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Start Preamble Start Printed Page 1158

AGENCY:

Office of the Secretary, HHS.

ACTION:

Semiannual regulatory agenda.

SUMMARY:

The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the Department semiannually to issue an inventory of rulemaking actions under development to provide the public a summary of forthcoming regulatory actions. This information will help the public more effectively participate in the Department's regulatory activity, and the Department welcomes comments on any aspect of this agenda.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Jennifer M. Cannistra, Executive Secretary, Department of Health and Human Services, Washington, DC 20201.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

The Department of Health and Human Services (HHS) is the Federal Government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS enhances the health and well-being of Americans by promoting effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. This agenda presents the rulemaking activities that the Department expects to undertake in the foreseeable future to advance this mission. The agenda furthers several Departmental goals, including strengthening health care; advancing scientific knowledge and innovation; advancing the health, safety, and well-being of the American people; increasing efficiency, transparency, and accountability of HHS programs; and strengthening the Nation's health and human services infrastructure and workforce.

HHS has an agency-wide effort to support the agenda's purpose of encouraging more effective public participation in the regulatory process. The Department's Public Participation Task Force, which was created as part of the HHS Retrospective Review plan in response to Executive Order 13563 (Improving Regulation and Regulatory Review), regularly meets to identify ways to make the rulemaking process more accessible to the general public. For example, to encourage public participation, HHS regularly updates its main regulatory Web page (http://www.HHS.gov/​regulations/​), which includes links to HHS rules currently open for public comment and provides a “regulations toolkit” with background information on regulations, the commenting process, how public comments influence the development of a rule, and how the public can provide effective comments. HHS also actively encourages meaningful public participation in its retrospective review of regulations, including through a comment form on the HHS retrospective review Web page (http://www.HHS.gov/​RetrospectiveReview). In addition, a cross-agency team at HHS is currently considering how to increase efficiency in rulemaking by organizing public comment on proposed rules.

The rulemaking abstracts included in this paper issue of the Federal Register only cover, as required by the Regulatory Flexibility Act of 1980, those prospective HHS rulemakings likely to have a significant economic impact on a substantial number of small entities. The Department's complete Regulatory Agenda is accessible online at http://www.RegInfo.gov.

Start Signature

Dated: August 21, 2013.

Jennifer M. Cannistra,

Executive Secretary to the Department.

End Signature

Food and Drug Administration—Prerule Stage

Sequence No.TitleRegulation Identifier No.
274Over-the-Counter (OTC) Drug Review—Sunscreen Products0910-AF43
275Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Section 610 Review)0910-AG14

Food and Drug Administration—Proposed Rule Stage

Sequence No.TitleRegulation Identifier No.
276Food Labeling; Revision of the Nutrition and Supplement Facts Labels (Reg Plan Seq No. 49)0910-AF22
277Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs (Reg Plan Seq No. 50)0910-AF23
278Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products0910-AF31
279Over-the-Counter (OTC) Drug Review—Internal Analgesic Products0910-AF36
280Updated Standards for Labeling of Pet Food0910-AG09
281Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Reg Plan Seq No. 51)0910-AG10
282Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products0910-AG12
283Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products0910-AG18
284Produce Safety Regulation0910-AG35
285Hazard Analysis and Risk-Based Preventive Controls0910-AG36
286“Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act (Reg Plan Seq No. 52)0910-AG38
287Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives0910-AG59
288Foreign Supplier Verification Program0910-AG64
289Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (Reg Plan Seq No. 55)0910-AG94
Start Printed Page 1159
290Veterinary Feed Directive (Reg Plan Seq No. 56)0910-AG95
291Format and Content of Reports Intended to Demonstrate Substantial Equivalence0910-AG96
292Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System0910-AH03
293Mammography Quality Standards Act; Regulatory Amendments0910-AH04
References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.

