[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Proposed Rules]
[Pages 1158-1169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29632]
[[Page 1157]]
Vol. 79
Tuesday,
No. 4
January 7, 2014
Part VIII
Department of Health and Human Services
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Semiannual Regulatory Agenda
Federal Register / Vol. 79, No. 4 / Tuesday, January 7, 2014 /
Unified Agenda
[[Page 1158]]
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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
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, Washington, DC
20201.
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, HHS regularly updates its main 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 only 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: August 21, 2013.
Jennifer M. Cannistra,
Executive Secretary to the Department.
Food and Drug Administration--Prerule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
274....................... Over-the-Counter (OTC) 0910-AF43
Drug Review--Sunscreen
Products.
275....................... Prescription Drug 0910-AG14
Marketing Act of 1987;
Prescription Drug
Amendments of 1992;
Policies, Requirements,
and Administrative
Procedures (Section 610
Review).
------------------------------------------------------------------------
Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
276....................... Food Labeling; Revision of 0910-AF22
the Nutrition and
Supplement Facts Labels
(Reg Plan Seq No. 49).
277....................... Food Labeling: Serving 0910-AF23
Sizes of Foods That Can
Reasonably Be Consumed at
One-Eating Occasion; Dual-
Column Labeling;
Updating, Modifying, and
Establishing Certain
RACCs (Reg Plan Seq No.
50).
278....................... Over-the-Counter (OTC) 0910-AF31
Drug Review--Cough/Cold
(Antihistamine) Products.
279....................... Over-the-Counter (OTC) 0910-AF36
Drug Review--Internal
Analgesic Products.
280....................... Updated Standards for 0910-AG09
Labeling of Pet Food.
281....................... Current Good Manufacturing 0910-AG10
Practice, Hazard
Analysis, and Risk-Based
Preventive Controls for
Food for Animals (Reg
Plan Seq No. 51).
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....................... Produce Safety Regulation. 0910-AG35
285....................... Hazard Analysis and Risk- 0910-AG36
Based Preventive Controls.
286....................... ``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. 52).
287....................... Requirements for the 0910-AG59
Testing and Reporting of
Tobacco Product
Constituents,
Ingredients, and
Additives.
288....................... Foreign Supplier 0910-AG64
Verification Program.
289....................... Supplemental Applications 0910-AG94
Proposing Labeling
Changes for Approved
Drugs and Biological
Products (Reg Plan Seq
No. 55).
[[Page 1159]]
290....................... Veterinary Feed Directive 0910-AG95
(Reg Plan Seq No. 56).
291....................... Format and Content of 0910-AG96
Reports Intended to
Demonstrate Substantial
Equivalence.
292....................... Radiology Devices; 0910-AH03
Designation of Special
Controls for the Computed
Tomography X-Ray System.
293....................... Mammography Quality 0910-AH04
Standards Act; Regulatory
Amendments.
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.
Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
294....................... Content and Format of 0910-AF11
Labeling for Human
Prescription Drugs and
Biologics; Requirements
for Pregnancy and
Lactation Labeling.
295....................... Infant Formula: Current 0910-AF27
Good Manufacturing
Practices; Quality
Control Procedures;
Notification
Requirements; Records and
Reports; and Quality
Factors.
296....................... Combinations of 0910-AF33
Bronchodilators With
Nasal Decongestants or
Expectorants; Cold,
Cough, Allergy,
Bronchodilator, and
Antiasthmatic Drug
Products for Over-the-
Counter Human Use.
297....................... Laser Products; Proposed 0910-AF87
Amendment to Performance
Standard.
298....................... Food Labeling: Calorie 0910-AG56
Labeling of Articles of
Food Sold in Vending
Machines (Reg Plan Seq
No. 57).
299....................... Food Labeling: Nutrition 0910-AG57
Labeling of Standard Menu
Items in Restaurants and
Similar Retail Food
Establishments (Reg Plan
Seq No. 58).
300....................... Use of Certain Symbols in 0910-AG74
Labeling.
301....................... Requirements for the 0910-AG81
Submission of Data Needed
To Calculate User Fees
for Manufacturers and
Importers of Tobacco
Products.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
302....................... Over-the-Counter (OTC) 0910-AF69
Drug Review--Topical
Antimicrobial Drug
Products.
