Department of Health and Human Services March 12, 2009 – Federal Register Recent Federal Regulation Documents
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Office of the National Coordinator for Health Information Technology; HIT Standards Committee and HIT Policy Committee Nomination Letters
The American Recovery and Reinvestment Act of 2009 (Act), Public Law 111-5 amends the Public Health Service Act (PHSA) to add new sections 3002 and 3003. The new section 3003 of the PHSA establishes the HIT Standards Committee to make recommendations to the National Coordinator for Health Information Technology on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of health information technology adoption. The HIT Standards Committee members are to be appointed by the Secretary of the Department of Health and Human Services with the National Coordinator taking a leading role. Membership of the HIT Standards Committee should at least reflect the following categories of stakeholders and will include other individuals: providers, ancillary healthcare workers, consumers, purchasers, health plans, technology vendors, researchers, relevant Federal agencies, and individuals with technical expertise on health care quality, privacy and security, and on the electronic exchange and use of health information. In addition, we also seek nominations to the HIT Policy Committee (established by the new section 3002 of the PHSA), which makes recommendations to the National Coordinator on the implementation of a nationwide health information technology infrastructure. The HIT Policy Committee will consist of at least 20 members. Three of these members will be appointed by the Secretary of the Department of Health and Human Services. Of the three members, one must be a representative of the Department of Health and Human Services and one must be a public health official. If, 45 days after the enactment of the Act, an official authorized under the Act to make appointments to the HIT Policy Committee has failed to make an appointment(s), the Act authorizes the Secretary of HHS to make such appointments. The Department of Health and Human Services is consequently accepting nominations for the HIT Policy Committee. New section 3008 of the PHSA allows the Secretary to recognize the NeHC (if modified to be consistent with the requirements of section 3002 and 3003 of the Act and other federal laws) as either the HIT Policy Committee or the HIT Standards Committee. At this time, the Department of Health and Human Services is evaluating options regarding the National eHealth Collaborative and its role in relation to those Committees. For appointments to either the HIT Standards Committee or the HIT Policy Committee, I am announcing the following: Letters of nomination and resumes should be submitted by March 16, 2009 to ensure adequate opportunity for review and consideration of nominees prior to appointment of members.
Determination of Regulatory Review Period for Purposes of Patent Extension; PROFENDER
The Food and Drug Administration (FDA) has determined the regulatory review period for PROFENDER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.
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