Appendix C
Title X Family Planning Program Regulations



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Appendix C Title X Family Planning Program Regulations 197

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198 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM Public Health Service, HHS Pt. 59 (2) The trainee is not eligible or able the interest of the public health, or the to continue in attendance in accord- conservation of grant funds. ance with its standards and practices. [45 FR 73658, Nov. 6, 1980. Redesignated at 61 FR 6131, Feb. 16, 1996] [45 FR 73658, Nov. 6, 1980. Redesignated at 61 FR 6131, Feb. 16, 1996] Subparts E–F [Reserved] § 58.232 What additional Department regulations apply to grantees? PART 59—GRANTS FOR FAMILY PLANNING SERVICES Several other Department regula- tions apply to grantees. They include, but are not limited to: Subpart A—Project Grants for Family Planning Services 42 CFR part 50, subpart D—Public Health Service grant appeals procedure Sec. 45 CFR part 16—Procedures of the Depart- 59.1 To what programs do these regulations mental Grant Appeals Board apply? 45 CFR part 46—Protection of human sub- 59.2 Definitions. jects 59.3 Who is eligible to apply for a family 45 CFR part 74—Administration of grants planning services grant? 45 CFR part 80—Nondiscrimination under 59.4 How does one apply for a family plan- programs receiving Federal assistance ning services grant? through the Department of Health and 59.5 What requirements must be met by a Human Services effectuation of title VI of family planning project? the Civil Rights Act of 1964 59.6 What procedures apply to assure the 45 CFR part 81—Practice and procedure for suitability of informational and edu- hearings under part 80 of this title cational material? 45 CFR part 83—Regulation for the adminis- 59.7 What criteria will the Department of tration and enforcement of sections 794 and Health and Human Services use to decide 855 of the Public Health Service Act which family planning services projects 45 CFR part 84—Nondiscrimination on the to fund and in what amount? basis of handicap in programs and activi- 59.8 How is a grant awarded? ties receiving or benefiting from Federal 59.9 For what purposes may grant funds be financial assistance used? 45 CFR part 86—Nondiscrimination on the 59.10 What other HHS regulations apply to basis of sex in education programs and ac- grants under this subpart? tivities receiving or benefiting from Fed- 59.11 Confidentiality. eral financial assistance 59.12 Additional conditions. 45 CFR part 91—Nondiscrimination on the Subpart B [Reserved] basis of age in HHS programs or activities receiving Federal financial assistance Subpart C—Grants for Family Planning 45 CFR part 93—New restrictions on lobbying Service Training [49 FR 38116, Sept. 27, 1984. Redesignated and amended at 61 FR 6131, Feb. 16, 1996] 59.201 Applicability. 59.202 Definitions. § 58.233 What other audit and inspec- 59.203 Eligibility. tion requirements apply to grant- 59.204 Application for a grant. ees? 59.205 Project requirements. Each entity which receives a grant 59.206 Evaluation and grant award. 59.207 Payments. under this subpart must meet the re- 59.208 Use of project funds. quirements of 45 CFR part 74 con- 59.209 Civil rights. cerning audit and inspection. 59.210 Inventions or discoveries. 59.211 Publications and copyright. [61 FR 6131, Feb. 16, 1996; 61 FR 51020, Sept. 59.212 Grantee accountability. 30, 1996] 59.213 [Reserved] § 58.234 Additional conditions. 59.214 Additional conditions. 59.215 Applicability of 45 CFR part 74. The Secretary may impose additional conditions in the grant award before or Subpart A—Project Grants for at the time of the award if he or she de- Family Planning Services termines that these conditions are nec- essary to assure or protect the ad- vancement of the approved activity, AUTHORITY: 42 U.S.C. 300a–4. 407 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00407 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD

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199 APPENDIX C § 59.1 42 CFR Ch. I (10–1–00 Edition) SOURCE: 65 FR 41278, July 3, 2000, unless way, Wake, et al.), the Marshall Is- otherwise noted. lands, the Federated State of Micro- nesia and the Republic of Palau. § 59.1 To what programs do these reg- ulations apply? [65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10, 2000] The regulations of this subpart are applicable to the award of grants under § 59.3 Who is eligible to apply for a section 1001 of the Public Health Serv- family planning services grant? ice Act (42 U.S.C. 300) to assist in the Any public or nonprofit private enti- establishment and operation of vol- ty in a State may apply for a grant untary family planning projects. These under this subpart. projects shall consist of the edu- cational, comprehensive medical, and § 59.4 How does one apply for a family social services necessary to aid individ- planning services grant? uals to determine freely the number (a) Application for a grant under this and spacing of their children. subpart shall be made on an authorized [65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10, form. 2000] (b) An individual authorized to act for the applicant and to assume on be- § 59.2 Definitions. half of the applicant the obligations As used in this subpart: imposed by the terms and conditions of Act means the Public Health Service the grant, including the regulations of Act, as amended. this subpart, must sign the application. Family means a social unit composed (c) The application shall contain— of one person, or two or more persons (1) A description, satisfactory to the living together, as a household. Secretary, of the project and how it Low income family means a family will meet the requirements of this sub- whose total annual income does not ex- part; ceed 100 percent of the most recent (2) A budget and justification of the Poverty Guidelines issued pursuant to amount of grant funds requested; 42 U.S.C. 9902(2). ‘‘Low-income family’’ (3) A description of the standards and also includes members of families qualifications which will be required whose annual family income exceeds for all personnel and for all facilities to this amount, but who, as determined be used by the project; and by the project director, are unable, for (4) Such other pertinent information good reasons, to pay for family plan- as the Secretary may require. ning services. For example, unemancipated minors who wish to re- § 59.5 What requirements must be met ceive services on a confidential basis by a family planning project? must be considered on the basis of (a) Each project supported under this their own resources. part must: Nonprofit, as applied to any private (1) Provide a broad range of accept- agency, institution, or organization, able and effective medically approved means that no part of the entity’s net family planning methods (including earnings benefit, or may lawfully ben- natural family planning methods) and efit, any private shareholder or indi- services (including infertility services vidual. and services for adolescents). If an or- Secretary means the Secretary of ganization offers only a single method Health and Human Services and any of family planning, it may participate other officer or employee of the De- as part of a project as long as the en- partment of Health and Human Serv- tire project offers a broad range of fam- ices to whom the authority involved ily planning services. has been delegated. State includes, in addition to the sev- (2) Provide services without sub- eral States, the District of Columbia, jecting individuals to any coercion to Guam, the Commonwealth of Puerto accept services or to employ or not to Rico, the Northern Mariana Islands, employ any particular methods of fam- the U.S. Virgin Islands, American ily planning. Acceptance of services Samoa, the U.S. Outlying Islands (Mid- must be solely on a voluntary basis and 408 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00408 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T

