[Federal Register Volume 79, Number 245 (Monday, December 22, 2014)]
[Proposed Rules]
[Pages 76718-76731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28964]
[[Page 76717]]
Vol. 79
Monday,
No. 245
December 22, 2014
Part VIII
Department of Health and Human Services
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Semiannual Regulatory Agenda
Federal Register / Vol. 79 , No. 245 / Monday, December 22, 2014 /
Unified Agenda
[[Page 76718]]
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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
(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: C'Reda J. Weeden, 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.
Dated: September 22, 2014.
C'Reda J. Weeden,
Executive Secretary to the Department.
Substance Abuse and Mental Health Services Administration--Proposed Rule
Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
275....................... SAMHSA User Fees for 0930-AA18
Publications.
------------------------------------------------------------------------
Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
276....................... Over-the-Counter (OTC) 0910-AF31
Drug Review_Cough/Cold
(Antihistamine) Products.
277....................... Over-the-Counter (OTC) 0910-AF36
Drug Review_Internal
Analgesic Products.
278....................... Over-the-Counter (OTC) 0910-AF69
Drug Review_Topical
Antimicrobial Drug
Products.
279....................... Abbreviated New Drug 0910-AF97
Applications and
505(b)(2).
280....................... Updated Standards for 0910-AG09
Labeling of Pet Food.
281....................... Current Good Manufacturing 0910-AG10
Practice and Hazard
Analysis and Risk-Based
Preventive Controls for
Food for Animals (Reg
Plan Seq No. 48).
282....................... Over-the-Counter (OTC) 0910-AG12
Drug Review_Pediatric
Dosing for Cough/Cold
Products.
283....................... Electronic Distribution of 0910-AG18
Prescribing Information
for Human Prescription
Drugs Including
Biological Products.
284....................... Standards for the Growing, 0910-AG35
Harvesting, Packing, and
Holding of Produce for
Human Consumption (Reg
Plan Seq No. 49).
285....................... Current Good Manufacturing 0910-AG36
and Hazard Analysis, and
Risk-Based Preventive
Controls for Human Food
(Reg Plan Seq No. 50).
286....................... Requirements for the 0910-AG59
Testing and Reporting of
Tobacco Product
Constituents,
Ingredients, and
Additives.
287....................... Foreign Supplier 0910-AG64
Verification Program (Reg
Plan Seq No. 52).
288....................... Format and Content of 0910-AG96
Reports Intended to
Demonstrate Substantial
Equivalence.
289....................... Food Labeling; Gluten-Free 0910-AH00
Labeling of Fermented,
Hydrolyzed, or Distilled
Foods.
290....................... Radiology Devices; 0910-AH03
Designation of Special
Controls for the Computed
Tomography X-Ray System.
291....................... Mammography Quality 0910-AH04
Standards Act; Regulatory
Amendments.
292....................... Investigational New Drug 0910-AH07
Application Annual
Reporting.
293....................... General and Plastic 0910-AH14
Surgery Devices: Sunlamp
Products.
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.
[[Page 76719]]
Food and Drug Administration--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
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294....................... 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.
295....................... Content and Format of 0910-AF11
Labeling for Human
Prescription Drugs and
Biologics; Requirements
for Pregnancy and
Lactation Labeling.
296....................... Combinations of 0910-AF33
Bronchodilators With
Nasal Decongestant; Cold,
Cough, Allergy,
Bronchodilator, and
Antiasthmatic Drug
Products for Over-the-
Counter Human Use.
297....................... Over-the-Counter (OTC) 0910-AF38
Drug Review_Laxative Drug
Products.
298....................... Laser Products; Amendment 0910-AF87
to Performance Standard.
299....................... ``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. 53).
300....................... Human Subject Protection; 0910-AG48
Acceptance of Data From
Clinical Investigations
for Medical Devices.
301....................... Food Labeling: Calorie 0910-AG56
Labeling of Articles of
Food Sold in Vending
Machines (Reg Plan Seq
No. 54).
302....................... Food Labeling: Nutrition 0910-AG57
Labeling of Standard Menu
Items in Restaurants and
Similar Retail Food
Establishments (Reg Plan
Seq No. 55).
303....................... Supplemental Applications 0910-AG94
Proposing Labeling
Changes for Approved
Drugs and Biological
Products (Reg Plan Seq
No. 58).
304....................... Veterinary Feed Directive 0910-AG95
(Reg Plan Seq No. 59).
305....................... Combinations of 0910-AH16
Bronchodilators With
Expectorants; Cold,
Cough, Allergy,
Bronchodilator, and
Antiasthmatic Drug
Products for Over-the-
Counter Human Use.
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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
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Regulation
Sequence No. Title Identifier No.
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306....................... Food Labeling; Revision of 0910-AF22
the Nutrition and
Supplement Facts Labels.
307....................... 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.
308....................... Focused Mitigation 0910-AG63
Strategies To Protect
Food Against Intentional
Adulteration.
