Department of Health and Human Services September 17, 2010 – Federal Register Recent Federal Regulation Documents

Medicaid Program; Review and Approval Process for Section 1115 Demonstrations
Document Number: 2010-23357
Type: Proposed Rule
Date: 2010-09-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would implement provisions of section 10201(i) of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) that set forth transparency and public notice procedures for experimental, pilot, and demonstration projects approved under section 1115 of the Social Security Act relating to Medicaid and the Children's Health Insurance Program (CHIP). This proposed rule would increase the degree to which information about Medicaid and CHIP demonstration applications and approved demonstration projects are publicly available and promote greater transparency in the review and approval of demonstrations. It would also codify existing statutory requirements pertaining to tribal consultation for section 1115 demonstration projects.
Medicare Program; Workshop Regarding Accountable Care Organizations, and Implications Regarding Antitrust, Physician Self-Referral, Anti-Kickback, and Civil Monetary Penalty (CMP) Laws
Document Number: 2010-23340
Type: Notice
Date: 2010-09-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Federal Trade Commission, Agencies and Commissions, Office of the Inspector General
This notice announces a public workshop hosted by the Federal Trade Commission (FTC), the Centers for Medicare & Medicaid Services (CMS), and the Office of the Inspector General (OIG) of the Department of Health and Human Services (DHHS). This workshop will include panel discussions and a listening session on certain legal issues related to Accountable Care Organizations (ACOs). Physicians, physician associations, hospitals, health systems, consumers, and all others interested in ACOs are invited to participate, in person or by calling into the teleconference. The meeting is open to the public, but attendance is limited to space and teleconference lines available. An agenda will be posted on the CMS Web site at https://www.cms.gov/center/ physician.asp prior to the session.
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2010-23306
Type: Notice
Date: 2010-09-17
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2010-23275
Type: Notice
Date: 2010-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2010-23270
Type: Notice
Date: 2010-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2010-23268
Type: Notice
Date: 2010-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2010-23265
Type: Notice
Date: 2010-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; Comment Request; Recruitment and Screening for the Insight Into Determination of Exceptional Aging and Longevity (IDEAL) Study
Document Number: 2010-23263
Type: Notice
Date: 2010-09-17
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 the opportunity for public comment on proposed data collection projects, the National Institute on Aging (NIA), 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: Recruitment and Screening for the Insight into Determination of Exceptional Aging and Longevity (IDEAL) Study. Type of Information Collection Request: NEW. Need and Use of Information Collection: The purpose of the project for is to conduct recruitment and screening for the IDEAL Study. A multifaceted recruitment approach will be used to reach the target audience in a wide variety of ways. Those who are interested in participating in the IDEAL study will be asked to complete a two stage recruitment process consisting of a telephone interview and a physical exam. The Stage One interview consists of questions concerning demographics, physical ability, health status, and medical conditions. Those who are eligible after completing the telephone interview will be asked to complete the second stage of the screening process. The physical examination is a modified version of the full BLSA assessment protocol consisting of the following components: general appearance; vital signs; chest and heart auscultation; sensory systems including vision, hearing, sensory proprioception, neuropathy and balance; and movement and strength of the upper and lower extremities. In addition the potential participant will also be asked to complete physical performance tests, cognitive exams, an electrocardiogram and a blood draw. Frequency of Response: Once. Affected Public: Individuals or households. Type of Respondents: Healthy individuals who are at least 80 years of age. The annual reporting burden is as follows: Estimated Number of Respondents: 1,500; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.833; and Estimated Total Annual Burden Hours Requested: 701. There is no annualized cost to respondents. There are no Capital costs to report. There are no Operating or Maintenance Costs to report.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Reports: In Vitro Ocular Safety Testing Methods and Strategies, and Routine Use of Topical Anesthetics, Systemic Analgesics, and Humane Endpoints for Ocular Safety Testing; Notice of Transmittal to Federal Agencies
Document Number: 2010-23262
Type: Notice
Date: 2010-09-17
Agency: Department of Health and Human Services
NICEATM announces availability of ICCVAM TMERs that provide recommendations regarding proposed in vitro ocular safety testing methods, testing strategies, and the routine use of anesthetics, analgesics, and humane endpoints for ocular safety testing to avoid or minimize any pain and distress. The reports and recommendations have been transmitted to Federal agencies for their review and response to ICCVAM in accordance with the ICCVAM Authorization Act of 2000. In the first report, ICCVAM recommends pain management procedures that should always be used to avoid or minimize pain and distress when it is determined necessary to conduct the rabbit eye test for regulatory safety purposes. In the second report, ICCVAM recommends that the Cytosensor microphysiometer (CM) test method can be used as a screening test to identify some types of substances that may cause permanent or severe eye injuries. ICCVAM also recommends that the CM test method can be used to determine if some types of substances will not cause sufficient injury to require hazard labeling for eye irritation. ICCVAM evaluated four other in vitro test methods for their usefulness and limitations for identifying substances with the potential to cause reversible and nonsevere ocular injuries, but concluded that the performance of these methods must be improved before they can be used for regulatory safety testing to classify such substances. The report includes ICCVAM recommendations for future studies that could potentially improve these test methods. In the third report, ICCVAM recommends further studies to characterize the usefulness and limitations of a non-animal in vitro testing strategy that uses three in vitro test methods. In the fourth report, ICCVAM recommends that a proposed low volume rabbit eye test (LVET) should not be used for regulatory testing due to performance issues when compared to the current standard rabbit eye test.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2010-23260
