HRSA Office of Pharmacy Affairs (OPA) has a process for registering covered entities who choose to participate in the section 340B Drug Pricing Program. These entities must comply with the requirements of 340B (a)(5)(A) of the PHS Act. The 340B Drug Pricing Program forms allow entities to provide registration and certifying information and to determine eligibility for the progam.
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.
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.
Manufacturer Data Required to Verify 340 B Ceiling Price Calculations