§ 202.504. Official business of the United States Government.
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/us/cfr/t28/s§ 202.504·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Exemption. Subparts C, and D, J, and K (other than § 202.1102 and § 202.1104) of this part do not apply to data transactions to the extent that they are for the conduct of the official business of the United States Government by its employees, grantees, or contractors; any authorized activity of any United States Government department or agency (including an activity that is performed by a Federal depository institution or credit union supervisory agency in the capacity of receiver or conservator); or transactions conducted pursuant to a grant, contract, or other agreement entered into with the United States Government.
(b)Examples---(1) Example 1. A U.S. hospital receives a Federal grant to conduct human genomic research on U.S. persons. As part of that federally funded human genomic research, the U.S. hospital contracts with a foreign laboratory that is a covered person, hires a researcher that is a covered person, and gives the laboratory and researcher access to the human biospecimens and human genomic data in bulk. The contract with the foreign laboratory and the employment of the researcher are exempt transactions but would be prohibited transactions if they were not part of the federally funded research.
(2)Example 2. A U.S. research institution receives a Federal grant to conduct human genomic research on U.S. and foreign persons. The Federal grant directs the U.S. research institution to publicize the results of its research, including the underlying human genomic data, via an internet-accessible database open to public health researchers with valid log-in credentials who pay a small annual fee to access the database, including covered persons primarily resident in a country of concern. The Federal grant does not cover the full costs of the authorized human genomic research or creation and publication of the database. The U.S. research institution obtains funds from private institutions and donors to fund the remaining costs. The human genomic research authorized by the Federal grant and publication of the database at the direction of the Federal grant would constitute a "transaction\[ \] conducted pursuant to a grant, contract, or other agreement entered into with the United States Government." The U.S. research institution must still comply with any requirements or prohibitions on sharing bulk U.S. sensitive personal data with countries of concern or covered persons required by the Federal grantmaker.
(3)Example 3. Same as Example 2, but the Federal grant is limited in scope to funding the U.S. research institution's purchase of equipment needed to conduct the human genomic research and does not include funding related to publication of the data. The Federal grant does not direct or authorize the U.S. research institution to publicize the human genomic research or make it available to country of concern or covered person researchers via the database for which researchers pay an annual fee to access, or otherwise fund the conduct of the human genomic research. The U.S. research institution contracts with a foreign laboratory that is a covered person and gives the laboratory access to the bulk human genomic data. The contract with the foreign laboratory is not an exempt transaction because that transaction is not within the scope of the Federal grant.