[Federal Register Volume 77, Number 142 (Tuesday, July 24, 2012)]
[Notices]
[Pages 43342-43343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17969]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice Regarding Section 340B of the Public Health Service Act
Registration Period
AGENCY: Department of Health and Human Services, Health Resources and
Services Administration.
ACTION: Notice.
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SUMMARY: The Health Resources and Services Administration (HRSA) is
issuing this notice to inform stakeholders of the revised deadlines for
registration of new covered entities and for adding outpatient
facilities and contract pharmacy arrangements to the 340B Drug Pricing
Program (340B Program).
DATES: Effective Date: October 1, 2012.
FOR FURTHER INFORMATION CONTACT: CDR Krista Pedley, Director, OPA, HSB,
HRSA, 5600 Fishers Lane, Parklawn Building, Room 10C-03, Rockville, MD
20857, or by telephone at 301-594-4353.
SUPPLEMENTARY INFORMATION:
I. Background
Section 340B(a)(4) of the Public Health Service Act (PHS) Act (42
U.S.C. 256b) lists the various types of organizations eligible to
participate in and purchase discounted drugs under the 340B Program.
For a complete list of eligible entities, visit the OPA Web site at
http://www.hrsa.gov/opa.introduction.htm. Eligibility for participation
in the 340B Program is limited to the categories of entities specified
in this section of the statute. Section 340B(a)(9) of the PHS Act
requires the Secretary to notify participating manufacturers of the
identity of those entities that meet the definition of covered entity
under 340B(a)(4). HRSA published final guidelines on the participation
of outpatient facilities in the Federal Register at 59 FR 47884 (Sept.
19, 1994). HRSA published final guidelines on the utilization of
Contract Pharmacy Arrangements in the Federal Register at 75 FR 10272
(March 5, 2010).
II. Registration Deadlines
This notice replaces all previous 340B Program guidance documents
addressing the deadline and enrollment period for the 340B Program
registration of new covered entities, addition of outpatient facilities
and contract pharmacies, including any individual
[[Page 43343]]
correspondence issued by HRSA on the subject.
(A) Registration Period for New Covered Entities and for the Addition
of Outpatient Facilities
The registration period for 340B Program registration of new
covered entities and the addition of outpatient facilities shall be
limited to the following: January 1-January 15 for an effective start
date of April 1; April 1-April 15 for an effective start date of July
1; July 1-July 15 for an effective start date of October 1; and October
1-October 15 for an effective start date of January 1.
In situations where the 15th falls on a Saturday, Sunday, or
Federal holiday, the deadline will be the next business day. Covered
entities will not be able to submit registrations outside of these date
parameters listed above except when the Secretary has declared a Public
Health Emergency. In addition to the complete on-line registration, any
required supporting documentation must be submitted on the same day as
on-line registration is completed. Incomplete packages will not be
considered. For more information on what constitutes a complete
package, visit the Office of Pharmacy Affairs (OPA) Web site at
www.hrsa.gov/opa.
(B) Registration Period for Contract Pharmacies
The registration period for 340B Program registration of contract
pharmacies shall be limited to the following: January 1-January 15 for
an effective start date of April 1; April 1-April 15 for an effective
start date of July 1; July 1-July 15 for an effective start date of
October 1; and October 1-October 15 for an effective start date of
January 1.
In situations where the 15th falls on a Saturday, Sunday, or
Federal holiday, the deadline will be the next business day. The
contract pharmacy registration process is not complete unless the
registration form has been completed in its entirety and the original,
signed copy is received by OPA.
Signed contract pharmacy registration forms are due to OPA within
15 days from the time online registration was completed. Incomplete
packages will not be considered. For more information on what
constitutes a complete package, visit the OPA Web site at www.hrsa.gov/opa.
(C) Other Deadlines
Deadlines for forms other than those listed above are not affected
by this notice. For example, change requests are not affected by this
notice and will be processed as they are received.
Dated: July 17, 2012.
Mary K. Wakefield,
Administrator.
[FR Doc. 2012-17969 Filed 7-23-12; 8:45 am]
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