[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Notices]
[Pages 20649-20650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08110]


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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.

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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 9, 
2016.

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 the Secretary of Health and Human Services 
will enter into a Pharmaceutical Pricing Agreement (PPA) with each 
manufacturer of covered outpatient drugs in which the manufacturer 
agrees to charge a price for covered outpatient drugs that will not 
exceed the average manufacturer price decreased by a rebate percentage. 
Under this PPA, a manufacturer agrees not to charge a price for covered 
outpatient drugs that exceeds 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 if such drug is made 
available to any other purchaser at any price. 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. In response to 
comments submitted during the first public review of this ICR, the 
language has been revised in this notice and in the draft instruments 
in order to align with the applicable statutory language regarding the 
obligation to sign the PPA, the circumstances under which participating 
manufacturers must offer covered outpatient drugs to covered entities, 
and the description of the ceiling price data required to be provided.
    The purpose of this revision is to include an addendum to the PPA 
to incorporate the administrative requirement for manufacturer 
integrity provisions directly addressed in the Affordable Care Act.
    Need and Proposed Use of the Information: HRSA is proposing 
revisions to the current PPA to include an addendum in response to 
manufacturer integrity provisions implemented in the Affordable Care 
Act. Section 7102(b) of the Affordable Care Act amends section 
340B(a)(1) of the Public Health Service Act (PHSA) to add two new 
requirements for inclusion in the PPA with manufacturers of covered 
outpatient drugs:
    I. ``Each such agreement shall require that the manufacturer 
furnish the Secretary with reports, on a quarterly basis, of the price 
for each covered outpatient drug subject to the agreement that, 
according to the manufacturer, represents the maximum price that 
covered entities may permissibly be required to pay for the drug . . 
.'' and
    II. ``. . . shall require that the manufacturer offer each covered 
entity covered outpatient drugs for purchase at or below the applicable 
ceiling price if such drug is made available to any other purchaser at 
any price.''
    These requirements shall be included in the PPA addendum to be 
signed by manufacturers participating in the 340B Program to ensure 
that the provisions of the 340B statute requiring inclusion in the PPA 
are satisfied. The execution of the addendum by manufacturers will 
fulfill the administrative requirement of the statute that these 
provisions be included in the PPA. The burden imposed on manufacturers 
by the proposed requirement of the PPA is minimal because the addendum 
does not impose requirements beyond review and a signature by the 
manufacturer.
    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.
    Total Estimated Annualized Burden Hours:

[[Page 20650]]



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                                                              Number of                                 Total
                Form name                     Number of     responses per     Total      Hours per      burden
                                             respondents     respondent     responses    respondent     hours
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                                Hospital Enrollment, Additions & Recertifications
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340B Program Registrations &                          194               1          194            2          388
 Certifications for Hospitals............
Certifications to Enroll Hospital                     697               8         5576          0.5         2788
 Outpatient Facilities...................
Hospital Annual Recertifications.........            2134               6        12804         0.25         3201
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                      Registrations and Recertifications for Entities Other Than Hospitals
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340B Registrations for Community Health               427               3         1281            1         1281
 Centers.................................
340B Registrations for STD/TB Clinics....             647               1          647            1          647
340B Registrations for Various Other                  405               1          405            1          405
 Eligible Entity Types...................
Community Health Center Annual                       1204               5         6020         0.25         1505
 Recertifications........................
STD & TB Annual Recertifications.........            3123               1         3123         0.25       780.75
Annual Recertification for entities other            4899               1         4899         0.25      1224.75
 than Hospitals, Community Health
 Centers, and STD/TB Clinics.............
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                          Contracted Pharmacy Services Registration & Recertifications
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Contracted Pharmacy Services Registration            1758               5         8790            1         8790
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                                          Other Information Collections
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Submission of Administrative Changes for             9396               1         9396          0.5         4698
 any Covered Entity......................
Submission of Administrative Changes for              350               1          350          0.5          175
 any Manufacturer........................
Manufacturer Data Required to Verify 340B             600               4         2400          0.5         1200
 Ceiling Price Calculations..............
Pharmaceutical Pricing Agreement.........             200               1          200            1          200
Pharmaceutical Pricing Agreement (PPA)                620               1          620          0.5          310
 Addendum................................
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    Total................................          26,654  ..............       56,705  ...........      27593.5
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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.

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-08110 Filed 4-7-16; 8:45 am]
BILLING CODE 4165-15-P