[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Proposed Rules]
[Pages 77960-77970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30620]



[[Page 77959]]

Vol. 80

Tuesday,

No. 240

December 15, 2015

Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

  Federal Register / Vol. 80 , No. 240 / Tuesday, December 15, 2015 / 
Unified Agenda  

[[Page 77960]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

25 CFR Ch. V

42 CFR Chs. I-V

45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII


Regulatory Agenda

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.

FOR FURTHER INFORMATION CONTACT: Madhura C. Valverde, Executive 
Secretary, Department of Health and Human Services, 200 Independence 
Avenue SW., Washington, DC 20201; (202) 690-5627.

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 reflects this complex mission through planned 
rulemakings structured to implement the Department's six arcs for 
implementation of its strategic plan: Leaving the Department Stronger; 
Keeping People Healthy and Safe; Reducing the Number of Uninsured and 
Providing Access to Affordable Quality Care; Leading in Science and 
Innovation; Delivering High Quality Care and Spending Our Health Care 
Dollars More Wisely; and Ensuring the Building Blocks for Success at 
Every Stage of Life.
    HHS has an agency-wide effort to support the Agenda's purpose of 
encouraging more effective public participation in the regulatory 
process. 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 welcomes 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.RegInfo.gov.

Madhura C. Valverde,
Executive Secretary to the Department.

              Office for Civil Rights--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
         Sequence No.                   Title            Identifier No.
------------------------------------------------------------------------
244..........................  Nondiscrimination Under         0945-AA02
                                the Patient Protection
                                and Affordable Care
                                Act.
------------------------------------------------------------------------


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
         Sequence No.                   Title            Identifier No.
------------------------------------------------------------------------
245..........................  Over-the-Counter (OTC)          0910-AF31
                                Drug Review--Cough/
                                Cold (Antihistamine)
                                Products.
246..........................  Over-the-Counter (OTC)          0910-AF69
                                Drug Review--Topical
                                Antimicrobial Drug
                                Products.
247..........................  Laser Products;                 0910-AF87
                                Amendment to
                                Performance Standard.
248..........................  Updated Standards for           0910-AG09
                                Labeling of Pet Food.
249..........................  Requirements for the            0910-AG59
                                Testing and Reporting
                                of Tobacco Product
                                Constituents,
                                Ingredients, and
                                Additives.
250..........................  Format and Content of           0910-AG96
                                Reports Intended to
                                Demonstrate
                                Substantial
                                Equivalence.
251..........................  Food Labeling; Gluten-          0910-AH00
                                Free Labeling of
                                Fermented, Hydrolyzed,
                                or Distilled Foods.
252..........................  Radiology Devices;              0910-AH03
                                Designation of Special
                                Controls for the
                                Computed Tomography X-
                                Ray System.
253..........................  Mammography Quality             0910-AH04
                                Standards Act;
                                Regulatory Amendments.
254..........................  Investigational New             0910-AH07
                                Drug Application
                                Annual Reporting.
255..........................  General and Plastic             0910-AH14
                                Surgery Devices:
                                Sunlamp Products.
256..........................  Requirements for                0910-AH22
                                Tobacco Product
                                Manufacturing Practice.
------------------------------------------------------------------------


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
         Sequence No.                   Title            Identifier No.
------------------------------------------------------------------------
257..........................  Requirements for                0910-AA49
                                Foreign and Domestic
                                Establishment
                                Registration and
                                Listing for Human
                                Drugs, Including Drugs
                                That Are Regulated
                                Under a Biologics
                                License Application,
                                and Animal Drugs.
258..........................  Food Labeling: Revision         0910-AF22
                                of the Nutrition and
                                Supplement Facts
                                Labels (Reg Plan Seq
                                No. 32).
259..........................  Food Labeling: Serving          0910-AF23
                                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. 33).
260..........................  Abbreviated New Drug            0910-AF97
                                Applications and
                                505(b)(2).
261..........................  Electronic Distribution         0910-AG18
                                of Prescribing
                                Information for Human
                                Prescription Drugs
                                Including Biological
                                Products.

