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. § 10.90

Food and Drug Administration regulations, recommendations, and agreements

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(a) Regulations. FDA regulations are issued in the Federal Register under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both. The dissemination of draft notices and regulations is subject to § 10.80.

(b) [Reserved]

(c) Recommendations. In addition to the guidance documents subject to § 10.115, FDA often formulates and disseminates recommendations about matters which are authorized by, but do not involve direct regulatory action under, the laws administered by the Commissioner, e.g., model State and local ordinances, or personnel practices for reducing radiation exposure, issued under 42 U.S.C. 243 and 21 U.S.C. 360ii. These recommendations may, in the discretion of the Commissioner, be handled under the procedures established in § 10.115, except that the recommendations will be included in a separate public file of recommendations established by the Dockets Management Staff and will be separated from the guidance documents in the notice of availability published in the Federal Register, or be published in the Federal Register as regulations under paragraph (a) of this section.

(d) Agreements. Formal agreements, memoranda of understanding, or other similar written documents executed by FDA and another person will be included in the public file on agreements established by the Division of Freedom of Information (ELEM-1029)” and adding in its place “(the Freedom of Information Staff's address is available on the agency's web site at http://www.fda.gov) under § 20.108. A document not included in the public file is deemed to be rescinded and has no force or effect whatever.

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 65 FR 56477, Sept. 19, 2000; 75 FR 16346, Apr. 1, 2010; 79 FR 68114, Nov. 14, 2014]
Notes of Decisions
Cited in 3 cases, 1980–1987 · leading case: United States v. An Article of Drug Consisting of 4,680 Pails, More or Less, Each Pail Containing 60 Packets, Etc., Pfizer, Inc., Claimant-Appellant, 725 F.2d 976 (5th Cir. 1984).
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United States v. An Article of Drug Consisting of 4,680 Pails, More or Less, Each Pail Containing 60 Packets, Etc., Pfizer, Inc., Claimant-Appellant, 725 F.2d 976 (5th Cir. 1984). “Pfizer further argues that the “Human Health Safety Criteria,” which are incorporated in the FDA’s regulations, and which included the definition of “Feeds” as “any feedstuff including water to which antibacterial drugs are added,” has the force of law as set forth in 21 C.F.R.…”
Se. Minerals, Inc. & Marshall Minerals, Inc. v. Patricia Roberts Harris, as Sec'y of Health & Human Servs., 622 F.2d 758 (5th Cir. 1980). “See also 21 C.F.R. § 10.90 (b). Accordingly, the April 17, 1974, Guide is not legally conclusive of the GRAS status of gentian violet when that issue is raised either before the FDA in a subsequent agency proceeding or before a court in a subsequent judicial action.”
Cowdin v. Young, 681 F. Supp. 366 (W.D. La. 1987). · cites it 2× “According to 21 C.F.R. § 10.90 (b)(1), the CPG merely provides “procedures or standards of general applicability that are not legal requirements but are acceptable to FDA for subject matter which falls within the laws administered by the Commissioner.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.