A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results (2009)

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Appendix C Title X Family Planning Program Regulations 197 

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 [45 FR 73658, Nov. 6, 1980. Redesignated at 61 FR 6131, Feb. 16, 1996] FR 6131, Feb. 16, 1996] Subparts E–F [Reserved] § 58.232 What additional Department regulations apply to grantees? PART 59—GRANTS FOR FAMILY Several other Department regula- PLANNING SERVICES tions apply to grantees. They include, but are not limited to: Subpart A—Project Grants for Family 42 CFR part 50, subpart D—Public Health Planning Services Service grant appeals procedure 45 CFR part 16—Procedures of the Depart- Sec. mental Grant Appeals Board 59.1 To what programs do these regulations 45 CFR part 46—Protection of human sub- apply? jects 59.2 Definitions. 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 basis of age in HHS programs or activities Subpart B [Reserved] receiving Federal financial assistance 45 CFR part 93—New restrictions on lobbying Subpart C—Grants for Family Planning [49 FR 38116, Sept. 27, 1984. Redesignated and Service Training 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. under this subpart must meet the re- 59.207 Payments. quirements of 45 CFR part 74 con- 59.208 Use of project funds. cerning audit and inspection. 59.209 Civil rights. 59.210 Inventions or discoveries. [61 FR 6131, Feb. 16, 1996; 61 FR 51020, Sept. 59.211 Publications and copyright. 30, 1996] 59.212 Grantee accountability. 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 at the time of the award if he or she de- Subpart A—Project Grants for termines that these conditions are nec- Family Planning Services essary to assure or protect the ad- vancement of the approved activity, AUTHORITY: 42 U.S.C. 300a–4. 407 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00407 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD 

APPENDIX C 199 § 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, The regulations of this subpart are 2000] 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 establishment and operation of vol- Any public or nonprofit private enti- untary family planning projects. These ty in a State may apply for a grant projects shall consist of the edu- under this subpart. cational, comprehensive medical, and social services necessary to aid individ- § 59.4 How does one apply for a family planning services grant? uals to determine freely the number and spacing of their children. (a) Application for a grant under this 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 § 59.2 Definitions. for the applicant and to assume on be- 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 of one person, or two or more persons (c) The application shall contain— living together, as a household. (1) A description, satisfactory to the Low income family means a family Secretary, of the project and how it whose total annual income does not ex- will meet the requirements of this sub- ceed 100 percent of the most recent part; Poverty Guidelines issued pursuant to (2) A budget and justification of the 42 U.S.C. 9902(2). ‘‘Low-income family’’ amount of grant funds requested; also includes members of families (3) A description of the standards and whose annual family income exceeds qualifications which will be required this amount, but who, as determined for all personnel and for all facilities to by the project director, are unable, for be used by the project; and good reasons, to pay for family plan- (4) Such other pertinent information ning services. For example, as the Secretary may require. unemancipated minors who wish to re- ceive services on a confidential basis § 59.5 What requirements must be met by a family planning project? must be considered on the basis of their own resources. (a) Each project supported under this Nonprofit, as applied to any private part must: agency, institution, or organization, (1) Provide a broad range of accept- means that no part of the entity’s net able and effective medically approved earnings benefit, or may lawfully ben- family planning methods (including efit, any private shareholder or indi- natural family planning methods) and vidual. services (including infertility services Secretary means the Secretary of and services for adolescents). If an or- Health and Human Services and any ganization offers only a single method other officer or employee of the De- of family planning, it may participate partment of Health and Human Serv- as part of a project as long as the en- ices to whom the authority involved tire project offers a broad range of fam- has been delegated. ily planning services. 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 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00408 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T 

