[Federal Register Volume 82, Number 163 (Thursday, August 24, 2017)]
[Proposed Rules]
[Pages 40277-40287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16920]



[[Page 40277]]

Vol. 82

Thursday,

No. 163

August 24, 2017

Part VII





 Department of Health and Human Services





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Semiannual Regulatory Agenda

Federal Register / Vol. 82 , No. 163 / Thursday, August 24, 2017 / 
Unified Agenda

[[Page 40278]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

25 CFR Ch. V

42 CFR Chs. I-V

45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII


Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual Regulatory Agenda.

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

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
(EO) 12866 require the semiannual issuance of an inventory of 
rulemaking actions under development throughout the Department, 
offering for public review summarized information about forthcoming 
regulatory actions.

FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary, 
Department of Health and Human Services, 200 Independence Avenue SW., 
Washington, DC 20201; (202) 690-5627.

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services 
(HHS) is the Federal government's lead agency for protecting the health 
of all Americans and providing essential human services, especially for 
those who are least able to help themselves. HHS enhances the health 
and well-being of Americans by promoting effective health and human 
services and by fostering sound, sustained advances in the sciences 
underlying medicine, public health, and social services.
    This Agenda presents the regulatory activities that the Department 
expects to undertake in the foreseeable future to advance this mission. 
HHS has an agency-wide effort to support the Agenda's purpose of 
encouraging more effective public participation in the regulatory 
process. For example, to encourage public participation, we regularly 
update our regulatory Web page (http://www.HHS.gov/regulations) which 
includes links to HHS rules currently open for public comment, and also 
provides a ``regulations toolkit'' with background information on 
regulations, the commenting process, how public comments influence the 
development of a rule, and how the public can provide effective 
comments. HHS also actively encourages meaningful public participation 
in its retrospective review of regulations, through a comment form on 
the HHS retrospective review Web page (http://www.HHS.gov/RetrospectiveReview).
    The rulemaking abstracts included in this paper issue of the 
Federal Register cover, as required by the Regulatory Flexibility Act 
of 1980, those prospective HHS rulemakings likely to have a significant 
economic impact on a substantial number of small entities. The 
Department's complete Regulatory Agenda is accessible online at http://www.RegInfo.gov.

Ann C. Agnew,
Executive Secretary to the Department.

               Office of the Secretary--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
92........................  Removal of 2 CFR                   0991-AC08
                             Subsection 376.147
                             (Rulemaking Resulting
                             From a Section 610
                             Review).
93........................  Uniform Administrative             0991-AC09
                             Requirements, Costs
                             Principles and Adult
                             Requirements (45 CFR 75)
                             (Rulemaking Resulting
                             From a Section 610
                             Review).
------------------------------------------------------------------------


  Substance Abuse and Mental Health Services Administration--Completed
                                 Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
94........................  Requirements Governing the         0930-AA10
                             Use of Seclusion and
                             Restraint in Certain
                             Nonmedical Community-
                             Based Facilities for
                             Children and Youth.
95........................  Medication Assisted                0930-AA22
                             Treatment for Opioid Use
                             Disorders Reporting
                             Requirements.
------------------------------------------------------------------------


      Centers for Disease Control and Prevention--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
96........................  Establishment of Minimum           0920-AA46
                             Standards for Birth
                             Certificates.
------------------------------------------------------------------------


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
97........................  Human Subject Protection;          0910-AG48
                             Acceptance of Data From
                             Clinical Investigations
                             for Medical Devices.
98........................  Food Labeling; Gluten-Free         0910-AH00
                             Labeling of Fermented,
                             Hydrolyzed, or Distilled
                             Foods.
99........................  Safety and Effectiveness           0910-AH40
                             of Consumer Antiseptics;
                             Topical Antimicrobial
                             Drug Products for Over-
                             the-Counter Human Use
                             (Healthcare Antiseptic).
------------------------------------------------------------------------


[[Page 40279]]