309....................... Sanitary Transportation of 0910-AG98
Human and Animal Food.
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Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
310....................... Infant Formula: Current 0910-AF27
Good Manufacturing
Practices; Quality
Control Procedures;
Notification
Requirements; Records and
Reports; and Quality
Factors.
311....................... Postmarketing Safety 0910-AF96
Reports for Human Drug
and Biological Products:
Electronic Submission
Requirements.
312....................... Requirements for the 0910-AG81
Submission of Data Needed
to Calculate User Fees
for Domestic
Manufacturers and
Importers of Tobacco
Products.
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Centers for Medicare & Medicaid Services--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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313....................... Home Health Agency 0938-AG81
Conditions of
Participation (CMS-3819-
F) (Rulemaking Resulting
From a Section 610
Review).
314....................... Reform of Requirements for 0938-AR61
Long-Term Care Facilities
(CMS-3260-P) (Rulemaking
Resulting From a Section
610 Review) (Reg Plan Seq
No. 60).
315....................... Medicare Shared Savings 0938-AS06
Program; Accountable Care
Organizations (CMS-1461-
P) (Section 610 Review).
316....................... 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).
317....................... Medicare Clinical 0938-AS33
Diagnostic Laboratory
Test Payment System (CMS-
1621-P).
318....................... CY 2016 Revisions to 0938-AS40
Payment Policies under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1631-P) (Reg
Plan Seq No. 63).
319....................... 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-P) (Reg Plan
Seq No. 64).
320....................... 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-
P) (Reg Plan Seq No. 65).
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References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.
[[Page 76720]]
Centers for Medicare & Medicaid Services--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
321....................... Covered Outpatient Drugs 0938-AQ41
(CMS-2345-F) (Section 610
Review).
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Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
322....................... Emergency Preparedness 0938-AO91
Requirements for Medicare
and Medicaid
Participating Providers
and Suppliers (CMS-3178-
F).
323....................... Adoption of Operating 0938-AS01
Rules for HIPAA
Transactions (CMS-0036-
IFC).
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Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
324....................... Prospective Payment System 0938-AR62
for Federally Qualified
Health Centers; Changes
to Contracting Policies
for Rural Health Clinics
and CLIA Enforcement
Actions for Proficiency
Testing Referral (CMS-
1443-FC) (Completion of a
Section 610 Review).
325....................... Hospital Inpatient 0938-AS11
Prospective Payment
System for Acute Care
Hospitals and the Long-
Term Care Hospital
Prospective Payment
System and Fiscal Year
2015 Rates (CMS-1607-F)
(Completion of a Section
610 Review).
326....................... CY 2015 Revisions to 0938-AS12
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1612-FC)
(Section 610 Review).
327....................... CY 2015 End-Stage Renal 0938-AS13
Disease Prospective
Payment System, Quality
Incentive Program, and
Durable Medical
Equipment, Prosthetics,
Orthotics, and Supplies
(CMS-1614-F) (Section 610
Review).
328....................... CY 2015 Hospital 0938-AS15
Outpatient Prospective
Payment System (PPS)
Policy Changes and
Payment Rates, and CY
2015 Ambulatory Surgical
Center Payment System
Policy Changes and
Payment Rates (CMS-1613-
FC) (Section 610 Review).
329....................... Extension of Payment 0938-AS18
Adjustment for Low-Volume
Hospitals and the
Medicare-Dependent
Hospital Program Under
the FY 2014 Hospital
Inpatient Prospective
Payment System (CMS-1599-
IFC2) (Completion of a
Section 610 Review).
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Proposed Rule Stage
275. SAMHSA User Fees for Publications
Legal Authority: 31 U.S.C. 9701; 31 U.S.C. 1111; EO 8284; EO 11541;
Pub. L. 113-76
Abstract: SAMSHA is proposing to implement a modest cost recovery
program to partially offset the high costs of distributing its
materials to the public. This user fee would apply only to ``over-the-
limit'' non-governmental orders. An ``over the limit'' order is defined
as an order that exceeds either the average weight value (3.75 lbs) or
the average number of copies (8). The ``non-governmental orders'' do
not include: SAMHSA's Recovery Month bulk orders; orders by SAMHSA
staff for meetings or conferences; and orders from ``.gov'' and
``.mil'' addresses. Therefore, it is assumed that SAMHSA would not
charge shipping for orders by other Federal, State, and local
government agencies. The proposed rule would implement recent
legislation allowing the funds collected as part of a user fee for
publications and data requests to be available to SAMHSA until
expended.
Timetable:
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Action Date FR Cite
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NPRM................................ 02/00/15 .......................
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian Altman, Legislative Director, Department of
Health and Human Services, Substance Abuse and Mental Health Services
Administration, 1 Choke Cherry Road, Rockville, MD 02857, Phone: 240
276-2009, Email: [email protected].