303....................... Amendment to the Current 0910-AG20
Good Manufacturing
Practice Regulations for
Finished Pharmaceuticals--
Second Phase.
304....................... Human Subject Protection; 0910-AG48
Acceptance of Data From
Clinical Studies for
Medical Devices.
305....................... Amendments to the Current 0910-AG70
Good Manufacturing
Practice Regulations for
Finished Pharmaceuticals--
Components.
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Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
306....................... Unique Device 0910-AG31
Identification.
307....................... Food Labeling: Serving 0910-AG82
Sizes; Reference Amount
and Serving Size
Declaration for Hard
Candies and Breath Mints.
308....................... Food Labeling; Gluten-Free 0910-AG84
Labeling of Foods.
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Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
309....................... Emergency Preparedness 0938-AO91
Requirements for Medicare
and Medicaid
Participating Providers
and Suppliers (CMS-3178-
P) (Section 610 Review).
310....................... 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-F) (Section 610
Review).
311....................... 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)
(Reg Plan Seq No. 62).
312....................... CY 2015 Revisions to 0938-AS12
Payment Policies under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1612-P) (Reg
Plan Seq No. 63).
313....................... 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) (Reg Plan Seq No. 64).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.
[[Page 1160]]
Centers for Medicare & Medicaid Services--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
314....................... Covered Outpatient Drugs 0938-AQ41
(CMS-2345-F) (Section 610
Review).
315....................... 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).
316....................... Revisions to Payment 0938-AR56
Policies Under the
Physician Fee Schedule
and Medicare Part B for
CY 2014 (CMS-1600-F).
317....................... 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.
------------------------------------------------------------------------
318....................... Changes to the Hospital 0938-AR53
Inpatient and Long-Term
Care Prospective Payment
System for FY 2014 (CMS-
1599-F).
319....................... Changes to the Hospital 0938-AR54
Outpatient Prospective
Payment System and
Ambulatory Surgical
Center Payment System for
CY 2014 (CMS-1601-F).
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Prerule Stage
274. 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
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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.
ANPRM (Safety)...................... 06/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: David Eng, Regulatory Project Manager, Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-2773, Fax: 301 796-
9899, Email: [email protected].
RIN: 0910-AF43
275. Prescription Drug Marketing Act of 1987; Prescription Drug
Amendments of 1992; Policies, Requirements, and Administrative
Procedures (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 is currently reviewing regulations promulgated under
the Prescription Drug Marketing Act (PDMA). FDA is undertaking this
review to determine whether the regulations should be changed or
rescinded to minimize adverse impacts on a substantial number of small
entities. FDA has extended again the completion date by 1 year and will
complete the review by November 2013.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Begin Review of Current Regulation.. 11/24/08
End Review of Current Regulation.... 11/00/13
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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
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Proposed Rule Stage
276. Food Labeling; Revision of the Nutrition and Supplement Facts
Labels
Regulatory Plan: This entry is Seq. No. 49 in part II of this issue
of the Federal Register.
RIN: 0910-AF22
277. Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed at One-Eating Occasion; Dual-Column Labeling; Updating,
Modifying, and Establishing Certain RACCs
Regulatory Plan: This entry is Seq. No. 50 in part II of this issue
of the Federal Register.
RIN: 0910-AF23
278. 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
[[Page 1161]]
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)...... 12/00/13
------------------------------------------------------------------------
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
279. 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)........ 07/00/14
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
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 useful
information about the nutrient content and ingredient composition of
pet food products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/14
------------------------------------------------------------------------
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
281. Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Food for Animals
Regulatory Plan: This entry is Seq. No. 51 in part II of this issue
of the Federal Register.
RIN: 0910-AG10
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................................ 06/00/14
------------------------------------------------------------------------
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
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
[[Page 1162]]
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................................ 01/00/14
------------------------------------------------------------------------
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. 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 Jan. 4, 2011)
Abstract: FDA is proposing to 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
proposed rule is to reduce the risk of illness associated with fresh
produce.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/16/13 78 FR 3503
NPRM Comment Period End............. 05/16/13
NPRM Comment Period Extended........ 04/26/13 78 FR 24692
NPRM Comment Period Extended End.... 09/16/13
NPRM Comment Period Extended........ 08/09/13 78 FR 48637
NPRM Comment Period Extended End.... 11/15/13
Notice of Intent To Prepare an 08/19/13 78 FR 50358
Environmental Impact Statement for
the Proposed Rule.
