The Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated.

Sterilization means any medical procedure, treatment, or operation for the purpose of rendering an individual permanently incapable of reproducing.

[43 FR 52165, Nov. 8, 1978, as amended at 49 FR 38109, Sept. 27, 1984]

§ 50.203 Sterilization of a mentally competent individual aged 21 or older.

Programs or projects to which this subpart applies shall perform or arrange for the performance of sterilization of an individual only if the following requirements have been met:

(a) The individual is at least 21 years old at the time consent is obtained.

(b) The individual is not a mentally incompetent individual.

(c) The individual has voluntarily given his or her informed consent in accordance with the procedures of § 50.204 of this subpart.

(d) At least 30 days but not more than 180 days have passed between the date of informed consent and the date of the sterilization, except in the case of premature delivery or emergency abdominal surgery. An individual may consent to be sterilized at the time of premature delivery or emergency abdominal surgery, if at least 72 hours have passed after he or she gave informed consent to sterilization. In the case of premature delivery, the informed consent must have been given at least 30 days before the expected date of delivery.

or advice to the individual who is t sterilized:

(1) Advice that the individual t to withhold or withdraw consent procedure any time before the st lization without affecting his or right to future care or treatment without loss or withdrawal of any erally funded program benefits ¦ which the individual might be othe wise entitled:

(2) A description of available ar native methods of family planning birth control;

(3) Advice that the sterilization F cedure is considered to be irreversi

(4) A thorough explanation of specific sterilization procedure > performed;

(5) A full description of the disc forts and risks that may accompany follow the performing of the proced including an explanation of the and possible effects of any anesthe

to be used;

(6) A full description of the benef or advantages that may be expected a result of the sterilization; and

(7) Advice that the sterilization

not be performed for at least 30 d except under the circumstances spec fied in § 50.203(d) of this subpart.

(b) An interpreter must be provide to assist the individual to be sterilis if he or she does not understand th language used on the consent form the language used by the person taining the consent.

(c) Suitable arrangements must Imade to insure that the informatic specified in paragraph (a) of this s tion is effectively communicated blind, deaf or otherwise handicapped any individual to be sterilized who

(d) A witness chosen by the indiv ual to be sterilized may be preser

when consent is obtained.

tained while the individual to be ster (e) Informed consent may not be a

lized is:

(1) In labor or childbirth;

(2) Seeking to obtain or obtaining &

abortion; or

(3) Under the influence of alcohol other substances that affect the ind

vidual's sta“

(f) Any local law

N

of spousal consent, must be fold.

205 Consent form requirements. *) Required consent form. The consent in appended to this subpart or aner consent form approved by the retary must be used.

=) Required signatures. The consent In must be signed and dated by: 2) The individual to be sterilized;

!) The interpreter, if one is provided;

3) The person who obtains the cont; and

4) The physician who will perform sterilization procedure.

c) Required certifications. (1) The per1 obtaining the consent must certify signing the consent form that:

i) Before the individual to be steried signed the consent form, he or she Ivised the individual to be sterilized at no Federal benefits may be withawn because of the decision not to be erilized,

(ii) He or she explained orally the reirements for informed consent as set rth on the consent form, and

(iii) To the best of his or her knowllge and belief, the individual to be erilized appeared mentally competent and knowingly and voluntarily consented to be sterilized.

(2) The physician performing the Cerilization must certify by signing ne consent form, that:

(i) Shortly before the performance of he sterilization, he or she advised the ndividual to be sterilized that no Fedral benefits may be withdrawn behause of the decision not to be steriized,

(ii) He or she explained orally the requirements for informed consent as set Worth on the consent form, and

(iii) To the best of his or her knowledge and belief, the individual to be sterilized appeared mentally competent and knowingly and voluntarily consented to be sterilized. Except in the case of premature delivery or emergency abdominal surgery, the physician must further certify that at least 30 days have passed between the date of the individual's senature on the consent form n which the If pre

sterilizat

mature delivery occurs or emergency abdominal surgery is required within the 30-day period, the physician must certify that the sterilization was performed less than 30 days but not less than 72 hours after the date of the individual's signature on the consent form because of premature delivery or emergency abdominal surgery, as applicable. In the case of premature delivery, the physician must also state the expected date of delivery. In the case of emergency abdominal surgery, the physician must describe the emergency.