RIN: 0930-AA18
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Proposed Rule Stage
276. 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:
[[Page 76721]]
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Action Date FR Cite
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Reopening of Administrative Record.. 08/25/00 65 FR 51780
Comment Period End.................. 11/24/00 .......................
NPRM (Amendment) (Common Cold)...... 09/00/15 .......................
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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
277. Over-the-Counter (OTC) Drug Review--Internal Analgesic Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21
U.S.C. 379e
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective,
and not misbranded. After a final monograph (i.e., final rule) is
issued, only OTC drugs meeting the conditions of the monograph, or
having an approved new drug application, may be legally marketed. The
first action addresses acetaminophen safety. The second action
addresses products marketed for children under 2 years old and weight-
and age-based dosing for children's products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM (Amendment) (Required Warnings 12/26/06 71 FR 77314
and Other Labeling).
NPRM Comment Period End............. 05/25/07 .......................
Final Action (Required Warnings and 04/29/09 74 FR 19385
Other Labeling).
Final Action (Correction)........... 06/30/09 74 FR 31177
Final Action (Technical Amendment).. 11/25/09 74 FR 61512
NPRM (Amendment) (Pediatric)........ 10/00/15 .......................
NPRM (Amendment) (Acetaminophen).... 12/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Adams-King, Regulatory Health Project
Manager, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO 22, Room
5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-3713, Fax: 301 796-9899, Email: [email protected].
RIN: 0910-AF36
278. Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug
Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective,
and not misbranded. After a final monograph (i.e., final rule) is
issued, only OTC drugs meeting the conditions of the monograph, or
having an approved new drug application, may be legally marketed. This
action addresses antimicrobial agents in healthcare antiseptic
products.
Timetable:
------------------------------------------------------------------------
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 (Healthcare Antiseptic)........ 04/00/15 .......................
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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
279. 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................................ 11/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice L. Weiner, Senior Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 51, Room 6268, 10903 New
Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601,
Fax: 301 847-8440, Email: [email protected].
RIN: 0910-AF97
280. Updated Standards for Labeling of Pet Food
Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 110-85, sec
1002(a)(3)
Abstract: FDA is proposing updated standards for the labeling of
pet food that include nutritional and ingredient information, as well
as style and formatting standards. FDA is taking this action to provide
pet owners and animal health professionals more complete and consistent
information about the nutrient content and ingredient composition of
pet food products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: William Burkholder, Veterinary Medical Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Veterinary Medicine, Room 2642 (MPN-4, HFV-228), 7519
Standish Place, Rockville, MD 20855, Phone: 240 453-6865, Email:
[email protected].
RIN: 0910-AG09
281. Current Good Manufacturing Practice and Hazard Analysis and R-
Based Preventive Controls for Food for Animals
Regulatory Plan: This entry is Seq. No. 48 in part II of this issue
of the Federal Register.
RIN: 0910-AG10
[[Page 76722]]
282. Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/
Cold Products
Legal Authority: 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C.
355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective,
and not misbranded. After a final monograph (i.e., final rule) is
issued, only OTC drugs meeting the conditions of the monograph, or
having an approved new drug application, may be legally marketed. This
action will propose changes to the final monograph to address safety
and efficacy issues associated with pediatric cough and cold products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Adams-King, Regulatory Health Project
Manager, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO 22, Room
5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-3713, Fax: 301 796-9899, Email: [email protected].
RIN: 0910-AG12
283. Electronic Distribution of Prescribing Information for Human
Prescription Drugs Including Biological Products
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21
U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360;
21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374;
21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C.
264
Abstract: This rule would require electronic package inserts for
human drug and biological prescription products with limited
exceptions, in lieu of paper, which is currently used. These inserts
contain prescribing information intended for healthcare practitioners.
This would ensure that 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................................ 11/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Megan Velez, Policy Analyst, Department of Health
and Human Services, Food and Drug Administration, Office of Policy, WO
32, Room 4249, 10903 New Hampshire Avenue, Silver Spring, MD 20993,
Phone: 301 796-9301, Email: [email protected].
RIN: 0910-AG18
284. Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption
Regulatory Plan: This entry is Seq. No. 49 in part II of this issue
of the Federal Register.
RIN: 0910-AG35
285. Current Good Manufacturing and Hazard Analysis, and Risk-Based
Preventive Controls for Human Food
Regulatory Plan: This entry is Seq. No. 50 in part II of this issue
of the Federal Register.
RIN: 0910-AG36
286. Requirements for the Testing and Reporting of Tobacco Product
Constituents, Ingredients, and Additives
Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 387; The Family
Smoking Prevention and Tobacco Control Act
Abstract: The Federal Food, Drug, and Cosmetic Act, as amended by
the Family Smoking Prevention and Tobacco Control Act, requires the
Food and Drug Administration to promulgate regulations that require the
testing and reporting of tobacco product constituents, ingredients, and
additives, including smoke constituents, that the Agency determines
should be tested to protect the public health.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Carol Drew, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 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-AG59
287. Foreign Supplier Verification Program
Regulatory Plan: This entry is Seq. No. 52 in part II of this issue
of the Federal Register.
