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

Results 251 - 300 of 3,398
Statement of Organization, Functions, and Delegations of Authority
Document Number: 07-5866
Type: Notice
Date: 2007-11-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Sunscreen Drug Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph; Extension of Comment Period
Document Number: 07-5853
Type: Proposed Rule
Date: 2007-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending to December 26, 2007, the comment period for the August 27, 2007, proposed rule to amend the final monograph for over-the-counter (OTC) sunscreen drug products (72 FR 49070). The comment period for the proposed rule was to end on November 26, 2007. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the State Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2008 Through September 30, 2009
Document Number: 07-5847
Type: Notice
Date: 2007-11-28
Agency: Office of the Secretary, Department of Health and Human Services
The Federal Medical Assistance Percentages and Enhanced Federal Medical Assistance Percentages for Fiscal Year 2009 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2008 through September 30, 2009. This notice announces the calculated ``Federal Medical Assistance Percentages'' and ``Enhanced Federal Medical Assistance Percentages'' that The U.S. Department of Health and Human Services (HHS) will use in determining the amount of Federal matching for State medical assistance (Medicaid) and State Children's Health Insurance Program (SCHIP) expenditures, and Temporary Assistance for needy Families (TANF) Contingency Funds, the federal share of Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Funds, Foster Care Title IV-E Maintenance payments, and Adoption Assistance payments. The table gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. Programs under title XIX of the Act existing each jurisdiction. Programs under titles I, X, and XIV operate only in Guam and the Virgin Islands, while a program under the title XVI (Aid to the Aged, Blind, or Disabled) operates only in Puerto Rico. Programs under title XXI began operating in fiscal year 1998. The percentages in this notice apply to State expenditures for most medical services and medical insurance services, and assistance payments for certain social services. The statute provides separately for Federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Act require the Secretary, HHS to publish the Federal Medical Assistance Percentages each year. The Secretary is to calculate the percentages, using formulas in sections 1905(b) and 1101(a)(8)(B), from the Department of Commerce's statistics of average income per person in each State and for the Nation as a whole. The percentages are within the upper and lower limits given in section 1905(b) of the Act. The percentages to be applied to the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 states. The ``Federal Medical Assistance Percentages'' are for Medicaid. Section 1905(b) of the Act specifies the formula for calculating Federal Medical Assistance Percentages as follows:
National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy
Document Number: E7-23090
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
Behind the Counter Availability of Certain Drugs; Public Meeting; Comment Period Clarification
Document Number: E7-23026
Type: Notice
Date: 2007-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
In the Federal Register of October 4, 2007 (72 FR 56769), the Food and Drug Administration (FDA) published a notice that announced a public meeting to obtain comments regarding behind-the-counter (BTC) availability of human drugs. An incorrect date was published in that notice. This document clarifies that Docket No. 2007N-0356 will close on December 17, 2007.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-23015
Type: Notice
Date: 2007-11-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids
Document Number: E7-22991
Type: Proposed Rule
Date: 2007-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) proposes to issue this rule finding that certain nutrient content claims for foods, including conventional foods and dietary supplements, that contain omega-3 fatty acids, do not meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) and may not appear in food labeling. This rule is being proposed in response to three notifications submitted to FDA under the act. One notification concerning nutrient content claims for alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) was submitted collectively by Alaska General Seafoods, Ocean Beauty Seafoods, Inc., and Trans-Ocean Products, Inc. (the seafood processors notification); a second notification concerning nutrient content claims for ALA, DHA, and EPA was submitted by Martek Biosciences Corp. (the Martek notification); and a third notification concerning nutrient content claims for DHA and EPA was submitted by Ocean Nutrition Canada, Ltd. (the Ocean Nutrition notification). FDA has reviewed the information included in the three notifications and is proposing to prohibit the nutrient content claims for DHA and EPA set forth in the three notifications because they are not based on an authoritative statement that identifies a nutrient level to which the claims refer, as required by the controlling statutory authority. FDA is also proposing to prohibit the nutrient content claims for ALA set forth in the seafood processors notification because they are based on a daily value that was determined by a different method than daily values already established for other nutrients. Because of the different methodology used to set the daily value, the ALA claims set forth in the seafood processors notification do not enable the public to comprehend the information provided in the claims and to understand the relative significance of such information in the context of the daily diet, as required by the controlling statutory authority. FDA is proposing to take no regulatory action with respect to the nutrient content claims for ALA set forth in the Martek notification. Therefore, if this proposed rule is finalized without change, these claims will be allowed to remain on the market.
