Health Care -
Rule - Medical Devices: Ear, Nose, and Throat Devices; Classification of the Wireless ...
Food and Drug Administration
Rule
Medical Devices:
Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction Hearing Aid
,
34845-34847 [2011-14790]
Rules and Regulations Federal Register Federal Register / Vol. 76, No. 115 / Wednesday, June 15, 2011 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 874 [Docket No. FDA-2011-N-0361] Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction Hearing Aid AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the wireless air-conduction... [read document]
View Document | Download PDFProposed Rule - Medicare Programs: Proposed Changes to the Hospital Inpatient Prospective ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Programs:
Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Fiscal Year 2012 Rates; Corrections
,
34633-34634 [2011-14679]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 412, 413 and 476 [CMS-1518-CN] RIN 0938-AQ24 Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2012 Rates; Corrections AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Correction of proposed rule. SUMMARY: This document corrects technical... [read document]
View Document | Download PDFProposed Rule - Quality Assurance Requirements for Respirators: Withdrawal
Department of Health and Human Services
Proposed Rule
Quality Assurance Requirements for Respirators:
Withdrawal
,
33188-33189 [2011-14186]
DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 84 [Docket Number NIOSH-109] RIN 0920-AA04 Quality Assurance Requirements for Respirators; Notice of Withdrawal AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of proposed rulemaking; withdrawal. SUMMARY: The Department of Health and Human Services (HHS) is withdrawing its proposed rule to update the quality assurance and control requirements for the manufacture of... [read document]
View Document | Download PDFProposed Rule - Medicare Program: Availability of Medicare Data for Performance Measurement
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program:
Availability of Medicare Data for Performance Measurement
,
33566-33588 [2011-14003]
Vol. 76 Wednesday No. 110 June 8, 2011 Part III Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Part 401 Medicare Program; Availability of Medicare Data for Performance Measurement; Proposed Rule Federal Register / Vol. 76, No. 110 / Wednesday June 8, 2011 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 401 [CMS-5059-P] RIN 0938-AQ17 Medicare Program; Availability of Medicare Data for... [read document]
View Document | Download PDFRule - Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements: ...
Food and Drug Administration
Rule
Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements:
Investigational New Drug Applications and Bioavailability/Bioequivalence Studies; Availability
,
32863-32864 [2011-13950]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 312 and 320 [Docket No. FDA-2010-D-0482] Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of guidance. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and... [read document]
View Document | Download PDFRule - Medicaid Programs: Payment Adjustment for Provider Preventable Conditions Including ...
Centers for Medicare and Medicaid Services
Rule
Medicaid Programs:
Payment Adjustment for Provider Preventable Conditions Including Health Care Acquired Conditions
,
32816-32838 [2011-13819]
Vol. 76 Monday, No. 108 June 6, 2011 Part III Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Parts 434, 438 and 447 Medicaid Program; Payment Adjustment for Provider-Preventable Conditions Including Health Care-Acquired Conditions; Final Rule Federal Register / Vol. 76 , No. 108 / Monday, June 6, 2011 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 434, 438 and 447 [CMS-2400-F]... [read document]
View Document | Download PDFProposed Rule - Reducing Regulatory Burden; Retrospective Review under Executive Order 13563
Department of Health and Human Services
Proposed Rule
Reducing Regulatory Burden; Retrospective Review under Executive Order 13563
,
32330-32331 [2011-13908]
DEPARTMENT OF HEALTH AND HUMAN SERVICES 5 CFR Chapter XLV 21 CFR Chapter I 25 CFR Chapter V 42 CFR Chapters I and V 45 CFR Subtitle A and Chapters II, III, IV, X, and XIII Reducing Regulatory Burden; Retrospective Review Under Executive Order 13563 AGENCY: Department of Health and Human Services. ACTION: Request for information. SUMMARY: In accordance with Executive Order 13563, ``Improving Regulation and Regulatory Review,'' the Department of Health and Human Services (HHS) seeks public... [read document]
View Document | Download PDFProposed Rule - Filings of Food Additive Petitions; Animal Use: BASF Corp. ...
Food and Drug Administration
Proposed Rule
Filings of Food Additive Petitions; Animal Use:
BASF Corp.; Methyl Esters of Conjugated Linoleic Acid; Silicon Dioxide
,
32332-32333 [2011-13907]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2011-F-0365] BASF Corp.; Filing of Food Additive Petition (Animal Use); Methyl Esters of Conjugated Linoleic Acid; Silicon Dioxide AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA) is announcing that BASF Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of methyl... [read document]
View Document | Download PDFProposed Rule - Medicare Program: Five Year Review of Work Relative Value Units Under the ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program:
Five Year Review of Work Relative Value Units Under the Physician Fee Schedule
,
32410-32813 [2011-13052]
Vol. 76 Monday, No. 108 June 6, 2011 Part II Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Part 414 Medicare Program; Five-Year Review of Work Relative Value Units Under the Physician Fee Schedule; Proposed Rule Federal Register / Vol. 76 , No. 108 / Monday, June 6, 2011 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 414 [CMS-1582-PN] RIN 0938-AQ87 Medicare Program; Five-Year Review... [read document]
View Document | Download PDFRule - Medicare Program: Inpatient Psychiatric Facilities Prospective Payment System; Update ...
