(b) Chapter 1-43 of the Department Grants Administration Manual2 concerning animal welfare.

§ 86.20 Additional conditions.

The Secretary may with respect to any grant award impose additional conditions prior to or at the time of any award when in his judgment such conditions are necessary to assure or protect advancement of the approved project, the interests of public health, or the conservation of grant funds.

§ 86.21 Applicability of 45 CFR part 74.

The provisions of 45 CFR part 74, establishing uniform administrative requirements and cost principles, shall apply to all grants under this part to States and local governments as those terms are defined in subpart A of that part 74. The relevant provisions of the following subparts of part 74 shall also apply to grants to all grantee organizations under this part:

(b) for research relating to occupational safety and health, or (c) for teaching in occupational safety and health.

§ 86.31 Eligibility; minimum require

ments.

In order to be eligible for an award under this subpart an applicant must: (a) Have been accepted by a public or private institution for the purpose of the activity for which the traineeship is sought.

(b) Be a U.S. citizen, an alien lawfully admitted to the United States for permanent residence or a permanent resident of Guam, American Samoa, or the Trust Territory of the Pacific Islands.

[40 FR 29076, July 10, 1975, as amended at 47 FR 53012, Nov. 24, 1982] $86.32 Application traineeship.

for

direct

An application for a direct traineeship under this subpart shall be submitted to the Secretary at such times and in such form and manner as he may prescribe.1 In addition to the information supplied by the applicant in his application, such further information may be required as is necessary to determine his or her qualifications. [40 FR 29076, July 10, 1975, as amended at 49 FR 38117, Sept. 27, 1984]

§ 86.33 Human subjects; animal welfare.

Where the application is for training at a non-Federal institution, no award may be made under this subpart unless said institution has complied with:

(a) 45 CFR part 46 pertaining to the protection of human subjects; and

(b) Chapter 1-43 of the Department Grants Administration Manual 2 068 concerning animal welfare.

§86.34 Evaluation and award of direct traineeships.

Within the limits of funds available for such purpose and subject to the regulations of this part, the Secretary

1 Applications and instructions may be obtained from the Procurement and Grants Office, Centers for Disease Control, Atlanta, GA 30333.

2 See footnote 2 to § 86.19.

190-164 D-00--21

may award direct traineeships to those qualified applicants who are in his judgment best able to carry out the purpose of the traineeships taking into consideration the need for training in the area of study specified in the application.

§ 86.35 Payments.

(a) Individuals receiving awards shall be entitled to such stipends and allowances as the Secretary may designate, taking into account such factors as the needs of the program, the cost of living, and the availability of funds.

(NOTE: These are prescribed in chapter 3140 of the Department Grants Administration Manual2).

(b) Payments of stipends and allowances will, at the discretion of the Secretary, be made directly to the trainee or to the sponsoring institution for payment directly to the trainee.

§ 86.36 Duration and continuation.

Direct traineeship awards may be made for varying periods not in excess of 2 years. The Secretary may make one or more continuation awards for an additional period if he finds that satisfactory progress is being made toward accomplishment of the purpose of the initial traineeship award. Additional support may be provided on appropriate justification after expiration of the period of support in the previous award.

$86.37 Terms and conditions.

All direct traineeship awards shall be subject to the following terms and conditions:

(a) Training must be carried out at an institution found by the Secretary to provide a well-rounded course of instruction in the particular area of training for which the traineeship is awarded.

(b) No direct traineeship may be utilized to compensate any trainee for personal services or employment on behalf of the United States or any person.

§86.38 Accountability.

Accountability for payments will be subject to such requirements as may be specified by the Secretary.

(a) The Secretary may terminate a direct traineeship at any time upon request of the trainee.

(b) After reasonable notice to the trainee and an opportunity for the presentation of the trainee's views and relevant evidence, the Secretary may terminate any direct traineeship prior to the date it would otherwise expire upon a determination that the trainee's performance is unsatisfactory, that the trainee is no longer attending the sponsoring institution, or that he or she is unfit or unable to carry out the purpose of the traineeship.

(c) The views and evidence of the trainee shall be presented in writing unless the Secretary determines that an oral presentation is desirable.

