[Federal Register Volume 79, Number 114 (Friday, June 13, 2014)]
[Proposed Rules]
[Pages 34052-34067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13125]
[[Page 34051]]
Vol. 79
Friday,
No. 114
June 13, 2014
Part VIII
Department of Health and Human Services
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Semiannual Regulatory Agenda
Federal Register / Vol. 79 , No. 114 / Friday, June 13, 2014 /
Unified Agenda
[[Page 34052]]
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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
Semiannual 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
12866 require the Department semiannually to issue an inventory of
rulemaking actions under development to provide the public a summary of
forthcoming regulatory actions. This information will help the public
more effectively participate in the Department's regulatory activity,
and the Department welcomes comments on any aspect of this agenda.
FOR FURTHER INFORMATION CONTACT: Jennifer M. Cannistra, Executive
Secretary, Department of Health and Human Services, 200 Independence
Avenue SW., Washington, DC 20201; (202) 690-6827.
SUPPLEMENTARY INFORMATION: The Department of Health and Human Services
(HHS) is the Federal Government's principal agency for protecting the
health of all Americans and providing essential human services,
especially for those who are least able to help themselves. HHS
enhances the health and well-being of Americans by promoting effective
health and human services and by fostering sound, sustained advances in
the sciences underlying medicine, public health, and social services.
This Agenda 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. The Department's Public Participation Task Force, which was
created as part of the HHS Retrospective Review plan in response to
Executive Order 13563 (Improving Regulation and Regulatory Review),
regularly meets to identify ways to make the rulemaking process more
accessible to the general public. 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 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,
including through a comment form on the HHS retrospective review Web
page (http://www.HHS.gov/RetrospectiveReview). In addition, a cross-
agency team at HHS is currently considering how to increase efficiency
in rulemaking by organizing public comment on proposed rules.
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: February 20, 2014.
Jennifer M. Cannistra,
Executive Secretary to the Department.
Substance Abuse and Mental Health Services Administration--Proposed Rule
Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
120....................... SAMHSA User Fees for 0930-AA18
Publications.
------------------------------------------------------------------------
Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
121....................... Food Labeling; Revision of 0910-AF22
the Nutrition and
Supplement Facts Labels.
122....................... 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.
123....................... Over-the-Counter (OTC) 0910-AF31
Drug Review--Cough/Cold
(Antihistamine) Products.
124....................... Over-the-Counter (OTC) 0910-AF36
Drug Review--Internal
Analgesic Products.
125....................... Over-the-Counter (OTC) 0910-AF43
Drug Review--Sunscreen
Products.
126....................... Over-the-Counter (OTC) 0910-AF69
Drug Review--Topical
Antimicrobial Drug
Products.
127....................... Abbreviated New Drug 0910-AF97
Applications and
505(b)(2).
128....................... Updated Standards for 0910-AG09
Labeling of Pet Food.
129....................... Current Good Manufacturing 0910-AG10
Practice and Hazard
Analysis and Risk-Based
Preventive Controls for
Food for Animals.
130....................... Over-the-Counter (OTC) 0910-AG12
Drug Review--Pediatric
Dosing for Cough/Cold
Products.
131....................... Electronic Distribution of 0910-AG18
Prescribing Information
for Human Prescription
Drugs Including
Biological Products.
132....................... Produce Safety Regulation. 0910-AG35
133....................... Current Good Manufacturing 0910-AG36
and Hazard Analysis, and
Risk-Based Preventive
Controls for Human Food.
134....................... ``Tobacco Products'' 0910-AG38
Subject to the Federal
Food, Drug, and Cosmetic
Act, as Amended by the
Family Smoking Prevention
and Tobacco Control Act.
135....................... Requirements for the 0910-AG59
Testing and Reporting of
Tobacco Product
Constituents,
Ingredients, and
Additives.
136....................... Foreign Supplier 0910-AG64
Verification Program.
[[Page 34053]]
137....................... Format and Content of 0910-AG96
Reports Intended to
Demonstrate Substantial
Equivalence.
138....................... Sanitary Transportation of 0910-AG98
Human and Animal Food.