Centers for Medicare and Medicaid Services
Rule
Medicare Program:
Inpatient Psychiatric Facilities Prospective Payment System; Update for Rate Year Beginning July 1; Correction
,
32085-32086 [2011-13839]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 412 [CMS-1346-CN] RIN 0938-AQ23 Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System--Update for Rate Year Beginning July 1, 2011 (RY 2012); Correction AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Correction of final rule. SUMMARY: This document corrects two technical errors that appeared in the final rule published in the Federal Register on May... [read document]
View Document | Download PDFProposed Rule - Medicare Program: Proposed Changes to Electronic Prescribing Incentive Program
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program:
Proposed Changes to Electronic Prescribing Incentive Program
,
31547-31556 [2011-13463]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 414 [CMS-3248-P] RIN 0938-AR00 Medicare Program; Proposed Changes to the Electronic Prescribing (eRx) Incentive Program AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would modify the 2011 electronic prescribing (eRx) quality measure (that is, the eRx quality measure used for certain reporting periods in calendar year (CY) 2011),... [read document]
View Document | Download PDFProposed 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:
Negotiated Rulemaking Committee Meeting
,
31546-31547 [2011-13480]
DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 5 Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas; Notice of Meeting AGENCY: Health Resources and Services Administration, HHS. ACTION: Negotiated Rulemaking Committee meeting. SUMMARY: In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on... [read document]
View Document | Download PDFRule - Division of Freedom of Information: Change of Office Name, Address, Telephone Number, ...
Food and Drug Administration
Rule
Division of Freedom of Information:
Change of Office Name, Address, Telephone Number, and Fax Number; Technical Amendments
,
31468-31470 [2011-13488]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 5, 10, 14, 19, 20, 21, 314, 350, 516 and 814 [Docket No. FDA-2011-N-0318] Division of Freedom of Information; Change of Office Name, Address, Telephone Number, and Fax Number; Technical Amendments AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. SUMMARY: The Food and Drug Administration (FDA) is amending the Agency's regulations to reflect changes to the Division of Freedom of... [read document]
View Document | Download PDFProposed Rule - Permanent Certification Program for Health Information Technology; Revisions
Department of Health and Human Services
Proposed Rule
Permanent Certification Program for Health Information Technology; Revisions
,
31272-31279 [2011-13372]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 45 CFR Part 170 RIN 0991-AB77 Permanent Certification Program for Health Information Technology; Revisions to ONC-Approved Accreditor Processes AGENCY: Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services. ACTION: Proposed rule. SUMMARY: Under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section... [read document]
View Document | Download PDFProposed Rule - HIPAA Privacy Rule Accounting of Disclosures under the Health Information ...
Department of Health and Human Services
Proposed Rule
HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and Clinical Health Act
,
31426-31449 [2011-13297]
Vol. 76 Tuesday, No. 104 May 31, 2011 Part III Department of Health and Human Services 45 CFR Part 164 HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Proposed Rule Federal Register / Vol. 76 , No. 104 / Tuesday, May 31, 2011 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 45 CFR Part 164 RIN 0991-AB62 HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology... [read document]
View Document | Download PDFProposed Rule - Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and ...
Food and Drug Administration
Proposed Rule
Food Labeling:
Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Correction
,
30050-30051 [2011-12735]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 11 and 101 [Docket No. FDA-2011-F-0172] RIN 0910-AG57 Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; 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 April, 6, 2011 (76 FR 19192). To implement... [read document]
View Document | Download PDFProposed Rule - Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and ...
Food and Drug Administration
Proposed Rule
Food Labeling:
Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
,
30051-30052 [2011-12736]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 11 and 101 [Docket No. FDA-2011-F-0172] RIN 0910-AG57 Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is extending the comment period until July 5, 2011, for a proposed rule that was... [read document]
View Document | Download PDFRule - Rate Increase Disclosure and Review
Department of Health and Human Services
Rule
Rate Increase Disclosure and Review
,
29964-29988 [2011-12631]
Vol. 76 Monday, No. 99 May 23, 2011 Part IV Department of Health and Human Services 45 CFR Part 154 Rate Increase Disclosure and Review; Final Rule Federal Register / Vol. 76 , No. 99 / Monday, May 23, 2011 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 154 [CMS-9999-FC] RIN 0938-AQ68 Rate Increase Disclosure and Review AGENCY: Center for Consumer Information and Insurance Oversight, Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Final rule with... [read document]
View Document | Download PDFRule - Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities; Correction
Food and Drug Administration
Rule
Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities; Correction
,
29153 [2011-12410]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2006-N-0045; Formerly Docket No. 2006N-0109] Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities; 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, 2011 (76 FR 22805). The document announced that FDA is... [read document]
View Document | Download PDFProposed Rule - Exclusion of Orphan Drugs for Certain Covered Entities under 340B Program
Department of Health and Human Services
Proposed Rule
Exclusion of Orphan Drugs for Certain Covered Entities under 340B Program
,
29183-29190 [2011-12423]
DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 10 RIN 0906-AA94 Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of proposed rulemaking. SUMMARY: The ``Veterans Health Care Act of 1992,'' enacted section 340B of the Public Health Service Act (PHSA) ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B implemented a drug... [read document]
View Document | Download PDFProposed Rule - Draft Guidance for Industry and Staff; Availability: In Vitro Diagnostic ...
