[Federal Register Volume 81, Number 111 (Thursday, June 9, 2016)]
[Unknown Section]
[Pages 37294-37306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12904]
[[Page 37293]]
Vol. 81
Thursday,
No. 111
June 9, 2016
Part VIII
Department of Health and Human Services
-----------------------------------------------------------------------
Semiannual Regulatory Agenda
Federal Register / Vol. 81 , No. 111 / Thursday, June 9, 2016 /
Unified Agenda
[[Page 37294]]
-----------------------------------------------------------------------
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
(EO) 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: Wilma Robinson, Deputy 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 lead agency for protecting the health
of all Americans and providing essential human services, especially for
those who are least able to help themselves. HHS enhances the health
and well-being of Americans by promoting effective health and human
services and by fostering sound, sustained advances in the sciences
underlying medicine, public health, and social services.
This Agenda presents the rulemaking activities that the Department
expects to undertake in the foreseeable future to advance this mission.
The Agenda furthers several Departmental goals, including strengthening
health care; advancing scientific knowledge and innovation; advancing
the health, safety, and well-being of the American people; increasing
efficiency, transparency, and accountability of HHS programs; and
strengthening the nation's health and human services infrastructure and
workforce.
HHS has an agency-wide effort to support the Agenda's purpose of
encouraging more effective public participation in the regulatory
process. For example, to encourage public participation, we regularly
update our regulatory Web page (http://www.HHS.gov/regulations) which
includes links to HHS rules currently open for public comment, and also
provides a ``regulations toolkit'' with background information on
regulations, the commenting process, how public comments influence the
development of a rule, and how the public can provide effective
comments. HHS also actively encourages meaningful public participation
in its retrospective review of regulations, through a comment form on
the HHS retrospective review Web page (http://www.HHS.gov/RetrospectiveReview).
The rulemaking abstracts included in this paper issue of the
Federal Register cover, as required by the Regulatory Flexibility Act
of 1980, those prospective HHS rulemakings likely to have a significant
economic impact on a substantial number of small entities. The
Department's complete Regulatory Agenda is accessible online at http://www.RegInfo.gov.
Wilma Robinson,
Deputy Executive Secretary to the Department.
Office for Civil Rights--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
104....................... Nondiscrimination Under 0945-AA02
the Patient Protection
and Affordable Care Act.
------------------------------------------------------------------------
Office of the National Coordinator for Health Information Technology--
Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
105....................... ONC Health IT 0955-AA00
Certification Program:
Enhanced Oversight and
Accountability.
------------------------------------------------------------------------
Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
---------------------------------------------------------------------
106..................... Over-the-Counter (OTC) 0910-AF31
Drug Review--Cough/Cold
(Antihistamine)
Products.
107..................... Over-the-Counter (OTC) 0910-AF69
Drug Review--Topical
Antimicrobial Drug
Products.
108..................... Updated Standards for 0910-AG09
Labeling of Pet Food.
109..................... Format and Content of 0910-AG96
Reports Intended to
Demonstrate Substantial
Equivalence.
110..................... Mammography Quality 0910-AH04
Standards Act;
Regulatory Amendments.
111..................... Investigational New Drug 0910-AH07
Application Annual
Reporting.
112..................... Requirements for Tobacco 0910-AH22
Product Manufacturing
Practice.
113..................... Use of Ozone Depleting 0910-AH36
Substances (Section 610
Review).
------------------------------------------------------------------------
Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
114....................... Requirements for Foreign 0910-AA49
and Domestic
Establishment
Registration and Listing
for Human Drugs,
Including Drugs That Are
Regulated Under a
Biologics License
Application, and Animal
Drugs.
115....................... Postmarketing Safety 0910-AA97
Reporting Requirements
for Human Drug and
Biological Products.
116....................... Medical Gas Containers and 0910-AC53
Closures; Current Good
Manufacturing Practice
Requirements.
[[Page 37295]]
117....................... Food Labeling: Revision of 0910-AF22
the Nutrition and
Supplement Facts Labels.
118....................... 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.
119....................... Abbreviated New Drug 0910-AF97
Applications and
505(b)(2).
120....................... ``Tobacco Products'' 0910-AG38
Subject to the Federal
Food, Drug, and Cosmetic
Act, as Amended by the
Family Smoking Prevention
and Tobacco Control Act.
121....................... Human Subject Protection; 0910-AG48
Acceptance of Data From
Clinical Investigations
for Medical Devices.
