C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 10—ADMINISTRATIVE PRACTICES AND PROCEDURES › Subpart B—General Administrative Procedures

21 C.F.R. § 10.75

Internal agency review of decisions

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(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:

(1) At the request of the employee.

(2) On the initiative of the supervisor.

(3) At the request of an interested person outside the agency.

(4) As required by delegations of authority.

(b)(1) The review will be made by consultation between the employee and the supervisor or by review of the administrative file on the matter, or both. The review will ordinarily follow the established agency channels of supervision or review for that matter.

(2) A sponsor, applicant, or manufacturer of a drug or device regulated under the act or the Public Health Service Act (42 U.S.C. 262), may request review of a scientific controversy by an appropriate scientific advisory panel as described in section 505(n) of the act, or an advisory committee as described in section 515(g)(2)(B) of the act. The reason(s) for any denial of a request for such review shall be briefly set forth in writing to the requester. Persons who receive a Center denial of their request under this section may submit a request for review of the denial. The request should be sent to the Chief Mediator and Ombudsman.

(c) An interested person outside the agency may request internal agency review of a decision through the established agency channels of supervision or review. Personal review of these matters by center directors or the office of the Commissioner will occur for any of the following purposes:

(1) To resolve an issue that cannot be resolved at lower levels within the agency (e.g., between two parts of a center or other component of the agency, between two centers or other components of the agency, or between the agency and an interested person outside the agency).

(2) To review policy matters requiring the attention of center or agency management.

(3) In unusual situations requiring an immediate review in the public interest.

(4) As required by delegations of authority.

(d) Internal agency review of a decision must be based on the information in the administrative file. If an interested person presents new information not in the file, the matter will be returned to the appropriate lower level in the agency for reevaluation based on the new information.

(e) Each request by an interested person for review of a decision within the Center for Devices and Radiological Health shall also comply with § 800.75 of this chapter.

[44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 63 FR 63982, Nov. 18, 1998; 84 FR 31477, July 2, 2019]
Notes of Decisions
Cited in 8 cases (1 in the last 5 years), 1982–2023 · leading case: TMJ Implants, Inc. v. United States Dep't of Health & Human Servs., 584 F.3d 1290 (10th Cir. 2009).
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TMJ Implants, Inc. v. United States Dep't of Health & Human Servs., 584 F.3d 1290 (10th Cir. 2009). · cites it 6× “In particular, individuals may appeal the decision of an FDA employee to the employee’s supervisor under 21 CFR Part 10.75, Internal agency review of decisions.”
Stauffer Chem. Co. v. Food & Drug Admin., 670 F.2d 106 (9th Cir. 1982). · cites it 2× “21 C.F.R. § 10.75 (c) (1981). The relevant factors favor exhaustion.”
Fontem Us, LLC v. Fda, 82 F.4th 1207 (D.C. Cir. 2023). “” 21 C.F.R. § 10.75 (a). Nothing in the Act or the regulations suggests this informal process for reviewing employee “decisions” limits applicants’ ability to petition for review of marketing denial orders.”
Estee Lauder, Inc. v. United States Food & Drug Admin., 727 F. Supp. 1 (D.D.C. 1989). “21 C.F.R. § 10.75 (1988). Lauder could also have filed a “citizen petition” asking the FDA for a formal determination on its labeling.”
Clinical Reference Lab'y, Inc. v. Sullivan, 791 F. Supp. 1499 (D. Kan. 1992). “21 C.F.R. § 10.75 (1991). Parties should not be allowed to file preemptive suits for declaratory or injunc-tive relief in order to avoid what they perceive as unfavorable agency positions before the agency has had an opportunity to reach a final determination on the merits of…”
Prevor v. United States Food & Drug Admin., 895 F. Supp. 2d 90 (D.D.C. 2012). “See 21 C.F.R. § 10.75 . 4 . The Office of Special Medical Programs addressed PREVOR’s two studies in a footnote, rejecting them as "flawed because they do not simulate the conditions of use and therefore do not appear to measure or reflect the ac tions of the solution on the…”
Dietary Supplement Coalition, Inc. v. Sullivan, 796 F. Supp. 441 (D. Or. 1991). “21 C.F.R. § 10.75 . Defendants claim that plaintiffs have neither availed themselves of these administrative remedies nor have they alleged, or established, that it would be futile to address their concerns to the FDA.”
Oak Grove Smokehouse, Inc. v. United States Dep't of Agric., 704 F. Supp. 104 (M.D. La. 1988). “1982), the Court addressed a similar provision 21 C.F.R. § 10.75 (a)(3) (1981). This regulation states that “[a] decision of an FDA employee .”
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