[Code of Federal Regulations]
[Title 42, Volume 1, Parts 1 to 399]
[Revised as of October 1, 1996]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR50]

[Page 161-176]

                         TITLE 42--PUBLIC HEALTH

 CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 50--POLICIES OF GENERAL APPLICABILITY
Subpart A--Responsibility of PHS Awardee and Applicant Institutions for
        Dealing With and Reporting Possible Misconduct in Science
Sec.
50.101  Applicability.
50.102  Definitions.
50.103  Assurance--Responsibi
    Subpart B--Sterilization of Persons in Federally Assisted Family
                            Planning Projects
50.201  Applicability.
50.202  Definitions.
50.203  Sterilization of a mentally competent individual aged 21 or
          older.
50.204  Informed consent requirement.
50.205  Consent form requirements.
50.206  Sterilization of a mentally incompetent individual or of an
          institutionalized individual.
50.207  Sterilization by hysterectomy.
50.208  Program or project requirements.
50.209  Use of Federal financial assistance.
50.210  Review of regulation.

Appendix to Subpart B of Part 50--Required Consent Form

Subpart C--Abortions and Related Medical Services in Federally Assisted
                  Programs of the Public Health Service
50.301  Applicability.
50.302  Definitions.
50.303  General rule.
50.304  Life of the mother would be endangered.
50.305  [Reserved]
50.306  Rape and incest.
50.307  Documentation needed by programs or projects.
50.308  Drugs and devices and termination of ectopic pregnancies.
50.309  Recordkeeping requirements.
50.310  Confidentiality.

        Subpart D--Public Health Service Grant Appeals Procedure

50.401  What is the purpose of this subpart?
50.402  To what programs do these regulations apply?
50.403  What is the policy basis for these procedures?
50.404  What disputes are covered by these procedures?
50.405  What is the structure of review committees?
50.406  What are the steps in the process?

               Subpart E--Maximum Allowable Cost for Drugs

50.501  Applicability.
50.502  Definitions.
50.503  Policy.
50.504  Allowable cost of drugs.

  Subpart F--Responsibility of Applicants for Promoting Objectivity in
                Research for Which PHS Funding Is Sought

50.601  Purpose.
50.602  Applicability.
50.603  Definitions.
50.607  Other HHS regulations that apply.

    Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42
U.S.C. 216); Sec. 1006, Public Health Service Act, 84 Stat. 1507 (42
U.S.C. 300a-4), unless otherwise noted.

    Source: 43 FR 52165, Nov. 8, 1978, unless otherwise noted.

    Editorial Note: At 61 FR 56631, Nov. 4, 1996, a CFR correction was
published reinstating Secs. 50.604, 50.605 and 50.606.

Subpart A--Responsibility of PHS Awardee and Applicant Institutions for
        Dealing With and Reporting Possible Misconduct in Science

    Authority: Sec. 493, Public Health Service Act, as amended, 99 Stat.
874-875 (42 U.S.C. 289b); Sec. 501(f), Public Health Service Act, as
amended, 102 Stat. 4213 (42 U.S.C. 290aa(f)).

    Source: 54 FR 32449, Aug. 8, 1989, unless otherwise noted.

Sec. 50.101  Applicability.

    This subpart applies to each entity which applies for a research,
research-training, or research-related grant or cooperative agreement
under the Public Health Service (PHS) Act. It requires each such entity
to establish uniform policies and procedures for investigating and
reporting instances of alleged or apparent misconduct involving research
or research training, applications for support of research or research
training, or related research activities that are supported with funds
made available under the PHS Act.

[[Page 162]]

This subpart does not supersede and is not intended to set up an
alternative to established procedures for resolving fiscal
improprieties, issues concerning the ethical treatment of human or
animal subjects, or criminal matters.

Sec. 50.102  Definitions.

    As used in this subpart:
    Act means the Public Health Service Act, as amended, (42 U.S.C. 201
et seq.).
    Inquiry means information gathering and initial factfinding to
determine whether an allegation or apparent instance of misconduct
warrants an investigation.
    Institution means the public or private entity or organization
(including federal, state, and other agencies) that is applying for
financial assistance from the PHS, e.g., grant or cooperative
agreements, including continuation awards, whether competing or
noncompeting. The organization assumes legal and financial
accountability for the awarded funds and for the performance of the
supported activities.
    Investigation means the formal examination and evaluation of all
relevant facts to determine if misconduct has occurred.
    Misconduct or Misconduct in Science means fabrication,
falsification, plagiarism, or other practices that seriously deviate
from those that are commonly accepted within the scientific community
for proposing, conducting, or reporting research. It does not include
honest error or honest differences in interpretations or judgments of
data.
    OSI means the Office of Scientific Integrity, a component of the
Office of the Director of the National Institutes for Health (NIH),
which oversees the implementation of all PHS policies and procedures
related to scientific misconduct; monitors the individual investigations
into alleged or suspected scientific misconduct conducted by
institutions that receive PHS funds for biomedical or behavioral
research projects or programs; and conducts investigations as necessary.
    OSIR means the Office of Scientific Integrity Review, a component of
the Office of the Assistant Secretary for Health, which is responsible
for establishing overall PHS policies and procedures for dealing with
misconduct in science, overseeing the activities of PHS research
agencies to ensure that these policies and procedures are implemented,
and reviewing all final reports of investigations to assure that any
findings and recommendations are sufficiently documented. The OSIR also
makes final recommendations to the Assistant Secretary for Health on
whether any sanctions should be imposed and, if so, what they should be
in any case where scientific misconduct has been established.
    PHS means the Public Health Service, an operating division of the
Department of Health and Human Services (HHS). References to PHS include
organizational units within the PHS that have delegated authority to
award financial assistance to support scientific activities, e.g.,
Bureaus, Institutes, Divisions, Centers or Offices.
    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 may be delegated.

