BIO Submits Comments to OIRA Re: Enrollment and Re-certification of Entities in the 340B Program
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The Honorable Howard A. Shelanski</div>
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Administrator</div>
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Office of Information and Regulatory Affairs</div>
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Office of Management and Budget</div>
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725 17th Street, NW</div>
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Washington, DC 20503</div>
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BY ELECTRONIC SUBMISSION</div>
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Re: Information Collection Request: 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]</div>
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Dear Administrator Shelanski:</div>
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The Biotechnology Industry Organization (BIO) is pleased to submit the following comments to the Office of Information and Regulatory Affairs (OIRA) in response to the Health Resources and Services Administration’s (HRSA’s) proposed Information Collection Notice entitled “Proposed Collection Request: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program</div>
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Price Calculations”1 (the “Notice”). BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.</div>
