[Federal Register Volume 74, Number 155 (Thursday, August 13, 2009)]
[Notices]
[Pages 40821-40822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19381]


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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, e-mail 
[email protected] or call the HRSA Reports Clearance Office on (301) 
443-1129.
    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 [NEW]

    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 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) 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

[[Page 40822]]

is to determine eligibility for the 340B program. This information is 
received and verified according to 340B requirements and entered into 
the 340B database. Accurate records are critical to implementation of 
the 340B legislation especially to prevent diversion and duplicate 
discounts. To maintain accurate records, the OPA requests entities to 
submit modifications to any administrative information that they 
submitted when initially enrolling into the program. The burden 
requirement for these processes is minimal.

Contract Pharmacy Self-Certification

    In order to ensure that drug manufacturers and drug wholesalers 
recognize contract pharmacy arrangements, covered entities that elect 
to utilize a contract pharmacy are required to submit to OPA a self-
certification form similar to the registration form that they have 
signed an agreement with the contract pharmacy.
    The Estimates of annualized burden are as follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
      Reporting requirement         respondents     respondent       responses       response          hours
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                       DSH & Children's Hospital Enrollment, Additions & Recertifications
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340B Program Registrations &                  70               1              70            .25            17.5
 Certifications for
 Disproportionate Share
 Hospitals......................
340B Program Registrations &                  80               1              80            .25            20
 Certifications for Children's
 Hospitals......................
Certifications to Enroll DSH &               180               1             180            .083           14.94
 Children's Hospitals Outpatient
 facilities to 340B Program.....
DSH & Children's Hospitals'                  937               1             937            .5            468.5
 Annual Recertification.........
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                        Registration for Entities Other Than Hospitals & Recertifications
----------------------------------------------------------------------------------------------------------------
340B Registration Form (Family               170               1             170            .083           14.11
 Planning, STD, TB, and others).
Family Planning Annual                        85              47            3995            .083          331.59
 Recertification................
STD & TB Annual Recertification.             111              11            1221            .083          101.34
Other Entity Annual                          400              10            4000            .083          332
 Recertification for entities
 other than DSHs, FP, STD or TB
 entities.......................
Submission of Administrative                 460               1             460            .083           38.18
 Changes for any entity.........
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                          Contracted Pharmacy Services Registration & Recertifications
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services                2000               1            2000            .083          166
 Registration...................
    Total.......................          * 4493  ..............          13,313  ..............         1504.16
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* The total number of respondents may be overestimated since we are unable to avoid duplication of respondents
  who submit information to the OPA over the course of participation in the 340B Drug Pricing Program, via the
  initial registration process to any updates/modifications and enrolling contract pharmacies, if applicable, to
  the recertification process.

    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 e-mail to [email protected] or by fax to 202-395-6974. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: August 5, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-19381 Filed 8-12-09; 8:45 am]
BILLING CODE 4165-15-P