Sec. 50.103  Assurance--Responsibilities of PHS awardee and applicant
          institutions.

    (a) Assurances. Each institution that applies for or receives
assistance under the Act for any project or program which involves the
conduct of biomedical or behavioral research must have an assurance
satisfactory to the Secretary that the applicant:
    (1) Has established an administrative process, that meets the
requirements of this Subpart, for reviewing, investigating, and
reporting allegations of misconduct in science in connection with PHS-
sponsored biomedical and behavioral research conducted at the applicant
institution or sponsored by the applicant; and
    (2) Will comply with its own administrative process and the
requirements of this Subpart.
    (b) Annual Submission. An applicant or recipient institution shall
make an annual submission to the OSI as follows:
    (1) The institution's assurance shall be submitted to the OSI, on a
form prescribed by the Secretary, as soon as

[[Page 163]]

possible after November 8, 1989, but no later than January 1, 1990, and
updated annually therefter on a date specified by OSI. Copies of the
form may be requested through the Director, OSI.
    (2) An institution shall submit, along with its annual assurance,
such aggregate information on allegations, inquiries, and investigations
as the Secretary may prescribe.
    (c) General Criteria. In general, an applicant institution will be
considered to be in compliance with its assurance if it:
    (1) Establishes, keeps current, and upon request provides the OSIR,
the OSI, and other authorized Departmental officials the policies and
procedures required by this subpart.
    (2) Informs its scientific and administrative staff of the policies
and procedures and the importance of compliance with those policies and
procedures.
    (3) Takes immediate and appropriate action as soon as misconduct on
the part of employees or persons within the organization's control is
suspected or alleged.
    (4) Informs, in accordance with this subpart, and cooperates with
the OSI with regard to each investigation of possible misconduct.
    (d) Inquiries, Investigations, and Reporting--Specific Requirements.
Each applicant's policies and procedures must provide for:
    (1) Inquiring immediately into an allegation or other evidence of
possible misconduct. An inquiry must be completed within 60 calendar
days of its initiation unless circumstances clearly warrant a longer
period. A written report shall be prepared that states what evidence was
reviewed, summarizes relevant interviews, and includes the conclusions
of the inquiry. The individual(s) against whom the allegation was made
shall be given a copy of the report of inquiry. If they comment on that
report, their comments may be made part of the record. If the inquiry
takes longer than 60 days to complete, the record of the inquiry shall
include documentation of the reasons for exceeding the 60-day period.
    (2) Protecting, to the maximum extent possible, the privacy of those
who in good faith report apparent misconduct.
    (3) Affording the affected individual(s) confidential treatment to
the maximum extent possible, a prompt and thorough investigation, and an
opportunity to comment on allegations and findings of the inquiry and/or
the investigation.
    (4) Notifying the Director, OSI, in accordance with Sec. 50.104(a)
when, on the basis of the initial inquiry, the institution determines
that an investigation is warranted, or prior to the decision to initiate
an investigation if the conditions listed in Sec. 50.104(b) exist.
    (5) Notifying the OSI within 24 hours of obtaining any reasonable
indication of possible criminal violations, so that the OSI may then
immediately notify the Department's Office of Inspector General.
    (6) Maintaining sufficiently detailed documentation of inquiries to
permit a later assessment of the reasons for determining that an
investigation was not warranted, if necessary. Such records shall be
maintained in a secure manner for a period of at least three years after
the termination of the inquiry, and shall, upon request, be provided to
authorized HHS personnel.
    (7) Undertaking an investigation within 30 days of the completion of
the inquiry, if findings from that inquiry provide sufficient basis for
conducting an investigation. The investigation normally will include
examination of all documentation, including but not necessarily limited
to relevant research data and proposals, publications, correspondence,
and memoranda of telephone calls. Whenever possible, interviews should
be conducted of all individuals involved either in making the allegation
or against whom the allegation is made, as well as other individuals who
might have information regarding key aspects of the allegations;
complete summaries of these interviews should be prepared, provided to
the interviewed party for comment or revision, and included as part of
the investigatory file.
    (8) Securing necessary and appropriate expertise to carry out a
thorough and authoritative evaluation of the relevant evidence in any
inquiry or investigation.

[[Page 164]]

    (9) Taking precautions against real or apparent conflicts of
interest on the part of those involved in the inquiry or investigation.
    (10) Preparing and maintaining the documentation to substantiate the
investigation's findings. This documentation is to be made available to
the Director, OSI, who will decide whether that Office will either
proceed with its own investigation or will act on the institution's
findings.
    (11) Taking interim administrative actions, as appropriate, to
protect Federal funds and insure that the purposes of the Federal
financial assistance are carried out.
    (12) Keeping the OSI apprised of any developments during the course
of the investigation which disclose facts that may affect current or
potential Department of Health and Human Services funding for the
individual(s) under investigation or that the PHS needs to know to
ensure appropriate use of Federal funds and otherwise protect the public
interest.
    (13) Undertaking diligent efforts, as appropriate, to restore the
reputations of persons alleged to have engaged in misconduct when
allegations are not confirmed, and also undertaking diligent efforts to
protect the positions and reputations of those persons who, in good
faith, make allegations.
    (14) Imposing appropriate sanctions on individuals when the
allegation of misconduct has been substantiated.
    (15) Notifying the OSI of the final outcome of the investigation.

