Health Care - Regulations
- Proposed Rule - Medicare Program: Revisions to the Medicare Advantage and Prescription Drug ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program:
Revisions to the Medicare Advantage and Prescription Drug Benefit Program,
28556-28604 [08-1244]
Part II Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Parts 422 and 423 Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 422 and 423 [CMS 4131-P] RIN 0938-AP24 Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs AGENCY: Centers for Medicare and Medicaid... [read document]
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(May 15, 2008) - Rule - Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin,
28036-28037 [E8-10856]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 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 IVX Animal Health, Inc. The supplemental ANADA provides for the veterinary prescription use of... [read document]
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(May 14, 2008) - Rule - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding ...
Food and Drug Administration
Rule
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Technical Amendment,
27727-27728 [E8-10727]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 111 [Docket No. FDA-2008-N-0152] (Formerly Docket No. 1996N-0417) RIN 0910-AB88 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register... [read document]
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(May 13, 2008) - Rule - Medicare Program: Prospective Payment System for Long-Term Care Hospitals RY 2009: ...
Centers for Medicare and Medicaid Services
Rule
Medicare Program: Prospective Payment System for Long-Term Care Hospitals RY 2009:
Annual Payment Rate Updates, Policy Changes and Clarifications,
26788-26874 [08-1219]
Part III Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Part 412 Medicare Program; Prospective Payment System for Long-Term Care Hospitals RY 2009: Annual Payment Rate Updates, Policy Changes, and Clarifications; and Electronic Submission of Cost Reports: Revision to Effective Date of Cost Reporting Period; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 412 [CMS-1393-F and CMS-1199-F] RINs... [read document]
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(May 8, 2008) - Rule - Certain Other Dosage Form New Animal Drugs; Sevoflurane
Food and Drug Administration
Rule
Certain Other Dosage Form New Animal Drugs; Sevoflurane,
25507-25508 [E8-10153]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 529 Certain 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 an abbreviated new animal drug application (ANADA) filed by Minrad, Inc. The ANADA provides for the use of sevoflurane inhalant anesthetic in dogs. DATES: This rule is effective May 7,... [read document]
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(May 6, 2008) - Proposed Rule - Medicare Program; Prospective Payment System and Consolidated Billing for ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2009,
25918-25960 [08-1214]
Part III Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Part 413 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2009; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 413 [CMS-1534-P] RIN 0938-AP11 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2009 AGENCY: Centers for... [read document]
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(May 6, 2008) - Rule - Medicare Program; Changes for Long-Term Care Hospitals Required by Certain Provisions of ...
Centers for Medicare and Medicaid Services
Rule
Medicare Program; Changes for Long-Term Care Hospitals Required by Certain Provisions of the Medicare, Medicaid, SCHIP Extension Act of 2007:
3-Year Delay in the Application of Payment Adjustments for Short Stay Outliers and Changes to the Standard Federal Rate,
24871-24881 [08-1217]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 412 [CMS-1493-IFC] RIN 0938-AP33 Medicare Program; Changes for Long-Term Care Hospitals Required by Certain Provisions of the Medicare, Medicaid, SCHIP Extension Act of 2007: 3-Year Delay in the Application of Payment Adjustments for Short Stay Outliers and Changes to the Standard Federal Rate AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Interim final rule with comment... [read document]
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(May 5, 2008) - Proposed Rule - Medicare Program: Proposed Hospice Wage Index for Fiscal Year 2009
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program:
Proposed Hospice Wage Index for Fiscal Year 2009,
24000-24035 [08-1198]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 418 [CMS-1548-P] RIN 0938-AP14 Medicare Program; Proposed Hospice Wage Index for Fiscal Year 2009 AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule proposes the hospice wage index for fiscal year 2009. This proposed rule also proposes to phase-out the Medicare hospice budget neutrality adjustment factor and clarify two wage index... [read document]
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(April 30, 2008) - Rule - Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary ...