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
100.......................  Postmarketing Safety               0910-AA97
                             Reporting Requirements
                             for Human Drug and
                             Biological Products.
101.......................  Over-the-Counter (OTC)             0910-AF31
                             Drug Review--Cough/Cold
                             (Antihistamine) Products.
102.......................  Laser Products; Amendment          0910-AF87
                             to Performance Standard.
103.......................  Updated Standards for              0910-AG09
                             Labeling of Pet Food.
104.......................  Supplemental Applications          0910-AG94
                             Proposing Labeling
                             Changes for Approved
                             Drugs and Biological
                             Products.
105.......................  Radiology Devices;                 0910-AH03
                             Designation of Special
                             Controls for the Computed
                             Tomography X-Ray System.
106.......................  General and Plastic                0910-AH14
                             Surgery Devices: Sunlamp
                             Products.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
107.......................  Medical Gas Containers and         0910-AC53
                             Closures; Current Good
                             Manufacturing Practice
                             Requirements.
108.......................  Amendment to the Current           0910-AG20
                             Good Manufacturing
                             Practice Regulations for
                             Finished Pharmaceuticals--
                             Second Phase.
109.......................  Requirements for the               0910-AG59
                             Testing and Reporting of
                             Tobacco Product
                             Constituents,
                             Ingredients, and
                             Additives.
110.......................  Amendments to the Current          0910-AG70
                             Good Manufacturing
                             Practice Regulations for
                             Finished Pharmaceuticals--
                             Components.
111.......................  Format and Content of              0910-AG96
                             Reports Intended To
                             Demonstrate Substantial
                             Equivalence.
112.......................  Investigational New Drug           0910-AH07
                             Application Annual
                             Reporting.
113.......................  Requirements for Tobacco           0910-AH22
                             Product Manufacturing
                             Practice.
114.......................  Use of Ozone Depleting             0910-AH36
                             Substances (Section 610
                             Review).
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
115.......................  CY 2018 Revisions to               0938-AT02
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1676-P)
                             (Section 610 Review).
116.......................  CY 2018 Hospital                   0938-AT03
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1678-
                             P) (Section 610 Review).
117.......................  CY 2019 Notice of Benefit          0938-AT12
                             and Payment Parameters
                             (CMS-9930-P) (Section 610
                             Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
118.......................  Hospital Inpatient                 0938-AS98
                             Prospective Payment
                             System for Acute Care
                             Hospitals and the Long-
                             Term Care Hospital
                             Prospective Payment
                             System and FY 2018 Rates
                             (CMS-1677-P) (Section 610
                             Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
119.......................  Hospital and Critical              0938-AS21
                             Access Hospital (CAH)
                             Changes to Promote
                             Innovation, Flexibility,
                             and Improvement in
                             Patient Care (CMS-3295-F)
                             (Rulemaking Resulting
                             From a Section 610
                             Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
120.......................  Imaging Accreditation (CMS-        0938-AS62
                             3309-P).
121.......................  Merit-Based Incentive              0938-AS69
                             Payment System (MIPS) and
                             Alternative Payment
                             Models (APMs) in Medicare
                             Fee-for-Service (CMS-5517-
                             FC) (Completion of a
                             Section 610 Review).
122.......................  CY 2017 Home Health                0938-AS80
                             Prospective Payment
                             System Rate Update; Home
                             Health Value-Based
                             Purchasing Model; and
                             Home Health Quality
                             Reporting Requirements
                             (CMS-1648-F) (Completion
                             of a Section 610 Review).
123.......................  CY 2017 Revisions to               0938-AS81
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1654-F)
                             (Completion of a Section
                             610 Review).

[[Page 40280]]

 
124.......................  CY 2017 Hospital                   0938-AS82
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1656-
                             FC) (Completion of a
                             Section 610 Review).
------------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office of the Secretary (OS)

Completed Actions

92. Removal of 2 CFR Subsection 376.147 (Rulemaking Resulting From a 
Section 610 Review)

    Legal Authority: 5 U.S.C. 301; 31 U.S.C. 6101
    Abstract: HHS is amending its adoption of the Office of the 
Management and Budget's Nonprocurement Common Rule, found at 2 CFR part 
180. This will remove 2 CFR subsection 376.147, which provides 
information about the scope of HHS OIG exclusions under title XI of the 
Social Security Act.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   06/08/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Undetermined.
    Agency Contact: Tiffani Redding, Program Analyst, Department of 
Health and Human Services, Office of the Secretary, 200 Independence 
Avenue SW., Washington, DC 20201, Phone: 202 205-4321.
    RIN: 0991-AC08