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200 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM Public Health Service, HHS § 59.5 may not be made a prerequisite to eli- (8) Provide that charges will be made gibility for, or receipt of, any other for services to persons other than those services, assistance from or participa- from low-income families in accord- tion in any other program of the appli- ance with a schedule of discounts based cant.1 on ability to pay, except that charges (3) Provide services in a manner to persons from families whose annual which protects the dignity of the indi- income exceeds 250 percent of the lev- vidual. els set forth in the most recent Pov- (4) Provide services without regard to erty Guidelines issued pursuant to 42 religion, race, color, national origin, U.S.C. 9902(2) will be made in accord- handicapping condition, age, sex, num- ance with a schedule of fees designed to ber of pregnancies, or marital status. recover the reasonable cost of pro- (5) Not provide abortion as a method viding services. of family planning. A project must: (9) If a third party (including a Gov- (i) Offer pregnant women the oppor- ernment agency) is authorized or le- tunity to be provided information and gally obligated to pay for services, all counseling regarding each of the fol- reasonable efforts must be made to ob- lowing options: tain the third-party payment without (A) Prenatal care and delivery; application of any discounts. Where the (B) Infant care, foster care, or adop- cost of services is to be reimbursed tion; and under title XIX, XX, or XXI of the So- (C) Pregnancy termination. cial Security Act, a written agreement with the title XIX, XX or XXI agency (ii) If requested to provide such infor- is required. mation and counseling, provide neu- tral, factual information and nondirec- (10)(i) Provide that if an application tive counseling on each of the options, relates to consolidation of service and referral upon request, except with areas or health resources or would oth- respect to any option(s) about which erwise affect the operations of local or the pregnant woman indicates she does regional entities, the applicant must not wish to receive such information document that these entities have been and counseling. given, to the maximum feasible extent, (6) Provide that priority in the provi- an opportunity to participate in the de- sion of services will be given to persons velopment of the application. Local from low-income families. and regional entities include existing (7) Provide that no charge will be or potential subgrantees which have made for services provided to any per- previously provided or propose to pro- sons from a low-income family except vide family planning services to the to the extent that payment will be area proposed to be served by the appli- made by a third party (including a gov- cant. ernment agency) which is authorized to (ii) Provide an opportunity for max- or is under legal obligation to pay this imum participation by existing or po- charge. tential subgrantees in the ongoing pol- icy decisionmaking of the project. (11) Provide for an Advisory Com- 1 Section 205 of Pub. L. 94–63 states: ‘‘Any (1) officer or employee of the United States, mittee as required by § 59.6. (2) officer or employee of any State, political (b) In addition to the requirements of subdivision of a State, or any other entity, paragraph (a) of this section, each which administers or supervises the adminis- project must meet each of the fol- tration of any program receiving Federal fi- lowing requirements unless the Sec- nancial assistance, or (3) person who re- retary determines that the project has ceives, under any program receiving Federal established good cause for its omission. assistance, compensation for services, who coerces or endeavors to coerce any person to Each project must: undergo an abortion or sterilization proce- (1) Provide for medical services re- dure by threatening such person with the lated to family planning (including loss of, or disqualification for the receipt of, physician’s consultation, examination any benefit or service under a program re- prescription, and continuing super- ceiving Federal financial assistance shall be vision, laboratory examination, contra- fined not more than $1,000 or imprisoned for ceptive supplies) and necessary referral not more than one year, or both.’’ 409 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00409 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD

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201 APPENDIX C § 59.6 42 CFR Ch. I (10–1–00 Edition) to other medical facilities when medi- tation, and evaluation of the project by cally indicated, and provide for the ef- persons broadly representative of all fective usage of contraceptive devices significant elements of the population and practices. to be served, and by others in the com- (2) Provide for social services related munity knowledgeable about the com- to family planning, including coun- munity’s needs for family planning seling, referral to and from other social services. and medical services agencies, and any [65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10, ancillary services which may be nec- 2000] essary to facilitate clinic attendance. (3) Provide for informational and § 59.6 What procedures apply to assure the suitability of informational and educational programs designed to— educational material? (i) Achieve community under- standing of the objectives of the pro- (a) A grant under this section may be gram; made only upon assurance satisfactory (ii) Inform the community of the to the Secretary that the project shall availability of services; and provide for the review and approval of (iii) Promote continued participation informational and educational mate- in the project by persons to whom fam- rials developed or made available under ily planning services may be beneficial. the project by an Advisory Committee (4) Provide for orientation and in- prior to their distribution, to assure service training for all project per- that the materials are suitable for the sonnel. population or community to which (5) Provide services without the im- they are to be made available and the position of any durational residency re- purposes of title X of the Act. The quirement or requirement that the pa- project shall not disseminate any such tient be referred by a physician. materials which are not approved by (6) Provide that family planning the Advisory Committee. medical services will be performed (b) The Advisory Committee referred under the direction of a physician with to in paragraph (a) of this section shall special training or experience in family be established as follows: planning. (1) Size. The Committee shall consist (7) Provide that all services pur- of no fewer than five but not more than chased for project participants will be nine members, except that this provi- authorized by the project director or sion may be waived by the Secretary his designee on the project staff. for good cause shown. (8) Provide for coordination and use (2) Composition. The Committee shall of referral arrangements with other include individuals broadly representa- providers of health care services, local tive (in terms of demographic factors health and welfare departments, hos- such as race, color, national origin, pitals, voluntary agencies, and health handicapped condition, sex, and age) of services projects supported by other the population or community for which federal programs. the materials are intended. (9) Provide that if family planning (3) Function. In reviewing materials, services are provided by contract or the Advisory Committee shall: other similar arrangements with ac- (i) Consider the educational and cul- tual providers of services, services will tural backgrounds of individuals to be provided in accordance with a plan whom the materials are addressed; which establishes rates and method of (ii) Consider the standards of the pop- payment for medical care. These pay- ulation or community to be served ments must be made under agreements with respect to such materials; with a schedule of rates and payment (iii) Review the content of the mate- procedures maintained by the grantee. rial to assure that the information is The grantee must be prepared to sub- factually correct; stantiate, that these rates are reason- able and necessary. (iv) Determine whether the material (10) Provide, to the maximum fea- is suitable for the population or com- sible extent, an opportunity for partici- munity to which is to be made avail- pation in the development, implemen- able; and 410 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00410 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T