Food and Drug Administration—Final Rule Stage

Sequence No.TitleRegulation Identifier No.
294Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling0910-AF11
295Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors0910-AF27
296Combinations of Bronchodilators With Nasal Decongestants or Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use0910-AF33
297Laser Products; Proposed Amendment to Performance Standard0910-AF87
298Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines (Reg Plan Seq No. 57)0910-AG56
299Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Reg Plan Seq No. 58)0910-AG57
300Use of Certain Symbols in Labeling0910-AG74
301Requirements for the Submission of Data Needed To Calculate User Fees for Manufacturers and Importers of Tobacco Products0910-AG81
References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.

Food and Drug Administration—Long-Term Actions

Sequence No.TitleRegulation Identifier No.
302Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products0910-AF69
303Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Second Phase0910-AG20
304Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices0910-AG48
305Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Components0910-AG70

Food and Drug Administration—Completed Actions

Sequence No.TitleRegulation Identifier No.
306Unique Device Identification0910-AG31
307Food Labeling: Serving Sizes; Reference Amount and Serving Size Declaration for Hard Candies and Breath Mints0910-AG82
308Food Labeling; Gluten-Free Labeling of Foods0910-AG84

Centers for Medicare & Medicaid Services—Proposed Rule Stage

Sequence No.TitleRegulation Identifier No.
309Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-P) (Section 610 Review)0938-AO91
310Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics and CLIA Enforcement Actions for Proficiency Testing Referral (CMS-1443-F) (Section 610 Review)0938-AR62
311Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (CMS-1607-P) (Reg Plan Seq No. 62)0938-AS11
312CY 2015 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-P) (Reg Plan Seq No. 63)0938-AS12
313CY 2015 Hospital Outpatient Prospective Payment System (PPS) Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1613-P) (Reg Plan Seq No. 64)0938-AS15
References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register.
Start Printed Page 1160

Centers for Medicare & Medicaid Services—Final Rule Stage

Sequence No.TitleRegulation Identifier No.
314Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review)0938-AQ41
315CY 2014 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, ESRD Quality Incentive Program, and Durable Medical Equipment (CMS-1526-F)0938-AR55
316Revisions to Payment Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS-1600-F)0938-AR56
317Adoption of Operating Rules for HIPAA Transactions (CMS-0036-IFC)0938-AS01

Centers for Medicare & Medicaid Services—Completed Actions

Sequence No.TitleRegulation Identifier No.
318Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 2014 (CMS-1599-F)0938-AR53
319Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2014 (CMS-1601-F)0938-AR54

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Prerule Stage

274. Over-the-Counter (OTC) Drug Review—Sunscreen Products

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. 360; 21 U.S.C. 371

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 of the future actions will address the safety of sunscreen active ingredients.

Timetable:

ActionDateFR Cite
ANPRM (Sunscreen and Insect Repellent)02/22/0772 FR 7941
ANPRM Comment Period End05/23/07
NPRM (UVA/UVB)08/27/0772 FR 49070
NPRM Comment Period End12/26/07
Final Action (UVA/UVB)06/17/1176 FR 35620
NPRM (Effectiveness)06/17/1176 FR 35672
NPRM (Effectiveness) Comment Period End09/15/11
ANPRM (Dosage Forms)06/17/1176 FR 35669
ANPRM (Dosage Forms) Comment Period End09/15/11
ANPRM (Safety)06/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: David Eng, Regulatory Project Manager, 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, Email: david.eng@fda.hhs.gov.

RIN: 0910-AF43

275. Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures (Section 610 Review)

Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 351 to 353; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381

Abstract: FDA is currently reviewing regulations promulgated under the Prescription Drug Marketing Act (PDMA). FDA is undertaking this review to determine whether the regulations should be changed or rescinded to minimize adverse impacts on a substantial number of small entities. FDA has extended again the completion date by 1 year and will complete the review by November 2013.

Timetable:

ActionDateFR Cite
Begin Review of Current Regulation11/24/08
End Review of Current Regulation11/00/13

Regulatory Flexibility Analysis Required: Yes.

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, Email: pdma610(c)review@fda.hhs.gov.

RIN: 0910-AG14

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

276. Food Labeling; Revision of the Nutrition and Supplement Facts Labels

Regulatory Plan: This entry is Seq. No. 49 in part II of this issue of the Federal Register.