122....................... Focused Mitigation 0910-AG63
Strategies To Protect
Food Against Intentional
Adulteration.
123....................... Supplemental Applications 0910-AG94
Proposing Labeling
Changes for Approved
Drugs and Biological
Products.
124....................... Food Labeling; Gluten-Free 0910-AH00
Labeling of Fermented,
Hydrolyzed, or Distilled
Foods.
125....................... General and Plastic 0910-AH14
Surgery Devices: Sunlamp
Products.
------------------------------------------------------------------------
Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
126....................... Laser Products; Amendment 0910-AF87
to Performance Standard.
127....................... Requirements for the 0910-AG59
Testing and Reporting of
Tobacco Product
Constituents,
Ingredients, and
Additives.
128....................... Radiology Devices; 0910-AH03
Designation of Special
Controls for the Computed
Tomography X-Ray System.
129....................... Regulations on Human Drug 0910-AH10
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.
------------------------------------------------------------------------
130....................... Standards for the Growing, 0910-AG35
Harvesting, Packing, and
Holding of Produce for
Human Consumption.
131....................... Foreign Supplier 0910-AG64
Verification Program.
132....................... Sanitary Transportation of 0910-AG98
Human and Animal Food.
------------------------------------------------------------------------
Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
133....................... 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).
134....................... Merit-Based Incentive 0938-AS69
Payment System (MIPS) and
Alternative Payment
Models (APMs) in Medicare
Fee-for-Service (CMS-5517-
P) (Section 610 Review).
135....................... 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-F) (Section 610
Review).
136....................... CY 2017 Home Health 0938-AS80
Prospective Payment
System Rate Update; Home
Health Value-Based
Purchasing Model; and
Home Health Quality
Reporting Requirements
(Section 610 Review).
137....................... 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).
138....................... 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).
------------------------------------------------------------------------
Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
139....................... Emergency Preparedness 0938-AO91
Requirements for Medicare
and Medicaid
Participating Providers
and Suppliers (CMS-3178-
F) (Section 610 Review).
140....................... Reform of Requirements for 0938-AR61
Long-Term Care Facilities
(CMS-3260-F) (Rulemaking
Resulting From a Section
610 Review).
------------------------------------------------------------------------
Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
141....................... Conditions of 0938-AG81
Participation for Home
Health Agencies (CMS-3819-
F) (Rulemaking Resulting
From a Section 610
Review).
[[Page 37296]]
142....................... Medicare Clinical 0938-AS33
Diagnostic Laboratory
Test Payment System (CMS-
1621-F) (Section 610
Review).
143....................... Imaging Accreditation (CMS- 0938-AS62
3309-P) (Section 610
Review).
------------------------------------------------------------------------
Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
144....................... Covered Outpatient Drugs 0938-AQ41
(CMS-2345-FC) (Completion
of a Section 610 Review).
145....................... CY 2016 Revisions to 0938-AS40
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1631-FC)
(Completion of a Section
610 Review).
146....................... 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) (Completion of a
Section 610 Review).
147....................... Comprehensive Care for 0938-AS64
Joint Replacement (CMS-
5516-F) (Completion of a
Section 610 Review).
------------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office for Civil Rights (OCR)
Final Rule Stage
104. 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........................ 05/00/16
------------------------------------------------------------------------
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)
Office of the National Coordinator for Health Information Technology
(ONC)
Proposed Rule Stage
105. ONC Health IT Certification Program: Enhanced Oversight
and Accountability
Legal Authority: Not Yet Determined
Abstract: The rulemaking introduces modifications and new
requirements under the ONC Health IT Certification Program
(``Program''), including provisions related to the Office of the
National Coordinator for Health Information Technology (ONC)'s role in
the Program. The proposed rule proposes to establish processes for ONC
to directly review health IT certified under the Program and take
action when necessary, including requiring the correction of non-
conformities found in health IT certified under the Program and
suspending and terminating certifications issued to Complete EHRs and
Health IT Modules. The proposed rule includes processes for ONC to
authorize and oversee accredited testing laboratories under the
Program. It also includes a provision for the increased transparency
and availability of surveillance results.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/02/16 81 FR 11056
NPRM Comment Period End............. 05/02/16 .......................
