Health Care - Regulations
- Proposed Rule - Medicare Program: Proposed Hospice Wage Index (Fiscal Year 2010)
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program:
Proposed Hospice Wage Index (Fiscal Year 2010)
,
18912-18970 [E9-9417]
Part IV Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Parts 405 and 418 Medicare Program; Proposed Hospice Wage Index for Fiscal Year 2010; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 405 and 418 [CMS-1420-P] RIN 0938-AP45 Medicare Program; Proposed Hospice Wage Index for Fiscal Year 2010 AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Proposed rule; request... [read document]
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(April 23, 2009) - Rule - Substances Prohibited From Use in Animal Food or Feed: Confirmation of Effective Date of ...
Food and Drug Administration
Rule
Substances Prohibited From Use in Animal Food or Feed:
Confirmation of Effective Date of Final Rule
,
18626-18628 [E9-9466]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 589 [Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46 Substances Prohibited From Use in Animal Food or Feed; Confirmation of Effective Date of Final Rule AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; confirmation of effective date. SUMMARY: The Food and Drug Administration (FDA) is confirming the effective date of April 27, 2009, for the final rule that published in the... [read document]
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(April 23, 2009) - Rule - Medicaid Program: Disproportionate Share Hospital Payments; Correcting Amendment
Centers for Medicare and Medicaid Services
Rule
Medicaid Program:
Disproportionate Share Hospital Payments; Correcting Amendment
,
18656-18657 [E9-9232]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 447 and 455 [CMS-2198-F2] RIN-0938-AN09 Medicaid Program; Disproportionate Share Hospital Payments; Correcting Amendment AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Final rule; correcting amendment. SUMMARY: This correcting amendment corrects a technical error in the regulations text in the final rule published in the Federal Register on December 19, 2008 (73 FR 77904)... [read document]
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(April 23, 2009) - Rule - Oral Dosage Form New Animal Drugs: Fenbendazole Suspension
Food and Drug Administration
Rule
Oral Dosage Form New Animal Drugs:
Fenbendazole Suspension
,
17770 [E9-8822]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2009-N-0665] Oral Dosage Form New Animal Drugs; Fenbendazole Suspension AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: 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 human food safety warning for use... [read document]
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(April 16, 2009) - Proposed Rule - State Parent Locator Service; Safeguarding Child Support Information: Proposed ...
Children and Families Administration
Proposed Rule
State Parent Locator Service; Safeguarding Child Support Information: Proposed Delay of Effective Date
,
17445-17446 [E9-8542]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families 45 CFR Parts 302, 303 and 307 RIN 0970-AC01 State Parent Locator Service; Safeguarding Child Support Information: Proposed Delay of Effective Date AGENCY: Administration for Children and Families (ACF), Department of Heath and Human Services. ACTION: Proposed delay of effective date. SUMMARY: In accordance with the Memorandum of January 20, 2009, from the Assistant to the President and Chief of Staff entitled... [read document]
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(April 14, 2009) - Proposed Rule - Substances Prohibited From Use in Animal Food or Feed
Food and Drug Administration
Proposed Rule
Substances Prohibited From Use in Animal Food or Feed
,
16160-16161 [E9-8127]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 589 [Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Notice of proposed delay of effective date. SUMMARY: The Food and Drug Administration (FDA) is seeking public comment on a contemplated delay of 60 days in the effective date of the rule... [read document]
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(April 8, 2009) - Rule - Medicaid Program: State Flexibility for Medicaid Benefit Packages
Centers for Medicare and Medicaid Services
Rule
Medicaid Program:
State Flexibility for Medicaid Benefit Packages
,
15221-15222 [E9-7505]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 440 [CMS-2232-F2] RIN 0938-AP72 Medicaid Program; State Flexibility for Medicaid Benefit Packages AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Final rule; delay of effective date and reopening of comment period. SUMMARY: This action temporarily delays the effective date of the December 3, 2008 final rule entitled, ``Medicaid Program: State Flexibility for Medicaid Benefit... [read document]
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(April 1, 2009) - Rule - Revision of Organization and Conforming Changes to Regulations
Food and Drug Administration
Rule
Revision of Organization and Conforming Changes to Regulations
,
14720-14725 [E9-7349]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 5 [Docket No. FDA-2009-N-0144] Revision of Organization and Conforming Changes to Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organizational changes in the agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy... [read document]
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(March 30, 2009) - Rule - Medical Devices: Technical Amendment
Food and Drug Administration
Rule
Medical Devices:
Technical Amendment,
14478 [E9-7073]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 [Docket No. FDA-2009-N-0141] Medical Devices; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending a medical device regulation to correct a statutory reference to reflect the current citation and to ensure accuracy and clarity in the agency's regulations. DATES: This rule is effective March 31, 2009.... [read document]
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(March 29, 2009) - Rule - Medicaid Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, etc.