139....................... Radiology Devices; 0910-AH03
Designation of Special
Controls for the Computed
Tomography X-Ray System.
140....................... Mammography Quality 0910-AH04
Standards Act; Regulatory
Amendments.
141....................... Investigational New Drug 0910-AH07
Application Annual
Reporting.
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Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
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142....................... Content and Format of 0910-AF11
Labeling for Human
Prescription Drugs and
Biologics; Requirements
for Pregnancy and
Lactation Labeling.
143....................... Combinations of 0910-AF33
Bronchodilators With
Nasal Decongestants or
Expectorants; Cold,
Cough, Allergy,
Bronchodilator, and
Antiasthmatic Drug
Products for Over-the-
Counter Human Use.
144....................... Over-the-Counter (OTC) 0910-AF38
Drug Review--Laxative
Drug Products.
145....................... Laser Products; Amendment 0910-AF87
to Performance Standard.
146....................... Human Subject Protection; 0910-AG48
Acceptance of Data From
Clinical Studies for
Medical Devices.
147....................... Food Labeling: Calorie 0910-AG56
Labeling of Articles of
Food Sold in Vending
Machines.
148....................... Food Labeling: Nutrition 0910-AG57
Labeling of Standard Menu
Items in Restaurants and
Similar Retail Food
Establishments.
149....................... Requirements for the 0910-AG81
Submission of Data Needed
to Calculate User Fees
for Domestic
Manufacturers and
Importers of Tobacco
Products.
150....................... Supplemental Applications 0910-AG94
Proposing Labeling
Changes for Approved
Drugs and Biological
Products.
151....................... Veterinary Feed Directive. 0910-AG95
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Food and Drug Administration--Long-Term Actions
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Regulation
Sequence No. Title Identifier No.
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152....................... Infant Formula: Current 0910-AF27
Good Manufacturing
Practices; Quality
Control Procedures;
Notification
Requirements; Records and
Reports; and Quality
Factors.
153....................... Focused Mitigation 0910-AG63
Strategies To Protect
Food Against Intentional
Adulteration.
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Food and Drug Administration--Completed Actions
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Regulation
Sequence No. Title Identifier No.
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154....................... Prescription Drug 0910-AG14
Marketing Act of 1987;
Prescription Drug
Amendments of 1992;
Policies, Requirements,
and Administrative
Procedures (Completion of
a Section 610 Review).
155....................... General Hospital and 0910-AG54
Personal Use Devices:
Issuance of Draft Special
Controls Guidance for
Infusion Pumps.
156....................... Food Labeling: Nutrient 0910-AH13
Content Claims; Alpha-
Linolenic Acid,
Eicosapentaenoic Acid,
and Docosahexaenoic Acid
Omega-3 Fatty Acids.
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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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157....................... Home Health Agency 0938-AG81
Conditions of
Participation (CMS-3819-
P) (Rulemaking Resulting
From a Section 610
Review).
158....................... 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-P)
(Section 610 Review).
159....................... CY 2015 Revisions to 0938-AS12
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1612-P)
(Section 610 Review).
160....................... 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-
P) (Section 610 Review).
161....................... CY 2016 Notice of Benefit 0938-AS19
and Payment Parameters
(CMS-9944-P) (Section 610
Review).
162....................... 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).
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[[Page 34054]]
Centers for Medicare & Medicaid Services--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
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163....................... Covered Outpatient Drugs 0938-AQ41
(CMS-2345-F) (Section 610
Review).
164....................... 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) (Section 610
Review).
165....................... Adoption of Operating 0938-AS01
Rules for HIPAA
Transactions (CMS-0036-
IFC).
166....................... 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) (Section 610
Review).
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Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
167....................... Emergency Preparedness 0938-AO91
Requirements for Medicare
and Medicaid
Participating Providers
and Suppliers (CMS-3178-
F).
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Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
168....................... CY 2014 Changes to the End- 0938-AR55
Stage Renal Disease
(ESRD) Prospective
Payment System, ESRD
Quality Incentive
Program, and Durable
Medical Equipment (CMS-
1526-F) (Completion of a
Section 610 Review).