Food and Drug Administration
Rule
Food Labeling:
Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease,
23947-23953 [E8-9590]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2006-P-0405] (formerly Docket No. 2006P-0069) Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending its regulation authorizing a health claim on the relationship between soluble fiber from certain foods and risk of coronary heart... [read document]
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(April 30, 2008) - Proposed Rule - Medicare Program: Proposed Changes to the Hospital Inpatient Prospective ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program:
Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates,
23528-23938 [08-1135]
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(April 29, 2008) - Rule - New Animal Drugs: Change of Sponsor's Name
Food and Drug Administration
Rule
New Animal Drugs:
Change of Sponsor's Name,
23066-23067 [E8-9328]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 510 New Animal Drugs; Change of Sponsor's Name 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's name from Halocarbon Laboratories, Division of Halocarbon Products Corp., to Halocarbon Products Corp. DATES: This rule is effective April 29, 2008. FOR FURTHER INFORMATION CONTACT: David... [read document]
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(April 28, 2008) - Rule - Human Subject Protection: Foreign Clinical Studies Not Conducted Under an ...
Food and Drug Administration
Rule
Human Subject Protection:
Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application,
22800-22816 [E8-9200]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 312 [Docket No. 2004N-0018] Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (non-IND foreign clinical... [read document]
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(April 27, 2008) - Proposed Rule - Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury ...
Food and Drug Administration
Proposed Rule
Dental Devices:
Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy,
22877-22879 [08-1187]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 872 [Docket No. FDA-2008-N-0163] (formerly Docket No. 2001N-0067) Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; reopening of comment period. SUMMARY: The Food and Drug Administration (FDA) is reopening... [read document]
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(April 27, 2008) - Rule - Grants to States for Operation of Qualified High Risk Pools
Centers for Medicare and Medicaid Services
Rule
Grants to States for Operation of Qualified High Risk Pools,
22281-22287 [E8-9066]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 45 CFR Part 148 [CMS-2260-F] RIN 0938-A046 Grants to States for Operation of Qualified High Risk Pools AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Final Rule. SUMMARY: This rule finalizes the interim final rule with comment period that was published on July 27, 2007, regarding extended funding for seed and operational grants for State High Risk Pools under the Public Health Service... [read document]
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(April 24, 2008) - Rule - Substances Prohibited From Use in Animal Food or Feed
Food and Drug Administration
Rule
Substances Prohibited From Use in Animal Food or Feed,
22720-22758 [08-1180]
Part VI Department of Health and Human Services Food and Drug Administration 21 CFR Part 589 Substances Prohibited From Use in Animal Food or Feed; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 589 [Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46 Substances Prohibited From Use in Animal Food or Feed AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the... [read document]
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(April 24, 2008) - Proposed Rule - Medicare Program: Inpatient Rehabilitation Facility Prospective Payment System ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program:
Inpatient Rehabilitation Facility Prospective Payment System (2009 FY),
22674-22714 [08-1174]
Part IV Department of Health and Human Services Centers for Medicare and Medicaid 42 CFR Part 412 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2009; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 412 [CMS-1554-P] RIN 0938-AP19 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2009 AGENCY: Centers for Medicare and ... [read document]
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(April 24, 2008) - Rule - New Animal Drugs; Enrofloxacin
Food and Drug Administration
Rule
New Animal Drugs; Enrofloxacin,
21819 [E8-8713]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 522 and 556 New Animal Drugs; Enrofloxacin 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 a supplemental new animal drug application (NADA) filed by Bayer HealthCare LLC. The supplemental NADA provides for use of enrofloxacin injectable solution in swine for the... [read document]
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(April 22, 2008) - Proposed Rule - Designation of Medically Underserved Populations and Health Professional ...