RIN: 0910-AF22

277. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs

Regulatory Plan: This entry is Seq. No. 50 in part II of this issue of the Federal Register.

RIN: 0910-AF23

278. Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products

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. 360; 21 U.S.C. 371Start Printed Page 1161

Abstract: FDA will be proposing a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients. This proposed rule is the result of collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC) as part of efforts to reduce unnecessary duplication and differences. This pilot exercise will help determine the feasibility of developing an ongoing mechanism for alignment in review and adoption of OTC drug monograph elements.

Timetable:

ActionDateFR Cite
Reopening of Administrative Record08/25/0065 FR 51780
Comment Period End11/24/00
NPRM (Amendment) (Common Cold)12/00/13

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.

RIN: 0910-AF31

279. Over-the-Counter (OTC) Drug Review—Internal Analgesic Products

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. 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 first action addresses acetaminophen safety. The second action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products.

Timetable:

ActionDateFR Cite
NPRM (Amendment) (Required Warnings and Other Labeling)12/26/0671 FR 77314
NPRM Comment Period End05/25/07
Final Action (Required Warnings and Other Labeling)04/29/0974 FR 19385
Final Action (Correction)06/30/0974 FR 31177
Final Action (Technical Amendment)11/25/0974 FR 61512
NPRM (Amendment) (Pediatric)07/00/14
NPRM (Amendment) (Acetaminophen)12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.

RIN: 0910-AF36

280. Updated Standards for Labeling of Pet Food

Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 110-85, sec 1002(a)(3)

Abstract: FDA is proposing updated standards for the labeling of pet food that include nutritional and ingredient information, as well as style and formatting standards. FDA is taking this action to provide pet owners and animal health professionals more complete and useful information about the nutrient content and ingredient composition of pet food products.

Timetable:

ActionDateFR Cite
NPRM06/00/14

Regulatory Flexibility Analysis Required: Yes.

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, Email: william.burkholder@fda.hhs.gov.

RIN: 0910-AG09

281. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

Regulatory Plan: This entry is Seq. No. 51 in part II of this issue of the Federal Register.

RIN: 0910-AG10

282. Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products

Legal Authority: 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371

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 will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products.

Timetable:

ActionDateFR Cite
NPRM06/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.

RIN: 0910-AG12

283. Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264

Abstract: This rule would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that Start Printed Page 1162the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products.

Timetable:

ActionDateFR Cite
NPRM01/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Megan Velez, Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO 32, Room 4249, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-9301, Email: megan.velez@fda.hhs.gov.

RIN: 0910-AG18

284. Produce Safety Regulation

Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353 (signed on Jan. 4, 2011)

Abstract: FDA is proposing to establish science-based minimum standards for the safe production and harvesting of those types 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. The purpose of the proposed rule is to reduce the risk of illness associated with fresh produce.

Timetable:

ActionDateFR Cite
NPRM01/16/1378 FR 3503
NPRM Comment Period End05/16/13
NPRM Comment Period Extended04/26/1378 FR 24692
NPRM Comment Period Extended End09/16/13
NPRM Comment Period Extended08/09/1378 FR 48637
NPRM Comment Period Extended End11/15/13
Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Rule08/19/1378 FR 50358
Notice of Intent To Prepare Environmental Impact Statement for the Proposed Rule Comment Period End11/15/13
NPRM Comment Period Extended11/20/1378 FR 69605
NPRM Comment Period Extended End11/22/13
Environmental Impact Statement for the Proposed Rule; Comment Period Extended11/18/1378 FR 69006
Environmental Impact Statement for the Proposed Rule; Comment Period Extended End03/14/14

Regulatory Flexibility Analysis Required: Yes.

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: 240 402-1636, Email: samir.assar@fda.hhs.gov.

RIN: 0910-AG35

285. Hazard Analysis and Risk-Based Preventive Controls

Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353 (signed on Jan. 4, 2011)

Abstract: 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. This action is intended to prevent or, at a minimum, quickly identify foodborne pathogens before they get into the food supply.

