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

Advisory Committee on Organ Transplantation Request for Nominations for Voting Members
Document Number: E8-1730
Type: Notice
Date: 2008-01-31
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR part 121) and, in accordance with Public Law 92-463, was chartered on September 1, 2000.
National Institute of Child Health and Human Development Proposed Collection; Comment Request; Pilot Study for the National Children's Study
Document Number: E8-1690
Type: Notice
Date: 2008-01-31
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 of Child Health and Human Development (NICHD), 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 November 19, 2007, pages 65049-65050, and allowed 60 days for public comment. One comment was received questioning the utility of the proposed data collection. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Pilot Study for the National Children's Study, Type of Information Collection Request: New, Affected entities: Households and individuals. Types of respondents: People potentially affected by this action are pregnant women, women age 18-49 years of age, their husbands or partners, and their children who live in selected areas within seven (7) National Children's Study Vanguard sites. A small number of health care professionals, community leaders, and child care personnel are also potential respondents. Frequency of Response: On occasion. See burden table for estimated number of annual responses for each respondent. Need and use of information collection: The purpose of this Study is to pilot test protocols, policies, and procedures for the National Children's Study (NCS) with the goal of improving the efficiency of study procedures and enhancing the subsequent implementation of the NCS, a long-term cohort study of environmental influences on child health and development authorized under the Children's Health Act of 2000. This data collection will test procedures for population-based sampling and recruitment of pregnant women and women of child-bearing age, test study logistics, and estimates of subject burden, and evaluate data collection strategies including interviews and acquisition of biologic and environmental samples. In addition, participants will also be asked to provide qualitative and quantitative input on their feelings regarding participation in this study. Further details pertaining to the NCS background and planning, including the NCS Research Plan, can be found at: http://nationalchildrensstudy.gov. The Pilot Study is intended to begin with household enumeration and enrollment of women, proceed through pregnancy and birth, and continue with follow-up of children for up to 21 years. This application is for the first three years of data collection, which includes data collection through the visits at which some of the children will be 24 months old. Details of data collections beyond this period will be addressed at the time of renewal or in future applications. Women who are pregnant will be eligible for participation if, at the time of household enumeration and screening, they are within the first trimester of pregnancy. Women who are not pregnant will be eligible if, at the time of household enumeration and screening, they are 18-49 years of age, are neither surgically nor medically sterile, and can participate in the consent process. A subset of age-eligible women with a high likelihood of pregnancy (e.g., planning to become pregnant) will be enrolled to enable assessment of peri-conceptional exposures, should they become pregnant. The remainder of the study population will comprise women enrolled early in pregnancy. The seven centers combined will follow approximately 1000 infants born to women enrolled in the first year of this Pilot Study. Home visits before and during pregnancy will include collection of interview data, environmental specimens such as air and dust samples, maternal and paternal biospecimens such as blood and hair samples, and a brief physical examination including anthropometric measures and blood pressure. During pregnancy, women will receive up to three fetal ultrasounds to assess fetal growth. At birth, cord blood and placental samples will be collected and the infant will receive a brief developmental assessment. During infancy, home visits will include collection of interview data, environmental specimens, biospecimens from the infant and parents, a brief physical examination of the infant, and assessment of infant development and parental-infant interactions. Burden statement: The public burden for this study will vary depending on the eligibility and pregnancy status of potential participants at the time of household screening. Women who receive their first home visit during pregnancy will have a lower burden than those who receive their first visit before pregnancy. And, women who are not pregnant at the time of screening will have varying burden depending on their likelihood of pregnancy. The table provides an annualized average burden per person for each stage of the Pilot Study over the three year period of the study.
National Institute of Child Health and Human Development; Proposed Collection; Comment Request; Formative Research and Pilot Studies for the National Children's Study
Document Number: E8-1688
Type: Notice
Date: 2008-01-31
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 of Child Health and Human Development (NICHD), 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 November 19, 2007, pages 65047-8, and allowed 60 days for public comment. One comment was received questioning the utility of the proposed data collection. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Formative Research and Pilot Studies for the National Children's Study. Type of Information Collection Request: New. Need and use of information collection: The NICHD seeks to obtain OMB's generic approval to conduct formative research and pilot studies to be used in the development of instruments, materials, and procedures for the National Children's Study (NCS). The NCS is a long-term cohort study of environmental influences on child health and development authorized under the Children's Health Act of 2000. Further details pertaining to the NCS background and planning, including the NCS Research Plan, can be found at: http://nationalchildrensstudy.gov. The proposed data collection program will include community outreach materials, medical provider and participant materials, questionnaires and measures, use of technology such as Interactive Voice Recognition (IVR), and other aspects related to data collection. Activities will include small focused studies to test data collection items and methods on a specific or targeted population, validation of questionnaires for targeted populations, focus groups within the NCS communities to test forms and procedures, cognitive interviews to test data items, and the use of materials on targeted populations such as medical providers and hospitals, and materials translated into other languages. These activities will be conducted over the life of the study to develop procedures and materials for each stage of data collection. The results of these pilot tests will be used to maximize the efficiency of study procedures, materials, and methods for community outreach, engagement of the medical community, for recruiting and retaining study subjects prospectively across study visits and to ensure that data collection methodologies are efficient and valid for all potential participants. Without this information, NCS will be hampered in its efforts to effectively publicize the NCS, gain public and professional support, and effectively recruit and retain respondents and collect data over the life of the Study. Affected entities: Individuals. Types of respondents: People potentially affected by this action are pregnant women or women of childbearing age, their husbands or partners, health care professionals, and community leaders. The annual reporting burden is as follows: Estimated Number of Respondents: 3,150. Frequency of Response: On occasion (see Burden table). The Estimated Number of Responses per Respondent: 1. Average Burden Hours Per Response: Varies with study type. Estimated Total Annual Burden Hours Requested: 5,825. The estimated annualized cost to respondents is $114,250 (based on rates listed in the burden table). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 08-422
Type: Notice
Date: 2008-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 08-421
Type: Notice
Date: 2008-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 08-420
Type: Notice
Date: 2008-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 08-419
Type: Notice
Date: 2008-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 08-418
Type: Notice
Date: 2008-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Guidance for Industry and Food and Drug Administration Staff; Clinical Laboratory Improvement Amendments of 1988: Recommendations for Clinical Laboratory Improvement Amendments of 1988: Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Availability
Document Number: E8-1557
Type: Notice
Date: 2008-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.'' FDA is issuing this guidance to recommend approaches for determining whether a laboratory test may be performed by laboratories with a certificate of waiver under CLIA.
Proposed Collection; Comment Request; Case-Cohort Study of Cancer and Related Disorders Among Benzene-Exposed Workers in China (OMB No. 0925-0454)
Document Number: E8-1550
Type: Notice
Date: 2008-01-30
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), 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.
Notice of Meetings
Document Number: 08-388
Type: Notice
Date: 2008-01-30
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 08-384
Type: Notice
Date: 2008-01-30
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Information Collection Activity; Comment Request
Document Number: 08-383
Type: Notice
Date: 2008-01-30
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Information Collection Activity; Comment Request
Document Number: 08-382
Type: Notice
Date: 2008-01-30
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 08-380
Type: Notice
Date: 2008-01-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute On Drug Abuse; Amended Notice of Meeting
Document Number: 08-379
Type: Notice
Date: 2008-01-30
Agency: Department of Health and Human Services, National Institutes of Health
National Center For Complementary & Alternative Medicine; Notice of Closed Meetings
Document Number: 08-378
Type: Notice
Date: 2008-01-30
Agency: Department of Health and Human Services, National Institutes of Health
Statement of Policy for Section 19 of the Federal Deposit Insurance Act
Document Number: Z7-25128
Type: Notice
Date: 2008-01-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Securities and Exchange Commission, Agencies and Commissions, Federal Deposit Insurance Corporation
Statement of Organization, Functions, and Delegations of Authority
Document Number: E8-1517
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-1484
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Statement of Organization, Functions and Delegation of Authority
Document Number: E8-1479
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Statement of Organization, Functions, and Delegations of Authority
Document Number: E8-1466
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH)
Document Number: E8-1458
Type: Notice
Date: 2008-01-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Immunization Practices (ACIP)
Document Number: E8-1457
Type: Notice
Date: 2008-01-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-1456
Type: Notice
Date: 2008-01-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-1453
Type: Notice
Date: 2008-01-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: E8-1441
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: E8-1439
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services
Office of the Secretary; Notice of Interest Rate on Overdue Debts
Document Number: 08-370
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
Document Number: 08-369
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services
This notice announces the 23rd 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.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting
Document Number: 08-368
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services
This notice announces the 15th meeting of the American Health Information Community Quality 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: 08-367
Type: Notice
Date: 2008-01-29
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 Consumer Empowerment Workgroup Meeting
Document Number: 08-366
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services
This notice annoucnes the 23rd 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 Chronic Care Workgroup Meeting
Document Number: 08-365
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services
This notice announces the 22nd 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 Personalized Healthcare Workgroup Meeting
Document Number: 08-364
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services
This notice announces the 12th 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.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, and Security Workgroup Meeting
Document Number: 08-363
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services
This notice announces the 17th 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.).