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 (ii) If requested to provide such infor- with the title XIX, XX or XXI agency mation and counseling, provide neu- is required. 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. 1 Section 205 of Pub. L. 94–63 states: ‘‘Any (11) Provide for an Advisory Com- (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, which administers or supervises the adminis- paragraph (a) of this section, each tration of any program receiving Federal fi- project must meet each of the fol- nancial assistance, or (3) person who re- lowing requirements unless the Sec- ceives, under any program receiving Federal retary determines that the project has assistance, compensation for services, who established good cause for its omission. 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 loss of, or disqualification for the receipt of, lated to family planning (including any benefit or service under a program re- physician’s consultation, examination ceiving Federal financial assistance shall be prescription, and continuing super- fined not more than $1,000 or imprisoned for vision, laboratory examination, contra- not more than one year, or both.’’ ceptive supplies) and necessary referral 409 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00409 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD 

APPENDIX C 201 § 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 educational programs designed to— the suitability of informational and (i) Achieve community under- educational material? 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. (7) Provide that all services pur- (1) Size. The Committee shall consist chased for project participants will be of no fewer than five but not more than authorized by the project director or nine members, except that this provi- his designee on the project staff. sion may be waived by the Secretary (8) Provide for coordination and use for good cause shown. of referral arrangements with other (2) Composition. The Committee shall providers of health care services, local include individuals broadly representa- health and welfare departments, hos- tive (in terms of demographic factors pitals, voluntary agencies, and health such as race, color, national origin, services projects supported by other handicapped condition, sex, and age) of federal programs. the population or community for which (9) Provide that if family planning the materials are intended. services are provided by contract or (3) Function. In reviewing materials, other similar arrangements with ac- the Advisory Committee shall: tual providers of services, services will (i) Consider the educational and cul- be provided in accordance with a plan tural backgrounds of individuals to which establishes rates and method of whom the materials are addressed; payment for medical care. These pay- (ii) Consider the standards of the pop- ments must be made under agreements ulation or community to be served with a schedule of rates and payment with respect to such materials; procedures maintained by the grantee. (iii) Review the content of the mate- The grantee must be prepared to sub- rial to assure that the information is stantiate, that these rates are reason- factually correct; 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 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00410 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T 

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 what amount? year. Decisions regarding continuation 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; (5) The adequacy of the applicant’s § 59.9 For what purpose may grant facilities and staff; funds be used? (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 his estimate of the sum necessary for apply to grants under this subpart? 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, under section 1001, for less than 90 per- 37 CFR Part 401—Rights to inventions made cent of its costs in fiscal year 1975. In by nonprofit organizations and small busi- that case, the grant shall not be for ness firms under government grants, con- 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, (a) The notice of grant award speci- other nonprofit organizations, and com- 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 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00411 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD 

APPENDIX C 203 § 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 basis of handicap in programs and activi- (42 U.S.C. 300, 300a). ties receiving or benefitting from Federal financial assistance § 59.202 Definitions. 45 CFR Part 91—Nondiscrimination on the As used in this subpart: basis of age in HHS programs or activities (a) Act means the Public Health Serv- 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 § 59.11 Confidentiality. Samoa, or the Trust Territory of the 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 any grant, impose additional condi- § 59.203 Eligibility. 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. approved program, the interests of pub- (b) Eligible projects. Grants pursuant lic health, or the proper use of grant to section 1003 of the Act and this sub- funds. part may be made to eligible appli- cants for the purpose of providing pro- [65 FR 41278, July 3, 2000; 65 FR 49057, Aug. 10, 2000] grams, not to exceed three months in 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- AUTHORITY: Sec. 6(c), 84 Stat. 1507, 42 gram whose duration is longer than U.S.C. 300a–4; sec. 6(c), 84 Stat. 1507, 42 U.S.C. three months where he determines (1) 300a–1. that such program is consistent with SOURCE: 37 FR 7093, Apr. 8, 1972, unless oth- the purposes of this subpart and (2) erwise noted. that the program’s objectives cannot be accomplished within three months § 59.201 Applicability. because of the unusually complex or The regulations in this subpart are specialized nature of the training to be applicable to the award of grants pur- undertaken. 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 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00412 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T 

