[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Notices]
[Pages 42747-42748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17777]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, email 
[email protected] or call the HRSA Reports Clearance Office on (301) 
443-1984.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:

Proposed Project: Enrollment and Re-Certification of Entities in the 
340B Drug Pricing Program (OMB No. 0915-0327)--[Revision]

    Section 602 of Public Law 102-585, the Veterans Health Care Act of 
1992, enacted section 340B of the Public Health Service Act (PHS Act), 
``Limitation on Prices of Drugs Purchased by Covered Entities.'' 
Section 340B provides that a manufacturer who sells covered outpatient 
drugs to eligible entities must sign a Pharmaceutical Pricing Agreement 
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. Covered 
entities which choose to participate in the section 340B Drug Pricing 
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.
    In response to the statutory mandate of section 340B(a)(9) of the 
PHS Act to notify manufacturers of the identities of covered entities 
and the mandate of section 340B(a)(5)(A)(ii) to establish a mechanism 
to ensure against duplicate discounts and the ongoing responsibility to 
administer the 340B Drug Pricing Program while maintaining efficiency, 
transparency and integrity, the HRSA Office of Pharmacy Affairs (OPA) 
developed a process of registration of covered entities to enable it to 
address those mandates.

Enrollment/Registration

    To enroll and certify the eligible federally funded grantees and 
other safety net health care providers, OPA requires entities to submit 
administrative information (e.g. shipping and billing arrangements, 
Medicaid participation), certifying information and signatures from 
appropriate grantee level or entity level authorizing officials and 
state/local government representatives. The purpose of this 
registration information is to determine eligibility for the 340B Drug 
Pricing Program. This information is entered into the 340B database by 
entities and verified by OPA staff according to 340B Drug Pricing 
Program requirements. Accurate records are critical to implementation 
of the 340B Drug Pricing Program legislation, especially to prevent 
diversion and duplicate discounts. To maintain accurate records, 340B 
statute also requires that entities recertify eligibility annually and 
that they notify the program of updates to any administrative 
information that they submitted when initially enrolling into the 
program. The burden requirement is low for recertification and for 
submitting change requests.

Contract Pharmacy Self-Certification

    In order to ensure that drug manufacturers and drug wholesalers 
recognize contract pharmacy arrangements, covered entities that elect 
to utilize one or more contract pharmacies are also required to submit 
general information about the arrangements and to certify that signed 
agreements are in place with those contract pharmacies.

Pharmaceutical Pricing Agreement

    In accordance with the guidance found in the May 7, 1993, Federal 
Register, Section 340B provides that a manufacturer who sells covered 
outpatient drugs to eligible entities must sign a Pharmaceutical 
Pricing Agreement (the ``Agreement'') with the Secretary of Health and 
Human Services (the ``Secretary'') in which the manufacturer agrees to 
charge a price for covered outpatient drugs that will not exceed the 
average manufacturer price (``AMP'') decreased by a rebate percentage.
    The estimates of annualized burden are as follows:

----------------------------------------------------------------------------------------------------------------
                                   Number of      Responses per        Total         Hours per     Total  burden
     Reporting requirement        respondents      respondent        responses       response          hours
----------------------------------------------------------------------------------------------------------------
                                HOSPITAL ENROLLMENT, ADDITIONS & RECERTIFICATIONS
----------------------------------------------------------------------------------------------------------------
340B Program Registrations &               546                 1             546             2.0         1,092.0
 Certifications for Hospitals.
Certifications to Enroll                   606                 1             606             0.5           303.0
 Hospital Outpatient
 Facilities...................
Hospital Annual                          4,842                 1           4,842             0.5         2,421.0
 Recertification..............
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[[Page 42748]]

 
                      REGISTRATIONS AND RECERTIFICATIONS FOR ENTITIES OTHER THAN HOSPITALS
----------------------------------------------------------------------------------------------------------------
340B Registrations for                     253                 1             253             1.0           253.0
 Community Health Centers.....
340B Registrations for Family              353                 1             353             1.0           353.0
 Planning Programs, STD/TB
 Clinics and Various Other
 Eligible Entity Types........
Community Health Center Annual           4,507                 1           4,507             0.5         2,253.5
 Recertification..............
Family Planning Annual                   3,879                 1           3,879             0.5         1,939.5
 Recertification..............
STD & TB Annual                          2,754                 1           2,754             0.5         1,377.0
 Recertification..............
Annual Recertification for               1,174                 1           1,174             0.5           587.0
 entities other than
 Hospitals, Community Health
 Centers, Family Planning, STD
 or TB Clinics................
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                                   CONTRACTED PHARMACY SERVICES REGISTRATIONS
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services              2500                 1            2500             1.0          2500.0
 Registration.................
----------------------------------------------------------------------------------------------------------------
                                          OTHER INFORMATION COLLECTIONS
----------------------------------------------------------------------------------------------------------------
Submission of Administrative             2,500                 1           2,500             0.5         1,250.0
 Changes for any Covered
 Entity.......................
Submission of Administrative               350                 1             350             0.5           175.0
 Changes for any Manufacturer.
Pharmaceutical Pricing                     200                 1             200             1.0           200.0
 Agreement....................
                               ---------------------------------------------------------------------------------
    Total.....................          24,464  ................          24,464  ..............        14,704.0
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    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to 
the desk officer for HRSA, either by email to [email protected] or by fax to 202-395-6974. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: July 16, 2012.
Jennifer Riggle,
Deputy Director, Office of Management.
[FR Doc. 2012-17777 Filed 7-19-12; 8:45 am]
BILLING CODE 4165-15-P