New Animal Drugs For Use in Animal Feeds; Fenbendazole
Document Number: E7-22987
Type: Rule
Date: 2007-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet Inc. The supplemental NADA provides for a revised food safety warning on labeling for fenbendazole Type A medicated article and Type B and Type C medicated horse feeds.
HIV/AIDS Bureau; Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements
Document Number: E7-22982
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice solicits comments on the HRSA proposed uniform waiver standards for Ryan White HIV/AIDS Program grantees requesting a core medical services waiver for Fiscal Year 2008 and beyond. Title XXVI of the Public Health Service Act (PHS) Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White HIV/AIDS Program) requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the legislation, effective Fiscal Year (FY) 2007. HRSA has issued guidance for obtaining a waiver for FY 2007 and seeks to issue waiver requirements for grantees under Parts A, B, and C of Title XXVI of the PHS Act for FY 2008 and future years.
Proposed Information Collection Activity; Comment Request
Document Number: 07-5842
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Information Collection Activity; Comment Request
Document Number: 07-5841
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: 07-5835
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: 07-5832
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: 07-5831
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates, the Ambulatory Surgical Center Payment System and CY 2008 Payment Rates, the Hospital Inpatient Prospective Payment System and FY 2008 Payment Rates; and Payments for Graduate Medical Education for Affiliated Teaching Hospitals in Certain Emergency Situations Medicare and Medicaid Programs: Hospital Conditions of Participation; Necessary Provider Designations of Critical Access Hospitals
Document Number: 07-5507
Type: Rule
Date: 2007-11-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. We describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2008. In addition, the rule sets forth the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which the final policies of the ASC payment system apply, and other pertinent rate setting information for the CY 2008 ASC payment system. Furthermore, this final rule with comment period will make changes to the policies relating to the necessary provider designations of critical access hospitals and changes to several of the current conditions of participation requirements. The attached document also incorporates the changes to the FY 2008 hospital inpatient prospective payment system (IPPS) payment rates made as a result of the enactment of the TMA, Abstinence Education, and QI Programs Extension Act of 2007, Public Law 110-90. In addition, we are changing the provisions in our previously issued FY 2008 IPPS final rule and are establishing a new policy, retroactive to October 1, 2007, of not applying the documentation and coding adjustment to the FY 2008 hospital-specific rates for Medicare-dependent, small rural hospitals (MDHs) and sole community hospitals (SCHs). In the interim final rule with comment period in this document, we are modifying our regulations relating to graduate medical education (GME) payments made to teaching hospitals that have Medicare affiliation agreements for certain emergency situations.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Revisions to the Payment Policies of Ambulance Services Under the Ambulance Fee Schedule for CY 2008; and the Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions
Document Number: 07-5506
Type: Rule
Date: 2007-11-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period addresses certain provisions of the Tax Relief and Health Care Act of 2006, as well as making other proposed changes to Medicare Part B payment policy. We are making these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This final rule with comment period also discusses refinements to resource-based practice expense (PE) relative value units (RVUs); geographic practice cost indices (GPCI) changes; malpractice RVUs; requests for additions to the list of telehealth services; several coding issues including additional codes from the 5-Year Review; payment for covered outpatient drugs and biologicals; the competitive acquisition program (CAP); clinical lab fee schedule issues; payment for renal dialysis services; performance standards for independent diagnostic testing facilities; expiration of the physician scarcity area (PSA) bonus payment; conforming and clarifying changes for comprehensive outpatient rehabilitation facilities (CORFs); a process for updating the drug compendia; physician self referral issues; beneficiary signature for ambulance transport services; durable medical equipment (DME) update; the chiropractic services demonstration; a Medicare economic index (MEI) data change; technical corrections; standards and requirements related to therapy services under Medicare Parts A and B; revisions to the ambulance fee schedule; the ambulance inflation factor for CY 2008; and amending the e-prescribing exemption for computer-generated facsimile transmissions. We are also finalizing the calendar year (CY) 2007 interim RVUs and are issuing interim RVUs for new and revised procedure codes for CY 2008. As required by the statute, we are announcing that the physician fee schedule update for CY 2008 is -10.1 percent, the initial estimate for the sustainable growth rate for CY 2008 is -0.1 percent, and the conversion factor (CF) for CY 2008 is $34.0682.