Notice of Intent To Prepare 11/15/13
Environmental Impact Statement for
the Proposed Rule Comment Period
End.
NPRM Comment Period Extended........ 11/20/13 78 FR 69605
NPRM Comment Period Extended End.... 11/22/13
Environmental Impact Statement for 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.
------------------------------------------------------------------------
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
285. Hazard Analysis and Risk-Based Preventive Controls
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 proposed 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
------------------------------------------------------------------------
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
286. ``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. 52 in part II of this issue
of the Federal Register.
RIN: 0910-AG38
287. 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................................ 12/00/13
------------------------------------------------------------------------
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].
[[Page 1163]]
RIN: 0910-AG59
288. 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: FDA is proposing regulations that describe 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 .......................
------------------------------------------------------------------------
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
289. Supplemental Applications Proposing Labeling Changes for Approved
Drugs and Biological Products
Regulatory Plan: This entry is Seq. No. 55 in part II of this issue
of the Federal Register.
RIN: 0910-AG94
290. Veterinary Feed Directive
Regulatory Plan: This entry is Seq. No. 56 in part II of this issue
of the Federal Register.
RIN: 0910-AG95
291. 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................................ 03/00/14 .......................
------------------------------------------------------------------------
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
292. Radiology Devices; Designation of Special Controls for the
Computed Tomography X-Ray System
Legal Authority: 21 U.S.C. 360
Abstract: The proposed rule would establish special controls for
the computed tomography (CT) X-ray system, a class II device as defined
in 21 CFR 892.1750. 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, or, in extremely high doses, radiation
poisoning. Therefore, the design of a CT X-ray system needs to 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 special controls, combined
with the general controls, to provide reasonable assurance of the
safety and effectiveness of a class II CT X-ray system.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/14 .......................
------------------------------------------------------------------------
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
293. 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................................ 12/00/13 .......................
------------------------------------------------------------------------
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administrtion (FDA)
Final Rule Stage
294. 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 (21 CFR 201.56 and 201.57) to better communicate
risks.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/29/08 73 FR 30831
[[Page 1164]]
NPRM Comment Period End............. 08/27/08 .......................
Final Action........................ 05/00/14 .......................
------------------------------------------------------------------------
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
295. 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 in 21 CFR parts 106 and 107 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 .......................
Final Rule.......................... 11/00/13 .......................
------------------------------------------------------------------------
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
296. 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. This action
addresses 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........................ 06/00/14 .......................
------------------------------------------------------------------------
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
796-3713, Fax: 301 796-9899, Email: [email protected].
RIN: 0910-AF33
297. Laser Products; Proposed Amendment to Performance Standard
Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C.
393
Abstract: FDA is proposing to amend the 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 proposed
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........................ 06/00/14 .......................
------------------------------------------------------------------------
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
298. Food Labeling: Calorie Labeling of Articles of Food Sold in
Vending Machines
Regulatory Plan: This entry is Seq. No. 57 in part II of this issue
of the Federal Register.
RIN: 0910-AG56
299. Food Labeling: Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments
Regulatory Plan: This entry is Seq. No. 58 in part II of this issue
of the Federal Register.
RIN: 0910-AG57
300. Use of Certain Sysmbols in Labeling
Legal Authority: sec 502(c) of the Food Drug and Cosmetic Act (FD&C
Act), 21 U.S.C. 352(c); sec 514(c) of FD&C Act, 21 U.S.C. 360d(c),
enacted by the Food and Drug Modernization Act of 1997 (FDAMA)
Abstract: The purpose of this rule is to allow for the inclusion of
certain stand-alone symbols contained in a standard that FDA
recognizes, provided that such symbols are explained in a symbols
glossary that contemporaneously accompanies the medical device.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/19/13 78 FR 23508
NPRM Comment Period End............. 06/18/13 .......................
Final Action........................ 04/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mary Follette Story, Human Factors and Accessible
Medical Technology Specialist, Department of Health and Human Services,
Food and Drug Administration, Center for Devices
[[Page 1165]]
and Radiological Health, Room 2553, 10903 New Hampshire Avenue, Silver
Spring, MD 20993, Phone: 301 796-1456, Email: [email protected].