Final Action........................ 10/00/16 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michael Lipinski, Policy Analyst, Department of
Health and Human Services, Office of the National Coordinator for
Health Information Technology, Room 729D, Hubert H. Humphrey Building,
200 Independence Avenue SW., Washington, DC 20201, Phone: 202 690-7151.
RIN: 0955-AA00
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Proposed Rule Stage
106. 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)...... 01/00/17
------------------------------------------------------------------------
[[Page 37297]]
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
107. 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
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
108. 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................................ 10/00/16
------------------------------------------------------------------------
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
109. 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................................ 09/00/16
------------------------------------------------------------------------
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
110. 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 that have occurred since the regulations were
published in 1997 and to address breast density reporting to patient
and health care providers.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/00/16
------------------------------------------------------------------------
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
111. 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
[[Page 37298]]
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
112. Requirements for Tobacco Product Manufacturing Practice
Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387b; 21 U.S.C. 387f
Abstract: FDA is proposing requirements that govern the methods
used in, and the facilities and controls used for, the pre-production
design validation, manufacture, packing, and storage of tobacco
products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 03/19/13 78 FR 16824
ANPRM Comment Period End............ 05/20/13 .......................
NPRM................................ 12/00/16 .......................
------------------------------------------------------------------------
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
113. Use of Ozone Depleting Substances (Section 610 Review)
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 335; 21
U.S.C. 342; 21 U.S.C. 346a; 21 U.S.C. 348; 21 U.S.C. 351; 21 U.S.C.
352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 361; 21 U.S.C. 371; 21
U.S.C. 372; 21 U.S.C. 374; 15 U.S.C. 402; 15 U.S.C. 409
Abstract: The Food and Drug Administration (FDA or the Agency) is
proposing to amend its regulation (21 CFR 2.125) on uses of ozone-
depleting substances (ODSs), including chlorofluorocarbons (CFCs), to
remove designations for certain products as essential uses under the
Clean Air Act. Essential-use products are exempt from FDA's ban on the
use of CFC propellants in FDA-regulated products and the Environmental
Protection Agency's (EPA's) ban on the use of CFCs and other ODSs in
pressurized dispensers. This action, if finalized, will remove
essential use exemptions for sterile aerosol talc administered
intrapleurally by thoracoscopy for human use, metered-dose atropine
sulfate aerosol human drugs administered by oral inhalation, and
anesthetic drugs for topical use on accessible mucous membranes of
humans where a cannula is used for application. FDA is proposing this
action because alternative products that do not use ODSs are now
available and because these products are no longer being marketed in
approved versions that contain ODSs. On June 29, 2015, FDA published a
notice and request for comment concerning its tentative conclusion that
these products are no longer an essential use under the Clean Air Act
(80 FR 36937). The Agency received no comments concerning removal of
essential use designations for sterile aerosol talc and metered-dose
atropine sulfate, and is proposing to remove these designations by
direct final rule and a companion proposed rule in the event adverse
comments are received. FDA received one comment concerning removal of
anesthetic drugs for topical use in response to its 2015 notice and
request for comment, and is proposing to remove this exemption through
a separate notice. Because these products are not currently sold in the
approved form, no significant economic impact is anticipated.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/00/16 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Agency Contact: Daniel Orr, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Building 51
Room 5199, 10993 New Hampshire Avenue, Silver Spring, MD 20993, Phone:
240 402-0979, Email: [email protected].
RIN: 0910-AH36
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Final Rule Stage
114. 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; and sec 122; Pub. L. 105-115, 11 Stat. 2322 (21 U.S.C. 355 note)
Abstract: The rule will reorganize, consolidate, clarify, and
modify current regulations concerning who must register establishments
and list human drugs, including certain biological drugs, and animal
drugs. These regulations contain information on when, how, and where to
register drug establishments and list drugs, and what information must
be submitted. They also address National Drug Codes.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/29/06 71 FR 51276
NPRM Comment Period End............. 02/26/07 .......................
Final Action........................ 07/00/16 .......................
------------------------------------------------------------------------
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
115. Postmarketing Safety Reporting Requirements for Human Drug and
Biological Products
Legal Authority: 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 242a; 42
U.S.C. 262 and 263; 42 U.S.C. 263a to 263n; 42 U.S.C. 264; 42 U.S.C.
300aa; 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C.
355; 21 U.S.C. 360; 21 U.S.C. 360b to 360j; 21 U.S.C. 361a; 21 U.S.C.
371; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379e; 21 U.S.C. 381
Abstract: The final rule would amend the postmarketing expedited
and periodic safety reporting regulations for human drugs and
biological products to revise certain definitions and reporting formats
as recommended by the International Conference on Harmonisation and to
define new terms; to add to or revise current reporting requirements;
to revise certain reporting time frames; and to propose other revisions
to these regulations to enhance the quality of safety reports received
by FDA. These revisions were proposed as part of a single rulemaking
(68 FR 12406) to clarify and revise both premarketing and postmarketing
safety reporting requirements for human drug and biological products.
FDA plans to finalize the premarket and postmarket safety reporting
requirements in separate final rules. Premarketing safety reporting
requirements were finalized in a separate final rule published on
[[Page 37299]]
September 29, 2010 (75 FR 59961). This final rule applies to
postmarketing safety reporting requirements.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/14/03 68 FR 12406
NPRM Comment Period Extended........ 06/18/03 .......................
NPRM Comment Period End............. 07/14/03 .......................
NPRM Comment Period Extension End... 10/14/03 .......................
Final Action........................ 03/00/17 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6362, 10903 New Hampshire
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3469, Fax: 301
847-8440, Email: [email protected].
RIN: 0910-AA97
116. Medical Gas Containers and Closures; Current Good Manufacturing
Practice Requirements
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351 to 21 U.S.C. 353
Abstract: The Food and Drug Administration is amending its current
good manufacturing practice regulations and other regulations to
clarify and strengthen requirements for the label, color, dedication,
and design of medical gas containers and closures. Despite existing
regulatory requirements and industry standards for medical gases, there
have been repeated incidents in which cryogenic containers of harmful
industrial gases have been connected to medical oxygen supply systems
in hospitals and nursing homes and subsequently administered to
patients. These incidents have resulted in death and serious injury.
There have also been several incidents involving high-pressure medical
gas cylinders that have resulted in death and injuries to patients.
These amendments, together with existing regulations, are intended to
ensure that the types of incidents that have occurred in the past, as
well as other types of foreseeable and potentially deadly medical gas
accidents, do not occur in the future. FDA has described a number of
proposals in the proposed rule including requiring that gas use outlet
connections on portable cryogenic medical gas containers be securely
attached to the valve body.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/10/06 71 FR 18039
NPRM Comment Period End............. 07/10/06 .......................
Final Action........................ 07/00/16 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Patrick Raulerson, Regulatory Counsel, Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3522, Fax: 301
847-8440, Email: [email protected].
RIN: 0910-AC53
117. Food Labeling: Revision of the Nutrition and Supplement Facts
Labels
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: FDA is amending the labeling regulations for conventional
foods and dietary supplements to provide updated nutrition information
on the label to assist consumers in maintaining healthy dietary
practices. The rule would modernize the nutrition information found on
the Nutrition Facts label, as well as the format and appearance of the
label. On July 27, 2015, FDA issued a supplemental notice of proposed
rulemaking accepting comments on limited additional provisions until
October 13, 2015. Also on July 27, 2015, FDA reopened the comment
period on the proposed rule as to specific documents until September
25, 2015. In addition, in response to requests for the raw data related
to FDA's consumer studies on the nutrition label, FDA issued a notice
on September 10, 2015 to make the raw data available for comment until
October 13, 2015 and extended the comment period for the July 27, 2015
reopening as to specific documents to October 13, 2015. On October 20,
2015, FDA extended the comment period for the consumer studies and the
supplemental proposal to October 23, 2015.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 07/11/03 68 FR 41507
ANPRM Comment Period End............ 10/09/03 .......................
Second ANPRM........................ 04/04/05 70 FR 17008
Second ANPRM Comment Period End..... 06/20/05 .......................
Third ANPRM......................... 11/02/07 72 FR 62149
Third ANPRM Comment Period End...... 01/31/08 .......................
NPRM................................ 03/03/14 79 FR 11879
NPRM Comment Period End............. 06/02/14 .......................
Reopening of Comment Period as to 07/27/15 80 FR 44302
Specific Documents.
NPRM Comment Period End as to 09/25/15 .......................
Specific Documents.
Supplemental NPRM to Solicit Comment 07/27/15 80 FR 44303
on Limited Additional Provisions.
Supplemental NPRM to Solicit Comment 10/13/15 .......................
on Limited Additional Provisions
Comment Period End.
Administrative Docket Update; 09/10/15 80 FR 54446
Extension of Comment Period.
