[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]
BILLING CODE 4165-15-P