21 CFR 20.61 - Trade secrets and commercial or financial information which is privileged or confidential

Cite as21 CFR 20.61
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90 practice notes
  • Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...U.S. application number) for certain drugs, and whether you consider the name of the inactive ingredient to fall under Sec. 20.61 (21 CFR 20.61) of this chapter or to be otherwise prohibited from disclosure and, if so, why Dosage form Package size and type, including immediate unit-of- use ......
  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Food importation notice to FDA,
    • United States
    • Federal Register October 10, 2003
    • October 10, 2003
    ...Some that are relevant to prior notice include the Clinger-Cohen Act of 1996, the Computer Security Act of 1987, the Trade Secrets Act, 21 CFR 20.61 (Trade Secrets and Commercial or Financial Information Which Is Privileged or Confidential), OMB Circular A-130 (Management of Federal Informa......
  • Separate Parts In This Issue Part VI Health and Human Services Department, Food and Drug Administration,
    • United States
    • Federal Register October 10, 2003
    • October 10, 2003
    ...Some that are relevant to prior notice include the Clinger-Cohen Act of 1996, the Computer Security Act of 1987, the Trade Secrets Act, 21 CFR 20.61 (Trade Secrets and Commercial or Financial Information Which Is Privileged or Confidential), OMB Circular A-130 (Management of Federal Informa......
  • Part II
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...U.S. application number) for certain drugs, and whether you consider the name of the inactive ingredient to fall under Sec. 20.61 (21 CFR 20.61) of this chapter or to be otherwise prohibited from disclosure and, if so, why Dosage form Package size and type, including immediate unit-of- use ......
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19 cases
  • Anderson v. Department of Health and Human Services, Nos. 86-2246
    • United States
    • United States Courts of Appeals. United States Court of Appeals (10th Circuit)
    • June 22, 1990
    ...A trade secret is a process or device for continuous use in the operation of the business. The FDA has adopted that definition at 21 C.F.R. Sec. 20.61(a): "A trade secret may consist of any formula, pattern, device, or compilation of information which is used in one's business and which giv......
  • Rozema v. U.S. Dep't of Health & Human Servs., 5:14-CV-0495 (GTS/DEP)
    • United States
    • United States District Courts. 2nd Circuit. United States District Court of Northern District of New York
    • March 2, 2016
    ...FOIA Exemption 4, 5 U.S.C. § 552(b)(4), “shall be considered confidential and shall not be disclosed[.]” 21 U.S.C. 387f(c) ; see also 21 C.F.R. § 20.61(c) (“Data and information submitted or divulged to the Food and Drug Administration which fall within the definitions of a trade secret or ......
  • Public Citizen Health Research Group v. Food and Drug Admin., No. 82-1745
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • April 15, 1983
    ...is used in one's business and which gives him an opportunity to obtain an advantage over competitors who do not know or use it." 21 C.F.R. Sec. 20.61(a) (1982). Strictly applied, "this definition would classify virtually all undisclosed health and safety testing data as trade secrets." The ......
  • N.Y. Times Co. v. U.S. Food & Drug Admin., 19-CV-4740 (VEC)
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • March 29, 2021
    ...Request, mooting Plaintiffs’ appeal to HHS. Barnes Decl. ¶ 16; Def. Mem. at 4.Pursuant to an FDA regulation on public information, 21 C.F.R. § 20.61(e)(1), and Executive Order 12600, FDA sent Juul predisclosure notification letters concerning Plaintiffs’ FOIA requests, instructing Juul to r......
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3 firm's commentaries
1 books & journal articles
  • From Trade Secrecy to Seclusion
    • United States
    • Georgetown Law Journal Nbr. 109-6, August 2021
    • August 1, 2021
    ...gradual enactment of the Uniform Trade Secrets Act (UTSA) by state legislatures (as of this writing, New York is the sole outlier). 6. 21 C.F.R. § 20.61(a) (2020). 2021] FROM TRADE SECRECY TO SECLUSION 1341 Yet because these cases are easily viewed in isolation, and because attorneys and sc......

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