as provided in the Act. As

used in this subpart:

Act means the Public Health Service

Act, as amended (42 U.S.C. 201 et seq.).

Project period—See §59a.5(c).

Related instrumentality means a public

or private institution, organization, or

agency, other than a medical library,

whose primary function is the acquisition, preservation, dissemination, and/

or processing of information relating

to the health sciences.

Secretary means the Secretary of

Health and Human Services and any

other official of the Department of

Health and Human Services to whom

the authority involved is delegated.

171

Public Health Service, HHS § 50.202

examination of the facts versus the interests of the subject(s) of the investigation and the PHS in a timely resolution of the matter. If the request is

granted, the institution must file periodic progress reports as requested by

the OSI. If satisfactory progress is not

made in the institution’s investigation,

the OSI may undertake an investigation of its own.

(6) Upon receipt of the final report of

investigation and supporting materials, the OSI will review the information in order to determine whether the

investigation has been performed in a

timely manner and with sufficient objectivity, thoroughness and competence. The OSI may then request

clarification or additional information

and, if necessary, perform its own investigation. While primary responsibility for the conduct of investigations

and inquiries lies with the institution,

the Department reserves the right to

perform its own investigation at any

time prior to, during, or following an

institution’s investigation.

(7) In addition to sanctions that the

institution may decide to impose, the

Department also may impose sanctions

of its own upon investigators or institutions based upon authorities it possesses or may possess, if such action

seems appropriate.

(b) The institution is responsible for

notifying the OSI if it ascertains at

any stage of the inquiry or investigation, that any of the following conditions exist:

(1) There is an immediate health hazard involved;

(2) There is an immediate need to

protect Federal funds or equipment;

(3) There is an immediate need to

protect the interests of the person(s)

making the allegations or of the individual(s) who is the subject of the allegations as well as his/her co-investigators and associates, if any;

(4) It is probable that the alleged incident is going to be reported publicly.

(5) There is a reasonable indication of

possible criminal violation. In that instance, the institution must inform

OSI within 24 hours of obtaining that

information. OSI will immediately notify the Office of the Inspector General.

§ 50.105 Institutional compliance.

Institutions shall foster a research

environment that discourages misconduct in all research and that deals

forthrightly with possible misconduct

associated with research for which PHS

funds have been provided or requested.

An institution’s failure to comply with

its assurance and the requirements of

this subpart may result in enforcement

action against the institution, including loss of funding, and may lead to the

OSI’s conducting its own investigation.

Subpart B—Sterilization of Persons

in Federally Assisted Family

Planning Projects

§ 50.201 Applicability.

The provisions of this subpart are applicable to programs or projects for

health services which are supported in

whole or in part by Federal financial

assistance, whether by grant or contract, administered by the Public

Health Service.

§ 50.202 Definitions.

As used in this subpart:

Arrange for means to make arrangements (other than mere referral of an

individual to, or the mere making of an

appointment for him or her with, another health care provider) for the performance of a medical procedure on an

individual by a health care provider

other than the program or project.

Hysterectomy means a medical procedure or operation for the purpose of removing the uterus.

Institutionalized individual means an

individual who is (1) involuntarily confined or detained, under a civil or

criminal statute, in a correctional or

rehabilitative facility, including a

mental hospital or other facility for

the care and treatment of mental illness, or (2) confined, under a voluntary

commitment, in a mental hospital or

other facility for the care and treatment of mental illness.

Mentally incompetent individual means

an individual who has been declared

mentally incompetent by a Federal,

State, or local court of competent jurisdiction for any purpose unless he or

she has been declared competent for

172

§ 50.203 42 CFR Ch. I (10–1–00 Edition)

purposes which include the ability to

consent to sterilization.

Public Health Service means the Office

of the Assistant Secretary for Health,

Health Resources and Services Administration, National Institutes of

Health, Centers for Disease Control,

Alcohol, Drug Abuse and Mental

Health Administration and all of their

constituent agencies.

