Attachment 22: Public Health Surveillance Exclusion Request

JUSTIFICATION FOR PUBLIC HEALTH SURVEILLANCE EXCLUSION

An Offeror may request exclusion from applicability of the “revised Common Rule”1 if it believes that NIHfunded or -conducted activities associated with its solicitation may be “public health surveillance activities deemed not to be research” as far as the revised Common Rule is concerned. Offerors should not assume that approval of an exclusion will be granted when completing the PHS Human Subjects and Clinical Trials Information Form. It is anticipated that NIH-supported or -conducted research will be deemed public health surveillance activities that qualify for exclusion only in extremely rare cases. NIH will not consider NIH clinical trials for public health surveillance determination and exclusion requests. Additionally, NIH will not consider studies that contain any activity that does not qualify for exclusion, which includes the intent to store specimens and/or data for future use, for any public health surveillance determination and exclusion.
Offerors shall address each of the following topic areas in order to qualify for this exclusion: 1. In order to qualify for a public health surveillance exclusion Offerors shall provide a compelling justification as to why NIH-funded or -conducted activities should be considered public health surveillance activities deemed not to be research for the purposes of the revised Common Rule. All activities for which approval of the exclusion will be sought must be disclosed and described. 2. This justification shall include information/data that demonstrates all three (3) of the following: a) The proposed activity is strictly limited to only that necessary for NIH to identify, monitor, assess, or investigate:
i. Potential public health signals; or
ii. Onsets of disease outbreaks; or
iii. Conditions of public health importance (including trends, signals, risk factors, or patterns in diseases).
AND
b) The activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
AND
c) The activities will directly inform NIH public health decision-making or action. 3. An Offeror shall submit its compelling justification for exclusion with its technical proposal as a separate attachment, so that the justification can be detached from and evaluated separate from the Code of Federal Regulations (CFR) Title 45, Public Welfare, Department of Health and Human Services, Part 46,