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

Results 51 - 100 of 332
Submission for OMB Review; Comment Request
Document Number: E8-25419
Type: Notice
Date: 2008-10-27
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Eye Institute; Notice of Closed Meetings
Document Number: E8-25357
Type: Notice
Date: 2008-10-27
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey to Evaluate the Effectiveness of Mississippi Delta Fish Advisories
Document Number: E8-25472
Type: Notice
Date: 2008-10-24
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 the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a voluntary consumer survey of fishing and fish consumption habits in the Mississippi Delta.
Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Final Rule; Correction
Document Number: E8-25471
Type: Rule
Date: 2008-10-24
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 8, 2008 (73 FR 51919). The final rule was published with an inadvertent error in the ``Analysis of Impacts'' section. This document corrects that error.
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting
Document Number: E8-25470
Type: Notice
Date: 2008-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC); Notice of Meeting
Document Number: E8-25449
Type: Notice
Date: 2008-10-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-25423
Type: Notice
Date: 2008-10-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Request. 60-Day Public Comment Request, Grants
Document Number: E8-25391
Type: Notice
Date: 2008-10-24
Agency: Department of Health and Human Services
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
Document Number: E8-25389
Type: Notice
Date: 2008-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E8-25364
Type: Notice
Date: 2008-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E8-25363
Type: Notice
Date: 2008-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E8-25360
Type: Notice
Date: 2008-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Opportunity for Hearing on a Proposal to Withdraw Approval of Prescription Polyethylene Glycol 3350 Abbreviated New Drug Applications
Document Number: E8-25359
Type: Notice
Date: 2008-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to withdraw approval of the following abbreviated new drug applications (ANDAs) for drug products containing polyethylene glycol 3350 (PEG 3350) labeled for prescription only use: ANDA 76-652 held by Schwarz Pharma, Inc.; ANDA 77-736 held by Kali Laboratories, Inc.; ANDA 77-706 held by Nexgen Pharma Inc. (formerly known as Anabolic Laboratories, Inc.); ANDA 77-893 held by Coastal Pharmaceuticals, Inc.; and ANDA 77- 445 held by Teva Pharmaceutical Industries, Ltd. (collectively, the PEG 3350 ANDAs). The proposal is based on the switch of MiraLax from prescription only (``Rx only'') to over-the-counter (OTC) use. This switch was pursuant to the submission of a new drug application (NDA) for MiraLax (NDA 22-015), which was approved by the agency on October 6, 2006, establishing that PEG 3350 may be used safely and effectively without the supervision of a licensed healthcare professional. The Federal Food, Drug, and Cosmetic Act (the act) does not permit both Rx and OTC versions of the same drug product to be marketed at the same time. Under the act, a drug to which the prescription provisions of the act do not apply (i.e., an OTC drug) shall be deemed to be misbranded if at any time prior to dispensing the label of the product bears the ``Rx only'' symbol. Because the PEG 3350 generic drug products are labeled as Rx only, they are misbranded and may not be legally marketed. Thus, FDA is proposing to withdraw their approval.