Determination That ELOXATIN (Oxaliplatin for Injection), 50 and 100 Milligrams Per Vial, Sterile Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: E7-22973
Type: Notice
Date: 2007-11-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that ELOXATIN (oxaliplatin for injection), 50 and 100 milligrams (mg) per vial, sterile lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for oxaliplatin sterile lyophilized powder for injection, 50 and 100 mg/ vial.
New Animal Drugs For Use in Animal Feeds; Florfenicol
Document Number: E7-22942
Type: Rule
Date: 2007-11-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for the use of florfenicol by veterinary feed directive (VFD) for the control of mortality in freshwater-reared salmonids due to furunculosis associated with Aeromonas salmonicida.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-22930
Type: Notice
Date: 2007-11-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-22920
Type: Notice
Date: 2007-11-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-22919
Type: Notice
Date: 2007-11-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIH Consensus Development Conference: Hydroxyurea Treatment for Sickle Cell Disease; Notice
Document Number: E7-22907
Type: Notice
Date: 2007-11-26
Agency: Department of Health and Human Services, National Institutes of Health
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Report on In Vitro
Document Number: E7-22906
Type: Notice
Date: 2007-11-26
Agency: Department of Health and Human Services
NICEATM announces availability of the ICCVAM Test Method Evaluation Report: In Vitro Ocular Toxicity Test Methods for Identifying Severe Irritants and Corrosives (NIH Publication 07-4517). The report describes four ocular toxicity test methods evaluated by ICCVAM: (1) The Bovine Corneal Opacity and Permeability [BCOP] test, (2) the Isolated Chicken Eye [ICE] test, (3) the Isolated Rabbit Eye [IRE] test, and (4) the Hen's Egg TestChorioallantoic Membrane [HET- CAM]. The report includes ICCVAM's (a) final test method recommendations on the use of these four in vitro test methods, (b) recommended test method protocols for future testing, (c) recommendations for further optimization and validation studies for these test methods, and (d) recommended reference substances for validation studies. The report recommends that the BCOP and ICE methods, with specific limitations for certain chemical classes and/or physical properties, can be used in a tiered testing strategy to determine ocular hazards, and substances that test positive can be classified as ocular corrosives or severe irritants without further testing in animals. The report also recommends that these in vitro test methods should be considered before using animals for ocular testing and used when determined appropriate. NICEATM also announces availability of the final Background Review Documents (BRDs) for the BCOP, ICE, IRE, and HET-CAM test methods (NIH Publications 06-4512, 06-4513, 06-4514, and 06-4515, respectively). These BRDs provide the data and analyses used to assess the current validation status of these four test methods for identifying ocular corrosives and severe irritants. Electronic copies of the ICCVAM Test Method Evaluation Report and the four BRDs are available from the NICEATM/ICCVAM Web site at https:// iccvam.niehs.nih.gov or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT). The ICCVAM Test Method Evaluation Report and the final BRDs have been forwarded to U.S. Federal agencies for regulatory and other acceptance considerations where applicable. Responses will be posted on the ICCVAM/NICEATM Web site as they are received.
