Department of Health and Human Services April 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary National Retail Food Regulatory Program Standards'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Improving Quality through Health IT: Testing the Feasibility and Assessing the Impact of Using Existing Health IT Infrastructure for Better Care Delivery.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on February 15th, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

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 information collection related to implementation of the Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to 299b-26, in: ``Patient Safety Organization Certification and Related Forms and a Patient Safety Confidentiality Complaint Form.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on February 20th, 2008 and allowed 60 days for public comment. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA) is announcing a public meeting to obtain input from stakeholder groups, including, but not limited to, the Association of American Feed Control Officials (AAFCO), veterinary medical associations, animal health organizations, and pet food manufacturers, concerning the development of ingredient standards and definitions, processing standards, and labeling standards for pet food. These standards were mandated by the FDA Amendments Act of 2007 (FDAAA). We also would like to obtain input on whether the ingredient standards and definitions and processing standards should cover all animal feeds. Elsewhere in this issue of the Federal Register, FDA is announcing a related public meeting notice. Date and Time: The public meeting will be held on May 13, 2008, from 8 a.m. to 4:30 p.m. Location: The public meeting will be held at the Gaithersburg Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, MD 20877. There is parking adjacent to the building. The building is also accessible by public transportation. (Take the Metro Red Line to Shady Grove Station, then take Ride-On bus 124 to Frederick Rd. at Perry Pkwy., then cross the roadway and walk approximately 1 [frac1s2] blocks north to the building entrance.) Contact Persons: For general information, Tracey Forfa, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9000, FAX: 240-276-9030, e-mail: Tracey.Forfa@fda.hhs.gov; or for information on registration, Nanette Milton, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6840, FAX: 240-453- 6880, e-mail: Nanette.Milton@fda.hhs.gov. Registration: We request that you preregister to ensure there is sufficient room. Additionally, to assist us in scheduling, we ask that you notify us through the preregistration process if you wish to make a public comment at the meeting. To preregister, please send an electronic mail message to Nanette.Milton@fda.hhs.gov no later than May 7, 2008. Your e-mail should include the following information: Your name, company or association name and address as applicable, phone number, and e-mail address. Please state whether you are speaking on behalf of an organization or as an individual. You will receive a confirmation within 2 business days. FDA also will accept walk-in registration at the meeting site, but space is limited. FDA will try to accommodate all persons who wish to make a public comment at the meeting, including those who register at the meeting site; however, the time allotted for public comments may depend on the number of persons who wish to speak. Additionally, please notify FDA (see Contact Persons) if you need any special accommodations (such as wheelchair access or a sign language interpreter) at least 7 days in advance of the meeting. A notice in the Federal Register about last minute modifications that impact a previously announced public meeting cannot always be published quickly enough to provide timely notice. Accordingly, you should check the FDA Web site at https://www.fda.gov/cvm to learn about possible modifications before coming to the meeting. Comments: To ensure consideration of your comments regarding the development of standards for pet food, you should submit comments by June 13, 2008. While interested persons may comment orally at the public meeting, comments may also be submitted in writing or electronically in lieu of or in addition to oral comments. Send written comment submissions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. Follow the instructions for submitting comments. All comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. You may also view received comments at https://www.regulations.gov. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government- wide, electronic docket management system. Electronic submissions will be accepted by FDA only through FDMS at https://www.regulations.gov.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA provides for the veterinary prescription use of an injectable suspension of porcine insulin zinc for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.

This notice announces the availability of two interaction profiles prepared by ATSDR for public comments [draft documents].