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Proposed Rule

Regulatory Agenda

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Start Preamble Start Printed Page 35016

AGENCY:

Office of the Secretary, HHS.

ACTION:

Semiannual Regulatory Agenda.

SUMMARY:

The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

C'Reda J. Weeden, Executive Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201; (202) 690-5627.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

The Department of Health and Human Services (HHS) is the Federal government's lead 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 this year 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.

In the rules outlined for this Agenda, HHS continues its work to build a better, smarter, and stronger health care delivery system. Our aspiration is for patients to receive higher quality of care, for medical information to be easy to understand, and for health care dollars to be spent more wisely. We welcome the opportunity to build a more transparent health care delivery system and strengthen partnerships with patients, physicians, governments, and businesses. We continue our work by helping more people get and keep health insurance coverage and making health care more affordable for working families.

In addition, HHS strives to lead in the advancement of scientific knowledge and innovation to enable our nation's scientists and researchers to continue making new and improved vaccines, cures, therapies, and rapid diagnostics. The accompanying regulations promote advancements in science, research, and innovation to attract the best experts to accelerate cures; reduce administrative burdens and duplication; and promote data sharing to protect the health of the American people.

HHS has an agency-wide effort to support the Agenda's purpose of encouraging more effective public participation in the regulatory process and promote increase transparency to the public regarding our regulatory activity. For example, to encourage public participation, we regularly update our regulatory Web page (http://www.HHS.gov/​regulations) which includes links to HHS rules currently open for public comment, and also 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, through a comment form on the HHS retrospective review Web page (http://www.HHS.gov/​RetrospectiveReview).

The rulemaking abstracts included in this paper issue of the Federal Register 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.Reglnfo.gov.

Start Signature

C'Reda J. Weeden,

Executive Secretary to the Department.

End Signature

Substance Abuse and Mental Health Services Administration—Completed Actions

Sequence No.TitleRegulation Identifier No.
99SAMHSA User Fees for Publications0930-AA18

Food and Drug Administration—Proposed Rule Stage

Sequence No.TitleRegulation Identifier No.
100Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products0910-AF31
101Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products0910-AF69
102Abbreviated New Drug Applications and 505(b)(2)0910-AF97
103Updated Standards for Labeling of Pet Food0910-AG09
104Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products0910-AG18
105Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives0910-AG59
106Format and Content of Reports Intended to Demonstrate Substantial Equivalence0910-AG96
107Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods0910-AH00
108Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System0910-AH03
109Mammography Quality Standards Act; Regulatory Amendments0910-AH04
110Investigational New Drug Application Annual Reporting0910-AH07
111General and Plastic Surgery Devices: Sunlamp Products0910-AH14
112Requirements for Tobacco Product Manufacturing Practice0910-AH22
Start Printed Page 35017

Food and Drug Administration—Final Rule Stage

Sequence No.TitleRegulation Identifier no.
113Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs0910-AA49
114Food Labeling; Revision of the Nutrition and Supplement Facts Labels0910-AF22
115Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs0910-AF23
116Laser Products; Amendment to Performance Standard0910-AF87
117Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals0910-AG10
118Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption0910-AG35
119Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food0910-AG36
120“Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act0910-AG38
121Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices0910-AG48
122Foreign Supplier Verification Program0910-AG64
123Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products0910-AG94
124Veterinary Feed Directive0910-AG95
125Sanitary Transportation of Human and Animal Food0910-AG98

Food and Drug Administration—Long-Term Actions

Sequence No.TitleRegulation Identifier No.
126Focused Mitigation Strategies To Protect Food Against Intentional Adulteration0910-AG63

Food and Drug Administration—Completed Actions

Sequence No.TitleRegulation Identifier No.
127Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling0910-AF11
128Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines0910-AG56
129Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments0910-AG57

