View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0915-0327	ICR Reference No: 201504-0915-001
Status: Historical Active	Previous ICR Reference No: 201308-0915-006
Agency/Subagency: HHS/HSA	Agency Tracking No: 20345
Title: 340B Drug Pricing Program Forms
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/28/2015
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/01/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved	10/31/2015
Responses	52,591	0	24,464
Time Burden (Hours)	27,054	0	14,705
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	52,591	24,464	28,127
Annual Time Burden (Hours)	27,054	14,705	12,349
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Forms

Short Statement: Currently, there are 14,704 total reporting and record keeping burden hours in the OMB inventory. HRSA is requesting 27,483.5 burden hours, an increase of 12,779.5 hours. The increase is associated in part with the implementation of manufacturer data collection provisions of section 340B of the Public Health Service Act that were amended by section 7102 of the Affordable Care Act, enabling the Secretary to verify the accuracy of ceiling prices calculated by manufacturers and charged to covered entities by comparing them with ceiling prices calculated by the Secretary. In order to perform the comparison, HRSA must require manufacturers to submit the quarterly pricing data containing the average manufacturer price, unit rebate amount, package sizes, National Drug Code, and the manufacturer-determined 340B ceiling prices. The anticipated burden has also increased due to updates made to the estimated number of covered entity respondents and responses per respondent based on 2014 registration and recertification data; we have additionally modified the way respondents and responses are counted to more accurately reflect the number of organizations registering for the program and the number of locations registered by each of those organizations.