169....................... Revisions to Payment 0938-AR56
Policies Under the
Physician Fee Schedule
and Medicare Part B for
CY 2014 (CMS-1600-FC)
(Completion of a Section
610 Review).
170....................... CY 2015 Notice of Benefit 0938-AR89
and Payment Parameters
(CMS-9954-F) (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
120. 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................................ 12/00/14
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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
121. 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 proposing to amend 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. If finalized, this rule will modernize the nutrition
information found on the Nutrition Facts label, as well as the format
and appearance of the label.
Timetable:
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Action Date FR Cite
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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
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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,
[[Page 34055]]
Phone: 240 402-5429, Email: [email protected]">nutritionprogram[email protected].
RIN: 0910-AF22
122. 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 proposing to amend its labeling regulations for
foods to provide updated Reference Amounts Customarily Consumed (RACCs)
for certain food categories. If finalized, 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 considering amending the definition of single-serving
containers; amending the definition of serving size for breath mints;
and providing for dual-column labeling, which would provide nutrition
information per serving and per container or units, as applicable,
under certain circumstances.
Timetable:
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Action Date FR Cite
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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
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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]">nutritionprogram[email protected].
RIN: 0910-AF23
123. 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)...... 09/00/14
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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
124. 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:
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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)........ 12/00/14
NPRM (Amendment) (Acetaminophen).... 12/00/14
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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-AF36
125. Over-the-Counter (OTC) Drug Review--Sunscreen 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. The
first of the future actions will address the safety of sunscreen active
ingredients.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM (Sunscreen and Insect 02/22/07 72 FR 7941
Repellent).
ANPRM Comment Period End............ 05/23/07
NPRM (UVA/UVB)...................... 08/27/07 72 FR 49070
NPRM Comment Period End............. 12/26/07
Final Action (UVA/UVB).............. 06/17/11 76 FR 35620
NPRM (Effectiveness)................ 06/17/11 76 FR 35672
NPRM (Effectiveness) Comment Period 09/15/11
End.
ANPRM (Dosage Forms)................ 06/17/11 76 FR 35669
ANPRM (Dosage Forms) Comment Period 09/15/11
End.
Proposed Rule....................... 03/00/15
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Adams-King, Regulatory Health Project
Manager,
[[Page 34056]]
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-AF43
126. 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)........ 03/00/15
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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
127. 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................................ 05/00/14
------------------------------------------------------------------------
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
128. 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 useful
information about the nutrient content and ingredient composition of
pet food products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/00/14
------------------------------------------------------------------------
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
129. Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21
U.S.C. 350c; 21 U.S.C. 350d note; 21 U.S.C. 350g; 21 U.S.C. 350g note;
21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 264; 42 U.S.C. 243; 42 U.S.C.
271; . . .
Abstract: This rule establishes requirements for good manufacturing
practice, and to require that certain facilities establish and
implement hazard analysis and risk-based preventive controls for animal
food, including ingredients and mixed animal feed. This action is
intended to provide greater assurance that food marketed for all
animals, including pets, is safe.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/29/13 78 FR 64736
NPRM Comment Period Extension....... 02/03/14 79 FR 6111
NPRM Comment Period End............. 02/26/14
NPRM Comment Period Extension End... 03/31/14
Supplemental NPRM................... 07/00/14
Final Rule.......................... 08/00/15
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Kim Young, Deputy Director, Division of Compliance,
Department of Health and Human Services, Food and Drug Administration,
Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519
Standish Place, Rockville, MD 20855, Phone: 240 276-9207, Email:
[email protected].
RIN: 0910-AG10
130. 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................................ 12/00/14
------------------------------------------------------------------------
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
[[Page 34057]]
796-3713, Fax: 301 796-9899, Email: [email protected].
RIN: 0910-AG12
131. 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................................ 06/00/14
------------------------------------------------------------------------
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
132. Produce Safety Regulation
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
Enviromental Impact Statement for
the Proposed Rule.
Notice of Intent To Prepare 11/15/13
Enviromental 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 11/18/13 78 FR 69006
the Proposed Rule; Comment Period
Extended.