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- tain a full and adequate description of (c) Provision of a methodology to de- the project and of the manner in which fine the objectives of the training pro- the applicant intends to conduct the gram in light of the particular needs of project and carry out the requirements trainees defined pursuant to paragraph of this subpart, and a budget and jus- (b) of this section. tification of the amount of grant funds (d) Provision of a method for develop- requested, and such other pertinent in- ment of the training curriculum and formation as the Secretary may re- any attendant training materials and quire. resources. (b) The application shall be executed (e) Provision of a method for imple- by an individual authorized to act for mentation of the needed training. the applicant and to assume for the ap- (f) Provision of an evaluation meth- plicant the obligations imposed by the odology, including the manner in regulations of this subpart and any ad- which such methodology will be em- ditional conditions of the grant. ployed, to measure the achievement of 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)) [37 FR 7093, Apr. 8, 1972, as amended at 49 FR § 59.206 Evaluation and grant award. 38116, Sept. 27, 1984] (a) Within the limits of funds avail- § 59.205 Project requirements. able for such purpose, the Secretary 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- ices for the region in which the project is to family planning services; be conducted, or the Office of Family Plan- (iv) Expansion of family planning ning, Office of the Assistant Secretary for services, particularly in rural areas, Health, Washington, DC 20201. through new or improved approaches to 413 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00413 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD 

APPENDIX C 205 § 59.207 42 CFR Ch. I (10–1–00 Edition) program planning and deployment of § 59.207 Payments. 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; (5) The competence of the project the extent he determines such pay- staff in relation to the services to be ments necessary to promote prompt provided; and initiation and advancement of the ap- (6) The degree to which the project proved project. plan adequately provides for the re- § 59.208 Use of project funds. quirements set forth in § 59.205. (b) The amount of any award shall be (a) Any funds granted pursuant to determined by the Secretary on the this subpart as well as other funds to basis of his estimate of the sum nec- be used in performance of the approved essary for all or a designated portion of project shall be expended solely for direct project costs plus an additional carrying out the approved project in amount for indirect costs, if any, which accordance with the statute, the regu- will be calculated by the Secretary ei- lations of this subpart, the terms and ther: (1) On the basis of his estimate of conditions of the award, and, except as the actual indirect costs reasonably re- may otherwise be provided in this sub- lated to the project, or (2) on the basis part, the applicable cost principles pre- of a percentage of all, or a portion of, scribed by subpart Q of 45 CFR part 74. the estimated direct costs of the (b) Prior approval by the Secretary of project when there are reasonable as- revision of the budget and project plan surances that the use of such percent- is required whenever there is to be a age will not exceed the approximate significant change in the scope or na- actual indirect costs. Such award may ture of project activities. include an estimated provisional (c) The Secretary may approve the amount for indirect costs or for des- payment of grant funds to trainees for: ignated direct costs (such as travel or (1) Return travel to the trainee’s supply costs) subject to upward (within point of origin. the limits of available funds) as well as (2) Per diem during the training pro- downward adjustments to actual costs gram, and during travel to and from when the amount properly expended by the program, at the prevailing institu- the grantee for provisional items has tional or governmental rate, whichever been determined by the Secretary. is lower. (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 CFR part 74. § 59.209 Civil rights. (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, [37 FR 7093, Apr. 8, 1972, as amended at 38 FR has been issued by the Secretary of 26199, Sept. 19, 1973] Health and Human Services with the 414 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00414 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T 

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 otherwise. Appropriate measures shall (b) [Reserved] be taken by the grantee and by the (c) Accounting for grant-related in- Secretary to assure that no contracts, come—(1) Interest. Pursuant to section assignments or other arrangements in- 203 of the Intergovernmental Coopera- consistent with the grant obligation tion Act of 1968 (42 U.S.C. 4213), a State are continued or entered into and that will not be held accountable for inter- all personnel involved in the supported est earned on grant funds, pending 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 § 59.211 Publications and copyright. subsection, must return all interest earned on grant funds to the Federal Except as may otherwise be provided Government. under the terms and conditions of the award, the grantee may copyright (d) Grant closeout—(1) Date of final ac- without prior approval any publica- counting. A grantee shall render, with tions, films or similar materials devel- respect to each approved project, a full oped or resulting from a project sup- account, as provided herein, as of the ported by a grant under this part, sub- date of the termination of grant sup- ject, however, to a royalty-free, non- port. The Secretary may require other exclusive, and irrevocable license or special and periodic accounting. right in the Government to reproduce, (2) Final settlement. There shall be 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 project the grantee shall account for 74. the sum total of all amounts paid by Such total sum shall constitute a debt presenting or otherwise making avail- owed by the grantee to the Federal able evidence satisfactory to the Sec- Government and shall be recovered retary of expenditures for direct and from the grantee or its successors or 415 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00415 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD 