The 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.

Sterilization means any medical procedure, treatment, or operation for the

purpose of rendering an individual permanently incapable of reproducing.

[43 FR 52165, Nov. 8, 1978, as amended at 49

FR 38109, Sept. 27, 1984]

§ 50.203 Sterilization of a mentally

competent individual aged 21 or

older.

Programs or projects to which this

subpart applies shall perform or arrange for the performance of sterilization of an individual only if the following requirements have been met:

(a) The individual is at least 21 years

old at the time consent is obtained.

(b) The individual is not a mentally

incompetent individual.

(c) The individual has voluntarily

given his or her informed consent in

accordance with the procedures of

§50.204 of this subpart.

(d) At least 30 days but not more

than 180 days have passed between the

date of informed consent and the date

of the sterilization, except in the case

of premature delivery or emergency abdominal surgery. An individual may

consent to be sterilized at the time of

premature delivery or emergency abdominal surgery, if at least 72 hours

have passed after he or she gave informed consent to sterilization. In the

case of premature delivery, the informed consent must have been given

at least 30 days before the expected

date of delivery.

§ 50.204 Informed consent requirement.

Informed consent does not exist unless a consent form is completed voluntarily and in accordance with all the

requirements of this section and §50.205

of this subpart.

(a) A person who obtains informed

consent for a sterilization procedure

must offer to answer any questions the

individual to be sterilized may have

concerning the procedure, provide a

copy of the consent form, and provide

orally all of the following information

or advice to the individual who is to be

sterilized:

(1) Advice that the individual is free

to withhold or withdraw consent to the

procedure any time before the sterilization without affecting his or her

right to future care or treatment and

without loss or withdrawal of any federally funded program benefits to

which the individual might be otherwise entitled:

(2) A description of available alternative methods of family planning and

birth control;

(3) Advice that the sterilization procedure is considered to be irreversible;

(4) A thorough explanation of the

specific sterilization procedure to be

performed;

(5) A full description of the discomforts and risks that may accompany or

follow the performing of the procedure,

including an explanation of the type

and possible effects of any anesthetic

to be used;

(6) A full description of the benefits

or advantages that may be expected as

a result of the sterilization; and

(7) Advice that the sterilization will

not be performed for at least 30 days

except under the circumstances specified in §50.203(d) of this subpart.

(b) An interpreter must be provided

to assist the individual to be sterilized

if he or she does not understand the

language used on the consent form or

the language used by the person obtaining the consent.

(c) Suitable arrangements must be

made to insure that the information

specified in paragraph (a) of this section is effectively communicated to

any individual to be sterilized who is

blind, deaf or otherwise handicapped.

(d) A witness chosen by the individual to be sterilized may be present

when consent is obtained.

173

Public Health Service, HHS § 50.207

(e) Informed consent may not be obtained while the individual to be sterilized is:

(1) In labor or childbirth;

(2) Seeking to obtain or obtaining an

abortion; or

(3) Under the influence of alcohol or

other substances that affect the individual’s state of awareness.

(f) Any requirement of State and

local law for obtaining consent, except

one of spousal consent, must be followed.

§ 50.205 Consent form requirements.

(a) Required consent form. The consent

form appended to this subpart or another consent form approved by the

Secretary must be used.

(b) Required signatures. The consent

form must be signed and dated by:

(1) The individual to be sterilized;

and

(2) The interpreter, if one is provided;

and

(3) The person who obtains the consent; and

(4) The physician who will perform

the sterilization procedure.

(c) Required certifications. (1) The person obtaining the consent must certify

by signing the consent form that:

(i) Before the individual to be sterilized signed the consent form, he or she

advised the individual to be sterilized

that no Federal benefits may be withdrawn because of the decision not to be

sterilized,

(ii) He or she explained orally the requirements for informed consent as set

forth on the consent form, and

(iii) To the best of his or her knowledge and belief, the individual to be

sterilized appeared mentally competent and knowingly and voluntarily

consented to be sterilized.

