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

Results 101 - 150 of 337
National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: E8-8610
Type: Notice
Date: 2008-04-23
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: E8-8609
Type: Notice
Date: 2008-04-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Meeting
Document Number: E8-8608
Type: Notice
Date: 2008-04-23
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: E8-8605
Type: Notice
Date: 2008-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-8445
Type: Notice
Date: 2008-04-23
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Feasibility of secure messaging for pediatric patients with chronic disease: Pilot implementation in pediatric respiratory medicine.'' 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking
Document Number: E8-8682
Type: Notice
Date: 2008-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary National Retail Food Regulatory Program Standards
Document Number: E8-8680
Type: Notice
Date: 2008-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-8620
Type: Notice
Date: 2008-04-22
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: E8-8513
Type: Notice
Date: 2008-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-8453
Type: Notice
Date: 2008-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-8452
Type: Notice
Date: 2008-04-22
Agency: Department of Health and Human Services, National Institutes of Health
CDC/HRSA Advisory Committee on HIV and STD Prevention and Treatment
Document Number: E8-8475
Type: Notice
Date: 2008-04-21
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc), Centers for Disease Control and Prevention
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-8450
Type: Notice
Date: 2008-04-21
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-8444
Type: Notice
Date: 2008-04-21
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-8442
Type: Notice
Date: 2008-04-21
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: Technical Assistance for Health IT and Health Information Exchange in Medicaid and SCHIP. 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. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-8440
Type: Notice
Date: 2008-04-21
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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.
Designation of Medically Underserved Populations and Health Professional Shortage Areas
Document Number: 08-1167
Type: Proposed Rule
Date: 2008-04-21
Agency: Department of Health and Human Services
On February 29, 2008, HHS published a notice of proposed rulemaking, ``Designation of Medically Underserved Populations and Health Professional Shortage Areas'' (73 FR 11232), to revise and consolidate the criteria and processes for designating medically underserved populations (MUPs) and health professional shortage areas (HPSAs). HHS provided a 60-day public comment period, with written comments to be received on or before April 29, 2008. HHS and the Health Resources and Services Administration (HRSA) have received requests for an extension of the comment period. In consideration of these requests, HHS is extending the comment period an additional 30 days, with a new closing date of May 29, 2008.
Opportunity for Public Input on Standards for Pet Food and Other Animal Feeds; Notice of Meeting
Document Number: 08-1155
Type: Notice
Date: 2008-04-21
Agency: Food and Drug Administration, Department of Health and Human Services
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 http://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 http://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 http://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 http://www.regulations.gov.
Meeting to Present Changes to the Animal Feed Safety System Project and the Ranking of Feed Hazards According to the Risks They Pose to Animal and Public Health; Part 3: Swine Feed Example; Public Meeting
Document Number: 08-1154
Type: Notice
Date: 2008-04-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public meeting: ``Meeting to Present Changes to the Animal Feed Safety System (AFSS) Project and the Ranking of Feed Hazards According to the Risks They Pose to Animal and Public Health; Part 3: Swine Feed Example.'' We are holding the public meeting in an effort to gather further information from you, our stakeholders, on changes to AFSS that will help minimize risks to animal and human health associated with animal feed. The following topics will be discussed: The third draft of the AFSS Framework and work-in-progress on a method for ranking animal feed contaminants by their risks to animal and human health. 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 14, 2008, from 9 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 Metro Red Line to Shady Grove Station and board Ride-On bus 124 to Frederick Rd. at Perry Pkwy. Then, cross the roadway and walk approximately 1 [frac1s2] blocks north to building entrance.) Contact Person: For general information: Zoe Gill, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6867, FAX 240-453-6882, e- mail: zoe.gill@fda.hhs.gov. Registration: You may register by telephone, fax, or e-mail by contacting Nanette Milton, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6840, FAX 240-453-6880, e-mail: nanette.milton@fda.hhs.gov. Send registration information (including name, title, firm name, address, telephone, and fax number) to Nanette Milton. To obtain the registration form via the Web site, go to http://www.fda.gov/cvm/ AFSS.htm#Meetings. Due to limited meeting space, registration will be required. We strongly encourage early registration. Additionally, please notify Nanette Milton if you need any special accommodations (such as wheelchair access or a sign language interpreter) at least 7 days in advance of the meeting. Comments: Regardless of attendance at the public meeting, interested persons may submit written or electronic comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. 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. The docket will remain open for written or electronic comments for 30 days following the meeting. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug
Document Number: E8-8459
Type: Notice
Date: 2008-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Notice of Interest Rate on Overdue Debts
Document Number: E8-8374
Type: Notice
Date: 2008-04-18
Agency: Office of the Secretary, Department of Health and Human Services
Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting
Document Number: E8-8352
Type: Notice
Date: 2008-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting
Document Number: E8-8351
Type: Notice
Date: 2008-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance With Section 402(j) of the Public Health Service Act, Added by Title VIII of the Food and Drug Administration Amendments Act of 2007
Document Number: E8-8349
Type: Notice
Date: 2008-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or agency) is announcing the availability of a draft guidance for industry entitled ``Guidance for Sponsors, Industry, Researchers, Investigators, and FDA Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act (PHS Act), Added By Title VIII of The Food and Drug Administration Amendments Act of 2007.'' The draft guidance provides sponsors, industry, researchers, investigators, and FDA staff with the agency's views on some types of information and documents submitted to FDA that typically need not be accompanied by the certification described in section 402(j)(5)(B) of the PHS Act.
Implantation or Injectable Dosage Form New Animal Drugs; Insulin
Document Number: E8-8347
Type: Rule
Date: 2008-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol
Document Number: E8-8346
Type: Rule
Date: 2008-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for use of florfenicol injectable solution for the treatment of bovine respiratory disease.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-8344
Type: Notice
Date: 2008-04-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-8341
Type: Notice
Date: 2008-04-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-8340
Type: Notice
Date: 2008-04-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-8338
Type: Notice
Date: 2008-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-8229
Type: Notice
Date: 2008-04-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
National Institute on Aging; Notice of Meeting
Document Number: E8-8222
Type: Notice
Date: 2008-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Availability of Two Interaction Profiles [Draft Documents]
Document Number: E8-8167
Type: Notice
Date: 2008-04-18
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This notice announces the availability of two interaction profiles prepared by ATSDR for public comments [draft documents].