Proposed Collection; Comment Request; Questionnaire Cognitive Interview and Pretesting (ARP/DCCPS/NCI)
Document Number: E7-22905
Type: Notice
Date: 2007-11-26
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Questionnaire Cognitive Interview and Pretesting. Type of Information Collection Request: NEW. Need and Use of Information Collection: The purpose of the data collection is to conduct cognitive interviews, focus groups, Pilot household interviews, and experimental research in laboratory and field settings, both for applied questionnaire evaluation and more basic research on response errors in surveys. The most common evaluation method is the cognitive interview, in which a questionnaire design specialist interviews a volunteer participant. The interviewer administers the draft survey questions as written, but also probes the participant in depth about interpretations of questions, recall processes used to answer them, and adequacy of response categories to express answers, while noting points of confusion and errors in responding. Interviews are generally conducted in small rounds of 10-15 interviews. When possible, cognitive interviews are conducted in the survey's intended mode of administration. Cognitive interviewing provides useful information on questionnaire performance at minimal cost and respondent burden. Similar methodology has been adopted by other federal agencies, as well as by academic and commercial survey organizations. There are no costs to respondents other than their time. The total estimated annualized burden hours are 600. Frequency of Response: Once. Affected Public: Individuals or households.
Office of the Director, National Institutes of Health; Amended Notice of Meeting
Document Number: 07-5814
Type: Notice
Date: 2007-11-26
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 07-5813
Type: Notice
Date: 2007-11-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 07-5812
Type: Notice
Date: 2007-11-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 07-5811
Type: Notice
Date: 2007-11-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 07-5810
Type: Notice
Date: 2007-11-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 07-5809
Type: Notice
Date: 2007-11-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 07-5808
Type: Notice
Date: 2007-11-26
Agency: Department of Health and Human Services, National Institutes of Health
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on Impurities in New Veterinary Drug Substances (Revision); Availability
Document Number: E7-22902
Type: Notice
Date: 2007-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (92) entitled ``Impurities in New Veterinary Drug Substances (Revision)'' VICH GL10(R). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The revised document is intended to provide guidance for registration applicants on the content and qualification of impurities in new veterinary drug substances produced by chemical syntheses and not previously registered in a country, region, or member state.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on Impurities in New Veterinary Medicinal Products (Revision); Availability
Document Number: E7-22901
Type: Notice
Date: 2007-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (93) entitled ``Impurities in New Veterinary Medicinal Products (Revision)'' VICH GL11(R). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revised document is intended to assist in developing registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. The revised guidance addresses only those impurities in new veterinary medicinal drug products classified as degradation products.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision); Availability
Document Number: E7-22900
Type: Notice
Date: 2007-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (73) entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision) VICH GL3(R).'' This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revised document is intended to provide guidance regarding the development of stability testing data for new animal drug applications (referred to as registration applications in the guidance) submitted to the European Union (EU), Japan, and United States.
Draft Guidance for Industry on Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention; Availability
Document Number: E7-22884
Type: Notice
Date: 2007-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention.'' In this draft guidance, FDA provides recommendations on the development of drugs to be used to treat or prevent smallpox (variola) infection. This guidance is intended to help sponsors plan and design appropriate studies during the development of these drugs.
New Animal Drugs For Use in Animal Feeds; Ractopamine
Document Number: E7-22882
Type: Rule
Date: 2007-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for an increased level of monensin in two-way combination Type B and Type C medicated feeds containing ractopamine hydrochloride and monensin for cattle fed in confinement for slaughter.
Government-Owned Inventions; Availability for Licensing
Document Number: E7-22821
Type: Notice
Date: 2007-11-23
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice to Extend Expiration Date
Document Number: E7-22818
Type: Notice
Date: 2007-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the expiration date of the compliance policy guide (CPG) entitled ``Sec. 400.210Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs'' to December 31, 2008.
