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

Results 351 - 400 of 3,343
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representative on Public Advisory Committees and Request for Nominations for Nonvoting Industry Representative on Public Advisory Committees
Document Number: E8-26963
Type: Notice
Date: 2008-11-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CBER's public advisory committees. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for upcoming vacancies effective with this notice.
Grants Awarded: Program Titles and Funding Opportunity Announcements for Fiscal Year 2009
Document Number: E8-26889
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Administration for Children and Families (ACF) hereby gives notice to the public that certain programs within the Agency will administratively impose a matching requirement on grants awarded under the following program titles and funding opportunity announcements for Fiscal Year 2009:
Notice of a Safety Symposium Sponsored by the NIH Recombinant DNA Advisory Committee (RAC) and the Intragovernmental Select Agent and Toxin Technical Advisory Committee (ISATTAC)
Document Number: E8-26886
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health, Office of the Director, Office of Biotechnology Activities, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-26881
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health
Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans; Availability
Document Number: E8-26869
Type: Notice
Date: 2008-11-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans.'' The interim safety/risk assessment evaluated exposure to melamine and its analogues (cyanuric acid, ammelide and ammeline) in infant formula and other foods to identify, where possible, a level of exposure that would not raise public health concerns. FDA is seeking public comment on the interim safety/risk assessment.
National Library of Medicine; Notice of Meetings
Document Number: E8-26791
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health
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
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff; “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300”
Document Number: E8-26828
Type: Notice
Date: 2008-11-10
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 (the PRA).
Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex
Document Number: E8-26825
Type: Rule
Date: 2008-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.'' The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document no later than the effective date of this final rule.
Privacy Act of 1974; New OIG Privacy Act System of Records: Consolidated Data Repository
Document Number: E8-26725
Type: Notice
Date: 2008-11-10
Agency: Department of Health and Human Services, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
The Privacy Act of 1974 (5 U.S.C. 552(e)(4)) requires that all agencies publish in the Federal Register a notice of the existence and character of their system of records. Notice is hereby given that OIG is adding a new system of records entitled ``Consolidated Data RepositoryHHS-OIG'' (09-90-1000).
Determination of Regulatory Review Period for Purposes of Patent Extension; TYKERB
Document Number: E8-26679
Type: Notice
Date: 2008-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for TYKERB and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; IXEMPRA
Document Number: E8-26678
Type: Notice
Date: 2008-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for IXEMPRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: E8-26638
Type: Notice
Date: 2008-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: E8-26637
Type: Notice
Date: 2008-11-10
Agency: Department of Health and Human Services, National Institutes of Health
The Statement of Organization, Functions, and Delegations of Authority
Document Number: E8-26635
Type: Notice
Date: 2008-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; California Health Interview Survey Cancer Control Module (CHIS-CCM) 2009 (NCI)
Document Number: E8-26633
Type: Notice
Date: 2008-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 22, 2008 (Volume 73, No. 164, p. 49685) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: California Health Interview Survey Cancer Control Module (CHIS-CCM) 2009. Type of Information Collection Request: New. Need and Use of Information Collection: The NCI has sponsored four Cancer Control Modules in the California Health Interview Survey (CHIS), and will be sponsoring a fifth to be administered in 2009. CHIS is a telephone survey that collects population-based, standardized health-related data to assess California's progress in meeting Healthy People 2010 objectives for the nation and the state. The CHIS sample is designed to provide statistically reliable estimates statewide, for California counties, and for California's ethnically and racially diverse population. Initiated by the UCLA Center for Health Policy Research, the California Department of Health Services, and the California Public Health Institute, the survey is funded by a number of public and private sources. It was first administered in 2001 to 55,428 adults and subsequently in 2003 to 42,043 adults, in 2005 to 43,020 adults, and in 2007 to 48,150 adults. These adults are a representative sample of California's non-institutionalized population living in households. CHIS 2009, the fifth bi-annual survey, is planned for administration to 55,000 adult Californians. This study will allow NCI to examine patterns and trends in cancer screening and follow-up, as well as to study other cancer-related topics such as tobacco control, diet, physical activity, and obesity. Additionally, CHIS is designed to be comparable to the National Health Interview Survey (NHIS) data in order to conduct comparative analyses. CHIS provides enhanced estimates for cancer risk factors and screening among racial/ethnic minority populations. Frequency of Response: Once. Affected public: Individuals or households. Types of Respondents: U.S. adults and adolescents (persons 12 years of age and older). The total annual burden hours requested are 3,436.93 (see Table A). The annualized cost to respondents is estimated at: $57,825. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-26646
Type: Notice
Date: 2008-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-26644
Type: Notice
Date: 2008-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicaid Program; Clarification of Outpatient Hospital Facility (Including Outpatient Hospital Clinic) Services Definition
Document Number: E8-26554
Type: Rule
Date: 2008-11-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Outpatient hospital services are a mandatory part of the standard Medicaid benefit package. This final rule aligns the Medicaid definition of outpatient hospital services more closely to the Medicare definition in order to: Improve the functionality of the applicable upper payment limits (which are based on a comparison to Medicare payments for the same services), provide more transparency in determining available hospital coverage in any State, and generally clarify the scope of services for which Federal financial participation (FFP) is available under the outpatient hospital services benefit category.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: E8-26436
Type: Notice
Date: 2008-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E8-26435
Type: Notice
Date: 2008-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: E8-26434
Type: Notice
Date: 2008-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: E8-26331
Type: Notice
Date: 2008-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: E8-26330
Type: Notice
Date: 2008-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Document Number: E8-26282
Type: Rule
Date: 2008-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which required prior notification of imported food to begin on December 12, 2003. The final rule requires that the prior notice be submitted to FDA electronically via either the U.S. Customs and Border Protection (CBP or Customs) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PNSI). The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft compliance policy guide (CPG) entitled ``Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.''
Draft Compliance Policy Guide; “Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002;” Availability
Document Number: E8-26281
Type: Notice
Date: 2008-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft Compliance Policy Guide (CPG) entitled ``Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' The draft CPG provides written guidance to FDA's and Customs and Border Protection's (CBP's) staff on enforcement of section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulations, which require prior notice for food imported or offered for import into the United States. The final rule entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' is published elsewhere in this issue of the Federal Register.
Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing
Document Number: E8-26528
Type: Notice
Date: 2008-11-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on adding additional diseases to the list of tropical diseases recognized under the Food and Drug Administration Amendments Act (FDAAA), which adds a new section to the Federal Food, Drug, and Cosmetic Act (the act). The new section authorizes FDA to award priority review vouchers to sponsors of certain tropical disease product applications that meet the criteria specified by the act. The new section lists diseases considered to be ``tropical diseases'' for the purposes of this legislation, and provides for expansion of the list to include diseases meeting certain criteria. This public meeting is being held to obtain comments from the public on the criteria that should be used to determine whether an infectious disease should be added to the list, and to elicit suggestions for adding specific diseases.
Proposed Information Collection Activity; Comment Request
Document Number: E8-26519
Type: Notice
Date: 2008-11-06
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Availability of Draft Toxicological Profiles
Document Number: E8-26472
Type: Notice
Date: 2008-11-06
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)], directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 22nd set of toxicological profiles, which consists of four updated drafts prepared by ATSDR for review and comment. The toxicological profiles for formaldehyde and perfluoroalkyls are on a modified schedule pending additional review.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-26471
Type: Notice
Date: 2008-11-06
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: E8-26433
Type: Notice
Date: 2008-11-06
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: E8-26432
Type: Notice
Date: 2008-11-06
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-26429
Type: Notice
Date: 2008-11-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services