Attesting to Labeler Code Registrations

When you elect to attest to a registration submitted by a Primary Contact, the attestation statement is appended to the bottom of the summary page. You must attest to the registration before it can be submitted to OPA for approval.

screen shot of "Authorizing Official Signature" area of the registration summary page

AO Labeler Code Registration Attestation Controls
Control Description

Checkbox

"By checking this box, I represent that the contents of the registration request I am submitting are truthful and accurate."

Select this box if you intend to submit the registration to OPA for approval.

Cancel

Exit from the attestation page without taking action.

Submit

Click this button to submit the registration for OPA approval.

Reject

This button is displayed if the registration was submitted by a Primary Contact. Clicking this button will reject the registration and remove it from the My Tasks tab of My Dashboard.

  1. Click the Continue button. The system will display a PDF version of the Pharmaceutical Pricing Agreement (ClosedPPA This agreement is required for manufacturers who have executed a Medicaid rebate agreement with CMS. It is voluntary for those who do not have a current Medicaid rebate agreement. The PPA must be signed by a corporate officer of the company (e.g., president, chief executive officer, or general counsel). Signatures by vice presidents or directors of sales or marketing will not be accepted. A PPA remains in effect until terminated by either the manufacturer or the Secretary of HHS. It is not automatically terminated if a manufacturer terminates its Medicaid rebate agreement.) with a "Draft" watermark. You will not be able to view a countersigned version of the PPA until after review and acceptance by OPA.

    Example of PPA draft PDF for AO approval

    If you are using Google Chrome as your web browser, you will need to install a PDF viewer to view the PPA and addendum.

  2. Read the instructions for completing the PPA and review the information in the IX. Signatures section at the bottom of the document. Your name and contact information will appear as the signatory in the Accepted for the Manufacturer section.

    PPA Controls
    Control Description

    Checkbox

    "I acknowledge reviewing the 340B Drug Pricing Program Pharmaceutical Pricing Agreement (PPA) and attest the information submitted is truthful and accurate."

    Select this box if you intend to submit the registration to OPA for approval.

    Edit

    Return to the Manufacturer Labeler Code(s) page if you need to make changes.

    Cancel

    Cancel the registration and return to your My Tasks page.

    Continue

    Accept the PPA and view the PPA Addendum.

  3. Click the Continue button. The system will display a PDF version of the PPA Addendum with a "Draft" watermark. You will not be able to view a countersigned version of the PPA Addedum until after review and acceptance by OPA.

    Example of PPA Addendum draft PDF for AO approval

  4. Read the instructions for completing the PPA and review the information in the IX. Signatures section at the bottom of the document. Your name and contact information will appear as the signatory in the Accepted for the Manufacturer section.

    PPA Addendum Controls
    Controls Description

    Checkbox

    "I acknowledge reviewing the 340B Drug Pricing Program Pharmaceutical Pricing Agreement (PPA) Addendum and attest the information submitted is truthful and accurate."

    Select this box if you intend to submit the registration to OPA for approval.

    Back

    Return to the Pharmaceutical Pricing Agreement (PPA) page.

    Cancel

    Cancel the registration and return to your My Tasks page.

    Continue

    Accept the PPA Addendum.

  5. Click the Continue button. The system will display the Submit Manufacturer Registration page to confirm the electronic signatures of the PPA and Addendum.

    screen shot of Submit Manufacturer Registration page confirming electronic signature reading "This electronic signature is the legal equivalent of your manual/handwritten signature on this agreement. By completing this online registration and signing this agreement electronically, you represent that you are authorized to legally bind the manufacturer to the terms and conditions of this agreement. Your electronic signature means that you are authorized to enter into this agreement on behalf of the manufacturer named in this agreement and signifies the manufacturer's assent to be bound by the terms and conditions of this agreement."

    Manufacturer Registration Submission Controls
    Control Description

    Checkbox

    "By checking this box, I, <User First and Last Name>, agree to electronically sign this agreement as a part of the online MFR labeler registration and attest the information submitted is truthful and accurate."