Centers for Medicare & Medicaid Services—Proposed Rule Stage

Sequence No.TitleRegulation Identifier No.
130Reform of Requirements for Long-Term Care Facilities (CMS-3260-P) (Rulemaking Resulting From a Section 610 Review)0938-AR61
131Electronic Health Record (EHR) Incentive Programs—Stage 3 (CMS-3310-F) (Section 610 Review)0938-AS26
132Medicare Clinical Diagnostic Laboratory Test Payment System (CMS-1621-P) (Section 610 Review)0938-AS33
133CY 2016 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-P)0938-AS40
134Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2016 Rates (CMS-1632-F)0938-AS41
135CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1633-P)0938-AS42
136FY 2016 Inpatient Rehabilitation Facility Prospective Payment System (CMS-1624-F) (Section 610 Review)0938-AS45
137Electronic Health Record Incentive Program—Modifications to Meaningful Use in 2015 through 2017 (CMS-3311-F) (Section 610 Review)0938-AS58

Centers for Medicare & Medicaid Services—Final Rule Stage

Sequence No.TitleRegulation Identifier No.
138Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review)0938-AQ41
Start Printed Page 35018

Centers for Medicare & Medicaid Services—Long-Term Actions

Sequence No.TitleRegulation identifier No.
139Home Health Agency Conditions of Participation (CMS-3819-F) (Rulemaking Resulting From a Section 610 Review)0938-AG81
140Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-F) (Section 610 Review)0938-AO91
141Medicare Shared Savings Program; Accountable Care Organizations (CMS-1461-F) (Section 610 Review)0938-AS06
142Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P) (Rulemaking Resulting From a Section 610 Review)0938-AS21

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Completed Actions

99. SAMHSA USER FEES FOR PUBLICATIONS

Legal Authority: 31 U.S.C. 9701; 31 U.S.C. 1111; E.O. 8284; E.O. 11541; Pub. L. 113-76

Abstract: SAMSHA is proposing to implement a modest cost recovery program to partially offset the high costs of distributing its materials to the public. This user fee would apply only to over-the-limit” non-governmental orders. An over the limit” order is defined as an order that exceeds either the average weight value (3.75 lbs) or the average number of copies (8). The non-governmental orders” do not include: SAMHSA's Recovery Month bulk orders; orders by SAMHSA staff for meetings or conferences; and orders from .gov” and .mil” addresses. Therefore, it is assumed that SAMHSA would not charge shipping for orders by other Federal, State, and local government agencies. The proposed rule would implement recent legislation allowing the funds collected as part of a user fee for publications and data requests to be available to SAMHSA until expended.

Timetable:

ActionDateFR Cite
Withdrawn03/19/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Brian Altman, Legislative Director, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Rockville, MD 02857, Phone: 240 276-2009, Email: brian.altman@samhsa.gov.

RIN: 0930-AA18

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

100. 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. 371

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)09/00/15

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

101. 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 healthcare antiseptic products.

Timetable:

ActionDateFR Cite
NPRM (Healthcare)06/17/9459 FR 31402
Comment Period End12/15/95
NPRM (Consumer Hand Wash Products)12/17/1378 FR 76443
NPRM (Healthcare Antiseptic)05/01/1580 FR 25166
NPRM Comment Period End10/28/15

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-AF69

102. Abbreviated New Drug Applications and 505(B)(2)

Legal Authority: Pub. L. 108-173, title XI; 21 U.S.C. 355; 21 U.S.C. 371

Abstract: This proposed rule would make changes to certain procedures for Abbreviated New Drug Applications Start Printed Page 35019and related applications to patent certifications, notice to patent owners and application holders, the availability of a 30-month stay of approval, amendments and supplements, and the types of bioavailability and bioequivalence data that can be used to support these applications.

Timetable:

ActionDateFR Cite
NPRM02/06/1580 FR 6802
NPRM Comment Period Extended04/24/1580 FR 22953
NPRM Comment Period End05/07/15
NPRM Comment Period Extended End06/08/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice L. Weiner, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6268, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, Email: janice.weiner@fda.hhs.gov.

