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

Agency Information Collection Request; 60-Day Public Comment Request
Document Number: E8-22976
Type: Notice
Date: 2008-09-30
Agency: Department of Health and Human Services
Notice of Meeting; National Commission on Children and Disasters
Document Number: E8-22939
Type: Notice
Date: 2008-09-30
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the First Meeting of the National Commission on Children and Disasters, Department of Health and Human Services. The meeting will be held from approximately 8:30 a.m. to 5 p.m. on Tuesday, October 14, 2008, at the Administration for Children and Families, 370 L'Enfant Promenade, SW., Washington, DC. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).
National Cancer Institute; Notice of Closed Meetings
Document Number: E8-22921
Type: Notice
Date: 2008-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Antiviral Drugs Advisory Committee; Notice of Meeting
Document Number: E8-22912
Type: Notice
Date: 2008-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2009 Proposed Guidance Development
Document Number: E8-22911
Type: Notice
Date: 2008-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the Web location where the agency will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development in fiscal year (FY) 2009. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E8-22896
Type: Notice
Date: 2008-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E8-22895
Type: Notice
Date: 2008-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E8-22894
Type: Notice
Date: 2008-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive License: Therapeutics Based on Histone Deacetylase (HDAC) Inhibitors for the Prevention and Treatment of Central Nervous System (CNS) Metastases of Extra-CNS Origin Cancers
Document Number: E8-22893
Type: Notice
Date: 2008-09-30
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Application 60/891,856 filed February 27, 2007 (E-084-2007/0-US-01) and International Application PCT/US2008/055149 filed February 27, 2008 (E-084-2007/0- PCT-02), entitled ``Use of Histone Deacetylase Inhibitors for the Treatment of Central Nervous System Metastases,'' to Waypharm S.A.S. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be the United States and Europe, and the field of use may be limited to therapeutics based on CNS metastases of extra-CNS origin cancers.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: E8-22892
Type: Notice
Date: 2008-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: E8-22889
Type: Notice
Date: 2008-09-30
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.
Notice of Meeting of the Advisory Committee on Organ Transplantation
Document Number: E8-22821
Type: Notice
Date: 2008-09-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the fourteenth meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 8:30 a.m. to 5 p.m. on November 13, 2008, and from 8:30 a.m. to 3 p.m. on November 14, 2008, at the Hilton Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).
OIG Supplemental Compliance Program Guidance for Nursing Facilities
Document Number: E8-22796
Type: Notice
Date: 2008-09-30
Agency: Department of Health and Human Services, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
This Federal Register notice sets forth the supplemental compliance program guidance (CPG) for nursing facilities developed by the Office of Inspector General (OIG). OIG is supplementing its prior CPG for nursing facilities issued in 2000. The supplemental CPG contains new compliance recommendations and an expanded discussion of risk areas. The supplemental CPG takes into account Medicare and Medicaid nursing facility payment systems and regulations, evolving industry practices, current enforcement priorities (including the Government's heightened focus on quality of care), and lessons learned in the area of nursing facility compliance. The supplemental CPG provides voluntary guidelines to assist nursing facilities in identifying significant risk areas and in evaluating and, as necessary, refining ongoing compliance efforts.
Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
Document Number: E8-22833
Type: Rule
Date: 2008-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly. We are using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. In the proposed rule section of this issue of the Federal Register, we are concurrently proposing and soliciting comments on this rule. If significant adverse comments are received, we will withdraw this final rule and address the comments in a subsequent final rule. FDA will not provide additional opportunity for comment.
Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs; Companion Document to Direct Final Rule
Document Number: E8-22829
Type: Proposed Rule
Date: 2008-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend our regulations to require that the holder of a new drug application (NDA) submit certain information in an annual report regarding authorized generic drugs. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly.
Proposed Information Collection Activity; Comment Request
Document Number: E8-22754
Type: Notice
Date: 2008-09-29
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Information Collection Activity; Comment Request
Document Number: E8-22752
Type: Notice
Date: 2008-09-29
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
Document Number: E8-22731
Type: Notice
Date: 2008-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's requirements on content and format of labeling for human prescription drug and biological products.
Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
Document Number: E8-22730
Type: Rule
Date: 2008-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to include vitamin D so that, in addition to the claim for calcium and osteoporosis, an additional claim can be made for calcium and vitamin D and osteoporosis; eliminate the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; eliminate the requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis; eliminate the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make it optional; eliminate the requirement that the claim include a statement that a total dietary intake greater than 200 percent of the recommended daily intake (2,000 milligrams (mg) of calcium) has no further benefit to bone health when the food contains 400 mg or more of calcium per reference amount customarily consumed or per total daily recommended supplement intake; and allow reference for the need of physical activity in either of the health claims to be optional rather then required. This final rule is, in part, in response to a health claim petition submitted by The Beverage Institute for Health and Wellness, LLC.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-22729
Type: Notice
Date: 2008-09-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-22728
Type: Notice
Date: 2008-09-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
Proposed Information Collection Activity; Comment Request
Document Number: E8-22722
Type: Notice
Date: 2008-09-29
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Medicare and Medicaid Programs; Approval of Det Norske Veritas Healthcare, Inc. for Deeming Authority for Hospitals
Document Number: E8-22585
Type: Notice
Date: 2008-09-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces our decision to approve Det Norske Veritas Healthcare, Inc. (DNVHC) for recognition as a national accreditation program for hospitals seeking to participate in the Medicare or Medicaid programs.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-22698
Type: Notice
Date: 2008-09-26
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: E8-22693
Type: Rule
Date: 2008-09-26
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: (1) 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; (2) audit claims for payment of items or services furnished, or administrative services rendered, under a State plan; (3) identify overpayments to individuals or entities receiving Federal funds; and (4) educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This final rule will provide requirements for an eligible entity to enter into a contract under the Medicaid integrity audit program. The final rule will also establish the contracting requirements for eligible entities. The requirements will 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.
Statement of Organization, Functions, and Delegations of Authority
Document Number: E8-22690
Type: Notice
Date: 2008-09-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Draft Guidance for Industry on End-of-Phase 2A Meetings; Availability
Document Number: E8-22669
Type: Notice
Date: 2008-09-26
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 ``End-of-Phase 2A Meetings.'' This draft guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs) who seek guidance on employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, disease, placebo) to design trials for better dose response estimation, dose selection, and other appropriate issues. This draft guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and to improve the quality of drug applications through early meetings with sponsors.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: E8-22668
Type: Notice
Date: 2008-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
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.
National Institutes of Health
Document Number: E8-22611
Type: Notice
Date: 2008-09-26
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/689,746, filed June 10, 2005, now abandoned [HHS Ref. No. E-089-2005/0-US-01]; PCT Patent Application No. PCT/ US2006/22401, filed June 7, 2006, now abandoned [HHS Ref. No. E-089- 2005/0-US-02]; U.S. Patent Application No. 11/917,036, filed December 10, 2007 [HHS Ref. No. E-089-2005/0-US-03]; European Patent Application No. 06772641.4, filed December 7, 2007, which published as 1888064 on February 20, 2008 [HHS Ref. No. E-089-2005/0-EP-04]; Australian Patent Application No. 2006258035, filed November 30, 2007 [HHS Ref. No. E- 089-2005/0-AU-05]; Japanese Patent Application No. 2008-515947, filed December 7, 2007 [HHS Ref. No. E-089-2005/0-JP-06]; and Canadian Patent Application No. 2609577, filed November 23, 2007 [HHS Ref. No. E-089- 2005/0-CA-07], all of which are entitled ``Benztropinamine Analogs as Dopamine Uptake Inhibitors'' (Inventors: Amy Newman and Jonathan Katz, NIDA) to Shire LLC, having an office in at least Basingstoke, United Kingdom. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of benztropinamine analogs, specifically, compounds derived from Formula I, wherein B is NR \4\ and wherein R \4\ is not CH3 (methyl group) to treat psychiatric and neurological disorders.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-22610
Type: Notice
Date: 2008-09-26
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-22608
Type: Notice
Date: 2008-09-26
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.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: E8-22607
Type: Notice
Date: 2008-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: E8-22605
Type: Notice
Date: 2008-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting
Document Number: E8-22604