Environmental Impact Statement for 03/14/14
the Proposed Rule; Comment Period
Extended End.
Supplemental NPRM................... 07/00/14
Final Rule.......................... 10/00/15
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Samir Assar, Supervisory Consumer Safety Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition, Office of Food Safety,
5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1636,
Email: [email protected].
RIN: 0910-AG35
133. Current Good Manufacturing and Hazard Analysis, and Risk-Based
Preventive Controls for Human Food
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub.
L. 111-353 (signed on Jan. 4, 2011)
Abstract: This rule would require a food facility to have and
implement preventive controls to significantly minimize or prevent the
occurrence of hazards that could affect food manufactured, processed,
packed, or held by the facility. This action is intended to prevent or,
at a minimum, quickly identify foodborne pathogens before they get into
the food supply.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/16/13 78 FR 3646
NPRM Comment Period End............. 05/16/13 .......................
NPRM Comment Period Extended........ 04/26/13 78 FR 24691
NPRM Comment Period Extended End.... 09/16/13 .......................
NPRM Comment Period Extended........ 08/09/13 78 FR 48636
NPRM Comment Period Extended End.... 11/15/13 .......................
NPRM Comment Period Extended........ 11/20/13 78 FR 69604
NPRM Comment Period Extended End.... 11/22/13 .......................
Supplemental NPRM................... 07/00/14 .......................
Final Rule.......................... 08/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Jenny Scott, Senior Advisor, Department of Health
and Human Services, Food and Drug Administration, Office of Food
Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240
402-1488, Email: [email protected].
RIN: 0910-AG36
134. ``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 proposed rule would deem products meeting the statutory
definition of ``tobacco
[[Page 34058]]
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 .......................
Final Action........................ 06/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: May Nelson, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 9200 Corporate Boulevard, Rockville, MD 20850, Phone:
877 287-1373, Fax: 240 276-3904, Email: [email protected].
RIN: 0910-AG38
135. 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................................ 11/00/14 .......................
------------------------------------------------------------------------
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, 9200 Corporate Boulevard, Room 240 H, Rockville, MD
20850, Phone: 877 287-1373, Fax: 240 276-3904, Email:
[email protected].
RIN: 0910-AG59
136. 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................... 07/00/14 .......................
Final Rule.......................... 10/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian L. Pendleton, Senior Policy Advisor,
Department of Health and Human Services, Food and Drug Administration,
Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue, Silver
Spring, MD 20993-0002, Phone: 301 796-4614, Fax: 301 847-8616, Email:
[email protected].
RIN: 0910-AG64
137. 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 and compliance
with the FD&C Act (sections 905(j) and 910(a) of the FD&C Act). This
regulation also would provide information as to how the Agency will
review and act on these submissions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/15 .......................
------------------------------------------------------------------------
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, 9200 Corporate Boulevard, Rockville, MD 20850, Phone:
877 287-1373, Fax: 240 276-4193, Email: [email protected].
RIN: 0910-AG96
138. 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 End............. 05/31/14 .......................
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
139. 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.
[[Page 34059]]
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/14 .......................
------------------------------------------------------------------------
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
140. 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................................ 12/00/14 .......................
------------------------------------------------------------------------
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
141. 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................................ 03/00/15 .......................
------------------------------------------------------------------------
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Final Rule Stage
142. 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........................ 07/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Molly Flannery, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6246, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-3543, Email:
[email protected].
RIN: 0910-AF11
143. Combinations of Bronchodilators With Nasal Decongestants or
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 or 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 12/00/14 .......................
and Oral Nasal Decongestant).
Final Action (Oral Bronchodilator 12/00/14 .......................
and Expectorant).
------------------------------------------------------------------------
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
144. 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
[[Page 34060]]
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 Labeling-- 12/00/14 .......................
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
145. 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........................ 12/00/14 .......................
------------------------------------------------------------------------
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
146. Human Subject Protection; Acceptance of Data From Clinical Studies
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 studies for medical devices to require that clinical
studies conducted outside the United States 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.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/25/13 78 FR 12664
NPRM Comment Period End............. 05/28/13 .......................