Department of Health and Human Services
Proposed Rule
Designation of Medically Underserved Populations and Health Professional Shortage Areas,
21300-21301 [08-1167]
DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Parts 5 and 51c RIN 0906-AA44 Designation of Medically Underserved Populations and Health Professional Shortage Areas AGENCY: Department of Health and Human Services (HHS). ACTION: Notice of proposed rulemaking; extension of public comment period and clarification. SUMMARY: On February 29, 2008, HHS published a notice of proposed rulemaking, ``Designation of Medically Underserved Populations and Health Professional Shortage Areas'' (73 FR 11232),... [read document]
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(April 20, 2008) - Rule - Implantation or Injectable Dosage Form New Animal Drugs: Florfenicol
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs:
Florfenicol,
21041-21042 [E8-8346]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol 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 Schering-Plough Animal Health Corp. The NADA provides for use of florfenicol injectable solution for the treatment of bovine... [read document]
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(April 17, 2008) - Rule - Implantation or Injectable Dosage Form New Animal Drugs: Insulin
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs:
Insulin,
21042-21043 [E8-8347]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Insulin 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 the veterinary prescription use of an injectable suspension of... [read document]
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(April 17, 2008) - Rule - Use of Materials Derived From Cattle in Human Food and Cosmetics
Food and Drug Administration
Rule
Use of Materials Derived From Cattle in Human Food and Cosmetics,
20785-20794 [08-1142]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 189 and 700 [Docket No. 2004N-0081] RIN 0910-AF47 Use of Materials Derived From Cattle in Human Food and Cosmetics AGENCY: Food and Drug Administration, HHS. ACTION: Interim final rule and request for comments. SUMMARY: The Food and Drug Administration (FDA) is amending its regulations on the use of materials derived from cattle in human food and cosmetics. In these regulations, FDA has designated certain... [read document]
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(April 16, 2008) - Proposed Rule - Regulation on the Organizational Integrity of Entities Implementing Leadership ...
Department of Health and Human Services
Proposed Rule
Regulation on the Organizational Integrity of Entities Implementing Leadership Act Programs and Activities,
20900-20904 [08-1147]
DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 88 RIN 0991-AB46 Office of Global Health Affairs; Regulation on the Organizational Integrity of Entities Implementing Leadership Act Programs and Activities ACTION: Notice of proposed rulemaking. SUMMARY: The Office of Global Health Affairs within the U.S. Department of Health and Human Services (HHS) is issuing this Notice of Proposed Rulemaking (NPRM) to obtain input from stakeholders and other interested parties regarding the separation... [read document]
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(April 16, 2008) - Rule - Medicare Program; Modification to the Weighting Methodology Used to Calculate the ...
Centers for Medicare and Medicaid Services
Rule
Medicare Program; Modification to the Weighting Methodology Used to Calculate the Low-income Benchmark Amount; Correction,
20804-20807 [08-1136]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 422 and 423 [CMS-4133-CN] RIN 0938-AP25 Medicare Program; Modification to the Weighting Methodology Used To Calculate the Low-Income Benchmark Amount; Correction AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Correction of final. SUMMARY: This document corrects mathematical errors that appeared in the impact analysis accompanying the final rule that appeared in the Federal... [read document]
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(April 16, 2008) - Rule - Medicare Program: Policy and Technical Changes to the Medicare Presciption Drug Benefit
Centers for Medicare and Medicaid Services
Rule
Medicare Program:
Policy and Technical Changes to the Medicare Presciption Drug Benefit,
20486-20509 [08-1120]
Part III Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Part 423 Medicare Program; Policy and Technical Changes to the Medicare Prescription Drug Benefit; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 423 [CMS-4130-F] RIN 0938-AO74 Medicare Program; Policy and Technical Changes to the Medicare Prescription Drug Benefit AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.... [read document]
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(April 14, 2008) - Rule - Medicare and Medicaid Programs: Conditions for Coverage for End-Stage Renal Disease ...
