EPA is finalizing a regulation that
requires affected entities to submit information to EPA and an
institutional review board (IRB) prior to initiating, and to EPA
upon the completion of, certain studies that will involve human
research participants. Specifically, the final rule requires
affected entities to submit study protocols to EPA and/or an IRB
before testing is initiated for the sake of reviewing and accepting
the ethical standards that will be employed.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.