Food and Drug Administration
Proposed Rule
Draft Guidance for Industry and Staff; Availability:
In Vitro Diagnostic Devices for Bacillus Species Detection
,
28688-28689 [2011-12081]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-D-0102] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls... [read document]
View Document | Download PDFProposed Rule - Draft Guidance for Industry and Staff; Availability: Classification of In Vitro ...
Food and Drug Administration
Proposed Rule
Draft Guidance for Industry and Staff; Availability:
Classification of In Vitro Diagnostic Device for Bacillus Species Detection
,
28689-28696 [2011-12088]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-N-0103] Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Bacillus species (spp). detection into class II (special controls), in accordance with the recommendation of the... [read document]
View Document | Download PDFRule - Compliance Policy Guides: Surgeons' Gloves and Patient Examination Gloves; Defects; ...
Food and Drug Administration
Rule
Compliance Policy Guides:
Surgeons' Gloves and Patient Examination Gloves; Defects; Criteria for Direct Reference Seizure
,
28308-28309 [2011-12037]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 800 [Docket No. FDA-2011-D-0258] Compliance Policy Guide: Surgeons' Gloves and Patient Examination Gloves; Defects--Criteria for Direct Reference Seizure AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of Compliance Policy Guide Sec. 335.700, Surgeons' Gloves and Patient Examination Gloves; Defects--Criteria... [read document]
View Document | Download PDFProposed Rule - Medicare and Medicaid Programs: Opportunities for Alignment under Medicaid and ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare and Medicaid Programs:
Opportunities for Alignment under Medicaid and Medicare
,
28196-28207 [2011-11848]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Chapter IV [CMS-5507-NC] Medicare and Medicaid Programs; Opportunities for Alignment Under Medicaid and Medicare AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Request for information. SUMMARY: This document is a request for comments on opportunities to more effectively align benefits and incentives to prevent cost-shifting and improve access to care under the Medicare and... [read document]
View Document | Download PDFProposed Rule - Medicare and Medicaid Programs: Hospice Wage Index for Fiscal Year 2012
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare and Medicaid Programs:
Hospice Wage Index for Fiscal Year 2012
,
28195-28196 [C1-2011-10689]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 418 [CMS-1355-P] RIN 0938-AQ31 Medicare Program; Hospice Wage Index for Fiscal Year 2012 Correction In proposed rule document 2011-10689 appearing on pages 26805-26851 the issue of Monday, May 9, 2011 make the following corrections: On page 26806, in the first column, in the DATES section, in the fifth line, ``July 8, 2011'' should read ``June 27, 2011''. On page 26851, immediately following the... [read document]
View Document | Download PDFRule - Implantation or Injectable Dosage Form New Animal Drugs: Gonadotropin Releasing ...
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs:
Gonadotropin Releasing Factor-Diphtheria Toxoid Conjugate
,
27888-27889 [2011-11762]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 [Docket No. FDA-2011-N-0003] Implantation or Injectable Dosage Form New Animal Drugs; Gonadotropin Releasing Factor-Diphtheria Toxoid Conjugate 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 Pfizer, Inc. The NADA provides for the veterinary... [read document]
View Document | Download PDFProposed Rule - Medicare Program: Hospice Wage Index for Fiscal Year 2012
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program:
Hospice Wage Index for Fiscal Year 2012
,
26806-26851 [2011-10689]
Vol. 76 Monday, No. 89 May 9, 2011 Part II Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Part 418 Medicare Program; Hospice Wage Index for Fiscal Year 2012; Proposed Rule Federal Register / Vol. 76 , No. 89 / Monday, May 9, 2011 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 418 [CMS-1355-P] RIN 0938-AQ31 Medicare Program; Hospice Wage Index for Fiscal Year 2012 AGENCY: Centers for... [read document]
View Document | Download PDFProposed Rule - Medicaid Program: Methods for Assuring Access to Covered Medicaid Services
Centers for Medicare and Medicaid Services
Proposed Rule
Medicaid Program:
Methods for Assuring Access to Covered Medicaid Services
,
26342-26362 [2011-10681]
Vol. 76 Friday, No. 88 May 6, 2011 Part II Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Part 447 Medicare Program; Methods for Assuring Access to Covered Medicaid Services; Proposed Rule Federal Register / Vol. 76 , No. 88 / Friday, May 6, 2011 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 447 [CMS 2328-P] RIN 0938-AQ54 Medicaid Program; Methods for Assuring Access to Covered... [read document]
View Document | Download PDFProposed Rule - Medicaid Program: Prospective Payment System and Consolidated Billing for ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicaid Program:
Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities, etc.
