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.
Form 1 Manufacturer Data Required to Verify 340 B Ceiling Price Calculations
60-day FRN.pdf
List of all ICR documents.docx
Manufacturer Data Required to Verify 340 B Ceiling Price Calculations