Source: https://www.federalregister.gov/documents/2011/07/07/2011-15487/regulatory-agenda
Timestamp: 2017-10-20 14:33:20
Document Index: 487832322

Matched Legal Cases: ['art 71', 'art 70', 'art 71', 'art 71', 'art 70', 'art 70', 'art 84', 'art 203', 'art 203', 'art 203', 'art 203', 'art 203', 'art 203', 'art 203', 'art 110', 'arts 106', 'arts 201', 'art 16', '§\u2009101', '§\u2009101']

An Uncategorized Document by the Health and Human Services Department and the Homeland Security Department on 07/07/2011
76 FR 40052
40052-40073 (22 pages)
2011-15487
138. Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act
139. Status as a Grandfathered Health Plan Under the Affordable Care Act
140. Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section 610 Review)
141. Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical Community-Based Facilities for Children and Youth
142. Control of Communicable Diseases: Foreign and Possessions
143. Control of Communicable Diseases: Interstate
144. Quality Assurance Requirements for Respirators
145. Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Section 610 Review)
146. • Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents (Section 610 Review)
147. • General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification (Section 610 Review)
148. Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics
149. Over-the-Counter (OTC) Drug Review—Internal Analgesic Products
150. Over-the-Counter (OTC) Drug Review—Oral Health Care Products
151. Over-the-Counter (OTC) Drug Review—Sunscreen Products
152. Over-the-Counter (OTC) Drug Review—Weight Control Products
153. Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products
154. Import Tolerances for Residues of Unapproved New Animal Drugs in Food
155. Laser Products; Amendment to Performance Standard
156. Pet Food Labeling Requirements
157. Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding Animal Food
158. Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products
159. Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products
160. Unique Device Identification
161. Produce Safety Regulation
162. Hazard Analysis and Risk-Based Preventive Controls
163. “Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act
164. General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps
165. Food Labeling: Nutrition Labeling for Food Sold in Vending Machines
166. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
167. • Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives
168. • Further Amendments to General Regulations of the Food and Drug Administration To Incorporate Tobacco Products
169. Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors
170. Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products
171. Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products
172. Use of Materials Derived From Cattle in Human Food and Cosmetics
173. Label Requirement for Food That Has Been Refused Admission Into the United States
174. Cigarette Warning Label Statements
175. Postmarketing Safety Reporting Requirements for Human Drug and Biological Products
176. Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements
177. Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
178. Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling
179. Over-The-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products
180. Over-the-Counter (OTC) Drug Review—External Analgesic Products
181. Over-the-Counter (OTC) Drug Review—Laxative Drug Products
182. Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products
183. Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use
184. Over-the-Counter (OTC) Drug Review—Ophthalmic Products
185. Over-the-Counter (OTC) Drug Review—Skin Protectant Products
186. Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products
187. Over-the-Counter (OTC) Drug Review—Overindulgence In Food and Drink Products
188. Over-the-Counter (OTC) Drug Review—Antacid Products
189. Over-the-Counter (OTC) Drug Review—Skin Bleaching Products
190. Over-the-Counter (OTC) Drug Review—Stimulant Drug Products
191. Over-the-Counter (OTC) Drug Review—Antidiarrheal Drug Products
192. Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products
193. Over-the-Counter (OTC) Drug Review—Certain Category II Active Ingredients
194. Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution (Section 610 Review)
195. • Five Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS-1582-PN)
196. Home Health Agency (HHA) Conditions of Participation (COPS) (CMS-3819-P) (Section 610 Review)
197. Influenza Vaccination Standard for Certain Medicare Participating Providers and Suppliers (CMS-3213-P)
198. Hospital Conditions of Participation: Requirements for Hospital Inpatient Psychiatric and Rehabilitation Units Excluded From the Prospective Payment System and Ltch Requirements (CMS-3177-P)
199. Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2012 Rates and to the Long-Term Care Hospital PPS and FY 2012 Rates (CMS-1518-P)
200. Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2012 (CMS-1525-P)
201. Changes to the ESRD Prospective Payment System For Cy 2012 & Quality Incentives Program For CY 2013 (CMS-1577-P)
202. • Medicaid Program Integrity: Registration Of Billing Agents, Clearing Houses, Or Other Alternate Payees (CMS-2365-P)
203. • Medicaid Eligibility Expansion Under the Affordable Care Act of 2010 (CMS-2349-P)
204. • Payments for Primary Care Services Under the Medicaid Program (CMS-2370-P)
205. • Medicare and Medicaid Electronic Health Record Incentive Program—Stage 2 (CMS-0044-P)
206. Enhanced Federal Funding For Medicaid Eligibility Determination and Enrollment Activities (CMS-2346-F)
207. Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-F) (Section 610 Review)
208. Amendment to Payment Policies Under the Physician Fee Schedule and Part B for CY 2011 (CMS-1503-F2)
209. Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System For CY 2011 (CMS-1504-FC)
210. • Section 508 Hospitals—Medicare and Medicaid Extenders Act of 2010 Changes (CMS-1357-N)
https://www.federalregister.gov/d/2011-15487 https://www.federalregister.gov/d/2011-15487
Start Preamble Start Printed Page 40052
The following Agenda presents the results of the statutorily required semi-annual inventory of rulemaking actions currently under development within the U.S. Department of Health and Human Services. We hope that this information will enable interested members of the public to more effectively participate in the Department's regulatory activity.
Dawn L. Smalls, Executive Secretary, Department of Health and Human Services, Washington, DC 20201.
The information provided in the Agenda presents a forecast of the rulemaking activities that the Department of Health and Human Services (HHS) expects to undertake in the foreseeable future. Rulemakings are grouped according to pre-rulemaking actions, proposed rules, final rules, long-term actions, and rulemaking actions completed since the most recent Agenda was published on December 20, 2010. Please note that the actions included in this issue of the Federal Register, as required by the Regulatory Flexibility Act of 1980, relate only to those prospective rulemakings that are likely to have a significant economic impact on a substantial number of small entities.
