Department of Health and Human Services January 2007 – Federal Register Recent Federal Regulation Documents

This notice announces the 11th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's regulations for submission of petitions, including food and color additive petitions (including labeling) and generally recognized as safe (GRAS) affirmations, and electronic submission using FDA Forms 3503 and 3504. This notice also notifies the public of, and solicits comments on, FDA's proposal to transfer the collection of information and burden associated with petitions submitted to amend the indirect food additive regulations from the subject collection of information Office of Management and Budget (OMB) control number 0910- 0016 to the collection of information for the Food Contact Substances Notification System (OMB control number 0910-0495).

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Hanford Nuclear Reservation, Richland, Washington, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Hanford Nuclear Reservation. Location: Richland,Washington. Job Title and/or Job Duties: All former Dupont production workers in the 100 area and the 300 area and all 200 area production workers and all guards and construction workers. Period of Employment: January 1, 1943 through September 1, 1946 for former Dupont production workers in the 100 and 300 areas and December 1, 1944 through September 1, 1946 for all 200 area production workers and all guards and construction workers.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) is announcing a public meeting to explore opportunities to link private sector and public sector postmarket safety efforts to create a virtual, integrated, electronic ``Sentinel Network.'' Such a network would integrate existing and planned efforts to collect, analyze, and disseminate medical product safety information to health care practitioners and patients at the point-of-care. It would be established through multiple, broad-based, public-private partnerships. We are seeking input on a number of specific questions regarding opportunities for collaboration, the efficient use of information technology, and the collection and analysis of medical product safety information. Dates and Times: The public meeting will be held on March 7 and 8, 2007, from 8 a.m. to 5 p.m. Location: The public meeting will be held at the University System of Maryland Shady Grove Center, 8630 Gudelsky Dr., Rockville, MD 20850.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies'' dated December 2006. The draft guidance document provides recommendations that would allow the manufacturer, generally a cord blood bank, to apply for licensure of minimally manipulated, unrelated, allogeneic placental/umbilical cord blood, for specified indications. The document also contains information about the manufacture of minimally manipulated, unrelated, allogeneic placental/ umbilical cord blood and how to comply with applicable regulatory requirements.

The Food and Drug Administration (FDA) is issuing for public comment the recommendation of the Orthopaedic and Rehabilitation Devices Panel to deny a petition to reclassify the non-invasive bone growth stimulator from class III to class II. The Panel made this recommendation after reviewing the reclassification petition submitted by RS Medical Corp., as well as consideration of presentations made at the Panel meeting by the petitioner, FDA, and members of the public. FDA is also issuing for public comment its findings on the Panel's recommendation. After considering any public comments on the Panel's recommendation and FDA's findings, FDA will approve or deny the reclassification petition by order in the form of a letter to the petitioner. FDA's decision on the reclassification petition will be announced in the Federal Register.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

This announcement governs the proposed award of mandatory grants under the Family Violence Prevention and Services Act (FVPSA) to States (including Territories and Insular Areas). The purpose of these grants is to assist States in establishing, maintaining, and expanding programs and projects to prevent family violence and to provide immediate shelter and related assistance for victims of family violence and their dependents. This announcement sets forth the application requirements, the application process, and other administrative and fiscal requirements for grants in Fiscal Year (FY) 2007.

The Food and Drug Administration (FDA, we) is publishing proposed recommendations for the reauthorization of the Prescription Drug User Fee program for the process of human drug application review for fiscal years (FY) 2008 to 2012. These proposed recommendations were developed after discussions with regulated industry and consultation with appropriate scientific and academic experts, healthcare professionals, and representatives of patient and consumer advocacy groups. Section 505 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, enacted June 12, 2002, directs FDA to publish these proposed recommendations in the Federal Register; hold a meeting at which the public may present its views on such recommendations; and provide for a period of 30 days for the public to provide written comments on such recommendations.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Improving Quality of Care in Long Term Care.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.