Centers for Medicare and Medicaid Services
Rule
Medicare and Medicaid Programs: Conditions for Coverage for End-Stage Renal Disease Facilities,
20370-20484 [08-1102]
Part II Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Parts 405, 410, 413 et al. Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 405, 410, 413, 414, 488 and 494 [CMS-3818-F] RIN 0938-AG82 Medicare and Medicaid Programs; Conditions for Coverage for End- Stage Renal Disease Facilities AGENCY:... [read document]
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(April 14, 2008) - Proposed Rule - Developmental Disabilities Program
Department of Health and Human Services
Proposed Rule
Developmental Disabilities Program,
19708-19741 [E8-7412]
Part III Department of Health and Human Services 45 CFR Parts 1385, 1386, 1387 and 1388 Developmental Disabilities Program; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Parts 1385, 1386, 1387 and 1388 RIN 0970-AB11 Developmental Disabilities Program AGENCY: Administration on Developmental Disabilities, Administration for Children and Families, HHS. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: This rule proposes clarifications and new requirements to implement the... [read document]
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(April 9, 2008) - Rule - New Animal Drugs for Use in Animal Feed; Zilpaterol
Food and Drug Administration
Rule
New Animal Drugs for Use in Animal Feed; Zilpaterol,
19432 [E8-7583]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use in Animal Feed; Zilpaterol 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 Intervet Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride, monensin... [read document]
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(April 9, 2008) - Rule - New Animal Drugs for Use in Animal Feed: Zilpaterol; Technical Amendment
Food and Drug Administration
Rule
New Animal Drugs for Use in Animal Feed:
Zilpaterol; Technical Amendment,
18958-18960 [E8-7307]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feed; Zilpaterol; Technical Amendment 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 a new animal drug application (NADA) filed by Intervet Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles... [read document]
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(April 7, 2008) - Proposed Rule - Medicaid Program: Home and Community-Based State Plan Services
Centers for Medicare and Medicaid Services
Proposed Rule
Medicaid Program: Home and Community-Based State Plan Services,
18676-18700 [08-1084]
Part III Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Parts 431, 440 and 441 Medicaid Program: Home and Community-Based State Plan Services; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 431, 440 and 441 [CMS-2249-P] RIN 0938-AO53 Medicaid Program: Home and Community-Based State Plan Services AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Proposed rule.... [read document]
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(April 2, 2008) - Rule - Technical Amendment; Withdrawal of Approval of NADAs: Amendment to the Current Good ...
Food and Drug Administration
Rule
Technical Amendment; Withdrawal of Approval of NADAs:
Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals,
18440-18441 [E8-7107]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 210 and 211 [Docket No. FDA-2008-N-0179] (formerly Docket No. 2007N-0280) Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Withdrawal AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule; withdrawal. SUMMARY: The Food and Drug Administration (FDA) is withdrawing a direct final rule that published in the Federal Register of December 4, 2007 (72 FR... [read document]
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(April 2, 2008) - Rule - Technical Amendment; Withdrawal of Approval of NADAs: Animal Drugs, Feeds, and Related ...
Food and Drug Administration
Rule
Technical Amendment; Withdrawal of Approval of NADAs:
Animal Drugs, Feeds, and Related Products,
18441-18442 [E8-7103]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 526 and 558 Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of NADAs; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of seven new animal drug applications (NADAs) because FDA is withdrawing... [read document]
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(April 2, 2008) - Rule - Medicare Program: Modification to the Weighting Methodology Used to Calculate the ...
Centers for Medicare and Medicaid Services
Rule
Medicare Program:
Modification to the Weighting Methodology Used to Calculate the Low-income Benchmark Amount,
18176-18182 [08-1088]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 422 and 423 [CMS-4133-F] RIN 0938-AP25 Medicare Program; Modification to the Weighting Methodology Used To Calculate the Low-Income Benchmark Amount AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule changes the weighting methodology used to calculate the low-income benchmark premium amount (benchmark) for 2009 and thereafter. Under this... [read document]
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(April 1, 2008) - Rule - Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin,
17890 [E8-6706]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin 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 Bayer HealthCare, LLC. The supplemental NADA provides for the use of enrofloxacin injectable solution in female... [read document]
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(March 31, 2008) - Rule - Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Benzathine and ...
