161.33—Procedures for claims of confidentiality of data.
(a) General.
A data submitter must clearly identify any information which he claims is entitled to confidential treatment under FIFRA sec. 10. The procedures in this section must be followed to assert a claim of confidentiality.
(b) Claims of confidentiality for information described by FIFRA
Any information claimed to be confidential under FIFRA sec. 10(d)(1) (A) through (C) must be submitted in accordance with the following procedures:
(1)
The information must be contained in a separate attachment to the study. If any information is included in the body of the study rather than in the confidential attachment, the submitter waives a claim of confidentiality for such information under FIFRA sec. 10(d)(1) (A), (B), or (C).
(2)
The attachment must have a cover page which is clearly marked to indicate that the material contained in the attachment falls within the scope of FIFRA sec. 10(d)(1) (A), (B), or (C).
(3)
Each item in the attachment must be numbered. For each item, the submitter must cite the applicable portion of FIFRA sec. 10(d)(1) (A), (B), or (C) on which the claim of confidentiality is based. In addition, for each item, the submitter must provide a list of page numbers in the study where the item is cited (i.e., identified by number).
(4)
Each item in the attachment must be referenced in the body of the study by its number in the attachment.
Information claimed confidential on the basis of its falling within the scope of FIFRA sec. 10(d)(1)(A), (B), or (C) has been removed to a confidential appendix, and is cited by cross-reference number in the body of the study.
The statement must bear the name, title, and signature of the submitter or his properly designated agent, and the date of signature.
(c) No claim of confidentiality under FIFRA
If no claim of confidentiality is being made for information described by FIFRA sec. 10(d)(1)(A), (B), or (C), or if such information is not contained in the body of the study, the Statement of Data Confidentiality Claims must include the following statement:
No claim of confidentiality is made for any information contained in this study on the basis of its falling within the scope of FIFRA sec. 10(d)(1)(A), (B), or (C).
This statement must bear the name, title and signature of the submitter or his properly designated agent, and the date of signature.
(d) Claim of confidentiality for information not described by FIFRA
Any information not described by FIFRA sec. 10(d)(1) (A), (B), or (C) for which a claim of confidentiality is made must be submitted in accordance with the following procedures:
(2)
A separate Supplemental Statement of Data Confidentiality Claims must be submitted identifying by page and line number the location within the study of each item claimed confidential, and stating the basis for the claim.
(3)
The Supplemental Statement of Data Confidentiality Claims must bear the name, title, and signature of the submitter or his properly designated agent, and the date of signature.