in response to a published invitation, the Food and Drug Administration will publish in the FEDERAL REGISTER a notice of that fact together with the reasons for the decision. § 861.30 Development of standards. (a) Any person, including any Federal agency, engaged in the development of a proposed standard under this section shall: (1) Support its proposed performance standard by such test data or other documents or materials as the Food and Drug Administration may reasonably require; (2) Provide interested persons an opportunity to participate in the development of the standard by accepting comments and, where appropriate, holding public meetings on issues relating to development of the standard. Notice of the opportunity to participate in the development of the standard shall be furnished in a manner reasonably calculated to reach the majority of persons interested in the development of the standard. This requirement shall be satisfied by the Food and Drug Administration or any other Federal agency by publishing such a notice in the FEDERAL REGISTER. Whenever it is appropriate, FDA will use the FEDERAL REGISTER to make announcements about the standards development process of standard developers other than Federal agencies. (3) Maintain records disclosing the course of development of the proposed standard, the comments and other information submitted by any person in connection with such development (including comments and information regarding the need for a standard), and such other information as may be required by the Food and Drug Administration to evaluate the standard. (b) Any person engaged in the development of a standard shall, in addition to complying with paragraph (a) of this section: (1) Submit progress reports on a quarterly basis or as otherwise required by the Food and Drug Administration; (2) Cooperate fully with the Food and Drug Administration and permit duly authorized representatives of the Food and Drug Administration to in spect its facilities and developmental activities to determine whether satisfactory progress is being made toward completion of the standard; (3) If receiving contributions from the Food and Drug Administration toward the cost of developing the proposed standard: (i) Submit, on a quarterly basis, a full accounting of such contributions, (ii) Remit all unexpended amounts within 60 calendar days after submission of the standard, (iii) Maintain, for a period of 3 years after submission of the proposed standard, records that fully disclose the total costs and expenditures for the development of the standard and such other records as are necessary to permit an effective audit, (iv) Grant access to and audit of any books, documents, papers, and other records relating to the expenditure of any funds contributed by the Food and Drug Administration. (c) If it appears to the Food and Drug Administration that a person engaged in the development of a performance standard is not making satisfactory progress, that person will be afforded an opportunity either to demonstrate ability and willingness to complete the development of the standard within the designated time period or to justify the need for an extension of the development period. After evaluating available information, the Food and Drug Administration will terminate the person's role in the development process, extend the period for development of the proposed standard, or direct the person to complete the standard within the designated time period. Any person who has received a contribution from the Food and Drug Administration and whose role in the development process is terminated shall be required to submit to the Food and Drug Administration all information, records, and documents in its possession which relate to the development of the proposed standard, and to remit all funds contributed by the Food and Drug Administration that have not been expended. The Food and Drug Administration shall publish in the FEDERAL REGISTER a notice of the determination to terminate the role of any person in the development of a proposed standard, together with the reasons for this action. § 861.32 Contribution by the Food and Drug Administration to the costs of developing a proposed standard. (a) If an offer to develop a proposed standard is accepted, the Food and Drug Administration may agree to contribute to the costs of developing the standard if it is determined that such contribution is likely to result in the development of a more satisfactory standard. (b) The items of cost toward which the Food and Drug Administration may contribute are those allowable direct and indirect costs allocable to the development project as set forth in the applicable subparts of 48 CFR Parts 1-51 of the Federal Acquisition Regulations System. Typical standards development activities to which the Food and Drug Administration may contribute include: (1) Research and analysis of the existing literature pertaining to the medical device that is the subject of the development effort; (2) Testing of representative medical devices in support of the development effort; and (3) Preparation of, and participation in public review of, draft standards. (c) The items of cost to which the Food and Drug Administration may not contribute include: (1) Costs for the construction or acquisition of any interest in land or buildings; (2) Costs for the payment of salaries in excess of the amount paid by the offeror at the time immediately preceding the offer, excluding routine increases which may accrue during the development period; (3) Costs for the payment of items