93. Uniform Administrative Requirements, Costs Principles and Adult 
Requirements (45 CFR 75) (Rulemaking Resulting From a Section 610 
Review)

    Legal Authority: 5 U.S.C. 301
    Abstract: This will address the comments of the NPRM to 45 CFR 75 
and to include additional provision that are not in conflict with OMB's 
language, and provide additional guidance regulated community.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Final Rule..........................   12/12/16  81 FR 89393
Final Rule Effective................   01/17/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Quadira Dantro, Federal Assistance Policy 
Specialist, Department of Health and Human Services, Office of the 
Secretary, 200 Independence Avenue SW., Washington, DC 20201, Phone: 
202 260-6825.
    RIN: 0991-AC09

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Completed Actions

94. Requirements Governing the Use of Seclusion and Restraint in 
Certain Nonmedical Community-Based Facilities for Children and Youth

    Legal Authority: Pub. L. 106-310; 42 U.S.C. 290jj to 290jj-2
    Abstract: The Secretary is required by statute to publish 
regulations governing States that license nonmedical, community-based 
residential facilities for children and youth. The regulation would 
require States to develop licensing rules and monitoring requirements 
concerning behavior management practice that will ensure compliance; 
requires States to develop and implement such licensing rules and 
implementation requirements within one year; and ensures that States 
require such facilities to have adequate staff, and that the States 
provide training for professional staff.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   06/08/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Paolo Del Vecchio, Associate Director for Consumer 
Affairs, Department of Health and Human Services, Substance Abuse and 
Mental Health Services Administration, Room 13-103, Parklawn Building, 
5600 Fishers Lane, Rockville, MD 20857, Phone: 301 443-2619, Email: 
<a href="/cdn-cgi/l/email-protection#4e3e2f212221602a2b22382b2d2d2627210e3d2f23263d2f6026263d60292138"><span class="__cf_email__" data-cfemail="9dedfcf2f1f2b3f9f8f1ebf8fefef5f4f2ddeefcf0f5eefcb3f5f5eeb3faf2eb">[email protected]</span></a>.
    RIN: 0930-AA10

95. Medication Assisted Treatment for Opioid Use Disorders Reporting 
Requirements

    Legal Authority: 21 U.S.C. 823(g)(2)
    Abstract: On July 8, 2016, SAMHSA finalized a rule to increase 
access to buprenorphine and the combination buprenorphine/naloxone 
(Medication Assisted Treatment for Opioid Use Disorders). Concurrently 
with this final rule, SAMHSA issued a Supplemental Notice of Proposed 
Rulemaking seeking further comment on reporting provisions that would 
apply to physicians prescribing buprenorphine for up to 275 patients.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/30/16  81 FR 17639
NPRM Comment Period End.............   05/31/16
Final Action........................   09/27/16  81 FR 66191
Final Action Effective..............   10/27/16
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#0466766d656a2a65687069656a447765696c77652a636b72"><span class="__cf_email__" data-cfemail="fd9f8f949c93d39c9189909c93bd8e9c90958e9cd39a928b">[email protected]</span></a>.
    RIN: 0930-AA22

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Disease Control and Prevention (CDC)

Completed Actions

96. Establishment of Minimum Standards for Birth Certificates

    Legal Authority: 42 U.S.C. 264
    Abstract: This proposed rule establishes minimum standards to 
improve security related to the use of birth certificates by Federal 
agencies for official purposes.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   06/08/17
------------------------------------------------------------------------


[[Page 40281]]

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Charles Rothwell, Director, Division of Vital 
Statistics, Department of Health and Human Services, Centers for 
Disease Control and Prevention, 3311 Toledo Road, Room 7311, M, 
Hyattsville, MD 20782, Phone: 301 458-4555.
    RIN: 0920-AA46