87.3 Who is eligible to apply for a grant under this part?

87.4 For what purposes may grants be awarded?

87.5 What information must be included in the grant application?

87.6 How will grant applications be evaluated and the grants awarded?

87.7 For what period of time will grants be awarded?

87.8 How may a grantee use grant funds? 87.9 Which other HHS regulations apply?

AUTHORITY: Sec. 8(g), 84 Stat. 1600 (29 U.S.C. 657(g)), sec. 508, 83 Stat. 803 (30 U.S.C. 957).

SOURCE: 46 FR 58676, Dec. 3, 1981, unless otherwise noted.

$87.1 To which programs does this regulation apply?

This regulation applies to research and demonstration project grants under:

(a) Section 20(a)(1) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 669(a)(1)) for the support of studies related to occupational safety and health, and

(b) Section 501 of the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 951) for the support of health research in mining. These grants are awarded and administered by the National Institute for Occupational Safety and Health, Centers for Disease Control, of the Public Health Service.

§ 87.2 Definitions.

As used in this regulation:

Demonstration project grant means an award of funds to an eligible applicant to assist in meeting the cost of conducting a demonstration, either on a pilot or full-scale basis, of the technical or economic feasibility or application of a new or improved procedure, method, technique, or approach that will further the research purposes described in § 87.4.

Principal investigator for a research project, or project director for a demonstration project, means a single individual who is responsible for the scientific and technical direction of the project.

Research project grant means an award of funds to an eligible applicant to assist in meeting the costs of conducting an identified research activity or program, study, or experiment that will further the research purposes described in § 87.4.

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.

§87.3 Who is eligible to apply for a grant under this part?

Any public or private agency or institution is eligible to apply for a grant under this part, except Federal agencies or institutions not specifically authorized by law to receive such a grant.

$87.4 For what purposes may grants be awarded?

(a) The Occupational Safety and Health Act authorizes grants for research, experiments, and demonstrations relating to occupational safety and health, including studies of the psychological factors involved. This authority includes projects to develop innovative methods, techniques, and

approaches for dealing with occupational safety and health problems.

(b) The Federal Mine Safety and Health Act authorizes grants for research projects designed to:

(1) Improve working conditions and practices affecting health in coal or other mines and to prevent occupational diseases originating in the mining industry.

(2) Develop epidemiological information to (i) identify and define positive factors involved in occupational diseases of miners, (ii) provide information on the incidence and prevalence of pneumoconiosis and other respiratory ailments of miners, and (iii) improve health standards.

(3) Develop techniques for the prevention and control of occupational diseases of miners, including tests for hypersusceptibility and early detec

tion.

(4) Evaluate the effect on bodily impairment and occupational disability of miners afflicted with an occupational disease.

(5) Study the relationship between coal or other mine environments and occupational diseases of miners.

(6) Study matters involving the protection of life and the prevention of diseases in connection with persons who, although not miners, work with or around the products of coal or other mines in areas outside of such mines and under conditions which may adversely affect the health and well-being of such persons. Develop

(7) equipment.

effective respiratory

§ 87.5 What information must be included in the grant application?

The application must contain a complete description of the objective of the project and the plan for carrying out the research or demonstration, the name and qualifications of the principal investigator or project director and principal staff members, the total resources and facilities that will be available, and a justification of the amount of grant funds requested.

§ 87.6 How will grant applications be evaluated and the grants awarded? (a) The Secretary may award grants to those applicants whose approved

projects will best promote the purposes of either the Occupational Safety and Health Act or the Federal Mine Safety and Health Act on the basis of an evaluation conducted by experts or consultants engaged for this purpose.

(b) This evaluation will take into account the scientific merit and significance of the project, the competency of the proposed staff in relation to the type of research or demonstration involved, the feasibility of the project, the likelihood of its producing meaningful results, the proposed project period, the adequacy of the applicant's resources available for the project, the amount of grant funds necessary for completion, and for mining grant applications, the recommendations of the Mine Health Research Advisory Committee.