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202 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM Public Health Service, HHS § 59.10 (v) Establish a written record of its (b) Generally the grant will initially determinations. be for one year and subsequent con- tinuation awards will also be for one § 59.7 What criteria will the Depart- year at a time. A grantee must submit ment of Health and Human Services a separate application to have the sup- use to decide which family planning port continued for each subsequent services projects to fund and in year. Decisions regarding continuation what amount? awards and the funding level of such (a) Within the limits of funds avail- awards will be made after consider- able for these purposes, the Secretary ation of such factors as the grantee’s may award grants for the establish- progress and management practices, ment and operation of those projects and the availability of funds. In all which will in the Department’s judg- cases, continuation awards require a ment best promote the purposes of sec- determination by HHS that continued tion 1001 of the Act, taking into ac- funding is in the best interest of the count: government. (1) The number of patients, and, in (c) Neither the approval of any appli- particular, the number of low-income cation nor the award of any grant com- patients to be served; mits or obligates the United States in (2) The extent to which family plan- any way to make any additional, sup- ning services are needed locally; plemental, continuation, or other (3) The relative need of the applicant; award with respect to any approved ap- (4) The capacity of the applicant to plication or portion of an approved ap- make rapid and effective use of the fed- plication. eral assistance; § 59.9 For what purpose may grant (5) The adequacy of the applicant’s funds be used? facilities and staff; (6) The relative availability of non- Any funds granted under this subpart federal resources within the commu- shall be expended solely for the purpose nity to be served and the degree to for which the funds were granted in ac- which those resources are committed cordance with the approved application to the project; and and budget, the regulations of this sub- (7) The degree to which the project part, the terms and conditions of the plan adequately provides for the re- award, and the applicable cost prin- quirements set forth in these regula- ciples prescribed in 45 CFR Part 74 or tions. Part 92, as applicable. (b) The Secretary shall determine the amount of any award on the basis of § 59.10 What other HHS regulations apply to grants under this subpart? his estimate of the sum necessary for the performance of the project. No Attention is drawn to the following grant may be made for less than 90 per- HHS Department-wide regulations cent of the project’s costs, as so esti- which apply to grants under this sub- mated, unless the grant is to be made part. These include: for a project which was supported, 37 CFR Part 401—Rights to inventions made under section 1001, for less than 90 per- by nonprofit organizations and small busi- cent of its costs in fiscal year 1975. In ness firms under government grants, con- that case, the grant shall not be for tracts, and cooperative agreements less than the percentage of costs cov- 42 CFR Part 50, Subpart D—Public Health ered by the grant in fiscal year 1975. Service grant appeals procedure (c) No grant may be made for an 45 CFR Part 16—Procedures of the Depart- amount equal to 100 percent for the mental Grant Appeals Board project’s estimated costs. 45 CFR Part 74—Uniform administrative re- quirements for awards and subawards to § 59.8 How is a grant awarded? institutions of higher education, hospitals, other nonprofit organizations, and com- (a) The notice of grant award speci- mercial organizations; and certain grants fies how long HHS intends to support and agreements with states, local govern- the project without requiring the ments and Indian tribal governments project to recompete for funds. This pe- 45 CFR Part 80—Nondiscrimination under riod, called the project period, will usu- programs receiving Federal assistance ally be for three to five years. through the Department of Health and 411 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00411 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD

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203 APPENDIX C § 59.11 42 CFR Ch. I (10–1–00 Edition) Human Services effectuation of Title VI of provide the training for personnel to the Civil Rights Act of 1964 carry out family planning service pro- 45 CFR Part 81—Practice and procedure for grams described in sections 1001 and hearings under Part 80 of this Title 1002 of the Public Health Service Act 45 CFR Part 84—Nondiscrimination on the (42 U.S.C. 300, 300a). basis of handicap in programs and activi- ties receiving or benefitting from Federal § 59.202 Definitions. financial assistance As used in this subpart: 45 CFR Part 91—Nondiscrimination on the (a) Act means the Public Health Serv- basis of age in HHS programs or activities receiving Federal financial assistance ice Act. 45 CFR Part 92—Uniform administrative re- (b) State means one of the 50 States, quirements for grants and cooperative the District of Columbia, Puerto Rico, agreements to state and local governments Guam, the Virgin Islands, American Samoa, or the Trust Territory of the § 59.11 Confidentiality. Pacific Islands. All information as to personal facts (c) Nonprofit private entity means a and circumstances obtained by the private entity no part of the net earn- project staff about individuals receiv- ings of which inures, or may lawfully ing services must be held confidential inure, to the benefit of any private and must not be disclosed without the shareholder or individual. individual’s documented consent, ex- (d) Secretary means the Secretary of cept as may be necessary to provide Health and Human Services and any services to the patient or as required other officer or employee of the De- by law, with appropriate safeguards for partment of Health and Human Serv- confidentiality. Otherwise, information ices to whom the authority involved may be disclosed only in summary, sta- has been delegated. tistical, or other form which does not (e) Training means job-specific skill identify particular individuals. development, the purpose of which is to promote and improve the delivery of § 59.12 Additional conditions. family planning services. The Secretary may, with respect to § 59.203 Eligibility. any grant, impose additional condi- tions prior to or at the time of any (a) Eligible applicants. Any public or award, when in the Department’s judg- nonprofit private entity located in a ment these conditions are necessary to State is eligible to apply for a grant assure or protect advancement of the under this subpart. (b) Eligible projects. Grants pursuant approved program, the interests of pub- to section 1003 of the Act and this sub- lic health, or the proper use of grant part may be made to eligible appli- funds. cants for the purpose of providing pro- [65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10, grams, not to exceed three months in 2000] duration, for training family planning or other health services delivery per- Subpart B [Reserved] sonnel in the skills, knowledge, and at- titudes necessary for the effective de- Subpart C—Grants for Family livery of family planning services: Pro- Planning Service Training vided, That the Secretary may in par- ticular cases approve support of a pro- gram whose duration is longer than AUTHORITY: Sec. 6(c), 84 Stat. 1507, 42 three months where he determines (1) U.S.C. 300a–4; sec. 6(c), 84 Stat. 1507, 42 U.S.C. that such program is consistent with 300a–1. the purposes of this subpart and (2) SOURCE: 37 FR 7093, Apr. 8, 1972, unless oth- that the program’s objectives cannot erwise noted. be accomplished within three months § 59.201 Applicability. because of the unusually complex or specialized nature of the training to be The regulations in this subpart are undertaken. applicable to the award of grants pur- suant to section 1003 of the Public [37 FR 7093, Apr. 8, 1972, as amended at 40 FR Health Service Act (42 U.S.C. 300a–1) to 17991, Apr. 24, 1975] 412 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00412 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T

