Department of Health and Human Services 2007 – Federal Register Recent Federal Regulation Documents
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Family Violence Prevention and Services/Grants for Battered Women's Shelters/Grants to Native American Tribes (Including Alaska Native Villages) and Tribal Organizations
This announcement governs the proposed award of formula grants under the Family Violence Prevention and Services Act (FVPSA) to Native American Tribes (including Alaska Native Villages) and Tribal organizations. The purpose of these grants is to assist Tribes in establishing, maintaining, and expanding programs and projects to prevent family violence and to provide immediate shelter and related assistance for victims of family violence and their dependents. This announcement sets forth the application requirements, the application process, and other administrative and fiscal requirements for grants in Fiscal Year (FY) 2008. Grantees are to be mindful that although the expenditure period for grants is a two-year period, an application is required every year to provide continuity in the provision of services. (See Section II. Award Information, Expenditure Periods.)
Family Violence Prevention and Services/Grants for Battered Women's Shelters/Grants to States; Notice of Grant
This announcement governs the proposed award of mandatory grants under the Family Violence Prevention and Services Act (FVPSA) to States (including Territories and Insular Areas). The purpose of these grants is to assist States in establishing, maintaining, and expanding programs and projects to prevent family violence and to provide immediate shelter and related assistance for victims of family violence and their dependents. This announcement sets forth the application requirements, the application process, and other administrative and fiscal requirements for grants in Fiscal Year (FY) 2008.
Family Violence Prevention and Services/Grants to State Domestic Violence Coalitions; Notice of Grant
This announcement governs the proposed award of formula grants under the Family Violence Prevention and Services Act (FVPSA) to private, non-profit State Domestic Violence Coalitions (Coalitions). The purpose of these grants is to assist in the conduct of activities to promote domestic violence intervention and prevention and to increase public awareness of domestic violence issues. This notice for family violence prevention and services grants to Coalitions serves two purposes. The first is to confirm a Federal commitment to reducing domestic violence; and the second purpose is to urge States, localities, cities, and the private sector to become involved in State and local planning towards an integrated service delivery approach.
Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB); Correction
This document corrects a technical error in the notice [Document Identifier: CMS-10232] entitled ``State Plan Template to Implement Section 6062 of the Deficit Reduction Act (DRA) of 2005'' that was published in the December 7, 2007 Federal Register.
Draft Prescription Drug User Fee Act IV Information Technology Plan; Availability for Comment
The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan.'' This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving the automation of business processes and maintaining information systems that support the process for the review of human drug applications to achieve the objectives defined in the PDUFA Performance Goals.
Identification Of Priority Data Needs for Six Priority Hazardous Substances
This notice makes available for public comment the priority data needs for six priority hazardous substances (see Table 1) as part of the continuing development and implementation of the ATSDR Substance-Specific Applied Research Program (SSARP). The notice also serves as a continuous call for voluntary research proposals. The exposure and toxicity priority data needs in this notice were distilled from the data needs identified in ATSDR's toxicological profiles by the logical scientific approach described in a decision guide published in the Federal Register on September 11, 1989 (54 FR 37618). The priority data needs represent essential information to improve the database for conducting public health assessments. Research to address these priority data needs will help to determine the types or levels of exposure that may present significant risks of adverse health effects in people exposed to the hazardous substances. The priority data needs identified in this notice reflect the opinion of ATSDR, in consultation with other federal programs, about the research needed pursuant to ATSDR's authority under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (Superfund), or CERCLA, as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604(i)]. The needs identified here do not represent the priority data needs for any other agency or program. Consistent with Section 104(i)(12) of CERCLA as amended [42 U.S.C. 9604(i)(12)], nothing in this research program shall be construed to delay or otherwise affect or impair the President, the Administrator of ATSDR, or the Administrator of the Environmental Protection Agency (EPA) from exercising any authority regarding any other provision of law, including the Toxic Substances Control Act of 1976 (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (FIFRA), or the response and abatement authorities of CERCLA. ATSDR worked with other federal programs to determine common substance-specific data needs and mechanisms to implement research that may include authorities under TSCA and FIFRA, private-sector voluntarism, or the direct use of CERCLA funds. When deciding the type of research that should be done, ATSDR considers the recommendations of the Interagency Testing Committee (ITC) established under Section 4(e) of TSCA. Federally funded projects that collect information from 10 or more respondents and that are funded by cooperative agreements are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. If the proposed project involves research on human subjects, the applicants must comply with Department of Health and Human Services regulations (45 CFR part 46) regarding the protection of human subjects. The applicants must assure that the project will be subject to initial and continuing review by the appropriate institutional review committees. Overall, by providing additional scientific information for the risk assessment process, data generated from this research will support other researchers who are conducting human health assessments involving these six substances. Table 1 presents the priority data needs for six priority substances. The six substances are included in the ATSDR Priority List of Hazardous Substances (70 FR 72840, December 7, 2005). ATSDR invites comments from the public on the individual priority data needs and the priority data needs documents for these substances. After considering the comments, ATSDR will publish the final priority data needs for each substance. These priority data needs will be addressed by the mechanisms described in the ``Implementation of Substance-Specific Applied Research Program'' section of this Federal Register Notice.
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
The Food and Drug Administration (FDA) is issuing regulations to permit FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). Under this rule, the appropriate FDA Center Director may grant an exception or alternative to such labeling requirements if he or she determines that compliance with the requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of human drugs, biological products, or medical devices that are or will be included in the SNS, including not only those that are approved, licensed, or cleared for marketing, but also those that are investigational. A grant of an exception or alternative under these regulations will include any safeguards or conditions deemed appropriate by the FDA Center Director to ensure that the labeling of such products includes information for the safe and effective use of the products given their anticipated circumstances of use. This rule will facilitate the safety, effectiveness, and availability of appropriate medical countermeasures in the event of a public health emergency.
Administration for Children and Families; Notice of Cancellation of Funding
This notice cancels the FY 2004 Standing Announcement for Services to Recently Arrived Refugees (HHS-2004-ACF-ORR-RE-0004) that was published in the Federal Register on April 23, 2004 (Volume 69, pages 22275-22298). The three priority areas of the FY 2004 Standing Announcement for Services to Recently Arrived Refugees will be published in FY 2008 as three separate Standing Announcements at the Administration for Children and Families' Grant Opportunities Web page at https:// www.acf.hhs.gov/grants/ and at www.grants.gov. The titles of three Standing Announcements will be the Standing Announcement for the Preferred Communities Program; the Standing Announcement for Supplemental Services for Recently Arrived Refugees; and the Standing Announcement for Ethnic Community Self-Help. The new Standing Announcements and application packages will also be available at www.grants.gov. Interested parties should register with www.grants.gov to receive e-mail alerts announcing publication, application due dates, and application requirements.
Medicare Program; Notice of Supplemental Election Period for Participation in the Calendar Year (CY) 2008 Competitive Acquisition Program for Part B Drugs
This notice announces an additional physician election period for physicians who are not currently participating in the competitive acquisition program (CAP) for Medicare Part B drugs for calendar year (CY) 2008. The additional physician election period begins on January 15, 2008 and ends on February 15, 2008. Physicians who elect to join the CAP during this additional election period will enter into a physician election agreement effective April 1, 2008 through December 31, 2008.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2007
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July 2007 through September 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.
Medicaid Program; Fiscal Year Disproportionate Share Hospital Allotments and Disproportionate Share Hospital Institutions for Mental Disease Limits
This notice announces the final Federal share disproportionate share hospital (DSH) allotments for Federal fiscal year (FFY) 2006 and the preliminary Federal share DSH allotments for FFY 2008. This notice also announces the final FFY 2006 and the preliminary FFY 2008 limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of States' FFY DSH allotments.
Medicare Program; Quality Improvement Organization (QIO) Contracts: Solicitation of Proposals From In-State QIOs-Alaska, Idaho, Maine, South Carolina, Vermont, and Wyoming
This notice in accordance with section 1153(i) of the Social Security Act (the Act), gives at least 6 months advance notice of the expiration dates of contracts with out-of-State Quality Improvement Organizations (QIOs). It also specifies the period of time in which in- State QIOs may submit a proposal for those contracts.
Medicare Program; Request for Nominations for the Advisory Panel on Medicare Education
This notice requests nominations for individuals to serve on the Advisory Panel on Medicare Education (the Panel) to fill current vacancies and vacancies that will become available in 2008. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the effectiveness of consumer education strategies concerning the Medicare program.
Medicare Program; Town Hall Meeting on the Fiscal Year 2009 Applications for New Medical Services and Technologies Add-on Payments Under the Hospital Inpatient Prospective Payment System, February 21, 2008
This notice announces a Town Hall meeting in accordance with section 503 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) to discuss fiscal year (FY) 2009 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2009 new medical services and technologies applications meet the substantial clinical improvement criterion.
Medicare Program; Semi-Annual Winter Meeting of the Advisory Panel on Ambulatory Payment Classification Groups-March 5, 6, and 7, 2008
In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the first semi-annual winter meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2008. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the proposed rule that updates the hospital Outpatient Prospective Payment System (OPPS) for CY 2009.
Revisions to Procedures for the Departmental Appeals Board and Other Departmental Hearings
The Department of Health and Human Services (Department) proposes to amend Departmental regulations governing administrative review by the Departmental Appeals Board (DAB) and certain other administrative review regulations to ensure that the final administrative decision of the Department reflects the considered opinion of the Secretary of Health and Human Services (Secretary). Current regulations at 45 CFR Part 16 governing the review of grant disputes do not specifically require the DAB to follow published guidance issued by the Secretary or a Departmental component. The DAB decision is currently the final administrative decision of the Department on such disputes and currently there is no Secretarial review of this final decision. Similarly, the DAB currently provides the final agency review of the imposition of civil monetary penalties (CMPs) for which administrative appeal is available under 45 CFR Part 160, Subpart E, enforcement sanctions under 42 CFR Part 422 and 423, determinations subject to reconsideration and appeal under 42 CFR Part 498 and the imposition by the Inspector General of the Department (I.G.) or the Centers for Medicare and Medicaid Services (CMS) of exclusions, CMPs and assessments subject to appeal under 42 CFR Part 1005. As in 45 CFR Part 16, the decisions of the DAB under these processes are considered the final agency action on matters, though they are not subject to Secretarial review. This proposed rule would amend DAB regulations to require that the DAB follow published guidance that is not inconsistent with applicable statutes and regulations and would permit the Secretary an opportunity to review DAB decisions to correct errors in the application of law, or deviations from published guidance, in such disputes. This proposed rule would make technical changes to the regulations at 45 CFR Part 16. This proposed rule would also amend hearing and appeal procedures at 45 CFR Part 160, Subpart E and at 42 CFR Parts 422, 423 and 498 to include a parallel statement regarding the treatment of published guidance. Similarly, this proposed rule would amend the procedures at 45 CFR Part 81 to provide a similar statement regarding the treatment of published guidance by hearing examiners and reviewing authorities. In addition, this proposed rule would amend the hearing and appeal procedures at 45 CFR Part 160, Subpart E and 42 CFR Parts 422, 423, 498 and 1005 to provide a parallel opportunity for Secretarial review of DAB decisions. Finally, this proposed rule would revise the procedures for Head Start grantee appeals by applying the current 60-day time limit for ``final decisions'' to the Board's decision.
Medicaid Program; Elimination of Reimbursement Under Medicaid for School Administration Expenditures and Costs Related to Transportation of School-Age Children Between Home and School
Under the Medicaid program, Federal payment is available for the costs of administrative activities ``as found necessary by the Secretary for the proper and efficient administration of the State plan.'' This final rule eliminates Federal Medicaid payment for the costs of certain school-based administrative and transportation activities because the Secretary has found that these activities are not necessary for the proper and efficient administration of the Medicaid State plan and are not within the definition of the optional transportation benefit. Based on these determinations, under this final rule, Federal Medicaid payments will no longer be available for administrative activities performed by school employees or contractors, or anyone under the control of a public or private educational institution, and for transportation from home to school. In addition, this final rule responds to public comments received on the September 7, 2007 proposed rule.
Agency Information Collection Activities: Proposed Collection; Comment Request
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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection Activities: Proposed Collection; Comment Request
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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2008
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for administrative law judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2008. The 2008 AIC threshold amounts are $120 for ALJ hearings and $1,180 for judicial review.
New Animal Drugs; Change of Sponsor's Name
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Altana, Inc., to Nycomed US, Inc.
Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle; Public Workshop; Request for Comments
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are announcing a public workshop entitled ``Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle.'' The purpose of the public workshop is to solicit information and views from interested persons on research approaches and methods associated with the best ways to assess the public health benefit of collecting and reporting all adverse events (AEs). The input from this workshop will be used to publish a request for information to determine the types of outside organizations that would be interested in, and have the capability to conduct, the research described in this paragraph, followed by a request for proposal (RFP).
Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in clinical trial design for community-acquired pneumonia. This public workshop is intended to provide information for and to gain perspective from health care providers, academia, and industry on various aspects of antimicrobial drug development for community-acquired pneumonia, including diagnosis of community-acquired pneumonia, effect of antimicrobial treatment for community-acquired pneumonia, endpoints for trials of community- acquired pneumonia, and statistical issues in analysis of results of trials in community-acquired pneumonia. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on January 17, 2008, from 8 a.m. to 6 p.m. and on January 18, 2008, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel, Kennedy Room, 8777 Georgia Ave., Silver Spring, MD 20910, 301- 589-0800. Seating is limited and available only on a first-come, first- served basis. Contact Person: Chris Moser or Lori Benner, Center for Drug Evaluation and Research, Office of Antimicrobial Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6413, Silver Spring, MD 20993-0002, 301-796-0767, or 301-796-0849. Registration: There is no registration fee for the public workshop. Space is limited; therefore, interested parties are encouraged to register early. Seating will be available on a first-come, first-served basis. To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax number) to CAPwkshp@fda.hhs.gov by January 9, 2008. Persons without access to the Internet can call 301-796-1300 to register. Persons needing a sign language interpreter or other special accommodations should notify Chris Moser or Lori Benner (see Contact Person) at least 7 days in advance.
Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 12, 2007 (72 FR 70599). The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995. The document was published with an error. This document corrects that error.
DSM Nutritional Products, Inc.; Filing of Color Additive Petition; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of December 4, 2007 (72 FR 68166). The document announced that DSM Nutritional Products, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh.
Division of Loan Repayment; Proposed Collection; Comment Request; National Institutes of Health Loan Repayment Programs
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 Division of Loan Repayment, 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: National Institutes of Health Loan Repayment Programs. Type of Information Collection Request: Revision of currently approved collection (OMB No. 0925-0361, expiration date 6/30/ 08). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674-4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674-14, NIH 2674-15, NIH 2674-16, NIH 2674-17, NIH 2674-18, and NIH 2674-19. Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., Ph.D., Pharm.D., D.D.S., D.M.D., D.P.M., D.C., and N.D. degree holders, or the equivalent, who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees for a minimum of 2 years (3 years for the General Research Loan Repayment Program (LRP)) in research areas supporting the mission and priorities of the NIH. The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized by Section 487A of the Public Health Service Act (42 U.S.C. 288-1); the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by Section 487E (42 U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is authorized by Section 487C (42 U.S.C. 288-3); the Loan Repayment Program Regarding Clinical Researchers (LRP-CR) is authorized by Section 487F (42 U.S.C. 288-5a); the Pediatric Research Loan Repayment Program (PR-LRP) is authorized by Section 487F (42 U.S.C. 288-6); the Extramural Clinical Research LRP for Individuals from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment to Section 487E (42 U.S.C. 288-5); the Contraception and Infertility Research LRP (CIR-LRP) is authorized by Section 487B (42 U.S.C. 288-2); and the Health Disparities Research Loan Repayment Program (HD-LRP) is authorized by Section 485G (42 U.S.C. 287c-33). The Loan Repayment Programs provide for the repayment of up to $35,000 a year of the principal and interest of the educational loan debt of qualified health professionals who agree to conduct qualifying research for each year of obligated service. The information proposed for collection will be used to determine an applicant's eligibility for participation in the program. Frequency of Response: Initial application and annual or biennial renewal application. Affected Public: Applicants, financial institutions, research institutions, recommenders. Type of Respondents: Physicians, other scientific or medical personnel, and organizational officials. The annual reporting burden is as follows:
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the 22nd 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 Electronic Health Records Workgroup Meeting
This notice announces the 21st 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 Electronic Health Records Workgroup Meeting
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 Confidentiality, Privacy, and Security Workgroup Meeting
This notice announces the 16th 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.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the 22nd 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 Personalized Healthcare Workgroup Meeting
This notice announces the 11th 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.).
Proposed Collection; Comment Request; Cancer Care for Uninsured Individuals: A Feasibility Study (NCI)
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) of 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.
Health Claims and Qualified Health Claims; Dietary Lipids and Cancer, Soy Protein and Coronary Heart Disease, Antioxidant Vitamins and Certain Cancers, and Selenium and Certain Cancers; Reevaluation; Opportunity for Public Comment
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on its intent to reevaluate the scientific evidence for two previously authorized health claims (dietary lipids (fat) and cancer; soy protein and risk of coronary heart disease) and two qualified health claims that were the subject of letters of enforcement discretion (antioxidant vitamins and risk of certain cancers; selenium and certain cancers). The agency is undertaking a reevaluation of the scientific basis for these authorized health claims and qualified health claims because of new scientific evidence that has emerged for these substance-disease relationships. The new scientific evidence may have the effect of weakening the substance-disease relationship for these authorized health claims and either strengthening or weakening the scientific support for the substance-disease relationship for these qualified health claims.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): Ten-Year Anniversary Symposium and Five-Year Plan
NICEATM invites attendance at a public symposium to mark the tenth anniversary of ICCVAM. The symposium, entitled ``Celebrating Ten Years of Advancing Public Health and Animal Welfare With Sound Science: Envisioning New Directions in Toxicology'' will be held February 5, 2008, at the U.S. Consumer Product Safety Commission (CPSC) Headquarters in Bethesda, MD. The NICEATM-ICCVAM Five-Year Plan (2008- 2012) will also be discussed and made available on February 5.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Home and Community-Based Alternatives (CBA) to Psychiatric Residential Treatment Facilities (PRTF) Demonstration (CBA-PRTF), System No. 09-70-0594.'' The demonstration, created by section 6063 of the Deficit Reduction Act of 2005 (Pub. L. 109-171), allows up to 10 states (as defined for purposes of title XIX of the Social Security Act (the Act)) to provide home and community-based services to youth as alternatives to PRTFs. The purpose of the demonstration is to test the effectiveness in improving or maintaining a child's functional level and cost effectiveness of providing coverage of home and community-based alternatives to psychiatric residential treatment for children enrolled in the Medicaid program under title XIX of the Act. The purpose of this system is to collect and maintain individually identifiable information on Medicaid recipients, and providers of services who voluntarily participate in the national evaluation of the CBA-PRTF. 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, or consultant; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicaid 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 litigation involving the agency; and (5) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new 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 proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Money Follows the Person (MFP) Demonstration (MFPD), System No. 09-70-0593.'' The demonstration, created by section 6071 of the Deficit Reduction Act of 2005 (Pub. L. 109-171), provides to states a total of $1.75 billion in competitive grants. MFP demonstration grants have been awarded to 30 states and the District of Columbia. The states and the District of Columbia are using the grant funding to transition Medicaid beneficiaries who need long-term care services from institutional-based care to community-based care. The purpose of the demonstration is to help states continue their efforts to restructure their long-term care systems and shift the historical emphasis from institutional care to community-based care. The demonstration is based on the premise that many Medicaid beneficiaries currently residing in institutions want to live in the community and could do so if they had the adequate support, and that it would cost less than Medicaid currently spends to care for institutional care. The purpose of this system is to collect and maintain individually identifiable information on Medicaid recipients, those who participate in the MFP demonstration and other comparable Medicaid recipients, and to collect and maintain program level information on grantee implementation of the MFP demonstration. 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, or consultant; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicaid 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 litigation involving the agency; and (5) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new 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 proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Government-Owned Inventions; Availability for Licensing
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.
Announcement of Potential Eligibility for Compensation Under Public Readiness and Emergency Preparedness Act Declaration and Filing Deadlines
This Notice provides notification that individuals who have been injured by pandemic, epidemic, or security countermeasures identified in a declaration issued by the Secretary pursuant to section 319F-3(b) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d- 6d) have one (1) year from the time they receive the covered countermeasure to file requests for compensation for injuries directly resulting from administration or use of covered countermeasures under the Public Readiness and Emergency Preparedness Act (PREP Act).
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 019
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 019'' (Recognition List Number: 019), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Solicitation of New Safe Harbors and Special Fraud Alerts
In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Government-Owned Inventions; Availability for Licensing
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
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.
Over-the-Counter Vaginal Contraceptive and Spermicide Drug Products Containing Nonoxynol 9; Required Labeling
The Food and Drug Administration (FDA) is issuing a final rule establishing new warning statements and other labeling information for all over-the-counter (OTC) vaginal contraceptive drug products (also known as spermicides, hereinafter referred to as vaginal contraceptives or vaginal contraceptives/spermicides) containing nonoxynol 9 (N9). These warning statements will advise consumers that vaginal contraceptives/spermicides containing N9 do not protect against infection from the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), or against getting other sexually transmitted diseases (STDs). The warnings and labeling information will also advise consumers that use of vaginal contraceptives and spermicides containing N9 can irritate the vagina and rectum and may increase the risk of getting the AIDS virus (HIV) from an infected partner. This final rule is part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, and all relevant data and information on N9 that have come to our attention.
State Children's Health Insurance Program (SCHIP); Additional Allotments To Eliminate FY 2007 Funding Shortfalls
This notice describes the methodology and process we are using for determining the amounts of certain States' remaining SCHIP funding shortfalls in Federal fiscal year (FY) 2007, in accordance with the provisions of the U.S. Troop Readiness, Veteran's Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007. This notice also contains the amounts of the additional allotments to be provided to such States to eliminate such FY 2007 funding shortfalls, determined in accordance with this methodology.
Revisit User Fee Program for Medicare Survey and Certification Activities
This interim final rule with comment period implements the continuation of the revisit user fee program for Medicare Survey and Certification activities, in accordance with the statutory authority in the Further Continuing Appropriations, 2008 Resolution (``Continuing Resolution'') budget legislation passed by the Congress and signed by the President on November 13, 2007. On September 19, 2007, we published a final rule that established a system of revisit user fees applicable to health care facilities that have been cited for deficiencies during initial certification, recertification or substantiated complaint surveys and require a revisit to confirm that previously-identified deficiencies have been corrected.
Part C HIV Early Intervention Services Grant
HRSA will be providing temporary critical HIV medical care and treatment services through Chase Brexton Health Services to avoid a disruption of HIV clinical care to homeless populations in the Baltimore, Maryland, area.
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 2 on Test for Extractable Volume of Parenteral Preparations General Chapter; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Test for Extractable Volume of Parenteral Preparations General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This is the second annex to the core Q4B guidance, which was made available in draft in August 2006 (71 FR 45059, August 8, 2006).
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3 on Test for Particulate Contamination: Subvisible Particles General Chapter; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Test for Particulate Contamination: Subvisible Particles General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This is the third annex to the core Q4B guidance, which was made available in draft in the Federal Register of August 8, 2006 (71 FR 45059).
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Pantex Plant, Amarillo, TX, To Be Included in the Special Exposure Cohort
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 Pantex Plant, Amarillo, Texas, 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: Pantex Plant. Location: Amarillo, Texas. Job Titles and/or Job Duties: Production workers, technicians, including radiography, guards, physical plant, maintenance, administrative and support staff, contractors, and Atomic Energy Commission staff. Period of Employment: January 1, 1950 through December 31, 1991.
Guidance for Industry and Food and Drug Administration Review Staff: Collection of Platelets by Automated Methods; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods,'' dated December 2007. The guidance document provides to blood establishments and FDA staff revised recommendations for the collection of Platelets by automated methods (plateletpheresis). The guidance is intended to help blood establishments ensure donor safety and the safety, purity, and potency of Platelets collected by an automated blood cell separator device. For the purpose of this document, Platelets collected by automated methods will be referred to by the product name ``Platelets, Pheresis.'' The document contains recommendations for appropriate criteria for a biologics license application or supplement for manufacturing Platelets, Pheresis. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2005, and supersedes the guidance entitled ``Revised Guideline for the Collection of Platelets, Pheresis,'' dated October 1988.
Additional Consolidated Health Information (CHI) Health Information Technology Standards
This notice identifies three (3) additional Consolidated Health Informatics (CHI) messaging and vocabulary standards (Multimedia, Allergy, and Disability and Assessments) adopted for use in Federal government health information technology systems. This work supplements the work to further the adoption of the first set of 5 standards adopted on March 21, 2003 and second set of 15 standards adopted on May 6, 2004, as published in the December 23, 2005 Federal Register (70 FR 76287). The CHI initiative began in October 2001 as one of 24 E-Government initiatives included in the President's Management Agenda (PMA). The CHI collaborative worked to adopt Federal government-wide health information interoperability standards to be implemented by Federal agencies in order to enable the Fedral government to exchange electronic health information. By publication of this document, we are informing the public of the adoption of three new CHI standards, Multimedia, Allergy and Disability and Assessment (adoption reports available at: https://www.hhs.gov/healthit/chiinitiative.html).
Expert Meeting on Disease Management Outcomes Measurement
This notice announces the date and location of the Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (HHS/ASPE) Expert Meeting on Disease Management Outcomes Measurement. The objective of the meeting is to convene a panel of experts from government, academia, and private industry to discuss measurement of the impact of disease management on health outcomes and costs of care, with a focus on potential for public sector programs.
New Animal Drugs for Use in Animal Feeds; Oxytetracycline
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 Pennfield Oil Co. that provides for a zero- day preslaughter withdrawal time following use of oxytetracycline in turkey and swine feed.
New Animal Drugs For Use in Animal Feeds; Ractopamine
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 Elanco Animal Health. The supplemental NADA provides for an increased level of monensin in three-way combination Type C medicated feeds containing ractopamine, melengestrol, and monensin for heifers fed in confinement for slaughter.
Quality System Regulation Educational Forum on Design Controls; Public Workshop; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of public workshop entitled ``Quality System Regulation Educational Forum on Design Controls.'' This workshop was announced in the Federal Register of October 11, 2007 (72 FR 57951). The amendment is made to reflect a change in the Location portion of the document. There are no other changes.
Privacy Act of 1974; New System of Records
In accordance with the requirements of the Privacy Act, the Centers for Disease Control and Prevention (CDC) is proposing to establish a new system of records (SOR), 09-20-0171, ``Quarantine and Traveler-Related Activities, Including Records for Contact Tracing Investigation and Notification Under 42 CFR Parts 70 and 71, HHS/CDC/ CCID.'' The purpose of the system is to maintain records on the conduct of activities (e.g., quarantine, isolation) that fulfill HHS's and CDC's statutory authority under sections 311 and 361-368 of the Public Health Service Act: To prevent the introduction, transmission and spread of serious communicable diseases from persons arriving into the United States from foreign countries or engaged in interstate or international movement. Identifiable records are collected when an individual known or suspected to have been exposed to such communicable diseases arrives in the U.S. from a foreign country or travels from one state or possession to another state or possession. These records are used to: (1) Document reports of illness on airplanes, maritime vessels, and at land-border crossings of persons that may pose a public health risk and who are arriving from foreign countries or traveling between states; (2) perform contact tracing investigations and notifications of passengers and crew when known or suspected exposures to serious communicable diseases occur on board a conveyance arriving in the United States from a foreign country or while traveling from one state or possession to another; (3) inform state or local public health authorities so that these authorities may act to protect public health or safety; and (4) take actions (e.g., quarantine or isolation) as necessary to prevent the introduction, transmission, and spread of serious communicable diseases from persons arriving into the United States from foreign countries or persons engaged in interstate or international movement. Additional background information about the new system is included in the SUPPLEMENTARY INFORMATION section below.
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee (TRR Subcommittee). The primary agenda topic is the peer review of the findings and conclusions presented in seven draft NTP Technical Reports of rodent toxicology and carcinogenicity studies in conventional rats and mice, one draft NTP Technical Report on a study in Crl:SKH-1 hairless mice, and one draft NTP Toxicity Report (see Preliminary Agenda below). The TRR Subcommittee meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on any draft report discussed at the meeting (see ``Request for Comments'' below). The TRR Subcommittee deliberations on the draft reports will be reported to the NTP Board of Scientific Counselors (BSC) at a future date.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health and Diet Survey
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Nuclear Materials and Equipment Corporation (NUMEC) in Apollo, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On November 29, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Notice of Public Meeting and Availability for Public Comment
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting and request for public comment on the draft Current Intelligence Bulletin (CIB) entitled ``Interim Guidance on Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/public/115/. Comments may be provided to the NIOSH docket, as well as given orally at the following meeting. Public Comment Period: December 14, 2007 through February 15, 2008. Public Meeting Time and Date: 9 a.m.-4 p.m., January 30, 2008. Place: Robert A. Taft Laboratories, Taft Auditorium, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Purpose of Meeting: To discuss and obtain comments on the draft CIB ``Interim Guidance on Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles.'' Special emphasis will be placed on discussion of the following: (1) Do the data support the conclusions of the document? (2) Are the conclusions appropriate in light of the current understanding of toxicological data? (3) Is medical surveillance appropriate at this time for workers with potential exposure to engineered nanoparticles; if so, what form(s) of medical surveillance are specific for such workers? (4) What are the potential benefits, adverse impacts, and limitations of medical screening of workers potentially exposed to engineered nanoparticles? (5) What are the potential benefits, adverse impacts, and limitations of establishing an exposure registry for workers exposed to engineered nanoparticles? Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public, limited only by the space available. The meeting room accommodates 80 people. Due to limited space and security clearance requirements, notification of intent to attend the meeting must be made to the NIOSH Docket Office no later than Friday, January 18, 2008. Persons wanting to provide oral comments at the meeting are requested to notify the NIOSH Docket Office no later than January 11, 2008 at 513/533-8611 or by e-mail at nioshdocket@cdc.gov. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first- come basis. Unreserved walk-in attendees will not be admitted due to security clearance requirements. Persons wanting to provide oral comments will be permitted up to 20 minutes. If additional time becomes available, presenters will be notified. Oral comments given at the meeting will be recorded and included in the docket. Written comments will also be accepted at the meeting. Written comments may also be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226, telephone 513/533-8611. All material submitted to the Agency should reference docket number NIOSH-115 and must be submitted by February 15, 2008 (public review closing date) to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. Please make reference to docket number NIOSH-115. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Background: Concerns have been raised about whether workers exposed to engineered nanoparticles will be at increased risk of adverse health effects and whether medical screening or some other type of occupational health surveillance is appropriate for these workers. Although increasing evidence indicates that exposure to some engineered nanoparticles can cause adverse health effects in laboratory animals, insufficient medical evidence exists to recommend the medical screening of workers potentially exposed to engineered nanoparticles. However, NIOSH will continue to assess the scientific evidence and periodically update the guidance on medical screening. Because occupational exposure to engineered nanoparticles is likely to become more common in the future, NIOSH has recommended that employers identify the presence of engineered nanoparticles in their workplace and implement effective efforts to minimize worker exposure to these materials [NIOSH 2006]. This guidance document does not have the force and effect of the law. Contact Persons for Technical Information: Dr. Paul A. Schulte, M/S C-14, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone 513/533-8302, or Ralph Zumwalde, M/S C-32, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone 513/533-8320. Reference: NIOSH [2006]. Approaches to safe nanotechnology: an information exchange with NIOSH. Cincinnati, OH: Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, July 2006. Web address for this document: https://www.cdc.gov/niosh/topics/nanotech/safenano/.
Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the certification to accompany human drug, biological product, and device applications or submissions.
Establishment of Fiscal Year 2008 User Fee Rates for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products
The Food and Drug Administration (FDA) is issuing this notice, as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), to establish the fiscal year (FY) 2008 fees that will be charged for each FY 2008 advisory review submission to FDA and to fund the operating reserve established under FDAAA. The Federal Food, Drug, and Cosmetic Act (the act), as amended by FDAAA, authorizes FDA to collect user fees for certain direct-to-consumer (DTC) television advertisements submitted to FDA for advisory review.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Presubmission Conferences, New Animal Drug Applications and Supporting Regulations and Guidance 152, and Form FDA 356V
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions; Extension
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Advisory Committees; Filing of Closed Meeting Reports
The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2007.
Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until February 11, 2008, the comment period for the proposed rule published in the Federal Register of October 19, 2005 (70 FR 60751), (herein after referred to as the 2005 proposed rule). In that document, FDA proposed to amend its regulations to provide for the use of fluid ultrafiltered (UF) milk in the manufacture of standardized cheeses and related cheese products. FDA received a number of comments that were opposed to the proposed requirement to declare fluid UF milk, when used, as ``ultrafiltered milk'' or ``ultrafiltered nonfat milk,'' as appropriate, in the ingredient statement of the finished cheese. FDA is reopening the comment period on the 2005 proposed rule to seek further comment only on two specific issues raised by the comments concerning the proposed ingredient declaration.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Communicating With Health Care Providers About the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women With Chronic Conditions
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 Mental Models Study of Communicating With Health Care Providers About the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women With Chronic Conditions. Together with other information being collected, the results from this study will be used to help inform FDA about how health care providers use prescription drug labeling and other available information in making treatment decisions and how that use differs from how agency experts believe such information is used. It will also contribute to FDA's ability to plan internal and external communications activities that address any misperceptions and gaps in understanding about prescription drug labeling.
Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals
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 requirements for reports of corrections and removal.
Office of Child Support Enforcement (OCSE); Privacy Act of 1974, as Amended; Computer Matching Program
In accordance with the Privacy Act of 1974, as amended, OCSE is publishing notice of a computer matching program between OCSE and state agencies administering the Temporary Assistance for Needy Families (TANF) program (state TANF agencies).
Office of Child Support Enforcement (OCSE); Privacy Act of 1974, as Amended; Computer Matching Program
In accordance with the Privacy Act of 1974, as amended, the Office of Child Support Enforcement (OCSE) is publishing notice of a computer matching program between OCSE and state agencies administering an unemployment compensation (UC) program under Federal or state law.
Privacy Act of 1974; Report of a Modified or Altered System
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Intern and Resident Information System (IRIS), System No. 09-70-0524, last published at 67 Federal Register 48189 (July 23, 2002). We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 5 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of published routine uses number 7 and 8, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers increasingly more to specific beneficiary or recipient practices that result in unnecessary cost to Federally-funded health benefit programs. We will delete the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' does not apply because this system does not collect or maintain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' is not applicable to the data maintained in this system. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS' intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or by Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the SOR is to ensure that no interns and residents (IRs) are counted by the Medicare program as more than one full-time equivalent (FTE) employee in the calculation of payments for the costs of direct graduate medical education (GME) and indirect medical education (IME). Information retrieved from this SOR will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor or consultant, (2) assist another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent, (3) support providers and suppliers of services, (4) assist third-party contacts where necessary to establish or verify information, (5) support litigation involving the Agency, and (6) combat fraud, waste, and abuse in certain 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 routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Customer Satisfaction Survey
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 days advance opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) in publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. 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 continued 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).
Implantation or Injectable Dosage Form New Animal Drugs; Erythromycin
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 Cross Vetpharm Group Ltd. The supplemental NADA provides for use of a 100 milligram per milliliter (mg/mL) strength erythromycin injectable solution in cattle for the treatment of bovine respiratory disease.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at Massachusetts Institute of Technology, Cambridge, MA, To Be Included in the Special Exposure Cohort
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 Massachusetts Institute of Technology, Cambridge, Massachusetts, 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: Massachusetts Institute of Technology. Location: Cambridge, Massachusetts. Job Titles and/or Job Duties: All Atomic Weapons Employer employees. Period of Employment: August 13, 1942 through December 31, 1945; and Job Titles and/or Job Duties: All employees of the Department of Energy (DOE), its predecessor agencies, and DOE contractors or subcontractors, who worked in the Hood Building. Period of Employment: January 13, 1946 through December 31, 1963.
Notice of Hearing: Reconsideration of Disapproval of New York State Children's Health Insurance Program (SCHIP) State Child Health Plan Amendment (SPA) #10
This notice announces an administrative hearing to be held on January 16, 2008, at the CMS New York Regional Office, 38-110A, 26 Federal Plaza, New York, New York 10278, to reconsider CMS' decision to disapprove New York SCHIP SPA 10. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by December 21, 2007.
Office of Community Services
This notice cancels the standing program announcement for the Assets for Independence (AFI) Program (HHS-2005-ACF-OCS-EI-0053) that was published in the Federal Register on February 2, 2005. A new standing program announcement for the AFI program will be published at the Administration for Children and Families' Grant Opportunities Web page at https://www.acf.hhs.gov/grants/. The new standing program announcement and application package will also be available at www.grants.gov. Interested parties should register with www.grants.gov to receive e-mail alerts announcing publication, application due dates, and application requirements.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at SAM Laboratories, Columbia University, New York, New York, To Be Included in the Special Exposure Cohort
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 SAM Laboratories, Columbia University, New York, New York, 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: SAM Laboratories, Columbia University. Location: New York, New York. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1942 through December 31, 1947.
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize the U.S. Food and Drug Administration (FDA, the agency) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. At this time, FDA is issuing final regulations to implement section 572 of the act entitled ``Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' These regulations establish administrative procedures and criteria for index listing a new animal drug for use in a minor species. Such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor species.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the renewal of the generic information collection project: ``Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (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 August 15, 2007 and allowed 60 days for public comment. No comments were received. A 30-day Federal Register notice was published on October 19, 2007 to allow an additional 30 days for public comment. No comments were received. However, changes to the estimated annual respondent burden hours and the methodologies that will be used for the data collection require an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection: Comment Request
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 ``Voluntary Questionnaire and Data Collection Testing to Pretest Home Health Care CAHPS Questions and Methodology.'' This activity is being conducted under AHRQ's generic pre-testing clearance OMB 0935-0125. In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. Sec. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
New Animal Drugs For Use in Animal Feeds; Monensin
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 Elanco Animal Health. The supplemental NADA revises the concentration of monensin in two-way Type B and Type C medicated feeds containing monensin and tylosin to cattle fed in confinement for slaughter and a revision to bacterial pathogen nomenclature.
New Animal Drugs For Use in Animal Feeds; Monensin USP
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 Elanco Animal Health. The supplemental NADA removes the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats.
Oral Dosage Form New Animal Drugs; Carprofen
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Belcher Pharmaceuticals, Inc. The ANADA provides for veterinary prescription use of carprofen caplets in dogs.
Submission for OMB Review; Comment Request; the Cardiovascular Health Study (CHS)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on September 12, 2007, page 52155, and allowed 60 days for public comment. One comment was 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, any 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: The Cardiovascular Health Study. Type of Information Request: Reinstatement (OMB No. 0925-0334). Need and Use of Information Collection: This study quantifies associations between conventional and hypothetical risk factors and coronary heart disease (CHD) and stroke in people age 65 years and older. The primary objectives include quantifying associations of risk factors with subclinical disease; characterizing the natural history of CHD and stroke; and identifying factors associated with clinical course. The findings provide important information on cardiovascular disease in an older U.S. population and lead to early treatment of risk factors associated with disease and identification of factors that may be important in disease prevention. OBM clearance is being sought for data collection activities at only one of the four CHS field centers (the Pittsburgh field center), which are expected to end on May 31, 2008. Other data collection efforts in the CHS cohort are supported by various non-contract funding sources. Frequency of response: Twice a year (participants) or once per cardiovascular disease event (proxies); Affected public: Individuals. Types of Respondents: Individuals recruited for CHS and their selected proxies. The annual reporting burden is as follows: Estimated Number of Respondents: 467; Estimated Number of Responses per Respondent: 1.2; and Estimated Total Annual Burden Hours Requested: 281. The annualized cost to respondents is estimated at: $5,225. There are no capital, operating, or maintenance costs to report.
Government-Owned Inventions; Availability for Licensing
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.
Medicare Program; Revisions to the Medicare Advantage and Part D Prescription Drug Contract Determinations, Appeals, and Intermediate Sanctions Processes
This rule with comment period finalizes the Medicare program provisions relating to contract determinations involving Medicare Advantage (MA) organizations and Medicare Part D prescription drug plan sponsors, including eliminating the reconsideration process for review of contract determinations, revising the provisions related to appeals of contract determinations, and clarifying the process for MA organizations and Part D plan sponsors to complete corrective action plans. In this final rule with comment period, we also clarify the intermediate sanction and civil money penalty (CMP) provisions that apply to MA organizations and Medicare Part D prescription drug plan sponsors, modify elements of their compliance plans, retain voluntary self-reporting for Part D sponsors and implement a voluntary self- reporting recommendation for MA organizations, and revise provisions to ensure HHS has access to the books and records of MA organizations and Part D plan sponsors' first tier, downstream, and related entities. Although we have decided not to finalize the mandatory self-reporting provisions that we proposed, CMS remains committed to adopting a mandatory self-reporting requirement. To that end, we are requesting comments that will assist CMS in crafting a future proposed regulation for a mandatory self-reporting requirement.
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