Final Action........................ 12/00/14 .......................
------------------------------------------------------------------------
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
147. Food Labeling: Calorie Labeling of Articles of Food Sold in
Vending Machines
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: FDA published a proposed rule to establish requirements
for nutrition labeling of certain food items sold in certain vending
machines. FDA also proposed the terms and conditions for vending
machine operators registering to voluntarily be subject to the
requirements. FDA is issuing a final rule, and taking this action to
carry out section 4205 of the Patient Protection and Affordable Care
Act.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/06/11 76 FR 19238
NPRM Comment Period End............. 07/05/11 .......................
Final Action........................ 06/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Daniel Reese, Food Technologist, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition (HFS-820), 5100 Paint Branch Parkway,
College Park, MD 20740, Phone: 240 402-2126, Email:
[email protected].
RIN: 0910-AG56
148. Food Labeling: Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: FDA published a proposed rule in the Federal Register to
establish requirements for nutrition labeling of standard menu items in
chain restaurants and similar retail food establishments. FDA also
proposed the terms and conditions for restaurants and similar retail
food establishments registering to voluntarily be subject to the
Federal requirements. FDA is issuing a final rule, and taking this
action to carry out section 4205 of the Patient Protection and
Affordable Care Act.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/06/11 76 FR 19192
NPRM Comment Period End............. 07/05/11 .......................
Final Action........................ 06/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Daniel Reese, Food Technologist, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition (HFS-820), 5100 Paint Branch Parkway,
College Park, MD 20740, Phone: 240 402-2126, Email:
[email protected].
RIN: 0910-AG57
149. 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
[[Page 34061]]
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........................ 06/00/14 .......................
------------------------------------------------------------------------
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, Room 340K, 9200 Corporate Boulevard,
Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email:
[email protected].
RIN: 0910-AG81
150. Supplemental Applications Proposing Labeling Changes for Approved
Drugs and Biological Products
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21
U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262; . . .
Abstract: This rule would amend the regulations regarding new drug
applications (NDAs), abbreviated new drug applications (ANDAs), and
biologics license applications (BLAs) to revise and clarify procedures
for changes to the labeling of an approved drug to reflect certain
types of newly acquired information in advance of FDA's review of such
change. This rule would describe the process by which information
regarding ``changes being effected'' (CBE) labeling supplement
submitted by an NDA or ANDA holder would be made publicly available
during FDA's review of the labeling change.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/13/13 78 FR 67985
NPRM Comment Period End............. 01/13/14 .......................
Final Rule.......................... 12/00/14 .......................
------------------------------------------------------------------------
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-AG94
151. Veterinary Feed Directive
Legal Authority: 21 U.S.C. 354; 21 U.S.C. 360b; 21 U.S.C. 360ccc;
21 U.S.C. 360ccc-1; 21 U.S.C. 371
Abstract: The Animal Drug Availability Act created a new category
of products called veterinary feed directive (VFD) drug. This
rulemaking is intended to provide for the increased efficiency of the
VFD program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 03/29/10 75 FR 15387
ANPRM Comment Period End............ 06/28/10 .......................
NPRM................................ 12/12/13 78 FR 75515
NPRM Comment Period End............. 03/12/14 .......................
Final Rule.......................... 04/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Sharon Benz, Supervisory Animal Scientist,
Department of Health and Human Services, Food and Drug Administration,
Center for Veterinary Medicine, MPN-4, Room 2648, HFV-220, 7529
Standish Place, Rockville, MD 20855, Phone: 240 453-6864, Email:
[email protected].
RIN: 0910-AG95
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Long-Term Actions
152. 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 Rule.......................... 07/00/15 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Benson Silverman, Staff Director, Infant Formula
and Medical Foods, 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
402-1459, Email: [email protected].
RIN: 0910-AF27
153. 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 End............. 03/31/14 .......................
