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:
(1) The final ATSDR report of the health assessment or health effects study;
(2) Nonconfidential data and other information upon which that report is based or which was considered by ATSDR;
(3) Nonconfidential data or other information submitted by interested persons pertaining to the health assessment or health effects study;
(4) The protocol for the health effects study;
(5) A list of the individuals responsible for external peer review of the report of a health effects study, their comments, and ATSDR's response to the comments; and
(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.
(c) The Administrator may determine other documents are appropriate for inclusion in the record for health assessments or health effects studies.
(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.
(e) The record for ATSDR health assessments and health effects studies will be available for review, upon prior request, at ATSDR headquarters in Atlanta, Georgia.
(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.