Administrative Docket Update; 10/13/15 .......................
Comment Period End.
NPRM Reopening of Comment Period for 10/20/15 80 FR 63477
Certain Documents.
NPRM Reopening of Comment Period for 10/23/15 .......................
Certain Documents Comment Period
End.
Final Action........................ 05/00/16 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Blakeley Fitzpatrick, Interdisciplinary Scientist,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition, HFS-830, 5100 Paint
Branch Parkway, College Park, MD 20740, Phone: 240 402-5429, Email:
[email protected].
RIN: 0910-AF22
118. Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed at One Eating Occasion; Dual--Column Labeling; Updating,
Modifying, and Establishing Certain RACCS
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371; Pub.
L. 101-535, sec 2(b)(1)(A)
Abstract: FDA is amending its labeling regulations for foods to
provide update, modify, and establish Reference Amounts Customarily
Consumed (RACCs) for certain food categories. This
[[Page 37300]]
rule would provide consumers with nutrition information based on the
amount of food that is customarily consumed, which would assist
consumers in maintaining healthy dietary practices. In addition to
updating, modifying, and establishing certain RACCs, FDA is amending
the definition of a single-serving containers; amending the label
serving size for breath mints; and providing for dual-column labeling
under certain circumstances, which would provide nutrition information
per serving and per container or unit, as applicable; and making
technical amendments to various aspects fo the serving size
regulations.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 04/04/05 70 FR 17010
ANPRM Comment Period End............ 06/20/05 .......................
NPRM/Comment Period Extended........ 03/03/14 79 FR 11989
NPRM Comment Period End............. 06/02/14 .......................
NPRM Comment Period Extended........ 05/27/14 79 FR 29699
NPRM Comment Period End............. 08/01/14 .......................
Final Action........................ 05/00/16 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Cherisa Henderson, Nutritionist, Department of
Health and Human Services, Food and Drug Administration, HFS-830, 5100
Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-5429, Fax:
301 436-1191, Email: [email protected].
RIN: 0910-AF23
119. 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, Building 51, Room 6268, 10903
New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-
3601, Fax: 301 847-8440, Email: [email protected].
RIN: 0910-AF97
120. ``Tobacco Products'' Subject to the Federal Food, Drug, and
Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco
Control Act
Legal Authority: 21 U.S.C. 301 et seq.; The Federal Food, Drug, and
Cosmetic Act; Pub. L. 111-31; The Family Smoking Prevention and Tobacco
Control Act
Abstract: The Family Smoking Prevention and Tobacco Control Act
(Tobacco Control Act) provides the Food and Drug Administration (FDA)
authority to regulate cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to
issue regulations deeming other tobacco products to be subject to the
FD&C Act. This rule would deem additional products meeting the
statutory definition of ``tobacco product'' to be subject to the FD&C
Act, and would specify additional restrictions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/25/14 79 FR 23142
NPRM Comment Period End............. 07/09/14 .......................
NPRM Comment Period Extended........ 06/24/14 79 FR 35711
NPRM Comment Period Extended End.... 08/08/14 .......................
Final Action........................ 05/00/16 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Gerie Voss, Senior Regulatory Counsel, Department
of Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, Document Control Center, Building 71, Room G335,
10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287-
1373, Fax: 301 595-1426, Email: [email protected].
RIN: 0910-AG38
121. Human Subject Protection; Acceptance of Data From Clinical
Investigations for Medical Devices
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21
U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C.
360i; 21 U.S.C. 360j; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21
U.S.C. 393; 42 U.S.C. 264; 42 U.S.C. 271; . . .
Abstract: This rule will amend FDA's regulations on acceptance of
data for medical devices to require that clinical investigations
submitted in support of a premarket approval application, humanitarian
device exemption application, an investigational device exemption
application, or a premarket notification submission be conducted in
accordance with good clinical practice if conducted outside the United
States.
Timetable:
------------------------------------------------------------------------
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: Soma Kalb, Biomedical Engineer, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, Building 66, Room 1534, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6359, Email:
[email protected].
RIN: 0910-AG48
122. Focused Mitigation Strategies To Protect Food Against Intentional
Adulteration
Legal Authority: 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350g; 21
U.S.C. 350i; 21 U.S.C. 371; 21 U.S.C. 374; Pub. L. 111-353
Abstract: This rule would require domestic and foreign food
facilities that are required to register under the Federal Food, Drug,
and Cosmetic Act to address hazards that may be intentionally
introduced by acts of terrorism. These food facilities would be
required to identify and implement focused mitigation strategies to
significantly minimize or prevent significant vulnerabilities
identified at actionable process steps in a food operation.
