Non-Substantive Change Request

Non-Substantive Change Request to OMB Control Number 0920-0666; The National Healthcare Safety Network (NHSN)

Program Contact

Lee Samuel

National Center for Emerging and Zoonotic Infectious Diseases

Office of Policy

1600 Clifton Rd, C-12

Atlanta GA 30333

Submission Date: March 11, 2016

Circumstances of Change Request for OMB 0920-0666

CDC requests approval for a non-substantive change to OMB Control No. 0920-0666; The National Healthcare Safety Network (NHSN)

Form Name: Hemovigilance Module Monthly Reporting Denominators; CDC Form 57.303

HHS needs a standardized transfusion adverse reactions tracking system to monitor pathogen reduced blood products administered as part of a clinical trial. Currently, NHSN is the only system that tracks transfusion adverse reactions by standard methods. CDC/DHQP will analyze adverse reaction results of the clinical trial. Results will be shared with FDA so they can make a decision on approving pathogen reduction technology. This will impact the safety and sustainability of the blood supply in Puerto Rico and when Zika or another emerging pathogen affects the mainland.

Estimates of annualized burden hours for this change request will increase by ten minutes per response. Because there are expected to be 6,000 responses per year (500 respondents; 12 responses each), the total increase in burden will be 1,000 hours per year.

	Form Name	No. of Respondents	No. of responses per respondent	Avg. burden per response (hours)	Total burden (hours)
APPROVED	Hemovigilance Module Monthly Reporting Denominators	500	12	1	6,000
REQUESTED	Hemovigilance Module Monthly Reporting Denominators	500	12	70/60	7,000

For OMB clearance No. 0920-0666, the total burden will increase from 4,621,542 hours to 4,622,542 hours.

Description of Changes

Changes to Table 2 include the addition of pathogen reduced blood product categories for red blood cells, platelets, plasma, and cryoprecipitate (In the crosswalk below, new fields are highlighted).

Table 3 is a new table. Data collected in table 3 includes a breakdown of pathogen reduced apheresis platelets in plasma and in platelet additive solution.

Current Question

Requested Change

Table 2

Products		Unites Transfused	Aliquots Transfused	Total Discards
Platelets	Whole blood derived Psoralen-treated
	Apheresis Psoralen-treated
Plasma (all types)	Whole blood derived Psoralen-treated
	Apheresis Psoralen-treated

Table 2

Products			Unites Transfused	Aliquots Transfused	Total Discards
Red blood cells	Whole blood derived	TOTAL
		S-303-treated
		Riboflavin-treated
	Apheresis	TOTAL
		S-303-treated
		Riboflavin-treated
Platelets	Whole blood derived	TOTAL
		Psoralen-treated
		Riboflavin-treated
	Apheresis	TOTAL
		Psoralen-treated
		Riboflavin-treated
Plasma (all types)	Whole blood derived	TOTAL
		Psoralen-treated
		Riboflavin-treated
	Apheresis	TOTAL
		Psoralen-treated
		Riboflavin-treated
Cryoprecipitate		TOTAL
		Riboflavin-treated

N/A

Table 3

Products			Units Transfused	Aliquots Transfused	Total Discards
Platelets	Apheresis	Psoralen-treated
		Psoralen-treated and in Plasma
		Psoralen-treated and in Platelet additive solution
		Riboflavin-treated
		Riboflavin-treated and in Plasma
		Riboflavin-treated and in Platelet additive solution