(2) The physician performing the

sterilization must certify by signing

the consent form, that:

(i) Shortly before the performance of

the sterilization, he or she advised the

individual to be sterilized that no Federal benefits may be withdrawn because of the decision not to be sterilized,

(ii) He or she explained orally the requirements for informed consent as set

forth on the consent form, and

(iii) To the best of his or her knowledge and belief, the individual to be

sterilized appeared mentally competent and knowingly and voluntarily

consented to be sterilized. Except in

the case of premature delivery or emergency abdominal surgery, the physician must further certify that at least

30 days have passed between the date of

the individual’s signature on the consent form and the date upon which the

sterilization was performed. If premature delivery occurs or emergency

abdominal surgery is required within

the 30–day period, the physician must

certify that the sterilization was performed less than 30 days but not less

than 72 hours after the date of the individual’s signature on the consent form

because of premature delivery or emergency abdominal surgery, as applicable. In the case of premature delivery,

the physician must also state the expected date of delivery. In the case of

emergency abdominal surgery, the physician must describe the emergency.

(3) If an interpreter is provided, the

interpreter must certify that he or she

translated the information and advice

presented orally, read the consent form

and explained its contents and to the

best of the interpreter’s knowledge and

belief, the individual to be sterilized

understood what the interpreter told

him or her.

§ 50.206 Sterilization of a mentally incompetent individual or of an institutionalized individual.

Programs or projects to which this

subpart applies shall not perform or arrange for the performance of a sterilization of any mentally incompetent

individual or institutionalized individual.

§ 50.207 Sterilization by hysterectomy.

(a) Programs or projects to which

this subpart applies shall not perform

or arrange for the performance of any

hysterectomy solely for the purpose of

rendering an individual permanently

incapable of reproducing or where, if

there is more than one purpose to the

procedure, the hysterectomy would not

be performed but for the purpose of

rendering the individual permanently

incapable of reproducing.

174

§ 50.208 42 CFR Ch. I (10–1–00 Edition)

(b) Except as provided in paragraph

(c) of this section, programs or projects

to which this subpart applies may perform or arrange for the performance of

a hysterectomy not covered by paragraph (a) of this section only if:

(1) The person who secures the authorization to perform the

hysterectomy has informed the individual and her representative, if any,

orally and in writing, that the

hysterectomy will make her permanently incapable of reproducing; and

(2) The individual or her representative, if any, has signed a written acknowledgment of receipt of that information.

(c)(1) A program or project is not required to follow the procedures of paragraph (b) of this section if either of the

following circumstances exists:

(i) The individual is already sterile at

the time of the hysterectomy.

(ii) The individual requires a

hysterectomy because of a life-threatening emergency in which the physician determines that prior acknowledgment is not possible.

(2) If the procedures of paragraph (b)

of this section are not followed because

one or more of the circumstances of

paragraph (c)(1) exist, the physician

who performs the hysterectomy must

certify in writing:

(i) That the woman was already sterile, stating the cause of that sterility;

or

(ii) That the hysterectomy was performed under a life-threatening emergency situation in which he or she determined prior acknowledgment was

not possible. He or she must also include a description of the nature of the

emergency.

[43 FR 52165, Nov. 8, 1978, as amended at 47

FR 33701, Aug. 4, 1982]

§ 50.208 Program or project requirements.

(a) A program or project must, with

respect to any sterilization procedure

or hysterectomy it performs or arranges, meet all requirements of this

subpart.

(b) The program or project shall

maintain sufficient records and documentation to assure compliance with

these regulations, and must retain

such data for at least 3 years.

(c) The program or project shall submit other reports as required and when

requested by the Secretary.

§ 50.209 Use of Federal financial assistance.