Sec. 50.104  Reporting to the OSI.

    (a)(1) An institution's decision to initiate an investigation must
be reported in writing to the Director, OSI, on or before the date the
investigation begins. At a minimum, the notification should include the
name of the person(s) against whom the allegations have been made, the
general nature of the allegation, and the PHS application or grant
number(s) involved. Information provided through the notification will
be held in confidence to the extent permitted by law, will not be
disclosed as part of the peer review and Advisory Committee review
processes, but may be used by the Secretary in making decisions about
the award or continuation of funding.
    (2) An investigation should ordinarily be completed within 120 days
of its initiation. This includes conducting the investigation, preparing
the report of findings, making that report available for comment by the
subjects of the investigation, and submitting the report to the OSI. If
they can be identified, the person(s) who raised the allegation should
be provided with those portions of the report that address their role
and opinions in the investigation.
    (3) Institutions are expected to carry their investigations through
to completion, and to pursue diligently all significant issues. If an
institution plans to terminate an inquiry or investigation for any
reason without completing all relevant requirements under
Sec. 50.103(d), a report of such planned termination, including a
description of the reasons for such termination, shall be made to OSI,
which will then decide whether further investigation should be
undertaken.
    (4) The final report submitted to the OSI must describe the policies
and procedures under which the investigation was conducted, how and from
whom information was obtained relevant to the investigation, the
findings, and the basis for the findings, and include the actual text or
an accurate summary of the views of any individual(s) found to have
engaged in misconduct, as well as a description of any sanctions taken
by the institution.
    (5) If the institution determines that it will not be able to
complete the investigation in 120 days, it must submit to the OSI a
written request for an extension and an explanation for the delay that
includes an interim report on the progress to date and an estimate for
the date of completion of the report and other necessary steps. Any
consideration for an extension must balance the need for a thorough and
rigorous examination of the facts versus the interests of the subject(s)
of the investigation and the PHS in a timely resolution of the matter.
If the request is granted, the institution must file periodic progress
reports as requested by the OSI. If satisfactory progress is not made in
the institution's investigation,

[[Page 165]]

the OSI may undertake an investigation of its own.
    (6) Upon receipt of the final report of investigation and supporting
materials, the OSI will review the information in order to determine
whether the investigation has been performed in a timely manner and with
sufficient objectivity, thoroughness and competence. The OSI may then
request clarification or additional information and, if necessary,
perform its own investigation. While primary responsibility for the
conduct of investigations and inquiries lies with the institution, the
Department reserves the right to perform its own investigation at any
time prior to, during, or following an institution's investigation.
    (7) In addition to sanctions that the institution may decide to
impose, the Department also may impose sanctions of its own upon
investigators or institutions based upon authorities it possesses or may
possess, if such action seems appropriate.
    (b) The institution is responsible for notifying the OSI if it
ascertains at any stage of the inquiry or investigation, that any of the
following conditions exist:
    (1) There is an immediate health hazard involved;
    (2) There is an immediate need to protect Federal funds or
equipment;
    (3) There is an immediate need to protect the interests of the
person(s) making the allegations or of the individual(s) who is the
subject of the allegations as well as his/her co-investigators and
associates, if any;
    (4) It is probable that the alleged incident is going to be reported
publicly.
    (5) There is a reasonable indication of possible criminal violation.
In that instance, the institution must inform OSI within 24 hours of
obtaining that information. OSI will immediately notify the Office of
the Inspector General.

Sec. 50.105  Institutional compliance.

    Institutions shall foster a research environment that discourages
misconduct in all research and that deals forthrightly with possible
misconduct associated with research for which PHS funds have been
provided or requested. An institution's failure to comply with its
assurance and the requirements of this subpart may result in enforcement
action against the institution, including loss of funding, and may lead
to the OSI's conducting its own investigation.

    Subpart B--Sterilization of Persons in Federally Assisted Family
                            Planning Projects

Sec. 50.201  Applicability.

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

Sec. 50.202  Definitions.

    As used in this subpart:
    Arrange for means to make arrangements (other than mere referral of
an individual to, or the mere making of an appointment for him or her
with, another health care provider) for the performance of a medical
procedure on an individual by a health care provider other than the
program or project.
    Hysterectomy means a medical procedure or operation for the purpose
of removing the uterus.
    Institutionalized individual means an individual who is (1)
involuntarily confined or detained, under a civil or criminal statute,
in a correctional or rehabilitative facility, including a mental
hospital or other facility for the care and treatment of mental illness,
or (2) confined, under a voluntary commitment, in a mental hospital or
other facility for the care and treatment of mental illness.
    Mentally incompetent individual means an individual who has been
declared mentally incompetent by a Federal, State, or local court of
competent jurisdiction for any purpose unless he or she has been
declared competent for purposes which include the ability to consent to
sterilization.
    Public Health Service means the Office of the Assistant Secretary
for Health, Health Resources and Services Administration, National
Institutes of Health, Centers for Disease Control, Alcohol, Drug Abuse
and Mental Health Administration and all of their constituent agencies.

[[Page 166]]

    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]

Sec. 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 Sec. 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.

Sec. 50.204  Informed consent requirement.