RIN: 0910-AG74
301. Requirements for the Submission of Data Needed To Calculate User
Fees for Manufacturers and Importers of Tobacco Products
Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387s; Pub. L. 111-31
Abstract: FDA is proposing to 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........................ 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Long-Term Actions
302. Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug
Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses antimicrobial agents in consumer hand wash 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).. 12/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: David Eng, Regulatory Project Manager, Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-2773, Fax: 301 796-
9899, Email: [email protected].
RIN: 0910-AF69
303. Amendment to the Current Good Manufacturing Practice Regulations
for Pharmaceuticals--Second Phase
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C.
262; 42 U.S.C. 264
Abstract: FDA will revise regulations for ``current good
manufacturing practice'' for oversight and controls over the
manufacture of drugs to ensure quality, including managing the risk of
and establishing the safety of raw materials, materials used in the
manufacturing of drugs, and finished drug products. This revision will
update and harmonize requirements and improve detection and response to
emerging product safety and quality signals.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Paula Katz, Regulatory Counsel, Office of
Compliance, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO 51, Room
4314, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-6972, Fax: 301 847-8742, Email: [email protected].
RIN: 0910-AG20
304. 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 conducted in support of a premarket approval
application, humanitarian device exemption application, an
investigational device exemption application, or a premarket
notification submission for a medical device.
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
305. Amendments to the Current Good Manufacturing Practice Regulations
for Finished Pharmaceuticals--Components
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 360bbb-7; 21 U.S.C. 371; 21
U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264
Abstract: FDA will revise regulations for ``current good
manufacturing practice'' with regard to the control over components
used in manufacturing finished pharmaceuticals.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian Hasselbalch, Consumer Safety Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 51, Room 4364, 10903 New
Hampshire Avenue,
[[Page 1166]]
Silver Spring, MD 20993, Phone: 301 796-3279, Email:
[email protected].
Paula Katz, Consumer Safety Officer, Department of Health and Human
Services, Food and Drug Administration, Center for Drug Evaluation and
Research, WO 51, Room 1320, 10903 New Hampshire Avenue, Silver Spring,
MD 20993, Phone: 301 796-6972, Email: [email protected].
RIN: 0910-AG70
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Completed Actions
306. Unique Device Identification
Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360; 21
U.S.C. 360h; 21 U.S.C. 360i; 21 U.S.C. 360j; 21 U.S.C. 360l; 21 U.S.C.
371
Abstract: FDA is issuing a final rule establishing a unique device
identification system for medical devices. A unique device
identification system would allow healthcare professionals and others
to rapidly and precisely identify a device and obtain important
information concerning the device and would reduce medical errors.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/10/12 77 FR 40735
NPRM Comment Period End............. 11/07/12 .......................
Second NPRM......................... 11/19/12 77 FR 69393
Second NPRM Comment Period End...... 12/19/13 .......................
Final Action........................ 09/24/13 78 FR 58786
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: John J. Crowley, Senior Advisor for Patient Safety,
Department of Health and Human Services, Food and Drug Administration,
Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 980-1936, Email:
[email protected].
RIN: 0910-AG31
307. Food Labeling: Serving Sizes; Reference Amount and Serving Size
Declaration for Hard Candies and Breath Mints
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: FDA is proposing to change the nutrition label serving
size for breath mints to one unit. FDA is taking this action in
response to a citizen petition that requested a serving size for breath
mints that more accurately reflects the amount customarily consumed per
eating occasion and comments received on an advance notice of proposed
rulemaking published in 2005.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/30/97 62 FR 67775
NPRM Comment Period End............. 03/16/98 .......................
ANPRM............................... 04/05/05 70 FR 17010
ANPRM Comment Period End............ 06/20/05 .......................
Withdrawn and Merged with 0910-AF23. 08/14/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mark Kantor, Nutritionist, Department of Health and
Human Services, Food and Drug Administration, HFS-830, 5100 Paint
Branch Parkway, College Park, MD 20740, Phone: 240 402-1450, Fax: 301
436-1191, Email: [email protected].
RIN: 0910-AG82
308. Food Labeling; Gluten-Free Labeling of Foods
Legal Authority: Title II of Pub. L. 108-282; 21 U.S.C. 321; 21
U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371
Abstract: FDA is amending its regulations to define the term
``gluten-free'' for voluntary use in the labeling of foods. FDA is
taking this action to assist persons who have celiac disease to more
easily identify foods that they can eat while following a ``gluten-
free'' diet.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/23/07 72 FR 2795
NPRM Comment Period End............. 04/23/07 .......................