(a) Federal financial assistance

adminstered by the Public Health Service may not be used for expenditures

for sterilization procedures unless the

consent form appended to this section

or another form approved by the Secretary is used.

(b) A program or project shall not use

Federal financial assistance for any

sterilization or hysterectomy without

first receiving documentation showing

that the requirements of this subpart

have been met. Documentation includes consent forms, and as applicable, either acknowledgments of receipt

of hysterectomy information or certification of an exception for

hysterectomies.

[43 FR 52165, Nov. 8, 1978, as amended at 47

FR 33701, Aug. 4, 1982]

§ 50.210 Review of regulation.

The Secretary will request public

comment on the operation of the provisions of this subpart not later than 3

years after their effective date.

APPENDIX TO SUBPART B OF PART 50—

REQUIRED CONSENT FORM

NOTICE: YOUR DECISION AT ANY TIME

NOT TO BE STERILIZED WILL NOT RESULT IN THE WITHDRAWAL OR WITHHOLDING OF ANY BENEFITS PROVIDED

BY PROGRAMS OR PROJECTS RECEIVING

FEDERAL FUNDS.

CONSENT TO STERILIZATION

I have asked for and received information

about sterilization from lllllll (doctor or clinic). When I first asked for the information, I was told that the decision to be

sterilized is completely up to me. I was told

that I could decide not to be sterilized. If I

decide not to be sterilized, my decision will

not affect my right to future care or treatment. I will not lose any help or benefits

from programs receiving Federal funds, such

as A.F.D.C. or medicaid that I am now getting or for which I may become eligible.

I UNDERSTAND THAT THE STERILIZATION MUST BE CONSIDERED PERMANENT AND NOT REVERSIBLE. I HAVE DECIDED THAT I DO NOT WANT TO BECOME

PREGNANT, BEAR CHILDREN OR FATHER

CHILDREN.

175

Public Health Service, HHS Pt. 50, Subpt. B, App.

I was told about those temporary methods

of birth control that are available and could

be provided to me which will allow me to

bear or father a child in the future. I have rejected these alternatives and chosen to be

sterilized.

I understand that I will be sterilized by an

operation known as a lllllll. The discomforts, risks and benefits associated with

the operation have been explained to me. All

my questions have been answered to my satisfaction.

I understand that the operation will not be

done until at least 30 days after I sign this

form. I understand that I can change my

mind at any time and that my decision at

any time not to be sterilized will not result

in the withholding of any benefits or medical

services provided by federally funded programs.

I am at least 21 years of age and was born

on ll (day), ll (month), ll (year).

I, lllllll, hereby consent of my own

free will to be sterilized by lllllll by

a method called lllllll. My consent

expires 180 days from the date of my signature below.

I also consent to the release of this form

and other medical records about the operation to:

Representatives of the Department of

Health and Human Services or

Employees of programs or projects funded

by that Department but only for determining if Federal laws were observed.

I have received a copy of this form.

Signature llllllllllllllllll

Date: llllllllllllllllllll

(Month, day, year)

You are requested to supply the following

information, but it is not required:

Race and ethnicity designation (please

check)

Black (not of Hispanic origin) lllllll

Hispanic lllllllllllllllllll

Asian or Pacific Islander llllllllll

American Indian or Alaskan native llll

White (not of Hispanic origin) lllllll

INTERPRETER’S STATEMENT

If an interpreter is provided to assist the

individual to be sterilized:

I have translated the information and advice presented orally to the individual to be

sterilized by the person obtaining this consent. I have also read him/her the consent

form in lllllll language and explained

its contents to him/her. To the best of my

knowledge and belief he/she understood this

explanation.

Interpreter lllllllllllllllll

Date lllllllllllllllllllll

STATE OF PERSON OBTAINING CONSENT

Before lllllll (name of individual),

signed the consent form, I explained to him/

her the nature of the sterilization operation

lllllll, the fact that it is intended to

be a final and irreversible procedure and the

discomforts, risks and benefits associated

with it.

