memo to OMB re FRN comments final

M E M O

To: OMB Desk Officer

From: Robert Walsh

HRSA/HSB/ Division of Transplantation

Date: March 6, 2012

Re: Public Comment Responses to Proposed Extension to Information Collection Activity for the Organ Procurement and Transplantation Network Data System (OMB No. 0915–0157)

On February 17, 2012 OMB received one public comment in response to the Federal Register Notice (FRN) requesting comment on the on the proposed extension of the information collection activity for the Organ Procurement and Transplantation Network (OPTN) data system, which was published on January 19, 2012. This comment was submitted by Hart Health Strategies on behalf of an unnamed ‘interested client.’

The submitted comments do not focus directly on the proposed extension to this information collection activity and the corresponding burden on those submitting this information. Rather, the comments focus on concerns regarding the current structure of the contract the Health Resources and Services Administration has in place for the continued operation of the OPTN and the information technology (IT) infrastructure currently being implemented under this contract.

The respondent’s primary request is that HRSA “separate the data functions from the OPTN contract to foster competition for the most efficient, cost‐effective data system to support the many functions of the OPTN.” However, the authorizing statute, the National Organ Transplant Act of 1984 (NOTA), requires that the national system, including the operation of a computer system to match donor organs to individuals waiting for a transplant, be operated under contract by a private be a private nonprofit entity that has an expertise in organ procurement and transplantation. Therefore, the Department of Health and Human Services (HHS) does not have the authority to directly contract with an entity to implement only a portion of the OPTN’s functions.

The OPTN contract is up for renewal in 2012. In preparing for the competitive solicitation HRSA published a request for information (RFI) in FedBizOpps on January 6, 2012. The purpose of this RFI was to seek comments on the current statement of work and how the operation of the OPTN could be improved. This RFI specifically requested comments on whether or not the operation of the OPTN would be improved if certain tasks or elements of tasks were done by entities under subcontract with the prime OPTN contractor. Among other issues, the RFI also specifically requested input on the possibility of expanding the ability of the OPTN’s data system to quickly utilize IT advancements in the next OPTN contract. Hart Health Strategies submitted identical comments to this RFI as were submitted in response to the January 19 FRN. Comments received in response to that RFI will be considered when developing the statement of work for the next OPTN contract.

I hope this additional information is helpful to you as you consider the submitted comments. If you have any questions, please contact me at (301) 443-6839 or [email protected].