Centers for Medicare and Medicaid Services
Rule
Medicaid Program:
Surety Bond Requirement for Suppliers of Durable Medical Equipment, etc.
,
13345-13346 [E9-6778]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 424 [CMS-6006-F2] RIN 0938-AO84 Medicare Program; Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Correcting Amendment AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Final rule; correcting amendment. SUMMARY: This correcting amendment corrects a technical error in the amendatory instructions of the... [read document]
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(March 25, 2009) - Rule - Medicaid Program: Premiums and Cost Sharing
Centers for Medicare and Medicaid Services
Rule
Medicaid Program:
Premiums and Cost Sharing
,
13346-13348 [E9-6907]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 447 and 457 [CMS-2244-F3] RIN 0938-A047 Medicaid Program; Premiums and Cost Sharing AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Final rule; delay of effective date and reopening of comment period. SUMMARY: This action temporarily delays the effective date of the November 25, 2008 final rule entitled, ``Medicaid Program; Premiums and Cost Sharing'' (73 FR 71828) until... [read document]
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(March 25, 2009) - Rule - Change of Addresses and Names; Technical Amendment
Food and Drug Administration
Rule
Change of Addresses and Names; Technical Amendment
,
13111-13114 [E9-6795]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 26, 201, 203, 206, 310, 312, 314, 320 and 600 [Docket No. FDA-2009-N-0133] Change of Addresses and Names; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending its regulations to reflect a change of address for the Center for Drug Evaluation and Research's (CDER's) Central Document Room in Beltsville,... [read document]
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(March 24, 2009) - Rule - New Animal Drugs for Use in Animal Feeds; CFR Correction
Food and Drug Administration
Rule
New Animal Drugs for Use in Animal Feeds; CFR Correction
,
13114 [E9-6810]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds CFR Correction In title 21 of the Code of Federal Regulations, part 558, revised as of April 1, 2008, on page 410, in Sec. 558.58 (e)(1)(iii), the entry for Bambermycins 1 to 3, in the column under ``Limitations'' remove ``057926'' and in its place add ``016592''; in the column under ``Sponsors'', add ``016592''. [FR Doc. E9-6810 Filed 3-25-09; 8:45 am] BILLING CODE... [read document]
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(March 24, 2009) - Rule - State Parent Locator Service; Safeguarding Child Support Information
Children and Families Administration
Rule
State Parent Locator Service; Safeguarding Child Support Information
,
11879-11880 [E9-6165]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Office of Child Support Enforcement 45 CFR Parts 302, 303 and 307 RIN 0970-AC01 State Parent Locator Service; Safeguarding Child Support Information AGENCY: Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), Department of Health and Human Services. ACTION: Delay of effective date. SUMMARY: In accordance with the memorandum of January 20, 2009, from the Assistant to the... [read document]
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(March 18, 2009) - Rule - Implantation or Injectable Dosage Form New Animal Drugs: Tylosin
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs:
Tylosin,
11643-11644 [E9-6009]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 [Docket No. FDA-2009-N-0665] Implantation or Injectable Dosage Form New Animal Drugs; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: 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 changing scientific... [read document]
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(March 17, 2009) - Rule - Food Additives Permitted for Direct Addition to Food for Human Consumption: Silver ...
Food and Drug Administration
Rule
Food Additives Permitted for Direct Addition to Food for Human Consumption:
Silver Nitrate and Hydrogen Peroxide
,
11476-11478 [E9-5852]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 172 [Docket No. FDA-2005-F-0505] (formerly Docket No. 2005F-0138) Food Additives Permitted for Direct Addition to Food for Human Consumption; Silver Nitrate and Hydrogen Peroxide AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of an aqueous solution of silver nitrate and hydrogen... [read document]
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(March 16, 2009) - Rule - Food Additives Permitted for Direct Addition to Food for Human Consumption: Vitamin D
Food and Drug Administration
Rule
Food Additives Permitted for Direct Addition to Food for Human Consumption:
Vitamin D
,
11019-11022 [E9-5549]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 172 [Docket No. FDA-2007-F-0274] (formerly Docket No. 2007F-0355) Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of vitamin D2 as a nutrient supplement in soy-based food products. This action is in... [read document]
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(March 14, 2009) - Rule - Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: ...
Food and Drug Administration
Rule
Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling:
Cochineal Extract and Carmine Declaration; Confirmation of Effective Date
,
10483 [E9-5286]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 73 and 101 [Docket No. FDA-1998-P-0032] (formerly Docket No. 1998P-0724) Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; confirmation of effective date. SUMMARY: The Food and Drug Administration (FDA) is confirming the effective date of... [read document]
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(March 9, 2009) - Rule - Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: ...