APPENDIX C 207 § 59.213 42 CFR Ch. I (10–1–00 Edition) assignees by setoff or other action as 59a.7 Other HHS regulations that apply. provided by law. Subpart B—Establishment of Regional [36 FR 18465, Sept. 15, 1971, as amended at 38 FR 26199, Sept. 19, 1973] Medical Libraries 59a.11 Programs to which these regulations § 59.213 [Reserved] apply. § 59.214 Additional conditions. 59a.12 Definitions. 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 protect advancement of the approved SOURCE: 56 FR 29189, June 26, 1991, unless project, the interests of public health, otherwise noted. 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- quirements and cost principles, shall AUTHORITY: 42 U.S.C. 286b–2, 286b–5. 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 that part 74. The relevant provisions of (a) The regulations of this subpart the following subparts of part 74 shall apply to grants of funds, materials, or also apply to grants to all other grant- both, for establishing, expanding, and 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. B Cash Depositories. erative agreements awarded for this C Bonding and Insurance. purpose. In these circumstances, ref- D Retention and Custodial Requirements erences to ‘‘grant(s)’’ shall include ‘‘co- for Records. operative agreements(s).’’ F Grant-Related Income. G Matching and Cost Sharing. § 59a.2 Definitions. K Grant Payment Requirements. L Budget Revision Procedures. Undefined terms have the same M Grant Closeout, Suspension, and Termi- meaning as provided in the Act. As nation. used in this subpart: O Property. Q Cost Principles. Act means the Public Health Service 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. 59a.2 Definitions. other official of the Department of 59a.3 Who is eligible for a grant? Health and Human Services to whom 59a.4 How are grant applications evaluated? the authority involved is delegated. 59a.5 Awards. 59a.6 How may funds or materials be used? 416 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00416 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T 

208 A REVIEW OF THE HHS FAMILY PLANNING PROGRAM Public Health Service, HHS § 50.202 examination of the facts versus the in- § 50.105 Institutional compliance. 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 investigation has been performed in a Subpart B—Sterilization of Persons timely manner and with sufficient ob- in Federally Assisted Family jectivity, thoroughness and com- petence. The OSI may then request Planning Projects clarification or additional information § 50.201 Applicability. and, if necessary, perform its own in- vestigation. While primary responsi- The provisions of this subpart are ap- bility for the conduct of investigations plicable to programs or projects for and inquiries lies with the institution, health services which are supported in the Department reserves the right to whole or in part by Federal financial 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 Department also may impose sanctions As used in this subpart: of its own upon investigators or insti- Arrange for means to make arrange- tutions based upon authorities it pos- ments (other than mere referral of an sesses or may possess, if such action individual to, or the mere making of an seems appropriate. appointment for him or her with, an- (b) The institution is responsible for other health care provider) for the per- 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- tions exist: Hysterectomy means a medical proce- 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 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00171 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD 

APPENDIX C 209 § 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. Sterilization means any medical pro- lization without affecting his or her cedure, treatment, or operation for the right to future care or treatment and purpose of rendering an individual per- without loss or withdrawal of any fed- manently incapable of reproducing. erally funded program benefits to 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- § 50.203 Sterilization of a mentally native methods of family planning and competent individual aged 21 or birth control; older. (3) Advice that the sterilization pro- Programs or projects to which this cedure is considered to be irreversible; subpart applies shall perform or ar- (4) A thorough explanation of the range for the performance of steriliza- specific sterilization procedure to be tion of an individual only if the fol- performed; lowing requirements have been met: (5) A full description of the discom- (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 consent to be sterilized at the time of to assist the individual to be sterilized premature delivery or emergency ab- if he or she does not understand the dominal surgery, if at least 72 hours language used on the consent form or have passed after he or she gave in- the language used by the person ob- formed consent to sterilization. In the taining the consent. case of premature delivery, the in- (c) Suitable arrangements must be formed consent must have been given made to insure that the information at least 30 days before the expected specified in paragraph (a) of this sec- date of delivery. tion is effectively communicated to 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- Informed consent does not exist un- vidual to be sterilized may be present less a consent form is completed volun- when consent is obtained. 172 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00172 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T 

