[Federal Register Volume 73, Number 214 (Tuesday, November 4, 2008)]
[Notices]
[Pages 65609-65610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26271]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Comment Request

    In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995. To request more 
information on the proposed project or to obtain a copy of the data 
collection plans and draft instruments, e-mail [email protected] or 
call the HRSA Reports Clearance Officer on (301) 443-1129.
    Comments are invited on: (a) The proposed collection of information 
for the proper performance of the functions of the agency; (b) the 
accuracy of the agency's estimate of the burden of the proposed 
collection of information; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

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

[[Page 65610]]

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 
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.

Recertification

    The purposes of recertification are to request that 340B covered 
entities annually certify program eligibility and confirm the accuracy 
of all information in the covered entity's 340B database record. 
Recertification is an electronic process that will require the covered 
entity to review the current database record and submit required edits 
(i.e., covered entity name and address changes, changes to 340B 
designated contact information, billing and shipping arrangements). The 
recertification process will pose a minimal burden to 340B covered 
entities.

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:

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                                     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
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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
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Contracted Pharmacy Services                2000               1            2000            .083          166
 Registration...................
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    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.

    E-mail comments to [email protected] or mail the HRSA Reports 
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, 
Rockville, MD 20857. Written comments should be received within 60 days 
of this notice.

    Dated: October 28, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
 [FR Doc. E8-26271 Filed 11-3-08; 8:45 am]
BILLING CODE 4165-15-P