Department of Health and Human Services May 4, 2011 – Federal Register Recent Federal Regulation Documents

Section 3003(b)(3) of the American Recovery and Reinvestment Act of 2009 mandates that the HIT Standards Committee develop a schedule for the assessment of policy recommendations developed by the HIT Policy Committee and publish it in the Federal Register. This notice fulfills the requirements of Section 3003(b)(3) and updates the schedule posted in the Federal Register on October 8, 2010. In anticipation of receiving recommendations originally developed by the HIT Policy Committee, the HIT Standards Committee has created four (4) workgroups or subcommittees to analyze the areas of clinical quality, clinical operations, implementation, and privacy and security. HIT Standards Committee's Schedule for the Assessment of HIT Policy Committee Recommendations is as follows: The National Coordinator will establish priority areas based in part on recommendations received from the HIT Policy Committee regarding health information technology standards, implementation specifications, and/or certification criteria. Once the HIT Standards Committee is informed of those priority areas, it will: (A) Direct the appropriate workgroup or subcommittee to develop a report for the HIT Standards Committee, to the extent possible, within 90 days, which will include, among other items, the following: (1) An assessment of what standards, implementation specifications, and certification criteria are currently available to meet the priority area; (2) An assessment of where gaps exist (i.e., no standard is available or harmonization is required because more than one standard exists) and identify potential organizations that have the capability to address those gaps; and (3) A timeline, which may also account for NIST testing, where appropriate, and include dates when the HIT Standards Committee is expected to issue recommendation(s) to the National Coordinator. (B) Upon receipt of a subcommittee report, the HIT Standards Committee will: (1) Accept the timeline provided by the subcommittee, and, if necessary, revise it; and (2) Assign subcommittee(s) to conduct research and solicit testimony, where appropriate, and issue recommendations to the full committee in a timely manner. (C) Advise the National Coordinator, consistent with the accepted timeline in (B)(1) and after NIST testing, where appropriate, on standards, implementation specifications, and/or certification criteria, for the National Coordinator's review and determination whether or not to endorse the recommendations, and possible adoption of the proposed recommendations by the Secretary of the Department of Health and Human Services. For a listing of upcoming HIT Standards Committee meetings, please visit the ONC Web site at https://healthit.hhs.gov. Notice of this schedule is given under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.

The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of disodium 1-amino-4- [[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,1 0-dihydro- 9,10-dioxoanthracene-2-sulphonate (CAS Reg. No. 70209-99-3), also known as Reactive Blue 69, as a color additive in contact lenses. This action is in response to a petition filed by Sauflon Pharmaceuticals Ltd.

The Food and Drug Administration (FDA) is announcing the reestablishment of the Medical Imaging Drugs Advisory Committee in the Division of Advisory Committee and Consultants Management, Center for Drug Evaluation and Research.

This proposed rule would require certain Medicare and Medicaid providers and suppliers to offer all patients an annual influenza vaccination, unless medically contraindicated or unless the patient or patient's representative or surrogate declined vaccination. This proposed rule is intended to increase the number of patients receiving annual vaccination against seasonal influenza and to decrease the morbidity and mortality rates from influenza. This proposed rule would also require certain providers and suppliers to develop policies and procedures that would allow them to offer vaccinations for pandemic influenza, in case of a future pandemic influenza event for which a vaccine may be developed.