Department of Health and Human Services October 2005 – Federal Register Recent Federal Regulation Documents

Meeting of the National Vaccine Advisory Committee
Document Number: 05-21611
Type: Notice
Date: 2005-10-31
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 05-21601
Type: Notice
Date: 2005-10-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 05-21596
Type: Notice
Date: 2005-10-31
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 05-21540
Type: Notice
Date: 2005-10-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 05-21539
Type: Notice
Date: 2005-10-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Prescription Drug User Fee Act; Public Meeting; Correction
Document Number: 05-21525
Type: Notice
Date: 2005-10-28
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 October 18, 2005 (70 FR 60536). The document announced a public meeting on the Prescription Drug User Fee Act (PDUFA). The document was published with typographical errors in the DATES and FOR FURTHER INFORMATION CONTACT sections of the document. This document corrects those errors.
Psychopharmacologic Drugs Advisory Committee; Notice of Meeting
Document Number: 05-21524
Type: Notice
Date: 2005-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
Administration for Children and Families
Document Number: 05-21523
Type: Notice
Date: 2005-10-28
Agency: Department of Health and Human Services, Children and Families Administration
The Administration for Children and Families (ACF) will be holding a one-day Tribal Consultation Session on December 6, 2005, at the Wyndham Hotel (California Grand Ball Room) in Palm Springs, California.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 05-21517
Type: Notice
Date: 2005-10-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-21516
Type: Notice
Date: 2005-10-28
Agency: Office of the Secretary, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-21515
Type: Notice
Date: 2005-10-28
Agency: Office of the Secretary, Department of Health and Human Services
Oncologic Drugs Advisory Committee; Amendment of Notice
Document Number: 05-21493
Type: Notice
Date: 2005-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
Medicare and Medicaid Programs; Requirements for Long Term Care Facilities; Nursing Services; Posting of Nurse Staffing Information
Document Number: 05-21278
Type: Rule
Date: 2005-10-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In this rule, we finalize provisions specified in the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) that establish new data collection, posting, and recordkeeping requirements for skilled nursing facilities (SNFs) and nursing facilities (NFs). It requires that on a daily basis for each shift, SNFs and NFs must post nurse staffing data for the licensed and unlicensed staff directly responsible for resident care in the facility. Facility census information must also be posted. This final rule is also part of a broader communication outreach initiative by CMS to provide beneficiaries, their families, and the public with access to updated data and other information that can assist them in making healthcare decisions.
Medicare Program; Meeting of the Practicing Physicians Advisory Council, December 5, 2005
Document Number: 05-20316
Type: Notice
Date: 2005-10-28
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 carrier manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: 05-21473
Type: Notice
Date: 2005-10-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Council of Healthcare Research and Quality.
Notice of Senior Executive Service Performance Review Board Membership
Document Number: 05-21472
Type: Notice
Date: 2005-10-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 05-21454
Type: Notice
Date: 2005-10-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Advisory Council for the Elimination of Tuberculosis
Document Number: 05-21433
Type: Notice
Date: 2005-10-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Environmental Health/Agency for Toxic Substances and Disease Registry
Document Number: 05-21432
Type: Notice
Date: 2005-10-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Environmental Health/Agency for Toxic Substances and Disease Registry
Document Number: 05-21431
Type: Notice
Date: 2005-10-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Collection; Comment Request; The NIDA Primary Care Physician Outreach Project
Document Number: 05-21416
Type: Notice
Date: 2005-10-27
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collection of information, the National Institute on Drug Abuse (NIDA), 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. Proposed Collection: Title: The NIDA Primary Care Physician Outreach Project Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a 4-year generic clearance to study the extent to which NIDA is (1) increasing awareness among primary care physicians and other medical professionals about drug addiction as a major public health issue, (2) increasing their awareness of NIDA and NIDA-funded research, and (3) providing them with the information resources needed to incorporate such research findings into their clinical practices. Primary care physicians and other medical professionals, especially those who care for adolescents, are front line individuals helping patients with drug abuse-or drug addiction-related health and mental health problems. Each has key roles in obtaining, disseminating, and applying drug abuse and addiction resource materials in clinical practice. This effort is made according to Executive Order 12862, which directs Federal agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. Formative, process, and outcome evaluations using a multi-method approach (surveys, focus, groups, case studies) will be employed to determine the most appropriate resources and also the usefulness of the materials developed for physicians and other medical professionals. Measures will include the following variables: the information needs and learning styles and preferences of physicians and other medical professionals; their knowledge/awareness of NIDA and the NIDA resources developed for physicians and other medical professionals; their attitudes toward NIDA and the NIDA resources developed for them; their use of the resources developed by NIDA; and ways to strengthen NIDA's knowledge dissemination activities. Frequency of Response: This project will be conducted annually or biennially. Affected Public: Individuals, organizations, and businesses. Type of Respondents: physicians, physician assistants, nurses, medical office managers, hospital/clinic based health educators, and hospital/clinic based social workers. The reporting burden is as follows: Estimated Total Annual Number of Respondents: 1118; Estimated Number of Responses per Respondent: 2; Average Burden Hours per Response: 0.39. Estimated Total Annual Burden Hours Requested: 872.24. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 05-21415
Type: Notice
Date: 2005-10-27
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 05-21414
Type: Notice
Date: 2005-10-27
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 05-21413
Type: Notice
Date: 2005-10-27
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 05-21412
Type: Notice
Date: 2005-10-27
Agency: Department of Health and Human Services, National Institutes of Health
Assistant Secretary for Planning & Evaluation; Medicaid Program; Announcement of the Appointment of New Individuals To Serve on the Medicaid Commission
Document Number: 05-21411
Type: Notice
Date: 2005-10-27
Agency: Department of Health and Human Services
This notice announces the appointment of three new individuals to serve on the Medicaid Commission and the release of one Commissioner from service on the Medicaid Commission. Notice of this announcement is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 2(b)(5)). The Medicaid Commission will advise the Secretary on ways to modernize the Medicaid program so that it can provide high- quality health care to its beneficiaries in a financially sustainable way. New Medicaid Commission Voting Members: John Ellis ``Jeb'' Bush, Joe Manchin III, and Donald Young. Medicaid Commission Member Released from Service on the Medicaid Commission: Michael O'Grady.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-21356
Type: Notice
Date: 2005-10-26
Agency: Office of the Secretary, Department of Health and Human Services
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 05-21350
Type: Notice
Date: 2005-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Cystic Fibrosis Transmembrane Conductance Regulator Gene Mutation Detection Systems; Availability
Document Number: 05-21349
Type: Notice
Date: 2005-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems.'' This guidance document describes a means by which cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection systems may comply with the requirements of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify CFTR gene mutation detection systems into class II (special controls). This guidance document is immediately in effect as the special control for CFTR gene mutation detection systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; Immunology and Microbiology Devices; Classification of Cystic Fibrosis Transmembrane Conductance Regulator Gene Mutation Detection System
Document Number: 05-21348
Type: Rule
Date: 2005-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection systems into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the device.
