21 C.F.R. § 312.130

Availability for public disclosure of data and information in an IND

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(a) The existence of an investigational new drug application will not be disclosed by FDA unless it has previously been publicly disclosed or acknowledged.

(b) The availability for public disclosure of all data and information in an investigational new drug application for a new drug will be handled in accordance with the provisions established in § 314.430 for the confidentiality of data and information in applications submitted in part 314. The availability for public disclosure of all data and information in an investigational new drug application for a biological product will be governed by the provisions of §§ 601.50 and 601.51.

(c) Notwithstanding the provisions of § 314.430, FDA shall disclose upon request to an individual to whom an investigational new drug has been given a copy of any IND safety report relating to the use in the individual.

(d) The availability of information required to be publicly disclosed for investigations involving an exception from informed consent under § 50.24 of this chapter will be handled as follows: Persons wishing to request the publicly disclosable information in the IND 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, shall submit a request under the Freedom of Information Act.

[52 FR 8831, Mar. 19, 1987. Redesignated at 53 FR 41523, Oct. 21, 1988, as amended at 61 FR 51530, Oct. 2, 1996; 64 FR 401, Jan. 5, 1999; 68 FR 24879, May 9, 2003; 88 FR 45065, July 14, 2023]

Notes of Decisions

Cited in 5 cases, 1993–2010 · leading case: Eli Lilly & Co. v. Marshall, 850 S.W.2d 155 (Tex. 1993).

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Eli Lilly & Co. v. Marshall, 850 S.W.2d 155 (Tex. 1993). · cites it 2× “111 (c)(3)(ii)(b) (1991) (data and information submitted voluntarily to the FDA), and 21 C.F.R. § 312.130 (b) (1991) (data and information in an investigational new drug application).”

Pub. Citizen Health Rsch. Grp. v. Food & Drug Admin., 997 F. Supp. 56 (D.D.C. 1998). “See 21 C.F.R. § 312.130 (b) (stating that the availability of data and information in an IND will be handled in accordance with provisions established for NDAs in § 314.”

Pub. Citizen Health Rsch. Grp. v. Food & Drug Admin., 185 F.3d 898 (D.C. Cir. 1999). “Specifically, the FDA by regulation ( 21 C.F.R. § 312.130 (b)) provides that disclosure of information in an IND "will be handled in accordance with" the regulation governing disclosure of information in an NDA ( 21 C.”

Gov't Acct. Proj. v. US Dep't of Health & Human Servs., 691 F. Supp. 2d 170 (D.D.C. 2010). “’ MSJ at 7 (citing 21 C.F.R. §§ 312.130 , 314.430(c) & (d)).”

Gov't Acct. Proj. v. U.S. Dep't of Health & Human Servs. (D.D.C. 2010). “’ MSJ at 7 (citing 21 C.F.R. §§ 312.130 , 314.430(c) & (d)).”

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