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Benzathine and Penicillin G Procaine Suspension,
16754 [E8-6603]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Benzathine and Penicillin G Procaine 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 IVX Animal Health, Inc. The supplemental NADA provides for... [read document]
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(March 29, 2008) - Rule - New Animal Drugs For Use in Animal Feed; Zilpaterol
Food and Drug Administration
Rule
New Animal Drugs For Use in Animal Feed; Zilpaterol,
16754-16755 [E8-6601]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use in Animal Feed; Zilpaterol 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 Intervet Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride and... [read document]
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(March 29, 2008) - Rule - New Animal Drugs for Use in Animal Feeds: Bacitracin Methylene Disalicylate and Nicarbazin
Food and Drug Administration
Rule
New Animal Drugs for Use in Animal Feeds:
Bacitracin Methylene Disalicylate and Nicarbazin,
15884-15885 [E8-6063]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Nicarbazin 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 Alpharma, Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles... [read document]
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(March 24, 2008) - Rule - Medicare and State Health Care Programs; Fraud and Abuse; Issuance of Advisory Opinions ...
Inspector General Office, Health and Human Services Department
Rule
Medicare and State Health Care Programs; Fraud and Abuse; Issuance of Advisory Opinions by OIG,
15937-15939 [E8-6164]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Office of Inspector General 42 CFR Part 1008 Medicare and State Health Care Programs: Fraud and Abuse; Issuance of Advisory Opinions by OIG AGENCY: Office of Inspector General (OIG), HHS. ACTION: Interim final rule with comment period. SUMMARY: In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996, this final rule amends the OIG regulations at 42 CFR part 1008 by (1) revising the process... [read document]
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(March 24, 2008) - Rule - Registration of Food Facilities Under the Public Health Security and Bioterrorism ...
Food and Drug Administration
Rule
Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Technical Amendment,
15883 [E8-6052]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2008-N-0160] (formerly Docket No. 2002N-0276) Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; 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 change the fax number to which food facility... [read document]
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(March 24, 2008) - Rule - Civil Money Penalties Hearings; Maximum Penalty Amounts; Technical Amendment
Food and Drug Administration
Rule
Civil Money Penalties Hearings; Maximum Penalty Amounts; Technical Amendment,
15883-15884 [E8-6082]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 17 Civil Money Penalties Hearings; Maximum Penalty Amounts; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending its civil money penalties regulations to correct an inadvertent typographical error. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.... [read document]
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(March 24, 2008) - Rule - New Animal Drugs for Use in Animal Feed; Pyrantel; Technical Amendment
Food and Drug Administration
Rule
New Animal Drugs for Use in Animal Feed; Pyrantel; Technical Amendment,
15661 [E8-5928]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feed; Pyrantel; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending its animal drug regulations to correct an inadvertent omission in the list of concentrations of pyrantel tartrate Type A medicated articles approved for use by Phibro Animal Health. This action is... [read document]
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(March 23, 2008) - Rule - Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution,
14926 [E8-5598]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution 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 Norbrook Laboratories, Ltd. The supplemental NADA provides for changing scientific nomenclature for... [read document]
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(March 18, 2008) - Proposed Rule - Defining Small Number of Animals for Minor Use Designation
Food and Drug Administration
Proposed Rule
Defining Small Number of Animals for Minor Use Designation,
14411-14417 [E8-5385]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 516 [Docket No. 2008N-0011] RIN 0910-AG03 Defining Small Number of Animals for Minor Use Designation AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal... [read document]
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(March 16, 2008) - Rule - New Animal Drugs; Change of Sponsor's Name; Iron Injection; Technical Amendment
Food and Drug Administration
Rule
New Animal Drugs; Change of Sponsor's Name; Iron Injection; Technical Amendment,
14384-14385 [E8-5452]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 522 New Animal Drugs; Change of Sponsor's Name; Iron Injection; Technical Amendment 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 a change of sponsor's name from Animal Health Pharmaceuticals, LLC, to Pharmacosmos, Inc. DATES: This rule is effective March 18, 2008. FOR... [read document]
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(March 16, 2008) - Rule - New Animal Drugs for Use in Animal Feed; Zilpaterol
Food and Drug Administration
Rule
New Animal Drugs for Use in Animal Feed; Zilpaterol,
14385-14386 [E8-5450]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feed; Zilpaterol 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 Intervet, Inc. The NADA provides for use of approved, single-ingredient zilpaterol hydrochloride and monensin U.S.P. Type A medicated articles... [read document]
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(March 16, 2008) - Rule - Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Procaine Aqueous ...