Proposed Collection; Comment Request; Simulations for Drug Related Science Education
Document Number: E8-25356
Type: Notice
Date: 2008-10-24
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 Institute on Drug Abuse (NIDA), 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 June 26, 2008, (Vol. 73 No. 124, page 36337) 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 November 15, 2008, unless it displays a currently valid OMB control number. Proposed Collection: Title: Simulations for Drug Related Science Education. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to evaluate an interactive multimedia module developed by ArchieMD. This evaluation seeks to determine whether the multimedia module ArchieMD: The Science of Drugs (1) Increases students' knowledge in brain and heart biology and the effects drugs have on the body (2) Increases positive attitudes towards science education for high school students (3) Reinforces or instills negative attitudes towards substance abuse. In order to test the effectiveness of the interactive multimedia module, data will be collected in the form of pre and post test surveys from 10th and 11th grade high school students utilizing the developed module. The findings will provide valuable information regarding information pertaining to the use of interactive multimedia educational modules in high school science classrooms and their ability to increase knowledge and change attitudes and perceptions. Frequency of Response: 4. Affected Public: High school students engaged with the ArchieMD: The Science of Drugs program. Type of Respondent: Participants will include high school students enrolled in the tenth and eleventh grade. Estimated Total Annual Number of Respondents: 360. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: One high school period lasting 50 minutes. Estimated Total Annual Burden Hours Requested: 1,199.95. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-25355
Type: Notice
Date: 2008-10-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: E8-25233
Type: Notice
Date: 2008-10-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: E8-25232
Type: Notice
Date: 2008-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-25228
Type: Notice
Date: 2008-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-25206
Type: Notice
Date: 2008-10-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-25204
Type: Notice
Date: 2008-10-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Medicare Program; Application by the American Association of Diabetes Educators (AADE) for Recognition as a National Accreditation Organization for Accrediting Entities To Furnish Outpatient Diabetes Self-Management Training
Document Number: E8-25195
Type: Notice
Date: 2008-10-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice announces the receipt of an application from the American Association of Diabetes Educators (AADE) for recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training to Medicare beneficiaries. The statute requires that the Secretary publish a notice identifying the national accreditation body making the request, describing the nature of the request, and providing at least a 30-day public comment period.
Medicare and Medicaid Programs; Conditional Approval of the Joint Commission's Continued Deeming Authority for Critical Access Hospitals
Document Number: E8-25193
Type: Notice
Date: 2008-10-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces our decision to conditionally approve, with a probationary period, the Joint Commission's request for continued recognition as a national accreditation program for critical access hospitals (CAHs) seeking to participate in the Medicare or Medicaid programs.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-25044
Type: Notice
Date: 2008-10-24
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: ``The AHRQ Data Inventory.'' 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.
Medicare Program; Plan To Transition to a Medicare Value-Based Purchasing Program for Physician and Other Professional Services: Listening Session, December 9, 2008
Document Number: E8-24900
Type: Notice
Date: 2008-10-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a listening session being conducted as part of the development of a plan for the transition to a value-based purchasing program for physician and other professional services as required by section 131(d) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The purpose of the listening session is to solicit comments on an issues paper that will present the range of issues being considered for plan development. Physicians, physician associations, and all others interested in the pursuit of new payment approaches to enhance the quality and efficiency of physician and other professional services are invited to participate, in person or by calling in to the teleconference. The issues paper will be posted on the CMS Web site Physician Center Spotlights at http://www.cms.hhs.gov/ center/physician.asp no later than November 28, 2008. The issues identified and discussed during this meeting will assist us in developing options for the plan. The meeting is open to the public, but attendance is limited to space and teleconference lines available.
Medicare Program; Meeting of the Practicing Physicians Advisory Council, December 8, 2008
Document Number: E8-24898
Type: Notice
Date: 2008-10-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services. This meeting is open to the public.
Substances Prohibited From Use in Animal Food or Feed; Correction
Document Number: E8-25346
Type: Rule
Date: 2008-10-23
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 April 25, 2008 (73 FR 22720). The document amended the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to further strengthen existing safeguards against bovine spongiform encephalopathy (BSE). The document was inadvertently published with incorrect dollar amounts in two separate areas: The summary of economic impacts and the paperwork burden table. This document corrects those errors.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing
Document Number: E8-25338
Type: Notice
Date: 2008-10-23
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; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
Document Number: E8-25336
Type: Notice
Date: 2008-10-23
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 the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the record retention requirement of the soy protein/coronary heart disease health claim.