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

97. Human Subject Protection; Acceptance of Data From Clinical 
Investigations for Medical Devices

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 
U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C. 
360i; 21 U.S.C. 360j; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21 
U.S.C. 393; 42 U.S.C. 264; 42 U.S.C. 271; . . .
    Abstract: This rule updates FDA's requirements for accepting 
clinical data used to bring new medical devices to market as part of 
fulfilling FDA's mission. While helping to ensure the quality and 
integrity of clinical trial data and the protection of study 
participants, this rule should reduce burden on industry by avoiding 
the need for on-site inspections. This rule parallels the drug 
regulation, which should further reduce burden by having a harmonized 
approach. Under this new rule, a device applicant would provide FDA 
with information about the conduct of their study such as, the research 
sites where the study was conducted, the investigators who conducted 
the study, a summary of the protocol, information about how informed 
consent from the study participants was obtained, and information about 
the ethics committee that reviewed the study. (If such information is 
not available, the sponsor may explain why and request a waiver.)
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/25/13  78 FR 12664
NPRM Comment Period End.............   05/28/13
Final Action........................   12/00/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Soma Kalb, Biomedical Engineer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Heath, Building 66, Room 1534, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6359, Email: 
<a href="/cdn-cgi/l/email-protection#1665797b77387d777a7456707277387e7e6538717960"><span class="__cf_email__" data-cfemail="384b575559165359545a785e5c591650504b165f574e">[email protected]</span></a>.
    RIN: 0910-AG48

98. Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or 
Distilled Foods

    Legal Authority: Sec. 206 of the Food Allergen Labeling and 
Consumer Protection Act; 21 U.S.C. 343(a)(1); 21 U.S.C. 321(n); 21 
U.S.C. 371(a)
    Abstract: This proposed rule would establish requirements 
concerning compliance for using a ``gluten-free'' labeling claim for 
those foods for which there is no scientifically valid analytical 
method available that can reliably detect and accurately quantify the 
presence of 20 parts per million (ppm) gluten in the food.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/18/15  80 FR 71990
NPRM Comment Period Reopened........   01/22/16  81 FR 3751
NPRM Comment Period End.............   02/16/16
NPRM Comment Period Reopened........   02/22/16  81 FR 8869
NPRM Comment Period Reopened End....   04/25/16
Final Rule..........................   10/00/18
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Carol D'Lima, Staff Fellow, Department of Health 
and Human Services, Food and Drug Administration, Center for Food 
Safety and Applied Nutrition, Room 4D022, HFS 820, 5100 Paint Branch 
Parkway, College Park, MD 20740, Phone: 240 402-2371, Fax: 301 436-
2636, Email: <a href="/cdn-cgi/l/email-protection#7d1e1c0f121153191114101c3d1b191c5315150e531a120b"><span class="__cf_email__" data-cfemail="4b282a392427652f2722262a0b2d2f2a65232338652c243d">[email protected]</span></a>.
    RIN: 0910-AH00.

99. Safety and Effectiveness of Consumer Antiseptics; Topical 
Antimicrobial Drug Products for Over-the-Counter Human Use (Healthcare 
Antiseptic)

    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. 360 to 361; 21 U.S.C. 371; 21 U.S.C. 374 
to 375; 21 U.S.C. 379; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262
    Abstract: This rulemaking addresses whether FDA considers certain 
active ingredients in over the counter (OTC) consumer antiseptic hand 
wash and health care antiseptic products to be generally recognized as 
safe and effective. If FDA determines that the ingredient is not 
generally recognized as safe and effective, a manufacturer will not be 
able to market the product unless it submits and receives approval of a 
new drug application.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/17/13  78 FR 764444
NPRM Comment Period End.............   06/16/14
Final Action........................   01/00/18
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Pranvera Ikonomi, Biologist, Department of Health 
and Human Services, Food and Drug Administration, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 240 402-0272, Email: 
<a href="/cdn-cgi/l/email-protection#e39391828d95869182cd8a888c8d8c8e8aa3858782cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="dcacaebdb2aab9aebdf2b5b7b3b2b3b1b59cbab8bdf2b4b4aff2bbb3aa">[email protected]</span></a>.
    RIN: 0910-AH40

