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Since more than 180 days have passed since the end of the NOIRA stage, a Time Frame Waiver must be granted by the Governor's office.

This waiver was requested on 9/19/2012

Agency Reason: VDH is requesting a waiver to the 180-day time frame calling for a proposed stage to be submitted to DPB following close of the NOIRA comment period on revisions to these regulations. This time frame has passed. The reasons for this are varied and discussed below. A periodic review of these regulations was conducted with the comment period ending on November 11, 2007. After that comment period ended, VDH received suggested revisions from the Virginia Transplant Council (VTC). In February of 2008, a Notice of Intended Regulatory Action (NOIRA) was initiated, with Governor’s approval occurring in May 2008. The NOIRA was published in the Virginia Register, and the NOIRA comment period ended on July 9, 2008. A Proposed Regulation Agency Background Document (TH-02) was uploaded onto the Town Hall in September 2008 for certification by the Office of the Attorney General (OAG). The VTC submitted additional comments regarding revisions shared with that entity in December 2008. The suggested revisions were reviewed and appropriate revisions were made and forwarded on January 23, 2009, to the OAG for review. Following review, the OAG sent additional suggested revisions in February 2009; however, the VDH staffer who was working on the regulations somehow did not receive the memorandum containing these suggestions. In April 2009, the Board of Health approved the revised regulations for publication, i.e., the regulations that did not reflect OAG’s suggested revisions. On July 7, 2009, the TH-02 was updated to reflect the Board of Health’s action and uploaded onto the Town Hall. In the meantime, questions regarding the status of the regulatory process resulted in discovery of the February 2009 OAG memorandum which was then forwarded on July 15, 2009, to the individual working on the regulations. The revisions were then incorporated and sent back to the OAG for review which resulted in the OAG forwarding additional revisions on August 10, 2009. On August 25, 2009, a copy of the most recent revised regulations was forwarded to the VTC. On October 23, 2009, and following a review by an attorney working with the VTC, that entity forwarded yet additional suggested revisions. These revisions were reviewed by VDH staff and included in another set of revised regulations that were then forwarded on October 28, 2009, to the OAG for review. On November 16, 2009, comments from the OAG were received, appropriate changes were incorporated and another revised text of the regulations was forwarded to the OAG for review on December 22, 2009. On February 3, 2010, the OAG sent an approval letter but was, for some reason, unable to upload it onto the Town Hall. Unsuccessful attempts by VDH staff were made to upload the most recent revised regulations to the Regulatory Information System (RIS). In short, VDH has received, on multiple occasions, suggested revisions to the regulations from the VTC and the OAG throughout the time period discussed. While all persons involved have had the best of intentions, these developments have delayed and confused the preparation of a proposed set of regulations. These events have been further complicated by resourcing issues in the VDH program office assigned to administer these regulations and develop revisions to them. (Notably, in 2002, the VDH staff support position for the VTC and the Virginia Donor Registry was eliminated due to budget reductions.) The duties have since been assumed by VDH staff who have existing, unrelated, full-time responsibilities. In September 2011, the assigned staff person retired from VDH and the reorganization of the Office of Family Health Services left no position with the direct responsibility for the Donor Registry regulations. In the meantime, the 2012 General Assembly passed additional amendments to the Code of Virginia relating to the Virginia Transplant Council and prompted a fresh look at the Donor Registry regulations to ensure that any changes to the regulations accurately reflected the VTC’s legislated requirements. This required working closely with the OAG as well as the VTC. Also of note, VDH has applied twice for a federal grant from the Health Resources and Services Administration (HRSA) for funding an overall effort to update and improve the Virginia Donor Registry. The first grant application was submitted in December 2007 and was not awarded. The second grant application was submitted in December 2008 and resulted in funding beginning August 1, 2009, and running through July 31, 2010. Due to unforeseen contracting issues, HRSA granted VDH an extension of the grant funding in order to complete changes to the registry that would improve the mechanism, security and timeliness of the registry, improve information collection and evaluation of database demographics to assist in improving outreach and community education to increase enrollment and to translate the existing website info a second language for the rapidly expanding Hispanic population. The implementation and completion of the grant to improve the Donor Registry provided VDH an opportunity to receive and discuss additional suggestions for revisions to the regulations. During this period, action on preparing a draft regulation – one that comprehensively reflects all the improvements suggested – for the State Board of Health to propose was delayed in order to receive the benefit of all the analysis, comments and suggested revisions, and to prevent duplication of effort. As a result of the further analysis, comments and suggestions from VTC and the OAG proposed regulations were developed and submitted to the OAG for review. The proposed regulations were reviewed and certified by the OAG on September 18, 2012.

The request was approved on 10/6/2012