Submission for OMB Review; Comment Request
Document Number: E8-25285
Type: Notice
Date: 2008-10-23
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of the Biennial Progress Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): NIH Publication No. 08-6529
Document Number: E8-25223
Type: Notice
Date: 2008-10-23
Agency: Department of Health and Human Services
NICEATM announces the availability of the ``Biennial Progress Report: Interagency Coordinating Committee on the Validation of Alternative Methods: 2006-2007.'' In accordance with requirements of the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3), this report describes progress and activities during 2006-2007 by ICCVAM and NICEATM. The report is available on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/about/ICCVAMrpts.htm. Copies can also be requested from NICEATM at the address given below.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-25222
Type: Notice
Date: 2008-10-23
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: E8-25221
Type: Notice
Date: 2008-10-23
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: E8-25220
Type: Notice
Date: 2008-10-23
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: E8-25219
Type: Notice
Date: 2008-10-23
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 Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: E8-25216
Type: Notice
Date: 2008-10-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-25215
Type: Notice
Date: 2008-10-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-25212
Type: Notice
Date: 2008-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Data Collection Using MedWatchPlus
Document Number: E8-25211
Type: Notice
Date: 2008-10-23
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 the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of MedWatch\Plus\ Portal and Rational Questionnaire to collect electronically all adverse event, consumer complaint/product problem and medication use error data submitted to FDA.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-25210
Type: Notice
Date: 2008-10-23
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.
Final Guidance on Engagement of Institutions in Human Subjects Research
Document Number: E8-25177
Type: Notice
Date: 2008-10-23
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a guidance document entitled, ``OHRP Guidance on Engagement of Institutions in Human Subjects Research.'' The guidance document describes: (1) Scenarios that, in general, would result in an institution being considered engaged in a human subjects research project; (2) scenarios that would result in an institution being considered not engaged in a human subjects research project; and (3) IRB review considerations for cooperative research in which multiple institutions are engaged in the same non-exempt human subjects research project. The guidance document is intended primarily for institutional review boards (IRBs), research administrators and other relevant institutional officials, investigators, and funding agencies that may be responsible for the conduct, review and oversight of human subject research that is conducted or supported by the Department of Health and Human Services (HHS). The guidance document announced in this notice finalizes the draft guidance with the same title that was made available for public comment in the Federal Register on December 8, 2006 (71 FR 71169). OHRP received twenty-four comments on the draft guidance document, and those comments were considered as the guidance was finalized. The final guidance document replaces two existing OHRP guidance documents on the engagement of institutions in human subjects research: (1) The January 26, 1999, document on ``Engagement of Institutions in Research,'' and (2) the December 23, 1999, document on ``Engagement of Pharmaceutical Companies in HHS Supported Research.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-25201
Type: Notice
Date: 2008-10-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Notice of Hearing: Reconsideration of Disapproval of Arkansas State Plan Amendment (SPA) 07-024
Document Number: E8-25196
Type: Notice
Date: 2008-10-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Department of Health and Human Services (hhs)
This notice announces an administrative hearing to be held on December 9, 2008, at the CMS Dallas Regional Office, 1301 Young Street, Suite 833, Room 1196, Dallas, Texas 75202, to reconsider CMS' decision to disapprove Arkansas SPA 07-024.
Board of Scientific Counselors, National Center for Public Health Informatics, (BSC, NCPHI)
Document Number: E8-25131
Type: Notice
Date: 2008-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
CDC/Health Resources and Services Administration (HRSA) Advisory Committee on HIV and STD Prevention and Treatment
Document Number: E8-25129
Type: Notice
Date: 2008-10-22
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc), Centers for Disease Control and Prevention
Ethics Subcommittee, Advisory Committee to the Director, Centers for Disease Control and Prevention (CDC)
Document Number: E8-25126
Type: Notice
Date: 2008-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Interagency Committee on Smoking and Health (ICSH)
Document Number: E8-25122
Type: Notice
Date: 2008-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: E8-25109
Type: Notice
Date: 2008-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: E8-25038
Type: Notice
Date: 2008-10-22
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration