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

Results 151 - 200 of 275
Submission for OMB Review; Comment Request
Document Number: E8-5063
Type: Notice
Date: 2008-03-17
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: E8-5061
Type: Notice
Date: 2008-03-17
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Notice of Annual Meeting
Document Number: E8-5137
Type: Notice
Date: 2008-03-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice Regarding Revisions to the Laboratory Protocol To Measure the Quantity of Nicotine Contained in Smokeless Tobacco Products Manufactured, Imported, or Packaged in the United States
Document Number: E8-5136
Type: Notice
Date: 2008-03-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This notice amends the uniform protocol for the analysis of nicotine, total moisture, and pH in smokeless tobacco products (the ``protocol''). The protocol, originally published in 1999 [Federal Register, Vol. 64, No. 55, `` Annual Submission of the Quantity of Nicotine Contained in Smokeless tobacco products manufactured, imported, or packaged in the United States Requirement; Notice,'' 14085-14096 (FR Doc. 99-7022)], implements the requirement of the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) of 1986 (15 U.S.C. 4401 et seq., Pub. L. 99-252) that each entity manufacturing, packaging, or importing smokeless tobacco products shall annually provide the Secretary of Health and Human Services (HHS) with a specification of the quantity of nicotine contained in each smokeless tobacco product.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-5071
Type: Notice
Date: 2008-03-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-5069
Type: Notice
Date: 2008-03-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Customer Satisfaction Survey
Document Number: E8-5037
Type: Notice
Date: 2008-03-14
Agency: Department of Health and Human Services, Indian Health Service
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection project was previously published in the Federal Register (72 FR 69696) on December 10, 2007 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-NEW, ``Indian Health Service Customer Satisfaction Survey.'' Type of Information Collection Request: Three year approval of this new information collection, 0917-NEW, ``Indian Health Service Customer Satisfaction Survey.'' Form(s): Tribal Homeowner Survey, Tribal Partner Survey, Annual Operator Operation and Maintenance (O&M) Survey, and Post Construction O&M Survey. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission, the Sanitation Facilities Construction Program (SFCP) provides technical and financial assistance to American Indian Tribes and Alaska Native villages for cooperative development and continues operation of safe water, wastewater, and solid waste systems and related support facilities. The Indian Health Service Office of Environmental Health and Engineering (OEHE), SFCP, ``Customer Satisfaction Surveys,'' will provide the information needed to complete these goals. With the information collected from Tribal homeowners, Tribal leaders, and Tribal operation and maintenance operators the Sanitation facilities programs will make improvements that will result in improved quality of services. Voluntary customer satisfaction surveys will be conducted through phone calls, mail, and the Internet. The information gathered will be used by agency management and staff to identify strengths and weaknesses in current service provision, to plan and redirect resources, to make improvements that are practical and feasible, and to provide vital feedback to partner agencies, Tribal leaders, system operators, health boards, and community members regarding customer satisfaction or dissatisfaction with the SFCP. Affected Public: Individuals. Type of Respondents: Homeowners who are customers of the OEHE, SFCP. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-4935
Type: Notice
Date: 2008-03-14
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: ``Evaluation of the Effectiveness of AHRQ's Grant-Supported Research on Healthcare Costs, Productivity, and Market Forces.'' 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. This proposed information collection was previously published in the Federal Register on December 28th, 2007 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.
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-4934
Type: Notice
Date: 2008-03-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-4931
Type: Notice
Date: 2008-03-14
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: E8-4930
Type: Notice
Date: 2008-03-14
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-4928
Type: Notice
Date: 2008-03-14
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: ``Focus Groups on Consumer Engagement in Developing Electronic Health Information Systems.'' 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. This proposed information collection was previously published in the Federal Register on December 28th, 2007 and allowed 60 days for public comment. Comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-4927
Type: Notice
Date: 2008-03-14
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: E8-4924
Type: Notice
Date: 2008-03-14
Agency: Department of Health and Human Services, National Institutes of Health
Medicaid Program; Multiple Source Drug Definition
Document Number: 08-1022
Type: Rule
Date: 2008-03-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On July 17, 2007, we published a final rule with comment period in the Federal Register that implemented provisions of the Deficit Reduction Act of 2005 pertaining to prescription drugs under the Medicaid program. In that rule, we finalized certain provisions of the Medicaid drug rebate program, including definitions concerning average manufacturer price, best price, single source drug, and multiple source drug. In this interim final rule with comment period, we are revising the definition of ``multiple source drug'' to better conform with the statutory provisions. This interim final rule with comment period solicits additional public comment on the revised definition of ``multiple source drug.''