I counseled the individual to be sterilized

that alternative methods of birth control are

available which are temporary. I explained

that sterilization is different because it is

permanent.

I informed the individual to be sterilized

that his/her consent can be withdrawn at any

time and that he/she will not lose any health

services or any benefits provided by Federal

funds.

To the best of my knowledge and belief the

individual to be sterilized is at least 21 years

old and appears mentally competent. He/She

knowingly and voluntarily requested to be

sterilized and appears to understand the nature and consequence of the procedure.

Signature of person obtaining consent lll

Date lllllllllllllllllllll

Facility lllllllllllllllllll

Address lllllllllllllllllll

PHYSICIAN’S STATEMENT

Shortly before I performed a sterilization

operation upon lllllll (name of individual to be sterilized), on lllll (date of

sterilization), lllllll (operation), I explained to him/her the nature of the sterilization operation lllllll (specify type

of operation), the fact that it is intended to

be a final and irreversible procedure and the

discomforts, risks and benefits associated

with it.

I counseled the individual to be sterilized

that alternative methods of birth control are

available which are temporary. I explained

that sterilization is different because it is

permanent.

I informed the individual to be sterilized

that his/her consent can be withdrawn at any

time and that he/she will not lose any health

services or benefits provided by Federal

funds.

To the best of my knowledge and belief the

individual to be sterilized is at least 21 years

old and appears mentally competent. He/She

knowingly and voluntarily requested to be

sterilized and appeared to understand the nature and consequences of the procedure.

(Instructions for use of alternative final paragraphs: Use the first paragraph below except

in the case of premature delivery or emergency abdominal surgery where the sterilization is performed less than 30 days after the

date of the individual’s signature on the consent form. In those cases, the second paragraph below must be used. Cross out the

paragraph which is not used.)

176

§ 50.301 42 CFR Ch. I (10–1–00 Edition)

(1) At least 30 days have passed between

the date of the individual’s signature on this

consent form and the date the sterilization

was performed.

(2) This sterilization was performed less

than 30 days but more than 72 hours after the

date of the individual’s signature on this

consent form because of the following circumstances (check applicable box and fill in

information requested):

b Premature delivery

Individual’s expected date of delivery: lll

b Emergency abdominal surgery:

(Describe circumstances): llllllllll

Physician llllllllllllllllll

Date lllllllllllllllllllll

[43 FR 52165, Nov. 8, 1978, as amended at 58

FR 33343, June 17, 1993]

Subpart C—Abortions and Related

Medical Services in Federally

Assisted Programs of the Public Health Service

AUTHORITY: Sec. 118, Pub. L. 96–86, Oct. 12,

1979, unless otherwise noted.

SOURCE: 43 FR 4570, Feb. 2, 1978, unless otherwise noted.

§ 50.301 Applicability.

The provisions of this subpart are applicable to programs or projects for

health services which are supported in

whole or in part by Federal financial

assistance, whether by grant or contract, appropriated to the Department

of Health and Human Services and administered by the Public Health Service.

§ 50.302 Definitions.

As used in this subpart: (a) Law enforcement agency means an agency, or

any part thereof, charged under applicable law with enforcement of the general penal statutes of the United

States, or of any State or local jurisdiction.

(b) Medical procedures performed upon

a victim of rape or incest means any

medical service, including an abortion,

performed for the purpose of preventing or terminating a pregnancy

arising out of an incident of rape or incest.

(c) Physician means a doctor of medicine or osteopathy legally authorized

to practice medicine and surgery by

the State in which he or she practices.

(d) Public health service means: (1) An

agency of the United States or of a

State or local government, that provides health or medical services; and

(2) A rural health clinic, as defined

under section 1(d)(aa)(2) of Pub. L. 95–

210, 91 Stat. 1485; except that any agency or facility whose principal function

is the performance of abortions is specifically excluded from this definition.