    Informed consent does not exist unless a consent form is completed
voluntarily and in accordance with all the requirements of this section
and Sec. 50.205 of this subpart.
    (a) A person who obtains informed consent for a sterilization
procedure must offer to answer any questions the individual to be
sterilized may have concerning the procedure, provide a copy of the
consent form, and provide orally all of the following information or
advice to the individual who is to be sterilized:
    (1) Advice that the individual is free to withhold or withdraw
consent to the procedure any time before the sterilization without
affecting his or her right to future care or treatment and without loss
or withdrawal of any federally funded program benefits to which the
individual might be otherwise entitled:
    (2) A description of available alternative methods of family
planning and birth control;
    (3) Advice that the sterilization procedure is considered to be
irreversible;
    (4) A thorough explanation of the specific sterilization procedure
to be performed;
    (5) A full description of the discomforts and risks that may
accompany or follow the performing of the procedure, including an
explanation of the type and possible effects of any anesthetic to be
used;
    (6) A full description of the benefits or advantages that may be
expected as a result of the sterilization; and
    (7) Advice that the sterilization will not be performed for at least
30 days except under the circumstances specified in Sec. 50.203(d) of
this subpart.
    (b) An interpreter must be provided to assist the individual to be
sterilized if he or she does not understand the language used on the
consent form or the language used by the person obtaining the consent.
    (c) Suitable arrangements must be made to insure that the
information specified in paragraph (a) of this section is effectively
communicated to any individual to be sterilized who is blind, deaf or
otherwise handicapped.
    (d) A witness chosen by the individual to be sterilized may be
present when consent is obtained.
    (e) Informed consent may not be obtained while the individual to be
sterilized is:
    (1) In labor or childbirth;
    (2) Seeking to obtain or obtaining an abortion; or
    (3) Under the influence of alcohol or other substances that affect
the individual's state of awareness.
    (f) Any requirement of State and local law for obtaining consent,
except

[[Page 167]]

one of spousal consent, must be followed.

Sec. 50.205  Consent form requirements.

    (a) Required consent form. The consent form appended to this subpart
or another consent form approved by the Secretary must be used.
    (b) Required signatures. The consent form must be signed and dated
by:
    (1) The individual to be sterilized; and
    (2) The interpreter, if one is provided; and
    (3) The person who obtains the consent; and
    (4) The physician who will perform the sterilization procedure.
    (c) Required certifications. (1) The person obtaining the consent
must certify by signing the consent form that:
    (i) Before the individual to be sterilized signed the consent form,
he or she advised the individual to be sterilized that no Federal
benefits may be withdrawn because of the decision not to be sterilized,
    (ii) He or she explained orally the requirements for informed
consent as set forth on the consent form, and
    (iii) To the best of his or her knowledge and belief, the individual
to be sterilized appeared mentally competent and knowingly and
voluntarily consented to be sterilized.
    (2) The physician performing the sterilization must certify by
signing the consent form, that:
    (i) Shortly before the performance of the sterilization, he or she
advised the individual to be sterilized that no Federal benefits may be
withdrawn because of the decision not to be sterilized,
    (ii) He or she explained orally the requirements for informed
consent as set forth on the consent form, and
    (iii) To the best of his or her knowledge and belief, the individual
to be sterilized appeared mentally competent and knowingly and
voluntarily consented to be sterilized. Except in the case of premature
delivery or emergency abdominal surgery, the physician must further
certify that at least 30 days have passed between the date of the
individual's signature on the consent form and the date upon which the
sterilization was performed. If premature delivery occurs or emergency
abdominal surgery is required within the 30-day period, the physician
must certify that the sterilization was performed less than 30 days but
not less than 72 hours after the date of the individual's signature on
the consent form because of premature delivery or emergency abdominal
surgery, as applicable. In the case of premature delivery, the physician
must also state the expected date of delivery. In the case of emergency
abdominal surgery, the physician must describe the emergency.
    (3) If an interpreter is provided, the interpreter must certify that
he or she translated the information and advice presented orally, read
the consent form and explained its contents and to the best of the
interpreter's knowledge and belief, the individual to be sterilized
understood what the interpreter told him or her.

Sec. 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.

Sec. 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

[[Page 168]]

    (2) The individual or her representative, if any, has signed a
written acknowledgment of receipt of that information.
    (c)(1) A program or project is not required to follow the procedures
of paragraph (b) of this section if either of the following
circumstances exists:
    (i) The individual is already sterile at the time of the
hysterectomy.
    (ii) The individual requires a hysterectomy because of a life-
threatening emergency in which the physician determines that prior
acknowledgment is not possible.
    (2) If the procedures of paragraph (b) of this section are not
followed because one or more of the circumstances of paragraph (c)(1)
exist, the physician who performs the hysterectomy must certify in
writing:
    (i) That the woman was already sterile, stating the cause of that
sterility; or
    (ii) That the hysterectomy was performed under a life-threatening
emergency situation in which he or she determined prior acknowledgment
was not possible. He or she must also include a description of the
nature of the emergency.

[43 FR 52165, Nov. 8, 1978, as amended at 47 FR 33701, Aug. 4, 1982]

Sec. 50.208  Program or project requirements.

    (a) A program or project must, with respect to any sterilization
procedure or hysterectomy it performs or arranges, meet all requirements
of this subpart.
    (b) The program or project shall maintain sufficient records and
documentation to assure compliance with these regulations, and must
retain such data for at least 3 years.
    (c) The program or project shall submit other reports as required
and when requested by the Secretary.

Sec. 50.209  Use of Federal financial assistance.

    (a) Federal financial assistance adminstered by the Public Health
Service may not be used for expenditures for sterilization procedures
unless the consent form appended to this section or another form
approved by the Secretary is used.
    (b) A program or project shall not use Federal financial assistance
for any sterilization or hysterectomy without first receiving
documentation showing that the requirements of this subpart have been
met. Documentation includes consent forms, and as applicable, either
acknowledgments of receipt of hysterectomy information or certification
of an exception for hysterectomies.