Privacy Act of 1974; Report of a Modified or Altered System of Records
Document Number: E7-22817
Type: Notice
Date: 2007-11-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an SOR, ``Employee Building Pass File (EBP) System, System No. 09-70-3002,'' last published at 67 FR 40937 (June 14, 2002). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new assigned identifying number for this system should read: System No. 09-70-0529. We propose to modify existing routine use number 2 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 separately from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 3 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. Finally, 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's 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 because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (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 issue and control United States Government building passes issued to all CMS employees and non- CMS employees who require continuous access to CMS buildings in Baltimore and other CMS and HHS facilities. Information retrieved from this SOR will be used to: (1) Support regulatory and policy functions performed within the Agency or by a contractor, consultant, or grantee; (2) assist other Federal agencies with activities related to this system; and (3) support litigation involving the Agency. 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 proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-22811
Type: Notice
Date: 2007-11-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-22809
Type: Notice
Date: 2007-11-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-22808
Type: Notice
Date: 2007-11-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicaid Integrity Program; Eligible Entity and Contracting Requirements for the Medicaid Integrity Audit Program
Document Number: E7-22773
Type: Proposed Rule
Date: 2007-11-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Section 1936 of the Social Security Act (the Act) (as added by section 6034 of the Deficit Reduction Act of 2005 (DRA)) established the Medicaid Integrity Program to promote the integrity of the Medicaid program by requiring CMS to enter into contracts with eligible entities to: Review the actions of individuals or entities furnishing items or services (whether on a fee-for-service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of such plan approved under section 1115 of the Act; audit claims for payment of items or services furnished, or administrative services rendered, under a State plan; identify overpayments to individuals or entities receiving Federal funds; and educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This proposed rule would provide requirements for an eligible entity to enter into a contract under the Medicaid integrity audit program. The proposed rule would also establish the contracting requirements for eligible entities. The requirements would include procedures for identifying, evaluating, and resolving organizational conflicts of interest that are generally applicable to Federal acquisition and procurement; competitive procedures to be used; and procedures under which a contract may be renewed.
Medicare and Medicaid Programs; Waiver of Disapproval of Nurse Aide Training Program in Certain Cases and Nurse Aide Petition for Removal of Information for Single Finding of Neglect
Document Number: E7-22629
Type: Proposed Rule
Date: 2007-11-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would permit a waiver of nurse aide training disapproval as it applies to skilled nursing facilities, in the Medicare program, and nursing facilities, in the Medicaid program, that are assessed a civil money penalty of at least $5,000 for noncompliance that is not related to quality of care. This is a statutory provision enacted by section 932 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108- 173, enacted December 8, 2003.) In addition, this proposed rule would codify an additional statutory provision enacted by section 4755 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted on August 5, 1997) that requires the State to establish a procedure to permit a nurse aide to petition the State to have a single finding of neglect removed from the nurse aide registry if the State determines that the employment and personal history of the nurse aide does not reflect a pattern of abusive behavior or neglect and the neglect involved in the original finding was a single occurrence.
Medicare and Medicaid Programs; Approval of the American Osteopathic Association's Deeming Authority for Critical Access Hospitals
Document Number: E7-22628
Type: Notice
Date: 2007-11-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces our decision to approve the American Osteopathic Association (AOA) for recognition as a national accreditation program for critical access hospitals (CAHs) seeking to participate in the Medicare or Medicaid programs.
Medicare Program; Listening Session on Hospital-Acquired Conditions and Present on Admission Indicator Reporting, December 17, 2007
Document Number: 07-5801
Type: Notice
Date: 2007-11-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a listening session being conducted as part of the selection of Hospital-Acquired Conditions (HAC) and implementation of Present on Admission (POA) Indicator Reporting, as authorized by section 5001(c) of the Deficit Reduction Act of 2005 (DRA). The purpose of this listening session is to solicit informal comments in preparation for the fiscal year 2009 inpatient prospective payment system (IPPS) rulemaking process. Hospitals, hospital associations, representatives of consumer purchasers, payors of health care services, and all interested parties are invited to attend and make comments in person or in writing. It will also be possible to listen to the session by teleconference. However, because of time constraints, telephone participants will not be able to make verbal comments. Informal written comments will be accepted. This meeting is open to the public, but registration is required due to limited space and security requirements to enter the meeting location. This Listening Session is being held as a joint partnership between the Centers for Medicare & Medicaid Services and Centers for Disease Control and Prevention.
Memorandum of Understanding Between the Food and Drug Administration and Duke University
Document Number: 07-5793
Type: Notice
Date: 2007-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Duke University. The purpose of this MOU is to establish the terms of collaboration between FDA and Duke, beginning with an initiative to strengthen Human Subjects Protection by reexamining and modernizing the conduct of clinical trials to ensure that design, execution, and analysis are of optimal quality. To this end, Duke will be the convener of a Public Private Partnership, to which FDA will be a founding partner, to systematically modernize the clinical trial process.
Submission for OMB Review; Comment Request
Document Number: 07-5788
Type: Notice
Date: 2007-11-23
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
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