tion concerning the request and the potential consequences of any request that is disapproved.

(d) Non-competing continuation awards. Where a grantee has filed an application for continuation support and within the limits of funds available for this purpose, the Secretary may make a grant award for an additional budget period for any previously approved Center where the Secretary finds on the basis of such progress and accounting reports as may be required that the Center's activities during the current budget period justify continued support of the project for an additional budget period. Where the Secretary determines to continue support, the amount of grant award shall be determined in accordance with paragraph (b) of this section. Where the Secretary determines not to continue a project for an additional budget period, the grantee will be notified in writing before the end of the current budget period. In addition, where he determines such support is necessary, the Secretary may provide financial support for the orderly phase-out of the supported activity. 8 67.107 Operational requirements.

(a) Any Center supported under this subpart shall:

(1) Have a full-time Director who possesses a demonstrated capacity for sustained productivity and leadership in health services research, demonstrations, and evaluations. The Director shall oversee the research program and the general operation of the Center and shall to the extent practicable directly participate in research activities. Where the Director of a Center becomes unable to function in such capacity, the grantee shall so inform the Secretary as quickly as possible. Within five (5) days, the grantee shall designate an Interim Director and inform the Secretary of the name of such individual. Within ninety (90) days, the grantee shall nominate an Acting Director who, if approved by the Secretary, shall serve in that capacity until the end of the budget period. The failure to obtain Secretari. al approval of a new Director in the prescribed period of time shall result in immediate suspension of the grant;

(2) Have such additional full-time professional staff representing various disciplines relevant to health services research as necessary to plan, establish and operate the proposed Center and to carry out or administer research projects undertaken with the Center. The number and expertise of the staff shall be determined by the size of the proposed Center, the availability to it of staff resources other than its own immediate staff, and the nature and scope of the problems which its research will address:

(3) Be located within an established academic or research institution with available resources appropriate to the proposed activities to be conducted by the Center;

(4) Have written agreements with clinical settings which provide for settings appropriate for the initiation and evaluation of experiments in health services research;

(5) Select problems in health services for research, demonstrations and evaluations respecting:

(i) The accessibility, acceptability, planning, organization, distribution, technology, utilization, quality, and financing of health services and systems;

(ii) The supply and distribution, education and training, quality, utilization, organization, and cost of health manpower; and

(iii) The design, construction, utilization, organization, and cost of facilities and equipment on the basis of (A) their regional or national importance, (B) the unique potential for definitive research on the problem, (C) the opportunities for local application of the research findings;

(6) Provide educational opportunities, through formal mechanisms, for university students, health professionals or other appropriate individuals;

(7) Provide for the dissemination of its research findings, subject to the requirements for confidentiality as set forth in section 308(d) of the Act and § 67.112;

(8) Provide, through a formal mechanism, for consultations and technical assistance to concerned individuals and groups of the geographical area in which the Center will be located.

and procedures prescribed pursuant thereto.

8 67.113 Control of data.

Except as otherwise provided in the terms and conditions of the award and subject to the confidentiality requirements of $ 67.112, all data collected or assembled for the purposes of carrying out health services research, demonstration, or evaluation projects directly supported under this subpart (as that term is defined in § 67.112) shall be made available to the Secretary upon request.

8 67.111 Publications and copyright.

(a) Copyright. Except as may otherwise be provided under the terms and conditions of the award, the grantee is free to copyright any book or other copyrightable materials developed under the grant, subject to a royalty-free, nonexclusive and irrevocable license of the Department to reproduce, publish, alter or otherwise use, and to authorize others to use the work for Government purposes. In any case in which a copyright has been obtained, the Secretary shall be so notified.

(b) Publications. Any reports, papers, statistics, or other materials developed from work supported in whole or in part by an award made under this subpart shall be submitted to the Secretary. The Secretary may make such materials available and disseminate the material on as broad a basis as practicable and in such form as to make such materials understandable.

§ 67.112 Confidentiality.

No information obtained by a Center in the course of its health services research activities directly supported under this subpart may be used for any purpose other than the purpose for which it was supplied (which shall include the disclosure of such information to the Secretary for carrying out his responsibilities under the Health Services Research, Health Statistics, and Medical Libraries Act of 1974 (Pub. L. 93-353), unless authorized under regulations of the Secretary. Further, such information may not be published or released in other than statistical form if the person who supplied the information or who is described in it is identifiable unless such person has signed a written consent on such forms and in such manner as the Secretary may prescribe. For purposes of this section and $ 67.113, the term “directly supported”, as it relates to health services research, demonstration, or evaluation projects, means discrete, identifiable projects supported under this subpart and not to solely the provision of administrative and staff support for the Center.