Food and Drug Administration
Rule
Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling:
Sevoflurane
,
10484 [E9-4879]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 529 [Docket No. FDA-2009-N-0665] Other Dosage Form New Animal Drugs; Sevoflurane AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: 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 Abbott Laboratories, Inc. The supplemental NADA provides for a revised induction dose of sevoflurane... [read document]
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(March 9, 2009) - Rule - Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: ...
Food and Drug Administration
Rule
Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling:
Amprolium
,
10483-10484 [E9-5131]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2009-N-0665] Oral Dosage Form New Animal Drugs; Amprolium AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for the use of generic amprolium... [read document]
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(March 9, 2009) - Proposed Rule - Rescission of the Regulation entitled "Ensuring That Department of ...
Department of Health and Human Services
Proposed Rule
Rescission of the Regulation entitled "Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law",
10207-10211 [E9-5067]
DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 88 RIN 0991-AB49 Rescission of the Regulation Entitled ``Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law''; Proposal AGENCY: Office of the Secretary, HHS. ACTION: Proposed rule. SUMMARY: The Department of Health and Human Services proposes to rescind the December 19, 2008 final rule entitled ``Ensuring That Department of Health and Human... [read document]
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(March 8, 2009) - Rule - New Animal Drugs; Change of Sponsor: Methoxyflurane
Food and Drug Administration
Rule
New Animal Drugs; Change of Sponsor:
Methoxyflurane
,
9766-9767 [E9-4758]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 529 [Docket No. FDA-2009-N-0665] New Animal Drugs; Change of Sponsor; Methoxyflurane AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Schering-Plough Animal Health, Inc., to Medical Developments International, Ltd. DATES: This... [read document]
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(March 5, 2009) - Rule - Astringent Drug Products That Produce Aluminum Acetate; Skin Protectant Drug Products ...
Food and Drug Administration
Rule
Astringent Drug Products That Produce Aluminum Acetate; Skin Protectant Drug Products for Over-the-Counter Human Use; Technical Amendment
,
9759-9765 [E9-4746]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 310 and 347 [Docket No. FDA-1978N-0007] (Formerly Docket No. 78N-021A) RIN 0910-AF42 Astringent Drug Products That Produce Aluminum Acetate; Skin Protectant Drug Products for Over-the-Counter Human Use; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: We (Food and Drug Administration (FDA)) are amending the final monograph (FM) for over-the-counter... [read document]
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(March 5, 2009) - Rule - New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
Food and Drug Administration
Rule
New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
,
9765-9766 [E9-4813]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 314 [Docket No. FDA-2009-N-0099] New Drug Applications and Abbreviated New Drug Applications; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to update agency contacts for patent information and patent notifications... [read document]
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(March 5, 2009) - Proposed Rule - Office for Human Research Protections; Institutional Review Boards
Department of Health and Human Services
Proposed Rule
Office for Human Research Protections; Institutional Review Boards
,
9578-9583 [E9-4628]
DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 46 Office for Human Research Protections; Institutional Review Boards AGENCY: Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science, Office for Human Research Protections. ACTION: Advanced notice of proposed rulemaking; request for comments. SUMMARY: The Office for Human Research Protections (OHRP), Office of Public Health and Science is seeking information and comments on whether OHRP should... [read document]
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(March 4, 2009) - Proposed Rule - Quality Assurance Requirements for Respirators
Department of Health and Human Services
Proposed Rule
Quality Assurance Requirements for Respirators,
9381 [E9-4621]
DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 84 [Docket Number NIOSH-109] RIN 0920-AA04 Quality Assurance Requirements for Respirators AGENCY: Department of Health and Human Services. ACTION: Notice of proposed rulemaking; Reopening of comment period and notice of public meetings. SUMMARY: The Department of Health and Human Services (HHS) is reopening the comment period until April 10, 2009 and will hold public meetings concerning the proposed rule for Quality Assurance Requirements for... [read document]
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(March 3, 2009) - Proposed Rule - Approval Tests and Standards for Closed-Circuit Escape Respirators
Department of Health and Human Services
Proposed Rule
Approval Tests and Standards for Closed-Circuit Escape Respirators,
9380-9381 [E9-4620]
DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 84 [Docket Number NIOSH-005] RIN 0920-AA10 Approval Tests and Standards for Closed-Circuit Escape Respirators AGENCY: Centers for Disease Control and Prevention, HHS. ACTION: Notice of proposed rulemaking; Reopening of comment period and notice of public meetings. SUMMARY: The Department of Health and Human Services (DHHS) is reopening the comment period until April 10, 2009 and will hold public meetings concerning the proposed rule for... [read document]
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(March 3, 2009) - Rule - State Parent Locator Service; Safeguarding Child Support Information: Proposed Delay of ...