[43 FR 52165, Nov. 8, 1978, as amended at 47 FR 33701, Aug. 4, 1982]

Sec. 50.210  Review of regulation.

    The Secretary will request public comment on the operation of the
provisions of this subpart not later than 3 years after their effective
date.

         Appendix to Subpart B of Part 50--Required Consent Form

    Notice: YOUR DECISION AT ANY TIME NOT TO BE STERILIZED WILL NOT
RESULT IN THE WITHDRAWAL OR WITHHOLDING OF ANY BENEFITS PROVIDED BY
PROGRAMS OR PROJECTS RECEIVING FEDERAL FUNDS.

                        Consent to Sterilization

    I have asked for and received information about sterilization from
-------------- (doctor or clinic). When I first asked for the
information, I was told that the decision to be sterilized is completely
up to me. I was told that I could decide not to be sterilized. If I
decide not to be sterilized, my decision will not affect my right to
future care or treatment. I will not lose any help or benefits from
programs receiving Federal funds, such as A.F.D.C. or medicaid that I am
now getting or for which I may become eligible.
    I UNDERSTAND THAT THE STERILIZATION MUST BE CONSIDERED PERMANENT AND
NOT REVERSIBLE. I HAVE DECIDED THAT I DO NOT WANT TO BECOME PREGNANT,
BEAR CHILDREN OR FATHER CHILDREN.
    I was told about those temporary methods of birth control that are
available and could be provided to me which will allow me to bear or
father a child in the future. I have rejected these alternatives and
chosen to be sterilized.
    I understand that I will be sterilized by an operation known as a --
------------. The discomforts, risks and benefits associated with the
operation have been explained to me. All my questions have been answered
to my satisfaction.
    I understand that the operation will not be done until at least 30
days after I sign this form. I understand that I can change my

[[Page 169]]

mind at any time and that my decision at any time not to be sterilized
will not result in the withholding of any benefits or medical services
provided by federally funded programs.
    I am at least 21 years of age and was born on -- (day), ----------
(month), ---- (year).
    I, --------------, hereby consent of my own free will to be
sterilized by -------------- by a method called --------------. My
consent expires 180 days from the date of my signature below.
    I also consent to the release of this form and other medical records
about the operation to:
    Representatives of the Department of Health and Human Services or
    Employees of programs or projects funded by that Department but only
for determining if Federal laws were observed.
    I have received a copy of this form.

Signature_______________________________________________________________
Date:___________________________________________________________________
(Month, day, year)

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

Race and ethnicity designation (please check)
Black (not of Hispanic origin)__________________________________________
Hispanic________________________________________________________________
Asian or Pacific Islander_______________________________________________
American Indian or Alaskan native_______________________________________
White (not of Hispanic origin)__________________________________________

                         Interpreter's Statement

    If an interpreter is provided to assist the individual to be
sterilized:
    I have translated the information and advice presented orally to the
individual to be sterilized by the person obtaining this consent. I have
also read him/her the consent form in -------------- 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 ----------
---- (name of individual to be sterilized), on ---------- (date of
sterilization), -------------- (operation), I explained 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):

{time}  Premature delivery
Individual's expected date of delivery:_________________________________
{time}  Emergency abdominal surgery:
(Describe circumstances):_______________________________________________

Physician_______________________________________________________________

[[Page 170]]

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.

Sec. 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.

Sec. 50.302  Definitions.

    As used in this subpart: (a) Law enforcement agency means an agency,
or any part thereof, charged under applicable law with enforcement of
the general penal statutes of the United States, or of any State or
local jurisdiction.
    (b) Medical procedures performed upon a victim of rape or incest
means any medical service, including an abortion, performed for the
purpose of preventing or terminating a pregnancy arising out of an
incident of rape or incest.
    (c) Physician means a doctor of medicine or osteopathy legally
authorized to practice medicine and surgery by the State in which he or
she practices.
    (d) Public health service means: (1) An agency of the United States
or of a State or local government, that provides health or medical
services; and
    (2) A rural health clinic, as defined under section 1(d)(aa)(2) of
Pub. L. 95-210, 91 Stat. 1485; except that any agency or facility whose
principal function is the performance of abortions is specifically
excluded from this definition.

Sec. 50.303  General rule.

    Federal financial participation is not available for the performance
of an abortion in programs or projects to which this subpart applies
except under circumstances described in Sec. 50.304 or Sec. 50.306.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]

Sec. 50.304  Life of the mother would be endangered.

    Federal financial participation is available in expenditures for an
abortion when a physician has found, and so certified in writing to the
program or project, that on the basis of his/her professional judgment,
the life of the mother would be endangered if the fetus were carried to
term. The certification must contain the name and address of the
patient.

(Sec. 101, Pub. L. 95-205, 91 Stat. 1461, Dec. 9, 1977)

[43 FR 13868, July 21, 1978]
Sec. 50.305  [Reserved]

Sec. 50.306  Rape and incest.

    Federal financial participation is available in expenditures for
medical procedures performed upon a victim of rape or incest if the
program or project has received signed documentation from a law
enforcement agency or public health service stating:
    (a) That the person upon whom the medical procedure was performed
was reported to have been the victim of an incident of rape or incest;
    (b) The date on which the incident occurred;
    (c) The date on which the report was made, which must have been
within 60 days of the date on which the incident occurred;
    (d) The name and address of the victim and the name and address of
the person making the report (if different from the victim); and
    (e) That the report included the signature of the person who
reported the incident.