Consistent with Executive Order 13563, the purpose of the Agenda is to encourage more effective public participation in the regulatory process. HHS invites all interested members of the public to comment on the rulemaking actions included in this issuance of the Agenda including comments on whether any of these or related rulemaking actions should be modified, streamlined, expanded, or repealed in order to make the agency's regulatory program more effective or less burdensome in achieving regulatory objectives. The complete Agenda is accessible online at http://www.reginfo.gov in an interactive format that offers users enhanced capabilities to obtain information from the Agenda's database.
138 Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act 0991-AB57
Office of Consumer Information and Insurance Oversight—Completed Actions
139 Status as a Grandfathered Health Plan Under the Affordable Care Act 0950-AA17
140 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section 610 Review) 0930-AA14
Substance Abuse and Mental Health Services Administration—Long-Term Actions
141 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical Community-Based Facilities for Children and Youth 0930-AA10
Centers for Disease Control and Prevention—Final Rule Stage
142 Control of Communicable Diseases: Foreign and Possessions 0920-AA12
143 Control of Communicable Diseases: Interstate 0920-AA22
Start Printed Page 40053
Centers for Disease Control and Prevention—Completed Actions
144 Quality Assurance Requirements for Respirators 0920-AA04
145 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Section 610 Review) 0910-AG14
146 Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents (Section 610 Review) 0910-AG61
147 General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification (Section 610 Review) 0910-AG62
148 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics 0910-AC52
149 Over-the-Counter (OTC) Drug Review—Internal Analgesic Products 0910-AF36
150 Over-the-Counter (OTC) Drug Review—Oral Health Care Products 0910-AF40
151 Over-the-Counter (OTC) Drug Review—Sunscreen Products 0910-AF43
152 Over-the-Counter (OTC) Drug Review—Weight Control Products 0910-AF45
153 Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products 0910-AF69
154 Import Tolerances for Residues of Unapproved New Animal Drugs in Food 0910-AF78
155 Laser Products; Amendment to Performance Standard 0910-AF87
156 Pet Food Labeling Requirements 0910-AG09
157 Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding Animal Food 0910-AG10
158 Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products 0910-AG12
159 Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products 0910-AG18
160 Unique Device Identification 0910-AG31
161 Produce Safety Regulation 0910-AG35
162 Hazard Analysis and Risk-Based Preventive Controls 0910-AG36
163 “Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act 0910-AG38
164 General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps 0910-AG54
165 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines 0910-AG56
166 Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments 0910-AG57
167 Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives 0910-AG59
168 Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products 0910-AG60
169 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors 0910-AF27
170 Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products 0910-AF32
171 Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products 0910-AF33
172 Use of Materials Derived From Cattle in Human Food and Cosmetics 0910-AF47
173 Label Requirement for Food That Has Been Refused Admission Into the United States 0910-AF61
174 Cigarette Warning Label Statements 0910-AG41
175 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products 0910-AA97
176 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements 0910-AB88
177 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements 0910-AC53
Start Printed Page 40054
178 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling 0910-AF11
179 Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products 0910-AF31
180 Over-the-Counter (OTC) Drug Review—External Analgesic Products 0910-AF35
181 Over-the-Counter (OTC) Drug Review—Laxative Drug Products 0910-AF38
182 Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products 0910-AF34
183 Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use 0910-AF37
184 Over-the-Counter (OTC) Drug Review—Ophthalmic Products 0910-AF39
185 Over-the-Counter (OTC) Drug Review—Skin Protectant Products 0910-AF42
186 Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products 0910-AF44
187 Over-the-Counter (OTC) Drug Review—Overindulgence in Food and Drink Products 0910-AF51
188 Over-the-Counter (OTC) Drug Review—Antacid Products 0910-AF52
189 Over-the-Counter (OTC) Drug Review—Skin Bleaching Products 0910-AF53
190 Over-the-Counter (OTC) Drug Review—Stimulant Drug Products 0910-AF56
191 Over-the-Counter (OTC) Drug Review—Antidiarrheal Drug Products 0910-AF63
192 Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products 0910-AF70
193 Over-the-Counter (OTC) Drug Review—Certain Category II Active Ingredients 0910-AF95
194 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution (Section 610 Review) 0910-AG06
Centers for Medicare & Medicaid Services—Prerule Stage
195 Five Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS-1582-PN) 0938-AQ87
196 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 Review) 0938-AG81
197 Influenza Vaccination Standard for Certain Medicare Participating Providers and Suppliers (CMS-3213-P) 0938-AP92
198 Hospital Conditions of Participation: Requirements for Hospital Inpatient Psychiatric and Rehabilitation Units Excluded From the Prospective Payment System and LTCH Requirements (CMS-3177-P) 0938-AP97
199 Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2012 Rates and to the Long-Term Care Hospital PPS and FY 2012 Rates (CMS-1518-P) 0938-AQ24
200 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2012 (CMS-1525-P) 0938-AQ26
201 Changes to the ESRD Prospective Payment System for CY 2012 & Quality Incentives Program for CY 2013 (CMS-1577-P) 0938-AQ27
202 Medicaid Program Integrity: Registration of Billing Agents, Clearing Houses, or Other Alternate Payees (CMS-2365-P) 0938-AQ61
203 Medicaid Eligibility Expansion Under the Affordable Care Act of 2010 (CMS-2349-P) 0938-AQ62
204 Payments for Primary Care Services Under the Medicaid Program (CMS-2370-P) 0938-AQ63
205 Medicare and Medicaid Electronic Health Record Incentive Program—Stage 2 (CMS-0044-P) 0938-AQ84
206 Enhanced Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS-2346-F) 0938-AQ53
Start Printed Page 40055
207 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-F) (Section 610 Review) 0938-AP32
208 Amendment to Payment Policies Under the Physician Fee Schedule and Part B for CY 2011 (CMS-1503-F2) 0938-AP79
209 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2011 (CMS-1504-FC) 0938-AP82
210 Section 508 Hospitals—Medicare and Medicaid Extenders Act of 2010 Changes (CMS-1357-N) 0938-AQ97
Legal Authority: Pub. L. 111-5, secs 13400 to 13410
Abstract: The Department of Health and Human Services, Office for Civil Rights, will issue rules to modify the HIPAA Privacy, Security, and Enforcement Rules as necessary to implement the privacy, security, and certain enforcement provisions of subtitle D of the Health Information Technology for Economic and Clinical Health Act (title XIII of the American Recovery and Reinvestment Act of 2009).