    Select this box if you intend to submit the registration to OPA for approval.

    Back

    Return to the Pharmaceutical Pricing Agreement (PPA) page.

    Cancel

    Cancel the registration and return to your My Tasks page.

    Continue

    Electronically sign and submit the PPA and Addendum.

  6. The system will display the Manufacturer Registration Submission confirmation message. Click the OK button to return to the 340B home page.

    screen shot of Manufacturer Registration Submission confirmation message

    Upon OPA approval, the AO and the PC will both receive a Manufacturer 340B Participation Approval email and the labeler code's manufacturer status will be updated to "Approved."

  7. Click the Continue button. The system will display a PDF version of the Pharmaceutical Pricing Agreement (PPA) with a "Draft" watermark. You will not be able to view a countersigned version of the PPA until after review and acceptance by OPA.

    Example of PPA draft PDF for AO approval

    If you are using Google Chrome as your web browser, you will need to install a PDF viewer to view the PPA and addendum.

  8. Read the instructions for completing the PPA and review the information in the IX. Signatures section at the bottom of the document. Your name and contact information will appear as the signatory in the Accepted for the Manufacturer section.

    PPA Controls
    Control Description

    Checkbox

    "I acknowledge reviewing the 340B Drug Pricing Program Pharmaceutical Pricing Agreement (PPA) and attest the information submitted is truthful and accurate."

    Select this box if you intend to submit the registration to OPA for approval.

    Edit

    Return to the Manufacturer Labeler Code(s) page if you need to make changes.

    Cancel

    Cancel the registration and return to your My Tasks page.

    Continue

    Accept the PPA and view the PPA Addendum.

  9. Click the Continue button. The system will display a PDF version of the PPA Addendum with a "Draft" watermark. You will not be able to view a countersigned version of the PPA Addedum until after review and acceptance by OPA.

    Example of PPA Addendum draft PDF for AO approval

  10. Read the instructions for completing the PPA and review the information in the IX. Signatures section at the bottom of the document. Your name and contact information will appear as the signatory in the Accepted for the Manufacturer section.

    PPA Addendum Controls
    Controls Description

    Checkbox

    "I acknowledge reviewing the 340B Drug Pricing Program Pharmaceutical Pricing Agreement (PPA) Addendum and attest the information submitted is truthful and accurate."

    Select this box if you intend to submit the registration to OPA for approval.

    Back

    Return to the Pharmaceutical Pricing Agreement (PPA) page.

    Cancel

    Cancel the registration and return to your My Tasks page.

    Continue

    Accept the PPA Addendum.

  11. Click the Continue button. The system will display the Submit Manufacturer Registration page to confirm the electronic signatures of the PPA and Addendum.

    screen shot of Submit Manufacturer Registration page confirming electronic signature reading "This electronic signature is the legal equivalent of your manual/handwritten signature on this agreement. By completing this online registration and signing this agreement electronically, you represent that you are authorized to legally bind the manufacturer to the terms and conditions of this agreement. Your electronic signature means that you are authorized to enter into this agreement on behalf of the manufacturer named in this agreement and signifies the manufacturer's assent to be bound by the terms and conditions of this agreement."

    Manufacturer Registration Submission Controls
    Control Description

    Checkbox

    "By checking this box, I, <User First and Last Name>, agree to electronically sign this agreement as a part of the online MFR labeler registration and attest the information submitted is truthful and accurate."

    Select this box if you intend to submit the registration to OPA for approval.

    Back

    Return to the Pharmaceutical Pricing Agreement (PPA) page.

    Cancel

    Cancel the registration and return to your My Tasks page.

    Continue

    Electronically sign and submit the PPA and Addendum.

  12. The system will display the Manufacturer Registration Submission confirmation message. Click the OK button to return to the 340B home page.

    screen shot of Manufacturer Registration Submission confirmation message

    Upon OPA approval, the AO and the PC will both receive a Manufacturer 340B Participation Approval email and the labeler code's manufacturer status will be updated to "Approved."