Statement of Organization, Functions, and Delegations of Authority
Document Number: 08-355
Type: Notice
Date: 2008-01-29
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Medicare Program; Prospective Payment System for Long-Term Care Hospitals RY 2009: Proposed Annual Payment Rate Updates, Policy Changes, and Clarifications
Document Number: 08-297
Type: Proposed Rule
Date: 2008-01-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). In addition, we are proposing to consolidate the annual July 1 update for payment rates and the October 1 update for Medicare severity long-term care diagnosis related group (MS-LTC-DRG) weights to a single fiscal year (FY) update. In this proposed rule, we are also clarifying various policy issues. This proposed rule would also describe our evaluation of the possible one-time adjustment to the Federal payment rate.
Food Labeling: Revision of Reference Values and Mandatory Nutrients; Extension of Comment Period
Document Number: E8-1446
Type: Proposed Rule
Date: 2008-01-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending to April 30, 2008, the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of November 2, 2007 (72 FR 62149). In the ANPRM, FDA requested comments on what new reference values the agency should use to calculate the percent daily value (DV) in the Nutrition Facts and Supplement Facts labels and what factors the agency should consider in establishing such new reference values. In addition, FDA requested comments on whether it should require that certain nutrients be added or removed from the Nutrition Facts and Supplement Facts labels. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
National Advisory Council on the National Health Service Corps
Document Number: E8-1371
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration published a meeting notice for the National Advisory Council on the National Health Service Corps in the Federal Register of January 15, 2008 (FR Doc. E8- 581), on page 2510. The beginning date of the meeting has changed.
Statement of Organization, Functions and Delegations of Authority
Document Number: E8-1370
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-1363
Type: Notice
Date: 2008-01-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act
Document Number: E8-1362
Type: Notice
Date: 2008-01-28
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 information collection provisions of the draft guidance entitled ``Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.''
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: E8-1361
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
Awards to Eleven Office of Refugee Resettlement Shelter Care Providers
Document Number: E8-1360
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
This notice is hereby given that an award will be made to an unaccompanied alien shelter care provider, Southwest Regional Youth Village, Vincennes, Indiana, in the amount of $586,719. This funding will support services through September 30, 2008. This funding will support the expansion of secure program bed capacity to meet the number of unaccompanied alien children referrals from the Department of Homeland Security (DHS). The program is mandated by section 462 of the Homeland Security Act to ensure appropriate placement of all referrals from the DHS. ORR's ability to meet this mandate is often a challenge since the program is completely tied to DHS interior apprehension strategies and the sporadic number of border crossers. The program has very specific requirements for the provision of services. This grantee is one of the only entities with the infrastructure, licensing, experience and appropriate level of trained staff to meet the service requirements for secure capacity. The program's ability to meet the number of secure referrals from DHS can only be accommodated through the expansion of this program through the supplemental award process.
Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements
Document Number: E8-1356
Type: Notice
Date: 2008-01-28
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 notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, and cosmetics that may not be marketed or sold in the United States.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food and Drug Administration Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products
Document Number: E8-1355
Type: Notice
Date: 2008-01-28
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 ``FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey of Food Safety and Nutrition Information Provided to Pregnant Women by Health Care Providers and the Special Supplemental Nutrition Program for Women, Infants, and Children Educators
Document Number: E8-1353
Type: Notice
Date: 2008-01-28
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 ``Survey of Food Safety and Nutrition Information Provided to Pregnant Women by Health Care Providers and WIC Educators'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medicare Program; Meeting of the Practicing Physicians Advisory Council
Document Number: E8-1347
Type: Notice
Date: 2008-01-28
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 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.