RIN: 0910-AG64
288. 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................................ 07/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Gerie Voss, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, Document Control Center, Bldg. 71, Rm. G335, 10903
New Hampshire Ave., Silver Spring, MD 20993, Phone: 877 287-1373, Fax:
301 595-1426, Email: [email protected].
RIN: 0910-AG96
289. 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................................ 01/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Felicia Billingslea, Director, Food Labeling and
Standard Staff, Department of Health and Human Services, Food and Drug
[[Page 76723]]
Administration, Room 4D045, HFS 820, 5100 Paint Branch Parkway, College
Park, MD 20740, Phone: 240 402-1803, Fax: 301 436-2636, Email:
[email protected].
RIN: 0910-AH00
290. 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, when combined with the general controls, would
provide reasonable assurance of the safety and effectiveness of a class
II CT X-ray system.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/00/15 .......................
------------------------------------------------------------------------
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
291. 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................................ 04/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: [email protected].
RIN: 0910-AH04
292. Investigational New Drug Application Annual Reporting
Legal Authority: 21 U.S.C. 355(i); 21 U.S.C. 371(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 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................................ 09/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Peter A. Taschenberger, Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
10903 New Hampshire Avenue, Building 51, Room 6312, Silver Spring, MD
20993, Phone: 301 796-0018, Fax: 301 847-3529, Email:
[email protected].
RIN: 0910-AH07
293. 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................................ 03/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Paul Gadiock, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Final Rule Stage
294. Requirements for Foreign and Domestic Establishment Registration
and Listing for Human Drugs, Including Drugs That Are Regulated Under a
Biologics License Application, and Animal Drugs
Legal Authority: 21 U.S.C. 321 and 331; 21 U.S.C. 351 to 353; 21
U.S.C. 355 to 356c; 21 U.S.C. 360 and 360b; 21 U.S.C. 360c to 360f; 21
U.S.C. 360h to 360j; 21 U.S.C. 371 and 374; 21 U.S.C. 379e and 381; 21
U.S.C. 393; 15 U.S.C. 1451 to 1561; 42 U.S.C. 262 and 264; 42 U.S.C.
271
Abstract: The rule will reorganize, consolidate, clarify, and
modify current regulations concerning who must register establishments
and list human drugs, including certain biological drugs, and animal
drugs. These regulations contain information on when, how, and where to
register drug establishments and list drugs, and what information must
be submitted. They also address National Drug Codes.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/29/06 71 FR 51276
NPRM Comment Period End............. 02/26/07 .......................
Final Action........................ 10/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: David Joy, Senior Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, WO 51, Room
6254, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-2242, Email: [email protected].
RIN: 0910-AA49
[[Page 76724]]
295. Content and Format of Labeling for Human Prescription Drugs and
Biologics; Requirements for Pregnancy and Lactation Labeling
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21
U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42
U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264
Abstract: This final rule will amend the content and format of the
``Pregnancy,'' ``Labor and delivery,'' and ``Nursing mothers''
subsections of the ``Use in Specific Populations'' section of
regulations regarding the labeling for human prescription drug and
biological products to better communicate risks.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/29/08 73 FR 30831
NPRM Comment Period End............. 08/27/08 .......................
Final Action........................ 11/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Kathy Schreier, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, 10903 New Hampshire Ave., WO51, Rm. 6246,
Silver Spring, MD 20993, Phone: 301 796-3432, Email:
[email protected].
RIN: 0910-AF11
296. Combinations of Bronchodilators With Nasal Decongestant; Cold,
Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for
Over-the-Counter Human Use
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective,
and not misbranded. After a final monograph (i.e., final rule) is
issued, only OTC drugs meeting the conditions of the monograph, or
having an approved new drug application, may be legally marketed. These
actions address cough/cold drug products containing an oral
bronchodilator (ephedrine and its salts) in combination with any oral
nasal decongestant.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM (Amendment).................... 07/13/05 70 FR 40232
NPRM Comment Period End............. 11/10/05 .......................
Final Action (Technical Amendment).. 03/19/07 72 FR 12730
Final Action (Oral Bronchodilator & 07/00/15 .......................
Oral Nasal Decongestant).
------------------------------------------------------------------------
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-AF33
297. Over-the-Counter (OTC) Drug Review--Laxative 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 to 360a; 21 U.S.C. 371 to 371a
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective,
and not misbranded. After a final monograph (i.e., final rule) is
issued, only OTC drugs meeting the conditions of the monograph, or
having an approved new drug application, may be legally marketed. The
final rule listed will address the professional labeling for sodium
phosphate drug products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Final Action (Granular Psyllium).... 03/29/07 72 FR 14669
NPRM (Professional Labeling_Sodium 02/11/11 76 FR 7743
Phosphate).
NPRM Comment Period End............. 03/14/11 .......................
Final Action (Professional 10/00/15 .......................