Timetable:

ActionDateFR Cite
NPRM01/16/1378 FR 3646
NPRM Comment Period End05/16/13
NPRM Comment Period Extended04/26/1378 FR 24691
NPRM Comment Period Extended End09/16/13
NPRM Comment Period Extended08/09/1378 FR 48636
NPRM Comment Period Extended End11/15/13
NPRM Comment Period Extended11/20/1378 FR 69604
NPRM Comment Period Extended End11/22/13

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Jenny Scott, Senior Advisor, Department of Health and Human Services, Food and Drug Administration, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1488, Email: jenny.scott@fda.hhs.gov.

RIN: 0910-AG36

286. “Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act

Regulatory Plan: This entry is Seq. No. 52 in part II of this issue of the Federal Register.

RIN: 0910-AG38

287. Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives

Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 387; The Family Smoking Prevention and Tobacco Control Act

Abstract: The Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, requires the Food and Drug Administration to promulgate regulations that require the testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents, that the agency determines should be tested to protect the public health.

Timetable:

ActionDateFR Cite
NPRM12/00/13

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 9200 Corporate Boulevard, Room 240 H, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email: carol.drew@fda.hhs.gov. Start Printed Page 1163

RIN: 0910-AG59

288. Foreign Supplier Verification Program

Legal Authority: 21 U.S.C. 384a; title III, sec 301 of FDA Food Safety Modernization Act, Pub. L. 111-353, establishing sec 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Abstract: FDA is proposing regulations that describe what a food importer must do to verify that its foreign suppliers produce food that is as safe as food produced in the United States. FDA is taking this action to improve the safety of food that is imported into the United States.

Timetable:

ActionDateFR Cite
NPRM07/29/1378 FR 45729
NPRM Comment Period End11/26/13
NPRM Comment Period Extended11/20/1378 FR 69602
NPRM Comment Period Extended End01/27/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Brian L. Pendleton, Senior Policy Advisor, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-4614, Fax: 301 847-8616, Email: brian.pendleton@fda.hhs.gov.

RIN: 0910-AG64

289. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

Regulatory Plan: This entry is Seq. No. 55 in part II of this issue of the Federal Register.

RIN: 0910-AG94

290. Veterinary Feed Directive

Regulatory Plan: This entry is Seq. No. 56 in part II of this issue of the Federal Register.

RIN: 0910-AG95

291. Format and Content of Reports Intended To Demonstrate Substantial Equivalence

Legal Authority: 21 U.S.C. 387e(j); 21 U.S.C. 387j(a); secs 905(j) and 910(a) of the Federal Food, Drug, and Cosmetic Act

Abstract: This regulation would establish the format and content of reports intended to demonstrate substantial equivalence and compliance with the FD&C Act (sections 905(j) and 910(a) of the FD&C Act). This regulation also would provide information as to how the Agency will review and act on these submissions.

Timetable:

ActionDateFR Cite
NPRM03/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Gerie Voss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-4193, Email: gerie.voss@fda.hhs.gov.

RIN: 0910-AG96

292. Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System

Legal Authority: 21 U.S.C. 360

Abstract: The proposed rule would establish special controls for the computed tomography (CT) X-ray system, a class II device as defined in 21 CFR 892.1750. A CT X-ray system is a diagnostic X-ray imaging system intended to produce cross-sectional images of the body through use of a computer to reconstruct an image from the same axial plane taken at different angles. High doses of ionizing radiation can cause acute (deterministic) effects such as burns, reddening of the skin, cataracts, hair loss, sterility, or, in extremely high doses, radiation poisoning. Therefore, the design of a CT X-ray system needs to balance the benefits of the device (i.e., the ability of the device to produce a diagnostic quality image) with the known risks (e.g., exposure to ionizing radiation). FDA is establishing special controls, combined with the general controls, to provide reasonable assurance of the safety and effectiveness of a class II CT X-ray system.

Timetable:

ActionDateFR Cite
NPRM05/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Erica Blake, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4426, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-8145, Email: erica.blake@fda.hhs.gov.