Children and Families Administration
Rule
State Parent Locator Service; Safeguarding Child Support Information:
Proposed Delay of Effective Date
,
9171 [E9-4527]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families 45 CFR Parts 302, 303 and 307 RIN 0970-AC01 State Parent Locator Service; Safeguarding Child Support Information: Proposed Delay of Effective Date AGENCY: Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), Department of Heath and Human Services ACTION: Proposed delay of effective date. SUMMARY: In accordance with the memorandum of January 20, 2009, from the Assistant to the... [read document]
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(March 2, 2009) - Rule - Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin,
9049 [E9-4304]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 [Docket No. FDA-2009-N-0665] Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA adds claims for... [read document]
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(March 1, 2009) - Rule - Medicare Program: Changes to the Medicare Claims Appeal Procedures; Continuation of ...
Centers for Medicare and Medicaid Services
Rule
Medicare Program:
Changes to the Medicare Claims Appeal Procedures; Continuation of Effectiveness and Extension of Timeline for Publication
,
8867-8868 [E9-4223]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 401 and 405 [CMS-4064-RCN2] RIN 0938-AM73 Medicare Program; Changes to the Medicare Claims Appeal Procedures; Continuation of Effectiveness and Extension of Timeline for Publication of Final Rule AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Interim final rule with comment period; continuation of effectiveness and extension of timeline for publication of final rule.... [read document]
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(February 26, 2009) - Rule - Maximum Civil Money Penalty Amounts and Compliance, etc.: Confirmation of Effective Date
Food and Drug Administration
Rule
Maximum Civil Money Penalty Amounts and Compliance, etc.:
Confirmation of Effective Date,
8200 [E9-3831]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 17 [Docket No. FDA-2008-N-0561] Maximum Civil Money Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule; confirmation of effective date. SUMMARY: The Food and Drug Administration (FDA) is confirming the effective date of March 27, 2009, for the direct final rule that appeared in... [read document]
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(February 23, 2009) - Rule - Medicare Program: Changes to the Competitive Acquisition of Certain Durable Medical ...
Centers for Medicare and Medicaid Services
Rule
Medicare Program:
Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008
,
7653-7654 [E9-3491]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 414 [CMS-1561-IFC2] RIN 0938-AP59 Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Delay of effective date. SUMMARY: In accordance with the... [read document]
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(February 18, 2009) - Rule - Oral Dosage Form New Animal Drugs: Tiamulin
Food and Drug Administration
Rule
Oral Dosage Form New Animal Drugs:
Tiamulin
,
7180 [E9-3131]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2009-N-0665] Oral Dosage Form New Animal Drugs; Tiamulin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: 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 Novartis Animal Health US, Inc. The supplemental NADA provides for removal of a 250-pound weight restriction... [read document]
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(February 12, 2009) - Rule - Implantation or Injectable Dosage Form New Animal Drugs: Flunixin
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs:
Flunixin,
6993-6994 [E9-2941]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 [Docket No. FDA-2008-N-0039] Implantation or Injectable Dosage Form New Animal Drugs; Flunixin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The supplemental ANADA provides for the... [read document]
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(February 11, 2009) - Proposed Rule - Medicare Program: Changes to the Competitive Acquisition of Certain Durable ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program:
Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies; Correction,
7029 [Z9-2839]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 414 [CMS-1561-NC] RIN 0938-AP59 Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) Correction In proposed rule document E9-2839 beginning on page 6557 in the issue of Tuesday, February 10, 2009, make the following... [read document]
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(February 11, 2009) - Rule - New Animal Drugs: Bc6 Recombinant Deoxyribonucleic Acid Construct
Food and Drug Administration
Rule
New Animal Drugs:
Bc6 Recombinant Deoxyribonucleic Acid Construct,
6823-6824 [E9-2881]
Rules and Regulations Federal Register DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 528 [Docket No. FDA-2009-N-0665] New Animal Drugs; Bc6 Recombinant Deoxyribonucleic Acid Construct AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by GTC Biotherapeutics, Inc. The NADA... [read document]
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(February 10, 2009) - Rule - Applications for Food and Drug Administration Approval to Market a New Drug; ...
Food and Drug Administration
Rule
Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports:
Reporting Information about Authorized Generic Drugs; Withdrawal
,
6541 [E9-2746]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 314 [Docket No. FDA-2008-N-0341] Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs; Withdrawal AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule; withdrawal. SUMMARY: The Food and Drug Administration (FDA) published in the Federal Register of September 29, 2008 (73 FR 56487), a direct final rule... [read document]
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(February 9, 2009) - Proposed Rule - Medicare Program: Changes to the Competitive Acquisition of Certain Durable ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program:
Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)
,
6557-6558 [E9-2839]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 414 [CMS-1561-NC] RIN 0938-AP59 Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) ACTION: Notice of proposed delay of effective date. SUMMARY: In accordance with the memorandum of January 20, 2009 from the... [read document]
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(February 9, 2009) - Rule - Applications for Food and Drug Administration Approval to Market a New Drug; ...
