[Federal Register Volume 80, Number 202 (Tuesday, October 20, 2015)]
[Notices]
[Pages 63560-63561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

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 21, 2015.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 10-29, 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 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.
    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 
(referred to in this section as the ``ceiling price'') 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.

[[Page 63561]]



                                     Total Estimated Annualized Burden Hours
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                                                     Number of
            Form name                Number of     responses per       Total         Hours per     Total 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                     697               8            5576             0.5            2788
 Hospital 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             427               3            1281               1            1281
 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              1204               5            6020            0.25            1505
 Recertifications...............
STD & TB Annual Recertifications            3123               1            3123            0.25          780.75
Annual Recertification for                  4899               1            4899            0.25         1224.75
 entities other 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                1758               5            8790               1            8790
 Registration...................
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                                          Other Information Collections
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Submission of Administrative                9396               1            9396             0.5            4698
 Changes for any Covered Entity.
Submission of Administrative                 350               1             350             0.5             175
 Changes for any Manufacturer...
Manufacturer Data Required to                600               4            2400             0.5            1200
 Verify 340B Ceiling Price
 Calculations...................
Pharmaceutical Pricing Agreement             200               1             200               1             200
Pharmaceutical Pricing Agreement             620               1             620             0.5             310
 (PPA) Addendum.................
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    Total.......................          26,554  ..............          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. 2015-26522 Filed 10-19-15; 8:45 am]
 BILLING CODE 4165-15-P