(3) If an interpreter is provided, the interpreter must certify that he or she translated the information and advice presented orally, read the consent form and explained its contents and to the best of the interpreter's knowledge and belief, the individual to be sterilized understood what the interpreter told him or her.

§ 50.206 Sterilization of a mentally incompetent individual or of an institutionalized individual.

Programs or projects to which this subpart applies shall not perform or arrange for the performance of a sterilization of any mentally incompetent individual or institutionalized individual.

§ 50.207 Sterilization by hysterectomy.

(a) Programs or projects to which this subpart applies shall not perform or arrange for the performance of any hysterectomy solely for the purpose of rendering an individual permanently incapable of reproducing or where, if there is more than one purpose to the procedure, the hysterectomy would not be performed but for the purpose of rendering the individual permanently incapable of reproducing.

(b) Except as provided in paragraph (c) of this section, programs or projects to which this subpart applies may perform or arrange for the performance of a hysterectomy not covered by paragraph (a) of this section only if:

(1) The person who secures the authorization to perform the hysterectomy has informed the individual and her representative, if any, orally and in writing, that the hysterectomy will make her permanently incapable of reproducing; and

(b) A program or project shall not a Federal financial assistance for sterilization or hysterectomy within first receiving documentation sho that the requirements of this subpr have been met. Documentation 2 cludes consent forms, and as appl ble, either acknowledgments of rect of hysterectomy information or cer cation of an exception

hysterectomies.

[43 FR 52165, Nov. 8, 1978, as amended FR 33701, Aug. 4, 1982]

$50.210 Review of regulation.

The Secretary will request pu comment on the operation of the pro sions of this subpart not later than years after their effective date.

APPENDIX TO SUBPART B OF PART 50

REQUIRED CONSENT FORM

NOTICE: YOUR DECISION AT ANY THE NOT TO BE STERILIZED WILL NOT B SULT IN THE WITHDRAWAL OR WIE HOLDING OF ANY BENEFITS PROVIDE BY PROGRAMS OR PROJECTS RECEIVIN FEDERAL FUNDS.

CONSENT TO STERILIZATION

I have asked for and received informatio about sterilization from

tor or clinic). When I first asked for the formation, I was told that the decision to sterilized is completely up to me. I was to that I could decide not to be sterilized. decide not to be sterilized, my decision not affect my right to future care or tres ment. I will not lose any help or benef from programs receiving Federal funds, suc as A.F.D.C. or medicaid that I am now ge ting or for which I may become eligible.

I UNDERSTAND THAT THE STERILIZ TION MUST BE CONSIDERED PERMA NENT AND NOT REVERSIBLE. I HAVE DE CIDED THAT I DO NOT WANT TO BECOME PREGNANT, BEAR CHILDREN OR FATHER CHILDREN.

I was told about those temporary method of birth control that are available and cou be provided to me which will allow me w bear or father a child in the future. I have re jected these alternatives and chosen to be sterilized.

I understand that I will be sterilized by t operation known as a The dis comforts, risks and benefits associated with the operation have been explained to me. A my questions have been answered to my sa isfaction.

I understand that the or done until at least form. I understan

d at any time and that my decision at time not to be sterilized will not result he withholding of any benefits or medical -vices provided by federally funded pro

ms.

am at least 21 years of age and was born (day), (month), (year). hereby consent of my own

e will to be sterilized by by method called My consent bires 180 days from the date of my signae below.

also consent to the release of this form d other medical records about the operon to:

Representatives of the Department of alth and Human Services or Employees of programs or projects funded that Department but only for determinIg if Federal laws were observed.

I have received a copy of this form. gnature

ite:

Month, day, year)

You are requested to supply the following formation, but it is not required:

ace and ethnicity designation (please check)

lack (not of Hispanic origin) Hispanic

sian or Pacific Islander

.merican Indian or Alaskan native White (not of Hispanic origin)

INTERPRETER'S STATEMENT

If an interpreter is provided to assist the ndividual to be sterilized:

I have translated the information and advice presented orally to the individual to be sterilized by the person obtaining this consent. I have also read him/her the consent form in language and explained

its contents to him/her. To the best of my knowledge and belief he/she understood this explanation.