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204 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM Public Health Service, HHS § 59.206 § 59.204 Application for a grant. (b) Provision of a methodology to as- sess the particular training (e.g., skills, (a) An application for a grant under attitudes, or knowledge) that prospec- this subpart shall be submitted to the tive trainees in the area to be served Secretary at such time and in such need to improve their delivery of fam- form and manner as the Secretary may ily planning services. prescribe. 1 The application shall con- (c) Provision of a methodology to de- tain a full and adequate description of fine the objectives of the training pro- the project and of the manner in which gram in light of the particular needs of the applicant intends to conduct the trainees defined pursuant to paragraph project and carry out the requirements (b) of this section. of this subpart, and a budget and jus- (d) Provision of a method for develop- tification of the amount of grant funds ment of the training curriculum and requested, and such other pertinent in- any attendant training materials and formation as the Secretary may re- resources. quire. (e) Provision of a method for imple- (b) The application shall be executed mentation of the needed training. by an individual authorized to act for (f) Provision of an evaluation meth- the applicant and to assume for the ap- odology, including the manner in plicant the obligations imposed by the which such methodology will be em- regulations of this subpart and any ad- ployed, to measure the achievement of ditional conditions of the grant. the objectives of the training program. (Sec. 6(c), Public Health Service Act, 84 Stat. (g) Provision of a method and criteria 1506 and 1507 (42 U.S.C. 300, 300a–1, and 300a– by which trainees will be selected. 4)) § 59.206 Evaluation and grant award. [37 FR 7093, Apr. 8, 1972, as amended at 49 FR 38116, Sept. 27, 1984] (a) Within the limits of funds avail- able for such purpose, the Secretary § 59.205 Project requirements. may award grants to assist in the es- An approvable application must con- tablishment and operation of those tain each of the following unless the projects which will in his judgment Secretary determines that the appli- best promote the purposes of section cant has established good cause for its 1003 of the Act, taking into account: omission: (1) The extent to which a training (a) Assurances that: program will increase the delivery of (1) No portion of the Federal funds services to people, particularly low-in- will be used to train personnel for pro- come groups, with a high percentage of grams where abortion is a method of unmet need for family planning serv- family planning. ices; (2) No portion of the Federal funds (2) The extent to which the training will be used to provide professional program promises to fulfill the family training to any student as part of his planning services delivery needs of the education in pursuit of an academic de- area to be served, which may include, gree. among other things: (3) No project personnel or trainees (i) Development of a capability with- shall on the grounds of sex, religion, or in family planning service projects to creed be excluded from participation provide pre- and in-service training to in, be denied the benefits of, or be sub- their own staffs; jected to discrimination under the (ii) Improvement of the family plan- project. ning services delivery skills of family planning and health services personnel; 1 Applications and instructions may be ob- (iii) Improvement in the utilization tained from the Program Director, Family and career development of paraprofes- Planning Services, at the Regional Office of sional and paramedical manpower in the Department of Health and Human Serv- family planning services; ices for the region in which the project is to (iv) Expansion of family planning be conducted, or the Office of Family Plan- services, particularly in rural areas, ning, Office of the Assistant Secretary for through new or improved approaches to Health, Washington, DC 20201. 413 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00413 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD

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205 APPENDIX C § 59.207 42 CFR Ch. I (10–1–00 Edition) § 59.207 Payments. program planning and deployment of resources; The Secretary shall from time to (3) The capacity of the applicant to time make payments to a grantee of all make rapid and effective use of such or a portion of any grant award, either assistance; in advance or by way of reimbursement (4) The administrative and manage- for expenses incurred or to be incurred ment capability and competence of the in the performance of the project to applicant; the extent he determines such pay- (5) The competence of the project ments necessary to promote prompt staff in relation to the services to be initiation and advancement of the ap- provided; and proved project. (6) The degree to which the project plan adequately provides for the re- § 59.208 Use of project funds. quirements set forth in § 59.205. (a) Any funds granted pursuant to (b) The amount of any award shall be this subpart as well as other funds to determined by the Secretary on the be used in performance of the approved basis of his estimate of the sum nec- project shall be expended solely for essary for all or a designated portion of carrying out the approved project in direct project costs plus an additional accordance with the statute, the regu- amount for indirect costs, if any, which lations of this subpart, the terms and will be calculated by the Secretary ei- conditions of the award, and, except as ther: (1) On the basis of his estimate of may otherwise be provided in this sub- the actual indirect costs reasonably re- part, the applicable cost principles pre- lated to the project, or (2) on the basis scribed by subpart Q of 45 CFR part 74. of a percentage of all, or a portion of, (b) Prior approval by the Secretary of the estimated direct costs of the revision of the budget and project plan project when there are reasonable as- is required whenever there is to be a surances that the use of such percent- significant change in the scope or na- age will not exceed the approximate ture of project activities. actual indirect costs. Such award may (c) The Secretary may approve the include an estimated provisional payment of grant funds to trainees for: amount for indirect costs or for des- (1) Return travel to the trainee’s ignated direct costs (such as travel or point of origin. supply costs) subject to upward (within (2) Per diem during the training pro- the limits of available funds) as well as gram, and during travel to and from downward adjustments to actual costs the program, at the prevailing institu- when the amount properly expended by tional or governmental rate, whichever the grantee for provisional items has is lower. been determined by the Secretary. (c) Allowability of costs shall be in [37 FR 7093, Apr. 8, 1972, as amended at 38 FR conformance with the applicable cost 26199, Sept. 19, 1973] principles prescribed by Subpart Q of 35 § 59.209 Civil rights. CFR part 74. (d) All grant awards shall be in writ- Attention is called to the require- ing, shall set forth the amount of funds ments of Title VI of the Civil Rights granted and the period for which sup- Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d port is recommended. et seq.) and in particular section 601 of (e) Neither the approval of any proj- such Act which provides that no person ect nor any grant award shall commit in the United States shall, on the or obligate the United States in any grounds of race, color, or national ori- way to make any additional, supple- gin be excluded from participation in, mental, continuation, or other award be denied the benefits of, or be sub- with respect to any approved project or jected to discrimination under any pro- portion thereof. For continuation sup- gram or activity receiving Federal fi- port, grantees must make separate ap- nancial assistance. A regulation plication annually at such times and in impelmenting such title VI, which ap- such form as the Secretary may direct. plies to grants made under this part, has been issued by the Secretary of [37 FR 7093, Apr. 8, 1972, as amended at 38 FR Health and Human Services with the 26199, Sept. 19, 1973] 414 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00414 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T