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Procaine Aqueous Suspension,
14177 [E8-5217]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Procaine Aqueous 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 IVX Animal Health, Inc. The supplemental NADA provides for changing scientific... [read document]
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(March 15, 2008) - Proposed Rule - Medicare Program; Application of Certain Appeals Provisions to the Medicare ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program;
Application of Certain Appeals Provisions to the Medicare Prescription Drug Appeals Process,
14342-14370 [E8-5189]
Part III Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Part 423 Medicare Program; Application of Certain Appeals Provisions to the Medicare Prescription Drug Appeals Process; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 423 [CMS-4127-P] RIN 0938-AO87 Medicare Program; Application of Certain Appeals Provisions to the Medicare Prescription Drug Appeals Process AGENCY: Centers for... [read document]
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(March 15, 2008) - Rule - Medicaid Program: Multiple Source Drug Definition
Centers for Medicare and Medicaid Services
Rule
Medicaid Program:
Multiple Source Drug Definition,
13785-13788 [08-1022]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 447 [CMS-2238-IFC] RIN 0938-AP26 Medicaid Program; Multiple Source Drug Definition AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Interim final rule with comment period. SUMMARY: On July 17, 2007, we published a final rule with comment period in the Federal Register that implemented provisions of the Deficit Reduction Act of 2005 pertaining to prescription drugs under the... [read document]
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(March 12, 2008) - Rule - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding ...
Food and Drug Administration
Rule
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Technical Amendment,
13123-13124 [E8-4870]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 111 [Docket No. FDA-2008-N-0152] (formerly Docket No. 1996N-0417) RIN 0910-AB88 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register... [read document]
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(March 10, 2008) - Rule - Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Ferric Oxide ...
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Ferric Oxide Injection etc.,
12634-12635 [E8-4603]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Ferric Oxide Injection; Gleptoferron Injection; Iron Dextran Complex Injection; Iron Hydrogenated Dextran Injection 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 a change of sponsor for two new animal... [read document]
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(March 8, 2008) - Rule - Intramammary Dosage Forms; Cephapirin Benzathine
Food and Drug Administration
Rule
Intramammary Dosage Forms; Cephapirin Benzathine,
12262 [E8-4473]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 526 Intramammary Dosage Forms; Cephapirin Benzathine 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 Fort Dodge Animal Health, Division of Wyeth. The supplemental NADA provides for a revision to the labeling of cephapirin benzathine... [read document]
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(March 6, 2008) - Rule - Revision of Requirements for Live Vaccine Processing; Confirmation of Effective Date
Food and Drug Administration
Rule
Revision of Requirements for Live Vaccine Processing; Confirmation of Effective Date,
12262-12263 [E8-4471]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 600 [Docket No. FDA-2008-N-0135] (formerly Docket No. 2007N-0284] Revision of the Requirements for Live Vaccine Processing; 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 18, 2008, for the direct final rule that appeared in the Federal... [read document]
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(March 6, 2008) - Rule - New Animal Drugs: Albendazole
Food and Drug Administration
Rule
New Animal Drugs:
Albendazole,
11026-11027 [E8-3877]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 556 New Animal Drugs; Albendazole 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 Pfizer, Inc. The supplemental NADA provides for use of albendazole oral suspension in nonlactating goats for the treatment of liver flukes.... [read document]
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(February 28, 2008) - Rule - Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary ...