,
26364-26429 [2011-10555]
Vol. 76 Friday, No. 88 May 6, 2011 Part III Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Parts 413, 424 and 455 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Disclosures of Ownership and Additional Disclosable Parties Information; Proposed Rule Federal Register / Vol. 76 , No. 88 / Friday, May 6, 2011 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid... [read document]
View Document | Download PDFRule - Medicare Program: Inpatient Psychiatric Facilities Prospective Payment System - Update ...
Centers for Medicare and Medicaid Services
Rule
Medicare Program:
Inpatient Psychiatric Facilities Prospective Payment System - Update for Rate Year Beginning July 1, 2011 (RY 2012)
,
26432-26487 [2011-10562]
Vol. 76 Friday, No. 88 May 6, 2011 Part IV Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Part 412 Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System--Update for Rate Year Beginning July 1, 2011 (RY 2012); Final Rule Federal Register / Vol. 76 , No. 88 / Friday, May 6, 2011 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 412 [CMS-1346-F] RIN 0938-AQ23... [read document]
View Document | Download PDFRule - Medicare Program: Hospital Inpatient Value-Based Purchasing Program
Centers for Medicare and Medicaid Services
Rule
Medicare Program:
Hospital Inpatient Value-Based Purchasing Program
,
26490-26547 [2011-10568]
Vol. 76 Friday, No. 88 May 6, 2011 Part V Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Parts 422 and 480 Medicare Program; Hospital Inpatient Value-Based Purchasing Program; Final Rule Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 422 and 480 [CMS-3239-F] RIN 0938-AQ55 Medicare Program; Hospital Inpatient Value-Based... [read document]
View Document | Download PDFRule - Information Required in Prior Notice of Imported Food
Food and Drug Administration
Rule
Information Required in Prior Notice of Imported Food
,
25542-25545 [2011-10955]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2011-N-0179] RIN 0910-AG65 Information Required in Prior Notice of Imported Food AGENCY: Food and Drug Administration, HHS. ACTION: Interim final rule; request for comments. SUMMARY: The Food and Drug Administration (FDA) is amending its regulations on prior notice of imported food. As required by the FDA Food Safety Modernization Act, FDA is issuing this interim final rule to require an... [read document]
View Document | Download PDFRule - Changes Affecting Hospital and Critical Access Hospital Conditions of Participation: ...
Centers for Medicare and Medicaid Services
Rule
Changes Affecting Hospital and Critical Access Hospital Conditions of Participation:
Credentialing and Privileging of Telemedicine Physicians and Practitioners
,
25550-25565 [2011-10875]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 482 and 485 [CMS-3227-F] RIN 0938-AQ05 Medicare and Medicaid Programs: Changes Affecting Hospital and Critical Access Hospital Conditions of Participation: Telemedicine Credentialing and Privileging AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule will revise the conditions of participation (CoPs) for both hospitals and critical access... [read document]
View Document | Download PDFRule - Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption
Food and Drug Administration
Rule
Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption
,
25538-25542 [2011-10953]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 RIN 0910-AG67 [Docket No. FDA-2011-N-0197] Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption AGENCY: Food and Drug Administration, HHS. ACTION: Interim final rule; request for comments. SUMMARY: The Food and Drug Administration (FDA) is amending its regulations on administrative detention of food for human or animal consumption. As required by the FDA Food Safety... [read document]
View Document | Download PDFProposed Rule - Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Program:
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Fiscal Year 2012 Rates
,
25788-26084 [2011-9644]
[read document]
View Document | Download PDFProposed Rule - Medicare and Medicaid Programs: Influenza Vaccination Standard for Certain ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare and Medicaid Programs:
Influenza Vaccination Standard for Certain Medicare and Medicaid Participating Providers and Suppliers
,
25460-25477 [2011-10646]
Vol. 76 Wednesday, No. 86 May 4, 2011 Part III Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Parts 482, 485, 491, et al. Medicare and Medicaid Programs; Influenza Vaccination Standard for Certain Participating Providers and Suppliers; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 482, 485, 491 and 494 [CMS-3213-P] RIN 0938-AP92 Medicare and Medicaid Programs; Influenza Vaccination... [read document]
View Document | Download PDFRule - Listing of Color Additives Exempt From Certification; Reactive Blue 69
Food and Drug Administration
Rule
Listing of Color Additives Exempt From Certification; Reactive Blue 69
,
25234-25235 [2011-10869]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket No. FDA-2009-C-0543] Listing of Color Additives Exempt From Certification; Reactive Blue 69 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of disodium 1-amino-4- [[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro- 9,10-dioxoanthracene-2-sulphonate (CAS... [read document]
View Document | Download PDFProposed Rule - Medicare Programs: Inpatient Rehabilitation Facility Prospective Payment System ...
Centers for Medicare and Medicaid Services
Proposed Rule
Medicare Programs:
Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2012, etc.