NPRM 07/14/10 75 FR 40867
NPRM Comment Period End 09/13/10
Merged With 0991-AB80 03/02/11
Agency Contact: Andra Wicks, Privacy Specialist, Office of Civil Rights, Department of Health and Human Services, 200 Independence Avenue, SW., Washington, DC 20201, Phone: 202 205-2292, Fax: 202 205-4786, E-mail: andra.wicks@hhs.gov.
RIN: 0991-AB57
Legal Authority: Pub. L. 111-148
Abstract: The Affordable Care Act protects the ability of individuals and businesses to keep their current plan while providing important consumer protections. The new regulation also provides stability and flexibility to insurers and businesses that offer health insurance coverage as the nation transitions to a more competitive marketplace. In 2014, businesses and consumers will have more affordable choices through exchanges. This rule would finalize the requirements for group health plans and health insurance coverage in the group and individual markets and respond to any comments as the result of the interim final rule implementing this provision.
Interim Final Rule 06/17/10 75 FR 34538
Interim Final Rule Effective 07/12/10
Interim Final Rule Comment Period End 08/16/10
Merged With 0938-AQ80 02/11/11
Agency Contact: James Mayhew, Director, Division of Market Rules Compliance Office, Department of Health and Human Services, Office of Consumer Information and Insurance Oversight, Mail Stop C2-12016, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9244, E-mail: james.mayhew@cms.hhs.gov.
RIN: 0950-AA17
Legal Authority: 21 U.S.C. 823 (9); 42 U.S.C. 257a; 42 U.S.C. 290aa(d); 42 U.S.C. 290dd-2; 42 U.S.C. 300xx-23; 42 U.S.C. 300x-27(a); 42 U.S.C. 300y-11
Abstract: This rule will amend the Federal opioid treatment program regulations. It will modify the dispensing requirements for buprenorphine and buprenorphine combination products that are approved by the Food and Drug Administration (FDA) for opioid dependence and used in federally certified and registered opioid treatment programs.
NPRM 06/19/09 74 FR 29153
NPRM Comment Period End 08/18/09
Agency Contact: Nicholas Reuter, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Suite 2-1063, One Choke Cherry Road, Rockville, MD 20857, Phone: 240 276-2716, E-mail: nicholas.reuter@samhsa.hhs.gov.
Legal Authority: Pub. L. 106-310, 42 U.S.C. 290jj to 290jj-2
Abstract: The Secretary is required by statute to publish regulations governing States that license nonmedical, community-based residential facilities for children and youth. The regulation requires States to develop licensing rules and monitoring requirements concerning behavior management practice that will ensure compliance; requires States to develop and implement such licensing rules and implementation requirements within one year; and ensures that States require such facilities to have adequate staff, and that the States provide training for professional staff.
Agency Contact: Paolo Del Vecchio, Associate Director for Consumer Affairs, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Room 13-103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, Phone: 301 443-2619, E-mail: paolo.delvecchio@samhsa.hhs.gov.
RIN: 0930-AA10
Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. Communicable disease regulations are divided into two parts: Part 71 pertaining to foreign arrivals and part 70 pertaining to interstate matters. This rule (42 CFR Part 71) will update and improve CDC's response to both global and domestic disease threats by creating a multi-tiered illness detection and response process thus substantially enhancing the public health system's ability to slow the introduction, transmission, and spread of communicable disease. The final rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircrafts and ships, and the collection of specific traveler contact information for the purpose of CDC contacting travelers in the event of an exposure to a communicable disease.
NPRM 11/30/05 70 FR 71892
NPRM Comment Period End 01/20/06
Final Action 09/00/11
Agency Contact: Stacy Howard, Health Scientist, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E-03, 1600 Clifton Road, NE., Atlanta, GA 30329, Phone: 404 498-1600, E-mail: showard@cdc.gov.
RIN: 0920-AA12
Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. Communicable disease regulations are divided into two parts: Part 71 pertaining to foreign arrivals and part 70 pertaining to interstate matters. This rule (42 CFR Part 70) will update and improve CDC's response to both global and domestic disease threats by creating a multi-tiered illness detection and response process thus substantially enhancing the public health system's ability to slow the introduction, transmission, and spread of communicable disease. The proposed final rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircrafts, and the collection of specific traveler contact information for the purpose of CDC contacting travelers in the event of an exposure to a communicable disease.
NPRM Comment Period End 01/30/06
Agency Contact: Stacy Howard, Health Scientist, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E-03, 1600 Clifton Road NE., Atlanta, GA 30329, Phone: 404 498-1600, E-mail: showard@cdc.gov.
Legal Authority: 29 U.S.C. 651 et seq.; 30 U.S.C. 3; 30 U.S.C. 5; 30 U.S.C. 7; 30 U.S.C. 811; 30 U.S.C. 842(h); 30 U.S.C. 844
Abstract: NIOSH plans to modify the Administrative/Quality Assurance sections of 42 CFR part 84, Approval of Respiratory Protective Devices. Areas for potential modification in this module are: (1) Upgrade of quality assurance requirements; (2) ability to use private sector quality auditors and private sector testing laboratories in the approval program; and (3) revised approval label requirements.
NPRM 12/10/08 73 FR 75045
NPRM Comment Period End 02/09/09
NPRM Comment Period Reopened 03/04/09 74 FR 9381
NPRM Comment Period Reopened End 04/10/09
NPRM Comment Period Reopening Extended 05/21/09 74 FR 23815
NPRM Comment Period End 10/09/09
Withdrawn 05/01/11
Regulatory Flexibility Analysis Required: Yes.Start Printed Page 40057
Agency Contact: William E. Newcomb, Physical Scientist, Department of Health and Human Services, Centers for Disease Control and Prevention, PO Box 18070, 626 Cochran Mill Road, Pittsburgh, PA 15236, Phone: 412 386-5200, E-mail: wnewcomb@cdc.gov.