Food and Drug Administration
Rule
Food Labeling:
Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease,
9938-9947 [E8-3418]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2008-P-0090] (formerly Docket No. 2006P-0393) Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease AGENCY: Food and Drug Administration, HHS. ACTION: Interim final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the health claim regulation entitled ``Soluble fiber from certain foods and risk of coronary heart disease (CHD)'' to add... [read document]
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(February 24, 2008) - Rule - Oral Dosage Form New Animal Drugs: Altrenogest
Food and Drug Administration
Rule
Oral Dosage Form New Animal Drugs:
Altrenogest,
9455 [E8-3265]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Altrenogest 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 revised food safety labeling for altrenogest oral solution used in horses. DATES:... [read document]
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(February 20, 2008) - Rule - Oral Dosage Form New Animal Drugs: Ivermectin Liquid
Food and Drug Administration
Rule
Oral Dosage Form New Animal Drugs:
Ivermectin Liquid,
9455-9456 [E8-3266]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Ivermectin Liquid 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 a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA provides revised labeling for ivermectin oral... [read document]
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(February 20, 2008) - Rule - Generally Recognized As Safe Substances; Technical Amendments
Food and Drug Administration
Rule
Generally Recognized As Safe Substances; Technical Amendments,
8606-8608 [E8-2809]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 184 [Docket No. FDA-2008-N-0068] Generally Recognized As Safe Substances; Technical Amendments AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. SUMMARY: The Food and Drug Administration (FDA) is amending certain regulations regarding generally recognized as safe (GRAS) substances to remove references to FDA development of food-grade specifications in cooperation with the National... [read document]
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(February 13, 2008) - Rule - New Animal Drugs; Change of Sponsor: Ketamine
Food and Drug Administration
Rule
New Animal Drugs; Change of Sponsor:
Ketamine,
8191-8192 [E8-2607]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 522 New Animal Drugs; Change of Sponsor; Ketamine 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 an abbreviated new animal drug application (ANADA) for ketamine hydrochloride injectable solution from Veterinary Research Associates, Inc., to Putney, Inc. DATES: This rule... [read document]
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(February 12, 2008) - Rule - Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets
Food and Drug Administration
Rule
Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets,
8192 [E8-2608]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Phenylbutazone 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 two supplemental new animal drug applications (NADAs) filed by IVX Animal Health, Inc. The supplemental NADAs provide revised labeling for phenylbutazone tablets used in horses and... [read document]
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(February 12, 2008) - Proposed Rule - Proposal to Permit the Use of Ultrafiltered Milk; Extension of Comment Period: ...
Food and Drug Administration
Proposed Rule
Proposal to Permit the Use of Ultrafiltered Milk; Extension of Comment Period:
Cheeses and Related Cheese Products,
7692-7693 [E8-2454]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 133 [Docket No. FDA-2008-P-0086] (formerly Docket No. 2000P-0586) Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk; Extension of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; extension of the comment period. SUMMARY: The Food and Drug Administration (FDA) is extending the comment period until April 11, 2008, for a proposed rule that was... [read document]
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(February 10, 2008) - Proposed Rule - Devices: General Hospital and Personal Use Devices; Reclassification of Medical ...
Food and Drug Administration
Proposed Rule
Devices:
General Hospital and Personal Use Devices; Reclassification of Medical Device Data System,
7498-7503 [E8-2325]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 880 [Docket No. 2007N-0484] Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to reclassify, on its own initiative, the Medical Device Data System (MDDS) from class III (premarket approval) to class I (general controls). This action does not... [read document]
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(February 7, 2008) - Rule - Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; ...
