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BIO Submits Comments Re: HRSA's PPA Information Collection Request

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Captain Krista M. Pedley, PharmD, M.S., USPHS, Director</div>
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Office of Pharmacy Affairs</div>
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Health Resources and Services Administration</div>
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Department of Health and Human Services</div>
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5600 Fishers Lane, Parklawn Building, Mail Stop 10C-03</div>
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Rockville, Maryland 20857</div>
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&nbsp;</div>
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BY ELECTRONIC SUBMISSION</div>
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&nbsp;</div>
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Re: Proposed Information Collection: Enrollment and Re-Certification of Entities</div>
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in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify</div>
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340B Drug Pricing Program Ceiling Price Calculations [OMB No. 0915-0327-</div>
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Revision]</div>
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&nbsp;</div>
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Dear Captain Pedley:</div>
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&nbsp;</div>
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The Biotechnology Industry Organization (&ldquo;BIO&rdquo;) appreciates the opportunity to</div>
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submit the following comments in response to the proposed Information Collection Request</div>
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(&ldquo;ICR&rdquo;), issued by the Health Resources and Services Administration (&ldquo;HRSA&rdquo;) and</div>
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published in the Federal Register on October 20, 2015, entitled Enrollment and Re-</div>
<div>
Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer</div>
<div>
Data to Verify 340B Drug Pricing Program Ceiling Price Calculations [OMB No. 0915-0327-</div>
<div>
Revision] (the &ldquo;Proposed ICR&rdquo;).</div>

Captain Krista M. Pedley, PharmD, M.S., USPHS, Director
Office of Pharmacy Affairs
Health Resources and Services Administration
Department of Health and Human Services
5600 Fishers Lane, Parklawn Building, Mail Stop 10C-03
Rockville, Maryland 20857
 
BY ELECTRONIC SUBMISSION
 
Re: Proposed Information Collection: Enrollment and Re-Certification of Entities
in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify
340B Drug Pricing Program Ceiling Price Calculations [OMB No. 0915-0327-
Revision]
 
Dear Captain Pedley:
 
The Biotechnology Industry Organization (“BIO”) appreciates the opportunity to
submit the following comments in response to the proposed Information Collection Request
(“ICR”), issued by the Health Resources and Services Administration (“HRSA”) and
published in the Federal Register on October 20, 2015, entitled Enrollment and Re-
Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer
Data to Verify 340B Drug Pricing Program Ceiling Price Calculations [OMB No. 0915-0327-
Revision] (the “Proposed ICR”).
 
BIO represents an industry devoted to discovering new treatments and ensuring
patient access to them. Accordingly, we support the 340B Program as a way to improve
access to therapies for indigent patients. We believe that compliance with 340B Program
requirements by all parties—including manufacturers—is an important part of ensuring the
sustainability of the 340B Program. Accordingly, we applaud HRSA’s recent commitment
and activities to enforce program oversight and compliance, as well HRSA’s effort to finally
implement certain provisions added to the 340B statute by the Affordable Care Act (“ACA”)
by amending the Pharmaceutical Pricing Agreement (“PPA”) via a proposed addendum.

 

See the full comment letter here.