§ 5.20 - General redelegations of authority from the Commissioner to other officers of the Food and Drug Administration.

(a) Final authority of the Commissioner of Food and Drugs (Commissioner) is redelegated as set forth in these subparts. The Commissioner may continue to exercise all authority delegated in subparts B through L.

(b) The following officials are authorized to perform all of the functions of the Commissioner. These officials may not further redelegate this authority, or any part of this authority, except as elsewhere specified:

(1) Deputy Commissioner;

(2) Associate Commissioner for Regulatory Affairs;

(3) Senior Associate Commissioner;

(4) Senior Associate Commissioner for Management and Systems;

(5) Senior Associate Commissioner for Policy, Planning, and Legislation; and

(6) Deputy Commissioner for International and Constituent Relations.

(c)(1) During the absence or disability of the Commissioner or in the event of a vacancy in that position, the first official who is available in the following positions, or who has been designated by the Commissioner to act in such position, shall act as Commissioner:

(i) Deputy Commissioner;

(ii) Associate Commissioner for Regulatory Affairs; or

(iii) Senior Associate Commissioner.

(2) These officials may not further redelegate this authority. However, for a planned period of absence, the Commissioner (or someone “acting” on his/her behalf) may specify a different order of succession.

(d) Authority delegated to a position by title may be exercised by a person officially designated to serve in that position in an acting capacity or on a temporary basis, unless prohibited by a restriction in the document designating him/her as “acting” or unless not legally permissible.

(e)(1) The Senior Associate Commissioner is authorized to make determinations that advisory committee meetings are concerned with matters listed in 5 U.S.C. 552(b) and therefore may be closed to the public in accordance with 5.10(a)(17).

(2) The Senior Associate Commissioner is authorized to perform other associated advisory committee functions (e.g., establishing technical and scientific review groups (advisory committees)); appointing and paying members; approving waivers to appoint members to established advisory committees; renewing and rechartering of established advisory committees; amending charters of established advisory committees; and terminating established advisory committees.

(3) The Senior Associate Commissioner is authorized to approve conflict of interest waivers for special Government employees serving on advisory committees in accordance with 18 U.S.C. 208(b)(3), as amended.

(4) The Senior Associate Commissioner is authorized to select temporary members to advisory committees if such voting members are serving on an advisory committee managed by another center.

(5) The Senior Associate Commissioner may not further redelegate these authorities.

(f)(1) The Senior Associate Commissioner for Policy, Planning, and Legislation (SACPPL) and the Associate Commissioner for Policy (ACP) are authorized to perform any of the functions of the Commissioner with respect to the issuance of Federal Register notices and proposed and final regulations of the Food and Drug Administration. These officials may not further redelegate this authority.

(2) The SACPPL and the ACP are authorized to issue responses to the following matters under part 10 of this chapter as follows and these officials may not further redelegate this authority:

(i) Requests for waiver, suspension, or modification of procedural requirements under § 10.19 of this chapter;

(ii) Citizen petitions under § 10.30 of this chapter;

(iii) Petitions for reconsideration under § 10.33 of this chapter;

(iv) Petitions for stay under § 10.35 of this chapter; or

(v) Requests for advisory opinions under § 10.85 of this chapter.

(3) With respect to any matter delegated to the SACPPL and the ACP under this paragraph, the SACPPL and the ACP are authorized to perform the function of the Commissioner under §§ 10.40, 10.45, 10.50, 10.55, 10.60, 10.65, 10.80, 10.90, and 10.95 of this chapter and of the Deputy Commissioner under § 10.206(g) and (h) of this chapter. These officials may not further redelegate this authority.

(4) The SACPPL and the ACP are authorized under the Regulatory Flexibility Act (5 U.S.C. 605(b)) to certify that a proposed or final rule, if issued, will not have a significant economic impact on a substantial number of small entities. The SACPPL and the ACP may further redelegate this authority.

(g) The following officials are authorized to perform all the functions of the officials under them in their respective offices and they may not further redelegate this authority:

(1) Senior Associate Commissioner;

(2) Deputy Commissioner for International and Constituent Relations;

(3) Senior Associate Commissioner for Management and Systems; or

(4) Senior Associate Commissioner for Policy, Planning, and Legislation.

(h)(1) The Chief Mediator and Ombudsman and the Deputy Chief Mediator and Ombudsman are authorized to act upon requests for reconsideration of any user fee decisions under section 735 of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 379h) made by such officers and the former Deputy User Fee Waiver Officer prior to July 1, 1999. These officials may not further redelegate this authority. (See subpart C, § 5.108 for the user fee-related redelegation to officials within the Center for Drug Evaluation and Research.)

(2) The Senior Associate Commissioner for Management and Systems and the Director, Office of Financial Management, are authorized to perform the functions of the Commissioner under section 736(d)(1)(c) of the act (21 U.S.C. 379h(d)(1)(C)), as amended, to waive or reduce prescription drug user fees in situation where he or she finds that “the fees will exceed the anticipated present and future costs.” These officials may not further redelegate this authority.

(3) The Deputy Commissioner, or in the event of a vacancy in that position, the Senior Associate Commissioner, Office of the Commissioner, is designated as the User Fee Appeals Officer. The User Fee Appeals Officer is authorized to hear and decide user fee waiver appeals. The decision of the User Fee Appeals Officer will constitute final agency action on such matters. The User Fee Appeals Officer may not further redelegate this authority.

(i) The Senior Associate Commissioner for Management and Systems is authorized to perform all of the administrative authorities (i.e., financial, personnel, facilities management, property management, etc.) of the Commissioner. These authorities may be further redelegated, except when specifically prohibited.

(j) Unless specifically noted, the persons to whom the Commissioner has delegated authority in subparts B through L of this part may not further redelegate that authority.