Food and Drug Administration
Rule
Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports:
Ivermectin Paste
,
6541-6542 [E9-2749]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2008-N-0039] Oral Dosage Form New Animal Drugs; Ivermectin Paste AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA provides for use of ivermectin oral... [read document]
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(February 9, 2009) - Proposed Rule - Request for Public Comment Concerning Regulations for Transferring Children ...
Children and Families Administration
Proposed Rule
Request for Public Comment Concerning Regulations for Transferring Children from the Placement and Care Responsibility of a State Title IV-E Agency:
Tribal Title IV-E Agency and Tribal Share of Title IV-E Administration and Training Expenditures; Withdrawal
,
6362 [E9-2236]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families 45 CFR Parts 1355 and 1356 Request for Public Comment Concerning Regulations for Transferring Children From the Placement and Care Responsibility of a State Title IV-E Agency to a Tribal Title IV-E Agency and Tribal Share of Title IV-E Administration and Training Expenditures AGENCY: Department of Health and Human Services, Administration for Children and Families, Administration on Children, Youth and Families.... [read document]
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(February 8, 2009) - Rule - Medicaid Program: State Flexibility for Medicaid Benefit Packages; Delay of Effective Date
Centers for Medicare and Medicaid Services
Rule
Medicaid Program:
State Flexibility for Medicaid Benefit Packages; Delay of Effective Date,
5808-5809 [E9-2186]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 440 [CMS-2232-IFC] RIN 0938-A048 Medicaid Program; State Flexibility for Medicaid Benefit Packages: Delay of Effective Date AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Interim final rule with comment period: delay of effective date and reopening of the comment period. SUMMARY: In accordance with the memorandum of January 20, 2009, from the Assistant to the President and... [read document]
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(February 1, 2009) - Rule - Medicaid Program: Premiums and Cost Sharing
Centers for Medicare and Medicaid Services
Rule
Medicaid Program:
Premiums and Cost Sharing
,
4888-4889 [E9-1771]
Part IV Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Parts 447 and 457 Medicaid Program; Premiums and Cost Sharing; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 447 and 457 [CMS-2244-F2] RIN 0938-A047 Medicaid Program; Premiums and Cost Sharing AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Final rule; delay of effective date and reopening of comment period.... [read document]
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(January 26, 2009) - Proposed Rule - Regulations for Transferring Children from the Placement and Care ...
Children and Families Administration
Proposed Rule
Regulations for Transferring Children from the Placement and Care Responsibility of a State Title IV-E Agency to a Tribal Title IV-E Agency; Tribal Share of Title IV-E Administration and Training Expenditures
,
4365-4367 [E9-1338]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families 45 CFR Parts 1355 and 1356 Request for Public Comment Concerning Regulations for Transferring Children From the Placement and Care Responsibility of a State Title IV-E Agency to a Tribal Title IV-E Agency and Tribal Share of Title IV-E Administration and Training Expenditures AGENCY: Administration on Children, Youth and Families, Administration for Children and Families, Department of Health and Human Services.... [read document]
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(January 25, 2009) - Rule - Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY ...
Centers for Medicare and Medicaid Services
Rule
Medicare Program:
Changes to the Hospital Outpatient Prospective Payment System and CY 2009 Payment Rates, etc.
,
4343-4344 [E9-1519]
Rules and Regulations Federal Register DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 410, 416 and 419 [CMS-1404-CN] RIN 0938-AP17; RIN 0938-AL80; RIN 0938-AH17 Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and CY 2009 Payment Rates; Changes to the Ambulatory Surgical Center Payment System and CY 2009 Payment Rates; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant... [read document]
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(January 25, 2009) - Rule - Health Insurance Reform; Modifications to the Health Insurance Portability and ...
Department of Health and Human Services
Rule
Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards,
3296-3328 [E9-740]
Part VI Department of Health and Human Services 45 CFR Part 162 Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA); Final Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 45 CFR Part 162 [CMS-0009-F] RIN 0938-AM50 Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards AGENCY: Office of the Secretary, HHS. ACTION: Final rule. SUMMARY:... [read document]
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(January 15, 2009) - Rule - Medicare Program: Changes to the Competitive Acquisition of Certain Durable Medical ...
Centers for Medicare and Medicaid Services
Rule
Medicare Program:
Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS), etc.,
2873-2881 [E9-863]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 414 [CMS-1561-IFC] RIN 0938-AP59 Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Interim final rule with comment period. SUMMARY: This... [read document]
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(January 15, 2009) - Rule - Requirements for Submission of Bioequivalence Data
Food and Drug Administration
Rule
Requirements for Submission of Bioequivalence Data,
2849-2862 [E9-884]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 314 and 320 [Docket No. FDA-2003-N-0209] (Formerly Docket No. 2003N-0341) RIN 0910-AC23 Requirements for Submission of Bioequivalence Data; Final Rule AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending its regulations on the submission of bioequivalence data to require an abbreviated new drug application (ANDA) applicant to submit data from... [read document]
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(January 15, 2009) - Rule - Medicare Program: Medicare Advantage and Prescription Drug Programs MIPPA Drug Formulary ...