,
24214-24289 [2011-10159]
Vol. 76 Friday, No. 83 April 29, 2011 Part IV Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Part 412 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2012; Changes in Size and Square Footage of Inpatient Rehabilitation Units and Inpatient Psychiatric Units; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 412 [CMS-1349-P] RIN 0938-AQ28... [read document]
View Document | Download PDFProposed Rule - Periodic Reviews of Existing Regulations
Food and Drug Administration
Proposed Rule
Periodic Reviews of Existing Regulations
,
23520-23522 [2011-10131]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2011-N-0259] Periodic Review of Existing Regulations; Retrospective Review Under E.O. 13563 AGENCY: Food and Drug Administration, HHS. ACTION: Notification for request for comment. SUMMARY: In accordance with Executive Order 13563, ``Improving Regulation and Regulatory Review,'' the Food and Drug Administration (FDA) is conducting a review of its existing regulations to determine, in part,... [read document]
View Document | Download PDFRule - Medical Devices: Reclassification of the Topical Oxygen Chamber for Extremities
Food and Drug Administration
Rule
Medical Devices:
Reclassification of the Topical Oxygen Chamber for Extremities
,
22805-22807 [2011-9899]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2006-N-0045] (Formerly Docket No. 2006N-0109) Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply... [read document]
View Document | Download PDFRule - Implantation or Injectable Dosage Form New Animal Drugs: Enrofloxacin
Food and Drug Administration
Rule
Implantation or Injectable Dosage Form New Animal Drugs:
Enrofloxacin
,
22610-22611 [2011-9765]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 [Docket No. FDA-2011-N-0003] 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 addition of a... [read document]
View Document | Download PDFRule - Medicaid Program: Federal Funding for Medicaid Eligibility Determination and Enrollment ...
Centers for Medicare and Medicaid Services
Rule
Medicaid Program:
Federal Funding for Medicaid Eligibility Determination and Enrollment Activities
,
21950-21975 [2011-9340]
Vol. 76 Tuesday, No. 75 April 19, 2011 Part II Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Part 433 Medicaid Program; Federal Funding for Medicaid Eligibility Determination and Enrollment Activities; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Part 433 [CMS-2346-F] RIN 0938-AQ53 Medicaid Program; Federal Funding for Medicaid Eligibility Determination and Enrollment Activities AGENCY:... [read document]
View Document | Download PDFRule - Medicare Program: Changes to the Medicare Advantage and the Medicare Prescription Drug ...
Centers for Medicare and Medicaid Services
Rule
Medicare Program:
Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Changes
,
21432-21577 [2011-8274]
Vol. 76 Friday, No. 73 April 15, 2011 Part II Department of Health and Human Services Centers for Medicare and Medicaid Services 42 CFR Parts 417, 422 and 423 Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Changes; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 417, 422 and 423 [CMS-4144-F] RIN 0938-AQ00 Medicare Program; Changes to the... [read document]
View Document | Download PDFRule - Designation of Medically Underserved Populations: Negotiated Rulemaking Committee Meeting
Department of Health and Human Services
Rule
Designation of Medically Underserved Populations:
Negotiated Rulemaking Committee Meeting
,
20867 [2011-9081]
DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 5 Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas; Notice of Meeting AGENCY: Health Resources and Services Administration, HHS. ACTION: Negotiated Rulemaking Committee meeting. SUMMARY: In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on... [read document]
View Document | Download PDFProposed Rule - Further Amendments to General Regulations of Food and Drug Administration to ...
Food and Drug Administration
Proposed Rule
Further Amendments to General Regulations of Food and Drug Administration to Incorporate Tobacco Products
,
20901-20906 [2011-9044]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 7 and 16 [Docket No. FDA-2011-N-0121] RIN 0910-AG60 Further Amendments to General Regulations of the Food and Drug Administration To Incorporate Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to... [read document]
View Document | Download PDFRule - Medical Devices; General and Plastic Surgery Devices: Classification of the Low Level ...
Food and Drug Administration
Rule
Medical Devices; General and Plastic Surgery Devices:
Classification of the Low Level Laser System for Aesthetic Use
,
20840-20842 [2011-8944]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2011-N-0188] Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser System for Aesthetic Use AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the low level laser system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is... [read document]
View Document | Download PDFProposed Rule - Meetings: Food Safety Modernization Act, Focus on Preventive Controls for Facilities
Food and Drug Administration
Proposed Rule
Meetings:
Food Safety Modernization Act, Focus on Preventive Controls for Facilities
,
20588-20590 [2011-8785]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2011-N-0251] FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comment. SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting entitled ``FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities.'' The purpose of the... [read document]
View Document | Download PDFProposed Rule - Disqualification of a Clinical Investigator
Food and Drug Administration
Proposed Rule
Disqualification of a Clinical Investigator
,