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
[[Page 34062]]
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Completed Actions
154. Prescription Drug Marketing Act of 1987; Prescription Drug
Amendments of 1992; Policies, Requirements, and Administrative
Procedures (Completion of a Section 610 Review)
Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 351 to
353; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381
Abstract: FDA has completed their review of the regulations
promulgated under the Prescription Drug Marketing Act. The review was
done to determine whether the regulations should be changed or
rescinded to minimize adverse impacts on a substantial number of small
entities.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Begin Review of Current Regulation.. 11/24/08 .......................
End Review of Current Regulation.... 11/29/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Howard Muller, Office of Regulatory Policy,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New
Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601,
Fax: 301 847-8440, Email: pdma610(c)[email protected].
RIN: 0910-AG14
155. General Hospital and Personal Use Devices: Issuance of Draft
Special Controls Guidance for Infusion Pumps
Legal Authority: 21 U.S.C. 351; 21 U.S.C. 360; 21 U.S.C. 360c; 21
U.S.C. 360e; 21 U.S.C. 360j; 21 U.S.C. 371
Abstract: FDA is proposing to amend the classification of infusion
pumps from class II (performance standards) to class II (special
controls). FDA is taking this action to provide reasonable assurance of
the safety and effectiveness of these devices.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Withdrawn........................... 04/24/14 .......................
------------------------------------------------------------------------
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-AG54
156. Food Labeling: Nutrient Content Claims; Alpha-Linolenic
Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty
Acids
Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371
Abstract: The final rule addresses the nutrient content claims for
docosahexaenoic acid and eicosapentaenoic acid set forth in
notifications submitted by (1) Alaska General Seafoods, Ocean Beauty
Seafoods Inc., and Trans-Ocean Products Inc. (the seafood processors
notification), (2) Martek Biosciences Corp. (the Martek notification),
and (3) Ocean Nutrition Canada Ltd. The final rule also addresses the
nutrient content claims for alpha-linolenic acid set forth in the
seafood processors notification and the Martek notification.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/27/07 72 FR 66103
NPRM Comment Period End............. 02/11/08 .......................
Final Action........................ 04/28/14 79 FR 23262
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Vincent De Jesus, Nutritionist, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition, (HFS-830), Room 3D-031, 5100 Paint
Branch Parkway, College Park, MD 20740, Phone: 240 402-1774, Fax: 301
436-1191, Email: [email protected].
RIN: 0910-AH13
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Proposed Rule Stage
157. Home Health Agency Conditions of Participation (CMS-3819-P)
(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 proposed rule would revise the existing Conditions
of Participation that Home Health Agencies must meet to participate in
the Medicare program. The new requirements would 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......................... 05/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Agency Contact: Danielle Shearer, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Clinical Standards & Quality, Mail Stop S3-02-01,
7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6617,
Email: [email protected].
RIN: 0938-AG81
158. 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-P) (Section 610 Review)
Legal Authority: sec 1886(d) of the Social Security Act
Abstract: This annual proposed rule would revise the Medicare
hospital inpatient and long-term care hospital prospective payment
systems for operating and capital-related costs. This proposed rule
would implement changes arising from our continuing experience with
these systems.
[[Page 34063]]
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/14/14 79 FR 27977
NPRM Comment Period End............. 06/30/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian Slater, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop C4-07-07, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-6229, Email:
[email protected].
RIN: 0938-AS11
159. CY 2015 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1612-P) (Section
610 Review)
Legal Authority: Social Security Act, secs 1102, 1871 and 1848
Abstract: This annual proposed rule would revise payment policies
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, 2015.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/14 .......................
------------------------------------------------------------------------
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
160. 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-P)
(Section 610 Review)
Legal Authority: Sec 1833 of the Social Security Act
Abstract: This annual proposed rule would revise the Medicare
hospital outpatient prospective payment system (PPS) to implement
statutory requirements and changes arising from our continuing
experience with this system. The proposed rule describes changes to the
amounts and factors used to determine payment rates for services. In
addition, the rule proposes changes to the ambulatory surgical center
payment system list of services and rates.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/00/14 .......................
------------------------------------------------------------------------
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 Management, Mail Stop C4-03-06,
7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4617,
Email: [email protected].