§ 50.303 General rule.

Federal financial participation is not

available for the performance of an

abortion in programs or projects to

which this subpart applies except under

circumstances described in §50.304 or

§50.306.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR

61598, Oct. 26, 1979]

§ 50.304 Life of the mother would be

endangered.

Federal financial participation is

available in expenditures for an abortion when a physician has found, and so

certified in writing to the program or

project, that on the basis of his/her

professional judgment, the life of the

mother would be endangered if the

fetus were carried to term. The certification must contain the name and address of the patient.

(Sec. 101, Pub. L. 95–205, 91 Stat. 1461, Dec. 9,

1977)

[43 FR 13868, July 21, 1978]

§ 50.305 [Reserved]

§ 50.306 Rape and incest.

Federal financial participation is

available in expenditures for medical

procedures performed upon a victim of

rape or incest if the program or project

has received signed documentation

from a law enforcement agency or public health service stating:

(a) That the person upon whom the

medical procedure was performed was

reported to have been the victim of an

incident of rape or incest;

(b) The date on which the incident

occurred;

(c) The date on which the report was

made, which must have been within 60

days of the date on which the incident

occurred;

Office of Population Affairs 

Office of Family Planning 

Regional Program Consultants 

Region I

Suzanne C. Theroux 

JFK Federal Building, Room 2126 

Boston, MA 02203 

ph: 617-565-1063 

fx: 617-565-4265 

stheroux@osophs.dhhs.gov

CT, ME, MA, NH, RI, VT

Region II

Robin Lane 

26 Federal Plaza, Room 3337 

New York, NY 10278 

ph: 212-264-3935 

fx: 212-264-9908 

rlane@osophs.dhhs.gov

NJ, NY, PR, VI

Region III

Louis Belmonte (Acting) 

The Public Ledger Bldg., Ste. 426 

150 S. Independence Mall West 

Philadelphia, PA 19106-3499 

ph: 215-861-4641 

fx: 215-861-4623 

lbelmonte@osophs.dhhs.gov

DE, D.C., MD, PA, VA, WV

Region IV

Cristino Rodriguez 

Atlanta Federal Center 

61 Forsyth Street, S.W., 

Ste. 5B95 

Atlanta, GA 30303-8909 

ph: 404-562-7900 

fx: 404-562-7899 

crodriguez@osophs.dhhs.gov

KY, MS, NC, TN, AL, FL, GA, SC

Region V

Janice Ely 

233 North Michigan Avenue 

Suite 1300 

Chicago, IL 60601 

ph: 312-886-3864 

fx: 312-353-7800 

jely@osophs.dhhs.gov

IL, IN, MI, MN, OH, WI

Region VI

Evelyn Glass 

1301 Young Street, Suite 766 

Dallas, TX 75202 

ph: 214-767-3088 

fx: 214-767-3425 

eglass@osophs.dhhs.gov

AR, LA, NM, OK, TX

Region VII

Elizabeth Curtis 

Federal Office Building, Room 210 

601 East 12th Street 

Kansas City, MO 64106 

ph: 816-426-2924 

fx: 816-426-2178 

ecurtis@osophs.dhhs.gov

IA, KS, MO, NE

Region VIII

Laura Grogan - 303-844-7849 

 lgrogan@osophs.dhhs.gov

Jill Leslie - 303-844-7856 

 jleslie@osophs.dhhs.gov

Federal Building, 4th Floor 

1961 Stout Street 

Denver, CO 80294-3538 

fx: 303-844-2019 

CO, MT, ND, SD, UT, WY

Region IX

Nadine Simons, M.S., R.N. 

50 United Nations Plaza 

San Francisco, CA 94102 

ph: 415-437-7984 

fx: 415-437-8004 

nsimons@osophs.dhhs.gov

AZ, CA, HI, NV, and the six U.S. 