Draft Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims; Availability
Document Number: E8-5083
Type: Notice
Date: 2008-03-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This draft guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. Because blood pressure control is well established as beneficial in preventing serious cardiovascular events, FDA believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling. This draft guidance is intended to recommend standard labeling for antihypertensive drugs except where differences are clearly supported by clinical data.
Privacy Act of 1974; Revision to Existing System of Records; Revised
Document Number: E8-5056
Type: Notice
Date: 2008-03-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records for the C.W. Bill Young Cell Transplantation Program. This system of records is required to comply with the implementation directives of Public Law 109-129. Records are used for the C.W. Bill Young Cell Transplantation Program's planning, implementation, evaluation, monitoring, and document storage purposes. HRSA published in the Federal Register of August 17, 2007, a document concerning notice of a new system of records, 09-15-0068, C.W. Bill Young Cell Transplantation Program (FR. Doc. 07-4019). This document more fully explains the routine uses of records maintained in the system and amends the record retention and disposal policy. Accordingly, the notice is published below in its entirety, as amended.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: E8-4923
Type: Notice
Date: 2008-03-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: E8-4809
Type: Notice
Date: 2008-03-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: E8-4808
Type: Notice
Date: 2008-03-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: E8-4807
Type: Notice
Date: 2008-03-13
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: E8-4805
Type: Notice
Date: 2008-03-13
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request Title: Children's Justice Act Program.
Document Number: E8-4804
Type: Notice
Date: 2008-03-13
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Biodefense Science Board; Notification of a Public Teleconference
Document Number: E8-4947
Type: Notice
Date: 2008-03-12
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public teleconference. The meeting is open to the public.
National Center for Injury Prevention and Control/Initial Review Group, (NCIPC/IRG)
Document Number: E8-4945
Type: Notice
Date: 2008-03-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies
Document Number: E8-4903
Type: Notice
Date: 2008-03-12
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 good laboratory practice (GLP) for nonclinical laboratory studies regulations.
Fiscal Year (FY) 2008 Funding Opportunity
Document Number: E8-4892
Type: Notice
Date: 2008-03-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $600,000 (total costs) per year for up to three years to the National Association of State Alcohol and Drug Abuse Directors (NASADAD). This is not a formal request for applications. Assistance will be provided only to the National Association of State Alcohol and Drug Abuse Directors (NASADAD) based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: TI-08-002. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.
Proposed Collection: Comment Request; Revision of OMB No. 0925-0002, exp. 10/31/08, “Ruth L. Kirschstein NRSA Individual Fellowship Application and Related Forms”
Document Number: E8-4871
Type: Notice
Date: 2008-03-12
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 Office of Extramural Research, 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: Ruth L. Kirschstein NRSA Individual Fellowship Application and Related Forms. Type of Information Collection Request: Revision of a currently approved collection, OMB 0925-0002, Expiration Date 10/31/08. Form Numbers: PHS 416-1, 416-9, 416-5, 416-7, 6031, 6031-1. Need and Use of Information Collection: The PHS 416-1 and 416-9 are used by individuals to apply for direct research training support. Awards are made to individual applicants for specified training proposals in biomedical and behavioral research, selected as a result of a national competition. The other related forms (PHS 416-5, 416-7, 6031, 6031-1) are used by these individuals to activate, terminate, and provide for payback of a National Research Service Award. Frequency of response: Applicants may submit applications for published receipt dates. If awarded, annual progress is reported and trainees may be appointed or reappointed. Affected Public: Individuals or households; businesses or other for-profit; not- for-profit institutions; Federal Government; and State, Local or Tribal Governments. Type of Respondents: Adult scientific trainees and professionals. The annual reporting burden is as follows: Estimated Number of Respondents: 34,454; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 4.1; and Estimated Total Annual Burden Hours Requested: 142,301. The annualized cost to respondents is estimated at: $4,980,535. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. For Further Information Contact: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Ms. Mikia Currie, Division of Grants Policy, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3505, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number 301-435-0941, or e-mail your request, including your address to: curriem@od.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Technical Amendment
Document Number: E8-4870
Type: Rule
Date: 2008-03-12
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 June 25, 2007 (72 FR 34752). The final rule established current good manufacturing practice (CGMP) requirements in manufacturing, packaging, labeling, or holding operations for dietary supplements. The final rule was published with an inadvertent error in the codified section. This document corrects that error. This action is being taken to improve the accuracy of the agency's regulations.