Labeling_Sodium Phosphate).
------------------------------------------------------------------------
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-AF38
298. Laser Products; Amendment to Performance Standard
Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C.
393
Abstract: The regulation will amend the performance standard for
laser products to achieve closer harmonization between the current
standard and the International Electrotechnical Commission (IEC)
standard for laser products and medical laser products. The amendment
is intended to update FDA's performance standard to reflect
advancements in technology.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/24/13 78 FR 37723
NPRM Comment Period End............. 09/23/13 .......................
Final Action........................ 10/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: [email protected].
RIN: 0910-AF87
299. ``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. 53 in part II of this issue
of the Federal Register.
RIN: 0910-AG38
300. 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 from clinical investigations for medical devices to require that
clinical investigations conducted outside the United States in support
of a premarket approval application, humanitarian device exemption
application, an investigational device exemption
[[Page 76725]]
application, or a premarket notification submission be conducted in
accordance with good clinical practice.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/25/13 78 FR 12664
NPRM Comment Period End............. 05/28/13 .......................
Final Action........................ 01/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Sheila Anne Brown, Policy Analyst, Investigational
Device Exemptions Staff, Department of Health and Human Services, Food
and Drug Administration, WO 66, Room 1651, 10903 New Hampshire Avenue,
Silver Spring, MD 20993, Phone: 301 796-6563, Fax: 301 847-8120, Email:
[email protected].
RIN: 0910-AG48
301. Food Labeling: Calorie Labeling of Articles of Food Sold in
Vending Machines
Regulatory Plan: This entry is Seq. No. 54 in part II of this issue
of the Federal Register.
RIN: 0910-AG56
302. Food Labeling: Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments
Regulatory Plan: This entry is Seq. No. 55 in part II of this issue
of the Federal Register.
RIN: 0910-AG57
303. Supplemental Applications Proposing Labeling Changes for Approved
Drugs and Biological Products
Regulatory Plan: This entry is Seq. No. 58 in part II of this issue
of the Federal Register.
RIN: 0910-AG94
304. Veterinary Feed Directive
Regulatory Plan: This entry is Seq. No. 59 in part II of this issue
of the Federal Register.
RIN: 0910-AG95
305. Combinations of Bronchodilators With Expectorants; Cold,
Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for
Over-the-Counter Human Use
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective,
and not misbranded. After a final monograph (i.e. final rule) is
issued, only OTC drugs meeting the conditions of the monograph, or
having an approved new drug application, may be legally marketed. These
actions address cough/cold drug products containing an oral
bronchodilator (ephedrine and its salts) in combination with any
expectorant.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM (Amendment).................... 07/13/05 70 FR 40232
NPRM Comment Period End............. 11/10/05 .......................
Final Action (Technical Amendment).. 03/19/07 72 FR 12730
Final Action........................ 07/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Adams-King, Regulatory Health Project
Manager, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO 22, Room
5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-3713, Fax: 301 796-9899, Email: [email protected].
RIN: 0910-AH16
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Long-Term Actions
306. Food Labeling; Revision of the Nutrition and Supplement Facts
Labels
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: FDA is amending the labeling regulations for conventional
foods and dietary supplements to provide updated nutrition information
on the label to assist consumers in maintaining healthy dietary
practices. This rule will modernize the nutrition information found on
the Nutrition Facts label, as well as the format and appearance of the
label.
Timetable:
------------------------------------------------------------------------
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 .......................
Final Action........................ 03/00/16 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Blakeley Fitzpatrick, Interdisciplinary Scientist,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition (HFS-830), HFS-830, 5100
Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-5429,
Email: [email protected].
RIN: 0910-AF22
307. 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
Abstract: FDA is amending its labeling regulations for foods to
provide updated Reference Amounts Customarily Consumed (RACCs) for
certain food categories. This rule would provide consumers with
nutrition information based on the amount of food that is customarily
consumed, which would assist consumers in maintaining healthy dietary
practices. In addition to updating certain RACCs, FDA is also amending
the definition of single-serving containers; amending the label serving
size for breath mints; and providing for dual-column labeling, which
would provide nutrition information per serving and per container or
unit, as applicable, under certain circumstances.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 04/04/05 70 FR 17010
ANPRM Comment Period End............ 06/20/05 .......................
NPRM................................ 03/03/14 79 FR 11989
NPRM Comment Period End............. 06/02/14 .......................
Final Action........................ 03/00/16 .......................
------------------------------------------------------------------------
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
[[Page 76726]]
308. Focused Mitigation Strategies To Protect Food Against Intentional
Adulteration
Legal Authority: 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350g; 21
U.S.C. 350i; 21 U.S.C. 371; 21 U.S.C. 374; Pub. L. 111-353
Abstract: This rule would require domestic and foreign food
facilities that are required to register under the Federal Food, Drug,
and Cosmetic Act to address hazards that may be intentionally
introduced by acts of terrorism. These food facilities would be
required to identify and implement focused mitigation strategies to
significantly minimize or prevent significant vulnerabilities
identified at actionable process steps in a food operation.