Federal financial participation is also available in expenditures for
abortions for victims of rape or incest under the circumstances
described in Sec. 50.304

[[Page 171]]

without regard to the requirements of the preceding sentence.

(Sec. 101, Pub. L. 95-205, 91 Stat. 1461, Dec. 9, 1977)

[43 FR 13868, July 21, 1978, as amended at 44 FR 61598, Oct. 26, 1979]

Sec. 50.307  Documentation needed by programs or projects.

    Federal financial participation is unavailable for the performance
of abortions or other medical procedures otherwise provided for under
Secs. 50.304 and 50.306 if the program or project has paid without first
having received the certifications and documentation specified in those
sections.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]

Sec. 50.308  Drugs and devices and termination of ectopic pregnancies.

    Federal financial participation is available with respect to the
cost of drugs or devices to prevent implantation of the fertilized ovum,
and for medical procedures necessary for the termination of an ectopic
pregnancy.

Sec. 50.309  Recordkeeping requirements.

    Programs or projects to which this subpart applies must maintain
copies of the certifications and documentation specified in Secs. 50.304
and 50.306 for three years pursuant to the retention and custodial
requirements for records at 45 CFR 74.20 et seq.

[43 FR 4570, Feb. 2, 1978, as amended at 44 FR 61598, Oct. 26, 1979]

Sec. 50.310  Confidentiality.

    Information in the records or in the possession of programs or
projects which is acquired in connection with the requirements of this
subpart may not be disclosed in a form which permits the identification
of an individual without the individual's consent except as may be
necessary for the health of the individual or as may be necessary for
the Secretary to monitor the activities of those programs or projects.
In any event, any disclosure shall be subject to appropriate safeguards
which will minimize the likelihood of disclosures of personal
information in identifiable form.

        Subpart D--Public Health Service Grant Appeals Procedure

    Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42
U.S.C. 216); 45 CFR 16.3(c).

    Source: 54 FR 34770, Aug. 22, 1989, unless otherwise noted.

Sec. 50.401  What is the purpose of this subpart?

    This subpart establishes an informal procedure for the resolution of
certain postaward grant and cooperative agreement disputes within PHS.

Sec. 50.402  To what programs do these regulations apply?

    This subpart applies to all grant and cooperative agreement
programs, except block grants, which are administered by the U.S. Public
Health Service, including those administered by the National Institutes
of Health; the Health Resources and Services Administration; the Centers
for Disease Control; the Agency for Toxic Substances and Disease
Registry; the Alcohol, Drug Abuse, and Mental Health Administration; the
Food and Drug Administration; the Indian Health Service; the Office of
the Assistant Secretary for Health (OASH); and the PHS regional offices.

Sec. 50.403  What is the policy basis for these procedures?

    The Secretary of Health and Human Services has established a
Departmental Appeals Board for the purpose of providing a fair and
flexible process for the appeal of written final decisions involving
certain grant and cooperative agreement programs administered by
constituent agencies of the Department. The regulatory provision which
establishes the circumstances under which the Board will accept an
appeal (45 CFR 16.3) provides, among other things, that the appellant
must have exhausted any preliminary appeal process required by
regulation before a formal appeal to the Departmental Board will be
allowed. These regulations provide such an informal preliminary
procedure for resolution of disputes within PHS in order to preclude
submission of cases to the Departmental Appeals Board before PHS has

[[Page 172]]

had an opportunity to review decisions of its officials and to settle
disputes with grantees.

Sec. 50.404  What disputes are covered by these procedures?

    (a) These procedures are applicable to the following adverse
determinations under PHS discretionary project grants and cooperative
agreements (hereinafter both referred to as grants):
    (1) Termination, in whole or in part, of a grant for failure of the
grantee to carry out its approved project in accordance with the
applicable law and the terms and conditions of such assistance or for
failure of the grantee otherwise to comply with any law, regulation,
assurance, term, or condition applicable to the grant.
    (2) A determination that an expenditure not allowable under the
grant has been charged to the grant or that the grantee has otherwise
failed to discharge its obligation to account for grant funds.
    (3) A determination that a grant is void.
    (4) A denial of a noncompeting continuation award under the project
period system of funding where the denial is for failure to comply with
the terms of a previous award.
    (b) A determination subject to this subpart may not be reviewed by
the review committee described in Sec. 50.405 unless an officer or
employee of the agency, OASH, or the regional office has notified the
grantee in writing of the adverse determination. The notification must
set forth the reasons for the determination in sufficient detail to
enable the grantee to respond and must inform the grantee of the
opportunity for review under this subpart.

Sec. 50.405  What is the structure of review committees?

    The head of each agency or his/her designee shall appoint review
committees to review appeals of adverse determinations made by
headquarters officials for programs under the jurisdiction of that
agency. The Assistant Secretary for Health, or his/her designee, shall
appoint review committees to review adverse determinations made by OASH
officials and regional officials for programs under their jurisdiction.
A minimum of three employees shall be appointed (one of whom shall be
designated as chairperson) either on an ad hoc, case-by-case basis, or
as regular members of review committees for such terms as may be
designated. None of the members of the review committee reviewing any
given appeal may be from the office of the responsible official whose
adverse determination is being appealed (e.g., project officer, grants
specialist, program manager, grants management officer).

Sec. 50.406  What are the steps in the process?