20575-20588 [2011-8786]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16, 312, 511 and 812 [Docket No. FDA-2011-N-0079] RIN 0910-AG49 Disqualification of a Clinical Investigator AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to amend the regulations to expand the scope of clinical investigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator... [read document]
View Document | Download PDFRule - Revision of the Requirements for Constituent Materials
Food and Drug Administration
Rule
Revision of the Requirements for Constituent Materials
,
20513-20518 [2011-8885]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 610 [Docket No. FDA-2010-N-0099] Revision of the Requirements for Constituent Materials AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the biologics regulations to permit the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as appropriate, to approve... [read document]
View Document | Download PDFProposed Rule - Plan for Retrospective Review under Executive Order 13563
Department of Health and Human Services
Proposed Rule
Plan for Retrospective Review under Executive Order 13563
,
20568-20569 [2011-8780]
Proposed Rules Federal Register DEPARTMENT OF HEALTH AND HUMAN SERVICES 2 CFR Chapters III and XXX 5 CFR Chapter XLV 21 CFR Chapter I 25 CFR Chapter V 42 CFR Chapters I, IV and V 45 CFR Subtitle A and Chapters II, III, IV, X, XIII 48 CFR Chapter 3 HHS Plan for Retrospective Review Under Executive Order 13563 AGENCY: Department of Health and Human Services. ACTION: Notice; request for information. SUMMARY: In accordance with Executive Order 13563, ``Improving Regulation and Regulatory Review,''... [read document]
View Document | Download PDFRule - Irradiation in the Production, Processing, and Handling of Food
Food and Drug Administration
Rule
Irradiation in the Production, Processing, and Handling of Food
,
20509-20513 [2011-8815]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 179 [Docket No. FDA-1998-F-0072] (Formerly 98F-0165) Irradiation in the Production, Processing, and Handling of Food AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; denial of requests for a hearing and response to objections. SUMMARY: The Food and Drug Administration (FDA) is responding to objections and is denying requests that it received for a hearing on the final rule that amended the food... [read document]
View Document | Download PDFProposed Rule - Food Labeling: Calorie Labeling of Articles of Food in Vending Machines
Food and Drug Administration
Proposed Rule
Food Labeling:
Calorie Labeling of Articles of Food in Vending Machines
,
19238-19255 [2011-8037]
Vol. 76 Wednesday, No. 66 April 6, 2011 Part III Department of Health and Human Services Food and Drug Administration 21 CFR Parts 11 and 101 Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 11 and 101 [Docket No. FDA-2011-F-0171] RIN 0910-AG56 Food Labeling; Calorie Labeling of Articles of Food in Vending Machines AGENCY: Food and Drug Administration, HHS. ACTION: Proposed... [read document]
View Document | Download PDFProposed Rule - Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and ...
Food and Drug Administration
Proposed Rule
Food Labeling:
Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
,
19192-19236 [2011-7940]
Vol. 76 Wednesday, No. 66 April 6, 2011 Part II Department of Health and Human Services Food and Drug Administration 21 CFR Parts 11 and 101 Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 11 and 101 [Docket No. FDA-2011-F-0172] RIN 0910-AG57 Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food... [read document]
View Document | Download PDFRule - Oral Dosages Form New Animal Drugs: Robenacoxib
Food and Drug Administration
Rule
Oral Dosages Form New Animal Drugs:
Robenacoxib
,
18648 [2011-8053]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Robenacoxib 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 original new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of robenacoxib tablets... [read document]
View Document | Download PDFRule - New Animal Drugs: Amikacin Sulfate, Ampicillin Trihydrate, Ceftiofur Hydrochloride, ...
Food and Drug Administration
Rule
New Animal Drugs:
Amikacin Sulfate, Ampicillin Trihydrate, Ceftiofur Hydrochloride, Cephapirin Benzathine, etc.; Correcting Amendments
,
17336-17339 [2011-7313]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 522, 526 and 529 [Docket No. FDA-2011-N-0003] New Animal Drugs; Amikacin Sulfate, Ampicillin Trihydrate, Ceftiofur Hydrochloride, Cephapirin Benzathine, Chlortetracycline, Fenbendazole, Formalin, Furosemide, Glucose/Glycine/Electrolyte, Pyrantel Pamoate, Sulfadimethoxine, Sulfamethazine, and Tetracycline AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correcting amendments. SUMMARY: The Food... [read document]
View Document | Download PDFRule - New Animal Drugs: Arsanilate Sodium; Sulfaethoxypyridazine
Food and Drug Administration
Rule
New Animal Drugs:
Arsanilate Sodium; Sulfaethoxypyridazine
,
17026-17027 [2011-7214]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 522 and 558 [Docket No. FDA-2011-N-0003] New Animal Drugs; Arsanilate Sodium; Sulfaethoxypyridazine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correcting amendments. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to remove sections pertaining to use of arsanilate sodium and sulfaethoxypyridazine in medicated feed because there are no currently approved... [read document]
View Document | Download PDFRule - New Animal Drugs: Oxytetracycline
Food and Drug Administration
Rule
New Animal Drugs:
Oxytetracycline
,
17025-17026 [2011-7216]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 529 [Docket No. FDA-2011-N-0003] New Animal Drugs; Oxytetracycline 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 Pennfield Oil Co. The supplemental ANADA provides for use of oxytetracycline hydrochloride... [read document]
View Document | Download PDFRule - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug ...
