[Federal Register Volume 79, Number 189 (Tuesday, September 30, 2014)]
[Notices]
[Pages 58791-58793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23183]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Comment Request

ACTION: Notice.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (HRSA) announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks 
comments from the public regarding the burden estimate, below, or any 
other aspect of the ICR.

DATES: Comments on this Information Collection Request must be received 
no later than December 1, 2014.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 10C-03, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
draft instruments, email [email protected] or call the HRSA 
Information Collection Clearance Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: Enrollment and Re-
Certification of

[[Page 58792]]

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. The manufacturer shall rely on the 
information in the 340B database to determine if the 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 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.
    Pricing data submission, validation and dissemination:
    In order to implement Section 340B(d)(1)(B)(i)(II), HRSA has 
already developed a system to prospectively calculate 340B ceiling 
prices from data obtained from the Centers for Medicare and Medicaid 
Services as well as OPA-identified commercial databases. However, in 
order to conduct the comparison, HRSA must require manufacturers to 
submit the quarterly pricing data as referenced.
    HRSA has developed a mechanism for secure manufacturer submissions; 
the Agency currently proposes collecting Average Manufacturer Price, 
Unit Rebate Amount, Package Sizes, National Drug Code and manufacturer-
determined 340B ceiling price for each product 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 Information Collection Request are summarized in the table below.
    The annual estimate of burden is as follows:

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                                    Number of     Responses per       Total         Hours per      Total burden
     Reporting requirement         respondents     respondent       responses       response          hours
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                                Hospital Enrollment, Additions & Recertifications
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340B Program Registrations &                546               1             546            2.00           1092
 Certifications for Hospitals..
Certifications to Enroll                    606               1             606             .50            303
 Hospital Outpatient Facilities
Hospital Annual                            4842               1            4842             .50           2421
 Recertifications..............
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                      Registrations and Recertifications for Entities Other Than Hospitals
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340B Registrations for                      253               1             253            1.0             253
 Community Health Centers......
340B Registrations for Family               353               1             353            1.0             353
 Planning Programs, STD/TB
 Clinics and Various Other
 Eligible Entity Types.........
Community Health Center Annual             4507               1            4507             .50           2253.5
 Recertifications..............
Family Planning Annual                     3879               1            3879             .50           1939.5
 Recertifications..............
STD & TB Annual                            2754               1            2754             .50           1377
 Recertifications..............

[[Page 58793]]

 
Annual Recertification for                 1174               1            1174             .50            587
 entities other than Hospitals,
 Community Health Centers,
 Family Planning, STD or TB
 Clinics.......................
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                                          Other Information Collections
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Submission of Administrative               2500               1            2500             .50           1250
 Changes for any Covered Entity
Submission of Administrative                350               1             350             .50            175
 Changes for any Manufacturer..
Manufacturer Data Required to               600               4            2400             .50           1200
 Verify 340B Ceiling Price
 Calculations..................
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                          Contracted Pharmacy Services Registration & Recertifications
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Contracted Pharmacy Services               2500               1            2500            1.0            2500
 Registration..................
                                --------------------------------------------------------------------------------
    Total......................          24,664  ..............          26,464  ..............         15,704
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    HRSA specifically requests comments on: (1) The necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions, (2) the accuracy of the 
estimated burden, (3) ways to enhance the quality, utility, and clarity 
of the information to be collected, and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.

    Dated: September 23, 2014.
Jackie Painter,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2014-23183 Filed 9-29-14; 8:45 am]
BILLING CODE 4165-15-P