[Federal Register: August 13, 2009 (Volume 74, Number 155)]
[Notices]
[Page 40821-40822]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au09-46]
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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
paperwork@hrsa.gov 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:
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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...................
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 OIRA_
submission@omb.eop.gov 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