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206 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM Public Health Service, HHS § 59.212 approval of the President (45 CFR part indirect costs meeting the require- 80). ments of this part: Provided, however, That when the amount awarded for in- § 59.210 Inventions or discoveries. direct costs was based on a predeter- Any grant award pursuant to § 59.206 mined fixed-percentage of estimated di- is subject to the regulations of the De- rect costs, the amount allowed for indi- partment of Health and Human Serv- rect costs shall be computed on the ices as set forth in 45 CFR parts 6 and basis of such predetermined fixed-per- 8, as amended. Such regulations shall centage rates applied to the total, or a apply to any activity for which grant selected element thereof, of the reim- funds are in fact used whether within bursable direct costs incurred. the scope of the project as approved or (b) [Reserved] otherwise. Appropriate measures shall (c) Accounting for grant-related in- be taken by the grantee and by the come—(1) Interest. Pursuant to section Secretary to assure that no contracts, 203 of the Intergovernmental Coopera- assignments or other arrangements in- tion Act of 1968 (42 U.S.C. 4213), a State consistent with the grant obligation will not be held accountable for inter- are continued or entered into and that est earned on grant funds, pending all personnel involved in the supported activity are aware of and comply with their disbursement for grant purposes. such obligations. Laboratory notes, re- A State, as defined in section 102 of the lated technical data, and information Intergovernmental Cooperation Act, pertaining to inventions and discov- means any one of the several States, eries shall be maintained for such peri- the District of Columbia, Puerto Rico, ods, and filed with or otherwise made any territory or possession of the available to the Secretary, or those he United States, or any agency or instru- may designate at such times and in mentality of a State, but does not in- such manner, as he may determine nec- clude the governments of the political essary to carry out such Department subdivisions of the State. All grantees regulations. other than a State, as defined in this subsection, must return all interest § 59.211 Publications and copyright. earned on grant funds to the Federal Except as may otherwise be provided Government. under the terms and conditions of the (d) Grant closeout—(1) Date of final ac- award, the grantee may copyright counting. A grantee shall render, with without prior approval any publica- respect to each approved project, a full tions, films or similar materials devel- account, as provided herein, as of the oped or resulting from a project sup- date of the termination of grant sup- ported by a grant under this part, sub- port. The Secretary may require other ject, however, to a royalty-free, non- special and periodic accounting. exclusive, and irrevocable license or (2) Final settlement. There shall be right in the Government to reproduce, translate, publish, use, disseminate, payable to the Federal Government as and dispose of such materials and to final settlement with respect to each authorize others to do so. approved project the total sum of: (i) Any amount not accounted for § 59.212 Grantee accountability. pursuant to paragraph (a) of this sec- (a) Accounting for grant award pay- tion; ments. All payments made by the Sec- (ii) Any credits for earned interest retary shall be recorded by the grantee pursuant to paragraph (c)(1) of this sec- in accounting records separate from tion; the records of all other grant funds, in- (iii) Any other amounts due pursuant cluding funds derived from other grant to subparts F, M, and O of 45 CFR part awards. With respect to each approved 74. project the grantee shall account for Such total sum shall constitute a debt the sum total of all amounts paid by owed by the grantee to the Federal presenting or otherwise making avail- Government and shall be recovered able evidence satisfactory to the Sec- retary of expenditures for direct and from the grantee or its successors or 415 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00415 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD

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207 APPENDIX C § 59.213 42 CFR Ch. I (10–1–00 Edition) 59a.7 Other HHS regulations that apply. assignees by setoff or other action as provided by law. Subpart B—Establishment of Regional [36 FR 18465, Sept. 15, 1971, as amended at 38 Medical Libraries FR 26199, Sept. 19, 1973] 59a.11 Programs to which these regulations § 59.213 [Reserved] apply. 59a.12 Definitions. § 59.214 Additional conditions. 59a.13 Who is eligible for a grant? The Secretary may with respect to 59a.14 How to apply. any grant award impose additional 59a.15 Awards. conditions prior to or at the time of 59a.16 What other conditions apply? any award when in his judgment such 59a.17 Other HHS regulations that apply. conditions are necessary to assure or SOURCE: 56 FR 29189, June 26, 1991, unless protect advancement of the approved otherwise noted. project, the interests of public health, or the conservation of grant funds. Subpart A—Grants for Establishing, § 59.215 Applicability of 45 CFR part Expanding, and Improving 74. Basic Resources The provisions of 45 CFR part 74, es- tablishing uniform administrative re- AUTHORITY: 42 U.S.C. 286b–2, 286b–5. quirements and cost principles, shall apply to all grants under this subpart § 59a.1 Programs to which these regu- to State and local governments as lations apply. those terms are defined in subpart A of (a) The regulations of this subpart that part 74. The relevant provisions of apply to grants of funds, materials, or the following subparts of part 74 shall both, for establishing, expanding, and also apply to grants to all other grant- ee organizations under this subpart. improving basic medical library re- sources as authorized by section 474 of 45 CFR PART 74 the Act (42 U.S.C. 286b–5). Subpart: (b) This subpart also applies to coop- A General. erative agreements awarded for this B Cash Depositories. purpose. In these circumstances, ref- C Bonding and Insurance. erences to ‘‘grant(s)’’ shall include ‘‘co- D Retention and Custodial Requirements for Records. operative agreements(s).’’ F Grant-Related Income. G Matching and Cost Sharing. § 59a.2 Definitions. K Grant Payment Requirements. Undefined terms have the same L Budget Revision Procedures. M Grant Closeout, Suspension, and Termi- meaning as provided in the Act. As nation. used in this subpart: O Property. Act means the Public Health Service Q Cost Principles. Act, as amended (42 U.S.C. 201 et seq.). [38 FR 26199, Sept. 19, 1973] Project period—See § 59a.5(c). Related instrumentality means a public PART 59a—NATIONAL LIBRARY OF or private institution, organization, or MEDICINE GRANTS agency, other than a medical library, whose primary function is the acquisi- Subpart A—Grants for Establishing, Ex- tion, preservation, dissemination, and/ panding, and Improving Basic Re- or processing of information relating sources to the health sciences. Sec. Secretary means the Secretary of 59a.1 Programs to which these regulations Health and Human Services and any apply. other official of the Department of 59a.2 Definitions. Health and Human Services to whom 59a.3 Who is eligible for a grant? the authority involved is delegated. 59a.4 How are grant applications evaluated? 59a.5 Awards. 59a.6 How may funds or materials be used? 416 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00416 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T