    (a) A grantee with respect to whom an adverse determination
described in Sec. 50.404(a) above has been made and who desires a review
of that determination must submit a request for such review to the head
of the appropriate agency or his/her designee (or in the case of an OASH
program or regional office determination, to the Assistant Secretary for
Health or his/her designee) no later than 30 days after the written
notification of the determination is received, except that if the
grantee shows good cause why an extension of time should be granted, the
head of the appropriate agency or his/her designee (or in the case of an
OASH program or regional office determination, the Assistant Secretary
for Health or his/her designee) may grant an extension of time.
    (b) The request for review must include a copy of the adverse
determination, must identify the issue(s) in dispute, and must contain a
full statement of the grantee's position with respect to such issue(s)
and the pertinent facts and reasons in support of the grantee's
position. In addition to the required written statement, the grantee
shall provide copies of any documents supporting its claim.
    (c) When a request for review has been filed under this subpart with
respect to an adverse determination, no action may be taken by the
awarding agency, OASH, or regional office pursuant to such determination
until the request has been disposed of, except that the filing of the
request shall not affect any authority which the agency, OASH, or
regional office may have to suspend assistance or otherwise to withhold
or defer payments under the

[[Page 173]]

grant during proceedings under this subpart. This paragraph does not
require the awarding agency, OASH, or regional office to provide
continuation funding during the appeal process to a grantee whose
noncompeting continuation award has been denied.
    (d) Upon receipt of a request for review, the head of the agency or
his/her designee (or, if the adverse determination was made in an OASH
program or regional office, the Assistant Secretary for Health or his/
her designee) will make a decision as to whether the dispute is
reviewable under this subpart and will promptly notify the grantee and
the office responsible for the adverse determination of this decision.
If the head of the agency or his/her designee (or, if applicable, the
Assistant Secretary for Health or his/her designee) determines that the
dispute is reviewable, he/she will forward the matter to the review
committee appointed under Sec. 50.405.
    (e) The agency, OASH, or regional office involved will provide the
review committee appointed under Sec. 50.405 with copies of all relevant
background materials (including application(s), award(s), summary
statement(s), and correspondence) and any additional pertinent
information available. These materials must be tabbed and organized
chronologically and accompanied by an indexed list identifying each
document.
    (f) The grantee shall be given an opportunity to provide the review
committee with additional statements and documentation not provided in
the request for review described in paragraph (b) of this section. This
additional submission, which must be organized and indexed as indicated
under paragraph (e) of this section, should provide only material that
is relevant to the review committee's deliberation of the issues in the
case.
    (g) The review committee may, at its discretion, invite the grantee
and/or the agency/OASH/regional office staff to discuss the pertinent
issues with the committee and to submit such additional information as
the committee deems appropriate.
    (h) Based on its review, the review committee will prepare a written
decision to be signed by the chairperson and each of the other committee
members. The review committee shall send the written decision with a
transmittal letter to the grantee and shall send a copy of both to the
official responsible for the adverse determination. If the decision is
adverse to the grantee's position, the transmittal letter must state the
grantee's right to appeal to the Departmental Appeals Board under 45 CFR
part 16.

               Subpart E--Maximum Allowable Cost for Drugs

    Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42
U.S.C. 216).

    Source: 40 FR 34514, Aug. 15, 1975, unless otherwise noted.

Sec. 50.501   Applicability.

    This subpart is applicable to programs or projects for health
services which are supported in whole or in part by Federal financial
assistance, whether by grant or contract, administered by the Public
Health Service. It applies to Federal funds and to non-Federal funds
which are required to be expended as a condition to receiving Federal
funds under such programs or projects.

Sec. 50.502   Definitions.

    As used in this subpart:
    (a) Public Health Service means the Office of the Assistant
Secretary for Health, Health Resources and Services Administration,
National Institutes of Health, Centers for Disease Control, Alcohol,
Drug Abuse and Mental Health Administration, Food and Drug
Administration, and all of their constituent agencies.
    (b) 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.
    (c) Program funds means (1) Federal funds provided through grant or
contract to support a program or project covered by Sec. 50.501, and (2)
any non-Federal funds that are required as a condition of such grant or
contract to be expended to carry out such program or project.

[[Page 174]]

    (d) Provider means one who furnishes medical or pharmaceutical
services or supplies for which program funds may be expended under any
of the programs or projects described in Sec. 50.501.
    (e) Acquisition cost means the price generally and currently paid by
providers for a drug marketed or sold by a particular formulator or
labeler in the package size of drug most frequently purchased by
providers, as determined by the Secretary on the basis of drug price
information furnished by the Department.

[40 FR 34514, Aug. 15, 1975, as amended at 49 FR 38109, Sept. 27, 1984]

Sec. 50.503   Policy.

    It is the policy of the Secretary that program funds which are
utilized for the acquisition of drugs be expended in the most economical
manner feasible. In furtherance of this policy, the Secretary has
established, in 45 CFR part 19, a procedure for determining the Maximum
Allowable Cost for drugs which are purchased with program funds.

Sec. 50.504   Allowable cost of drugs.

