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

Results 51 - 100 of 3,398
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-24929
Type: Notice
Date: 2007-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop
Document Number: E7-24927
Type: Notice
Date: 2007-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in clinical trial design for community-acquired pneumonia. This public workshop is intended to provide information for and to gain perspective from health care providers, academia, and industry on various aspects of antimicrobial drug development for community-acquired pneumonia, including diagnosis of community-acquired pneumonia, effect of antimicrobial treatment for community-acquired pneumonia, endpoints for trials of community- acquired pneumonia, and statistical issues in analysis of results of trials in community-acquired pneumonia. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on January 17, 2008, from 8 a.m. to 6 p.m. and on January 18, 2008, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel, Kennedy Room, 8777 Georgia Ave., Silver Spring, MD 20910, 301- 589-0800. Seating is limited and available only on a first-come, first- served basis. Contact Person: Chris Moser or Lori Benner, Center for Drug Evaluation and Research, Office of Antimicrobial Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6413, Silver Spring, MD 20993-0002, 301-796-0767, or 301-796-0849. Registration: There is no registration fee for the public workshop. Space is limited; therefore, interested parties are encouraged to register early. Seating will be available on a first-come, first-served basis. To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax number) to CAPwkshp@fda.hhs.gov by January 9, 2008. Persons without access to the Internet can call 301-796-1300 to register. Persons needing a sign language interpreter or other special accommodations should notify Chris Moser or Lori Benner (see Contact Person) at least 7 days in advance.
Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction
Document Number: E7-24914
Type: Notice
Date: 2007-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 12, 2007 (72 FR 70599). The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995. The document was published with an error. This document corrects that error.
DSM Nutritional Products, Inc.; Filing of Color Additive Petition; Correction
Document Number: E7-24911
Type: Notice
Date: 2007-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of December 4, 2007 (72 FR 68166). The document announced that DSM Nutritional Products, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh.
Division of Loan Repayment; Proposed Collection; Comment Request; National Institutes of Health Loan Repayment Programs
Document Number: E7-24899
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
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, the Division of Loan Repayment, 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. Proposed Collection: Title: National Institutes of Health Loan Repayment Programs. Type of Information Collection Request: Revision of currently approved collection (OMB No. 0925-0361, expiration date 6/30/ 08). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674-4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674-14, NIH 2674-15, NIH 2674-16, NIH 2674-17, NIH 2674-18, and NIH 2674-19. Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., Ph.D., Pharm.D., D.D.S., D.M.D., D.P.M., D.C., and N.D. degree holders, or the equivalent, who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees for a minimum of 2 years (3 years for the General Research Loan Repayment Program (LRP)) in research areas supporting the mission and priorities of the NIH. The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized by Section 487A of the Public Health Service Act (42 U.S.C. 288-1); the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by Section 487E (42 U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is authorized by Section 487C (42 U.S.C. 288-3); the Loan Repayment Program Regarding Clinical Researchers (LRP-CR) is authorized by Section 487F (42 U.S.C. 288-5a); the Pediatric Research Loan Repayment Program (PR-LRP) is authorized by Section 487F (42 U.S.C. 288-6); the Extramural Clinical Research LRP for Individuals from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment to Section 487E (42 U.S.C. 288-5); the Contraception and Infertility Research LRP (CIR-LRP) is authorized by Section 487B (42 U.S.C. 288-2); and the Health Disparities Research Loan Repayment Program (HD-LRP) is authorized by Section 485G (42 U.S.C. 287c-33). The Loan Repayment Programs provide for the repayment of up to $35,000 a year of the principal and interest of the educational loan debt of qualified health professionals who agree to conduct qualifying research for each year of obligated service. The information proposed for collection will be used to determine an applicant's eligibility for participation in the program. Frequency of Response: Initial application and annual or biennial renewal application. Affected Public: Applicants, financial institutions, research institutions, recommenders. Type of Respondents: Physicians, other scientific or medical personnel, and organizational officials. The annual reporting burden is as follows:
National Institute of Dental & Craniofacial Research; Notice of Meetings
Document Number: 07-6171
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 07-6170
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 07-6169
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 07-6168
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 07-6167
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis And Musculoskeletal And Skin Diseases; Notice of Closed Meeting
Document Number: 07-6166
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 07-6165
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 07-6163
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 07-6162
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 07-6160
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 07-6159
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 07-6158
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
Document Number: 07-6157
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services
This notice announces the 22nd meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee act (Pub. L. 92-463, 5 U.S.C., App.)
Submission for OMB Review; Comment Request
Document Number: 07-6143
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 07-6141
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 07-6140
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 07-6139
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services, National Institutes of Health
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
Document Number: 07-6136
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services
This notice announces the 21st meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
Document Number: 07-6135
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services
This notice announces the 21st meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, and Security Workgroup Meeting
Document Number: 07-6134
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services
This notice announces the 16th meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
Document Number: 07-6133
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services
This notice announces the 22nd meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Personalized Healthcare Workgroup Meeting
Document Number: 07-6132
Type: Notice
Date: 2007-12-26
Agency: Department of Health and Human Services
This notice announces the 11th meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Statement of Organization, Functions, and Delegations of Authority
Document Number: 07-6130
Type: Notice
Date: 2007-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Collection; Comment Request; Cancer Care for Uninsured Individuals: A Feasibility Study (NCI)
Document Number: E7-24872
Type: Notice
Date: 2007-12-21
Agency: Department of Health and Human Services, National Institutes of Health
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, the National Cancer Institute (NCI) of 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E7-24824
Type: Notice
Date: 2007-12-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Health Claims and Qualified Health Claims; Dietary Lipids and Cancer, Soy Protein and Coronary Heart Disease, Antioxidant Vitamins and Certain Cancers, and Selenium and Certain Cancers; Reevaluation; Opportunity for Public Comment
Document Number: E7-24813
Type: Notice
Date: 2007-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on its intent to reevaluate the scientific evidence for two previously authorized health claims (dietary lipids (fat) and cancer; soy protein and risk of coronary heart disease) and two qualified health claims that were the subject of letters of enforcement discretion (antioxidant vitamins and risk of certain cancers; selenium and certain cancers). The agency is undertaking a reevaluation of the scientific basis for these authorized health claims and qualified health claims because of new scientific evidence that has emerged for these substance-disease relationships. The new scientific evidence may have the effect of weakening the substance-disease relationship for these authorized health claims and either strengthening or weakening the scientific support for the substance-disease relationship for these qualified health claims.
Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting
Document Number: E7-24812
Type: Notice
Date: 2007-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): Ten-Year Anniversary Symposium and Five-Year Plan
Document Number: E7-24799
Type: Notice
Date: 2007-12-21
Agency: Department of Health and Human Services
NICEATM invites attendance at a public symposium to mark the tenth anniversary of ICCVAM. The symposium, entitled ``Celebrating Ten Years of Advancing Public Health and Animal Welfare With Sound Science: Envisioning New Directions in Toxicology'' will be held February 5, 2008, at the U.S. Consumer Product Safety Commission (CPSC) Headquarters in Bethesda, MD. The NICEATM-ICCVAM Five-Year Plan (2008- 2012) will also be discussed and made available on February 5.
Privacy Act of 1974; Report of a New System of Records
Document Number: E7-24788
Type: Notice
Date: 2007-12-21
Agency: Department of Health and Human Services, Centers for Medicare & Medicaid Services
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Home and Community-Based Alternatives (CBA) to Psychiatric Residential Treatment Facilities (PRTF) Demonstration (CBA-PRTF), System No. 09-70-0594.'' The demonstration, created by section 6063 of the Deficit Reduction Act of 2005 (Pub. L. 109-171), allows up to 10 states (as defined for purposes of title XIX of the Social Security Act (the Act)) to provide home and community-based services to youth as alternatives to PRTFs. The purpose of the demonstration is to test the effectiveness in improving or maintaining a child's functional level and cost effectiveness of providing coverage of home and community-based alternatives to psychiatric residential treatment for children enrolled in the Medicaid program under title XIX of the Act. The purpose of this system is to collect and maintain individually identifiable information on Medicaid recipients, and providers of services who voluntarily participate in the national evaluation of the CBA-PRTF. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, or consultant; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicaid benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Privacy Act of 1974; Report of a New System of Records
Document Number: E7-24786
Type: Notice
Date: 2007-12-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Money Follows the Person (MFP) Demonstration (MFPD), System No. 09-70-0593.'' The demonstration, created by section 6071 of the Deficit Reduction Act of 2005 (Pub. L. 109-171), provides to states a total of $1.75 billion in competitive grants. MFP demonstration grants have been awarded to 30 states and the District of Columbia. The states and the District of Columbia are using the grant funding to transition Medicaid beneficiaries who need long-term care services from institutional-based care to community-based care. The purpose of the demonstration is to help states continue their efforts to restructure their long-term care systems and shift the historical emphasis from institutional care to community-based care. The demonstration is based on the premise that many Medicaid beneficiaries currently residing in institutions want to live in the community and could do so if they had the adequate support, and that it would cost less than Medicaid currently spends to care for institutional care. The purpose of this system is to collect and maintain individually identifiable information on Medicaid recipients, those who participate in the MFP demonstration and other comparable Medicaid recipients, and to collect and maintain program level information on grantee implementation of the MFP demonstration. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, or consultant; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicaid benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Government-Owned Inventions; Availability for Licensing
Document Number: E7-24784
Type: Notice
Date: 2007-12-21
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.
Announcement of Potential Eligibility for Compensation Under Public Readiness and Emergency Preparedness Act Declaration and Filing Deadlines
Document Number: 07-6180
Type: Notice
Date: 2007-12-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
This Notice provides notification that individuals who have been injured by pandemic, epidemic, or security countermeasures identified in a declaration issued by the Secretary pursuant to section 319F-3(b) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d- 6d) have one (1) year from the time they receive the covered countermeasure to file requests for compensation for injuries directly resulting from administration or use of covered countermeasures under the Public Readiness and Emergency Preparedness Act (PREP Act).
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-24704
Type: Notice
Date: 2007-12-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-24701
Type: Notice
Date: 2007-12-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Cancer Institute; Notice of Meeting
Document Number: 07-6104
Type: Notice
Date: 2007-12-20
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 07-6089
Type: Notice
Date: 2007-12-20
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 07-6087
Type: Notice
Date: 2007-12-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute On Drug Abuse; Notice of Closed Meeting
Document Number: 07-6086
Type: Notice
Date: 2007-12-20
Agency: Department of Health and Human Services, National Institutes of Health
National Advisory Council on Drug Abuse; Notice of Meeting
Document Number: 07-6085
Type: Notice
Date: 2007-12-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 07-6084
Type: Notice
Date: 2007-12-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 07-6083
Type: Notice
Date: 2007-12-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 07-6082
Type: Notice
Date: 2007-12-20
Agency: Department of Health and Human Services, National Institutes of Health
Office Of The Director, National Institutes Of Health; Notice of Meeting
Document Number: 07-6081
Type: Notice
Date: 2007-12-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Meeting
Document Number: 07-6080
Type: Notice
Date: 2007-12-20
Agency: Department of Health and Human Services, National Institutes of Health