RIN: 0910-AH03

293. Mammography Quality Standards Act; Regulatory Amendments

Legal Authority: 21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e); 42 U.S.C. 263b

Abstract: FDA is proposing to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA). FDA is taking this action to address changes in mammography technology and mammography processes, such as breast density reporting, that have occurred since the regulations were published in 1997.

Timetable:

ActionDateFR Cite
NPRM12/00/13

Regulatory Flexibility Analysis Required: Yes.

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, Email: nancy.pirt@fda.hhs.gov.

RIN: 0910-AH04

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administrtion (FDA)

Final Rule Stage

294. Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling

Legal Authority: 21 U.S.C. 321; 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. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264

Abstract: This final rule will amend the content and format of the “Pregnancy,” “Labor and delivery,” and “Nursing mothers” subsections of the “Use in Specific Populations” section of regulations regarding the labeling for human prescription drug and biological products (21 CFR 201.56 and 201.57) to better communicate risks.

Timetable:

ActionDateFR Cite
NPRM05/29/0873 FR 30831
Start Printed Page 1164
NPRM Comment Period End08/27/08
Final Action05/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Molly Flannery, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6246, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3543, Email: molly.flannery@fda.hhs.gov.

RIN: 0910-AF11

295. Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 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.

Timetable:

ActionDateFR Cite
NPRM07/09/9661 FR 36154
NPRM Comment Period End12/06/96
NPRM Comment Period Reopened04/28/0368 FR 22341
NPRM Comment Period Extended06/27/0368 FR 38247
NPRM Comment Period End08/26/03
NPRM Comment Period Reopened08/01/0671 FR 43392
NPRM Comment Period End09/15/06
Final Rule11/00/13

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Benson Silverman, Staff Director, Infant Formula and Medical Foods, 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: 240 402-1459, Email: benson.silverman@fda.hhs.gov

RIN: 0910-AF27

296. Combinations of Bronchodilators With Nasal Decongestants or Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use

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. 360; 21 U.S.C. 371

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.

Timetable:

ActionDateFR Cite
NPRM (Amendment)07/13/0570 FR 40232
NPRM Comment Period End11/10/05
Final Action (Technical Amendment)03/19/0772 FR 12730
Final Action06/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.

RIN: 0910-AF33

297. Laser Products; Proposed Amendment to Performance Standard

Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 393

Abstract: FDA is proposing to amend the performance standard for laser products to achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The proposed amendment is intended to update FDA's performance standard to reflect advancements in technology.

Timetable:

ActionDateFR Cite
NPRM06/24/1378 FR 37723
NPRM Comment Period End09/23/13
Final Action06/00/14

Regulatory Flexibility Analysis Required: Yes.

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, Email: nancy.pirt@fda.hhs.gov.

RIN: 0910-AF87

298. Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines

Regulatory Plan: This entry is Seq. No. 57 in part II of this issue of the Federal Register.

RIN: 0910-AG56

299. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

Regulatory Plan: This entry is Seq. No. 58 in part II of this issue of the Federal Register.

RIN: 0910-AG57

300. Use of Certain Sysmbols in Labeling

Legal Authority: sec 502(c) of the Food Drug and Cosmetic Act (FD&C Act), 21 U.S.C. 352(c); sec 514(c) of FD&C Act, 21 U.S.C. 360d(c), enacted by the Food and Drug Modernization Act of 1997 (FDAMA)

Abstract: The purpose of this rule is to allow for the inclusion of certain stand-alone symbols contained in a standard that FDA recognizes, provided that such symbols are explained in a symbols glossary that contemporaneously accompanies the medical device.

Timetable:

ActionDateFR Cite
NPRM04/19/1378 FR 23508
NPRM Comment Period End06/18/13
Final Action04/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Mary Follette Story, Human Factors and Accessible Medical Technology Specialist, Department of Health and Human Services, Food and Drug Administration, Center for Devices Start Printed Page 1165and Radiological Health, Room 2553, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-1456, Email: molly.story@fda.hhs.gov.

RIN: 0910-AG74

301. Requirements for the Submission of Data Needed To Calculate User Fees for Manufacturers and Importers of Tobacco Products

Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387s; Pub. L. 111-31

Abstract: FDA is proposing to require manufacturers and importers of tobacco products to submit certain market share data to FDA. USDA currently collects such data, but its program sunsets at the end of September 2014 and USDA will cease collection of this information. FDA is taking this action so that it may continue to calculate market share percentages needed to compute user fees.

Timetable:

ActionDateFR Cite
NPRM05/31/1378 FR 32581
NPRM Comment Period End08/14/13
Final Action06/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Annette L. Marthaler, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Room 340K, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email: annette.marthaler@fda.hhs.gov.

RIN: 0910-AG81

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

302. Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products

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. 360; 21 U.S.C. 371

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 antimicrobial agents in consumer hand wash products.

Timetable:

ActionDateFR Cite
NPRM (Healthcare)06/17/9459 FR 31402
Comment Period End12/15/95
NPRM (Consumer Hand Wash Products)12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: David Eng, Regulatory Project Manager, 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, Email: david.eng@fda.hhs.gov.

RIN: 0910-AF69

303. Amendment to the Current Good Manufacturing Practice Regulations for Pharmaceuticals—Second Phase

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264

Abstract: FDA will revise regulations for “current good manufacturing practice” for oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products. This revision will update and harmonize requirements and improve detection and response to emerging product safety and quality signals.

Timetable:

ActionDateFR Cite
NPRM11/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Paula Katz, Regulatory Counsel, Office of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 4314, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6972, Fax: 301 847-8742, Email: paula.katz@fda.hhs.gov.

RIN: 0910-AG20

304. Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C. 360i; 21 U.S.C. 360j; 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; 42 U.S.C. 271; * * *

Abstract: This rule will amend FDA's regulations on acceptance of data from clinical studies conducted in support of a premarket approval application, humanitarian device exemption application, an investigational device exemption application, or a premarket notification submission for a medical device.

Timetable:

ActionDateFR Cite
NPRM02/25/1378 FR 12664
NPRM Comment Period End05/28/13
Final Action12/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Sheila Anne Brown, Policy Analyst, Investigational Device Exemptions Staff, Department of Health and Human Services, Food and Drug Administration, WO 66, Room 1651, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6563, Fax: 301 847-8120, Email: sheila.brown@fda.hhs.gov.

RIN: 0910-AG48

305. Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Components

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 360bbb-7; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264

Abstract: FDA will revise regulations for “current good manufacturing practice” with regard to the control over components used in manufacturing finished pharmaceuticals.

Timetable:

ActionDateFR Cite
NPRM11/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Brian Hasselbalch, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 4364, 10903 New Hampshire Avenue, Start Printed Page 1166Silver Spring, MD 20993, Phone: 301 796-3279, Email: brian.hasselbalch@fda.hhs.gov.

Paula Katz, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 1320, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6972, Email: paula.katz@fda.hhs.gov.

RIN: 0910-AG70

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

306. Unique Device Identification

Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360h; 21 U.S.C. 360i; 21 U.S.C. 360j; 21 U.S.C. 360l; 21 U.S.C. 371

Abstract: FDA is issuing a final rule establishing a unique device identification system for medical devices. A unique device identification system would allow healthcare professionals and others to rapidly and precisely identify a device and obtain important information concerning the device and would reduce medical errors.

Timetable:

ActionDateFR Cite
NPRM07/10/1277 FR 40735
NPRM Comment Period End11/07/12
Second NPRM11/19/1277 FR 69393
Second NPRM Comment Period End12/19/13
Final Action09/24/1378 FR 58786

Regulatory Flexibility Analysis Required: Yes.

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, Email: jay.crowley@fda.hhs.gov.

RIN: 0910-AG31

307. Food Labeling: Serving Sizes; Reference Amount and Serving Size Declaration for Hard Candies and Breath Mints

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371

Abstract: FDA is proposing to change the nutrition label serving size for breath mints to one unit. FDA is taking this action in response to a citizen petition that requested a serving size for breath mints that more accurately reflects the amount customarily consumed per eating occasion and comments received on an advance notice of proposed rulemaking published in 2005.

Timetable:

ActionDateFR Cite
NPRM12/30/9762 FR 67775
NPRM Comment Period End03/16/98
ANPRM04/05/0570 FR 17010
ANPRM Comment Period End06/20/05
Withdrawn and Merged with 0910-AF2308/14/13

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Mark Kantor, Nutritionist, Department of Health and Human Services, Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1450, Fax: 301 436-1191, Email: mark.kantor@fda.hhs.gov.

RIN: 0910-AG82

308. Food Labeling; Gluten-Free Labeling of Foods

Legal Authority: Title II of Pub. L. 108-282; 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371

Abstract: FDA is amending its regulations to define the term “gluten-free” for voluntary use in the labeling of foods. FDA is taking this action to assist persons who have celiac disease to more easily identify foods that they can eat while following a “gluten-free” diet.

Timetable:

ActionDateFR Cite
NPRM01/23/0772 FR 2795
NPRM Comment Period End04/23/07
NPRM Comment Period Reopened08/03/1176 FR 46671
NPRM Comment Period Reopened End10/03/11
Final Action08/05/1378 FR 47154

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Felicia Billingslea, Director, Food Labeling and Standard Staff, Department of Health and Human Services, Food and Drug Administration, Room 4D045, HFS 820, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1803, Fax: 301 436-2636, Email: felicia.billingslea@fda.hhs.gov.

RIN: 0910-AG84

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

309. Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-P) (Section 610 Review)

Legal Authority: 42 U.S.C. 1821; 42 U.S.C. 1861 (ff) (3)(B)(i)(ii); 42 U.S.C. 1913 (c)(1) et al

Abstract: This rule proposes emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers to ensure that they adequately plan for both natural and man-made disasters and coordinate with Federal, State, tribal, regional, and local emergency preparedness systems. This rule would ensure providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations.

Timetable:

ActionDateFR Cite
NPRM11/00/13

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Graham, Health Insurance Specialist, Clincal Standards Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clincial Standards and Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-1850, Phone: 410 786-8020, Email: janice.graham@cms.hhs.gov.

RIN: 0938-AO91

310. Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics and CLIA Enforcement Actions for Proficiency Testing Referral (CMS-1443-F) (Section 610 Review)

Legal Authority: Pub. L. 111-148, sec 10501

Abstract: This final rule establishes methodology and payment rates for a prospective payment system (PPS) for federally qualified health center (FQHC) Start Printed Page 1167services under Medicare Part B beginning on October 1, 2014, in compliance with the statutory requirement of the Affordable Care Act. This rule also establishes a policy which would allow rural health clinics (RHCs) to contract with nonphysician practitioners when statutory requirements for employment of nurse practitioners and physician assistants are met, and makes other technical and conforming changes to the RHC and FQHC regulations. Finally, this rule makes changes to the Clinical Laboratory Improvement Amendments (CLIA) regulations regarding enforcement actions for proficiency testing referral.

Timetable:

ActionDateFR Cite
NPRM09/23/1378 FR 58386
NPRM Comment Period End11/18/13
Final Action08/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Sarah Harding, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-01-26, 7500 Security Boulevard, Windsor Mill, MD 21244, Phone: 410 786-4001, Email: sarah.harding@cms.hhs.gov.

RIN: 0938-AR62

311. • Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (CMS-1607-P)

Regulatory Plan: This entry is Seq. No. 62 in part II of this issue of the Federal Register.

RIN: 0938-AS11

312. • CY 2015 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-P)

Regulatory Plan: This entry is Seq. No. 63 in part II of this issue of the Federal Register.

RIN: 0938-AS12

313. • CY 2015 Hospital Outpatient Prospective Payment System (PPS) Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1613-P)

Regulatory Plan: This entry is Seq. No. 64 in part II of this issue of the Federal Register.