Type: Notice
Date: 2008-09-26
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Revisions to the Medicare Advantage and Part D Prescription Drug Contract Determinations, Appeals, and Intermediate Sanctions Processes; Correcting Amendment
Document Number: E8-22592
Type: Rule
Date: 2008-09-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In the December 5, 2007 issue of the Federal Register, we published a final rule finalizing 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 sponsors to complete corrective action plans. In that final rule, we also clarified the intermediate sanction and civil money penalty provisions that apply to MA organizations and Part D sponsors, modified elements of MA organizations and Part D sponsors' compliance plans, retained voluntary self-reporting for Part D sponsors, implemented voluntary self-reporting for MA organizations, and revised provisions to ensure HHS has access to the books and records of MA organizations and Part D sponsors' first tier, downstream, and related entities. This correcting amendment corrects a limited number of technical and typographical errors identified in the December 5, 2007 final rule.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-November 19, 2008
Document Number: E8-22591
Type: Notice
Date: 2008-09-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, November 19, 2008. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of computed tomography colonography (CTC), also referred to as virtual colonoscopy, as a cancer screening test for average risk individuals (See section 1861(pp) of the Social Security Act (42 U.S.C. section 1395x(pp))). The meeting will discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2009
Document Number: E8-22589
Type: Notice
Date: 2008-09-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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, 2009. The 2009 AIC threshold amounts are $120 for ALJ hearings and $1,220 for judicial review.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-22584
Type: Notice
Date: 2008-09-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-22582
Type: Notice
Date: 2008-09-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Medicare Program; Termination of Non-Random Prepayment Complex Medical Review
Document Number: E8-22307
Type: Rule
Date: 2008-09-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule implements requirements regarding the termination of non-random prepayment complex medical review as required under the Medicare Prescription Drug, Improvement and Modernization Act of 2003. This final rule sets forth the criteria CMS contractors will use for terminating a provider or supplier from non-random prepayment complex medical review.
State Parent Locator Service; Safeguarding Child Support Information
Document Number: E8-22054
Type: Rule
Date: 2008-09-26
Agency: Department of Health and Human Services, Administration for Children and Families, Office of Child Support Enforcement, Children and Families Administration
The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) created and expanded State and Federal title IV-D child support enforcement databases and significantly enhanced access to information for title IV-D child support purposes. States are moving toward integrated service delivery and developing enterprise architecture initiatives to link their program databases. This final rule prescribes requirements for: State Parent Locator Service responses to authorized location requests; and State IV-D program safeguarding of confidential information and authorized disclosures of this information. This rule restricts the use of confidential data and information to child support purposes, with exceptions for certain disclosures permitted by statute.
Medicare Program; Announcement of Meeting of the Advisory Panel on Medicare Education, October 22, 2008
Document Number: E8-21910
Type: Notice
Date: 2008-09-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, this notice announces a meeting of Advisory Panel on Medicare Education (the Panel). 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. This meeting is open to the public.
Exemption of Certain Systems of Records Under the Privacy Act
Document Number: E8-21909
Type: Rule
Date: 2008-09-26
Agency: Office of the Secretary, Department of Health and Human Services
This final rule exempts four systems of records (SORs) from subsections (c)(3), (d)(1) through (d)(4), (e)(4)(G) and (H), and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2): The Automated Survey Processing Environment (ASPEN) Complaint/ Incidents Tracking System (ACTS), HHS/CMS, System No. 09-70-0565; the Health Insurance Portability and Accountability Act (HIPAA) Information Tracking System (HITS), HHS/CMS, System No. 09-70-0544; the Organ Procurement Organizations System (OPOS), HHS/CMS, System No. 09-70-0575; and the Fraud Investigation Database (FID), HHS/CMS, System No. 09-70-0527.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2008
Document Number: E8-21594
Type: Notice
Date: 2008-09-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2008 through June 2008, 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
Document Number: E8-22636
Type: Notice
Date: 2008-09-25
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-22594
Type: Notice
Date: 2008-09-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: E8-22580
Type: Notice
Date: 2008-09-25
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.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
Document Number: E8-22577
Type: Notice
Date: 2008-09-25
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.