Centers for Medicare and Medicaid Services
Rule
Medicare Program:
Medicare Advantage and Prescription Drug Programs MIPPA Drug Formulary and Protected Classes Policies,
2881-2888 [E9-783]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 423 [CMS 4138-IFC4] RIN 0938-AP24 Medicare Program: Medicare Advantage and Prescription Drug Programs MIPPA Drug Formulary and Protected Classes Policies AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Interim final rule with comment period. SUMMARY: This interim final rule with comment period revises the regulations governing the Medicare prescription drug benefit... [read document]
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(January 15, 2009) - Rule - Office of Global Health Affairs: Regulation on the Organizational Integrity of Entities ...
Department of Health and Human Services
Rule
Office of Global Health Affairs:
Regulation on the Organizational Integrity of Entities That Are Implementing Programs and Activities Under the Leadership Act; Correction,
2888-2889 [E9-843]
DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Parts 88 and 89 RIN 0991-AB46 Office of Global Health Affairs: Regulation on the Organizational Integrity of Entities That Are Implementing Programs and Activities Under the Leadership Act; Correction OFFICE: Office of Global Health Affairs, HHS. ACTION: Rule; Correction. SUMMARY: This document corrects technical errors that appeared in the final rule published in the Federal Register on December 24, 2008, entitled ``Regulation on the... [read document]
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(January 15, 2009) - Rule - HIPAA Administrative Simplification: Modifications to Medical Data Code Set Standards ...
Department of Health and Human Services
Rule
HIPAA Administrative Simplification: Modifications to Medical Data Code Set Standards to Adopt ICD-10-CM and ICD-10-PCS,
3328-3362 [E9-743]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 45 CFR Part 162 [CMS-0013-F] RIN 0958-AN25 HIPAA Administrative Simplification: Modifications to Medical Data Code Set Standards To Adopt ICD-10-CM and ICD-10-PCS AGENCY: Office of the Secretary, HHS. ACTION: Final rule. SUMMARY: This final rule adopts modifications to two of the code set standards adopted in the Transactions and Code Sets final rule published in the Federal Register pursuant to certain provisions of the... [read document]
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(January 15, 2009) - Rule - Institutional Review Boards; Registration Requirements
Food and Drug Administration
Rule
Institutional Review Boards; Registration Requirements
,
2358-2369 [E9-682]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 56 [Docket No. FDA-2004-N-0117] (formerly Docket No. 2004N-0242) RIN 0910-AB88 Institutional Review Boards; Registration Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA, we) is issuing a final rule to require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). The... [read document]
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(January 14, 2009) - Proposed Rule - Milk and Cream Products and Yogurt Products: Proposal to Revoke the Standards ...
Food and Drug Administration
Proposed Rule
Milk and Cream Products and Yogurt Products:
Proposal to Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and to Amend the Standard for Yogurt
,
2443-2460 [E9-736]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 131 [Docket No. FDA-2000-P-0126] (formerly Docket No. 2000P-0685) Milk and Cream Products and Yogurt Products; Proposal to Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and to Amend the Standard for Yogurt AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to revoke its regulations on the standards of identity for lowfat yogurt... [read document]
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(January 14, 2009) - Rule - Oral Dosage Form New Animal Drugs: Phenylbutazone Tablets and Boluses
Food and Drug Administration
Rule
Oral Dosage Form New Animal Drugs:
Phenylbutazone Tablets and Boluses,
1146 [E9-265]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2008-N-0039] Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets and Boluses AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: 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 First Priority, Inc. The supplemental application provides for revising the... [read document]
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(January 11, 2009) - Rule - Listing of Color Additives Exempt From Certification: Food, Drug, and Cosmetic Labeling; ...
Food and Drug Administration
Rule
Listing of Color Additives Exempt From Certification:
Food, Drug, and Cosmetic Labeling; Cochineal Extract and Carmine Declaration,
207-217 [E8-31253]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 73 and 101 [Docket No. FDA-1998-P-0032] (formerly Docket No. 1998P-0724) RIN 0910-AF12 Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is revising its requirements for cochineal extract and carmine by requiring their... [read document]
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(January 4, 2009) - Rule - Medical, Immunology and Microbiology Devices: Tiamulin
Food and Drug Administration
Rule
Medical, Immunology and Microbiology Devices:
Tiamulin,
6 [E8-31128]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2008-N-0039] New Animal Drugs for Use in Animal Feeds; Tiamulin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Novartis Animal Health US, Inc. The supplemental NADAs provide for removal of a 250-pound weight... [read document]
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(January 1, 2009) - Rule - Medical, Immunology and Microbiology Devices: Classification of Enterovirus Nucleic Acid ...