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-4867
Type: Notice
Date: 2008-03-12
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Lawrence Livermore National Laboratory, Livermore, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 3, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-4866
Type: Notice
Date: 2008-03-12
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Mound Plant, near Dayton, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 3, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-4865
Type: Notice
Date: 2008-03-12
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at Combustion Engineering, Windsor, Connecticut, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 3, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: E8-4680
Type: Notice
Date: 2008-03-12
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section l0(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Clinical Center; Notice of Meeting
Document Number: E8-4654
Type: Notice
Date: 2008-03-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-4652
Type: Notice
Date: 2008-03-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-4649
Type: Notice
Date: 2008-03-12
Agency: Department of Health and Human Services, National Institutes of Health
Secretary's Advisory Committee on Human Research Protections
Document Number: E8-4793
Type: Notice
Date: 2008-03-11
Agency: Department of Health and Human Services
Pursuant to section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its fifteenth meeting. The meeting will be open to the public.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
Document Number: E8-4791
Type: Notice
Date: 2008-03-11
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
Agency Information Collection Activities: Proposed Collection Comment Request
Document Number: E8-4787
Type: Notice
Date: 2008-03-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Center for Research Resources; Notice of Closed Meetings
Document Number: E8-4565
Type: Notice
Date: 2008-03-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-4564
Type: Notice
Date: 2008-03-11
Agency: Department of Health and Human Services, National Institutes of Health
National Toxicology Program (NTP); Report on Carcinogens (RoC); Request for Public Comments on the RoC Expert Panel's Recommendations on Listing Status for Captafol and Ortho-nitrotoluene in the 12th RoC and the Scientific Justifications for the Recommendations
Document Number: E8-4782
Type: Notice
Date: 2008-03-10
Agency: Department of Health and Human Services
The RoC Office invites public comment on the recommendations from an expert panel on listing status for captafol and ortho- nitrotoluene in the 12th RoC and the scientific justification for the recommendations. The recommendation and scientific justification for each candidate substance are available electronically in Part B of the Expert Panel Report http://ntp.niehs.nih.gov/go/29682, (see Expert Panel Report Part B) or in printed text from the RoC Office (see FOR FURTHER INFORMATION CONTACT below). The RoC Office convened a nine- member expert panel of scientists from the public and private sectors on October 15-16, 2007. The panel was asked (1) to apply the RoC listing criteria to the relevant scientific evidence and make a recommendation regarding listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for captafol and for ortho-nitrotoluene in the 12th RoC and (2) to provide the scientific justification for the recommendation.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Savannah River Site, Aiken, SC, To Be Included in the Special Exposure Cohort
Document Number: E8-4762
Type: Notice
Date: 2008-03-10
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Savannah River Site, Aiken, South Carolina, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Savannah River Site. Location: Aiken, South Carolina. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1950 through December 31, 2007.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Savannah River Site, Aiken, SC, To Be Included in the Special Exposure Cohort
Document Number: E8-4761
Type: Notice
Date: 2008-03-10
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Savannah River Site, Aiken, South Carolina, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Savannah River Site. Location: Aiken, South Carolina. Job Titles and/or Job Duties: All laborers, foremen, and construction workers. Period of Employment: March 9, 1951 through October 24, 1986.
Clinical Laboratory Improvement Advisory Committee: Notice of Charter Renewal
Document Number: E8-4719
Type: Notice
Date: 2008-03-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services