NPRM Comment Period Reopened........ 08/03/11 76 FR 46671
NPRM Comment Period Reopened End.... 10/03/11 .......................
Final Action........................ 08/05/13 78 FR 47154
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Felicia Billingslea, Director, Food Labeling and
Standard Staff, Department of Health and Human Services, Food and Drug
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-AG84
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Proposed Rule Stage
309. Emergency Preparedness Requirements for Medicare and Medicaid
Participating Providers and Suppliers (CMS-3178-P) (Section 610 Review)
Legal Authority: 42 U.S.C. 1821; 42 U.S.C. 1861 (ff) (3)(B)(i)(ii);
42 U.S.C. 1913 (c)(1) et al
Abstract: This rule proposes 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 would ensure 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................................ 11/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Graham, Health Insurance Specialist, Clincal
Standards Group, 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
310. 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-F)
(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)
[[Page 1167]]
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 Action........................ 08/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Sarah Harding, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop C4-01-26, 7500 Security Boulevard, Windsor
Mill, MD 21244, Phone: 410 786-4001, Email: [email protected].
RIN: 0938-AR62
311. 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)
Regulatory Plan: This entry is Seq. No. 62 in part II of this issue
of the Federal Register.
RIN: 0938-AS11
312. CY 2015 Revisions to Payment Policies Under the Physician
Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-P)
Regulatory Plan: This entry is Seq. No. 63 in part II of this issue
of the Federal Register.
RIN: 0938-AS12
313. 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)
Regulatory Plan: This entry is Seq. No. 64 in part II of this issue
of the Federal Register.
RIN: 0938-AS15
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Final Rule Stage
314. 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........................ 05/00/14 .......................
------------------------------------------------------------------------
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].
RIN: 0938-AQ41
315. CY 2014 Changes to the End-Stage Renal Disease (ESRD) Prospective
Payment System, ESRD Quality Incentive Program, and Durable Medical
Equipment (CMS-1526-F)
Legal Authority: MIPPA sec 153(b); Pub. L. 111-148 sec 3401(h);
ATRA sec 632(a)
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........................ 11/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michelle Cruse, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, Mailstop C5-05-27,
Baltimore, MD 21244, Phone: 410 786-7540, Email:
[email protected].
RIN: 0938-AR55
316. Revisions to Payment Policies Under the Physician Fee Schedule and
Medicare Part B for CY 2014 (CMS-1600-F)
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........................ 11/00/13 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Kathy Bryant, Deputy 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
317. 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.................. 06/00/14 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Christine Stahlecker, Acting Director,
Administrative Simplification Group, Office of E-Health Standards and
Services, Department of
[[Page 1168]]
Health and Human Services, Centers for Medicare & Medicaid Services,
Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244,
Phone: 410 786-6405, Email: [email protected].
RIN: 0938-AS01
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Completed Actions
318. Changes to the Hospital Inpatient and Long-Term Care Prospective
Payment System for FY 2014 (CMS-1599-F)
Legal Authority: sec 1886(d) of the Social Security Act
Abstract: This annual 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................................ 05/10/13 78 FR 27485
NPRM Comment Period End............. 06/25/13 .......................
Final Action........................ 08/19/13 78 FR 50419
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Roechel Kujawa, 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: 410 786-9111, Email:
[email protected].
RIN: 0938-AR53
319. Changes to the Hospital Outpatient Prospective Payment System and
Ambulatory Surgical Center Payment System for CY 2014 (CMS-1601-F)
Legal Authority: sec 1833 of the Social Security Act
Abstract: This final rule revises the Medicare hospital outpatient
prospective payment system to implement applicable statutory
requirements and changes arising from our continuing experience with
this system. The rule also describes changes to the amounts and factors
used to determine payment rates for services. In addition, the rule
finalizes changes to the Ambulatory Surgical Center Payment System list
of services and rates.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/19/13 78 FR 43534
NPRM Comment Period End............. 09/06/13 .......................
Final Action........................ 09/06/13 78 FR 54842
------------------------------------------------------------------------
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-AR54
[FR Doc. 2013-29632 Filed 1-6-14; 8:45 am]
BILLING CODE 4150-24-P