Food and Drug Administration
Rule
Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Confirmation of Effective Date and Technical Amendment,
7463-7464 [E8-2322]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 606, 607, 610 and 640 [Docket No. FDA-2008-N-0067] Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Confirmation of Effective Date and Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule; confirmation of effective date and technical amendment. SUMMARY: The Food and Drug Administration (FDA) is confirming the effective date of February 19,... [read document]
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(February 7, 2008) - Rule - Oral Dosage Form New Animal Drugs: Spectinomycin
Food and Drug Administration
Rule
Oral Dosage Form New Animal Drugs:
Spectinomycin,
6607 [E8-2065]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Spectinomycin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to correct an error in the indications for use for spectinomycin oral solution in swine. FDA is also amending the regulations for other oral dosage forms of spectinomycin to reflect a current format. These actions... [read document]
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(February 4, 2008) - Rule - Implantation or Injectable Dosage Form New Animal Drugs: Zilpaterol
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs:
Zilpaterol,
6018-6019 [E8-1903]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use in Animal Feed; Zilpaterol 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 Intervet, Inc. The NADA provides for use of zilpaterol, monensin, and tylosin in three-way combination Type B and Type C medicated feeds for... [read document]
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(January 31, 2008) - Rule - Implantation or Injectable Dosage Form New Animal Drugs: Tulathromycin
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs:
Tulathromycin,
6017-6018 [E8-1906]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin 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 Pfizer, Inc. The supplemental NADA provides for veterinarian prescription use of tulathromycin injectable... [read document]
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(January 31, 2008) - Rule - Skin Protectant Drug Products for Over-the-Counter Human Use; Reduced Labeling; ...
Food and Drug Administration
Rule
Skin Protectant Drug Products for Over-the-Counter Human Use; Reduced Labeling; Technical Amendment,
6014-6017 [E8-1818]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 347 [Docket Nos. 1978N-0021 and 1978N-0021P] (formerly Docket Nos. 78N-0021 and 78N-0021P) RIN 0910-AF42 Skin Protectant Drug Products for Over-the-Counter Human Use; Reduced Labeling; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending the regulation that establishes conditions under which... [read document]
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(January 31, 2008) - Proposed Rule - Food Labeling: Revision of Reference Values and Mandatory Nutrients
Food and Drug Administration
Proposed Rule
Food Labeling:
Revision of Reference Values and Mandatory Nutrients,
4765 [E8-1446]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2008-N-0040] (Formerly Docket No. 2006N-0168) Food Labeling: Revision of Reference Values and Mandatory Nutrients; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Advance notice of proposed rulemaking; extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is extending to April 30, 2008, the comment period for the advance notice of proposed... [read document]
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(January 27, 2008) - Rule - Oral Dosage Form New Animal Drugs; Clindamycin
Food and Drug Administration
Rule
Oral Dosage Form New Animal Drugs; Clindamycin,
4077 [E8-1199]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 520 Oral Dosage Form New Animal Drugs; Clindamycin 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 Novopharm Ltd. The ANADA provides for the veterinary prescription use of clindamycin hydrochloride oral capsules in dogs for... [read document]
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(January 23, 2008) - Rule - Human Cells, Tissues, and Cellular and Tissue-Based Products CFR Correction
Food and Drug Administration
Rule
Human Cells, Tissues, and Cellular and Tissue-Based Products
CFR Correction,
3387 [08-55500]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products CFR Correction In Title 21 of the Code of Federal Regulations, Parts 800 to 1299, revised as of April 1, 2007, in part 1271, on page 718, Sec. 1271.22 is reinstated to read as follows: Sec. 1271.22 How and where do I register and submit an HCT/P list? (a) You must use Form FDA 3356 for: (1) Establishment registration, (2) HCT/P listings, and (3)... [read document]
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(January 17, 2008) - Rule - Intramammary Dosage Forms; Cephapirin Sodium
Food and Drug Administration
Rule
Intramammary Dosage Forms; Cephapirin Sodium,
3181 [E8-816]
Rules and Regulations Federal Register DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 526 Intramammary Dosage Forms; Cephapirin Sodium 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 supplemental new animal drug applications (NADAs) filed by Fort Dodge Animal Health, Division of Wyeth. The supplemental NADAs provide for revisions to the... [read document]
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(January 16, 2008)