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

100. Postmarketing Safety Reporting Requirements for Human Drug and 
Biological Products

    Legal Authority: 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 242a; 42 
U.S.C. 262 and 263; 42 U.S.C. 263a to 263n; 42 U.S.C. 264; 42 U.S.C. 
300aa; 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 
355; 21 U.S.C. 360; 21 U.S.C. 360b to 360j; 21 U.S.C. 361a; 21 U.S.C. 
371; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379e; 21 U.S.C. 381
    Abstract: The final rule would amend the postmarketing expedited 
and periodic safety reporting regulations for human drugs and 
biological products to revise certain definitions and reporting formats 
as recommended by the International Council on Harmonisation and to 
define new terms; to add to or revise current reporting requirements; 
to revise certain reporting time frames; and to propose other revisions 
to these regulations to enhance the quality of safety reports received 
by FDA. These revisions were proposed as part of a single rulemaking 
(68 FR 12406) to clarify and revise both premarketing and postmarketing 
safety reporting requirements for human drug and biological products. 
Premarketing safety reporting requirements were finalized in a separate 
final rule published on September 29, 2010 (75 FR 59961). This

[[Page 40282]]

final rule applies to postmarketing safety reporting requirements.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/14/03  68 FR 12406
NPRM Comment Period Extended........   06/18/03
NPRM Comment Period End.............   07/14/03
NPRM Comment Period Extension End...   10/14/03
Final Rule..........................   10/00/18
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 6278, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3469, Fax: 301 
847-8440, Email: <a href="/cdn-cgi/l/email-protection#89e3e8e7eca7ebe8e5fcfafac9efede8a7e1e1faa7eee6ff"><span class="__cf_email__" data-cfemail="deb4bfb0bbf0bcbfb2abadad9eb8babff0b6b6adf0b9b1a8">[email protected]</span></a>.
    RIN: 0910-AA97

101. 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)......   10/00/18
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#5a303b3433393f743b3e3b3729773133343d1a3c3e3b74323229743d352c"><span class="__cf_email__" data-cfemail="066c67686f6563286762676b752b6d6f686146606267286e6e7528616970">[email protected]</span></a>.
    RIN: 0910-AF31

102. Laser Products; Amendment to Performance Standard

    Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 
393
    Abstract: FDA is proposing to amend the 2013 proposed rule for the 
performance standard for laser products, which will amend the 
performance standard for laser products to achieve closer harmonization 
between the current standard and the recently amended International 
Electrotechnical Commission (IEC) standard for laser products and 
medical laser products. The amendment is intended to update FDA's 
performance standard to reflect advancements in technology.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/24/13  78 FR 37723
NPRM Comment Period End.............   09/23/13
NPRM (Reproposal)...................   10/00/18
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Erica Blake-Payne, 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: <a href="/cdn-cgi/l/email-protection#debbacb7bdbff0aebfa7b0bb9eb8babff0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="7e1b0c171d1f500e1f07101b3e181a1f5016160d50191108">[email protected]</span></a>.
    RIN: 0910-AF87

103. Updated Standards for Labeling of Pet Food

    Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 110-85, sec 
1002(a)(3)
    Abstract: FDA is proposing updated standards for the labeling of 
pet food that include nutritional and ingredient information, as well 
as style and formatting standards. FDA is taking this action to provide 
pet owners and animal health professionals more complete and consistent 
information about the nutrient content and ingredient composition of 
pet food products.
    Timetable: Next Action Undetermined.
    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: William Burkholder, Veterinary Medical Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine, MPN-4, Room 2642, HFV-228, 7519 
Standish Place, Rockville, MD 20855, Phone: 240 402-5900, Email: 
<a href="/cdn-cgi/l/email-protection#c6b1afaaaaafa7abe8a4b3b4adaea9aaa2a3b486a0a2a7e8aeaeb5e8a1a9b0"><span class="__cf_email__" data-cfemail="6d1a040101040c00430f181f0605020109081f2d0b090c4305051e430a021b">[email protected]</span></a>.
    RIN: 0910-AG09