RIN: 0938-AS15

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

314. Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review)

Legal Authority: Pub. L. 111-48, secs 2501, 2503, 3301(d)(2); Pub. L. 111-152, sec 1206; Pub. L. 111-8, sec 221

Abstract: This final rule revises requirements pertaining to Medicaid reimbursement for covered outpatient drugs to implement provisions of the Affordable Care Act. This rule also revises other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program.

Timetable:

ActionDateFR Cite
NPRM02/02/1277 FR 5318
NPRM Comment Period End04/02/12
Final Action05/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Wendy Tuttle, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, Mail Stop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-8690, Email: wendy.tuttle@cms.hhs.gov.

RIN: 0938-AQ41

315. CY 2014 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, ESRD Quality Incentive Program, and Durable Medical Equipment (CMS-1526-F)

Legal Authority: MIPPA sec 153(b); Pub. L. 111-148 sec 3401(h); ATRA sec 632(a)

Abstract: This final rule updates the bundled payment system for End Stage Renal Disease (ESRD) facilities by 1/1/13. The rule also updates the Quality Incentives in the ESRD Program. In addition, this rule clarifies the grandfathering provision related to the 3-year minimum lifetime requirement for Durable Medical Equipment (DME). It also provides clarification of the definition of routinely purchased DME.

Timetable:

ActionDateFR Cite
NPRM07/08/1378 FR 40835
NPRM Comment Period End08/30/13
Final Action11/00/13

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Michelle Cruse, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mailstop C5-05-27, Baltimore, MD 21244, Phone: 410 786-7540, Email: michelle.cruse@cms.hhs.gov.

RIN: 0938-AR55

316. Revisions to Payment Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS-1600-F)

Legal Authority: Social Security Act secs 1102, 1871, 1848

Abstract: This final rule revises payment polices under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes are applicable to services furnished on or after January 1 annually.

Timetable:

ActionDateFR Cite
NPRM07/19/1378 FR 43282
NPRM Comment Period End09/06/13
Final Action11/00/13

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Kathy Bryant, Deputy Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-01-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3448, Email: kathy.bryant@cms.hhs.gov.

RIN: 0938-AR56

317. • Adoption of Operating Rules for HIPAA Transactions (CMS-0036-IFC)

Legal Authority: Pub. L. 104-191, sec 1104

Abstract: Under the Affordable Care Act, this interim final rule adopts operating rules for HIPAA transactions for health care claims or equivalent encounter information, enrollment and disenrollment of a health plan, health plan premium payments, and referral certification and authorization.

Timetable:

ActionDateFR Cite
Interim Final Rule06/00/14

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Christine Stahlecker, Acting Director, Administrative Simplification Group, Office of E-Health Standards and Services, Department of Start Printed Page 1168Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6405, Email: christine.stahlecker@cms.hhs.gov.

RIN: 0938-AS01

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

318. Changes to the Hospital Inpatient and Long-Term Care Prospective Payment System for FY 2014 (CMS-1599-F)

Legal Authority: sec 1886(d) of the Social Security Act

Abstract: This annual rule revises the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This rule implements changes arising from our continuing experience with these systems.

Timetable:

ActionDateFR Cite
NPRM05/10/1378 FR 27485
NPRM Comment Period End06/25/13
Final Action08/19/1378 FR 50419

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Roechel Kujawa, 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: 410 786-9111, Email: roechel.kujawa@cms.hhs.gov.

RIN: 0938-AR53

319. Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2014 (CMS-1601-F)

Legal Authority: sec 1833 of the Social Security Act

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 finalizes changes to the Ambulatory Surgical Center Payment System list of services and rates.

Timetable:

ActionDateFR Cite
NPRM07/19/1378 FR 43534
NPRM Comment Period End09/06/13
Final Action09/06/1378 FR 54842

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Marjorie Baldo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, Mail Stop C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4617, Email: marjorie.baldo@cms.hhs.gov.

RIN: 0938-AR54

End Supplemental Information

[FR Doc. 2013-29632 Filed 1-6-14; 8:45 am]

BILLING CODE 4150-24-P