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- (1) In labor or childbirth; petent and knowingly and voluntarily (2) Seeking to obtain or obtaining an consented to be sterilized. Except in abortion; or the case of premature delivery or emer- (3) Under the influence of alcohol or gency abdominal surgery, the physi- other substances that affect the indi- cian must further certify that at least vidual’s state of awareness. 30 days have passed between the date of (f) Any requirement of State and the individual’s signature on the con- local law for obtaining consent, except sent form and the date upon which the one of spousal consent, must be fol- sterilization was performed. If pre- lowed. mature delivery occurs or emergency abdominal surgery is required within § 50.205 Consent form requirements. the 30–day period, the physician must (a) Required consent form. The consent certify that the sterilization was per- form appended to this subpart or an- formed less than 30 days but not less other consent form approved by the than 72 hours after the date of the indi- Secretary must be used. vidual’s signature on the consent form (b) Required signatures. The consent because of premature delivery or emer- form must be signed and dated by: gency abdominal surgery, as applica- (1) The individual to be sterilized; ble. In the case of premature delivery, and the physician must also state the ex- (2) The interpreter, if one is provided; pected date of delivery. In the case of and emergency abdominal surgery, the phy- (3) The person who obtains the con- sician must describe the emergency. sent; and (3) If an interpreter is provided, the (4) The physician who will perform interpreter must certify that he or she the sterilization procedure. translated the information and advice (c) Required certifications. (1) The per- presented orally, read the consent form son obtaining the consent must certify and explained its contents and to the by signing the consent form that: best of the interpreter’s knowledge and (i) Before the individual to be steri- belief, the individual to be sterilized lized signed the consent form, he or she understood what the interpreter told advised the individual to be sterilized him or her. 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- quirements for informed consent as set Programs or projects to which this forth on the consent form, and subpart applies shall not perform or ar- (iii) To the best of his or her knowl- range for the performance of a steri- edge and belief, the individual to be lization of any mentally incompetent sterilized appeared mentally com- individual or institutionalized indi- petent and knowingly and voluntarily vidual. consented to be sterilized. § 50.207 Sterilization by hysterectomy. (2) The physician performing the sterilization must certify by signing (a) Programs or projects to which the consent form, that: this subpart applies shall not perform (i) Shortly before the performance of or arrange for the performance of any the sterilization, he or she advised the hysterectomy solely for the purpose of individual to be sterilized that no Fed- rendering an individual permanently eral benefits may be withdrawn be- incapable of reproducing or where, if cause of the decision not to be steri- there is more than one purpose to the lized, procedure, the hysterectomy would not (ii) He or she explained orally the re- be performed but for the purpose of quirements for informed consent as set rendering the individual permanently forth on the consent form, and incapable of reproducing. 173 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00173 Fmt 8010 Sfmt 8010 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD 

APPENDIX C 211 § 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 a hysterectomy not covered by para- § 50.209 Use of Federal financial assist- graph (a) of this section only if: ance. (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- ment is not possible. § 50.210 Review of regulation. (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; or NOTICE: YOUR DECISION AT ANY TIME (ii) That the hysterectomy was per- NOT TO BE STERILIZED WILL NOT RE- formed under a life-threatening emer- SULT IN THE WITHDRAWAL OR WITH- 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- clude a description of the nature of the CONSENT TO STERILIZATION emergency. I have asked for and received information [43 FR 52165, Nov. 8, 1978, as amended at 47 about sterilization from (doc- FR 33701, Aug. 4, 1982] tor or clinic). When I first asked for the in- formation, I was told that the decision to be § 50.208 Program or project require- sterilized is completely up to me. I was told ments. that I could decide not to be sterilized. If I 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 or hysterectomy it performs or ar- from programs receiving Federal funds, such ranges, meet all requirements of this as A.F.D.C. or medicaid that I am now get- subpart. ting or for which I may become eligible. 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 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00174 Fmt 8010 Sfmt 8002 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T 