[[Page 37301]]
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/24/13 78 FR 78014
NPRM Comment Period Extended........ 03/25/14 79 FR 16251
NPRM Comment Period End............. 03/31/14
NPRM Comment Period Extended End.... 06/30/14
Final Rule.......................... 06/00/16
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Jody Menikheim, Supervisory General Health
Scientist, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-005),
5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1864,
Fax: 301 436-2633, Email: [email protected].
RIN: 0910-AG63
123. Supplemental Applications Proposing Labeling Changes for Approved
Drugs and Biological Products
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21
U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262; . . .
Abstract: This rule would amend the regulations regarding new drug
applications (NDAs), abbreviated new drug applications (ANDAs), and
biologics license application (BLAs) to revise and clarify procedures
for changes to the labeling of an approved drug to reflect certain
types of newly acquired information in advance of FDA's review of such
change.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/13/13 78 FR 67985
NPRM Comment Period Extended........ 12/27/13 78 FR 78796
NPRM Comment Period End............. 01/13/14
NPRM Comment Period Extended End.... 03/13/14
NPRM Comment Period Reopened........ 02/18/15 80 FR 8577
NPRM Comment Period Reopened End.... 04/27/15
Final Rule.......................... 04/00/17
------------------------------------------------------------------------
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, Building 51, Room 6268, 10903
New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-
3601, Fax: 301 847-8440, Email: [email protected].
RIN: 0910-AG94
124. 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................................ 11/18/15 80 FR 71990
NPRM Comment Period Reopened........ 02/16/16 81 FR 3751
Comment Period Extended............. 02/22/16 81 FR 8869
Final Action........................ 04/00/17
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Carol D'Lima, Staff Fellow, 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: 240 402-2371, Fax: 301 436-
2636, Email: [email protected].
RIN: 0910-AH00
125. 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................................ 12/22/15 80 FR 79493
NPRM Comment Period End............. 03/21/16
Final Action........................ 11/00/16
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ian Ostermiller, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Building 66
Room 5515, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone:
301 796-5678, Email: [email protected].
RIN: 0910-AH14
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Long-Term Actions
126. 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)................... 06/00/17
------------------------------------------------------------------------
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-AF87
127. Requirements for the Testing and Reporting of Tobacco Product
Constituents, Ingredients, and Additives
Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 387; The Family
Smoking Prevention and Tobacco Control Act
Abstract: The Federal Food, Drug, and Cosmetic Act, as amended by
the Family Smoking Prevention and Tobacco Control Act, requires the
Food and Drug Administration to promulgate regulations that require the
testing and reporting of tobacco product constituents, ingredients, and
additives, including smoke constituents, that the
[[Page 37302]]
Agency determines should be tested to protect the public health.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/17
------------------------------------------------------------------------
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, Building 71, G335, 10903 New Hampshire Avenue, Silver
Spring, MD 20993, Phone: 877 287-1373, Email:
[email protected].
RIN: 0910-AG59
128. 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................................ 05/00/17
------------------------------------------------------------------------
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
129. 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................................ 12/00/17
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Sarah Rothman, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, Building 51, Room 5197, 10903 New
Hampshire Avenue, 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
130. Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42
U.S.C. 264; Pub. L. 111-353 (signed on January 4, 2011)
Abstract: This rule will establish science-based minimum standards
for the safe production and harvesting of those types of fruits and
vegetables that are raw agricultural commodities for which the
Secretary has determined that such standards minimize the risk of
serious adverse health consequences or death. The purpose of the rule
is to reduce the risk of illness associated with fresh produce.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/16/13 78 FR 3503
NPRM Comment Period End............. 05/16/13
NPRM Comment Period Extended........ 04/26/13 78 FR 24692
NPRM Comment Period Extended End.... 09/16/13
NPRM Comment Period Extended........ 08/09/13 78 FR 48637
NPRM Comment Period Extended End.... 11/15/13
Notice of Intent To Prepare an 08/19/13 78 FR 50358
Environmental Impact Statement for
the Proposed Rule.
Notice of Intent To Prepare 11/15/13
Environmental Impact Statement for
the Proposed Rule Comment Period
End.
