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For prior year communications, please see the Advocacy Archives

Letter dated 12/13/10 – Centers for Medicare and Medicaid Services and Food and Drug Administration [html], [text] or [PDF File] - Parallel Review of Medical Products; request for comments; 75 Fed. Reg. 57045 (September 17, 2010)  [PDF File] or [text]; Fact Sheet Summarizing Advocacy's Letter.

Letter dated 10/4/10 – Department of Health and Human Services, Centers for Medicare and Medicaid Services [html], [text] or [PDF File] - Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices; Proposed Rule ; 75 Fed. Reg. 43235 (July 23, 2010)  [PDF File] or [text]; Fact Sheet Summarizing Advocacy's Letter.

Letter dated 09/14/10 – Department of Health and Human Services, Centers for Medicare and Medicaid Services [html], [text] or [PDF File] - Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices; Proposed Rule ; 75 Fed. Reg. 43235 (July 23, 2010)  [PDF File] or [text]; Fact Sheet Summarizing Advocacy's Letter.

Letter dated 09/09/10 – Department of Health and Human Services, Office for Civil Rights [html], [text] or [PDF File] - Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act; 75 Fed. Reg. 40867 (July 14, 2010 )  [PDF File] or [text]; Fact Sheet Summarizing Advocacy's Letter.

Letter dated 05/10/10 – Department of Agriculture, Food and Safety Inspection Services [html], [text] or [PDF File] - Hazard Analysis and Critical Control Point (HAACP) system validation; Fact Sheet Summarizing Advocacy's Letter.

Letter dated 03/15/10 – Department of Health and Human Services, Centers for Medicare & Medicaid Services [html], [text] or [PDF File] - Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule; ; 75 Fed. Reg. 1844 January 13, 2010  [PDF File] or [text];  Fact Sheet Summarizing Advocacy's Letter.

Letter dated 12/11/09 - Department of Health and Human Services, Food and Drug Administration [html], [text] or [PDF File] - Regulation of Tobacco Products; Request for Comments; 74 Fed. Reg. 31457, July 1, 2009; [PDF File] or [text];   Fact Sheet Summarizing Advocacy's Letter

Letter dated 03/17/09 – Department of Health and Human Services, Centers for Medicare & Medicaid Services [html], [text] or [PDF File] - Medicare, Medicaid, and Clinical Laboratory Improvement Amendments of 1988 (CLIA) Program; Cytology Proficiency Testing (PT); 73 Fed. Reg. 3264 (January 16, 2009) [PDF File] or [text]; Fact Sheet Summarizing Advocacy's Letter

Letter dated 02/02/09 – Department of Agriculture, Animal and Plant Health Inspection Service [html], [text] or [PDF File] - Handling of Animals; Contingency Plans ; 73 Fed. Reg. 63085 (October 23, 2008) [PDF File] or [text]; Fact Sheet Summarizing Advocacy's Letter

Letter dated 12/17/08 – Department of Health and Human Services, Centers for Medicare & Medicaid Services [html], [text] or [PDF File] - Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; 73 Fed. Reg. 69725 (November 19, 2008) [PDF File] or [text]; Fact Sheet Summarizing Advocacy's Letter

Letter dated 10/09/08 – Social Security Administration [html], [text] or [PDF File] - Revised Medical Criteria for Evaluating Hearing Loss; 73 Fed. Reg. 47103 (August 13, 2008) [PDF File] or [text]; Fact Sheet Summarizing Advocacy's Letter

Letter dated 10/09/08 – United States Department of Agriculture, Animal and Plant health Inspection Service [html], [text] or [PDF File] - Viral Hemorrhagic Septicemia; Interstate Movement and Import Restrictions on Certain Live Fish; 73 Fed. Reg. 52173 (September 9, 2008) [PDF File] or [text]; Fact Sheet Summarizing Advocacy's Letter

Letter dated 02/28/08 – Department of Health and Human Services, Food and Drug Administration [html], [text] or [PDF File] - Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; 73 Fed. Reg. 197 (January 2, 2008) [PDF File] and 73 Fed. Reg. 196 (January 2, 2008) [PDF File];  Fact Sheet Summarizing Advocacy's Letter

Letter dated 09/13/07 - Department of Health and Human Services, Centers for Medicare & Medicaid Services [html], [text] or [PDF File] - Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); 72 Fed. Reg. 42001 (August 1, 2007).  [PDF File] or [text].  Fact Sheet Summarizing Advocacy's Letter.

Letter dated 02/16/07 - Department of Health and Human Services, Centers for Medicare & Medicaid Services [html], [text] or [PDF File] - Medicaid Program; Prescription Drugs; Proposed Rule; 71 Fed. Reg. 77174 (December 22, 2006).  [PDF File] or [text].  Fact Sheet Summarizing Advocacy's Letter.