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 expires 180 days from the date of my signa- Signature of person obtaining consent ture below. Date I also consent to the release of this form Facility and other medical records about the oper- Address ation to: PHYSICIAN’S STATEMENT Representatives of the Department of Health and Human Services or Shortly before I performed a sterilization Employees of programs or projects funded operation upon (name of indi- by that Department but only for deter- vidual to be sterilized), on (date of mining if Federal laws were observed. sterilization), (operation), I ex- I have received a copy of this form. plained to him/her the nature of the steri- 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 Race and ethnicity designation (please available which are temporary. I explained check) that sterilization is different because it is 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 If an interpreter is provided to assist the old and appears mentally competent. He/She individual to be sterilized: knowingly and voluntarily requested to be I have translated the information and ad- sterilized and appeared to understand the na- vice presented orally to the individual to be ture and consequences of the procedure. sterilized by the person obtaining this con- (Instructions for use of alternative final para- sent. I have also read him/her the consent graphs: Use the first paragraph below except form in language and explained in the case of premature delivery or emer- its contents to him/her. To the best of my gency abdominal surgery where the steriliza- knowledge and belief he/she understood this tion is performed less than 30 days after the explanation. date of the individual’s signature on the con- sent form. In those cases, the second para- Interpreter graph below must be used. Cross out the Date paragraph which is not used.) 175 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00175 Fmt 8010 Sfmt 8002 Y:\SGML\190164T.XXX pfrm02 PsN: 190164TVerD 

APPENDIX C 213 § 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. (2) This sterilization was performed less vides health or medical services; and than 30 days but more than 72 hours after the (2) A rural health clinic, as defined date of the individual’s signature on this under section 1(d)(aa)(2) of Pub. L. 95– consent form because of the following cir- 210, 91 Stat. 1485; except that any agen- cumstances (check applicable box and fill in cy or facility whose principal function information requested): is the performance of abortions is spe- Premature delivery cifically excluded from this definition. Individual’s expected date of delivery: Emergency abdominal surgery: § 50.303 General rule. (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- SOURCE: 43 FR 4570, Feb. 2, 1978, unless oth- tion when a physician has found, and so erwise noted. certified in writing to the program or project, that on the basis of his/her § 50.301 Applicability. professional judgment, the life of the The provisions of this subpart are ap- mother would be endangered if the plicable to programs or projects for fetus were carried to term. The certifi- health services which are supported in cation must contain the name and ad- whole or in part by Federal financial dress of the patient. 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- ministered by the Public Health Serv- [43 FR 13868, July 21, 1978] ice. § 50.305 [Reserved] § 50.302 Definitions. § 50.306 Rape and incest. As used in this subpart: (a) Law en- forcement agency means an agency, or Federal financial participation is any part thereof, charged under appli- available in expenditures for medical cable law with enforcement of the gen- procedures performed upon a victim of eral penal statutes of the United rape or incest if the program or project States, or of any State or local juris- has received signed documentation diction. from a law enforcement agency or pub- (b) Medical procedures performed upon lic health service stating: a victim of rape or incest means any (a) That the person upon whom the medical service, including an abortion, medical procedure was performed was performed for the purpose of pre- reported to have been the victim of an venting or terminating a pregnancy incident of rape or incest; arising out of an incident of rape or in- (b) The date on which the incident cest. occurred; (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 Date 11<MAY>2000 01:34 Nov 17, 2000 Jkt 190164 PO 00000 Frm 00176 Fmt 8010 Sfmt 8002 Y:\SGML\190164T.XXX pfrm02 PsN: 190164T