RIN: 0910-AF97

103. 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 consistent information about the nutrient content and ingredient composition of pet food products.

Timetable:

ActionDateFR Cite
NPRM09/00/15

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, MPN-4, Room 2642, HFV-228, 7519 Standish Place, Rockville, MD 20855, Phone: 240 402-5900, Email: william.burkholder@fda.hhs.gov.

RIN: 0910-AG09

104. 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 the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products.

Timetable:

ActionDateFR Cite
NPRM12/18/1479 FR 75506
NPRM Comment Period Extended03/09/1580 FR 12364
NPRM Comment Period End03/18/15
NPRM Comment Period Extended End05/18/15
Final Action03/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Emily Gebbia, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6226, Silver Spring, MD 20993, Phone: 240 402-0980, Email: emily.gebbia@fda.hhs.gov.

RIN: 0910-AG18

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

Legal Authority: 21 U.S.C. 301 et seq.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
NPRM02/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Laura Rich, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 10903 New Hampshire Avenue, Building 71, G335, Silver Spring, MD 20993, Phone: 877 287-1373, Email: ctpregulations@fda.hhs.gov.

RIN: 0910-AG59

106. 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. This regulation also would provide information as to how the Agency will review and act on these submissions.

Timetable:

ActionDateFR Cite
NPRM11/00/15

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, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 877 287-1426, Email: ctpregulations@fda.hhs.gov.

RIN: 0910-AG96

107. Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods

Legal Authority: sec 206 of the Food Allergen Labeling and Consumer Protection Act; 21 U.S.C. 343(a)(1); 21 U.S.C. 321(n); 21 U.S.C. 371(a)

Abstract: This proposed rule would establish requirements concerning compliance for using a “gluten-free” labeling claim for those foods for which there is no scientifically valid analytical method available that can reliably detect and accurately quantify the presence of Start Printed Page 3502020 parts per million (ppm) gluten in the food.

Timetable:

ActionDateFR Cite
NPRM05/00/15

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-AH00

108. Radiaology Devices; Designation of Special Controls for the Computed Tomography X-Ray System

Legal Authority: 21 U.S.C. 360c

Abstract: The proposed rule would establish special controls for the computed tomography (CT) X-ray system. 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, and, in extremely high doses, radiation poisoning. The design of a CT X-ray system should 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 proposed special controls, which, when combined with the general controls, would provide reasonable assurance of the safety and effectiveness of a class II CT X-ray system.

Timetable:

ActionDateFR Cite
NPRM03/00/16

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

109. 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
NPRM10/00/15

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

110. Investigational New Drug Application Annual Reporting

Legal Authority: 21 U.S.C. 355(i); 21 U.S.C. 371(a); 42 U.S.C. 262(a)

Abstract: This proposed rule would revise the requirements concerning annual reports submitted to investigational new drug applications (INDs) by replacing the current annual reporting requirement with a requirement that is generally consistent with the format, content, and timing of submission of the development safety update report devised by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Timetable:

ActionDateFR Cite
NPRM12/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Peter A. Taschenberger, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 6312, Silver Spring, MD 20993, Phone: 301 796-0018, Fax: 301 847-3529, Email: peter.taschenberger@fda.hhs.gov.

RIN: 0910-AH07

111. General and Plastic Surgery Devices: Sunlamp Products

Legal Authority: 21 U.S.C. 360j(e)

Abstract: This proposed rule would apply device restrictions to sunlamp products.

Timetable:

ActionDateFR Cite
NPRM05/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Paul Gadiock, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, W0-66, Room 4432, Silver Spring, MD 20993-0002, Phone: 301 796-5736, Fax: 301 847-8145, Email: paul.gadiock@fda.hhs.gov.

RIN: 0910-AH14

112. • Requirements for Tobacco Product Manufacturing Practice

Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387b; 21 U.S.C. 387f

Abstract: FDA is proposing requirements that govern the methods used in, and the facilities and controls used for, the pre-production design validation, manufacture, packing, and storage of tobacco products.

Timetable:

ActionDateFR Cite
ANPRM03/19/1378 FR 16824
ANPRM Comment Period End05/20/13
NPRM02/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Darin Achilles, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 301 595-1426, Email: ctpregulations@fda.hhs.gov.

RIN: 0910-AH22

Start Printed Page 35021

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

113. Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That are Regulated Under A Biologics License Application, and Animal Drugs

Legal Authority: 21 U.S.C. 321 and 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355 to 356c; 21 U.S.C. 360 and 360b; 21 U.S.C. 360c to 360f; 21 U.S.C. 360h to 360j; 21 U.S.C. 371 and 374; 21 U.S.C. 379e and 381; 21 U.S.C. 393; 15 U.S.C. 1451 to 1561; 42 U.S.C. 262 and 264; 42 U.S.C. 271

Abstract: The rule will reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, including certain biological drugs, and animal drugs. These regulations contain information on when, how, and where to register drug establishments and list drugs, and what information must be submitted. They also address National Drug Codes.

Timetable:

ActionDateFR Cite
NPRM08/29/0671 FR 51276
NPRM Comment Period End02/26/07
Final Action10/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: David Joy, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, WO 51, Room 6254, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-2242, Email: david.joy@fda.hhs.gov.

RIN: 0910-AA49

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

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

Abstract: FDA is amending the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. This rule will modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label.

Timetable:

ActionDateFR Cite
ANPRM07/11/0368 FR 41507
ANPRM Comment Period End10/09/03
Second ANPRM04/04/0570 FR 17008
Second ANPRM Comment Period End06/20/05
Third ANPRM11/02/0772 FR 62149
Third ANPRM Comment Period End01/31/08
NPRM03/03/1479 FR 11879
NPRM Comment Period End06/02/14
Final Action03/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Blakeley Fitzpatrick, Interdisciplinary Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-830), HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-5429, Email: nutritionprogramstaff@fda.hhs.gov.

RIN: 0910-AF22

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

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 101-535, sec 2(b)(1)(A)

Abstract: FDA is amending its labeling regulations for foods to provide updated Reference Amounts Customarily Consumed (RACCs) for certain food categories. This rule would provide consumers with nutrition information based on the amount of food that is customarily consumed, which would assist consumers in maintaining healthy dietary practices. In addition to updating certain RACCs, FDA is also amending the definition of single-serving containers; amending the label serving size for breath mints; and providing for dual-column labeling, which would provide nutrition information per serving and per container or unit, as applicable, under certain circumstances.

Timetable:

ActionDateFR Cite
ANPRM04/04/0570 FR 17010
ANPRM Comment Period End06/20/05
NPRM03/03/1479 FR 11989
NPRM Comment Period End06/02/14
Final Action03/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Cherisa Henderson, Nutritionist, Department of Health and Human Services, Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-5429, Fax: 301 436-1191, Email: nutritionprogramstaff@fda.hhs.gov.

RIN: 0910-AF23

116. Laser Products; Amendment to Performance Standard

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

Abstract: The regulation will 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 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 Action04/00/16

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

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

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350c; 21 U.S.C. 350d note; 21 U.S.C. 350g; 21 U.S.C. 350g note; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 264; 42 U.S.C. 243; 42 U.S.C. 271; * * *

Abstract: This rule establishes requirements for good manufacturing practice, and requires that certain facilities establish and implement hazard analysis and risk-based preventive controls for animal food, including ingredients and mixed animal feed. This action is intended to provide greater assurance that food for all animals, including pets, is safe.

Timetable: Start Printed Page 35022

ActionDateFR Cite
NPRM10/29/1378 FR 64736
NPRM Comment Period Extension02/03/1479 FR 6111
NPRM Comment Period End02/26/14
NPRM Comment Period Extension End03/31/14
Supplemental NPRM09/29/1479 FR 58475
Supplemental NPRM Comment Period End12/15/14
Final Rule08/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Jeanette (Jenny) B. Murphy, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 2671 (MPN-4, HFV-200), 7519 Standish Place, Rockville, MD 20855, Phone: 240 453-6845, Email: jenny.murphy@fda.hhs.gov.

RIN: 0910-AG10

118. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

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 January 4, 2011)

Abstract: This rule will 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 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 Extended03/11/1479 FR 13593
Environmental Impact Statement for the Proposed Rule; Comment Period Extended End04/18/14
Supplemental NPRM09/29/1479 FR 58433
Supplemental NPRM Comment Period End12/15/14
Draft Environmental Impact Statement01/14/1580 FR 1852
Draft Environmental Impact Statement Comment Period End03/13/15
Final Rule10/00/15

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

119. Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food

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 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
Supplemental NPRM09/29/1479 FR 58523
Supplemental NPRM Comment Period End12/15/14
Final Rule08/00/15

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

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

Legal Authority: 21 U.S.C. 301 et seq.; The Federal Food, Drug, and Cosmetic Act; Pub. L. 111-31; The Family Smoking Prevention and Tobacco Control Act

Abstract: The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides the Food and Drug Administration (FDA) authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. 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 products to be Start Printed Page 35023subject to the FD&C Act. This rule would deem additional products meeting the statutory definition of “tobacco product” to be subject to the FD&C Act, and would specify additional restrictions.

Timetable:

ActionDateFR Cite
NPRM04/25/1479 FR 23142
NPRM Comment Period End07/09/14
NPRM Comment Period Extended06/24/1479 FR 35711
NPRM Comment Period End08/08/14
Final Action06/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Gerie Voss, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 301 595-1426, Email: ctpregulations@fda.hhs.gov.

Laura Rich, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 10903 New Hampshire Avenue, Building 71, G335, Silver Spring, MD 20993, Phone: 877 287-1373, Email: ctpregulations@fda.hhs.gov.

RIN: 0910-AG38

121. Human Subject Protection; Acceptance of Data From Clinical Investigations 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 for medical devices to require that clinical investigations submitted in support of a premarket approval application, humanitarian device exemption application, an investigational device exemption application, or a premarket notification submission be conducted in accordance with good clinical practice if conducted outside the United States.

Timetable:

ActionDateFR Cite
NPRM02/25/1378 FR 12664
NPRM Comment Period End05/28/13
Final Action12/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Aaliyah K. Eaves, Policy Advisor, Office of the Director, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 5422, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-2948, Fax: 301 847-8120, Email: aaliyah.eaves-leanos@fda.hhs.gov.

RIN: 0910-AG48

122. 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: This rule describes 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
Supplemental NPRM09/29/1479 FR 58573
Supplemental NPRM Comment Period End12/15/14
Final Rule10/00/15

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

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

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262; * * *

Abstract: This rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change.

Timetable:

ActionDateFR Cite
NPRM11/13/1378 FR 67985
NPRM Comment Period Extended12/27/1378 FR 78796
NPRM Comment Period End01/13/14
NPRM Comment Period Extended End03/13/14
NPRM Comment Period Reopened02/18/1580 FR 8577
NPRM Comment Period Reopened End04/27/15
Final Rule02/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice L. Weiner, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6268, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, Email: janice.weiner@fda.hhs.gov.

RIN: 0910-AG94

124. Veterinary Feed Directive

Legal Authority: 21 U.S.C. 354; 21 U.S.C. 360b; 21 U.S.C. 360ccc; 21 U.S.C. 360ccc-1; 21 U.S.C. 371

Abstract: The Animal Drug Availability Act created a new category of products called veterinary feed directive (VFD) drugs. This rulemaking is intended to provide for the increased efficiency of the VFD program.

Timetable:

ActionDateFR Cite
ANPRM03/29/1075 FR 15387
ANPRM Comment Period End06/28/10
NPRM12/12/1378 FR 75515
Start Printed Page 35024
NPRM Comment Period End03/12/14
Final Rule05/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Sharon Benz, Supervisory Animal Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, MPN-4, Room 2648, HFV-220, 7519 Standish Place, Rockville, MD 20855, Phone: 240 402-5939, Email: sharon.benz@fda.hhs.gov.

RIN: 0910-AG95

125. Sanitary Transportation of Human and Animal Food

Legal Authority: 21 U.S.C. 350e; 21 U.S.C. 373; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 371; * * *

Abstract: This rule would establish requirements for parties including shippers, carriers by motor vehicle or rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated.

Timetable:

ActionDateFR Cite
ANPRM04/30/1075 FR 22713
ANPRM Comment Period End08/30/10
NPRM02/05/1479 FR 7005
NPRM Comment Period Extended05/23/1479 FR 29699
NPRM Comment Period End05/31/14
NPRM Comment Period Extended End07/30/14
Final Rule03/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Michael E. Kashtock, 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: 240 402-2022, Fax: 301 346-2632, Email: michael.kashtock@fda.hhs.gov.

RIN: 0910-AG98

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

126. Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

Legal Authority: 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350g; 21 U.S.C. 350i; 21 U.S.C. 371; 21 U.S.C. 374; Pub. L. 111-353

Abstract: This rule would require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act to address hazards that may be intentionally introduced by acts of terrorism. These food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation.

Timetable:

ActionDateFR Cite
NPRM12/24/1378 FR 78014
NPRM Comment Period Extended03/25/1479 FR 16251
NPRM Comment Period End03/31/14
NPRM Comment Period Extended End06/30/14
Final Rule05/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Jody Menikheim, Supervisory General Health Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-005), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1864, Fax: 301 436-2633, Email: fooddefense@fda.hhs.gov.

RIN: 0910-AG63

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

127. 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 to better communicate risks.

Timetable:

ActionDateFR Cite
NPRM05/29/0873 FR 30831
NPRM Comment Period End08/27/08
Final Action12/04/1479 FR 72064

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Kathy Schreier, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., WO51, Rm. 6246, Silver Spring, MD 20993, Phone: 301 796-3432, Email: kathy.schreier@fda.hhs.gov.

RIN: 0910-AF11

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

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

Abstract: FDA published a proposed rule to establish requirements for nutrition labeling of certain food items sold in certain vending machines. FDA also proposed the terms and conditions for vending machine operators registering to voluntarily be subject to the requirements. FDA is issuing a final rule, and taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act.

Timetable:

ActionDateFR Cite
NPRM04/06/1176 FR 19238
NPRM Comment Period End07/05/11
Final Action12/01/1479 FR 71259

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Daniel Reese, Food Technologist, 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: 240 402-2126, Email: daniel.reese@fda.hhs.gov.

RIN: 0910-AG56Start Printed Page 35025

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

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

Abstract: FDA published a proposed rule in the Federal Register to establish requirements for nutrition labeling of standard menu items in chain restaurants and similar retail food establishments. FDA also proposed the terms and conditions for restaurants and similar retail food establishments registering to voluntarily be subject to the Federal requirements. FDA is issuing a final rule, and taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act.

Timetable:

ActionDateFR Cite
NPRM04/06/1176 FR 19192
NPRM Comment Period End07/05/11
Final Action12/01/1479 FR 71156

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Daniel Reese, Food Technologist, 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: 240 402-2126, Email: daniel.reese@fda.hhs.gov.

RIN: 0910-AG57

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

130. Reform of Requirements for Long-Term Care Facilities (CMS-3260-P) (Rulemaking Resulting From a Section 610 Review)

Legal Authority: Pub. L. 111-148, sec 6102; 42 U.S.C. 263a; 42 U.S.C. 1302; 42 U.S.C. 1395hh; 42 U.S.C. 1395rr

Abstract: This proposed rule would revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These proposed changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. These proposals are also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through Federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.