[[Page 77961]]

 
262..........................  Standards for the               0910-AG35
                                Growing, Harvesting,
                                Packing, and Holding
                                of Produce for Human
                                Consumption (Reg Plan
                                Seq No. 34).
263..........................  ``Tobacco Products''            0910-AG38
                                Subject to the Federal
                                Food, Drug, and
                                Cosmetic Act, as
                                Amended by the Family
                                Smoking Prevention and
                                Tobacco Control Act
                                (Reg Plan Seq No. 35).
264..........................  Human Subject                   0910-AG48
                                Protection; Acceptance
                                of Data From Clinical
                                Investigations for
                                Medical Devices.
265..........................  Focused Mitigation              0910-AG63
                                Strategies To Protect
                                Food Against
                                Intentional
                                Adulteration (Reg Plan
                                Seq No. 37).
266..........................  Foreign Supplier                0910-AG64
                                Verification Program
                                (Reg Plan Seq No. 38).
267..........................  Supplemental                    0910-AG94
                                Applications Proposing
                                Labeling Changes for
                                Approved Drugs and
                                Biological Products
                                (Reg Plan Seq No. 40).
268..........................  Sanitary Transportation         0910-AG98
                                of Human and Animal
                                Food (Reg Plan Seq No.
                                41).
------------------------------------------------------------------------
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
------------------------------------------------------------------------
                                                           Regulation
         Sequence No.                   Title            Identifier No.
------------------------------------------------------------------------
269..........................  Regulations on Human            0910-AH10
                                Drug Compounding Under
                                Sections 503A and 503B
                                of the Federal Food,
                                Drug, and Cosmetic Act.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
         Sequence No.                   Title            Identifier No.
------------------------------------------------------------------------
270..........................  Current Good                    0910-AG10
                                Manufacturing Practice
                                and Hazard Analysis
                                and Risk-Based
                                Preventive Controls
                                for Food for Animals.
271..........................  Current Good                    0910-AG36
                                Manufacturing and
                                Hazard Analysis, and
                                Risk-Based Preventive
                                Controls for Human
                                Food.
272..........................  Veterinary Feed                 0910-AG95
                                Directive.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
         Sequence No.                   Title            Identifier No.
------------------------------------------------------------------------
273..........................  Hospital and Critical           0938-AS21
                                Access Hospital (CAH)
                                Changes to Promote
                                Innovation,
                                Flexibility, and
                                Improvement in Patient
                                Care (CMS-3295-P)
                                (Rulemaking Resulting
                                From a Section 610
                                Review).
274..........................  Medicare Clinical               0938-AS33
                                Diagnostic Laboratory
                                Test Payment System
                                (CMS-1621-F) (Section
                                610 Review).
275..........................  Merit-Based Incentive           0938-AS69
                                Payment System (MIPS)
                                and Alternative
                                Payment Models (APMs)
                                in Medicare Fee-for-
                                Service (CMS-5517-P)
                                (Section 610 Review)
                                (Reg Plan Seq No. 44).
276..........................  Hospital Inpatient              0938-AS77
                                Prospective Payment
                                System for Acute Care
                                Hospitals and the Long-
                                Term Care Hospital
                                Prospective Payment
                                System and FY 2017
                                Rates (CMS-1655-P)
                                (Section 610 Review)
                                (Reg Plan Seq No. 45).
277..........................  CY 2017 Home Health             0938-AS80
                                Prospective Payment
                                System Refinements and
                                Rate Update (CMS-1648-
                                P) (Section 610
                                Review).
278..........................  CY 2017 Revisions to            0938-AS81
                                Payment Policies Under
                                the Physician Fee
                                Schedule and Other
                                Revisions to Medicare
                                Part B (CMS-1654-P)
                                (Section 610 Review)
                                (Reg Plan Seq No. 46).
279..........................  CY 2017 Hospital                0938-AS82
                                Outpatient PPS Policy
                                Changes and Payment
                                Rates and Ambulatory
                                Surgical Center
                                Payment System Policy
                                Changes and Payment
                                Rates (CMS-1656-P)
                                (Section 610 Review)
                                (Reg Plan Seq No. 47).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
         Sequence No.                   Title            Identifier No.
------------------------------------------------------------------------
280..........................  Covered Outpatient              0938-AQ41
                                Drugs (CMS-2345-F)
                                (Section 610 Review).
281..........................  Reform of Requirements          0938-AR61
                                for Long-Term Care
                                Facilities (CMS-3260-
                                F) (Rulemaking
                                Resulting From a
                                Section 610 Review).
282..........................  CY 2016 Revisions to            0938-AS40
                                Payment Policies Under
                                the Physician Fee
                                Schedule and Other
                                Revisions to Medicare
                                Part B (CMS-1631-FC)
                                (Section 610 Review).
283..........................  CY 2016 Hospital                0938-AS42
                                Outpatient PPS Policy
                                Changes and Payment
                                Rates and Ambulatory
                                Surgical Center
                                Payment System Policy
                                Changes and Payment
                                Rates (CMS-1633-FC)
                                (Section 610 Review).
284..........................  Comprehensive Care for          0938-AS64
                                Joint Replacement (CMS-
                                5516-F) (Section 610
                                Review).
------------------------------------------------------------------------


[[Page 77962]]


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
         Sequence No.                   Title            Identifier No.
------------------------------------------------------------------------
285..........................  Home Health Agency              0938-AG81
                                Conditions of
                                Participation (CMS-
                                3819-F) (Rulemaking
                                Resulting From a
                                Section 610 Review).
286..........................  Emergency Preparedness          0938-AO91
                                Requirements for
                                Medicare and Medicaid
                                Participating
                                Providers and
                                Suppliers (CMS-3178-F)
                                (Section 610 Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
         Sequence No.                   Title            Identifier No.
------------------------------------------------------------------------
287..........................  Medicare Shared Savings         0938-AS06
                                Program; Accountable
                                Care Organizations
                                (CMS-1461-F)
                                (Completion of a
                                Section 610 Review).
288..........................  Electronic Health               0938-AS26
                                Record Incentive
                                Program--Stage 3 and
                                Modifications to
                                Meaningful Use in 2015
                                through 2017 (CMS-3310-
                                F) (Section 610
                                Review).
289..........................  Hospital Inpatient              0938-AS41
                                Prospective Payment
                                System for Acute Care
                                Hospitals and the Long-
                                Term Care Hospital
                                Prospective Payment
                                System and FY 2016
                                Rates (CMS-1632-FC)
                                (Completion of a
                                Section 610 Review).
290..........................  FY 2016 Inpatient               0938-AS45
                                Rehabilitation
                                Facility Prospective
                                Payment System (CMS-
                                1624-F) (Completion of
                                a Section 610 Review).
291..........................  CY 2016 Home Health             0938-AS46
                                Prospective Payment
                                System Refinements and
                                Rate Update (CMS-1625-
                                F) (Section 610
                                Review).
292..........................  Electronic Health               0938-AS58
                                Record Incentive
                                Program--Modifications
                                to Meaningful Use in
                                2015 through 2017 (CMS-
                                3311-F) (Completion of
                                a Section 610 Review).
------------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office for Civil Rights (OCR)

Proposed Rule Stage

244. Nondiscrimination Under the Patient Protection and Affordable Care 
Act

    Legal Authority: 42 U.S.C. 18116
    Abstract: This final rule implements prohibitions against 
discrimination on the basis of race, color, national origin, sex, age, 
and disability as provided in section 1557 of the Affordable Care Act. 
Section 1557 provides protection from discrimination in health programs 
and activities of covered entities. This section also identifies 
additional forms of Federal financial assistance to which the section 
will apply.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/08/15  80 FR 54172
NPRM Comment Period End.............   11/09/15  .......................
Final Action........................   06/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Eileen Hanrahan, Senior Civil Rights Analyst, 
Department of Health and Human Services, Office for Civil Rights, 200 
Independence Avenue SW., Washington, DC 20201, Phone: 202 205-4925, 
Email: [email protected].
    RIN: 0945-AA02

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

245. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Reopening of Administrative Record..   08/25/00  65 FR 51780
Comment Period End..................   11/24/00  .......................
NPRM (Amendment) (Common Cold)......   03/00/16  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AF31

246. 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 antiseptic hand wash.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Healthcare)...................   06/17/94  59 FR 31402
Comment Period End..................   12/15/95  .......................
NPRM (Consumer Hand Wash Products)..   12/17/13  78 FR 76443

[[Page 77963]]

 
NPRM (Consumer Hand Wash) Comment      06/16/14  .......................
 Period End.
NPRM (Healthcare Antiseptic)........   05/01/15  80 FR 25166
NPRM Comment Period End (Healthcare    10/28/15  .......................
 Antiseptic).
NPRM (Consumer Hand Rub)............   06/00/16  .......................
Final Rule (Consumer Hand Wash).....   09/00/16  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AF69

247. 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: FDA is proposing to amend the 2013 proposed rule for the 
performance standard for laser products, which will amend the 
performance standard for laser products to achieve closer harmonization 
between the current standard and the recently amended 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/24/13  78 FR 37723
NPRM Comment Period End.............   09/23/13  .......................
NPRM (Reproposal)...................   07/00/16  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AF87

248. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/16  .......................
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AG09

249. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/00/16  .......................
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AG59

250. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/00/16  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AG96

251. 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 20 parts per million (ppm) gluten in the food.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/15  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Carol D'Lima, Department of Health and Human 
Services, Food and Drug Administration, Center for Food Safety and 
Applied Nutrition, Room 4D022, HFS 820, 5100 Paint Branch Parkway, 
College Park, MD 20740, Phone: 240

[[Page 77964]]

402-2371, Fax: 301 436-2636, Email: [email protected].
    RIN: 0910-AH00

252. Radiology 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 are necessary to provide reasonable assurance 
of the safety and effectiveness of a class II CT X-ray system.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/00/16  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AH03

253. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/00/16  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AH04

254. Investigational New Drug Application Annual Reporting

    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(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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ebla Ali Ibrahim, Project Manager, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Building 51, Room 6302, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3691, Email: 
[email protected].
    RIN: 0910-AH07

255. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/15  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AH14

256. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   03/19/13  78 FR 16824
ANPRM Comment Period End............   05/20/13  .......................
NPRM................................   04/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Darin Achilles, 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: 
[email protected].
    RIN: 0910-AH22

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

257. 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

[[Page 77965]]

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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/29/06  71 FR 51276
NPRM Comment Period End.............   02/26/07  .......................
Final Action........................   04/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: David Joy, Senior 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 6254, Silver Spring, MD 20993, Phone: 301 796-2242, Email: 
[email protected].
    RIN: 0910-AA49

258. Food Labeling: Revision of the Nutrition and Supplement Facts 
Labels

    Regulatory Plan: This entry is Seq. No. 32 in part II of this issue 
of the Federal Register.
    RIN: 0910-AF22

259. 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. 33 in part II of this issue 
of the Federal Register.
    RIN: 0910-AF23

260. 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 and 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/06/15  80 FR 6802
NPRM Comment Period End.............   05/07/15  .......................
NPRM Comment Period Extended........   04/24/15  80 FR 22953
NPRM Comment Period Extended End....   06/08/15  .......................
Final Action........................   08/00/16  .......................
------------------------------------------------------------------------

    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, 10903 New Hampshire Avenue, 
Building 51, Room 6268, Silver Spring, MD 20993-0002, Phone: 301 796-
3601, Fax: 301 847-8440, Email: [email protected].
    RIN: 0910-AF97

261. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/18/14  79 FR 75506
NPRM Comment Period Extended........   03/09/15  80 FR 12364
NPRM Comment Period End.............   03/18/15
NPRM Comment Period Extended End....   05/18/15
Final Action........................   10/00/16
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AG18

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

    Regulatory Plan: This entry is Seq. No. 34 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG35

263. ``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. 35 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG38

264. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/25/13  78 FR 12664
NPRM Comment Period End.............   05/28/13
Final Action........................   05/00/16
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AG48

[[Page 77966]]

265. Focused Mitigation Strategies To Protect Food Against Intentional 
Adulteration

    Regulatory Plan: This entry is Seq. No. 37 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG63

266. Foreign Supplier Verification Program

    Regulatory Plan: This entry is Seq. No. 38 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG64

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

    Regulatory Plan: This entry is Seq. No. 40 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG94

268. Sanitary Transportation of Human and Animal Food

    Regulatory Plan: This entry is Seq. No. 41 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG98

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

269. Regulations on Human Drug Compounding Under Sections 503A and 503B 
of the Federal Food, Drug, and Cosmetic Act

    Legal Authority: 21 U.S.C. 353a; 21 U.S.C. 353b; 21 U.S.C. 371
    Abstract: FDA will propose regulations to define and implement 
certain statutory conditions under which compounded products may 
qualify for exemptions from certain requirements.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sarah Rothman, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 10903 New Hampshire Avenue, Building 51, Room 5197, Silver 
Spring, MD 20993, Phone: 301 796-3536, Email: 
[email protected].
    RIN: 0910-AH10

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

270. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/29/13  78 FR 64736
NPRM Comment Period Extension.......   02/03/14  79 FR 6111
NPRM Comment Period End.............   02/26/14
NPRM Comment Period Extension End...   03/31/14
Supplemental NPRM...................   09/29/14  79 FR 58475
Supplemental NPRM Comment Period End   12/15/14
Final Rule..........................   09/17/15  80 FR 56169
Final Rule Effective................   11/16/15
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AG10

271. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/16/13  78 FR 3646
NPRM Comment Period End.............   05/16/13
NPRM Comment Period Extended........   04/26/13  78 FR 24691
NPRM Comment Period Extended End....   09/16/13
NPRM Comment Period Extended........   08/09/13  78 FR 48636
NPRM Comment Period Extended End....   11/15/13
NPRM Comment Period Extended........   11/20/13  78 FR 69604
NPRM Comment Period Extended End....   11/22/13
Supplemental NPRM...................   09/29/14  79 FR 58523
Supplemental NPRM Comment Period End   12/15/14
Final Rule..........................   09/17/15  80 FR 55907
Final Action Effective..............   11/16/15
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AG36

272. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   03/29/10  75 FR 15387
ANPRM Comment Period End............   06/28/10
NPRM................................   12/12/13  78 FR 75515
NPRM Comment Period End.............   03/12/14

[[Page 77967]]

 
Final Action........................   06/03/15  80 FR 31708
Final Action (Correction)...........   06/23/15  80 FR 35841
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AG95

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

273. 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 Critical Access Hospitals (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 to 
support improvements in quality of care, reduce barriers to care, and 
reduce some issues that may exacerbate workforce shortage concerns.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/00/16
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AS21

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

    Legal Authority: Pub. L. 113-93, sec 216
    Abstract: This final rule requires 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/01/15  80 FR 59385
NPRM Comment Period End.............   11/25/15
Final Action........................   10/00/18
------------------------------------------------------------------------

    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: [email protected].
    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: [email protected].
    RIN: 0938-AS33

275.  Merit-Based Incentive Payment System (MIPS) and 
Alternative Payment Models (APMS) in Medicare Fee-for-Service (CMS-
5517-P) (Section 610 Review)

    Regulatory Plan: This entry is Seq. No. 44 in part II of this issue 
of the Federal Register.
    RIN: 0938-AS69

276.  Hospital Inpatient Prospective Payment System for Acute 
Care Hospitals and the Long-Term Care Hospital Prospective Payment 
System and FY 2017 Rates (CMS-1655-P) (Section 610 Review)

    Regulatory Plan: This entry is Seq. No. 45 in part II of this issue 
of the Federal Register.
    RIN: 0938-AS77

277.  CY 2017 Home Health Prospective Payment System 
Refinements and Rate Update (CMS-1648-P) (Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual proposed rule would update the 60-day 
national episode rate based on the applicable home health market basket 
update and case-mix adjustment. It would also update the national per-
visit rates used to calculate low utilization payment adjustments 
(LUPAs) and outlier payments under the Medicare prospective payment 
system for home health agencies. These changes would apply to services 
furnished during home health episodes beginning on or after January 1, 
2017.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Hillary Loeffler, Technical Advisor, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare, MS: C5-07-28, 7500 Security Boulevard, Baltimore, 
MD 21244, Phone: 410 786-0456, Email: [email protected].
    RIN: 0938-AS80

278.  CY 2017 Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Medicare Part B (CMS-1654-P) 
(Section 610 Review)

    Regulatory Plan: This entry is Seq. No. 46 in part II of this issue 
of the Federal Register.
    RIN: 0938-AS81

279.  CY 2017 Hospital Outpatient PPS Policy Changes and 
Payment Rates and Ambulatory Surgical Center Payment System Policy 
Changes and Payment Rates (CMS-1656-P) (Section 610 Review)

    Regulatory Plan: This entry is Seq. No. 47 in part II of this issue 
of the Federal Register.
    RIN: 0938-AS82

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

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

    Legal Authority: Pub. L. 111- 48, sec 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

[[Page 77968]]

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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/02/12  77 FR 5318
NPRM Comment Period End.............   04/02/12
Final Action........................   11/00/15
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AQ41

