PART 59—GRANTS FOR FAMILY PLANNING SERVICES Subpart A—Project Grants for Family Planning Services Source: 86 FR 56177, Oct. 7, 2021, 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. § 59.2 Definitions. As used in this subpart: Act Adolescent-friendly health services Clinical services provider Client-centered care Culturally and linguistically appropriate services Family Family planning services Health equity Inclusive Low-income family Nonprofit, Quality healthcare Secretary Service site State Trauma-informed § 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 pregnancy testing and counseling, assistance to achieve pregnancy, basic infertility services, STI services, preconception health services, and adolescent-friendly health services). 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 acceptable and effective medically approved family planning methods and services. Title X service sites that are unable to provide clients with access to a broad range of acceptable and effective medically approved family planning methods and services, must be able to provide a prescription to the client for their method of choice or referrals to another provider, as requested. (2) Provide services without subjecting individuals to any coercion to accept services or to employ or not to employ any particular methods of family planning. Acceptance of services must be solely on a voluntary basis and may not be made a prerequisite to eligibility for, or receipt of, any other services, assistance from or participation in any other program of the applicant. 1 1 (3) Provide services in a manner that is client-centered, culturally and linguistically appropriate, inclusive, and trauma-informed; protects the dignity of the individual; and ensures equitable and quality service delivery consistent with nationally recognized standards of care. (4) Provide services in a manner that does not discriminate against any client based on religion, race, color, national origin, disability, age, sex, sexual orientation, gender identity, sex characteristics, number of pregnancies, or marital status. (5) Not provide abortion as a method of family planning. 2 2 (i) Offer pregnant clients 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 client indicates they do not wish to receive such information and counseling. (6) Provide that priority in the provision of services will be given to clients from low-income families. (7) Provide that no charge will be made for services provided to any clients 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 clients 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. (i) Family income should be assessed before determining whether copayments or additional fees are charged. (ii) With regard to insured clients, clients whose family income is at or below 250 percent of the FPL should not pay more (in copayments or additional fees) than what they would otherwise pay when the schedule of discounts is applied. (9) Take reasonable measures to verify client income, without burdening clients from low-income families. Recipients that have lawful access to other valid means of income verification because of the client's participation in another program may use those data rather than re-verify income or rely solely on clients' self-report. If a client's income cannot be verified after reasonable attempts to do so, charges are to be based on the client's self-reported income. (10) 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. (11)(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 subrecipients 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 subrecipients in the ongoing policy decision making of the project. (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 consultation by a clinical services provider, examination, prescription and continuing supervision, laboratory examination, contraceptive supplies), in person or via telehealth, and necessary referral to other medical facilities when medically indicated, and provide for the effective usage of contraceptive devices and practices. (2) Provide for social services related to family planning, including counseling, referral to and from other social and medical service agencies, and any ancillary services which may be necessary to facilitate clinic attendance. (3) Provide for opportunities for community education, participation, and engagement 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 diverse persons to whom family planning services may be beneficial to ensure access to equitable, affordable, client-centered, quality family planning services. (4) Provide for orientation and in-service training for all project personnel. (5) Provide services without the imposition of any durational residency requirement or requirement that the patient be referred by a physician. (6) Provide that family planning medical services will be performed under the direction of a clinical services provider, with services offered within their scope of practice and allowable under state law, and 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 their designee on the project staff. (8) Provide for coordination and use of referrals and linkages with primary healthcare providers, other providers of healthcare services, local health and welfare departments, hospitals, voluntary agencies, and health services projects supported by other federal programs, who are in close physical proximity to the Title X site, when feasible, in order to promote access to services and provide a seamless continuum of care. (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 recipient. The recipient must be prepared to substantiate that these rates are reasonable and necessary. (10) Provide, to the maximum feasible extent, an opportunity for participation in the development, implementation, and evaluation of the project by persons broadly representative of all significant elements of the population to be served, and by others in the community knowledgeable about the community's needs for family planning services. § 59.6 What procedures apply to assure the suitability of informational and educational material (print and electronic)? (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 (print and electronic) 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. (2) Composition. (3) Function. (i) Consider the educational, cultural, and diverse 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, medically accurate, culturally and linguistically appropriate, inclusive, and trauma informed; (iv) Determine whether the material is suitable for the population or community to which is to be made available; and (v) Establish a written record of its determinations. § 59.7 What criteria will the Department of Health and Human Services use to decide which family planning services projects to fund and in what amount? (a) Within the limits of funds available for these purposes, the Secretary may award grants for the establishment and operation of those projects which will in the Department's judgment best promote the purposes of section 1001 of the Act, taking into account: (1) The number of clients, and, in particular, the number of low-income clients to be served; (2) The extent to which family planning services are needed locally; (3) The ability of the applicant to advance health equity; (4) The relative need of the applicant; (5) The capacity of the applicant to make rapid and effective use of the federal assistance; (6) The adequacy of the applicant's facilities and staff; (7) The relative availability of non-federal resources within the community to be served and the degree to which those resources are committed to the project; and (8) 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 an 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 anticipated 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 recipient 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 recipient'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 2 CFR parts 200 and 300, subpart E. [86 FR 56177, Oct. 7, 2021, as amended at 89 FR 80067, Oct. 2, 2024] § 59.10 Confidentiality. (a) 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. Reasonable efforts to collect charges without jeopardizing client confidentiality must be made. Recipient must inform the client of any potential for disclosure of their confidential health information to policyholders where the policyholder is someone other than the client. (b) To the extent practical, Title X projects shall encourage family participation. 3 3 § 59.11 Additional conditions. The Secretary may, with respect to any grant, impose additional conditions prior to, at the time of, or during 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. 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 (b) State (c) Nonprofit (d) Secretary (e) Training § 59.203 Eligibility. (a) Eligible applicants. (b) Eligible projects. Provided, [37 FR 7093, Apr. 8, 1972, as amended at 40 FR 17991, Apr. 24, 1975] § 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 1 (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 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 2 CFR parts 200 and 300, subpart E. (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; 81 FR 3009, Jan. 20, 2016; 89 FR 80067, Oct. 2, 2024] § 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 2 CFR parts 200 and 300, subpart E. (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; 81 FR 3009, Jan. 20, 2016; 89 FR 80067, Oct. 2, 2024] § 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. § 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. Provided, however, (b) [Reserved] (c) Accounting for grant-related income Interest. (d) Grant closeout Date of final accounting. (2) Final settlement. (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 2 CFR 200.307, 2 CFR 200.339 through 200.344, and 200.310 through 200.316 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 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; 81 FR 3009, Jan. 20, 2016; 89 FR 80067, Oct. 2, 2024] § 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 2 CFR parts 200 and 300. The provisions of 2 CFR parts 200 and 300, establishing uniform administrative requirements and cost principles, shall apply to all grants under this part. [81 FR 3009, Jan. 20, 2016, as amended at 89 FR 80067, Oct. 2, 2024]