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(g) Governor means the chief executive of a State.

(h) Grantee means any public agency or private nonprofit mental health organization which pursuant to this part, is awarded a grant for the purpose of providing professional mental health crisis counseling services or mental health training for disaster workers.

(i) Major disaster means any hurricane, tornado, storm, flood, highwater, wind-driven water, tidal wave, tsunami, earthquake, volcanic eruption, landslide, mudslide, snowstorm, drought, fire, explosion, or other catastrophe in any part of the United States which, in the determination of the President, causes damage of sufficient severity and magnitude to warrant major disaster assistance under the Act above and beyond emergency services by the Federal Government, to supplement the efforts and available resources of the States, local governments, and disaster relief organizations, in alleviating the damage, loss, hardship, or suffering caused thereby.

(j) Regional Director means a director of a regional office of the Federal Disaster Assistance Administration (FDAA).

(k) 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.

(1) State means any of the fifty States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, the Canal Zone, or the Trust Territory of the Pacific Islands.

(m) State Coordinating Officer means the person appointed by the Governor to act in cooperation with the appointed Federal Coordinating Officer.

(n) Training means the specific instruction which may be required to enable disaster workers to provide professional mental health crisis counseling to victims of a major disaster or its aftermath. $38.3 Assistance; procedures, limita

tions. (a) Application. In order to obtain assistance under this part, the Governor or his State Coordinating Officer must,

not later than 60 days following a major disaster declaration by the President, file with the appropriate Regional Director a request which includes:

(1) An estimate of the number of disaster victims who may need professional mental health crisis counseling services and of the number of disaster workers who may need training in the provision of such services;

(2) Identification of the geographical areas in which the need exists;

(3) An estimate of the period during which assistance under this part will be required and of the total funds which will be required to provide such assistance;

(4) A description of the types of mental health problems caused or aggravated by the major disaster or its aftermath; and

(5) Identification of the State and local agencies and private mental health organizations capable of providing professional mental health crisis counseling to disaster victims or training of disaster workers.

(b) Review, approval. The Secretary, upon notification by the Administrator of a State request for assistance under this part, will conduct a review to determine the extent to which such assistance is needed to supplement assistance programs provided by State and local governments and private organizations and, on the basis of that review, prepare and submit recommendation and report for consideration by the Administrator. Upon approval by the Administrator and his advancement of funds for carrying out the approved assistance, the Secretary may, within the limits of the funds advanced, provide the approved services either directly or through a grant or contract.

(c) Eligibility for services. (1) In order to be eligible for the professional mental health crisis counseling services available under this part an individual must:

(i) Have been located within the designated major disaster area or have been a resident of such area at the time of the major disaster or its aftermath; and

a

(ii) Have a mental health problem (1) Progress reports, to be submitted which was caused or aggravated by the at the end of the first 30 days of the major disaster or its aftermath.

contract period and every 30 days (2) Disaster workers who are avail- therafter; able on short notice to provide profes- (2) A final report to be submitted sional mental health crisis counseling within 60 days of the date upon which services in a major disaster area are el- the contract terminates; and igible for training under this part.

(3) Such additional reports as the (d) Time limitation. Contracts and Secretary may prescribe including grants awarded under this part will not

those which may be required to enable continue beyond 180 days after the first

the Federal Coordinating Officer to day services are provided pursuant to

carry out his functions. such contracts and grants, except that upon the recommendation of the Sec- $38.5 Grant assistance. retary (1) the Regional Director may

(a) Eligibility. Public agencies and priextend the 180 day period for up to 30 days or (2) the Administrator may ex

vate nonprofit mental health organiza

tions which are determined by the Sectend the 180 day period for more than 30 days.

retary to be capable of providing the

professional mental health crisis coun$38.4 Contracts.

seling services or mental health train

ing of disaster workers needed as a re(a) Eligibility. Public agencies and pri

sult of a major disaster are eligible for vate mental health organizations

a grant award under this part. which are determined by the Secretary

(b) Application. The application shall to be capable of providing the profes

contain: sional mental health crisis counseling services or mental health training of

(1) A proposed plan for the provision disaster workers needed as a result of a

of the services for which grant assistmajor disaster are eligible for the

ance is requested; award of a contract under this part.