Guidance for Industry on Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing; Availability
Document Number: 05-21347
Type: Notice
Date: 2005-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing.'' This guidance document provides recommendations to sponsors of abbreviated new drug applications (ANDAs) on the design of bioequivalence studies for modified-release dosage forms of potassium chloride.
Supplemental Financial Disclosure Requirements for Employees of the Department of Health and Human Services; Corrections
Document Number: 05-21343
Type: Rule
Date: 2005-10-26
Agency: Department of Health and Human Services
The Department of Health and Human Services published a final rule in the Federal Register on Wednesday, August 31, 2005 (70 FR 51559), establishing supplemental financial disclosure reporting requirements for certain employees of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). That document contained language that incorrectly rendered the supplemental reporting requirements inapplicable to new entrant employees who file either a public or confidential financial disclosure report. This document corrects the final regulation by revising the appropriate sections.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel; Meeting
Document Number: 05-21341
Type: Notice
Date: 2005-10-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Childhood Lead Poisoning Prevention
Document Number: 05-21259
Type: Notice
Date: 2005-10-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Department of Health and Human Services, CDC published a document in the Federal Register of September 20, 2005, concerning the ACCLPP. Correction: In the Federal Register of September 20, 2005, (Volume 70, Number 1811) [Notices] Page 55132 ``Place: The Hubert Humphrey Federal Building, 200 Independence Avenue, Washington, DC 20021'' Should read: 330 Independence Avenue, Room 5051, Snow Room Cohen Building, Washington, DC 20201. Telephone: 202-619-0814. Contact Person For More Information: Claudine Johnson, Lead Poisoning Prevention Branch, Division of Emergency and Environmental Health Services, NCEH, CDC, 4770 Buford Hwy, NE., M/S F-40, Atlanta, Georgia 30341. Telephone: (770) 488-3300, fax: (770) 488-3635. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry.
Availability of Draft Toxicological Profiles
Document Number: 05-21254
Type: Notice
Date: 2005-10-25
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 19th set of toxicological profiles, which consists of one new draft and seven updated drafts, prepared by ATSDR for review and comment.
Office of the Assistant Secretary for Public Affairs; Statement of Organization, Functions and Delegations of Authority
Document Number: 05-21249
Type: Notice
Date: 2005-10-25
Agency: Office of the Secretary, Department of Health and Human Services
Advisory Committee on Infant Mortality; Notice of Meeting
Document Number: 05-21245
Type: Notice
Date: 2005-10-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
Advisory Committee on Organ Transplantation; Notice of Meeting
Document Number: 05-21244
Type: Notice
Date: 2005-10-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration published a notice in the Federal Register of September 29, 2005 (70 FR 56926- 56927) announcing an Advisory Committee on Organ Transplantation meeting on November 3-4 2005. The notice is being amended to change type of meeting, place, dates, and time.
National Advisory Council on Nurse Education and Practice; Notice of Meeting
Document Number: 05-21243
Type: Notice
Date: 2005-10-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science; Notice of Meeting
Document Number: 05-21241
Type: Notice
Date: 2005-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and Drug Administration Rapid Response Surveys
Document Number: 05-21240
Type: Notice
Date: 2005-10-25
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 use of rapid response surveys to obtain data on safety information to support quick- turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals and other user-facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.
National Center for Environmental Health/Agency for Toxic Substances and Disease Registry
Document Number: 05-21175
Type: Notice
Date: 2005-10-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 05-21163
Type: Notice
Date: 2005-10-24
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Delegation of Authority
Document Number: 05-21162
Type: Notice
Date: 2005-10-24
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices
Document Number: 05-21158
Type: Notice
Date: 2005-10-24
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; 2005 Food Safety Survey
Document Number: 05-21157
Type: Notice
Date: 2005-10-24
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 ``2005 Food Safety Survey'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
Document Number: 05-21156
Type: Notice
Date: 2005-10-24
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, 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 information collection contained in the guidance for industry on formal dispute resolution for appeals above the division level.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Food Contact Substances Notification
Document Number: 05-21155
Type: Notice
Date: 2005-10-24
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; Submission for Office of Management and Budget Review; Comment Request; Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
Document Number: 05-21154
Type: Notice
Date: 2005-10-24
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).