Type: Notice
Date: 2010-09-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
Submission for OMB Review; Comment Request
Document Number: 2010-23253
Type: Notice
Date: 2010-09-17
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Parallel Review of Medical Products
Document Number: 2010-23252
Type: Notice
Date: 2010-09-17
Agency: Food and Drug Administration, Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. This process will serve the public interest by reducing the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs). The agencies are establishing a docket to receive information and comment from the public on what products would be appropriate for parallel review by the two agencies, what procedures should be developed, how a parallel review process should be implemented, and other issues related to the effective operation of the process. The agencies are also announcing their intent to create a pilot program for parallel review of medical devices. The pilot program will begin after both agencies have reviewed the public comments on this notice. A memorandum of understanding (MOU) concerning the exchange of data and information has been completed between the two agencies. See https://www.fda.gov/AboutFDA/ PartnershipsCollaborations/MemorandaofUnderstandingMOUs/Domes ticMOUs/ ucm217585.htm.
Decision To Evaluate a Petition To Designate a Class of Employees From the Grand Junction Operations Office, Grand Junction, CO, To Be Included in the Special Exposure Cohort
Document Number: 2010-23242
Type: Notice
Date: 2010-09-17
Agency: 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 from the Grand Junction Operations Office, Grand Junction, Colorado, 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: Grand Junction Operations Office. Location: Grand Junction, Colorado. Job Titles and/or Job Duties: All laborers, labor supervisors, painters, grounds personnel, and Fire Chief. Period of Employment: January 1, 1943 through July 31, 2010.
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2010-23241
Type: Notice
Date: 2010-09-17
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from the Blockson Chemical Company in Joliet, Illinois, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 3, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:
NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010
Document Number: 2010-23239
Type: Notice
Date: 2010-09-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the publication of the following document entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010.'' The document can be found at https://www.cdc.gov/niosh/docs/2010-167/. Background: The NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings was published in September 2004 (https://www.cdc.gov/niosh/docs/2004-165/). From that time until June 2007, approximately 60 new drugs have received FDA approval and approximately 60 drugs have received special warnings (usually black box warnings) based on reported adverse effects in patients. An additional 18 drugs were included from the updated NIH Hazardous Drug List. From this list of approximately 150 drugs, 62 drugs were determined to have one or more characteristic of a hazardous drug and published for comment in NIOSH Docket Number 105. After expert panel review, public review and comment, input from stakeholders and review of the scientific literature NIOSH proposed a second, draft list of hazardous drugs that was published in NIOSH Docket 105A. The second, draft list identified 24 drugs that fit the NIOSH definition of hazardous drugs. The second draft list also proposed removing Bacillus Calmette-Guerin (BCG), based on additional comments received by NIOSH. Following the second Federal Register Notice, BCG was reinstated to the list and a total of 21 new drugs were added to the 2004 list in Appendix A of the Alert. This guidance document does not have the force and effect of law.
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics Subcommittee (ES)
Document Number: 2010-23228
Type: Notice
Date: 2010-09-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2010-23207
Type: Notice
Date: 2010-09-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Information Collection Activity; Comment Request
Document Number: 2010-23200
Type: Notice
Date: 2010-09-17
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Flunisolide, etc.); Correction
Document Number: 2010-23195
Type: Rule
Date: 2010-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 14, 2010 (75 FR 19213). The document amended FDA's regulation on the use of ozone- depleting substances (ODSs) in self-pressurized containers to remove the essential-use designations for flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil used in oral pressurized metered-dose inhalers (MDIs). The document was published with an inadvertent error. This document corrects that error.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2010-23160
Type: Notice
Date: 2010-09-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2010-23110
Type: Notice
Date: 2010-09-17
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of the National Guideline Clearinghouse.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Patient Safety Organizations: Voluntary Delisting
Document Number: 2010-23077
Type: Notice
Date: 2010-09-17
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
AHRQ has accepted a notification of voluntary relinquishment from the Coalition for Quality and Patient Safety of Chicagoland (CQPS) of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21-b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.
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