Timetable:
------------------------------------------------------------------------
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.......................... 05/00/16 .......................
------------------------------------------------------------------------
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
309. 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 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.......................... 03/00/16 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition, Office of
Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone:
240 402-2022, Fax: 301 346-2632, Email: [email protected].
RIN: 0910-AG98
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Completed Actions
310. Infant Formula: Current Good Manufacturing Practices; Quality
Control Procedures; Notification Requirements; Records And Reports; and
Quality Factors
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 350a; 21
U.S.C. 371
Abstract: The Food and Drug Administration (FDA) is revising its
infant formula regulations to establish requirements for current good
manufacturing practices (CGMP), including audits; to establish
requirements for quality factors; and to amend FDA's quality control
procedures, notification, and record and reporting requirements for
infant formula. FDA is taking this action to improve the protection of
infants who consume infant formula products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/09/96 61 FR 36154
NPRM Comment Period End............. 12/06/96 .......................
NPRM Comment Period Reopened........ 04/28/03 68 FR 22341
NPRM Comment Period Extended........ 06/27/03 68 FR 38247
NPRM Comment Period End............. 08/26/03 .......................
NPRM Comment Period Reopened........ 08/01/06 71 FR 43392
NPRM Comment Period End............. 09/15/06 .......................
Interim Final Rule.................. 02/10/14 79 FR 7934
Interim Final Rule Comment Period 03/27/14 .......................
End.
Final Action........................ 06/10/14 79 FR 33057
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Leila Beker, Biologist, Department of Health and
Human Services, Food and Drug Administration, Center for Food Safety
and Applied Nutrition (HFS-850), 5100 Paint Branch Parkway, College
Park, MD 20740, Phone: 240 402-1451, Email: [email protected].
RIN: 0910-AF27
311. Postmarketing Safety Reports for Human Drug and Biological
Products: Electronic Submission Requirements
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355 to 355a; 21 U.S.C. 356 to 356c; 21 U.S.C. 360; 21
U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379k-l; 21 U.S.C.
379aa; 21 U.S.C. 381; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264; . .
.
Abstract: The final rule would amend FDA's postmarketing safety
reporting regulations for human drug and biological products to require
that mandatory safety reports submitted to the Agency be transmitted in
an electronic format that FDA can process, review, and archive. The
rule will allow the Agency to review safety reports more quickly, to
identify emerging safety problems, and disseminate safety information
more rapidly in support of FDA's public health mission. The amendments
also would be a key element in harmonizing FDA's postmarketing safety
reporting regulations with international and International
Harmonization Standards standards for the electronic submission of
safety information.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 11/05/98 63 FR 59746
ANPRM Comment Period End............ 02/03/99 .......................
NPRM................................ 08/21/09 74 FR 42184
NPRM Comment Period End............. 11/19/09 .......................
Final Action........................ 06/10/14 79 FR 33072
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
[[Page 76727]]
Agency Contact: Reena Raman, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6238, 10903 New Hampshire
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-7577, Fax: 301
847-8440, Email: [email protected].
RIN: 0910-AF96
312. Requirements for the Submission of Data Needed To Calculate User
Fees for Domestic Manufacturers and Importers of Tobacco Products
Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387s; Pub. L. 111-31
Abstract: This rule will require manufacturers and importers of
tobacco products to submit certain market share data to FDA. USDA
currently collects such data, but its program sunsets at the end of
September 2014, and USDA will cease collection of this information. FDA
is taking this action so that it may continue to calculate market share
percentages needed to compute user fees.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/31/13 78 FR 32581
NPRM Comment Period End............. 08/14/13 .......................
Final Action........................ 07/10/14 79 FR 39302
------------------------------------------------------------------------
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-AG81
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Proposed Rule Stage
313. 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 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
Second NPRM Comment Period End...... 12/08/14 .......................
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
314. Reform of Requirements for Long-Term Care Facilities (CMS-3260-P)
(Rulemaking Resulting From a Section 610 Review)
Regulatory Plan: This entry is Seq. No. 60 in part II of this issue
of the Federal Register.
RIN: 0938-AR61
315. Medicare Shared Savings Program; Accountable Care Organizations
(CMS-1461-P) (Section 610 Review)
Legal Authority: PL-111-148, sec 3022
Abstract: This proposed rule addresses 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................................ 11/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Terri Postma, Medical Officer, Department of Health
and Human Services, Centers for Medicare & Medicaid Services, Mail Stop
C5-15-24, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
4169, Email: [email protected].
RIN: 0938-AS06
316. Hospital and Critical Access Hospital (CAH) Changes To Promote
Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P)
(Rulemaking Resulting From a Section 610 Review)
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr
Abstract: This proposed rule would update the requirements that
hospitals and CAHs must meet to participate in the Medicare and
Medicaid programs. These proposals are intended to conform the
requirements to current standards of practice and support improvements
in quality of care, reduce barriers to care, and reduce some issues
that may exacerbate workforce shortage concerns.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/15 .......................