(2) A proposed budget for the expendi(b) Use of local agencies. Preference

ture of the requested grant funds; and will be given to the extent feasible and

(3) Such other pertinent information practicable, to those agencies and orga

and assurances as the Secretary may nizations which are located or do busi

require. ness primarily in the area affected by

(c) Grant awards. (1) Preference will the major disaster.

be given, to the extent feasible and (c) General requirements. Contracts practicable, to those public and private under this part shall be entered into nonprofit agencies and organizations and carried out in accordance with the which are located or do business priprovisions of chapters 1 and 3 of title 41 marily in the area affected by the of the Code of Federal Regulations and

major disaster. all other applicable laws and regula- (2) Within the limits of the funds adtions.

vanced by the Administrator, the (d) Payments. The Secretary shall amount of any grant award shall be defrom time to time make payments to

termined on the basis of the Secthe contractor of all or a portion of the

retary's estimate of the sum necessary contract award, either by way of reim

to carry out the grant purpose. bursement for expenses incurred or in (3) Neither the approval of any appliadvance for expenses to be incurred, to cation nor the award of any grant comthe extent he determines such pay- mits or obligates the United States in ments are necessary to promote any way to make any additional, supprompt initiation and advancement of plemental, continuation,

other the services to be provided under the award with respect to any approved apcontract. All payments not expended plication or portion of an approved apby the contractor within the period of plication. the contract shall be returned to the (d) Other HHS regulations that apply. Secretary.

Several other regulations apply to (e) Reports. Contractors shall submit grants under this grant. These include, the following reports to the Secretary: but are not limited to:

or

discrimination on the grounds of race. religion, sex, color, age, economic status, or national origin in the provision of disaster assistance.

42 CFR part 50, subpart D-Public Health

Service grant appeals procedure 45 CFR part 16–Procedures of the Depart

mental Grant Appeals Board 45 CFR part 74-Administration of grants 45 CFR part 75—Informal grant appeals pro

cedures 45 CFR part 80—Nondiscrimination under

programs receiving Federal assistance through the Department of Health and Human Services effectuation of Title VI of

the Civil Rights Act of 1964 45 CFR part 81—Practice and procedure for

hearings under part 80 of this title 45 CFR part 84—Nondiscrimination on the

basis of handicap in programs and activities receiving or benefiting from Federal

financial assistance 45 CFR part 86—Nondiscrimination on the

basis of sex in education programs and activities receiving or benefiting from Fed

eral financial assistance 45 CFR part 91-Nondiscrimination on the

basis of age in HHS programs or activities receiving Federal financial assistance

(e) Expenditure of grant funds. Any funds granted pursuant to this part shall be expended solely for the purposes for which the funds were granted in accordance with the approved application and budget, the regulations of this part, the terms and the conditions of the award, and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.

(f) Reports. In exceptional circumstances, a grantee may be required to submit special progress reports, in addition to those otherwise required, relating to the conduct and results of the approved grant. [41 FR 52052, Nov. 26, 1976, as amended at 45 FR 57396, Aug. 28, 1980; 49 FR 38109, Sept. 27, 1984)

$38.7 Nonliability.

Attention is called to section 308 of the Act (42 U.S.C. 5148) which provides that the Federal Government shall not be liable for any claim based upon the exercise or performance of or the failure to exercise or perform a discretionary function or duty on the part of a Federal agency or an employee of the Federal Government in carrying out the provisions of the Act. $38.8 Criminal and civil penalties.

Attention is called to section 317 of the Act (42 U.S.C. 5157) which provides:

(a) Any individual who fraudulently or willfully misstates any fact in connection with a request for assistance under this Act shall be fined not more than $10,000 or imprisoned for not more than one year or both for each violation.

(b) Any individual who knowingly violates any order or regulation under this Act shall be subject to a civil penalty of not more than $5,000 for each violation.