Letter dated 05/04/06 - Department of Agriculture, Food Safety and Inspection Service [PDF File] or [text] - Regarding Notice of Proposed Rulemaking Availability of Lists of Retail Consignees during Meat or Poultry Product Recalls; 71 Fed. Reg. 11326; (March 7, 2006) [PDF File] or [text].Fact Sheet Summarizing Advocacy's Letter [PDF File].

Letter dated 01/18/05 - Centers for Medicare and Medicaid Services, Office of Strategic Operations and Regulatory Affairs [html], [text] or [PDF File] - Agency Information Collection Activities; Proposed Collection; Comment Request; 69 Fed. Reg. 67745 (November 19, 2004).  [PDF File] or [text].  Fact Sheet Summarizing Advocacy's Letter.

Letter dated 12/05/03 -  Department of Agriculture, Agricultural Marketing Service [html], [text], or [PDF File] - Proposed rule, Mandatory Country of Origin Labeling of Beef, Lamb, Pork, Fish, Perishable Agricultural commodities, and Peanuts; 68 Fed. Reg. 61944, (October 30, 2003) [PDF File] or [text]  Fact Sheet Summarizing Advocacy's Letter.

Letter dated 11/03/03 - Department of Health and Human Services, Center for Medicare and Medicaid Services  [html], [text] or [PDF File] - Proposed rule, Medicare Program; Changes to the Criteria for Being Classified as an Inpatient Rehabilitation Facility; 68 Fed. Reg. 53266 (September 9, 2003) [PDF File] or [text].  Fact Sheet Summarizing Advocacy's Letter.

Letter dated 04/07/03 - Department of Health and Human Services, Food and Drug Administration  [html], [text] or [PDF File] - Proposed rule, Dietary Supplements Containing Ephedrine Alkaloids, Reopening of the Comment Period; 68 Fed. Reg. 10417 (March 5, 2003) [PDF File] or [text].

Letter dated 11/27/02 - Department of Health and Human Services, Food and Drug Administration  [html], [text] or [PDF File] - Support for the Petition for Continuation of Stay of Action; FDA Final Rule on Policies, Requirements and   Procedures; Prescription Drug Marketing Act of 1987;  Prescription Drug Amendments of 1992 ; 64 Fed. Reg. 67720 (December 3, 1999) [PDF File].

Letter dated 07/18/02 -  Department of Health and Human Services, Centers for Medicare and Medicaid Services  [html], [text], or [PDF File]- Thank you regarding progress made between the Office of Advocacy and the Centers for Medicare and Medicaid Services on several important small business issues.

Letter dated 05/03/02 - Department of Health and Human Services, Center for Medicare and Medicaid Services [html], [text], or [PDF File] - Medicare Program; Medicare-Endorsed Prescription Drug Card Initiative; 67 Fed. Reg. 10262 (March 6, 2002) or [text],

Letter dated 12/28/01 - Department of Health and Human Services, Center for Medicare and Medicaid Services [html], [text], or [PDF File] - Medicare Program; Revisions to Payment Policies and Five-Year Review of and Adjustment to the Relative Value Units Under the Physician Fee Schedule for Calendar Year 2002; 66 Fed. Reg. 55245 (November 1, 2001).

Letter dated 12/0701 - Department of Agriculture,  Food Safety and Inspection Service [html], [text] or [PDF File] - Notice and Request for Comment on intentions to harmonize procedures with those of the Food and Drug Administration with respect to the target tissue/marker residue policy in testing animal tissues for residues of new animal drugs ; 66 Fed. Reg. 40964 (August 6, 2001) [PDF File] or [text].

Letter dated 11/05/01 - Department of Health and Human Services, Food and Drug Administration [html], [text], or [PDF File] - Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement; 66 Fed. Reg. 1508 (January 8, 2001) [PDF File] or [text].

Letter dated 08/16/01 - Department of Agriculture,   Food Safety and Inspection Service [html], [text] or [PDF File] -Labeling of Natural or Regenerated Collagen Sausage Casings; 66 Fed. Reg. 40843 (August 6, 2001) [PDF File] or [text].

Letter dated 03/30/01 - Department of Health and Human Services [html], [text], or [PDF File] - Final Rule on the Standards for Privacy of Individually Identifiable Health Information; 65 Fed. Reg. 82462 (December 28, 2000).

Letter dated 01/31/01 - Department of Health and Human Services, Health Care Financing Administration [html], [text], or [PDF File] - Interim Final Rule on the Use of Restraint and Seclusion in Psychiatric Residential Treatment Facilities Providing Psychiatric Services to Individuals Under Age 21; 66 Fed. Reg. 7148 (January 22, 2001) [PDF File].

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