Department of Health and Human Services November 12, 2008 – Federal Register Recent Federal Regulation Documents

Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
Document Number: E8-26868
Type: Rule
Date: 2008-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, September 29, 2008 (73 FR 56477). The final rule was published with an inadvertent error in the ``Analysis of Economic Impacts'' section. This document corrects that error.
Maximum Civil Money Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act
Document Number: E8-26866
Type: Rule
Date: 2008-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a new regulation to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within our jurisdiction. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended. The last adjustment was published in the Federal Register of July 20, 2004 (69 FR 43299), and the FCPIAA requires Federal agencies to adjust their civil money penalties at least once every 4 years. This rule does not adjust the civil money provisions enacted by the Food and Drug Administration Amendments Act of 2007 (FDAAA). We are using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. In the proposed rule section of this issue of the Federal Register, we are concurrently proposing and soliciting comments on this rule. If significant adverse comments are received, we will withdraw this final rule and address the comments in a subsequent final rule. FDA will not provide additional opportunity for comment.
Maximum Civil Money Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act
Document Number: E8-26864
Type: Proposed Rule
Date: 2008-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend our regulations to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within our jurisdiction. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended. The last adjustment was published in the Federal Register of July 20, 2004 (69 FR 43299), and the FCPIAA requires Federal agencies to adjust their civil money penalties at least once every 4 years. This proposed rule does not adjust the civil money provisions enacted by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
Document Number: E8-26863
Type: Notice
Date: 2008-11-12
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: Proposed Collection: Comment Request
Document Number: E8-26816
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
Board of Scientific Counselors, National Center for Health Marketing (BSC, NCHM)
Document Number: E8-26803
Type: Notice
Date: 2008-11-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Injury Prevention and Control, Initial Review Group, (NCIPC, IRG)
Document Number: E8-26801
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc), Centers for Disease Control and Prevention
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-26796
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Board of Scientific Counselors, Coordinating Center for Infectious Diseases (CCID)
Document Number: E8-26795
Type: Notice
Date: 2008-11-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: E8-26794
Type: Notice
Date: 2008-11-12
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.
Notice of Approval of Original Abbreviated New Animal Drug Application; Phenylbutazone Tablets
Document Number: E8-26793
Type: Notice
Date: 2008-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice that it has approved an original abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for veterinary prescription use of phenylbutazone tablets in horses for the relief of inflammatory conditions associated with the musculoskeletal system.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-26790
Type: Notice
Date: 2008-11-12
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: E8-26789
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive License: Non-Invasive Diabetes Diagnostics
Document Number: E8-26788
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), a federal agency under the Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in HHS Ref. Nos. E-091-1998 ``Method For Non- Invasive Identification Of Individuals At Risk For Diabetes;'' U.S. Patent No. 6,721,583; and HHS Ref. No. E-079-1998 ``Optical Fiber Probe and Methods for Measuring Optical Properties;'' U.S. Patent No. 6,678,541; to Eyelight Diagnostics, Inc., a corporation formed under the laws of the state of Connecticut and having a principle place of business therein. The United States of America is the assignee of the patent rights in the above inventions. The contemplated exclusive license may be granted in a field of use limited to devices and integrated systems for non-invasive ocular clinical diagnostics for diabetes.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-26787
Type: Notice
Date: 2008-11-12
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.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-26786
Type: Notice
Date: 2008-11-12
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 Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: E8-26779
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-26684
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, National Institutes of Health