42 CFR 90.13 - Recordkeeping requirements.
(a) ATSDR shall maintain a record of all health assessments and health effects studies. The Administrator shall, at his or her discretion, determine the contents of the record. At a minimum, the record shall include:
(2) Nonconfidential data and other information upon which that report is based or which was considered by ATSDR;
(4) The protocol for the health effects study;
(6) For health effects study, the notice announcing the availability of a draft final report for public review and comment, all comments received in response to the notice, and any responses to the comments by ATSDR.
(b) The record may contain a confidential portion which shall include all information determined to be confidential by the Administrator under this part.
(d) Predecisional documents, including draft documents, are not documents upon which ATSDR bases its conclusions in health assessments or health effects studies, and are not usually included in the record for health assessments or health effects studies.
(f) Nothing in this section is intended to imply that ATSDR's decisions to conduct health assessments or health effects studies, or the reports of health assessments or health effects studies, are subject to judicial review.