Food and Drug Administration
Rule
Medical, Immunology and Microbiology Devices:
Classification of Enterovirus Nucleic Acid Assay,
6-8 [E8-31213]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2008-N-0517] Medical Devices; Immunology and Microbiology Devices; Classification of Enterovirus Nucleic Acid Assay AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying enterovirus nucleic acid assay into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class... [read document]
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(January 1, 2009) - Rule - Ophthalmic and Topical Dosage Form New Animal Drugs: Triamcinolone Cream
Food and Drug Administration
Rule
Ophthalmic and Topical Dosage Form New Animal Drugs:
Triamcinolone Cream,
79318 [E8-30694]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0039] 21 CFR Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs; Triamcinolone Cream AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The ANADA provides for veterinary... [read document]
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(December 28, 2008) - Rule - Food Additives Permitted in Feed and Drinking Water of Animals; CFR correction
Food and Drug Administration
Rule
Food Additives Permitted in Feed and Drinking Water of Animals; CFR correction,
78958-78959 [E8-30840]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 Food Additives Permitted in Feed and Drinking Water of Animals CFR Correction In title 21 of the Code of Federal Regulations, parts 500 to 599, revised as of April 1, 2008, on pages 551 and 552, in Sec. 573.640, in paragraphs (b)(4)(i) and (b)(4)(ii), before the words ``at the National Archives and Records Administration (NARA)'', insert the words ``available for inspection''. [FR Doc. E8-30840 Filed 12-23-08;... [read document]
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(December 23, 2008) - Rule - New Animal Drugs: Tylosin
Food and Drug Administration
Rule
New Animal Drugs:
Tylosin,
76946-76947 [E8-29861]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0039] 21 CFR Parts 520 and 558 New Animal Drugs; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Elanco Animal Health. The supplemental NADAs provide for use of tylosin tartrate soluble powder in drinking water... [read document]
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(December 17, 2008) - Proposed Rule - Withdrawal of Certain Proposed Rules and Other Proposed Actions
Food and Drug Administration
Proposed Rule
Withdrawal of Certain Proposed Rules and Other Proposed Actions,
75625-75626 [E8-29331]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2008-N-0622] Withdrawal of Certain Proposed Rules and Other Proposed Actions AGENCY: Food and Drug Administration, HHS. ACTION: Notice of withdrawal. SUMMARY: The Food and Drug Administration (FDA) is announcing the withdrawal of a certain advance notice of proposed rulemaking (ANPRM) and proposed rules (NPRMs) that published in the Federal Register more than 5 years ago. These proposals are no... [read document]
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(December 11, 2008) - Rule - New Animal Drugs for Use in Animal Feeds: Ractopamine
Food and Drug Administration
Rule
New Animal Drugs for Use in Animal Feeds:
Ractopamine,
75323-75324 [E8-29177]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2008-N-0039] New Animal Drugs for Use in Animal Feeds; Ractopamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for an... [read document]
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(December 10, 2008) - Rule - Uniform Compliance Date for Food Labeling Regulations
Food and Drug Administration
Rule
Uniform Compliance Date for Food Labeling Regulations,
74349-74350 [E8-28920]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2000-N-0011] (formerly Docket No. 2000N-1596) Uniform Compliance Date for Food Labeling Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is establishing January 2, 2012, as the uniform compliance date for food labeling regulations that are issued between January 1, 2009, and December 31, 2010. (January 1, 2012, falls on a... [read document]
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(December 7, 2008) - Rule - New Animal Drugs: Ractopamine
Food and Drug Administration
Rule
New Animal Drugs:
Ractopamine,
72714-72715 [E8-28384]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 556 and 558 [Docket No. FDA-2008-N-0039] New Animal Drugs; Ractopamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for use of ractopamine hydrochloride Type A medicated articles to make Type B and Type... [read document]
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(November 30, 2008) - Rule - New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Revocation of Order ...
Food and Drug Administration
Rule
New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Revocation of Order of Prohibition; Withdrawal,
71923 [E8-28093]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 530 [Docket No. FDA-2008-N-0326] New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Revocation of Order of Prohibition; Withdrawal AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; withdrawal. SUMMARY: The Food and Drug Administration (FDA) is revoking the order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals. FDA received many substantive... [read document]
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(November 25, 2008) - Rule - Oral Dosage Form New Animal Drugs: Amprolium; Correction
Food and Drug Administration
Rule
Oral Dosage Form New Animal Drugs:
Amprolium; Correction,
70276 [E8-27646]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2008-N-0039] Oral Dosage Form New Animal Drugs; Amprolium; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Correcting amendments. SUMMARY: The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) that appeared in the Federal Register of August 6, 2008 (73 FR 45610).... [read document]
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(November 19, 2008) - Rule - Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and ...