RIN: 0920-AA04
Abstract: Pursuant to section 610 of the Regulatory Flexibility Act, FDA is currently undertaking a review of regulations promulgated under the Prescription Drug Marketing Act (PDMA) including those contained in 21 CFR part 203 and 21 CFR 205.3 and 205.50 (as amended in 64 FR 67762 and 67763). The purpose of this review is to determine whether the regulations in 21 CFR part 203 and 21 CFR 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities. FDA solicited comments on the following: (1) The continued need for the regulations in 21 CFR part 203 and 21 CFR 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (2) the nature of complaints or comments received from the public concerning the regulations in 21 CFR part 203 and 21 CFR 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of the regulations in 21 CFR part 203 and 21 CFR 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (4) the extent to which the regulations in 21 CFR part 203 and 21 CFR 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State and local governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in 21 CFR part 203 and 21 CFR 205.3 and 205.50 (as amended in 64 FR 67762 and 67763).
FDA received one comment on this review; and FDA notes that portions of the PDMA have been stayed in connection with RxUSA Wholesale, Inc., v. HHS, 467 F. Supp.2d 285 (E.D.N.Y. 2006), aff'd, 2008 U.S. App. LEXIS 14661 (2d Cir. 2008); and that the litigation itself has been administratively closed (with either party having the right to reopen) through June 30, 2011. FDA is certifying that it is not feasible for the agency to complete its review by December 4, 2010, and therefore is extending the completion date by one year.
Begin Review of Current Regulation 11/24/08
End Review of Current Regulation 12/00/11
Agency Contact: Howard Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, E-mail: pdma610(c)review@fda.hhs.gov.
Abstract: FDA is undertaking a review of 21 CFR 610.40, 610.41, 610.42, 610.44, 640.67, 640.70, (as amended in 66 FR 31146) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in 21 CFR 610.40, 610.41, 610.42, 610.44, 640.67, 640.70 (as amended in 66 FR 31146) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule.
Begin Review of Current Regulation 06/00/11
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 and 352; 21 U.S.C. 355; 21 U.S.C. 360 and 360j; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 216; 42 U.S.C. 262; 42 U.S.C. 263a; 42 U.S.C. 264; et seq.
Abstract: FDA is undertaking a review of 21 CFR 606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in 21 CFR 606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; Start Printed Page 40058and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule.
Begin Review 06/00/11
End Review 12/00/11
Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262
Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments, be provided in an electronic format that FDA can process, review, and archive.
Agency Contact: Martha Nguyen, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6352, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3471, Fax: 301 847-8440, E-mail: martha.nguyen@fda.hhs.gov.
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses products labeled to relieve upset stomach associated with overindulgence in food and drink and to relieve symptoms associated with a hangover. The second action addresses acetaminophen safety. The third action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products. The fourth action addresses combination products containing the analgesic acetaminophen or aspirin and sodium bicarbonate used as an antacid ingredient. The last document finalizes the internal analgesic products monograph.
NPRM (Acetaminophen) 04/00/12
NPRM (Amendment) (Pediatric) To Be Determined
NPRM (Amendment) (Sodium Bicarbonate) To Be Determined
NPRM (Overindulgence/Hangover) To Be Determined
Final Action (Internal Analgesics) To Be Determined
Agency Contact: Mary Chung, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-0260, Fax: 301 796-9899, E-mail: mary.chung@fda.hhs.gov.
ANPRM (Plaque Gingivitis) 05/29/03 68 FR 32232
ANPRM Comment Period End 08/27/03
NPRM (Benzocaine) 12/00/11
NPRM (Plaque Gingivitis) To Be Determined
Agency Contact: David Eng, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-2773, Fax: 301 796-9899, E-mail: david.eng@fda.hhs.gov.
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action finalizes Start Printed Page 40059sunscreen labeling and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The second action addresses other safety and effectiveness issues for OTC sunscreen drug products. The third action addresses active ingredients reviewed under Time and Extent Applications. The fourth action addresses the safety of sunscreen products. The last action addresses combination products containing sunscreen and insect repellent ingredients.
Final Action (UVA/UVB) 08/00/11
NPRM (Safety and Effectiveness) 08/00/11
NPRM (Time and Extent Applications) 04/00/12
ANPRM (Safety) 06/00/12
NPRM (Sunscreen and Insect Repellent) To Be Determined
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM addresses the use of benzocaine for weight control. The first final action finalizes the 2005 proposed rule for weight control products containing phenylpropanolamine. The second final action will finalize the proposed rule for weight control products containing benzocaine.
Final Action (Benzocaine) To Be Determined
NPRM (Healthcare) 06/17/94 59 FR 31402
Comment Period End 12/15/95
NPRM (Consumer) 01/00/12
NPRM (Food Handlers) To Be Determined
NPRM (Testing) To Be Determined
Final Action (Consumer) To Be Determined
Final Action (Testing) To Be Determined
Final Action (Food Handlers) To Be Determined
Final Action (First Aid Antiseptic) To Be Determined
NPRM Comment Period End 12/00/11
Agency Contact: Thomas Moskal, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 101, (MPN-4, HFV-232), 7519 Standish Place, Rockville, MD 20855, Phone: 240 276-9242, Fax: 240 276-9241, E-mail: thomas.moskal@fda.hhs.gov.
RIN: 0910-AF78Start Printed Page 40060
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-8145, E-mail: nancy.pirt@fda.hhs.gov.
NPRM Comment Period End 06/00/12
Agency Contact: William Burkholder, Veterinary Medical Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 2642 (MPN-4, HFV-228), 7519 Standish Place, Rockville, MD 20855, Phone: 240 453-6865, E-mail: william.burkholder@fda.hhs.gov.
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350e; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 264; Pub. L. 110-85, sec 1002(a)(2); Pub. L. 111-353
Abstract: The Food and Drug Administration (FDA) is proposing regulations for preventive controls for animal feed ingredients and mixed animal feed to provide greater assurance that marketed animal feed ingredients and mixed feeds intended for all animals, including pets, are safe. This action is being taken as part of the FDA's Animal Feed Safety System initiative. This action is also being taken to carry out the requirements of the Food and Drug Administration Amendments Act of 2007, under section 1002(a), and the Food Safety Modernization Act of 2010, under section 103.
Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 Standish Place, Rockville, MD 20855, Phone: 240 276-9207, E-mail: kim.young@fda.hhs.gov.
Abstract: This rule would require electronic package inserts for human drug and biological prescription products, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products.
Agency Contact: Lisa Dwyer, Senior Advisor for Pharmacy Affairs, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO 32, Room 4253, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Start Printed Page 40061Phone: 301 796-4709, E-mail: lisa.dwyer@fda.hhs.gov.
Abstract: The Food and Drug Administration Amendments Act of 2007 (FDAAA), amended the Federal Food, Drug, and Cosmetic Act by adding section 519(f) (21 U.S.C. 360i(f)). This section requires FDA to promulgate regulations establishing a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless FDA specifies an alternative placement or provides for exceptions. The unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number.
Agency Contact: John J. Crowley, Senior Advisor for Patient Safety, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 980-1936, E-mail: jay.crowley@fda.hhs.gov.
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353 (signed on January 4, 2011)
Abstract: The Food Safety Modernization Act requires the Secretary to establish and publish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. FDA is proposing to promulgate regulations setting enforceable standards for fresh produce safety at the farm and packing house. The purpose of the proposed rule is to reduce the risk of illness associated with contaminated fresh produce. The proposed rule will be based on prevention-oriented public health principles and incorporate what we have learned in the past decade since the agency issued general good agricultural practice guidelines entitled “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” (GAPs Guide). The proposed rule also will reflect comments received on the agency's 1998 update of its GAPs guide and its July 2009 draft commodity specific guidances for tomatoes, leafy greens, and melons. Although the proposed rule will be based on recommendations that are included in the GAPs guide, FDA does not intend to make the entire guidance mandatory. FDA's proposed rule would, however, set out clear standards for implementation of modern preventive controls. The proposed rule also would emphasize the importance of environmental assessments to identify hazards and possible pathways of contamination and provide examples of risk reduction practices recognizing that operators must tailor their preventive controls to particular hazards and conditions affecting their operations. The requirements of the proposed rule would be scale appropriate and commensurate with the relative risks and complexity of individual operations. FDA intends to issue guidance to assist industry in complying with the requirements of the new regulation.
Agency Contact: Samir Assar, Supervisory Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436-1636, E-mail: samir.assar@fda.hhs.gov.
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353, (signed on January 4, 2011)
Abstract: The Food and Drug Administration (FDA) Food Safety Modernization Act (the FSMA) requires the Secretary of Health and Human Services to promulgate regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls; and to define the terms `small business' and `very small business.' The FSMA also requires the Secretary to promulgate regulations with respect to activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on a farm or another farm under the same ownership and activities that constitute on farm manufacturing or processing of food that is not grown, raised, or consumed on a farm or another farm under the same ownership.
FDA is proposing to amend its current good manufacturing practice (CGMP) regulations (21 CFR Part 110) for manufacturing, packing, or holding human food to require food facilities to develop and implement a written food safety plan. This proposed rule would require a food facility to have and implement preventive controls to significantly minimize or prevent the occurrence of hazards that could affect food manufactured, processed, packed, or held by the facility and to provide assurances that such food will not be adulterated under section 402 or misbranded under section 403(w).
Agency Contact: John F. Sheehan, Director, Office of Food Safety, Division of Plant and Dairy Food Safety, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-315), Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436-1488, Fax: 301 436-2632, E-mail: john.sheehan@fda.hhs.gov.
Abstract: The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Section 901 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco Start Printed Page 40062products to be subject to the FD&C Act. This proposed rule would deem products meeting the statutory definition of “tobacco product” found at section 201(rr) of the FD&C Act to be subject to FDA's jurisdiction. The scope of the proposed rule deeming cigars to be subject to FDA's jurisdiction that was previously included in the Unified Agenda is being broadened to encompass products that meet the statutory definition of “tobacco product.”
Agency Contact: May Nelson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, E-mail: may.nelson@fda.hhs.gov.
Abstract: Since 2003, FDA has seen a dramatic increase in the number of device recalls, as well as an increase in the number of death and serious injury reports submitted regarding infusion pumps. An analysis of the reports reveals that a majority of the recalls and failures were caused by user error and/or device design flaw. As a result of these incidents, FDA is proposing to issue a draft special controls guidance document that, when final, will be a special control for infusion pumps. The agency believes that establishing these special controls for infusion pumps is necessary to provide reasonable assurance of the safety and effectiveness of these devices.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66 Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-8145, E-mail: nancy.pirt@fda.hhs.gov.
Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371
Abstract: The Food and Drug Administration (FDA) is proposing regulations to establish requirements for nutrition labeling of certain food sold in certain vending machines. FDA is also proposing the terms and conditions for vending machine operators registering to voluntarily be subject to the requirements of section 4205. FDA is taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act (“Affordable Care Act” or “ACA”), which was signed into law on March 23, 2010.
NPRM 04/06/11 76 FR 19238
Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and Labeling Team, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436-1802, Fax: 301 436-2636, E-mail: geraldine.june@fda.hhs.gov.
Abstract: The Food and Drug Administration (FDA) is proposing regulations to establish requirements for nutrition labeling of standard menu items in chain restaurants and similar retail food establishments. FDA is also proposing the terms and conditions for restaurants and similar retail food establishments registering to voluntarily be subject to the requirements of section 4205. FDA is taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act (“Affordable Care Act” or “ACA”), which was signed into law on March 23, 2010.
NPRM 04/06/11 76 FR 19192
NPRM Comment Period End 06/06/11
NPRM Comment Period End 04/00/12
Agency Contact: Carol Drew, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Rm 240 H, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, E-mail: carol.drew@fda.hhs.gov.
Abstract: The Food and Drug Administration is seeking to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Start Printed Page 40063Tobacco Control Act. The proposed rule would cover revisions to the document reporting requirements and definition of “product.”