(c) The Secretary may evaluate and approve two or more concurrent applications, each dealing with one or more specified aspects of the project, and make two or more concurrent grant awards for the project. This may be necessary when a project involves a number of different but related problems, activities, or disciplines which would require evaluation by different groups, or when support for a project could be more effectively administered by separate handling of various aspects of the project.

§ 87.7 For what period of time will grants be awarded?

(a) The notice of grant award specifies how long the Secretary intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for 3-5 years.

(b) Generally, the grant will initially be for 1 year and subsequent continuation awards will also be for 1 year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be of such factors as the grantee's progress and management

practices, and the availability of funds. In all cases, continuation awards require a determination by the Secretary that continued funding is in the best interest of the Federal Government.

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

$87.8 How may a grantee use grant funds?

A grantee shall only spend funds it receives under this part according to the approved application and budget, the authorizing legislation, the terms and conditions of the grant award, the applicable cost principles specified in subpart Q of 45 CFR part 74, and the regulations of this part.

§ 87.9 Which other HHS regulations apply?

Several other regulations apply to grants under this part. These include, but are not limited to:

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 46-Protection of human subjects

45 CFR part 74—Administration of grants 45 CFR part 75-Informal grant appeals procedures

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 hearing 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 91-Nondiscrimination on the basis of age in HHS programs or activities receiving Federal financial assistance [49 FR 38117, Sept. 27, 1984]

90.3 Procedures for requesting health assessments.

90.4 Contents of requests for health assessments.

90.5 Acting on requests.

90.6 Notification of determination to conduct a health assessment in response to a request from the public.

90.7 Decision to conduct health effects study.

90.8 Conduct of health assessments and health effects studies.

90.9 Public health advisory. 90.10 Notice and comment period. 90.11 Reporting of results of health assessments and health effects studies. 90.12 Confidentiality of information. 90.13 Recordkeeping requirements. 90.14

Documentation and cost recovery. AUTHORITY: 42 U.S.C. 9615; 42 U.S.C. 6939a(c).

SOURCE: 55 FR 5138, Feb. 13, 1990, unless otherwise noted.

§ 90.1 Purpose and applicability.

The provisions of this part set forth the policies and procedures of the Agency for Toxic Substances and Disease Registry (ATSDR) with respect to its conduct of health assessments and health effects studies under section 104(i) of Comprehensive Environmental Response, Compensation, and Liability Act, as amended by the Superfund Amendments and Reauthorization Act of 1986, and section 3019 of the Resource Conservation and Recovery Act. These provisions apply to ATSDR, as well as its contractors, agents, and those carrying out health assessments and health effects studies pursuant to agreements with ATSDR, such as other Federal agencies and States.

§ 90.2 Definitions.

Administrator means the Administrator of the Agency for Toxic Sub

stances and Disease Registry or designee.

ATSDR means the Agency for Toxic Substances and Disease Registry, Public Health Service, U.S. Department of Health and Human Services.

CERCLA means the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (42 U.S.C. 9601 et seq., Pub. L. 96-520), as amended by the Superfund Amendments and Reauthorization Act of 1986 (Pub. L. 99-499).

EPA means the U.S. Environmental Protection Agency.

Facility is defined in 42 U.S.C. 9601(9). Hazardous substance is defined in 42 U.S.C. 9601(14). In addition, the term includes any pollutant or contaminant which the Administrator determines is appropriate for the purposes of carrying out his or her responsibilities under CERCLA.

Health assessment means the evaluation of data and information on the release of hazardous substances into the environment in order to assess any current or future impact on public health, develop health advisories or other recommendations, and identify studies or actions needed to evaluate and mitigate or prevent human health effects.

Health effects study means research, investigation, or study performed by ATSDR or other parties pursuant to an agreement with ATSDR to evaluate the health effects of exposure to hazardous substances at specific sites. This term includes, but is not limited to, epidemiological studies, exposure and disease registries, and health surveillance programs. This term does not include health assessments.

Owner or operator is defined in 42 U.S.C. 9601(20).

Peer review means review for scientific quality by a panel consisting of no less than three nor more than seven members, who shall be disinterested scientific experts selected by the Administrator of ATSDR on the basis of their reputation for scientific objectivity and the lack of institutional ties