Associated Pacific jurisdictions

Region X

Janet Wildeboor 

Blanchard Plaza 

2201 Sixth Avenue, M/S RX-29 

Seattle, WA 98121-2500 

ph: 206-615-2776 

fx: 206-615-2481 

jwildeboor@osophs.dhhs.gov

AK, ID, OR, WA

Revised: 12/2002 
Office of Population Affairs 

Office of Family Planning 

Regional Health Administrators 

Region I

Betsy Rosenfeld (Acting) 

JFK Federal Bldg., Room 2100 

Boston, MA 02203 

ph: 617-565-1505 

fx: 617-565-1491 

CT, ME, MA, NH, RI, VT

Region II

Gilberto Cardona, M.D. 

26 Federal Plaza, Room 3835 

New York, NY 10278 

ph: 212-264-2560 

fx: 212-264-1324 

NJ, NY, PR, VI

Region III

Dalton Paxman 

The Public Ledger Bldg., Ste. 436 

150 S. Independence Mall West 

Philadelphia, PA 19106-3499 

ph: 215-861-4639 

fx: 215-861-4617 

DE, D.C., MD, PA, VA, WV

Region IV

J. Jarrett Clinton, M.D., M.P.H. 

61 Forsyth Street, S.W. 

Suite 5B95 

Atlanta, GA 30303-8909 

ph: 404-562-7890 

fx: 404-562-7899 

KY, MS NC, TN, AL, FL, GA, SC

Region V

Steven Potsic, M.D., M.P.H., F.A.C.P.M. 

233 North Minchigan Avenue 

Suite 1300 

Chicago, IL 60601 

ph: 312-353-1385 

fx: 312-353-0718 

IL, IN, MI, MN, OH, WI

Region VI

James Doss (Acting) 

1301 Young Street, Suite 1124 

Dallas, TX 75202 

ph: 214-767-3879 

fx: 214-767-3617 

AR, LA, NM, OK, TX

Region VII

Diane E. Cassity, M.P.A. (Acting) 

Federal Office Building 

601 East 12th Street, Room 210 

Kansas City, MO 64106 

ph: 816-426-3294 

fx: 816-426-2178 

IA, KS, MO, NE

Region VIII

Hugh S. Sloan, D.S.W. 

Federal Building 

1961 Stout Street, Room 498 

Denver, CO 80294 

ph: 303-844-6163 Ext. 342 

fx: 303-844-2019(fax) 

CO, MT, ND, SD, UT, WY

Region IX

Ronald Banks, M.D. 

50 United Nations Plaza, Room 327 

San Francisco, CA 94102 

ph: 415-437-8070 

fx: 415-437-8004 

AZ, CA, HI, NV, and the six U.S. 

Associated Pacific jurisdictions

Region X

Karen Matsuda, M.N., R.N. (Acting) 

Blanchard Plaza 

2201 Sixth Avenue, M/S RX-20 

Seattle, WA 98121-2500 

ph: 206-615-2469 

fx: 206-615-2481 

AK, ID, OR, WA

Revised: 12/2002 
1

Resource List for Title X Family Planning Programs

The following is a list of selected resources that provide additional guidance in specific areas. It is

intended to assist programs in administering their Title X grant and in providing services to clients. The

list is not intended to be exhaustive, nor does it imply endorsement of any of the non-governmental

resources.

The Law, Regulations, and Guidelines

The Title X Family Planning statute (42 USC 300 et. seq.) and regulations can be obtained from :

‘ Office of Family Planning

Office of Population Affairs

Office of Public Health and Science

U.S. Department of Health and Human Services

4350 East West Highway, Suite 200

Bethesda, MD 20817

(301) 594-4008

http://www.hhs.gov/opa/

‘ Office of Population Affairs Clearinghouse

P.O. Box 30686

Bethesda, MD 20824-0686

301-654-6190

E-mail: OPA@Tascon.com

Application, Grants Administration, and Legal Issues

‘ Grants Management 

Http://www.hhs.gov/grantsnet

‘ Grants Process Policy Notices for Title X Family Planning Services, rev. 1999

(Available from Title X Grants Management Office. 1301 Young Street, Ste.766, Dallas, 

TX 75202; 214-767-3490)
2

Project Management and Reporting Requirements

‘ Annual Report for OPA Title X Family Planning Program Grantees Forms and Instructions

(Available from the Regional Office).