Interpreter Date

STATE OF PERSON OBTAINING CONSENT Before (name of individual), signed the consent form, I explained to him/ her the nature of the sterilization operation the fact that it is intended to be a final and irreversible procedure and the discomforts, risks and benefits associated with it.

I counseled the individual to be sterilized that alternative methods of birth control are available which are temporary. I explained that sterilization is different because it is permanent.

I informed the individual to be sterilized that his/her consent can be withdrawn at any time and that he/she will not lose any health

services or any benefits provided by Federal funds.

To the best of my knowledge and belief the individual to be sterilized is at least 21 years old and appears mentally competent. He/She knowingly and voluntarily requested to be sterilized and appears to understand the nature and consequence of the procedure. Signature of person obtaining consent Date

Facility Address

PHYSICIAN'S STATEMENT

Shortly before I performed a sterilization operation upon

vidual to be sterilized), on sterilization),

(name of indi(date of (operation), I ex

plained to him/her the nature of the sterilization operation (specify type

of operation), the fact that it is intended to be a final and irreversible procedure and the discomforts, risks and benefits associated with it.

I counseled the individual to be sterilized that alternative methods of birth control are available which are temporary. I explained that sterilization is different because it is permanent.

I informed the individual to be sterilized that his/her consent can be withdrawn at any time and that he/she will not lose any health services or benefits provided by Federal funds.

To the best of my knowledge and belief the individual to be sterilized is at least 21 years old and appears mentally competent. He/She knowingly and voluntarily requested to be sterilized and appeared to understand the nature and consequences of the procedure.

(Instructions for use of alternative final paragraphs: Use the first paragraph below except in the case of premature delivery or emergency abdominal surgery where the sterilization is performed less than 30 days after the date of the individual's signature on the consent form. In those cases, the second paragraph below must be used. Cross out the paragraph which is not used.)

(1) At least 30 days have passed between the date of the individual's signature on this consent form and the date the sterilization was performed.

(2) This sterilization was performed less than 30 days but more than 72 hours after the date of the individual's signature on this consent form because of the following circumstances (check applicable box and fill in information requested):

Date

[43 FR 52165, Nov. 8, 1978, as amended at 58 FR 33343, June 17, 1993]

Subpart C-Abortions and Related Medical Services in Federally Assisted Programs of the Public Health Service

AUTHORITY: Sec. 118, Pub. L. 96-86, Oct. 12, 1979, unless otherwise noted.

SOURCE: 43 FR 4570, Feb. 2, 1978, unless otherwise noted.

$50.301 Applicability.

The provisions of this subpart are applicable to programs or projects for health services which are supported in whole or in part by Federal financial assistance, whether by grant or contract, appropriated to the Department of Health and Human Services and administered by the Public Health Service.

$50.302 Definitions.

As used in this subpart: (a) Law enforcement agency means an agency, or any part thereof, charged under applicable law with enforcement of the general penal statutes of the United States, or of any State or local jurisdiction.

(b) Medical procedures performed upon a victim of rape or incest means any medical service, including an abortion, performed for the purpose of preventing or terminating a pregnancy arising out of an incident of rape or incest.

(c) Physician means a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he or she practices.

(d) Public health service means: (1) An agency of the United States or of a State or local government, that provides health or medical services; and

(2) A rural health clinic, as defined under section 1(d)(aa)(2) of Pub. L. 95210, 91 Stat. 1485; except that any agency or facility whose principal function is the performance of abortions is specifically excluded from this definition.

§50.303 General rule.

Federal financial participation is not available for the performance of an

abortion in programs or projecta which this subpart applies except circumstances described in $50.304 § 50.306.

[43 FR 4570, Feb. 2, 1978, as amended at #E 61598, Oct. 26, 1979]

$50.304 Life of the mother would b endangered.

Federal financial participation › available in expenditures for an abe tion when a physician has found, andi certified in writing to the program : project, that on the basis of hist professional judgment, the life of mother would be endangered if fetus were carried to term. The certi Ication must contain the name and dress of the patient.

(Sec. 101, Pub. L. 95-205, 91 Stat. 1461, Dec

1977)

wi th (S 19

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