[Federal Register: November 4, 2008 (Volume 73, Number 214)]
[Notices]
[Page 65609-65610]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no08-68]
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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 paperwork@hrsa.gov 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 paperwork@hrsa.gov 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