Food and Drug Administration
Rule
Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis,
66754 [E8-26868]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2004-P-0205 (formerly Docket No. 2004P-0464)] Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, September 29, 2008 (73 FR 56477). The final rule was... [read document]
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(November 11, 2008) - Rule - Maximum Civil Money Penalty Amounts and Compliance with the Federal Civil Penalties ...
Food and Drug Administration
Rule
Maximum Civil Money Penalty Amounts and Compliance with the Federal Civil Penalties Inflation Adjustment Act,
66750-66754 [E8-26866]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 17 [Docket No. FDA-2008-N-0561] Maximum Civil Money Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule. SUMMARY: The Food and Drug Administration (FDA) is issuing a new regulation to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within our... [read document]
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(November 11, 2008) - Proposed Rule - Maximum Civil Money Penalty Amounts and Compliance with the Federal Civil ...
Food and Drug Administration
Proposed Rule
Maximum Civil Money Penalty Amounts and Compliance with the Federal Civil Penalties Inflation Adjustment Act,
66811-66815 [E8-26864]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 17 [Docket No. FDA-2008-N-0561] Maximum Civil Money Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: 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... [read document]
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(November 11, 2008) - Rule - Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms ...
Food and Drug Administration
Rule
Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex,
66522-66539 [E8-26825]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 [Docket No. FDA-2004-N-0511] (formerly Docket No. 2004N-0556) RIN 0910-AF21 Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of... [read document]
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(November 9, 2008) - Rule - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism ...
Food and Drug Administration
Rule
Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act (2002),
66294-66410 [E8-26282]
Part II Department of Health and Human Services Food and Drug Administration 21 CFR Part 1 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Draft Compliance Policy Guide; ``Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002;'' Availability; Final Rule and Notice DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1... [read document]
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(November 6, 2008) - Rule - Oral Dosage Form New Animal Drugs: Firocoxib Tablets
Food and Drug Administration
Rule
Oral Dosage Form New Animal Drugs:
Firocoxib Tablets,
64885 [E8-26020]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2008-N-0039] Oral Dosage Form New Animal Drugs; Firocoxib Tablets AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: 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 Merial Ltd. The supplemental NADA provides for veterinary prescription use of firocoxib chewable... [read document]
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(October 29, 2008) - Rule - Food Additives Permitted in Feed and Drinking Water of Animals: Methyl Esters of ...
Food and Drug Administration
Rule
Food Additives Permitted in Feed and Drinking Water of Animals:
Methyl Esters of Conjugated Linoleic Acid (Cis-9, Trans-11 and Trans-10, Cis-12-Octadecadienoic Acids),
64197-64199 [E8-25719]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2003-F-0398] (formerly Docket No. 2003F-0048] Food Additives Permitted in Feed and Drinking Water of Animals; Methyl Esters of Conjugated Linoleic Acid (Cis-9, Trans-11 and Trans- 10, Cis-12-Octadecadienoic Acids) AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and... [read document]
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(October 27, 2008) - Rule - Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
Food and Drug Administration
Rule
Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products,
63886-63897 [E8-25670]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201, 208 and 209 [Docket No. FDA-2003-N-0313] (formerly Docket No. 2003N-0342) RIN 0910-AC35 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule that confirms the interim final rule entitled ``Toll-Free Number for Reporting Adverse Events on Labeling... [read document]
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(October 26, 2008) - Proposed Rule - Label Requirement for Food That Has Been Refused Admission Into the United ...
Food and Drug Administration
Proposed Rule
Label Requirement for Food That Has Been Refused Admission Into the United States; Correction,
63663 [E8-25588]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2007-N-0465] Label Requirement for Food That Has Been Refused Admission Into the United States; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of Thursday, September 18, 2008 (73 FR 54106). The document issued a proposed rule that would... [read document]
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(October 25, 2008) - Rule - Amendments to the Current Good Manufacturing Practice Regulations for Finished ...
Food and Drug Administration
Rule
Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Final Rule; Correction,
63361-63362 [E8-25471]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 210 and 211 [Docket No. FDA-2007-N-0379] (formerly Docket No. 2007N-0280) Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Final Rule; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, September 8, 2008 (73 FR... [read document]
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(October 23, 2008) - Rule - Substances Prohibited From Use in Animal Food or Feed; Correction
Food and Drug Administration
Rule
Substances Prohibited From Use in Animal Food or Feed; Correction,
63072-63073 [E8-25346]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 589 [Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46 Substances Prohibited From Use in Animal Food or Feed; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 25, 2008 (73 FR 22720). The document amended the agency's regulations to... [read document]
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(October 22, 2008)