‘ Office of Pharmacy Affairs, Health Resources and Services Administration, U.S. Department

of Health and Human Services. http://www.bphc.hrsa.gov/odpp/

Client Services

‘ Cultural Competence

http://www.omhrc.gov/clas/index.htm

‘ Title VI of the Civil Rights Act of 1964; Policy Guidance on the Prohibition Against National

Origin Discrimination as it Affects Persons with Limited English Proficiency. Federal Register,

Vol. 65, No. 169. 52762 – 52774. http://www.hhs.gov/ocr/lep/

‘ U.S. Preventive Services Task Force. Guide to Clinical Preventive Services, 2nd Edition. 

Chapter 63 Counseling to Prevent Unintended Pregnancy. Washington, DC: U.S. 

Department of Health and Human Services, 1996. 

http://odphp.osophs.dhhs.gov/pubs/guidecps/

‘ Hatcher, Robert A., et. al. Contraceptive Technology, Seventeenth Revised Edition, Ardent

Media, Inc. 1998.

‘ American College of Obstetricians and Gynecologists. Emergency Oral Contraception.

ACOG Practice Patterns. Number 3. Washington, DC: The American College of Obstetrics

and Gynecologists, December, 1996.

‘ Your Contraceptive Choices for Now, for Later. Bethesda, MD: U.S. Department of Health

and Human Services, Public Health Service, Office of Population Affairs. Updated Spring

1998.

‘ Green M, Palfrey JS, eds. 2000 Bright Futures: Guidelines for Health Supervision of 

Infants, Children and Adolescents. Arlington, VA: National Center for Education in 

Maternal and Child Health. http://www.brightfutures.org./

‘ American Medical Association. Guidelines for Adolescent Preventive Services (GAPS):

recommendations and rationale. Chicago: American Medical Association. 1994
3

‘ Primary and Preventive Health Care for Female Adolescents, American College of 

Obstetricians and Gynecologists, November 1999.

‘ American College or Obstetricians and Gynecologists, Guidelines for Women’s Health Care,

1996.

‘ Centers for Disease Control and Prevention. 1998 Guidelines for Treatment of Sexually 

Transmitted Diseases. MMWR 1998: 47 (RR-1); 1-118. 

http://www.cdc.gov/nchstp/dstd/1998_STD_Guidlines/98m1633.pdf

‘ Centers for Disease Control and Prevention. Revised Guidelines for HIV Counseling, 

Testing and Referral. October 17, 2000. http://www.cdc.gov/hiv/frn.htm

Health Promotion/Disease Prevention

‘ U.S. Department of Health and Human Services. Healthy People 2010. 2nd ed. With

Understanding and Improving Health and Objectives for Improving Health. 2 vols. . 

Washington, DC: U.S. Government Printing Office, November, 2000.

http://www.health.gov/healthypeople/

‘ Guidelines for Health Education and Risk Reduction Activities CDC, National Center for 

Prevention Services, Division of Sexually Transmitted Diseases/HIV Prevention Publication

date: 04/01/1995 http://aepo-xdv-www.epo.cdc.gov/wonder/PrevGuid

‘ U.S. Preventive Services Task Force. Guide to Clinical Preventive Services, 2nd Edition. 

Chapter 63 Counseling to Prevent Unintended Pregnancy. Washington, DC: U.S. Department

of Health and Human Services (HHS), 1996. http://odphp.osophs.dhhs.gov/pubs/guidecps/