RIN: 0938-AS15
161. CY 2016 Notice of Benefit and Payment Parameters (CMS-
9944-P) (Section 610 Review)
Legal Authority: Pub. L. 111-148, title I
Abstract: This proposed rule would establish the CY 2016 payment
parameters for the cost-sharing reductions, advance payments of the
premium tax credit, reinsurance, and risk adjustment programs as
required by the Affordable Care Act.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Sharon Arnold, Director, Payment Policy and
Financial Management Group, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Center for Consumer
Information & Insurance Oversight, Mail Stop 733H.02, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 301 492-4286, Email:
[email protected].
RIN: 0938-AS19
162. 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 revise the requirements that
hospitals and CAHs must meet to participate in the Medicare and
Medicaid programs. These changes are necessary to reflect substantial
advances in healthcare delivery and in patient safety knowledge and
practices, and would allow hospitals and CAHs the flexibility to
implement innovative patient care practices. The changes are also an
integral part of our efforts to achieve broad-based improvements in
patient safety and in the quality of health care furnished through
Federal programs.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/00/14 .......................
------------------------------------------------------------------------
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Final Rule Stage
163. 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........................ 06/00/14 .......................
------------------------------------------------------------------------
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].
[[Page 34064]]
RIN: 0938-AQ41
164. 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)
(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
Final Rule With 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
165. 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.................. 03/00/15 .......................
------------------------------------------------------------------------
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
166. 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) (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.
------------------------------------------------------------------------
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Long-Term Actions
167. 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 Clinical Standards and Quality, Mail Stop
S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-1850, Phone: 410
786-8020, Email: [email protected].
RIN: 0938-AO91
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Completed Actions
168. CY 2014 Changes to the End-Stage Renal Disease (ESRD) Prospective
Payment System, ESRD Quality Incentive Program, and Durable Medical
Equipment (CMS-1526-F) (Completion of a Section 610 Review)
Legal Authority: MIPPA; sec 153(b); Pub. L. 111-148; sec 3401(h);
ATRA; sec 632(a)
[[Page 34065]]
Abstract: This final rule updates the bundled payment system for
End Stage Renal Disease (ESRD) facilities by 1/1/13. The rule also
updates the Quality Incentives in the ESRD Program. In addition, this
rule clarifies the grandfathering provision related to the 3-year
minimum lifetime requirement for Durable Medical Equipment (DME). It
also provides clarification of the definition of routinely purchased
DME.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/08/13 78 FR 40835
NPRM Comment Period End............. 08/30/13 .......................
Final Action........................ 12/02/13 78 FR 72156
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michelle Cruse, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop C5-05-27, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-7540, Email:
[email protected].
RIN: 0938-AR55
169. Revisions to Payment Policies Under the Physician Fee Schedule and
Medicare Part B for CY 2014 (CMS-1600-FC) (Completion of a Section 610
Review)
Legal Authority: Social Security Act, secs 1102, 1871, 1848
Abstract: This final rule revises payment polices under the
Medicare physician fee schedule, and make other policy changes to
payment under Medicare Part B. These changes are applicable to services
furnished on or after January 1, annually.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/19/13 78 FR 43282
NPRM Comment Period End............. 09/06/13 .......................
Final Action........................ 12/10/13 78 FR 74230
------------------------------------------------------------------------
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-AR56
170. CY 2015 Notice of Benefit and Payment Parameters (CMS-9954-F)
(Completion of a Section 610 Review)
Legal Authority: Pub. L. 111-148
Abstract: This final rule establishes the CY 2015 payment
parameters for the cost-sharing reductions, advance premium tax credit,
reinsurance, and risk adjustment programs as required by the Affordable
Care Act.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/02/13 78 FR 72322
NPRM Comment Period End............. 12/26/13 .......................
Final Action........................ 03/11/14 79 FR 13743
Final Action Effective.............. 05/12/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Sharon Arnold, Director, Payment Policy and
Financial Management Group, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Center for Consumer
Information & Insurance Oversight, Mail Stop 733H.02, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 301 492-4286, Email:
[email protected].
RIN: 0938-AR89
[FR Doc. 2014-13125 Filed 6-12-14; 8:45 am]
BILLING CODE 4150-24-P