    (a) The maximum amount which may be expended from program funds for
the acquisition of any drug shall be the lowest of
    (1) The maximum allowable cost (MAC) of the drug, if any,
established in accordance with 45 CFR part 19, plus a dispensing fee
determined by the Secretary in accordance with paragraph (b) of this
section, to be reasonable;
    (2) The acquisition cost of the drug plus a dispensing fee
determined by the Secretary, in accordance with paragraph (b) of this
section, to be reasonable; or
    (3) The provider's usual and customary charge to the public for the
drug; Provided, That the MAC established for any drug shall not apply to
a brand of that drug prescribed for a patient which the prescriber has
certified, in accordance with paragraph (c) of this section, is
medically necessary for that patient; And Provided further, That where
compensation for drug dispensing is included in other costs allowable
under the applicable program statute and regulations, the terms and
conditions of the grant or contract, and the applicable cost principles
prescribed in 45 CFR part 74, no separate dispensing fee will be
recognized.
    (b) In determining whether a dispensing fee is reasonable, the
Secretary will take into account:
    (1) Cost components such as overhead, professional services, and
profits,
    (2) Payment practices of third-party payment organizations,
including other Federal programs such as titles XVIII and XIX of the
Social Security Act; and
    (3) Any surveys by States, universities or others of costs of
pharmacy operations and the fees charged in the particular area.
    (c) A certification by a prescriber, pursuant to paragraph (a) of
this section, that a brand of drug is medically necessary for a
particular patient shall be in the prescriber's own handwriting, in such
form and manner as the Secretary may prescribe. An example of an
acceptable certification is the notation ``brand necessary''. A
procedure for checking a box on a form will not constitute an acceptable
certification.

  Subpart F--Responsibility of Applicants for Promoting Objectivity in
                Research for Which PHS Funding Is Sought

    Authority: 42 U.S.C. 216, 289b-1, 299c-3.

    Source: 60 FR 35815, July 11, 1995; 60 FR 39076, July 31, 1995,
unless otherwise noted.

Sec. 50.601  Purpose.

    This subpart promotes objectivity in research by establishing
standards to ensure there is no reasonable expectation that the design,
conduct, or reporting of research funded under PHS grants or cooperative
agreements will be biased by any conflicting financial interest of an
Investigator.

Sec. 50.602  Applicability.

    This subpart is applicable to each Institution that applies for PHS
grants or cooperative agreements for research and, through the
implementation of this subpart by each Institution, to each Investigator
participating in such research (see Sec. 50.604(a)); provided, that this
subpart does not apply to SBIR Program Phase I applications. In those

[[Page 175]]

few cases where an individual, rather than an institution, is an
applicant for PHS grants or cooperative agreements for research, PHS
Awarding Components will make case-by-case determinations on the steps
to be taken to ensure that the design, conduct, and reporting of the
research will not be biased by any conflicting financial interest of the
individual.

Sec. 50.603  Definitions.

    As used in this subpart:
    HHS means the United States Department of Health and Human Services,
and any components of the Department to which the authority involved may
be delegated.
    Institution means any domestic or foreign, public or private, entity
or organization (excluding a Federal agency).
    Investigator means the principal investigator and any other person
who is responsible for the design, conduct, or reporting of research
funded by PHS, or proposed for such funding. For purposes of the
requirements of this subpart relating to financial interests,
``Investigator'' includes the Investigator's spouse and dependent
children.
    PHS means the Public Health Service, an operating division of the
U.S. Department of Health and Human Services, and any components of the
PHS to which the authority involved may be delegated.
    PHS Awarding Component means the organizational unit of the PHS that
funds the research that is subject to this subpart.
    Public Health Service Act or PHS Act means the statute codified at
42 U.S.C. 201 et seq.
    Research means a systematic investigation designed to develop or
contribute to generalizable knowledge relating broadly to public health,
including behavioral and social-sciences research. The term encompasses
basic and applied research and product development. As used in this
subpart, the term includes any such activity for which research funding
is available from a PHS Awarding Component through a grant or
cooperative agreement, whether authorized under the PHS Act or other
statutory authority.
    Significant Financial Interest means anything of monetary value,
including but not limited to, salary or other payments for services
(e.g., consulting fees or honoraria); equity interests (e.g., stocks,
stock options or other ownership interests); and intellectual property
rights (e.g., patents, copyrights and royalties from such rights). The
term does not include:
    (1) Salary, royalties, or other remuneration from the applicant
institution;
    (2) Any ownership interests in the institution, if the institution
is an applicant under the SBIR Program;
    (3) Income from seminars, lectures, or teaching engagements
sponsored by public or nonprofit entities;
    (4) Income from service on advisory committees or review panels for
public or nonprofit entities;
    (5) An equity interest that when aggregated for the Investigator and
the Investigator's spouse and dependent children, meets both of the
following tests: Does not exceed $10,000 in value as determined through
reference to public prices or other reasonable measures of fair market
value, and does not represent more than a five percent ownership
interest in any single entity; or
    (6) Salary, royalties or other payments that when aggregated for the
Investigator and the Investigator's spouse and dependent children over
the next twelve months, are not expected to exceed $10,000.
    Small Business Innovation Research (SBIR) Program means the
extramural research program for small business that is established by
the Awarding Components of the Public Health Service and certain other
Federal agencies under Pub. L. 97-219, the Small Business Innovation
Development Act, as amended. For purposes of this subpart, the term SBIR
Program includes the Small Business Technology Transfer (STTR) Program,
which was established by Pub. L. 102-564.

Sec. 50.607  Other HHS regulations that apply.

    Several other regulations and policies apply to this subpart.
    They include, but are not necessarily limited to:

[[Page 176]]

42 CFR Part 50, Subpart D--Public Health Service grant appeals procedure
45 CFR Part 16--Procedures of the Departmental Grant Appeals Board
45 CFR Part 74--Uniform Administrative Requirements for Awards and
Subawards to Institutions of Higher Education, Hospitals, Other Non-
Profit Organizations, and Commercial Organizations; and Certain Grants
and Agreements with States, Local Governments and Indian Tribal
Governments
45 CFR Part 76--Government-wide debarment and suspension (non-
procurement)
45 CFR Part 79--Program Fraud Civil Remedies
45 CFR Part 92--Uniform Administrative Requirements for Grants and
Cooperative Agreements to State and Local Governments