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208 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM Public Health Service, HHS § 50.202 § 50.105 Institutional compliance. examination of the facts versus the in- terests of the subject(s) of the inves- Institutions shall foster a research tigation and the PHS in a timely reso- environment that discourages mis- lution of the matter. If the request is conduct in all research and that deals granted, the institution must file peri- forthrightly with possible misconduct odic progress reports as requested by associated with research for which PHS the OSI. If satisfactory progress is not funds have been provided or requested. made in the institution’s investigation, An institution’s failure to comply with the OSI may undertake an investiga- its assurance and the requirements of tion of its own. this subpart may result in enforcement (6) Upon receipt of the final report of action against the institution, includ- investigation and supporting mate- ing loss of funding, and may lead to the rials, the OSI will review the informa- OSI’s conducting its own investigation. tion in order to determine whether the Subpart B—Sterilization of Persons investigation has been performed in a in Federally Assisted Family timely manner and with sufficient ob- jectivity, thoroughness and com- Planning Projects petence. The OSI may then request clarification or additional information § 50.201 Applicability. and, if necessary, perform its own in- The provisions of this subpart are ap- vestigation. While primary responsi- plicable to programs or projects for bility for the conduct of investigations health services which are supported in and inquiries lies with the institution, whole or in part by Federal financial the Department reserves the right to assistance, whether by grant or con- perform its own investigation at any tract, administered by the Public time prior to, during, or following an Health Service. institution’s investigation. (7) In addition to sanctions that the § 50.202 Definitions. institution may decide to impose, the As used in this subpart: Department also may impose sanctions Arrange for means to make arrange- of its own upon investigators or insti- ments (other than mere referral of an tutions based upon authorities it pos- individual to, or the mere making of an sesses or may possess, if such action appointment for him or her with, an- seems appropriate. other health care provider) for the per- (b) The institution is responsible for formance of a medical procedure on an notifying the OSI if it ascertains at individual by a health care provider any stage of the inquiry or investiga- other than the program or project. tion, that any of the following condi- Hysterectomy means a medical proce- tions exist: dure or operation for the purpose of re- (1) There is an immediate health haz- moving the uterus. ard involved; Institutionalized individual means an (2) There is an immediate need to individual who is (1) involuntarily con- protect Federal funds or equipment; fined or detained, under a civil or (3) There is an immediate need to criminal statute, in a correctional or protect the interests of the person(s) rehabilitative facility, including a making the allegations or of the indi- mental hospital or other facility for vidual(s) who is the subject of the alle- the care and treatment of mental ill- gations as well as his/her co-investiga- ness, or (2) confined, under a voluntary tors and associates, if any; commitment, in a mental hospital or (4) It is probable that the alleged in- other facility for the care and treat- cident is going to be reported publicly. ment of mental illness. (5) There is a reasonable indication of Mentally incompetent individual means possible criminal violation. In that in- an individual who has been declared stance, the institution must inform mentally incompetent by a Federal, OSI within 24 hours of obtaining that State, or local court of competent ju- information. OSI will immediately no- risdiction for any purpose unless he or tify the Office of the Inspector General. she has been declared competent for 171 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00171 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD

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209 APPENDIX C § 50.203 42 CFR Ch. I (10–1–00 Edition) purposes which include the ability to tarily and in accordance with all the consent to sterilization. requirements of this section and § 50.205 Public Health Service means the Office of this subpart. of the Assistant Secretary for Health, (a) A person who obtains informed Health Resources and Services Admin- consent for a sterilization procedure istration, National Institutes of must offer to answer any questions the Health, Centers for Disease Control, individual to be sterilized may have Alcohol, Drug Abuse and Mental concerning the procedure, provide a Health Administration and all of their copy of the consent form, and provide constituent agencies. orally all of the following information The Secretary means the Secretary of or advice to the individual who is to be Health and Human Services and any sterilized: other officer or employee of the De- (1) Advice that the individual is free partment of Health and Human Serv- to withhold or withdraw consent to the ices to whom the authority involved procedure any time before the steri- has been delegated. lization without affecting his or her Sterilization means any medical pro- right to future care or treatment and cedure, treatment, or operation for the without loss or withdrawal of any fed- purpose of rendering an individual per- erally funded program benefits to manently incapable of reproducing. which the individual might be other- [43 FR 52165, Nov. 8, 1978, as amended at 49 wise entitled: FR 38109, Sept. 27, 1984] (2) A description of available alter- native methods of family planning and § 50.203 Sterilization of a mentally competent individual aged 21 or birth control; older. (3) Advice that the sterilization pro- cedure is considered to be irreversible; Programs or projects to which this (4) A thorough explanation of the subpart applies shall perform or ar- specific sterilization procedure to be range for the performance of steriliza- performed; tion of an individual only if the fol- (5) A full description of the discom- lowing requirements have been met: (a) The individual is at least 21 years forts and risks that may accompany or old at the time consent is obtained. follow the performing of the procedure, (b) The individual is not a mentally including an explanation of the type incompetent individual. and possible effects of any anesthetic (c) The individual has voluntarily to be used; given his or her informed consent in (6) A full description of the benefits accordance with the procedures of or advantages that may be expected as § 50.204 of this subpart. a result of the sterilization; and (d) At least 30 days but not more (7) Advice that the sterilization will than 180 days have passed between the not be performed for at least 30 days date of informed consent and the date except under the circumstances speci- of the sterilization, except in the case fied in § 50.203(d) of this subpart. of premature delivery or emergency ab- (b) An interpreter must be provided dominal surgery. An individual may to assist the individual to be sterilized consent to be sterilized at the time of if he or she does not understand the premature delivery or emergency ab- language used on the consent form or dominal surgery, if at least 72 hours the language used by the person ob- have passed after he or she gave in- taining the consent. formed consent to sterilization. In the (c) Suitable arrangements must be case of premature delivery, the in- made to insure that the information formed consent must have been given specified in paragraph (a) of this sec- at least 30 days before the expected tion is effectively communicated to date of delivery. any individual to be sterilized who is § 50.204 Informed consent require- blind, deaf or otherwise handicapped. ment. (d) A witness chosen by the indi- vidual to be sterilized may be present Informed consent does not exist un- less a consent form is completed volun- when consent is obtained. 172 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00172 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T

