[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22207-22209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09079]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Health Resources and Services Administration 
(HRSA) has submitted an Information Collection Request (ICR) to the 
Office of Management and Budget (OMB) for review and approval. Comments 
submitted during the first public review of this ICR will be provided 
to OMB. OMB will accept further comments from the public during the 
review and approval period.

DATES: Comments on this ICR should be received no later than May 21, 
2015.

ADDRESSES: Submit your comments, including the Information Collection 
Request Title, to the desk officer for HRSA, either by email to 
[email protected] or by fax to 202-395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email the HRSA Information 
Collection Clearance Officer at [email protected] or call (301) 443-
1984.

SUPPLEMENTARY INFORMATION: Information Collection Request Title: 
Enrollment and Re-Certification of Entities in the 340B Drug Pricing 
Program and Collection of Manufacturer Data to Verify 340B Drug Pricing 
Program Ceiling Price Calculations.

OMB No. 0915-0327--Revision

    Abstract: Section 602 of Public Law 102-585, the Veterans Health 
Care Act of 1992, enacted as Section 340B of the Public Health Service 
Act (PHS Act; ``Limitation on Prices of Drugs Purchased by Covered 
Entities''), provides that a manufacturer who sells covered outpatient 
drugs to eligible entities must sign a Pharmaceutical Pricing Agreement 
(PPA) with the Secretary of Health and Human Services in which the 
manufacturer agrees to charge a price for covered outpatient drugs that 
will not exceed an amount determined under a statutory formula 
(``ceiling price'').
    A manufacturer subject to a PPA must offer all covered outpatient 
drugs at no more than the ceiling price to a covered entity listed in 
the 340B Program database. Manufacturers rely on the information in the 
340B database to determine if a covered entity is participating in the 
340B Program or for any notifications of changes to eligibility that 
may occur within a quarter. By signing the PPA, the manufacturer agrees 
to comply with all applicable statutory and regulatory requirements, 
including any changes that occur after execution of the PPA.
    Covered entities which choose to participate in the 340B Program 
must comply with the requirements of Section 340B(a)(5) of the PHS Act. 
Section 340B(a)(5)(A) prohibits a covered entity from accepting a 
discount for a drug that would also generate a Medicaid rebate. 
Further, Section 340B(a)(5)(B) prohibits a covered entity from 
reselling or otherwise transferring a discounted drug to a person who 
is not a patient of the entity.
    Need and Proposed Use of the Information: Section 340B(d)(1)(B)(i) 
of the PHS Act requires the development of a system to enable the 
Secretary to verify the accuracy of ceiling prices calculated by 
manufacturers under subsection (a)(1) and charged to covered entities, 
which shall include the following:
    (I) Developing and publishing through an appropriate policy or 
regulatory issuance, precisely defined standards and methodology for 
the calculation of ceiling prices under such subsection.
    (II) Comparing regularly the ceiling prices calculated by the 
Secretary with

[[Page 22208]]

the quarterly pricing data that is reported by manufacturers to the 
Secretary.
    (III) Performing spot checks of sales transactions by covered 
entities.
    (IV) Inquiring into the cause of any pricing discrepancies that may 
be identified and either taking, or requiring manufacturers to take, 
such corrective action as is appropriate in response to such price 
discrepancies.
    HRSA's Office of Pharmacy Affairs (OPA) has previously obtained 
approval for information collections in support of 340B covered entity 
recertification and registration, as well as registration of contract 
pharmacy arrangements and the PPA itself. OPA is requesting comments on 
an additional information collection in response to the above pricing 
verification requirements, as well as the routine renewal of approval 
for the existing information collections. The previously approved 
collections are substantially unchanged, except that HRSA has 
transitioned completely to online versus hardcopy forms.
    Pricing data submission, validation and dissemination: In order to 
implement Section 340B(d)(1)(B)(i)(II), HRSA has already developed a 
system to calculate 340B ceiling prices prospectively from data 
obtained from the Centers for Medicare & Medicaid Services as well as 
OPA-identified commercial databases. However, in order to conduct the 
comparison required under the statute, manufacturers must submit the 
quarterly pricing data as required by section 340B(d)(1)(B)(i)(II).
    HRSA is developing a mechanism for secure manufacturer submissions. 
This notice proposes collecting Average Manufacturer Price, Unit Rebate 
Amount, Package Sizes, National Drug Code (NDC), period of sale (year 
and quarter), and manufacturer-determined 340B ceiling price for each 
NDC produced by a manufacturer subject to a PPA. Once any discrepancies 
between the manufacturer and OPA-calculated prices have been resolved, 
the validated prices will be made available to registered covered 
entities via a secure Internet-accessible platform as required by 
Section 340B(d)(1)(B)(iii).
    Accurate and timely pricing data submissions are critical to 
successful implementation of the 340B Program, ensuring that covered 
entities have confidence that the amounts being charged are in 
accordance with statutorily-defined ceiling prices. The burden imposed 
on manufacturers by this requirement is low because the information 
requested is readily available.
    Likely Respondents: Drug Manufacturers.
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information; to search data sources; to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this ICR are summarized in the table below.

                                    Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Form name                Number of     responses per       Total         Hours per     Total burden
                                    respondents     respondent       responses      respondent         hours
----------------------------------------------------------------------------------------------------------------
                                Hospital Enrollment, Additions & Recertifications
----------------------------------------------------------------------------------------------------------------
340B Program Registrations &                 194               1             194            2                388
 Certifications for Hospitals...
Certifications to Enroll                     697               8           5,576            0.5            2,788
 Hospital Outpatient Facilities.
Hospital Annual Recertifications           2,134               6          12,804            0.25           3,201
----------------------------------------------------------------------------------------------------------------
                      Registrations and Recertifications for Entities Other Than Hospitals
----------------------------------------------------------------------------------------------------------------
340B Registrations for Community             427               3           1,281            1              1,281
 Health Centers.................
340B Registrations for STD/TB                647               1             647            1                647
 Clinics........................
340B Registrations for Various               405               1             405            1                405
 Other Eligible Entity Types....
Community Health Center Annual             1,204               5           6,020            0.25           1,505
 Recertifications...............
STD & TB Annual Recertifications           3,123               1           3,123            0.25          780.75
Annual Recertification for                 4,899               1           4,899            0.25        1,224.75
 entities other than Hospitals,
 Community Health Centers, and
 STD/TB Clinics.................
----------------------------------------------------------------------------------------------------------------
                          Contracted Pharmacy Services Registration & Recertifications
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services               1,758               5           8,790            1              8,790
 Registration...................
----------------------------------------------------------------------------------------------------------------
                                          Other Information Collections
----------------------------------------------------------------------------------------------------------------
Submission of Administrative               9,396               1           9,396            0.5            4,698
 Changes for any Covered Entity.
Submission of Administrative                 350               1             350            0.5              175
 Changes for any Manufacturer...
Manufacturer Data Required to                600               4           2,400            0.5            1,200
 Verify 340B Ceiling Price
 Calculations...................
Pharmaceutical Pricing Agreement             200               1             200            1                200
                                 -------------------------------------------------------------------------------
    Total.......................          26,034  ..............  ..............  ..............        27,283.5
----------------------------------------------------------------------------------------------------------------



[[Page 22209]]

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-09079 Filed 4-20-15; 8:45 am]
 BILLING CODE 4165-15-P