NPRM 04/14/11 76 FR 20901
NPRM Comment Period End 06/13/11
Agency Contact: Gerie Voss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-4193, E-mail: gerie.voss@fda.hhs.gov.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 350a; 21 U.S.C. 371
Abstract: The Food and Drug Administration (FDA) is revising its infant formula regulations in 21 CFR parts 106 and 107 to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products.
NPRM 07/09/96 61 FR 36154
NPRM Comment Period End 12/06/96
NPRM Comment Period Reopened 04/28/03 68 FR 22341
NPRM Comment Period Extended 06/27/03 68 FR 38247
NPRM Comment Period End 08/26/03
NPRM Comment Period Reopened 08/01/06 71 FR 43392
NPRM Comment Period End 09/15/06
Agency Contact: Benson Silverman, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-850), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436-1459, E-mail: benson.silverman@fda.hhs.gov.
NPRM (Amendment—Ephedrine Single Ingredient) 07/13/05 70 FR 40237
Final Action (Technical Amendment) 11/30/07 72 FR 67639
Final Action (Amendment—Single Ingredient Labeling) 06/00/11
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant or any oral nasal decongestant.
RIN: 0910-AF33
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 361; 21 U.S.C. 371
Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material and to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) beef. Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent Start Printed Page 40064hexane-insoluble impurities and tallow derivatives. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE.
Interim Final Rule 07/14/04 69 FR 42256
Interim Final Rule Effective 07/14/04
Interim Final Rule Comment Period End 10/12/04
Interim Final Rule (Amendments) 09/07/05 70 FR 53063
Interim Final Rule (Amendments) Effective 10/07/05
Interim Final Rule (Amendments) Comment Period End 11/07/05
Interim Final Rule (Amendments) 04/17/08 73 FR 20785
Interim Final Rule (Amendments) Comment Period End 07/16/08
Interim Final Rule (Amendments) Effective 07/16/08
Agency Contact: Amber McCoig, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS-316), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436-2131, Fax: 301 436-2644, E-mail: amber.mccoig@fda.hhs.gov.
Agency Contact: Daniel Sigelman, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, WO Building 1, Room 4245, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-4706, E-mail: daniel.sigelman@fda.hhs.gov.
NPRM 11/12/10 75 FR 69524
NPRM Comment Period End 01/11/11
Abstract: The final rule would amend the postmarketing expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and to propose other revisions to these regulations to enhance the quality of safety reports received by FDA. These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. FDA plans to finalize the premarket and postmarket safety reporting requirements in separate final rules. Premarketing safety reporting requirements were finalized in a separate final rule published on September 29, 2010 (75 FR 59961). This final rule applies to postmarketing safety reporting requirements.
Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room Start Printed Page 400656362, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3469, Fax: 301 847-8440, E-mail: jane.baluss@fda.hhs.gov.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 343; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21 U.S.C. 393; 42 U.S.C. 264
ANPRM 02/06/97 62 FR 5700
ANPRM Comment Period End 06/06/97
NPRM 03/13/03 68 FR 12157
NPRM Comment Period End 08/11/03
Final Rule 06/25/07 72 FR 34752
Interim Final Rule 06/25/07 72 FR 34959
Interim Final Rule Comment Period End 10/24/07
Agency Contact: Linda Kahl, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 301 436-2784, Fax: 301 436-2657, E-mail: linda.kahl@fda.hhs.gov.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351 to 21 U.S.C. 353
Abstract: The Food and Drug Administration is amending its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving high-pressure medical gas cylinders that have resulted in death and injuries to patients. These amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas accidents, do not occur in the future. FDA has described a number of proposals in the proposed rule including requiring that gas use outlet connections on portable cryogenic medical gas containers be securely attached to the valve body.
NPRM 04/10/06 71 FR 18039
NPRM Comment Period End 07/10/06
Agency Contact: Patrick Raulerson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3522, Fax: 301 847-8440, E-mail: patrick.raulerson@fda.hhs.gov.
RIN: 0910-AC53
Abstract: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR parts 201.56, 201.57, and 201.80). Under FDA's current regulations, labeling concerning the use of prescription drugs in pregnancy uses letter categories (A, B, C, D, X) to characterize the risk to the fetus of using the drug in pregnancy. One of the deficiencies of the category system is that drugs may be assigned to the same category when the severity, incidence, and types of risk are quite different. Dissatisfaction with the category system has been expressed by health care providers, medical organizations, experts in the study of birth defects, women's health researchers, and women of childbearing age. Stakeholders consulted through a public hearing, several focus groups, and several advisory committees have recommended that FDA replace the category system with a concise narrative summarizing a product's risks to pregnant women and to women of childbearing age. Therefore, the revised format and the information provided in the labeling would make it easier for health care providers to understand the risks and benefits of drug use during pregnancy and lactation.
NPRM 05/29/08 73 FR 30831
NPRM Comment Period End 08/27/08
Agency Contact: Rachel S. Bressler, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation Research, WO 51, Room 6224, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-4288, Fax: 301 847-8440, E-mail: rachel.bressler@fda.hhs.gov.
RIN: 0910-AF11
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph Start Printed Page 40066(i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses antihistamine labeling claims for the common cold.
NPRM (Amendment) (Common Cold) 08/00/12
Final Action (GRASE dosage forms) 06/00/12
NPRM (Amendment) To Be Determined
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first NPRM listed will address the professional labeling for sodium phosphate drug products. The second NPRM listed will address all other professional labeling requirements for laxative drug products. The final action will address laxative drug products.
NPRM (Professional Labeling) To Be Determined
Final Action (Laxative Drug Products) To Be Determined
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the ingredient phenylpropanolamine.
NPRM (Amendment) (Sinusitis Claim) 08/02/04 69 FR 46119
NPRM Comment Period End 11/01/04
NPRM (Phenylephrine Bitartrate) 11/02/04 69 FR 63482
NPRM Comment Period End 01/31/05
Final Action (Amendment) (Sinusitis Claim) 10/31/05 70 FR 58974
Final Action (Phenylephrine Bitartrate) 08/01/06 71 FR 83358
Withdrawn 03/11/11
RIN: 0910-AF34
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 371; 21 UCS 374; 21 U.S.C. 379e
Abstract: The OTC drug review establishes conditions under which Start Printed Page 40067OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for convenience (small) size OTC drug packages.
NPRM (Convenience Sizes) 12/12/06 71 FR 74474
NPRM Comment Period End 04/11/07
RIN: 0910-AF37
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action finalizes the monograph for emergency first aid eyewash drug products.
NPRM (Amendment) (Emergency First Aid Eyewashes) 02/19/03 68 FR 7917
NPRM Comment Period End 05/20/03
RIN: 0910-AF39
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action identifies safe and effective skin protectant active ingredients to treat and prevent diaper rash. The second action addresses skin protectant products used to treat fever blisters and cold sores.
Final Action (Technical Amendments) 02/01/08 73 FR 6014
Final Action (Aluminum Acetate) (Technical Amendment) 03/06/09 74 FR 9759
RIN: 0910-AF42
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The proposed rule addresses vaginal contraceptive drug products.
Final Action (Warnings) 12/19/07 72 FR 71769
RIN: 0910-AF44
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses products containing bismuth subsalicylate for relief of symptoms of upset stomach due to overindulgence resulting from food and drink.
NPRM (Amendment) 01/05/05 70 FR 741
NPRM Comment Period End 04/05/05
RIN: 0910-AF51
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally Start Printed Page 40068recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. One action addresses the labeling of products containing sodium bicarbonate as an active ingredient. The other action addresses the use of antacids to relieve upset stomach associated with overindulgence in food and drink.
RIN: 0910-AF52
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses skin bleaching drug products containing hydroquinone.
NPRM 08/29/06 71 FR 51146
NPRM Comment Period End 12/27/06
RIN: 0910-AF53
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the use of stimulant active ingredients to relieve symptoms associated with a hangover.
RIN: 0910-AF56
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. These actions address new labeling for antidiarrheal drug products.
RIN: 0910-AF63
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the products used for urinary pain relief.
RIN: 0910-AF70
Abstract: The Food and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA issued this proposed rule because we did not receive any data and information on these ingredients in response to our request on December 31, 2003 (68 FR 75585). This rule will finalize the 2008 proposed rule.
NPRM 06/19/08 73 FR 34895
NPRM Comment Period End 09/17/08
Agency Contact: David Eng, Department of Health and Human Services, Food and Drug Administration, Center for Drug Start Printed Page 40069Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-2773, Fax: 301 796-9899, E-mail: david.eng@fda.hhs.gov.
RIN: 0910-AF95
Legal Authority: 15 U.S.C. 1453 to 1455; 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342 and 343; 21 U.S.C. 348; 21 U.S.C. 371; 42 U.S.C. 243; 42 U.S.C. 264; 42 U.S.C. 271
Abstract: Section 101.17(h) (21 CFR 101.17(h)) describes requirements for the labeling of the cartons of shell eggs that have not been treated to destroy Salmonella microorganisms. Section 115.50 (21 CFR 115.50) describes requirements for refrigeration of shell eggs held for retail distribution. Section 16.5(a)(4) (21 CFR 16.5(a)(4)) provides that part 16 does not apply to a hearing on an order for relabeling, diversion, or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264) and §§ 101.17(h) and 115.50. FDA amended 21 CFR 101.17(h) on August 20, 2007 (72 FR 46375) to permit the safe handling statement to appear on the inside lid of egg cartons to provide the industry greater flexibility in the placement of the statement, provided the words “keep refrigerated” appear on the principal display panel or information panel. FDA is undertaking a review of 21 CFR 101.17(h), 115.50, and 16.5(a)(4) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in §§ 101.17(h), 115.50 and 16.5(a)(4) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule.
Begin Review 12/15/09
End Review 12/30/10
RIN: 0910-AG06
Notice 06/00/11
Agency Contact: Rebecca Cole, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop: C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-1589, E-mail: rebecca.cole@cms.hhs.gov.
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395x; 42 U.S.C. 1395cc(a); 42 U.S.C. 1395hh; 42 U.S.C. 1395bb
Abstract: This proposed rule would revise the existing Conditions of Participation (CoPs) that Home Health Agencies (HHAs) must meet to participate in the Medicare program. The CoPs were last revised in 1989. The new requirements will focus on the actual care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our efforts to achieve broad-based improvements and measurements of the quality of care furnished through federal programs while at the same time reducing procedural burdens on providers.
NPRM 03/10/97 62 FR 11005
NPRM Comment Period End 06/09/97
Second NPRM 09/00/11
Agency Contact: Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards & Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6617, E-mail: danielle.shearer@cms.hhs.gov.
RIN: 0938-AG81
Legal Authority: Social Security Act secs 1881, 1861, 1102, 1871
Abstract: This proposed rule would require certain Medicare and Medicaid providers and suppliers to offer all patients an annual influenza vaccination, unless medically contraindicated or unless the patient or patient's representative or surrogate declined vaccination. This proposed rule is intended to increase the number of patients receiving annual vaccination against seasonal influenza and to Start Printed Page 40070decrease the morbidity and mortality rate from influenza. This proposed rule would also require certain providers and suppliers to develop policies and procedures that would allow them to offer vaccinations for pandemic influenza in case of a future pandemic influenza event for which a vaccine may be developed.
Agency Contact: Lauren Oviatt, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4683, E-mail: lauren.oviatt@cms.hhs.gov.
RIN: 0938-AP92
Legal Authority: 42 U.S.C. 1385 X; 42 U.S.C. 1396 d; 42 U.S.C. 1395 hh
Abstract: This rule proposes requirements for inpatient psychiatric units and inpatient rehabilitation facilities under the hospital conditions of participation (CoPs). This would allow accrediting organizations to deem these units as part of their hospital accreditation process providing a timely and cost effective survey and certification process under the CoPs. In addition, this rule would propose long term care hospital requirements mandated by the Medicare, Medicaid and SCHIP Extension Act of 2007.
Agency Contact: Capt. Katherine Berkhousen, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244, Phone: 410 786-1154, E-mail: katherine.berkhousen@cms.hhs.gov.