------------------------------------------------------------------------
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
317. Medicare Clinical Diagnostic Laboratory Test Payment
System (CMS-1621-P)
Legal Authority: Pub. L. 113-93, sec 216
Abstract: Under section 216 of the Protecting Access to Medicare
Act of 2014, this proposed rule would require Medicare payment for
clinical laboratory tests to be based on private payor rates beginning
January 1, 2017. Beginning January 1, 2016, and every 3 years
thereafter (or, annually, for certain laboratory tests), applicable
laboratories must report to CMS the amount they are
[[Page 76728]]
paid by each private payor for a test, and the volume of such tests
performed for each such payer for the period. The payment rate reported
by a laboratory must reflect all discounts, rebates, coupons, and other
price concessions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Anne Hauswald, 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 Blvd., Baltimore, MD 21244, Phone: 410 786-4546, Email: [email protected].
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].
RIN: 0938-AS33
318. CY 2016 Revisions to Payment Policies Under the Physician
Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-P)
Regulatory Plan: This entry is Seq. No. 63 in part II of this issue
of the Federal Register.
RIN: 0938-AS40
319. Hospital Inpatient Prospective Payment System for Acute
Care Hospitals and the Long-Term Care Hospital Prospective Payment
System and FY 2016 Rates (CMS-1632-P)
Regulatory Plan: This entry is Seq. No. 64 in part II of this issue
of the Federal Register.
RIN: 0938-AS41
320. CY 2016 Hospital Outpatient PPS Policy Changes and
Payment Rates and Ambulatory Surgical Center Payment System Policy
Changes and Payment Rates (CMS-1633-P)
Regulatory Plan: This entry is Seq. No. 65 in part II of this issue
of the Federal Register.
RIN: 0938-AS42
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
321. Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review)
Legal Authority: Pub. L. 111- 48, secs 2501, 2503, 3301(d)(2); Pub.
L. 111-152, sec 1206; Pub. L. 111-8, sec 221
Abstract: This final rule revises requirements pertaining to
Medicaid reimbursement for covered outpatient drugs to implement
provisions of the Affordable Care Act. This rule also revises other
requirements related to covered outpatient drugs, including key aspects
of Medicaid coverage, payment, and the drug rebate program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/02/12 77 FR 5318
NPRM Comment Period End............. 04/02/12 .......................
Final Action........................ 04/00/15 .......................
------------------------------------------------------------------------
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Long-Term Actions
322. Emergency Preparedness Requirements for Medicare and Medicaid
Participating Providers and Suppliers (CMS-3178-F)
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
323. Adoption of Operating Rules for HIPAA Transactions (CMS-0036-IFC)
Legal Authority: Pub. L. 104-191, sec 1104
Abstract: Under the Affordable Care Act, this interim final rule
adopts operating rules for HIPAA transactions for health care claims or
equivalent encounter information, enrollment and disenrollment of a
health plan, health plan premium payments, and referral certification
and authorization.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 11/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Geanelle Herring, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Administrative Simplification Group, Office of E-
Health Standards and Services, Mail Stop S2-26-17, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-4466, Email:
[email protected].
RIN: 0938-AS01
[[Page 76729]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Completed Actions
324. Prospective Payment System for Federally Qualified Health Centers;
Changes to Contracting Policies for Rural Health Clinics and CLIA
Enforcement Actions for Proficiency Testing Referral (CMS-1443-FC)
(Completion of a Section 610 Review)
Legal Authority: Pub. L. 111-148, sec 10501
Abstract: This final rule establishes methodology and payment rates
for a prospective payment system (PPS) for Federally qualified health
center (FQHC) services under Medicare Part B beginning on October 1,
2014, in compliance with the statutory requirement of the Affordable
Care Act. This rule also establishes a policy which would allow rural
health clinics (RHCs) to contract with nonphysician practitioners when
statutory requirements for employment of nurse practitioners and
physician assistants are met, and makes other technical and conforming
changes to the RHC and FQHC regulations. Finally, this rule makes
changes to the Clinical Laboratory Improvement Amendments (CLIA)
regulations regarding enforcement actions for proficiency testing
referral.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/23/13 78 FR 58386
NPRM Comment Period End............. 11/18/13 .......................
Final Rule.......................... 05/02/14 79 FR 25436
Comment Period End.................. 07/01/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Corinne Axelrod, Health Insurance Specialist,
Hospital and Ambulatory Policy Group, Department of Health and Human
Services, Centers for Medicare & Medicaid Services, Mailstop C5-14-03,
7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5620,
Email: [email protected].