Timetable:

ActionDateFR Cite
NPRM06/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Ronisha Davis, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6882, Email: ronisha.davis@cms.hhs.gov.

RIN: 0938-AR61

131. Electronic Health Record (EHR) Incentive Programs—Stage 3 (CMS-3310-F) (Section 610 Review)

Legal Authority: Pub. L. 111-5, title IV of Division B

Abstract: This final rule specifies the meaningful use criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/or Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments under Medicare for Stage 3 of the EHR Incentive Programs. This rule also establishes an EHR reporting period for all providers under a calendar year timeline except for providers in the first year of the Medicaid EHR Incentive Program where states may continue to allow an introductory 90-day period; requires the electronic submission of clinical quality measures (CQMs); creates a single set of meaningful use requirements for Stage 3 which will be optional for providers in 2017 and applicable for all providers beginning in 2018; and ensure privacy and security requirements continue to protect patient health information (PHI).

Timetable:

ActionDateFR Cite
NPRM03/30/1580 FR 16732
NPRM Comment Period End05/29/15
Final Action03/00/18

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Elizabeth S. Holland, Director, Division of HIT Initiatives, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-1309, Email: elizabeth.holland@cms.hhs.gov.

RIN: 0938-AS26

132. Medicare Clinical Diagnostic Laboratory Test Payment System (CMS-1621-P) (Section 610 Review)

Legal Authority: Pub. L. 113-93, sec 216

Abstract: This proposed rule would require Medicare payment for clinical laboratory tests to be based on private payor rates beginning January 1, 2017, as required by section 216(a) of the Protecting Access to Medicare Act of 2014.

Timetable:

ActionDateFR Cite
NPRM06/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Valerie Miller, Deputy Director, Division of Ambulatory Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, Mail Stop C4-01-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4535, Email: valerie.miller@cms.hhs.gov.

Sarah Harding, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4535, Email: sarah.harding@cms.hhs.gov.

RIN: 0938-AS33

133. CY 2016 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-P)

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

Abstract: This annual proposed rule would revise payment polices under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes would apply to services furnished beginning January 1, 2016.

Timetable:

ActionDateFR Cite
NPRM06/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: John McInnes, Acting Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-15, 7500 Security Start Printed Page 35026Boulevard, Baltimore, MD 21244, Phone: 410 786-0791, Email: john.mcinnes@cms.hhs.gov.

RIN: 0938-AS40

134. Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2016 Rates (CMS-1632-F)

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

Abstract: This annual final 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
NPRM04/30/1580 FR 24323
NPRM Comment Period End06/16/15
Final Action08/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Donald Thompson, Deputy Director, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: donald.thompson@cms.hhs.gov.

RIN: 0938-AS41

135. CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1633-P)

Legal Authority: Sec 1833 of the Social Security Act

Abstract: This annual proposed rule would revise the Medicare hospital outpatient prospective payment system to implement statutory requirements and changes arising from our continuing experience with this system. The proposed rule 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.

Timetable:

ActionDateFR Cite
NPRM06/00/15

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, MS: C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4617, Email: marjorie.baldo@cms.hhs.gov.

RIN: 0938-AS42

136. FY 2016 Inpatient Rehabilitation Facility Prospective Payment System (CMS-1624-F) (Section 610 Review)

Legal Authority: Social Security Act, sec 1886(j); Pub. L. 106-554; Pub. L. 106-113

Abstract: This annual final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for fiscal year 2016.

Timetable:

ActionDateFR Cite
NPRM04/27/1580 FR 23332
NPRM Comment Period End06/22/15
Final Action08/00/15

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Gwendolyn Johnson, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5-06-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6954, Email: gwendolyn.johnson@cms.hhs.gov.

RIN: 0938-AS45

137. • Electronic Health Record Incentive Program—Modifications to Meaningful Use in 2015 Through 2017 (CMS-3311-F) (Section 610 Review)

Legal Authority: 42 U.S.C. 1302 and 1395hh; Pub. L. 111-5

Abstract: This final rule changes the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program EHR reporting period in 2015 to a 90-day period aligned with the calendar year, and also aligns the reporting period in 2016 with the calendar year. In addition, this rule modifies the patient action measures in the Stage 2 objectives related to patient engagement. Finally, it streamlines the program by removing reporting requirements on measures which have become redundant, duplicative, or topped out through advancements in EHR function and provider performance for Stage 1 and Stage 2 of the Medicare and Medicaid EHR Incentive Programs.

Timetable:

ActionDateFR Cite
NPRM04/15/1580 FR 20346
NPRM Comment Period End06/15/15
Final Action04/00/18

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Elizabeth S. Holland, Director, Division of HIT Initiatives, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-1309, Email: elizabeth.holland@cms.hhs.gov.

RIN: 0938-AS58

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

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

Legal Authority: Pub. L. 111- 48, secs 2501; Pub. L. 111- 48, 2503; Pub. L. 111- 48, 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 Action08/00/15

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

Start Printed Page 35027

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

139. Home Health Agency Conditions of Participation (CMS-3819-F) (Rulemaking Resulting From a Section 610 Review)

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 final rule revises the existing Conditions of Participation that Home Health Agencies (HHA) must meet to participate in the Medicare program. The new requirements 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 improve patient safety and achieve broad-based improvements in the quality of care furnished through Federal programs, while at the same time reducing procedural burdens on providers.

Timetable:

ActionDateFR Cite
NPRM03/10/9762 FR 11005
NPRM Comment Period End06/09/97
Second NPRM10/09/1479 FR 61163
NPRM Comment Period Extended12/01/1479 FR 71081
Second NPRM Comment Period End01/07/15
Final Action10/00/17

Regulatory Flexibility Analysis Required: No.

Agency Contact: Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards & Quality, MS: S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6617, Email: danielle.shearer@cms.hhs.gov.

RIN: 0938-AG81

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

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

Abstract: This rule finalizes 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 ensures providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations.

Timetable:

ActionDateFR Cite
NPRM12/27/1378 FR 79082
NPRM Comment Period Extended02/21/1479 FR 9872
NPRM Comment Period End03/31/14
Final Action12/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Janice Graham, Health Insurance Specialist, 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

141. Medicare Shared Savings Program; Accountable Care Organizations (CMS-1461-F) (Section 610 Review)

Legal Authority: Pub. L. 111-148, sec 3022

Abstract: This rule finalizes changes to the Medicare Shared Savings Program (Shared Savings Program), including provisions relating to the payment of Accountable Care Organizations (ACOs) participating in the Shared Savings Program. Under the Shared Savings Program, providers of services and suppliers that participate in an ACO continue to receive traditional Medicare fee for service (FFS) payments under Parts A and B and are eligible for additional payments from the ACO if they meet specified quality and savings requirements.

Timetable:

ActionDateFR Cite
NPRM12/08/1479 FR 72760
NPRM Comment Period End02/06/15
Final Action12/00/17

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: Terri Postma, Medical Officer, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C5-15-24, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4169, Email: terri.postma@cms.hhs.gov.

RIN: 0938-AS06

142. Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P) (Rulemaking Resulting From a Section 610 Review)

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr

Abstract: This proposed rule would update the requirements that hospitals and CAHs must meet to participate in the Medicare and Medicaid programs. These proposals are intended to conform the requirements to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns.

Timetable:

ActionDateFR Cite
NPRM12/00/16

Regulatory Flexibility Analysis Required: Yes.

Agency Contact: CDR Scott Cooper, Senior Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S3-01-02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9465, Email: scott.cooper@cms.hhs.gov.

RIN: 0938-AS21

End Supplemental Information

[FR Doc. 2015-14352 Filed 6-17-15; 8:45 am]

BILLING CODE 4150-03-P