C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 20—PUBLIC INFORMATION › Subpart C—Procedures and Fees

21 C.F.R. § 20.40

Filing a request for records

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) All requests for Food and Drug Administration records shall be made in writing by mailing or delivering the request to the Freedom of Information Staff at the address on the Agency's website at https://www.fda.gov, by faxing it to the fax number listed on the Agency's website at https://www.fda.gov, or by submission through the Agency's online FOIA submission portal at https://www.fda.gov. All requests must contain the postal address and telephone number of the requester and the name of the person responsible for payment of any fees that may be charged.

(b) A request for Food and Drug Administration records shall reasonably describe the records being sought, in a way that they can be identified and located. A request should include all pertinent details that will help identify the records sought.

(1) If the description is insufficient to locate the records requested, the Food and Drug Administration will so notify the person making the request and indicate the additional information needed to identify the records requested.

(2) Every reasonable effort shall be made by the Food and Drug Administration to assist in the identification and location of the records sought.

(c) Upon receipt of a request for records, the Division of Freedom of Information shall enter it in a public log. The log shall state the date received, the name of the person making the request, the nature of the record requested, the action taken on the request, the date of determination letter sent pursuant to § 20.41(b), and the date(s) any records are subsequently furnished.

(d) A request by an individual, as defined in § 21.3(a) of this chapter, for a record about himself shall be subject to:

(1) The special requirements of part 21 of this chapter (the privacy regulations), and not to the provisions of this subpart, if the record requested is retrieved by the individual's name or other personal identifier and is contained in a Privacy Act Record System, as defined in § 21.3(c) of this chapter.

(2) The provisions of this subpart if the record requested is not retrieved by the individual's name or other personal identifier, whether or not the record is contained in a Privacy Act Record System.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 68 FR 25285, May 12, 2003; 76 FR 31469, June 1, 2011; 79 FR 68114, Nov. 14, 2014; 87 FR 55912, Sept. 13, 2022]
Notes of Decisions
Cited in 3 cases (1 in the last 5 years), 2011–2022 · leading case: CareToLive v. Food & Drug Admin., 631 F.3d 336 (6th Cir. 2011).
Sort: Relevance Newest Treatment
CareToLive v. Food & Drug Admin., 631 F.3d 336 (6th Cir. 2011). “This delay appears to have occurred because CareToLive sent the request to the FDA’s Cincinnati District Office and not directly to its Division of Freedom of Information as required by 21 C.F.R. § 20.40 (a) (2010). 2 . The division between the "Simple” and “Complex” tracks…”
Informed Consent Action Network v. United States Food & Drug Admin. (S.D.N.Y. 2022). · cites it 3× “” 21 C.F.R. § 20.40 (b). III. Discussion The FDA argues that summary judgment is justified because ICAN’s request—namely, for only those trials “that had a safety review period longer than seven days following administration of this vaccine”—did not “reasonably describe” the…”
CareToLive v. FDA (6th Cir. 2011). “”2 The Division of Information Disclosure 1 This delay appears to have occurred because CareToLive sent the request to the FDA’s Cincinnati District Office and not directly to its Division of Freedom of Information as required by 21 C.F.R. § 20.40 (a) (2010). 2 The division…”
— 21 C.F.R. § 20.40(b) — 1 case
Informed Consent Action Network v. United States Food & Drug Admin. (S.D.N.Y. 2022). “” 21 C.F.R. § 20.40 (b). III. Discussion The FDA argues that summary judgment is justified because ICAN’s request—namely, for only those trials “that had a safety review period longer than seven days following administration of this vaccine”—did not “reasonably describe” the…”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.