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210 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM Public Health Service, HHS § 50.207 (e) Informed consent may not be ob- (iii) To the best of his or her knowl- tained while the individual to be steri- edge and belief, the individual to be lized is: sterilized appeared mentally com- petent and knowingly and voluntarily (1) In labor or childbirth; consented to be sterilized. Except in (2) Seeking to obtain or obtaining an the case of premature delivery or emer- abortion; or gency abdominal surgery, the physi- (3) Under the influence of alcohol or cian must further certify that at least other substances that affect the indi- 30 days have passed between the date of vidual’s state of awareness. the individual’s signature on the con- (f) Any requirement of State and sent form and the date upon which the local law for obtaining consent, except sterilization was performed. If pre- one of spousal consent, must be fol- mature delivery occurs or emergency lowed. abdominal surgery is required within § 50.205 Consent form requirements. the 30–day period, the physician must certify that the sterilization was per- (a) Required consent form. The consent formed less than 30 days but not less form appended to this subpart or an- than 72 hours after the date of the indi- other consent form approved by the vidual’s signature on the consent form Secretary must be used. because of premature delivery or emer- (b) Required signatures. The consent gency abdominal surgery, as applica- form must be signed and dated by: ble. In the case of premature delivery, (1) The individual to be sterilized; the physician must also state the ex- and pected date of delivery. In the case of (2) The interpreter, if one is provided; emergency abdominal surgery, the phy- and sician must describe the emergency. (3) The person who obtains the con- (3) If an interpreter is provided, the sent; and interpreter must certify that he or she (4) The physician who will perform translated the information and advice the sterilization procedure. presented orally, read the consent form (c) Required certifications. (1) The per- and explained its contents and to the son obtaining the consent must certify best of the interpreter’s knowledge and by signing the consent form that: belief, the individual to be sterilized (i) Before the individual to be steri- understood what the interpreter told lized signed the consent form, he or she him or her. advised the individual to be sterilized that no Federal benefits may be with- § 50.206 Sterilization of a mentally in- drawn because of the decision not to be competent individual or of an insti- sterilized, tutionalized individual. (ii) He or she explained orally the re- Programs or projects to which this quirements for informed consent as set subpart applies shall not perform or ar- forth on the consent form, and range for the performance of a steri- (iii) To the best of his or her knowl- lization of any mentally incompetent edge and belief, the individual to be individual or institutionalized indi- sterilized appeared mentally com- vidual. petent and knowingly and voluntarily consented to be sterilized. § 50.207 Sterilization by hysterectomy. (2) The physician performing the (a) Programs or projects to which sterilization must certify by signing this subpart applies shall not perform the consent form, that: or arrange for the performance of any (i) Shortly before the performance of hysterectomy solely for the purpose of the sterilization, he or she advised the rendering an individual permanently individual to be sterilized that no Fed- incapable of reproducing or where, if eral benefits may be withdrawn be- cause of the decision not to be steri- there is more than one purpose to the lized, procedure, the hysterectomy would not be performed but for the purpose of (ii) He or she explained orally the re- rendering the individual permanently quirements for informed consent as set forth on the consent form, and incapable of reproducing. 173 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00173 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD

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211 APPENDIX C § 50.208 42 CFR Ch. I (10–1–00 Edition) (b) Except as provided in paragraph (c) The program or project shall sub- (c) of this section, programs or projects mit other reports as required and when to which this subpart applies may per- requested by the Secretary. form or arrange for the performance of § 50.209 Use of Federal financial assist- a hysterectomy not covered by para- ance. graph (a) of this section only if: (1) The person who secures the au- (a) Federal financial assistance thorization to perform the adminstered by the Public Health Serv- hysterectomy has informed the indi- ice may not be used for expenditures vidual and her representative, if any, for sterilization procedures unless the orally and in writing, that the consent form appended to this section hysterectomy will make her perma- or another form approved by the Sec- nently incapable of reproducing; and retary is used. (2) The individual or her representa- (b) A program or project shall not use tive, if any, has signed a written ac- Federal financial assistance for any knowledgment of receipt of that infor- sterilization or hysterectomy without mation. first receiving documentation showing (c)(1) A program or project is not re- that the requirements of this subpart quired to follow the procedures of para- have been met. Documentation in- graph (b) of this section if either of the cludes consent forms, and as applica- following circumstances exists: ble, either acknowledgments of receipt (i) The individual is already sterile at of hysterectomy information or certifi- the time of the hysterectomy. cation of an exception for (ii) The individual requires a hysterectomies. hysterectomy because of a life-threat- [43 FR 52165, Nov. 8, 1978, as amended at 47 ening emergency in which the physi- FR 33701, Aug. 4, 1982] cian determines that prior acknowledg- § 50.210 Review of regulation. ment is not possible. (2) If the procedures of paragraph (b) The Secretary will request public of this section are not followed because comment on the operation of the provi- one or more of the circumstances of sions of this subpart not later than 3 paragraph (c)(1) exist, the physician years after their effective date. who performs the hysterectomy must certify in writing: APPENDIX TO SUBPART B OF PART 50— (i) That the woman was already ster- REQUIRED CONSENT FORM ile, stating the cause of that sterility; NOTICE: YOUR DECISION AT ANY TIME or NOT TO BE STERILIZED WILL NOT RE- (ii) That the hysterectomy was per- SULT IN THE WITHDRAWAL OR WITH- formed under a life-threatening emer- HOLDING OF ANY BENEFITS PROVIDED gency situation in which he or she de- BY PROGRAMS OR PROJECTS RECEIVING termined prior acknowledgment was FEDERAL FUNDS. not possible. He or she must also in- CONSENT TO STERILIZATION clude a description of the nature of the emergency. I have asked for and received information about sterilization from (doc- [43 FR 52165, Nov. 8, 1978, as amended at 47 tor or clinic). When I first asked for the in- FR 33701, Aug. 4, 1982] formation, I was told that the decision to be sterilized is completely up to me. I was told § 50.208 Program or project require- that I could decide not to be sterilized. If I ments. decide not to be sterilized, my decision will (a) A program or project must, with not affect my right to future care or treat- respect to any sterilization procedure ment. I will not lose any help or benefits from programs receiving Federal funds, such or hysterectomy it performs or ar- as A.F.D.C. or medicaid that I am now get- ranges, meet all requirements of this ting or for which I may become eligible. subpart. I UNDERSTAND THAT THE STERILIZA- (b) The program or project shall TION MUST BE CONSIDERED PERMA- maintain sufficient records and docu- NENT AND NOT REVERSIBLE. I HAVE DE- mentation to assure compliance with CIDED THAT I DO NOT WANT TO BECOME these regulations, and must retain PREGNANT, BEAR CHILDREN OR FATHER such data for at least 3 years. CHILDREN. 174 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00174 Fmt 8010 Sfmt 8002 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T