NPRM Comment Period Extended........ 11/20/13 78 FR 69605
NPRM Comment Period Extended End.... 11/22/13
Environmental Impact Statement for 03/11/14 79 FR 13593
the Proposed Rule; Comment Period
Extended.
Environmental Impact Statement for 04/18/14
the Proposed Rule; Comment Period
Extended End.
Supplemental NPRM................... 09/29/14 79 FR 58433
Supplemental NPRM Comment Period End 12/15/14
Final Action--Draft Environmental 01/14/15 80 FR 1852
Impact Statement.
Final Action--Draft Environmental 03/13/15
Impact Statement Comment Period End.
Final Action Effective.............. 01/26/16
Final Rule.......................... 11/27/15 80 FR 74353
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Samir Assar, Supervisory Consumer Safety Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition, Office of Food Safety,
5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1636,
Email: [email protected].
RIN: 0910-AG35
[[Page 37303]]
131. Foreign Supplier Verification Program
Legal Authority: 21 U.S.C. 384a; title III, sec 301 of FDA Food
Safety Modernization Act; Pub. L. 111-353, establishing sec 805 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act)
Abstract: This rule describes what a food importer must do to
verify that its foreign suppliers produce food that is as safe as food
produced in the United States. FDA is taking this action to improve the
safety of food that is imported into the United States.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/29/13 78 FR 45729
NPRM Comment Period End............. 11/26/13
NPRM Comment Period Extended........ 11/20/13 78 FR 69602
NPRM Comment Period Extended End.... 01/27/14
Supplemental NPRM................... 09/29/14 79 FR 58573
Supplemental NPRM Comment Period End 12/15/14
Final Rule.......................... 11/27/15 80 FR 74225
Final Rule Effective................ 01/27/16
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian L. Pendleton, Senior Policy Advisor,
Department of Health and Human Services, Food and Drug Administration,
Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue, Silver
Spring, MD 20993-0002, Phone: 301 796-4614, Fax: 301 847-8616, Email:
[email protected].
RIN: 0910-AG64
132. Sanitary Transportation of Human and Animal Food
Legal Authority: 21 U.S.C. 350e; 21 U.S.C. 373; 21 U.S.C. 331; 21
U.S.C. 342; 21 U.S.C. 371; . . .
Abstract: This rule would establish requirements for parties
including shippers, carriers by motor vehicle or rail vehicle, and
receivers engaged in the transportation of food, including food for
animals, to use sanitary transportation practices to ensure that food
is not transported under conditions that may render the food
adulterated.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 04/30/10 75 FR 22713
ANPRM Comment Period End............ 08/30/10
NPRM................................ 02/05/14 79 FR 7005
NPRM Comment Period Extended........ 05/23/14 79 FR 29699
NPRM Comment Period End............. 05/31/14
NPRM Comment Period Extended End.... 07/30/14
Final Rule.......................... 04/06/16 81 FR 20092
Final Rule Effective................ 06/06/16
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition, Office of
Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone:
240 402-2022, Fax: 301 346-2632, Email: [email protected].
RIN: 0910-AG98
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Proposed Rule Stage
133. 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................................ 05/00/16
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
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
134. Merit-Based Incentive Payment System (MIPS) and Alternative
Payment Models (APMS) in Medicare Fee-For-Service (CMS-5517-P) (Section
610 Review)
Legal Authority: Pub. L. 114-10, sec 101
Abstract: This proposed rule would implement provisions of the
Medicare Access and CHIP Reauthorization Act (MACRA) related to MIPS
and APMs. Section 101 of MACRA authorizes a new MIPS, which repeals the
Medicare sustainable growth rate and improves Medicare payments for
physician services. MACRA consolidates the current programs of the
Physician Quality Reporting System, the Value-Based Modifier, and the
Electronic Health Records Incentive Program into one program, MIPS,
that streamlines and improves on the three distinct incentive programs.
Additionally, MACRA authorizes incentive payments for providers who
participate in eligible APMs.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/09/16 81 FR 28161
NPRM Comment Period End............. 06/27/16
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: James Sharp, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare & Medicaid Innovation Center,
MS: WB-06-05, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410
786-7388, Email: [email protected].
