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(ii) Have a mental health problem which was caused or aggravated by the major disaster or its aftermath.

(2) Disaster workers who are available on short notice to provide professional mental health crisis counseling services in a major disaster area are eligible for training under this part.

(d) Time limitation. Contracts and grants awarded under this part will not continue beyond 180 days after the first day services are provided pursuant to such contracts and grants, except that upon the recommendation of the Secretary (1) the Regional Director may extend the 180 day period for up to 30 days or (2) the Administrator may extend the 180 day period for more than 30 days.

(1) Progress reports, to be submitted at the end of the first 30 days of the contract period and every 30 days therafter;

(2) A final report to be submitted within 60 days of the date upon which the contract terminates; and

(3) Such additional reports as the Secretary may prescribe including those which may be required to enable the Federal Coordinating Officer to carry out his functions.

$38.4 Contracts.

(a) Eligibility. Public agencies and private mental health organizations which are determined by the Secretary to be capable of providing the professional mental health crisis counseling services or mental health training of disaster workers needed as a result of a major disaster are eligible for the award of a contract under this part.

(b) Use of local agencies. Preference will be given to the extent feasible and practicable, to those agencies and organizations which are located or do business primarily in the area affected by the major disaster.

(c) General requirements. Contracts under this part shall be entered into and carried out in accordance with the provisions of chapters 1 and 3 of title 41 of the Code of Federal Regulations and all other applicable laws and regulations.

(d) Payments. The Secretary shall from time to time make payments to the contractor of all or a portion of the contract award, either by way of reimbursement for expenses incurred or in advance for expenses to be incurred, to the extent he determines such payments

necessary to promote prompt initiation and advancement of the services to be provided under the contract. All payments not expended by the contractor within the period of the contract shall be returned to the Secretary.

(e) Reports. Contractors shall submit the following reports to the Secretary:

8 38.5 Grant assistance.

(a) Eligibility. Public agencies and private nonprofit mental health organizations which are determined by the Secretary to be capable of providing the professional mental health crisis counseling services or mental health training of disaster workers needed as a result of a major disaster are eligible for a grant award under this part.

(b) Application. The application shall contain:

(1) A proposed plan for the provision of the services for which grant assistance is requested;

(2) A proposed budget for the expenditure of the requested grant funds; and

(3) Such other pertinent information and assurances as the Secretary may require.

(c) Grant awards. (1) Preference will be given, to the extent feasible and practicable, to those public and private nonprofit agencies and organizations which are located or do business primarily in the area affected by the major disaster.

(2) Within the limits of the funds advanced by the Administrator, the amount of any grant award shall be determined on the basis of the Secretary's estimate of the sum necessary to carry out the grant purpose.

(3) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.

(d) Other HHS regulations that apply. Several other regulations apply to grants under this grant. These include, but are not limited to:


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.

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. 838.8 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 E-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

50.504 Allowable cost of drugs. awardee and applicant institutions. 50.104 Reporting to the OSI. 50.105 Institutional compliance.

Subpart F-Responsibility of Applicants for

Promoting Objectivity in Research for Subpart B-Sterilization 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 BOF 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. 50.305 (Reserved)

Act, as amended, 99 Stat. 874-875 (42 U.S.C. 50.306 Rape and incest.

289b); Sec. 501(f), Public Health Service Act, 50.307 Documentation needed by programs

as amended, 102 Stat. 4213 (42 U.S.C. 290aa(f)). 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.

850.101 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? 50.402 To what programs do these regula

lic Health Service (PHS) Act. It retions 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 Seryices (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 Seryices to whom the authority involved may be delegated.

850.103 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.

(b) Annual Submission. An applicant takes longer than 60 days to complete, or recipient institution shall make an the record of the inquiry shall include annual submission to the OSI as fol- documentation of the reasons for exlows:

ceeding the 60-day period. (1) The institution's assurance shall (2) Protecting, to the maximum exbe submitted to the OSI, on a form pre- tent possible, the privacy of those who scribed by the Secretary, as soon as in good faith report apparent mispossible after November 8, 1989, but no conduct. later than January 1, 1990, and updated

(3) Affording the affected indiannually therefter on a date specified

vidual(s) confidential treatment to the by OSI. Copies of the form may be re- maximum extent possible, a prompt quested through the Director, OSI.

and thorough investigation, and an op(2) An institution shall submit, along

portunity to comment on allegations with its annual assurance, such aggre

and findings of the inquiry and/or the gate information on allegations, in

investigation. quiries, and investigations as the Sec

(4) Notifying the Director, OSI, in acretary may prescribe.

cordance with $50.104(a) when, on the (c) General Criteria. In general, an ap

basis of the initial inquiry, the instituplicant institution will be considered

tion determines that an investigation to be in compliance with its assurance

is warranted, or prior to the decision to if it: (1) Establishes, keeps current, and

initiate an investigation if the condi

tions listed in $ 50.104(b) exist. upon request provides the OSIR, the OSI, and other authorized Depart

(5) Notifying the OSI within 24 hours mental officials the policies and proce

of obtaining any reasonable indication

of possible criminal violations, so that dures required by this subpart.

the OSI may then immediately notify (2) Informs its scientific and administrative staff of the policies and proce

the Department's Office of Inspector dures and the importance of compli

General ance with those policies and proce

(6) Maintaining sufficiently detailed dures.

documentation of inquiries to permit a (3) Takes immediate and appropriate

later assessment of the reasons for deaction as soon as misconduct on the

termining that an investigation was part of employees or persons within the

not warranted, if necessary. Such organization's control is suspected or

records shall be maintained in a secure alleged.

manner for a period of at least three (4) Informs, in accordance with this years after the termination of the insubpart, and cooperates with the OSI quiry, and shall, upon request, be prowith regard to each investigation of vided to authorized HHS personnel. possible misconduct.

(7) Undertaking an

investigation (d) Inquiries, Investigations, and Re- within 30 days of the completion of the porting-Specific Requirements. Each ap- inquiry, if findings from that inquiry plicant's policies and procedures must provide sufficient basis for conducting provide for:

an investigation. The investigation (1) Inquiring immediately into an al- normally will include examination of legation or other evidence of possible all documentation, including but not misconduct. An inquiry must be com- necessarily limited to relevant repleted within 60 calendar days of its search data and proposals, publicainitiation unless circumstances clearly tions, correspondence, and memoranda warrant a longer period. A written re- of telephone calls. Whenever possible, port shall be prepared that states what interviews should be conducted of all evidence was reviewed, summarizes rel- individuals involved either in making evant interviews, and includes the con- the allegation or against whom the alclusions of the inquiry. The indi- legation is made, as well as other individual(s) against whom the allegation viduals who might have information was made shall be given a copy of the regarding key aspects of the allegareport of inquiry. If they comment on tions; complete summaries of these that report, their comments may be interviews should be prepared, provided made part of the record. If the inquiry to the interviewed party for comment

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