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212 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM Public Health Service, HHS Pt. 50, Subpt. B, App. I was told about those temporary methods STATE OF PERSON OBTAINING CONSENT of birth control that are available and could Before (name of individual), be provided to me which will allow me to signed the consent form, I explained to him/ bear or father a child in the future. I have re- her the nature of the sterilization operation jected these alternatives and chosen to be , the fact that it is intended to sterilized. be a final and irreversible procedure and the I understand that I will be sterilized by an discomforts, risks and benefits associated operation known as a . The dis- with it. comforts, risks and benefits associated with I counseled the individual to be sterilized the operation have been explained to me. All that alternative methods of birth control are my questions have been answered to my sat- available which are temporary. I explained isfaction. that sterilization is different because it is I understand that the operation will not be permanent. done until at least 30 days after I sign this I informed the individual to be sterilized form. I understand that I can change my that his/her consent can be withdrawn at any mind at any time and that my decision at time and that he/she will not lose any health any time not to be sterilized will not result services or any benefits provided by Federal in the withholding of any benefits or medical funds. services provided by federally funded pro- To the best of my knowledge and belief the grams. individual to be sterilized is at least 21 years I am at least 21 years of age and was born old and appears mentally competent. He/She on (day), (month), (year). knowingly and voluntarily requested to be I, , hereby consent of my own sterilized and appears to understand the na- free will to be sterilized by by ture and consequence of the procedure. a method called . My consent Signature of person obtaining consent expires 180 days from the date of my signa- Date ture below. Facility I also consent to the release of this form Address and other medical records about the oper- ation to: PHYSICIAN’S STATEMENT Representatives of the Department of Shortly before I performed a sterilization Health and Human Services or operation upon (name of indi- Employees of programs or projects funded vidual to be sterilized), on (date of by that Department but only for deter- sterilization), (operation), I ex- mining if Federal laws were observed. plained to him/her the nature of the steri- I have received a copy of this form. lization operation (specify type Signature of operation), the fact that it is intended to Date: be a final and irreversible procedure and the (Month, day, year) discomforts, risks and benefits associated with it. You are requested to supply the following I counseled the individual to be sterilized information, but it is not required: that alternative methods of birth control are available which are temporary. I explained Race and ethnicity designation (please that sterilization is different because it is check) permanent. Black (not of Hispanic origin) I informed the individual to be sterilized Hispanic that his/her consent can be withdrawn at any Asian or Pacific Islander time and that he/she will not lose any health American Indian or Alaskan native services or benefits provided by Federal White (not of Hispanic origin) funds. To the best of my knowledge and belief the INTERPRETER’S STATEMENT individual to be sterilized is at least 21 years old and appears mentally competent. He/She If an interpreter is provided to assist the knowingly and voluntarily requested to be individual to be sterilized: sterilized and appeared to understand the na- I have translated the information and ad- ture and consequences of the procedure. vice presented orally to the individual to be (Instructions for use of alternative final para- sterilized by the person obtaining this con- graphs: Use the first paragraph below except sent. I have also read him/her the consent in the case of premature delivery or emer- form in language and explained gency abdominal surgery where the steriliza- its contents to him/her. To the best of my tion is performed less than 30 days after the knowledge and belief he/she understood this date of the individual’s signature on the con- explanation. sent form. In those cases, the second para- Interpreter graph below must be used. Cross out the Date paragraph which is not used.) 175 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00175 Fmt 8010 Sfmt 8002 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD

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213 APPENDIX C § 50.301 42 CFR Ch. I (10–1–00 Edition) (1) At least 30 days have passed between (d) Public health service means: (1) An the date of the individual’s signature on this agency of the United States or of a consent form and the date the sterilization State or local government, that pro- was performed. vides health or medical services; and (2) This sterilization was performed less (2) A rural health clinic, as defined than 30 days but more than 72 hours after the under section 1(d)(aa)(2) of Pub. L. 95– date of the individual’s signature on this 210, 91 Stat. 1485; except that any agen- consent form because of the following cir- cumstances (check applicable box and fill in cy or facility whose principal function information requested): is the performance of abortions is spe- cifically excluded from this definition. Premature delivery Individual’s expected date of delivery: § 50.303 General rule. Emergency abdominal surgery: (Describe circumstances): Federal financial participation is not Physician available for the performance of an Date abortion in programs or projects to [43 FR 52165, Nov. 8, 1978, as amended at 58 which this subpart applies except under FR 33343, June 17, 1993] circumstances described in § 50.304 or § 50.306. Subpart C—Abortions and Related [43 FR 4570, Feb. 2, 1978, as amended at 44 FR Medical Services in Federally 61598, Oct. 26, 1979] Assisted Programs of the Pub- lic Health Service § 50.304 Life of the mother would be endangered. AUTHORITY: Sec. 118, Pub. L. 96–86, Oct. 12, Federal financial participation is 1979, unless otherwise noted. available in expenditures for an abor- tion when a physician has found, and so SOURCE: 43 FR 4570, Feb. 2, 1978, unless oth- certified in writing to the program or erwise noted. project, that on the basis of his/her § 50.301 Applicability. professional judgment, the life of the mother would be endangered if the The provisions of this subpart are ap- fetus were carried to term. The certifi- plicable to programs or projects for cation must contain the name and ad- health services which are supported in dress of the patient. whole or in part by Federal financial assistance, whether by grant or con- (Sec. 101, Pub. L. 95–205, 91 Stat. 1461, Dec. 9, tract, appropriated to the Department 1977) of Health and Human Services and ad- [43 FR 13868, July 21, 1978] ministered by the Public Health Serv- ice. § 50.305 [Reserved] § 50.302 Definitions. § 50.306 Rape and incest. As used in this subpart: (a) Law en- Federal financial participation is forcement agency means an agency, or available in expenditures for medical any part thereof, charged under appli- procedures performed upon a victim of cable law with enforcement of the gen- rape or incest if the program or project eral penal statutes of the United has received signed documentation States, or of any State or local juris- from a law enforcement agency or pub- diction. lic health service stating: (b) Medical procedures performed upon (a) That the person upon whom the a victim of rape or incest means any medical procedure was performed was medical service, including an abortion, reported to have been the victim of an performed for the purpose of pre- incident of rape or incest; venting or terminating a pregnancy (b) The date on which the incident arising out of an incident of rape or in- occurred; cest. (c) Physician means a doctor of medi- (c) The date on which the report was cine or osteopathy legally authorized made, which must have been within 60 to practice medicine and surgery by days of the date on which the incident the State in which he or she practices. occurred; 176 ate 112000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00176 Fmt 8010 Sfmt 8002 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T

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