RIN: 0938-AR62
325. Hospital Inpatient Prospective Payment System for Acute Care
Hospitals and the Long-Term Care Hospital Prospective Payment System
and Fiscal Year 2015 Rates (CMS-1607-F) (Completion of a Section 610
Review)
Legal Authority: sec 1886(d) of the Social Security Act
Abstract: This 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................................ 05/14/14 79 FR 27977
NPRM Comment Period End............. 06/30/14 .......................
Final Action........................ 08/22/14 79 FR 49853
------------------------------------------------------------------------
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-AS11
326. CY 2015 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1612-FC) (Section
610 Review)
Legal Authority: Social Security Act, secs 1102, 1871 and 1848
Abstract: This final rule addresses changes to the physician fee
schedule, and other Medicare Part B payment policies to ensure that our
payment systems are updated to reflect changes in medical practice and
the relative value of services, as well as changes in the statute.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/11/14 79 FR 40318
NPRM Comment Period End............. 09/02/14 .......................
Final Action........................ 11/13/14 79 FR 67548
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Kathy Bryant, Director, Division of Practitioner
Services, Department of Health and Human Services, Centers for Medicare
& Medicaid Services, Mail Stop C4-01-27, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-3448, Email:
[email protected].
RIN: 0938-AS12
327. CY 2015 End-Stage Renal Disease Prospective Payment System,
Quality Incentive Program, and Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (CMS-1614-F) (Section 610 Review)
Legal Authority: Social Security Act, sec 1834(a)(1)(6); MIPPA, sec
153(b)
Abstract: This final rule updates and makes revisions to the End-
Stage Renal Disease (ESRD) prospective payment system (PPS) for
calendar year (CY) 2015. This rule also sets forth requirements for the
ESRD quality incentive program (QIP), including payment years (PYs)
2017 and 2018. This rule also makes a technical correction to remove
outdated terms and definitions. In addition, this rule sets forth the
methodology for adjusting Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS) fee schedule payment amounts using
information from the Medicare DMEPOS Competitive Bidding Program (CBP);
makes alternative payment rules for DME and enteral nutrition under the
Medicare DMEPOS CBP; clarifies the statutory Medicare hearing aid
coverage exclusion and specifies devices not subject to the hearing aid
exclusion; updates the definition of minimal self-adjustment regarding
what specialized training is needed by suppliers to provide custom
fitting services if they are not certified orthotists; clarifies the
Change of Ownership (CHOW) and provides for an exception to the current
requirements; revises the appeal provisions for termination of a
contract and notification to beneficiaries under the Medicare DMEPOS
CBP, and adds a technical change related to submitting bids for
infusion drugs under the Medicare DMEPOS CBP.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/11/14 79 FR 40208
NPRM Comment Period End............. 09/02/14 .......................
Final Action........................ 11/06/14 79 FR 66120
Final Action Effective.............. 01/01/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michelle Cruse, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, Mail Stop C5-05-27, 7500
Security Boulevard, Baltimore,
[[Page 76730]]
MD 21244, Phone: 410 786-7540, Email: [email protected].
RIN: 0938-AS13
328. CY 2015 Hospital Outpatient Prospective Payment System (PPS)
Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical
Center Payment System Policy Changes and Payment Rates (CMS-1613-FC)
(Section 610 Review)
Legal Authority: sec 1833 of the Social Security Act
Abstract: This final rule revises the Medicare hospital outpatient
prospective payment system (OPPS) and the Medicare ambulatory surgical
center (ASC) payment system for CY 2015 to implement applicable
statutory requirements and changes arising from our continuing
experience with these systems. In this rule, we describe the changes to
the amounts and factors used to determine the payment rates for
Medicare services paid under the OPPS and those paid under the ASC
payment system. In addition, this rule updates and refines the
requirements for the Hospital Outpatient Quality Reporting (OQR)
Program and the ASC Quality Reporting (ASCQR) Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/14/14 79 FR 40916
NPRM Comment Period End............. 09/02/14 .......................
Final Action........................ 11/13/14 79 FR 66770
Final Action Effective.............. 01/01/15 .......................
------------------------------------------------------------------------
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-AS15
329. Extension of Payment Adjustment for Low-Volume Hospitals and the
Medicare-Dependent Hospital Program Under the FY 2014 Hospital
Inpatient Prospective Payment System (CMS-1599-IFC2) (Completion of a
Section 610 Review)
Legal Authority: Pub. L. 113-67, secs 1105 and 1106
Abstract: This interim final rule implements changes to the payment
adjustment for low-volume hospitals and to the Medicare-dependent
hospital program under the hospital inpatient prospective payment
systems for FY 2014 (through March 31, 2014) in accordance with
sections 1105 and 1106, respectively, of the Pathway for SGR Reform Act
of 2013.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 03/18/14 79 FR 15022
Interim Final Rule Comment Period 05/12/14 .......................
End.
Merged With 0938-AS11............... 06/01/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michele Hudson, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop C4-10-07, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-5490, Email:
[email protected].
RIN: 0938-AS18
[FR Doc. 2014-28964 Filed 12-19-14; 8:45 am]
BILLING CODE 4150-24-P