[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.

-----------------------------------------------------------------------

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.
------------------------------------------------------------------------


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
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
------------------------------------------------------------------------


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
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).
------------------------------------------------------------------------


[[Page 34054]]


       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
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).
------------------------------------------------------------------------


       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).
------------------------------------------------------------------------


       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).
------------------------------------------------------------------------


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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/14
------------------------------------------------------------------------

    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   07/11/03  68 FR 41507
ANPRM Comment Period End............   10/09/03
Second ANPRM........................   04/04/05  70 FR 17008
Second ANPRM Comment Period End.....   06/20/05
Third ANPRM.........................   11/02/07  72 FR 62149
Third ANPRM Comment Period End......   01/31/08
NPRM................................   03/03/14  79 FR 11879
NPRM Comment Period End.............   06/02/14
------------------------------------------------------------------------

    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   04/04/05  70 FR 17010
ANPRM Comment Period End............   06/20/05
NPRM................................   03/03/14  79 FR 11989
NPRM Comment Period End.............   06/02/14
------------------------------------------------------------------------

    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
------------------------------------------------------------------------

    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:

------------------------------------------------------------------------
               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
------------------------------------------------------------------------

    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
------------------------------------------------------------------------

    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