RIN: 0938-AS69
135. Hospital Inpatient Prospective Payment System for Acute Care
Hospitals and the Long-Term Care Hospital Prospective Payment System
and FY 2017 Rates (CMS-1655-F) (Section 610 Review)
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
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:
[[Page 37304]]
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/27/16 81 FR 24946
NPRM Comment Period End............. 06/17/16
Final Action........................ 08/00/16
------------------------------------------------------------------------
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-AS77
136. CY 2017 Home Health Prospective Payment System Rate Update; Home
Health Value-Based Purchasing Model; and Home Health Quality Reporting
Requirements (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, 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. The
rule would also update the provisions of the Home Health Value-Based
Purchasing (HHVBP) program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/16
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Hillary Loeffler, Deputy Director, Division of Home
Health and Hospice, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, Center for Medicare, MS: C5-07-22,
7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0456,
Email: [email protected].
RIN: 0938-AS80
137. CY 2017 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1654-P) (Section
610 Review)
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; Pub. L. 114-10
Abstract: This annual proposed rule would revise payment polices
under the Medicare physician fee schedule, and make other policy
changes to payment under Medicare Part B. These changes would apply to
services furnished beginning January 1, 2017.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/16 .......................
------------------------------------------------------------------------
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-AS81
138. 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)
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual proposed rule would revise the Medicare
hospital outpatient prospective payment system to implement statutory
requirements and changes arising from our continuing experience with
this system. The rule describes changes to the amounts and factors used
to determine payment rates for services. In addition, the rule would
change the ambulatory surgical center payment system list of services
and rates.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/00/16 .......................
------------------------------------------------------------------------
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-AS82
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Final Rule Stage
139. 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
140. 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-
[[Page 37305]]
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............. 09/14/15 .......................
NPRM Comment Period Extended 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Long-Term Actions
Centers for Medicare & Medicaid Services (CMS)
141. Conditions of Participation for Home Health Agencies (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 conditions of participation
(CoPs) that home health agencies (HHAs) must meet in order to
participate in the Medicare and Medicaid programs. The requirements
focus on the care delivered to patients by HHAs, reflect an
interdisciplinary view of patient care, allow HHAs greater flexibility
in meeting quality care standards, and eliminate unnecessary procedural
requirements. These changes are an integral part of our overall effort
to achieve broad-based, measurable improvements in the quality of care
furnished through the Medicare and Medicaid programs, while at the same
time eliminating unnecessary 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
NPRM Comment Period End............. 12/08/14 .......................
NPRM Comment Period Extended 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, 7500
Security Boulevard, MS: S3-02-01, Baltimore, MD 21244, Phone: 410 786-
6617, Email: [email protected].
RIN: 0938-AG81
142. 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 revises the Medicare payment system for
clinical diagnostic laboratory tests and implements other changes
required by section 216 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
143. Imaging Accreditation (CMS-3309-P) (Section 610 Review)
Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1102
Abstract: This proposed rule would establish standards for Imaging
Accreditation. These proposed standards would address qualifications
for clinical personnel, standards to ensure that suppliers have
established policies and procedures governing the use of equipment in
furnishing the technical component of advanced diagnostic imaging, and
the establishment and maintenance of a quality assurance and quality
control program to ensure reliability, clarity, and accuracy of the
diagnostic images.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ To Be Determined
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Sonia Swancy, 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-
8445, Email: [email protected].
RIN: 0938-AS62
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Completed Actions
Centers for Medicare & Medicaid Services (CMS)
144. Covered Outpatient Drugs (CMS-2345-FC) (Completion of a 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 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........................ 02/01/16 81 FR 5170
[[Page 37306]]
Final Action Effective.............. 04/01/16 .......................
------------------------------------------------------------------------
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
145. CY 2016 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1631-FC)
(Completion of a 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........................ 11/16/15 80 FR 70886
Final Action Effective.............. 01/01/16 .......................
------------------------------------------------------------------------
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
146. CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates
and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates (CMS-1633-FC) (Completion of a 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........................ 11/13/15 80 FR 70298
Final Action Effective.............. 01/01/16 .......................
------------------------------------------------------------------------
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
147. Comprehensive Care for Joint Replacement (CMS-5516-F) (Completion
of a 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........................ 11/24/15 80 FR 73273
Final Action Effective.............. 01/15/16 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Claire Schreiber, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare & Medicaid Innovation, MS: WB-
08-62, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
8939, Email: [email protected].
RIN: 0938-AS64
[FR Doc. 2016-12904 Filed 6-8-16; 8:45 am]
BILLING CODE 4150-03-P