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

National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E7-19297
Type: Notice
Date: 2007-09-28
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 Ames Laboratory, Ames, Iowa, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 12, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Office of Planning, Research and Evaluation
Document Number: E7-19276
Type: Notice
Date: 2007-09-28
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Notice is hereby given that the Administration for Children and Families (ACF), Office of Planning, Research and Evaluation (OPRE) will award a non-competitive successor grant to OMNI Institute, Inc., a non-profit research organization located in Denver, CO. OMNI Institute, Inc. will assume a grant awarded under the Head Start University Partnership Research Grants: Curriculum Development and Enhancement for Head Start and Early Head Start Programs for the remainder of the project period July 15, 2007 to September 29, 2008. This action is taken as the original grantee, the University of Colorado Health Sciences Center, has relinquished the grant.
Submission for OMB Review; Comment Request; Revision of OMB No. 0925-0001/exp. 09/30/07, Research and Research Training Grant Applications and Related Forms
Document Number: E7-19265
Type: Notice
Date: 2007-09-28
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 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 July 24, 2007, page 40313 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 September 30, 2007, unless it displays a currently valid OMB control number. Proposed Collection: Title: Research and Research Training Grant Applications and Related Forms. Type of Information Collection Request: Revision, OMB 0925-0001, Expiration Date 9/30/2007, Form Numbers: PHS 398, 2590, 2271, 3734 and HHS 568. Need and Use of Information Collection: The application is used by applicants to request Federal assistance for research and research-related training. The other related forms are used for trainee appointment, final invention reporting, and to relinquish rights to a research grant. 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; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: Adult scientific professionals. The annual reporting burden is as follows: Estimated Number of Respondents: 164,820; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 15.2; and Estimated Total Annual Burden Hours Requested: 2,517,458. The estimated annualized cost to respondents is $88,110,030. 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: 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 30 days of the date of this publication.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E7-19247
Type: Notice
Date: 2007-09-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E7-19243
Type: Notice
Date: 2007-09-28
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 Hanford Engineer Works, Richland, Washington, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 12, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-19200
Type: Notice
Date: 2007-09-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-19198
Type: Notice
Date: 2007-09-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicaid Program; Clarification of Outpatient Clinic and Hospital Facility Services Definition and Upper Payment Limit
Document Number: E7-19154
Type: Proposed Rule
Date: 2007-09-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would amend the regulatory definition of outpatient hospital services for the Medicaid program. Outpatient hospital services are a mandatory part of the standard Medicaid benefit package. The current regulatory definition at 42 CFR 440.20 is broader than the definition in Medicare, and can overlap with other covered benefit categories. The purpose of this amendment is to align the Medicaid definition more closely to the Medicare definition in order to improve the functionality of the applicable upper payment limits under 42 CFR 447.321 (which are based on a comparison to Medicare payments for the same services), provide more transparency in determining available coverage in any State, and generally clarify the scope of services for which Federal financial participation (FFP) is available under the outpatient hospital services benefit category.
Notice of Hearing: Reconsideration of Disapproval of Pennsylvania State Plan Amendment (SPA) 06-007
Document Number: E7-19141
Type: Notice
Date: 2007-09-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces an administrative hearing to be held on November 16, 2007, at Suite 216, The Public Ledger Building, 150 S. Independence Mall West, Conference Room 241, the Pennsylvania Room, Philadelphia, PA 19106, to reconsider CMS's decision to disapprove Pennsylvania SPA 06-007. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by October 15, 2007.
Privacy Act of 1974; Report of a New System of Records
Document Number: E7-19110
Type: Notice
Date: 2007-09-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the Privacy Act of 1974, we are proposing to establish a new SOR, ``Post-Acute Care Payment Reform / Continuity of Assessment Record and Evaluation Demonstration and Evaluation (PAC- CARE),'' System No. 09-70-0569. Information maintained in this system will continue to enable CMS to better understand the relationships among patient needs, post-acute care placement, patient outcomes, and post-acute care related costs in the Medicare program. Additionally, as required by Section 5008 of the Deficit Reduction Act of 2005, CMS is developing a comprehensive assessment for use at the time of hospital discharge which identifies the needs and clinical characteristics of the patient. Additionally, this standardized patient assessment instrument shall be used across post-acute care sites, including skilled nursing facilities, home health agencies, long term care hospitals and inpatient rehabilitation facilities, to measure functional status and other factors during treatment and at discharge from each provider. CMS proposes to broaden the scope of the disclosure requirement by adding a new routine use number 6, authorizing disclosure of personal health information to providers to facilitate the proper transfer of health information for beneficiaries being discharged from their site of care to an admitting provider's care. Individuals from the admitting providers will only be granted access to personal health information, if they have the approved, authenticated, role based authority to do so, and the need to know and review the admitted patient's personal health information. Individuals will only be granted access to this information if they meet the following requirements: they must (1) provide an attestation or other qualifying information that they are providing assistance to qualified acute care or post-acute care beneficiaries admitted to their care site, (2) have physically admitted the beneficiary to their site and have initiated an assessment of the beneficiary, (3) safeguard the confidentiality of the data and prevent unauthorized access, and (4) accept an on-line statement attesting to the information recipient's understanding of and willingness to abide by these provisions. The routine uses will then be prioritized and reordered according to their usage. The primary purpose of this proposed system is to collect and maintain, and release when appropriate, demographic, health records, and health resource use related data on the target population of Medicare and potentially, Medicaid beneficiaries who require treatment by a designated acute care or post-acute care provider. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support the functions of Quality Improvement Organizations; (5) support the functions of national accreditation organizations; (6) permit the release of personal health information to complete a transfer-out (discharge) event and/or a transfer-in (admission) event; (7) support litigation involving the agency; and (8) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the modified or altered routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2007
Document Number: E7-18733
Type: Notice
Date: 2007-09-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2007 through June 2007, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare- approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomogrogphy for dementia, and a list of Medicare-approved bariatric surgery facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Corrections
Document Number: E7-18732
Type: Rule
Date: 2007-09-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the August 3, 2007 Federal Register, entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2008; Final Rule.''
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington
Document Number: E7-18731
Type: Notice
Date: 2007-09-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that laboratories located in and licensed by the State of Washington that possess a valid license under the Medical Test Site Licensure Law, Chapter 70.42 of the Revised Code of Washington, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 until September 28, 2013.
Medicare and Medicaid Programs; Application by the Indian Health Service (IHS) for Continued Recognition as a National Accreditation Organization for Accrediting American Indian and Alaska Native Entities To Furnish Outpatient Diabetes Self-Management Training
Document Number: E7-18470
Type: Notice
Date: 2007-09-28
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
This proposed notice announces the receipt of an application from the Indian Health Service for continued recognition as a national accreditation organization for accrediting American Indian and Alaska Native entities that wish to furnish outpatient diabetes self- management training to Medicare beneficiaries. This notice also announces a 30-day public comment period.
Medicare Program; Special Enrollment Period and Medicare Premium Changes
Document Number: E7-18467
Type: Proposed Rule
Date: 2007-09-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would provide a special enrollment period (SEP) for Medicare Part B and premium Part A for certain individuals who are sponsored by prescribed organizations as volunteers outside of the United States and who have health insurance that covers them while outside the United States. Under the SEP provision, qualifying volunteers can delay enrollment in Part B and premium Part A, or terminate such coverage, for the period of service outside of the United States and reenroll without incurring a premium surcharge for late enrollment or reenrollment. This proposed rule would also codify provisions that require certain beneficiaries to pay an income-related monthly adjustment amount (IRMAA) in addition to the standard Medicare Part B premium, plus any applicable increase for late enrollment or reenrollment. The income-related monthly adjustment amount is to be paid by beneficiaries who have a modified adjusted gross income that exceeds certain threshold amounts. It also represents the amount of decreases in Medicare Part B premium subsidy, that is, the amount of the Federal government's contribution to the Federal Supplementary Medicare Insurance (SMI) Trust Fund.
Medicare Program; Medicare Provider Feedback Group Town Hall Meeting-October 16, 2007
Document Number: E7-18113
Type: Notice
Date: 2007-09-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the annual Medicare Provider Feedback Group (MPFG) Town Hall meeting. This meeting is open to all Medicare fee-for-service (FFS) providers and suppliers that participate in the Medicare program, including physicians, hospitals, home health agencies, other third-party billers and other interested parties, to present their individual views and opinions on selected FFS Medicare topics. In addition, we will be soliciting input on how we can improve communications to better serve the Medicare providers and suppliers. The meeting agenda and discussion materials will be available by October 12, 2007. The public can access these materials at http:// www.cms.hhs.gov/center/provider.asp. The feedback provided during this meeting will assist us as we evaluate FFS Medicare policy, operational issues and CMS' provider and supplier communication activities. The meeting is open to the public, but attendance is limited to space available. Registered participants from the meeting will be included in the Medicare Provider Feedback Group and may be contacted throughout the year for follow-up meetings to solicit additional opinions and clarify any issues that may arise from the October 16, 2007 meeting.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 07-4773
Type: Notice
Date: 2007-09-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
AHRQ Health Care Innovations Exchange
Document Number: 07-4771
Type: Notice
Date: 2007-09-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
To support its objective of accelerating the diffusion and adoption of innovative health care delivery changes, the Agency for Healthcare Research and Quality (AHRQ) recently launched version 1.0 of the AHRQ Health Care Innovations Exchange (HCIE) Web site, http:// www.innovations.ahrq.gov. The HCIE is a new initiative designed to support health care professionals in sharing and adopting innovations that improve health care quality. Version 1.0 of the Web site is focused on stimulating creativity and innovation and will serve as a virtual place to which innovators will be encouraged to submit their innovations and experiences from which potential adopters can begin learning about the nuances of implementation. In Spring 2008, AHRQ will deploy version 2.0 of its Health Care Innovations Exchange site making hundreds of profiles of health care service innovations of varying degrees of novelty and scientific rigor accessible to the public. Version 2.0 will also offer expert commentary; stories; tools; lessons learned; ``change packages''sets of innovations implemented simultaneously; expanded content on implementation; and opportunities to learn and network. To build the database of innovations profiles, AHRQ invites submissions of health service innovations to its Health Care Innovations Exchange. The AHRQ Health Care Innovations Exchange database will cover the broad spectrum of health care settings, systems, and providers. Public health priority diseases/conditions, priority populations, and efforts to reduce disparities in quality will be highlighted. The AHRQ Health Care Innovations Exchange is seeking a broad range of novel health care strategies, activities, and tools. AHRQ invites participation in its Health Care Innovations Exchange by submitting descriptions of innovative efforts to improve the delivery of health care services.
Availability of Draft Public Health Service (PHS) Clinical Practice Guideline Update on Treating Tobacco Use and Dependence
Document Number: 07-4770
Type: Notice
Date: 2007-09-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) announces the availability of a draft Public Health Service clinical practice guideline Update on Treating Tobacco Use and Dependence for pre-publication review. This PHS guideline update is being produced by a multidisciplinary private-sector panel of experts convened by the agencies of the Public Health Service. The expert panel will not respond to individual comments but will consider all comments in determining revisions to the guideline.
Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials; Availability
Document Number: E7-19155
Type: Notice
Date: 2007-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials,'' dated September 2007. The guidance document provides sponsors of vaccine trials with recommendations on assessing the severity of clinical and laboratory abnormalities in healthy adult and adolescent volunteers enrolled in clinical trials. In particular, the guidance includes toxicity grading scale tables to use as a guideline for selecting the assessment criteria. The guidance announced in this notice finalizes the draft guidance of the same title dated April 2005.
Request for Nominations for Voting Members on Public Advisory Committee, Veterinary Medicine Advisory Committee
Document Number: E7-19130
Type: Notice
Date: 2007-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
Solicitation of Nomination for Appointment to the Advisory Committee on Minority Health; Extension
Document Number: E7-19084
Type: Notice
Date: 2007-09-27
Agency: Department of Health and Human Services
The Department of Health and Human Services published a document in the Federal Register of July 17, 2007, Vol 72, No. 136, pages 39068 through 39069. The notice solicits nominations for appointment to the Advisory Committee on Minority Health. This notice is for the purpose of extending the period for nominations for an additional 45 days.
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: E7-19083
Type: Notice
Date: 2007-09-27
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-19073
Type: Notice
Date: 2007-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin
Document Number: E7-18983
Type: Rule
Date: 2007-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for the addition of a pathogen to the indication for use of tulathromycin, by injection, for the control of respiratory disease in high-risk cattle.
National Cancer Institute; Notice of Meeting
Document Number: 07-4739
Type: Notice
Date: 2007-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Disease; Notice of Closed Meetings
Document Number: 07-4738
Type: Notice
Date: 2007-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 07-4737
Type: Notice
Date: 2007-09-26
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E7-18911
Type: Notice
Date: 2007-09-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
Draft Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions; Availability
Document Number: E7-18816
Type: Notice
Date: 2007-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions.'' The draft guidance explains, using a question and answer format, FDA's current thinking on a number of microbiological issues unique to the preparation of premarket submissions for antimicrobial food additives.
Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Companion Document to Direct Final Rule; Correction
Document Number: E7-18802
Type: Proposed Rule
Date: 2007-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a proposed rule that appeared in the Federal Register of August 16, 2007 (72 FR 45993). That document proposed to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. The proposal published as a companion document to the direct final rule that published in the same issue of the Federal Register (August 16, 2007, 72 FR 45883). Both documents published with a typographical error in the codified section. This document corrects the error in the proposed rule. Elsewhere in this issue of the Federal Register we are correcting the error in the direct final rule.
Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Correction
Document Number: E7-18799
Type: Rule
Date: 2007-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). That document amended the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. A proposal was published as a companion document to the direct final rule in the same issue of the Federal Register (August 16, 2007, 72 FR 45993). Both documents published with a typographical error in the codified section. This document corrects the error in the direct final rule. Elsewhere in this issue of the Federal Register we are correcting the error in the proposed rule.
Government-Owned Inventions; Availability for Licensing
Document Number: E7-18798
Type: Notice
Date: 2007-09-24
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: E7-18774
Type: Notice
Date: 2007-09-24
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.
Proposed Collection; Comment Request; Quality of Life Outcomes in Neurological Disorders
Document Number: E7-18772
Type: Notice
Date: 2007-09-24
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 Institute of Neurological Disorders and Stroke (NINDS), 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: Quality of Life Outcomes in Neurological Disorders; Type of Information Collection Request: New; Form Number: NA; Need and Use of Information Collection: In order to improve outcome measurement in clinical trials of neurological conditions, NINDS is developing a health-related quality of life (HRQL) measurement system for major neurological diseases that affect the United States population. This measurement system must be consistent enough across the selected conditions to allow for cross-disease comparison, and yet flexible enough to capture condition-specific HRQL issues. The primary end users of this measurement system will be clinical trialists and other clinical neurology researchers; however the measurement system will also be appropriate for clinical practice. The proposed information collection will support psychometric testing of HRQL item banks and testing of Spanish translation of the final questionnaires. Frequency of Response: Once; Affected Public: Individuals; Type of Respondent: Adults and children. The annual reporting burden is shown in the following table. There are no Capital Costs, Operating Costs or Maintenance Costs to report.
Announcement of Availability of Funds for a Cooperative Agreement to Provide Baccalaureate Nursing Education Supportive of Maternal-Child Nursing at Kabul Medical University (KMU) and Support for the Development of a Nursing Board for Registration and Licensure at the Ministry of Public Health; Cancellation
Document Number: E7-18763
Type: Notice
Date: 2007-09-24
Agency: Department of Health and Human Services
The Department of Health and Human Services published a document in the Federal Register of August 16, 2007, Vol. 72, No. 158, pages 46063 through 46073. The notice announced the sole source award of funds to provide Baccalaureate Nursing Education Supportive of Maternal-Child Nursing at Kabul Medical University (KMU) and Support for the Development of a Nursing Board for Registration and Licensure at the Ministry of Public Health. This award is being withdrawn.
Meeting of the National Vaccine Advisory Committee
Document Number: E7-18758
Type: Notice
Date: 2007-09-24
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.
Secretary's Advisory Committee on Human Research Protections
Document Number: E7-18757
Type: Notice
Date: 2007-09-24
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 fourteenth meeting. The meeting will be open to the public.
Announcement of Availability of Funds for a Cooperative Agreement To Provide Basic Medical Education Supportive of Maternal-Child Health at Kabul Medical University (KMU) and Clinical Training in Obstetrics and Gynecology to Resident Physicians and Refresher Training to Attending Physicians at the Rabia Balkhi Women's Hospital; Cancellation
Document Number: E7-18756
Type: Notice
Date: 2007-09-24
Agency: Department of Health and Human Services
The Department of Health and Human Services published a document in the Federal Register of August 16, 2007, Vol. 72, No. 158, pages 46073 through 46082. The notice announced the sole source award of funds to provide Basic Medical Education Supportive of Maternal- Child Health at Kabul Medical University (KMU) and Clinical Training in Obstetrics and Gynecology to Resident Physicians and Refresher Training to Attending Physicians at the Rabia Balkhi Women's Hospital. This award is being withdrawn.
Advisory Board on Radiation and Worker Health: Notice of Charter Renewal
Document Number: E7-18749
Type: Notice
Date: 2007-09-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Injury Prevention and Control Initial Review Group: Notice of Charter Renewal
Document Number: E7-18748
Type: Notice
Date: 2007-09-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 07-4710
Type: Notice
Date: 2007-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung and Blood Institute; Notice of Closed Meeting
Document Number: 07-4708
Type: Notice
Date: 2007-09-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request; Radioactive Drug Research Committees
Document Number: E7-18646
Type: Notice
Date: 2007-09-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on 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 regulations governing the use of radioactive drugs for basic informational research.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pharmaceutical Development Study
Document Number: E7-18641
Type: Notice
Date: 2007-09-21
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 ``Pharmaceutical Development Study'' 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
Document Number: E7-18494
Type: Notice
Date: 2007-09-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E7-18468
Type: Notice
Date: 2007-09-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services