[Federal Register Volume 77, Number 108 (Tuesday, June 5, 2012)]
[Notices]
[Pages 33226-33227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-13617]
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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, etc.), 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, OPA
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 for these processes is low for recertification and
minimal 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 certifications that
signed agreements are in place with those contract pharmacies.
The estimates of annualized burden are as follows:
[[Page 33227]]
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Number of Responses per Total Hours per Total burden
Reporting requirement respondents respondent responses response hours
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HOSPITAL ENROLLMENT, ADDITIONS & RECERTIFICATIONS
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340B Program Registrations & 546 1 546 2.00 1092.0
Certifications for Hospitals...
Certifications to Enroll 606 1 606 0.50 303.0
Hospital Outpatient Facilities.
Hospital Annual Re- 4842 1 4842 0.50 2421.0
Certifications.................
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REGISTRATIONS AND RECERTIFICATIONS FOR ENTITIES OTHER THAN HOSPITALS
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340B Registrations for Community 253 1 253 1.00 253.0
Health Centers.................
340B Registrations for Family 353 1 353 1.00 353.0
Planning Programs, STD/TB
Clinics and Various Other
Eligible Entity Types..........
Community Health Center Annual 4507 1 4507 0.50 2253.5
Re-Certifications..............
Family Planning Annual Re- 3879 1 3879 0.50 1939.5
Certifications.................
STD & TB Annual Re- 2754 1 2754 0.50 1377.0
Certifications.................
Annual Re-Certification for 1174 1 1174 0.50 587.0
Entities Other Than Hospitals,
Community Health Centers,
Family Planning, STD or TB
Clinics........................
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OTHER INFORMATION COLLECTIONS
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Submission of Administrative 2500 1 2500 0.50 1250.0
Changes for Any Covered Entity.
Submission of Administrative 350 1 350 0.50 175.0
Changes for Any Manufacturer...
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CONTRACTED PHARMACY SERVICES REGISTRATION & RECERTIFICATIONS
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Contracted Pharmacy Services 2500 1 2500 1.00 2500.0
Registration...................
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TOTAL....................... 24,264 .............. 24,264 .............. 14,504.0
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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: May 29, 2012.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2012-13617 Filed 6-4-12; 8:45 am]
BILLING CODE 4165-15-P