Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB No. 0915-0327-Revision

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Health Resources and Services Administration</SUBAGY> <SUBJECT>Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB No. 0915-0327—Revision</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Comments on this ICR should be received no later than October 6, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments to <E T="03">paperwork@hrsa.gov</E> or by mail to the HRSA Information Collection Clearance Officer, Room 14NWH04, 5600 Fishers Lane, Rockville, MD 20857. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email <E T="03">paperwork@hrsa.gov</E> or call Samantha Miller, the HRSA Information Collection Clearance Officer, at (301) 443-3983. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> When submitting comments or requesting information, please include the information collection request title for reference. <E T="03">Information Collection Request Title:</E> Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB No. 0915-0327—Revision. <E T="03">Abstract:</E> Section 602 of Public Law 102-585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service (PHS) Act, which instructs HHS to enter into a Pharmaceutical Pricing Agreement (PPA) with manufacturers of covered outpatient drugs. Manufacturers are also required by section 1927(a)(5)(A) of the Social Security Act to enter into agreements with the Secretary of HHS (Secretary) that comply with section 340B of the PHS Act if they participate in the Medicaid Drug Rebate Program. When a drug manufacturer signs a PPA, it is opting into the 340B Drug Pricing Program (340B Program), and it agrees to the statutory requirement that prices charged for covered outpatient drugs to covered entities will not exceed statutorily defined 340B ceiling prices. When an eligible covered entity voluntarily decides to enroll and participate in the 340B Program, it accepts responsibility for ensuring compliance with all provisions of the 340B Program, including all associated costs. Covered entities that choose to participate in the 340B Program must comply with the requirements of section 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) of the PHS Act prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) of the PHS Act prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the covered entity. <E T="03">Need and Proposed Use of the Information:</E> To ensure the ongoing responsibility to administer the 340B Program while maintaining efficiency, transparency, and integrity, HRSA developed a process of registration for covered entities to enable it to address specific statutory mandates. Specifically, section 340B(a)(9) of the PHS Act requires HRSA to notify manufacturers of the identities of covered entities and of their status pertaining to certification and annual recertification in the 340B Program pursuant to section 340B(a)(7) and the establishment of a mechanism to prevent duplicate discounts as outlined at section 340B(a)(5)(A)(ii) of the PHS Act. In addition, section 340B(a)(1) of the PHS Act requires each participating manufacturer to enter into an agreement with the Secretary to offer covered outpatient drugs to 340B covered entities. Finally, section 340B(d)(1)(B)(i) of the PHS Act requires the development of a system to enable the Secretary to verify the accuracy of ceiling prices calculated by manufacturers under subsection (a)(1) and charged to covered entities. HRSA is requesting approval for existing information collections. HRSA notes that the previously approved collections are mostly unchanged, except some forms have been revised to increase program efficiency and integrity. Below are descriptions of each form and any resulting revisions that are captured in both the registration and pricing component of the 340B Office of Pharmacy Affairs Information System (OPAIS). <HD SOURCE="HD1">Enrollment/Registration/Recertification</HD> To enroll and certify the eligibility of federally funded grantees and other safety net health care providers, HRSA requires covered entities to submit administrative information ( <E T="03">e.g.,</E> shipping and billing arrangements, Medicaid participation), certifying information ( <E T="03">e.g.,</E> Medicare Cost Report information, documentation supporting the hospital's selected classification), and attestation from appropriate grantee-level or entity-level authorizing officials and primary contacts. To maintain accurate records, HRSA requests entities submit modifications to any administrative information that they submitted when initially enrolling into the Program. Covered entities participating in the 340B Program have an ongoing responsibility to immediately notify HRSA in the event of any change in eligibility for the 340B Program. Covered entities must comply with the statutory mandates of the Program and, at least annually, they need to certify the accuracy of the information provided and continued maintenance of their eligibility. Registration and annual recertification information is entered into the 340B OPAIS by covered entities and verified by HRSA staff according to 340B Program requirements. The following forms are being revised: (1) 340B Registration, Recertification and Change Requests for Shipping Address: HRSA is providing additional clarification for covered entities to complete the shipping address section in 340B OPAIS to improve transparency and assist in determining the exact shipping address location and relationship to the covered entity. The information collected will help determine whether the shipping address is a pharmacy, health care delivery site, or other receiving location. The information collected will also help determine if the location should be listed as a shipping address or potentially registered separately in OPAIS as a contract pharmacy or covered entity. Reviewing shipping addresses has become difficult and inefficient for both the covered entity and HRSA because it can involve sending the task back to the covered entity, sometimes multiple times, before HRSA can appropriately act on the task. The burden will not be significantly affected since the requested language facilitates a more efficient review with fewer exchanges between the covered entity and HRSA. (2) 340B Registration and Recertification for Sexually Transmitted Disease (STD) and Tuberculosis (TB) Grantees: HRSA is requesting that STD and TB grantees provide supporting documentation to demonstrate 340B eligibility pursuant to section 340B(a)(4)(K) of the PHS Act during initial registration as well as during recertification if requested to ensure compliance. The requested documentation will include a copy of the federal grant notice of award that identifies the grantor, grant number, period of funding, and recipient information. If the entity is a subgrantee then they will also need to provide a copy of the executed written subrecipient agreement that includes the name and address of the recipient and subrecipient, the grant and notice of funding opportunity number, and the terms and conditions of support. This new requirement streamlines the verification process and enhances program integrity for STD and TB entity types. This requirement will slightly increase the burden on covered entities since eligible covered entities should already have this documentation readily available prior to registering and recertifying for the 340B Program. (3) 340B Program Registrations, Recertifications, and Change Requests for Family Planning: HRSA is requesting to collect the time period that assistance was received for Family Planning covered entities. The addition of these fields is consistent with information collected from Ryan White, STD, and TB entities at registration and recertification and will support HRSA's ability to verify a Family Planning covered entity's eligibility in the 340B Program as outlined in section 340B(a)(4)(C) of the PHS Act. This collection of time period information is a minor addition that will not significantly affect the burden on covered entities, as the time period when assistance was received is a readily available data point for Family Planning covered entities. (4) 340B Recertification and Change Requests for Street Address: HRSA is providing additional clarification for covered entities that revise their street address in 340B OPAIS to assist in determining continued eligibility as outlined in section 340B(a)(4) of the PHS Act. OPAIS will prompt the covered entity to state if they are still receiving federal funding that makes them eligible for the 340B Program and/or if the service remains open at the old address. The answers to these questions will help determine the next appropriate action take ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 19k characters. 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