§ 67.114 Grantee accountability.

(a) Accounting for grant award payments. All payments made by the Secretary shall be recorded by the grantee in accounting records separate from the records of all other funds, including funds derived from other grant awards. With respect to each approved project the grantee shall account for the sum total of all amounts paid by presenting or otherwise making available evidence satisfactory to the Secretary of expenditures for direct and indirect costs meeting the requirements of this subpart; Provided however, That when the amount awarded for indirect costs was based on a predetermined fixed percentage of estimated direct costs, the amount allowed for indirect costs shall be computed on the basis of such predetermined fixedpercentage rates applied to the total, or a selected element thereof, of the reimbursable direct costs incurred.

(b) Accounting for royalties. Royalties received by grantees from copyrights on publications or other works developed under the grant, or from patents or inventions conceived or first actually reduced to practice in the course of or under such grant, shall be accounted for as follows:

(1) State and local governments. When the grantee is a State or local government as defined in 45 CFR 74.3, royalties shall be accounted for as provided in 45 CFR 74.44.

(2) Grantees other than State and local governments. Where the grantee is not a State or local government as so defined, royalties shall be accounted for as follows:

(i) Patent royalties, whether ceived during or after the project period, shall be governed by agree

re

the date that such project is initiated. Such notification shall include:

(a) A description of the project, including the hypotheses to be tested or the objectives to be pursued;

(b) The names of the principal investigators and the principal staff members that will be assigned to the project; and

(c) A budget, including an identification of the source of funds.

8 67.116 Human subjects.

No award may be made under this Subpart unless the applicant has complied with 45 CFR Part 46 and other applicable requirements pertaining to the protection of human subjects.

ments between the Assistant Secretary for Health, Department of Health and Human Services, and the grantee, pursuant to the Department's patent regulations (45 CFR Parts 6 and 8).

(ii) Copyright royalties, whether received during or after the grant period, shall first be used to reduce the Federal share of the grant to cover the costs of publishing or producing the materials; and any royalties in excess of the costs of publishing or producing such materials shall be distributed in accordance with Chapter 1-420 or the Department of Health and Human Services Grants Administration Manual. 2

(c) Grant closeout-(1) Date of final accounting. In addition to such other special and periodic accounting as the Secretary may require, a grantee shall render with respect to each Center a full account, as provided herein, as of the termination of grant support which shall be (i) the end of the project period, or (ii) the date of any termination of grant support pursuant to Subpart M of 45 CFR Part 74.

(2) Final settlement. There shall be payable to the United States as final settlement with respect to each approved project the total sum of (i) any amount not accounted for pursuant to paragraph (a) of this section and (ii) any other amounts due pursuant to Subparts F, M, and 0 of 45 CFR Part 74. Such total sum shall constitute a debt owed by the grantee to the United States and shall be recovered from the grantee or its successors or assignees by set-off or other action as provided by law.

§ 67.117 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 subpart 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 other grantee organizations under this subpart:

45 CFR PART 74

Subpart:
A General
B Cash Depositories.
C Bonding and Insurance.
D Retention and Custodial Requirements

for Records.
F Grant-Related Income.
G Matching and Cost Sharing.
K Grant Payment Requirements.
L Budget Revision Procedures.
M Grant Closeout, Suspension, and Termi.

nation. O Property. Q Cost Principles.

8 67.115 Reports.

Each grant awarded under this subpart shall be subject to the condition that the grantee shall file written notification with the Secretary of each research, demonstration or evaluation project undertaken by the Center on

2 The Department of Health and Human Services Grants Administration Manual is available for public inspection and copying at the Department's and Regional Offices' information centers listed in 45 CFR 5.31 and may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

8 67.118 Additional conditions.

The Secretary may, with respect to any grant awarded under this subpart, 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 Center or the conservation of grant funds.

Subpart H-Pratique: Vessels and Aircraft

Subpart E-General Requirements Upon Arriv

al at Ports Under Control of the United

States 71.61 Applicability. 71.62 General provisions: Vessels and air

71.121 General requirement: Vessels only. 71.122 Free pratique: Vessels only. 71.123 Provisional pratique and remand:

Vessels only. 71.124 Radio pratique: Vessels only. 71.125 Presentation of pratique: Vessels

only. 71.126 Pratique and remand: Aircraft only. 71.127 Notification of remands: Vessels and

aircraft. 71.128 Vessels and aircraft not submitting

to prescribed measures.