104. Supplemental Applications Proposing Labeling Changes for Approved 
Drugs and Biological Products

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21 
U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262; . . .
    Abstract: This rule would amend the regulations regarding new drug 
applications (NDAs), abbreviated new drug applications (ANDAs), and 
biologics license application (BLAs) to revise and clarify procedures 
for changes to the labeling of an approved drug to reflect certain 
types of newly acquired information in advance of FDA's review of such 
change.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/13/13  78 FR 67985
NPRM Comment Period Extended........   12/27/13  78 FR 78796
NPRM Comment Period End.............   01/13/14
NPRM Comment Period Extended End....   03/13/14
NPRM Comment Period Reopened........   02/18/15  80 FR 8577
NPRM Comment Period Reopened End....   04/27/15
Next Action Undetermined............
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice L. Weiner, Senior Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, Building 51, Room 6268, 10903 
New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-
3601, Fax: 301 847-8440, Email: <a href="/cdn-cgi/l/email-protection#9af0fbf4f3f9ffb4edfff3f4ffe8dafcfefbb4f2f2e9b4fdf5ec"><span class="__cf_email__" data-cfemail="1c767d72757f79326b797572796e5c7a787d3274746f327b736a">[email protected]</span></a>.
    RIN: 0910-AG94

105. 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

[[Page 40283]]

the same axial plane taken at different angles. High doses of ionizing 
radiation can cause acute (deterministic) effects such as burns, 
reddening of the skin, cataracts, hair loss, sterility, and, in 
extremely high doses, radiation poisoning. The design of a CT X-ray 
system should balance the benefits of the device (i.e., the ability of 
the device to produce a diagnostic quality image) with the known risks 
(e.g., exposure to ionizing radiation). FDA is establishing proposed 
special controls, which are necessary to provide reasonable assurance 
of the safety and effectiveness of a class II CT X-ray system.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/18
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Erica Blake-Payne, 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: <a href="/cdn-cgi/l/email-protection#0461766d67652a74657d6a61446260652a6c6c772a636b72"><span class="__cf_email__" data-cfemail="93f6e1faf0f2bde3f2eafdf6d3f5f7f2bdfbfbe0bdf4fce5">[email protected]</span></a>.
    RIN: 0910-AH03

106. General and Plastic Surgery Devices: Sunlamp Products

    Legal Authority: 21 U.S.C. 360j(e)
    Abstract: This rule would apply device restrictions to sunlamp 
products. The incidence of skin cancer, including melanoma, has been 
increasing, and a large number of skin cancer cases are attributable to 
the use of sunlamp products. The devices may cause about 400,000 cases 
of skin cancer per year, and 6,000 of which are melanoma. Beginning 
sunlamp product use at young ages, as well as frequently using sunlamp 
products, both increase the risk of developing skin cancers and other 
illnesses, and sustaining other injuries. Even infrequent use, 
particularly at younger ages, can significantly increase these risks.
    Sunlamp products incorporate ultraviolet (UV) lamps and include 
devices such as UV tanning beds and booths. People who use sunlamp 
products are at increased risk of developing skin cancer and other 
illnesses, and sustaining injuries.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/22/15  80 FR 79493
NPRM Comment Period End.............   03/21/16
Final Rule..........................   10/00/18
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ian Ostermiller, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Building 66, 
Room 5515, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 
301 796-5678, Email: <a href="/cdn-cgi/l/email-protection#6900080747061a1d0c1b040005050c1b290f0d084701011a470e061f"><span class="__cf_email__" data-cfemail="a3cac2cd8dccd0d7c6d1cecacfcfc6d1e3c5c7c28dcbcbd08dc4ccd5">[email protected]</span></a>.
    RIN: 0910-AH14

