21 CFR 12.24 - Ruling on objections and requests for hearing

Cite as21 CFR 12.24
    • This document is available in original version only for vLex customers

      View this document and try vLex for 7 days
    • TRY VLEX
39 practice notes
  • Debarment orders: Girdhari, Premchand,
    • United States
    • Federal Register January 21, 2000
    • January 21, 2000
    ...issue of fact requiring a hearing. Moreover, the legal arguments that Mr. Girdhari offers do not create a basis for a hearing. (See 21 CFR 12.24(b)(1).) Mr. Girdhari's arguments are discussed Mr. Girdhari's Arguments in Support of a Hearing Retroactive Application of Statute Is Improper Mr.......
  • Prescription Polyethylene Glycol 3350; Denial of a Hearing and Order Withdrawing Approval of Abbreviated New Drug Applications
    • United States
    • Federal Register April 02, 2018
    • April 2, 2018
    ...21 CFR Part 12 Hearings The specific criteria considered when determining whether a hearing is justified are set out in Sec. 12.24(b) (21 CFR 12.24(b)). Under that regulation, a hearing will be granted if the material submitted by the requester shows, among other things, the following: (1) ......
  • Debarment orders: Bhutani, Baldev Raj,
    • United States
    • Federal Register December 02, 2004
    • December 2, 2004
    ...descriptions of positions and contentions, nor on data and information insufficient to justify the factual determination urged. (See 21 CFR 12.24(b).) The Associate Commissioner for Regulatory Affairs has considered Mr. Bhutani's arguments and concludes that they are unpersuasive and fail t......
  • Community Nutrition Institute v. Young, Nos. 84-1153
    • United States
    • U.S. Court of Appeals — District of Columbia Circuit
    • September 24, 1985
    ...21 U.S.C. Sec. 348(f) (1982). The FDA has promulgated regulations that require the FDA to take a hard look at the objections. See 21 C.F.R. Sec. 12.24(b)(1)-(3). While the FDA's denial of the hearing obviates our need to assess whether the instant case meets the mandamus standard, we could ......
  • Request a trial to view additional results
4 cases
  • Community Nutrition Institute v. Young, Nos. 84-1153
    • United States
    • U.S. Court of Appeals — District of Columbia Circuit
    • September 24, 1985
    ...21 U.S.C. Sec. 348(f) (1982). The FDA has promulgated regulations that require the FDA to take a hard look at the objections. See 21 C.F.R. Sec. 12.24(b)(1)-(3). While the FDA's denial of the hearing obviates our need to assess whether the instant case meets the mandamus standard, we could ......
  • Pharm. Mfg. Research Servs., Inc. v. Food & Drug Admin., No. 18-1335
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • May 1, 2020
    ...... under the governing law." John D. Copanos & Sons, Inc. v. FDA , 854 F.2d 510, 522–23 (D.C. Cir. 1988) (citation omitted); see also 21 C.F.R. § 12.24(b)(4) ("A hearing will not be granted on factual issues that are not determinative with respect to the action requested."). For many of th......
  • Tamas v. Safeway, Inc., G050114
    • United States
    • California Court of Appeals
    • February 23, 2015
    ...“that the objectors raise a genuine and substantial issue of fact that must be resolved at a public hearing as provided for in 21 CFR 12.24.” (Ibid. )Thus, in accordance with title 21 United States Code section 371(e), the FDA announced it was “staying the effective date of the provisions .......
  • Marshall Minerals, Inc. v. Food and Drug Administration, No. 80-7369
    • United States
    • United States Courts of Appeals. United States Court of Appeals (5th Circuit)
    • November 16, 1981
    ...reasoned and articulated response" to the safety issues raised in said order. According to FDA, 21 C.F.R. § 571.10 and 21 C.F.R. §§ 12.22 and 12.24 any petitioner for whom a food additive petition has been denied and who desires a hearing to submit reasons why the application should not be ......

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT