[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Unknown Section]
[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.
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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.
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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:
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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:
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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