The 2023 Florida Statutes (including Special Session C)
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. . . . § 130.14(b). . . . of only violating the "federally mandated minimum standard of fill" set forth in title 21, sections 130.14 . . . labels had properly contained the statement 'Below Standard in Fill,' " as required by title 21, section 130.14 . . . that the cans were "Below Standard in Fill," which it did not. 21 C.F.R. § 161.190(c)(4) ; 21 C.F.R. § 130.14 . . .
. . . The ordinance, now codified at Eureka Municipal Code Section 130.14, provides that “ ‘no Person shall . . . The new ordinance, Eureka Municipal Code Section Í30Í4 (“Section 130.14”), entitled “Storage of Personal . . . Section 130.14 provides that “ ‘no Person shall Store Personal Property in Public Areas,’ and ‘All Stored . . . on public property and that they face a credible threat that Defendants will try to enforce Section 130.14 . . . the Court could. adjudicate an as-applied challenge to the immediate destruction provision of Section 130.14 . . .
. . . . § 130.14(a). . . .
. . . ” in the regulation, “the label shall bear the general statement of substandard fill provided in §. 130.14 . . . Section 130.14(b), in turn, requires the “Below Standard in Fill” label statement to be a specified type . . . appears so conspicuously as to be easily seen under customary conditions of purchase.” 21 C.F.R. § 130.14 . . .
. . . she make twenty-three monthly payments of $150.00 beginning on June 1, 1996 and a final payment of $130.14 . . .
. . . . § 130.14(b) (1971). . . .
. . . . § 130.14 specifies the contents of notice of hearing. . . . . . § 130.14(b) states that “[w]hen it clearly appears from the data in the application and from the reasons . . .
. . . . § 130.14(b) (1973) provides, inter alia, that a request for a hearing must be accompanied by “a well-organized . . .
. . . Under the FDA regulations, 21 C.F.R. 130.14(b), a hearing can be denied only if the petitioners fail . . . Petitioners duly submitted a written appearance requesting a hearing pursuant to 21 C.F.R. 130.14(b) . . . The regulation, 21 C.F.R. 130.14(a), spells out the due notice requirement as follows: “The notice to . . . In that case the Supreme Court held that 21 U.S.C. § 355(e) and 21 C.F.R. 130.14 set up a type of summary . . . ) and (e) and 21 C.F.R. 135.15 which parallel the provisions of 21 U.S.C. § 355(e) and- 21 C.F.R. § 130.14 . . .
. . . . § 130.14(b) (April 1, 1973). . . . See also 21 C.F.R. § 130.14(b) (April 1, 1973). . . . . It is stated in 21 C.F.R. § 130.14(b) : When it clearly appears from the data in the application and . . .
. . . presentation could the Commissioner fairly impose upon the petitioner the heavy sanctions of 21 CFR § 130.14 . . . The Notice stated: . 21 C.F.R. § 130.14(a) (1973). . 37 Fed.Reg. 15,747 (August 4,1972). . . . . provision is in the final paragraph of § 360b (e)(1). . 38 Fed.Reg. 10,488 (April 27, 1973). . 21 C.F.R. § 130.14 . . . See note 25, supra, and accompanying text. . 21 C.F.R. § 130.14(b) (1973). . . .
. . . The section of the regulations outlining the summary judgment procedure, 21 CFR § 130.14(b), by its language . . . identical with drugs with effective NDAs. . 35 Fed.Reg. 7251, amending 21 C.F.R. §§ 130.12(a) (5) and 130.14 . . . the application as provided in section 505(e) of the act and in accordance with the procedure in §§ 130.14 . . .
. . . genuine and substantial issue of fact” requiring a hearing on the ultimate issue of efficacy, 21 CFR § 130.14 . . . deny a hearing and enter an order withdrawing the application based solely on these data. 21 CFR § 130.14 . . . Reg. 7251, amending 21 CFR §§ 130.12 (a) (5) and 130.14. Section 505 (e) as amended, 21 U. S. . . .
. . . . § 130.14(b) (1971) is ambiguous, it appears that a hearing, when permitted, must commence as soon as . . . As the court reads 21 C.F.R. § 130.14(b), a hearing on withdrawal of a new drug application is to be . . . applied to antibiotics. . 21 C.F.R. § 330.14(a) (1971). . 21 C.F.R. § 330.15 (1971). . 21 C.F.R. § 130.14 . . .
. . . . § 130.14 (1968). . . . order on this data, making findings and conclusions on such data. 35 Fed.Reg. 7252 (1970); 21 C.F.R. § 130.14 . . . The Commissioner acted pursuant to 21 C.F.R. § 130.14, the regulation establishing a summary judgment . . . presentation could the Commissioner fairly impose upon the petitioner the heavy sanctions of 21 C.F.R. § 130.14 . . .
. . . 192. . 21 F.R. 13014, October 6, 1966. . 21 F.R. 13014. . 33 F.R. 7701. . 34 F.R. 5556. . 21 C.F.R. 130.14 . . . Richardson (2d Cir. 1970) 434 F.2d 536. . 21 C.F.R. 130.14(b). . USV Pharmaceutical Corp. v. . . .
. . . FDA Regulation No. 130.14(b), 21 C. . . . Register, 35 F.Reg. 8609 (1970), inviting interested persons to request a hearing pursuant to 21 C.F.R. 130.14 . . . As noted, the regulation, 21 C.F.R. 130.14(b), supra, authorizes denial of an evidentiary hearing prior . . . withdrawal of approval . . . the Commissioner will enter an order [without having held a hearing.] 21 C.F.R. 130.14 . . . Consequently, no evidentary hearing was required. 21 C.F.R. 130.14(b), supra. . . .
. . . . §§ 130.12, 130.14. . . .
. . . Ibid., part 2, p. 6. . 35 Fed.Reg. 7250. . 35 Fed.Reg. 7252; codified as 21 CFR, § 130.14(b) and § 146.1 . . .
. . . the goals of the Act, and the safeguards devised to protect legitimate trade secrets (see 21 CFR § 130.14 . . .
. . . Section 130.14(b) is revised to read as follows: § 130.14 Contents of notice of hearing. * * * * * * . . .
. . . the goals of the Act, and the safeguards devised to protect legitimate trade secrets (see 21 CFR § 130.14 . . .
. . . This $10,000 is in addition to the $51,-130.14 and interest thereon stipulated by the parties hereinbefore . . .