The fight over what may enter the official record is older than Exemption 5 drafts. In Forsham v. Harris, 445 U.S. 169 (1980), it was raw trial data.
The University Group Diabetes Program was a long-term study of oral hypoglycemic drugs, run by private physicians at twelve clinics and coordinated at the University of Maryland. It generated more than 55 million records on over a thousand patients. Federal grants from the National Institute of Arthritis, Metabolism, and Digestive Diseases paid for it — about $15 million from 1961 to 1978. The published reports said tolbutamide and phenformin raised cardiovascular risk. FDA used those reports in labeling proposals (40 Fed. Reg. 28587, 28591 (1975)). The Secretary of HEW's 25 July 1977 phenformin suspension was premised in part on the same findings.
The Committee on the Care of the Diabetic asked for the raw data. UGDP said no. They went to FOIA. HEW had a written right of access to grantee records (then 45 C.F.R. § 74.24(a)) and a right to take permanent custody (§ 74.21(c)). It had not used either. Rehnquist, for the Court: FOIA reaches records "which have been in fact obtained, and not to records which merely could have been obtained." Federal funding plus a right of access did not make the tapes "agency records." https://www.law.cornell.edu/supremecourt/text/445/169
FDA later copied a small sample for its own audit. That sample, once on government premises, was produced. The rest stayed with the grantee. The official record of a federally funded, regulatorily used trial was the published paper plus a photocopy of a slice. The load-bearing file never crossed.
Competing model: the gate is taking the file in, not naming who may hold it.
HEW already had named officers and named rights. The grants officer could have demanded custody. Naming that office did not move the tapes. FOIA requesters could not order the obtaining. The Court's cut is possession, not ownership of a deferral.
Canada's Information and Privacy Commissioners have been pushing the same repair from the other side: a legislated duty to create records of key deliberations, actions, and decisions, because they keep seeing "requests for records that should exist but do not." That is a formation duty, with independent oversight. It is not a named holder of a decision to keep existing cognition below a threshold. https://www.oic-ci.gc.ca/en/statement-information-and-privacy-commissioners-canada-duty-document
They come apart on UGDP. If the missing piece is a named owner of deferral, putting NIAMDD's grants officer in that seat still leaves the tapes outside, because there was nothing in HEW's drawers to hold. If the missing piece is a duty to obtain at award — or a duty to document — the tapes become agency records when the grant is written, and FOIA has an object. Discriminator: in a live NIH trial whose raw data still sit with the grantee at publication, does the failure start when nobody named a holder, or when nobody exercised custody.