Food and Drug Administration
Rule
Animal Drugs, Feeds, and Related Products;
Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran; Roxarsone; Correction
,
16533-16534 [2011-6790]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran; Roxarsone; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Correcting amendment. SUMMARY: The Food and Drug Administration (FDA) published a document in the Federal Register of October 26, 2010 (75 FR 65565)... [read document]
View Document | Download PDFRule - Animal Drugs, Feeds, and Related Products; Detomidine; Correction
Food and Drug Administration
Rule
Animal Drugs, Feeds, and Related Products;
Detomidine; Correction
,
16533 [2011-6791]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 529 [Docket No. FDA-2010-N-0002] Certain Other Dosage Form New Animal Drugs; Detomidine; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Correcting amendment. SUMMARY: The Food and Drug Administration (FDA) published a document in the Federal Register of April 23, 2010 (75 FR 21162), that amended the animal drug regulations to reflect approval of an original new animal drug application (NADA). FDA is... [read document]
View Document | Download PDFRule - Animal Drugs, Feeds, and Related Products; Florfenicol; Correction
Food and Drug Administration
Rule
Animal Drugs, Feeds, and Related Products;
Florfenicol; Correction
,
16534 [2011-6789]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Correcting amendments. SUMMARY: The Food and Drug Administration (FDA) published a document in the Federal Register of June 17, 2010 (75 FR 34361) revising the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA). That... [read document]
View Document | Download PDFRule - Animal Drugs, Feeds, and Related Products; Change of Sponsor's Name and Address; Corrections
Food and Drug Administration
Rule
Animal Drugs, Feeds, and Related Products;
Change of Sponsor's Name and Address; Corrections
,
16532-16533 [2011-6795]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 529 [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor's Name and Address; Corrections AGENCY: Food and Drug Administration, HHS. ACTION: Correcting amendments. SUMMARY: The Food and Drug Administration (FDA) published a document in the Federal Register of April 20, 2010 (75 FR 20522) amending the animal drug regulations to reflect changes to a sponsor's name and address. That document... [read document]
View Document | Download PDFProposed Rule - Medical Devices Ovarian Adnexal Mass Assessment Score Test System; Labeling; ...
Food and Drug Administration
Proposed Rule
Medical Devices
Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions
,
16350-16353 [2011-6621]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0029] Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to amend the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that... [read document]
View Document | Download PDFRule - Food Additives Permitted for Direct Addition to Food for Human Consumption: ...
Food and Drug Administration
Rule
Food Additives Permitted for Direct Addition to Food for Human Consumption:
2-Acetylamino-5-Nitrothiazole; Buquinolate; Chlorobutanol; Estradiol and Related Esters, etc.; Correcting Amendments
,
16290-16291 [2011-6796]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 556 [Docket No. FDA-2011-N-0003] Tolerances for Residues of New Animal Drugs in Food; 2- Acetylamino-5-Nitrothiazole; Buquinolate; Chlorobutanol; Estradiol and Related Esters; Ethylenediamine; Florfenicol; Flunixin; Furazolidone; Hydrocortisone; Methylparaben; Methylprednisolone; Prednisolone; Prednisone; Progesterone; Propylparaben; and Salicylic Acid AGENCY: Food and Drug Administration, HHS. ACTION: Final rule;... [read document]
View Document | Download PDFRule - Food Additives Permitted for Direct Addition to Food for Human Consumption: ...
Food and Drug Administration
Rule
Food Additives Permitted for Direct Addition to Food for Human Consumption:
Bacteriophage Preparation
,
16285-16290 [2011-6792]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 172 [Docket No. FDA-2002-F-0198] (formerly Docket No. 2002F-0316) Food Additives Permitted for Direct Addition to Food for Human Consumption; Bacteriophage Preparation AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; response to objections and denial of requests for a hearing and stay of effective date. SUMMARY: The Food and Drug Administration (FDA) is responding to objections and is denying requests... [read document]
View Document | Download PDFRule - Food Additives Permitted for Direct Addition to Food for Human Consumption: ...
Food and Drug Administration
Rule
Food Additives Permitted for Direct Addition to Food for Human Consumption:
Classification of Ovarian Adnexal Mass Assessment Score Test System
,
16292-16294 [2011-6620]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the ovarian adnexal mass assessment score test system into class II (special controls). The special control that will apply to these... [read document]
View Document | Download PDFRule - Irradiation in the Production, Processing, and Handling of Food
Food and Drug Administration
Rule
Irradiation in the Production, Processing, and Handling of Food
,
15841-15852 [2011-6625]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 179 [Docket No. FDA-1999-F-0056; Formerly Docket No. 1999F-4372] Irradiation in the Production, Processing, and Handling of Food; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; denial of requests for a stay of effective date and for a hearing; response to objections; confirmation of effective date. SUMMARY: The Food and Drug Administration (FDA) is denying requests for... [read document]
View Document | Download PDFRule - Investigational New Drug Applications and Abbreviated New Drug Applications
Food and Drug Administration
Rule
Investigational New Drug Applications and Abbreviated New Drug Applications
,
13880 [2011-5946]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 312 and 314 [Docket No. FDA-2011-N-0130] Investigational 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 investigational new drug application (IND) regulations and abbreviated new drug application regulations to correct inaccurate... [read document]
View Document | Download PDFProposed Rule - Weight Control Drug Products for Over-the-Counter Human Use: Benzocaine; Status ...