in excess of the offeror's actual costs; (4) Costs for an item with a usable lifespan extending beyond the development period, except that contribution may be made toward the portion of an item's cost allocable to the development of the proposed standard as determined by the difference between the item's estimated market value at the termination of the development period and the total cost of its acquisition; and (5) Costs determined not to be allowable under generally accepted accounting principles and practices of 48 CFR Parts 1-51 of the Federal Acquisition Regulations System. [45 FR 7484, Feb. 1, 1980, as amended at 53 FR 11253, Apr. 6, 1988] § 861.34 Amendment or revocation of a standard. (a) The Food and Drug Administration will provide for periodic evaluation of performance standards to determine whether such standards should be changed to reflect new medical, scientific, or other technological data. (b) The Food and Drug Administration may, on its own initiative or upon petition of an interested party, amend or revoke by regulation a standard established under this part. (c) Any petition to amend or revoke a standard shall: (1) Identify the specific device and standard for which the amendment or revocation is sought; and (2) Be submitted in accordance with the requirements of § 10.30. (d) Proceedings to amend or revoke a performance standard shall be conducted in accordance with the rulemaking procedures of § 10.40. In addition, a notice of proposed rulemaking to amend or revoke a standard shall set forth proposed findings with respect to the degree of risk or illness to be eliminated or reduced and the benefit the public will derive from the proposed amendment or revocation. § 861.36 Effective dates. (a) A regulation establishing, amending, or revoking a performance standard will set forth the date upon which it will take effect. To the extent practical, consistent with the public health and safety, such effective date will be established so as to minimize economic loss to, and disruption or dislocation of, domestic and international trade. (b) Except as provided in paragraph (c) of this section, no regulation establishing, amending, or revoking a standard may take effect before 1 year after the date of its publication unless: (1) The Food and Drug Administration determines that an earlier effective date is necessary to protect the public health and safety; or (2) The standard has been established for a device that, by the effective date of the standard, has been reclassified from class III to class II. (c) The Food and Drug Administration may declare a proposed regulation amending a standard effective on publication in the FEDERAL REGISTER if it determines, after affording interested persons an opportunity for an informal hearing conducted in accordance with Part 16 of this chapter, that making the regulation so effective is in the public interest. A proposed amendment of a performance standard made effective upon publication may not prohibit the introduction or delivery for introduction into interstate commerce of a device that conforms to the standard without the change changes provided in the proposed amendment until the effective date of any final action on the proposal. § 861.38 Standards advisory committees. or (a) The Food and Drug Administration will establish advisory committees to which proposed regulations may be referred, and these committees shall consider such referrals in accordance with this section and Part 14 of this chapter. Such advisory committees, which may not be classification panels, shall be considered ad hoc advisory committees. Their members shall be selected in accordance with §§ 14.82 and 14.84, except that no member may be a regular full-time FDA employee. Each advisory committee established under this section shall include as nonvoting members a representative of consumer interests and a representative of interests of the device manufacturing industry. (b) A proposed regulation to establish, amend, or revoke a performance standard shall be referred to an advisory committee for a report and recommendation with respect to any matter involved in the proposed regulation which requires the exercise of scientific judgment if: (1) The Food and Drug Administration determines that such referral is necessary or appropriate under the circumstances; or (2) (i) Requested by an interested person, in the form of a citizen petition in accordance with § 10.30, within the period provided for comment on the proposed regulation; and, (ii) The Food and Drug Administration does not determine the request to be without good cause or on a matter not involving scientific judgment. (c) When a proposed regulation is referred to an advisory committee, the Food and Drug Administration will furnish the committee with the data and information upon which the proposed regulation is based. After independently reviewing the materials furnished by the Food and Drug Administration and any other available data and information, the advisory committee shall, within 60 days of the referral, submit a report and recommendation on the proposed regulation, together with all underlying data and information and a statement of the reason or basis for the recommendation. A copy of the report and recommendation will be publicly displayed in the office of the Dockets Management Branch, Food and Drug Administration. (d) Where appropriate, each proposed regulation establishing a standard published in the FEDERAL REGISTER will include a call for nominations to the advisory committee for that particular standard. |