(c) Whoever knowingly misapplies the proceeds of a loan or other cash benefit obtained under any section of this Act shall be subject to a fine in an amount equal to one and one half times the original principal amount of the loan or cash benefit.

$38.9 Federal audits.

The Secretary, the Administrator, and the Comptroller General of the United States, or their duly authorized representatives shall have access to any books, documents, papers, and records that pertain to Federal funds, equipment, and supplies received under this part for the purpose of audit and examination.

$38.6 Nondiscrimination.

Attention is called to the requirements of 24 CFR 2205.13 relating to non

PART 50-POLICIES OF GENERAL 50.404 What disputes are covered by these APPLICABILITY

procedures? 50.405 What is the structure of review com

mittees? Subpart A-Responsibility of PHS Awardee

50.406 What are the steps in the process? and Applicant Institutions for Dealing With and Reporting Possible Mis

Subpart Maximum Allowable Cost for conduct in Science

Drugs Sec.

50.501 Applicability. 50.101 Applicability.

50.502 Definitions. 50.102 Definitions.

50.503 Policy. 50.103 Assurance Responsibilities of PHS Awardee and Applicant Institutions.

50.504 Allowable cost of drugs. 50.104 Reporting to the OSI. 50.105 Institutional compliance.

Subpart Responsibility of Applicants for

Promoting Objectivity in Research for Subpart BSterilization of Persons in

Which PHS Funding Is Sought Federally Assisted Family Planning Projects

50.601 Purpose. 50.201 Applicability.

50.602 Applicability. 50.202 Definitions.

50.603 Definitions. 50.203 Sterilization of a mentally competent 50.604 Institutional responsibility regarding individual aged 21 or older.

conflicting interests of investigators 50.204 Informed consent requirement.

50.605 Management of conflicting interests. 50.205 Consent form requirements.

50.606 Remedies. 50.206 Sterilization of a mentally incom

50.607 Other HHS regulations that apply. petent individual or of an institutionalized individual.

AUTHORITY: Sec. 215, Public Health Service 50.207 Sterilization by hysterectomy.

Act, 58 Stat. 690 (42 U.S.C. 216); Sec. 1006, 50.208 Program or project requirements. Public Health Service Act, 84 Stat. 1507 (42 50.209 Use of Federal financial assistance. U.S.C. 300a-4), unless otherwise noted. 50.210 Review of regulation.

SOURCE: 43 FR 52165, Nov. 8, 1978, unless APPENDIX TO SUBPART B OF PART 50_RE

otherwise noted. QUIRED CONSENT FORM Subpart c-Abortions and Related Med- Subpart A Responsibility of PHS

ical Services in Federally Assisted Pro- Awardee and Applicant Instigrams of the Public Health Service

tutions for Dealing with and 50.301 Applicability.

Reporting Possible Mis50.302 Definitions.

conduct in Science 50.303 General rule. 50.304 Life of the mother would be endan

AUTHORITY: Sec. 493, Public Health Service gered.

Act, as amended, 99 Stat. 874-875 (42 U.S.C. 50.305 [Reserved)

289b); Sec. 501(f), Public Health Service Act, 50.306 Rape and incest.

as amended, 102 Stat. 4213 (42 U.S.C. 290aa(f)). 50.307 Documentation needed by programs or projects.

SOURCE: 54 FR 32449, Aug. 8, 1989, unless 50.308 Drugs and devices and termination of otherwise noted.

ectopic pregnancies. 50.309 Recordkeeping requirements.

$ 50.101 Applicability. 50.310 Confidentiality.

This subpart applies to each entity Subpart D-Public Health Service Grant which applies for a research, researchAppeals Procedure

training, or research-related grant or

cooperative agreement under the Pub50.401 What is the purpose of this subpart?

lic Health Service (PHS) Act. It re50.402 To what programs do these regulations apply?

quires each such entity to establish 50.403 What is the policy basis for these pro

uniform policies and procedures for incedures?

vestigating 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. 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.

8 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. 8 50.103 Assurance Responsibilities of

PHS awardee and applicant institu

tions. (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.

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