281. Reform of Requirements for Long-Term Care Facilities (CMS-3260-F) 
(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 final rule revises the requirements that long-term 
care facilities must meet to participate in the Medicare and Medicaid 
programs. These 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. The rule is also an 
integral part of CMS 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/16/15  80 FR 42167
NPRM Comment Period Extension.......   09/15/15  80 FR 55284
NPRM Comment Period End.............   10/14/15
Final Action........................   09/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ronisha Blackstone, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Clinical Standards and Quality, MS: S3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
6882, Email: [email protected].
    RIN: 0938-AR61

282. CY 2016 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1631-FC) (Section 
610 Review)

    Legal Authority: 42 U.S.C. 405(a), 1302, 1395x, 1395y(a), 1395ff, 
1395kk, 1395rr and 1395ww(k); 42 U.S.C. 263a; 42 U.S.C. 1395m, 1395hh, 
and 1395ddd; 42 U.S.C. 1395w-101 through 1395w-152, and 1395nn; . . .
    Abstract: This annual final rule revises payment polices under the 
Medicare physician fee schedule, and makes other policy changes to 
payment under Medicare Part B. These changes apply to services 
furnished beginning January 1, 2016.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/15/15  80 FR 41686
NPRM Comment Period End.............   09/08/15
Final Action........................   11/00/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ryan Howe, 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 
Boulevard, Baltimore, MD 21244, Phone: 410 786-3355, Email: 
[email protected].
    RIN: 0938-AS40

283. CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1633-FC) (Section 610 Review)

    Legal Authority: 42 U.S.C. 1302, 1395m, 1395hh, and 1395ddd
    Abstract: This annual final rule revises the Medicare hospital 
outpatient prospective payment system to implement statutory 
requirements and changes arising from our continuing experience with 
this system. The rule describes changes to the amounts and factors used 
to determine payment rates for services. In addition, the rule changes 
the ambulatory surgical center payment system list of services and 
rates.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/08/15  80 FR 39200
NPRM Comment Period End.............   08/31/15
Final Action........................   11/00/15
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0938-AS42

284.  Comprehensive Care for Joint Replacement (CMS-5516-F) 
(Section 610 Review)

    Legal Authority: Social Security Act, sec 1115A
    Abstract: This final rule implements a new Medicare Part A and B 
payment model under section 1115A of the Social Security Act, called 
the Comprehensive Care Joint Replacement Model, in which acute care 
hospitals in certain selected geographic areas receive retrospective 
bundled payments for episodes of care for lower extremity joint 
replacement or reattachment of a lower extremity. All related care 
within 90 days of hospital discharge from the joint replacement 
procedures would be included in the episode of care. We believe this 
model furthers our goals in improving the efficiency and quality of 
care for Medicare beneficiaries for these common medical procedures.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/14/15  80 FR 41198
NPRM Comment Period End.............   09/08/15
Final Action........................   11/00/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Gabriel Scott, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare & Medicaid Innovation, MS: WB-
06-05, 7500 Security Blvd., Baltimore, MD 21244, Phone: 410 786-3928, 
Email: [email protected].
    RIN: 0938-AS64


[[Page 77969]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

285. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/10/97  62 FR 11005
NPRM Comment Period End.............   06/09/97
Second NPRM.........................   10/09/14  79 FR 61163
NPRM Comment Period Extended........   12/01/14  79 FR 71081
Second NPRM Comment Period End......   01/07/15
Final Action........................   10/00/17
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AG81

286. 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/27/13  78 FR 79082
NPRM Comment Period Extended........   02/21/14  79 FR 9872
NPRM Comment Period End.............   03/31/14
Final Action........................   12/00/16
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AO91

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

287. Medicare Shared Savings Program; Accountable Care Organizations 
(CMS-1461-F) (Completion of a 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/08/14  79 FR 72760
NPRM Comment Period End.............   02/06/15
Final Action........................   06/09/15  80 FR 32691
Final Action Effective..............   08/03/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Terri Postma, Medical Officer, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Center 
for Medicare, MS:C5-15-24, 7500 Security Boulevard, Baltimore, MD 
21244, Phone: 410 786-4169, Email: [email protected].
    RIN: 0938-AS06

288. Electronic Health Record Incentive Program--Stage 3 and 
Modifications to Meaningful Use in 2015 Through 2017 (CMS-3310-F) 
(Section 610 Review)

    Legal Authority: Pub. L. 111-5, title IV of Division B
    Abstract: This final rule specifies the requirements that eligible 
professionals, eligible hospitals, and critical access hospitals must 
meet in order to qualify for Medicare and Medicaid electronic health 
record (EHR) incentive payments and avoid downward payment adjustments 
under the Medicare EHR Incentive Program. In addition, it changes the 
Medicare and Medicaid EHR Incentive Programs reporting period in 2015 
to a 90-day period aligned with the calendar year. This rule also 
removes reporting requirements on measures that have become redundant, 
duplicative, or topped out from the Medicare and Medicaid EHR incentive 
programs. In addition, this rule establishes the requirements for Stage 
3 of the program as optional in 2017 and required for all participants 
beginning in 2018. The rule continues to encourage the electronic 
submission of clinical quality measure data, establishes requirements 
to transition the program to a single stage, and aligns reporting for 
providers in the Medicare and Medicaid EHR Incentive Programs.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/30/15  80 FR 16732
NPRM Comment Period End.............   05/29/15
Final Action........................   10/16/15  80 FR 62762
Final Action Effective..............   12/12/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Elizabeth S. Holland, Technical Advisor, Department 
of Health and Human Services, Centers for

[[Page 77970]]

Medicare & Medicaid Services, Center for Clinical Standards and 
Quality, MS: S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, 
Phone: 410 786-1309, Email: [email protected].
    RIN: 0938-AS26

289. Hospital Inpatient Prospective Payment System for Acute Care 
Hospitals and the Long-Term Care Hospital Prospective Payment System 
and FY 2016 Rates (CMS-1632-FC) (Completion of a Section 610 Review)

    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/30/15  80 FR 24323
NPRM Comment Period End.............   06/16/15
Final Action and Interim Final Rule.   08/17/15  80 FR 49325
Interim Final Rule Comment Period      09/29/15
 End.
Final Action Effective..............   10/01/15
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0938-AS41

290. FY 2016 Inpatient Rehabilitation Facility Prospective Payment 
System (CMS-1624-F) (Completion of a 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/27/15  80 FR 23332
NPRM Comment Period End.............   06/22/15
Final Action........................   08/06/15  80 FR 47035
Final Action Effective..............   10/01/15
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0938-AS45

291. CY 2016 Home Health Prospective Payment System Refinements and 
Rate Update (CMS-1625-F) (Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395(hh)
    Abstract: This annual final rule updates the 60-day national 
episode rate based on the applicable home health market basket update 
and case-mix adjustment. It also updates the national per-visit rates 
used to calculate low utilization payment adjustments (LUPAs) and 
outlier payments under the Medicare prospective payment system for home 
health agencies. These changes apply to services furnished during home 
health episodes beginning on or after January 1, 2016. Additionally, 
this rule will implement a Home Health value-based purchasing model, 
beginning January 1, 2016, in which all Medicare-Certified Home Health 
Agencies in selected states will be required to participate.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/10/15  80 FR 39840
NPRM Comment Period End.............   09/04/15
Final Action........................   11/05/15  80 FR 68624
Final Rule Effective................   01/01/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Hillary Loeffler, Technical Advisor, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare, MS: C5-07-28, 7500 Security Boulevard, Baltimore, 
MD 21244, Phone: 410 786-0456, Email: [email protected].
    RIN: 0938-AS46

292. Electronic Health Record Incentive Program--Modifications to 
Meaningful Use in 2015 Through 2017 (CMS-3311-F) (Completion of a 
Section 610 Review)

    Legal Authority: 42 U.S.C. 1302 and 1395hh; Pub. L. 111-5
    Abstract: This rule would implement changes to the Medicare and 
Medicaid Electronic Health Record (EHR) Incentive Program EHR reporting 
requirements. These changes will be finalized in the ``Electronic 
Health Record Incentive Program--Stage 3 and Modifications to 
Meaningful Use in 2015 through 2017'' final rule.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/15/15  80 FR 20346
NPRM Comment Period End.............   06/15/15
Merged With 0938-AS26...............   07/24/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Elizabeth S. Holland, Technical Advisor, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Clinical Standards and Quality, MS: S2-26-17, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-1309, Email: 
[email protected].
    RIN: 0938-AS58

[FR Doc. 2015-30620 Filed 12-14-15; 8:45 am]
 BILLING CODE 4150-24-P