Food and Drug Administration
Proposed Rule
Weight Control Drug Products for Over-the-Counter Human Use:
Benzocaine; Status Change
,
12916-12920 [2011-5145]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 310 [Docket No. FDA-1981-N-0012] (Formerly Docket No. 1981N-0022) RIN 0910-AF45 Benzocaine; Weight Control Drug Products for Over-the-Counter Human Use AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed rule to reclassify benzocaine from its previously proposed monograph status (category I) for over-the-counter (OTC) weight control... [read document]
View Document | Download PDFRule - Requests for Exemption From the Bar Code Label Requirements; Change of Address
Food and Drug Administration
Rule
Requests for Exemption From the Bar Code Label Requirements; Change of Address
,
12847 [2011-5288]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 201 [Docket No. FDA-2011-N-0101] Change of Address; Requests for Exemption From the Bar Code Label Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending its regulations to update the address for submitting bar code exemption requests to the Center for Drug Evaluation and Research (CDER). This action is being taken... [read document]
View Document | Download PDFRule - Amendments to General Regulations of the Food and Drug Administration
Food and Drug Administration
Rule
Amendments to General Regulations of the Food and Drug Administration
,
12563 [2011-5147]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 14 and 17 [Docket No. FDA-2010-N-0560] RIN 0910-AG55 Amendments to General Regulations of the Food and Drug Administration; 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 April 14, 2011, for the final rule that appeared in the Federal Register... [read document]
View Document | Download PDFRule - Oral Dosage Form New Animal Drugs: Spinosad and Milbemycin Oxime
Food and Drug Administration
Rule
Oral Dosage Form New Animal Drugs:
Spinosad and Milbemycin Oxime
,
12563-12564 [2011-5144]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Spinosad and Milbemycin Oxime 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 veterinary prescription use of chewable tablets... [read document]
View Document | Download PDFRule - Temperature-Indicating Devices: Thermally Processed Low-Acid Foods Packaged in ...
Food and Drug Administration
Rule
Temperature-Indicating Devices:
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
,
11892-11924 [2011-4475]
Vol. 76 Thursday, No. 42 March 3, 2011 Part III Department of Health and Human Services Food and Drug Administration 21 CFR Part 113 Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 113 [Docket No. FDA-2007-N-0265; Formerly Docket No. 2007P-0026] Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed... [read document]
View Document | Download PDFRule - New Animal Drugs for Minor Use and Minor Species; Confirmation of Effective Date
Food and Drug Administration
Rule
New Animal Drugs for Minor Use and Minor Species; Confirmation of Effective Date
,
11331-11332 [2011-4593]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 516 [Docket No. FDA-2010-N-0534] RIN 0910-AG58 New Animal Drugs for Minor Use and Minor Species; 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 30, 2011, for the final rule that appeared in the Federal Register of November 15, 2010 (75 FR... [read document]
View Document | Download PDFRule - Secondary Direct Food Additives Permitted in Food for Human Consumption
Food and Drug Administration
Rule
Secondary Direct Food Additives Permitted in Food for Human Consumption
,
11328-11330 [2011-4497]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 173 [Docket No. FDA-2010-F-0200] Secondary Direct Food Additives Permitted in Food for Human Consumption AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the food additive regulations to permit the use of hydrogen peroxide as an antimicrobial agent in the manufacture of modified whey by ultrafiltration methods. This action is in response to a... [read document]
View Document | Download PDFRule - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug ...
Food and Drug Administration
Rule
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications:
Phenylbutazone; Pyrantel; Tylosin
,
11330-11331 [2011-4546]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520 and 558 [Docket No. FDA-2011-N-0003] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of eight new animal drug... [read document]
View Document | Download PDFProposed Rule - Health Claim; Phytosterols and Risk of Coronary Heart Disease
Food and Drug Administration
Proposed Rule
Health Claim; Phytosterols and Risk of Coronary Heart Disease
,
9525-9527 [2011-3678]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2000-P-0102, FDA-2000-P-0133, and FDA-2006-P-0033] Health Claim; Phytosterols and Risk of Coronary Heart Disease AGENCY: Food and Drug Administration, HHS. ACTION: Extension of enforcement discretion. SUMMARY: The Food and Drug Administration (FDA) is extending the period of time that it intends to exercise enforcement discretion, concerning the use of the health claim for phytosterols and risk... [read document]
View Document | Download PDFRule - Medical Devices; Medical Device Data Systems
Food and Drug Administration
Rule
Medical Devices; Medical Device Data Systems
,
8637-8649 [2011-3321]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 880 [Docket No. FDA-2008-N-0106] (formerly Docket No. 2007N-0484) Medical Devices; Medical Device Data Systems AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to... [read document]
View Document | Download PDFProposed Rule - Professional Labeling for Laxative Drug Products for Over-the-Counter Human ...
Food and Drug Administration
Proposed Rule
Professional Labeling for Laxative Drug Products for Over-the-Counter Human Use:
Amendment to Tentative Final Monograph
,
7743-7757 [2011-3091]
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 310 and 334 [Docket No. FDA-1978-N-0021; Formerly Docket No. 78N-036L] RIN 0910-AF38 Professional Labeling for Laxative Drug Products for Over-the- Counter Human Use; Proposed Amendment to the Tentative Final Monograph AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed rulemaking to amend the tentative final monograph (1985 TFM)... [read document]
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