Jeannie Miller, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3164, E-mail: jeannie.miller@cms.hhs.gov.
RIN: 0938-AP97
Legal Authority: sec 1886(d) of the Social Security Act; Pub. L. 111-148
Abstract: This annual major proposed rule would revise the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems.
Agency Contact: AnKit Patel, Health Insurance Specialist, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Hospital and Ambulatory Policy Group, Mail Stop, C4-25-11, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4537, E-mail: ankit.patel@cms.hhs.gov.
Legal Authority: Social Security Act, sec 1833; Pub. L. 111-148
Abstract: This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The proposed rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to the Ambulatory Surgical Center Payment System list of services and rates.
Agency Contact: Paula Smith, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop, C5-01-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-7809, E-mail: paula.smith@cms.hhs.gov.
Legal Authority: Sec 1881 of the Social Security Act
Abstract: This major proposed rule would update the bundled payment system for End Stage Renal Disease (ESRD) facilities by January 1, 2012. The rule would also update the Quality Incentives in the ESRD Program.
Agency Contact: Janet Samen, Director, Division of Chronic Care Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C5-05-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4533, E-mail: janet.samen@cms.hhs.gov.
RIN: 0938-AQ27
Legal Authority: 42 U.S.C. 1396a(a)(79) Social Security Act; Pub. L. 111-148, sec 6503
Abstract: This proposed rule would require any agent, clearinghouse, or other alternate payee that submits claims on behalf of a health care provider to register with the State and the Secretary in a form and manner specified by the Secretary.
Agency Contact: Richard Friedman, Director, Division of State Systems, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S3-18-13, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4451, E-mail: richard.friedman@cms.hhs.gov.
RIN: 0938-AQ61Start Printed Page 40071
Legal Authority: Pub. L. 111-148, secs 1413, 2001, 2002, 2201
Abstract: The Affordable Care Act authorizes a major Medicaid expansion to individuals who are under 65, not pregnant, not receiving Medicare and not eligible for other mandatory eligibility categories. This proposed rule would set forth policies for Medicaid expansion including household income and household composition, coordination with Exchanges, simplifying and streamlining Medicaid eligibility determinations.
Agency Contact: Sarah DeLone, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0615, E-mail: sarah.delone@cms.hhs.gov.
RIN: 0938-AQ62
Legal Authority: Pub. L. 111-152, sec 1202
Abstract: This regulation implements section 1202 of the Health Care and Education Reconciliation Act of 2010, which increases Medicaid payments for certain primary care services provided in 2013 and 2014. The increased payments pertain to services provided by a physician with a specialty designation of family medicine, general internal medicine, and pediatric medicine. States must pay for these services at a rate equal to or greater than the rate paid under Medicare Part B. Rates in Medicaid managed care must be consistent with these minimum payment rates. The FMAP to states for such services will equal 100% for the portion of cost for such primary care services, which is comprised of the difference between the Medicare Part B rate and the amount applicable in the State Plan as of July 1, 2009.
Agency Contact: Cherly Powell, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9239, E-mail: cherly.powell@cms.hhs.gov.
RIN: 0938-AQ63
Agency Contact: Elizabeth Holland, Director, Health Initiatives Group/Office of e-Health Standards and Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-1309, E-mail: elizabeth.holland@cms.hhs.gov.
NPRM 11/08/10 75 FR 68583
NPRM Comment Period End 01/07/11
Agency Contact: Richard H. Friedman, Director, Division of State Systems, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S3-18-13, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4451, E-mail: richard.friedman@cms.hhs.gov.
Abstract: This rule establishes that in order to participate in the Medicare and Medicaid programs, long-term care facilities must have an agreement with hospice agencies when hospice care is Start Printed Page 40072provided in a long-term care facility. The rule also contains quality of care requirements.
NPRM 10/22/10 75 FR 65282
NPRM Comment Period End 12/21/10
Final Action 10/00/13
Agency Contact: Kadie Thomas, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0468, E-mail: kadie.thomas@cms.hhs.gov.
Mary Collins, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3189, E-mail: mary.collins@cms.hhs.gov.
RIN: 0938-AP32
Abstract: This amends the “Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011” that appeared in the November 29, 2010, Federal Register.
NPRM 07/13/10 75 FR 40040
NPRM Comment Period End 09/24/10
Final Action 11/29/10 75 FR 73169
2nd Final Action 01/10/11 76 FR 1366
Agency Contact: Carol Bazell, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6960, E-mail: carol.bazell@cms.hhs gov.
RIN: 0938-AP79
Legal Authority: sec 1833 of the Social Security Act; BBA, BA, BIPA, MMA, Pub. L. 111.148
Abstract: This final rule revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule changes the Ambulatory Surgical Center Payment System list of services and rates.
NPRM 08/03/10 75 FR 46169
Final Action 11/24/10 75 FR 71800
Agency Contact: Alberta Dwivedi, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C5-01-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0763, E-mail: alberta.dwivedi@cms.hhs.gov.
RIN: 0938-AP82
Legal Authority: MMEA, Sec 102
Abstract: Section 102 of the Medicare and Medicaid Extenders Act of 2010 extends section 508 of the Medicare Modernization Act of 2003 (MMA) and certain additional special exception hospital reclassifications from October 1, 2010, through September 30, 2011. Effective April 1, 2011, section 102 also requires removing section 508 and special exception hospitals' wage data from the calculation of the reclassified wage index if doing so raises the reclassified wage index. All hospitals affected by section 102 will be assigned an individual special wage index effective April 1, 2011. If the section 508 or special exception hospital's wage index applicable for the period beginning on October 1, 2010, and ending on March 31, 2011, is lower than for the period beginning on April 1, 2011, and ending on September 30, 2011, the hospital will be paid an additional amount that reflects the difference between the wage indices. The provision applies to both inpatient and outpatient hospital payments, although the implementation timeframe differs for outpatient hospital payments.
Notice 04/07/11 76 FR 19365
Agency Contact: Brian Slater, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5229, E-mail: brian.slater@cms.hhs.gov.
RIN: 0938-AQ97
[FR Doc. 2011-15487 Filed 7-6-11; 8:45 am]