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

107. Medical Gas Containers and Closures; Current Good Manufacturing 
Practice Requirements

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351 to 21 U.S.C. 353
    Abstract: The Food and Drug Administration is amending its current 
good manufacturing practice regulations and other regulations to 
clarify and strengthen requirements for the label, color, dedication, 
and design of medical gas containers and closures. Despite existing 
regulatory requirements and industry standards for medical gases, there 
have been repeated incidents in which cryogenic containers of harmful 
industrial gases have been connected to medical oxygen supply systems 
in hospitals and nursing homes and subsequently administered to 
patients. These incidents have resulted in death and serious injury. 
There have also been several incidents involving high-pressure medical 
gas cylinders that have resulted in death and injuries to patients. 
These amendments, together with existing regulations, are intended to 
ensure that the types of incidents that have occurred in the past, as 
well as other types of foreseeable and potentially deadly medical gas 
accidents, do not occur in the future. FDA has described a number of 
proposals in the proposed rule including requiring that gas use outlet 
connections on portable cryogenic medical gas containers be securely 
attached to the valve body.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/10/06  71 FR 18039
NPRM Comment Period End.............   07/10/06
Final Action........................   11/18/16  81 FR 81685
Final Action Effective..............   01/17/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Patrick Raulerson, Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3522, Fax: 301 
847-8440, Email: <a href="/cdn-cgi/l/email-protection#76061702041f151d580417031a130405191836101217581e1e0558111900"><span class="__cf_email__" data-cfemail="f5859481879c969edb879480999087869a9bb5939194db9d9d86db929a83">[email protected]</span></a>.
    RIN: 0910-AC53

108. Amendment to the Current Good Manufacturing Practice Regulations 
for Finished Pharmaceuticals--Second Phase

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21 
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 
262; 42 U.S.C. 264
    Abstract: FDA will revise regulations for ``current good 
manufacturing practice'' for oversight and controls over the 
manufacture of drugs to ensure quality, including managing the risk of 
and establishing the safety of raw materials, materials used in the 
manufacturing of drugs, and finished drug products. This revision will 
update and harmonize requirements and improve detection and response to 
emerging product safety and quality signals.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   06/08/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Paula Katz, Regulatory Counsel, Office of 
Compliance, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO 51, Room 
4314, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 
796-6972, Fax: 301 847-8742, Email: <a href="/cdn-cgi/l/email-protection#a7d7c6d2cbc689ccc6d3dde7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="bcccddc9d0dd92d7ddc8c6fcdad8dd92d4d4cf92dbd3ca">[email protected]</span></a>.
    RIN: 0910-AG20

109. 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,

[[Page 40284]]

including smoke constituents, that the Agency determines should be 
tested to protect the public health.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   04/05/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Laura Rich, Senior Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Tobacco Products, Building 71, G335, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993, Phone: 877 287-1373, Email: 
<a href="/cdn-cgi/l/email-protection#2d4e595d5f484a58414c594442435e6d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="61021511130406140d0015080e0f12210705004f0909124f060e17">[email protected]</span></a>.
    RIN: 0910-AG59

110. Amendments to the Current Good Manufacturing Practice Regulations 
for Finished Pharmaceuticals--Components

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21 
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 360bbb-7; 21 U.S.C. 371; 21 
U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264
    Abstract: FDA will revise regulations for ``current good 
manufacturing practice'' with regard to control over components used in 
manufacturing finished pharmaceuticals.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   06/08/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian Hasselbalch, Consumer Safety Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, WO 51, Room 4364, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3279, Email: 
<a href="/cdn-cgi/l/email-protection#1b7969727a7535737a68687e77797a7778735b7d7f7a35737368357c746d"><span class="__cf_email__" data-cfemail="4f2d3d262e2161272e3c3c2a232d2e232c270f292b2e6127273c61282039">[email protected]</span></a>.
    Paula Katz, Consumer Safety Officer, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO 51, Room 1320, 10903 New Hampshire Avenue, Silver Spring, 
MD 20993, Phone: 301 796-6972, Email: <a href="/cdn-cgi/l/email-protection#6f1f0e1a030e41040e1b152f090b0e4107071c41080019"><span class="__cf_email__" data-cfemail="9feffeeaf3feb1f4feebe5dff9fbfeb1f7f7ecb1f8f0e9">[email protected]</span></a>.
    RIN: 0910-AG70

111. Format and Content of Reports Intended To Demonstrate Substantial 
Equivalence

    Legal Authority: 21 U.S.C. 387e(j); 21 U.S.C. 387j(a); 21 U.S.C. 
371; 21 U.S.C. 374; 21 U.S.C. 387b; 21 U.S.C 387c; 21 U.S.C. 387i
    Abstract: This regulation would establish the format and content of 
reports intended to demonstrate substantial equivalence. This 
regulation also would provide information as to how the Agency will 
review and act on these submissions.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   04/05/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Annette L. Marthaler, Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Tobacco Products, Document Control Center, