21 C.F.R. § 314.430

Availability for public disclosure of data and information in an application or abbreviated application

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(a) The Food and Drug Administration will determine the public availability of any part of an application or abbreviated application under this section and part 20 of this chapter. For purposes of this section, the application or abbreviated application includes all data and information submitted with or incorporated by reference in the application or abbreviated application, including investigational new drug applications, drug master files under § 314.420, supplements submitted under § 314.70 or § 314.97, reports under § 314.80 or § 314.98, and other submissions. For purposes of this section, safety and effectiveness data include all studies and tests of a drug on animals and humans and all studies and tests of the drug for identity, stability, purity, potency, and bioavailability.

(b) FDA will not publicly disclose the existence of an application or abbreviated application before an approval letter is sent to the applicant under § 314.105 or tentative approval letter is sent to the applicant under § 314.107, unless the existence of the application or abbreviated application has been previously publicly disclosed or acknowledged.

(c) If the existence of an unapproved application or abbreviated application has not been publicly disclosed or acknowledged, no data or information in the application or abbreviated application is available for public disclosure.

(d)(1) If the existence of an application or abbreviated application has been publicly disclosed or acknowledged before the agency sends an approval letter to the applicant, no data or information contained in the application or abbreviated application is available for public disclosure before the agency sends an approval letter, but the Commissioner may, in his or her discretion, disclose a summary of selected portions of the safety and effectiveness data that are appropriate for public consideration of a specific pending issue; for example, for consideration of an open session of an FDA advisory committee.

(2) Notwithstanding paragraph (d)(1) of this section, FDA will make available to the public upon request the information in the investigational new drug application that was required to be filed in Docket Number 95S-0158 in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, for investigations involving an exception from informed consent under § 50.24 of this chapter. Persons wishing to request this information shall submit a request under the Freedom of Information Act.

(e) After FDA sends an approval letter to the applicant, the following data and information in the application or abbreviated application are immediately available for public disclosure, unless the applicant shows that extraordinary circumstances exist. A list of approved applications and abbreviated applications, entitled “Approved Drug Products with Therapeutic Equivalence Evaluations,” is available from the Government Printing Office, Washington, DC 20402. This list is updated monthly.

(1) [Reserved]

(2) If the application applies to a new drug, all safety and effectiveness data previously disclosed to the public as set forth in § 20.81 and a summary or summaries of the safety and effectiveness data and information submitted with or incorporated by reference in the application. The summaries do not constitute the full reports of investigations under section 505(b)(1) of the act (21 U.S.C. 355(b)(1)) on which the safety or effectiveness of the drug may be approved. The summaries consist of the following:

(i) For an application approved before July 1, 1975, internal agency records that describe safety and effectiveness data and information, for example, a summary of the basis for approval or internal reviews of the data and information, after deletion of the following:

(a) Names and any information that would identify patients or test subjects or investigators.

(b) Any inappropriate gratuitous comments unnecessary to an objective analysis of the data and information.

(ii) For an application approved on or after July 1, 1975, a Summary Basis of Approval (SBA) document that contains a summary of the safety and effectiveness data and information evaluated by FDA during the drug approval process. The SBA is prepared in one of the following ways:

(a) Before approval of the application, the applicant may prepare a draft SBA which the Center for Drug Evaluation and Research will review and may revise. The draft may be submitted with the application or as an amendment.

(b) The Center for Drug Evaluation and Research may prepare the SBA.

(3) A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial information in § 20.61.

(4) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information after deletion of the following:

(i) Names and any information that would identify the person using the product.

(ii) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution.

(5) A list of all active ingredients and any inactive ingredients previously disclosed to the public as set forth in § 20.81.

(6) An assay procedure or other analytical procedure, unless it serves no regulatory or compliance purpose and is shown to fall within the exemption established for trade secrets and confidential commercial information in § 20.61.

(7) All correspondence and written summaries of oral discussions between FDA and the applicant relating to the application, under the provisions of part 20.

(f) All safety and effectiveness data and information which have been submitted in an application and which have not previously been disclosed to the public are available to the public, upon request, at the time any one of the following events occurs unless extraordinary circumstances are shown:

(1) No work is being or will be undertaken to have the application approved.

(2) A final determination is made that the application is not approvable and all legal appeals have been exhausted.

(3) Approval of the application is withdrawn and all legal appeals have been exhausted.

(4) A final determination has been made that the drug is not a new drug.

(5) For applications submitted under section 505(b) of the act, the effective date of the approval of the first abbreviated application submitted under section 505(j) of the act which refers to such drug, or the date on which the approval of an abbreviated application under section 505(j) of the act which refers to such drug could be made effective if such an abbreviated application had been submitted.

(6) For abbreviated applications submitted under section 505(j) of the act, when FDA sends an approval letter to the applicant.

(g) The following data and information in an application or abbreviated application are not available for public disclosure unless they have been previously disclosed to the public as set forth in § 20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they do not represent a trade secret or confidential commercial or financial information under § 20.61 of this chapter:

(1) Manufacturing methods or processes, including quality control procedures.

(2) Production, sales distribution, and similar data and information, except that any compilation of that data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure.

(3) Quantitative or semiquantitative formulas.

(h) The compilations of information specified in § 20.117 are available for public disclosure.

[50 FR 7493, Feb. 22, 1985, as amended at 50 FR 21238, May 23, 1985; 55 FR 11580, Mar. 29, 1990; 57 FR 17996, Apr. 28, 1992; 61 FR 51530, Oct. 2, 1996; 64 FR 26698, May 13, 1998; 64 FR 402, Jan. 5, 1999; 66 FR 1832, Jan. 10, 2001; 68 FR 24879, May 9, 2003; 69 FR 18766, Apr. 8, 2004; 73 FR 39610, July 10, 2008; 88 FR 45066, July 14, 2023]

Notes of Decisions

Cited in 27 cases (3 in the last 5 years), 1990–2025 · leading case: Jerome Stevens Pharm., Inc. v. Food & Drug Admin., 402 F.3d 1249 (D.C. Cir. 2005).

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Jerome Stevens Pharm., Inc. v. Food & Drug Admin., 402 F.3d 1249 (D.C. Cir. 2005). “§ 552 (b)(4) (2000); 21 C.F.R. § 314.430 (2004)); Br. of Appellee at 18-23.”

Teva Pharm. USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010). · cites it 2× “Though the FDA does not formally announce which ANDA filer was the first to submit a paragraph IV certification with respect to a brand drug (or whether any generic manufacturer is officially entitled to exclusivity) until the date on which generic sales can actually begin, see…”

Eli Lilly & Co. v. Marshall, 850 S.W.2d 155 (Tex. 1993). · cites it 4× “rmacists, and so forth, relating to such matters as adverse reactions they have observed, and which thus relate to complaints made on behalf of other persons, the Commissioner concludes on the basis of the longstanding experience of the Food and Drug Administration that it is…”

Pub. Citizen Health Rsch. Grp. v. Food & Drug Admin., 997 F. Supp. 56 (D.D.C. 1998). · cites it 4× “Under the statute and the FDA regulations, safety and effectiveness data which has been supplied in an application “shall be made available to the public, upon request, unless extraordinary circumstances are shown” under five conditions, one of which is if “no work is being done…”

Pub. Citizen Health Rsch. Grp. v. Food & Drug Admin., 964 F. Supp. 413 (D.D.C. 1997). · cites it 3× “21 C.F.R. § 314.430 (d). Once an approval letter has been sent, certain data and information are immediately available for disclosure “unless the applicant shows that exceptional circumstances exist.”

Viropharma Inc. v. Dep't of Health & Human Servs., 839 F. Supp. 2d 184 (D.D.C. 2012). “Documents Referencing Pending ANDAs Defendants argue that all information referencing pending ANDAs may properly be withheld under Exemption 4 because FDA is barred by its own regulations from releasing any information about a drug application prior to its approval, see 21…”

In Re Gabapentin Pat. Litig., 312 F. Supp. 2d 653 (D.N.J. 2004). “21 C.F.R. § 314.430 (b)-(d). It stands to reason that IPDA should not be able to gain access to that information through a court case arising out of an ANDA filing when it could not obtain the information in the ANDA filing directly.”

Forst v. SmithKline Beecham Corp., 602 F. Supp. 2d 960 (E.D. Wis. 2009). “11) (citing 21 C.F.R. § 314.430 (e)(2)). Exhibit 14 is the Summary Basis of Approval for Paxil.”

Gov't Acct. Proj. v. US Dep't of Health & Human Servs., 691 F. Supp. 2d 170 (D.D.C. 2010). · cites it 9× “§ 355 (i)(1); 21 C.F.R. § 314.430 (f). As Defendants note, 21 U.”

Takeda Pharm., U.S.A., Inc. v. Burwell, 78 F. Supp. 3d 65 (D.D.C. 2015). “See 21 C.F.R. § 314.430 (b) (“FDA will not publicly disclose the existence of an application or abbreviated application before an approval letter is sent to the applicant under § 314.”

Amneal Pharm. LLC v. Food & Drug Admin., 285 F. Supp. 3d 328 (D.C. Cir. 2018). “represents that, across a portfolio of 95 approved ANDAs, Amneal has never previously been asked to produce a commercial-scale lot as a condition of approval. As described above, FDA's practice has been to ask for pre-approval production of commercial-scale batches in very…”

Teva Pharm. United States, Inc. v. Azar, 369 F. Supp. 3d 183 (D.C. Cir. 2019). “" 21 C.F.R. § 314.430 (b). For present purposes, the Court need not, and does not, address whether Teva can meet the "final agency action" requirement under the APA because that requirement is non-jurisdictional, see Trudeau v.”

Show all 27 citing cases →

— 21 C.F.R. § 314.430(d)(1) — 1 case

Pfizer Inc. v. Synthon Pharm., Inc. (M.D.N.C. 2024).

— 21 C.F.R. § 314.430(e) — 1 case

Eli Lilly & Co. v. Marshall, 850 S.W.2d 155 (Tex. 1993). “rmacists, and so forth, relating to such matters as adverse reactions they have observed, and which thus relate to complaints made on behalf of other persons, the Commissioner concludes on the basis of the longstanding experience of the Food and Drug Administration that it is…”

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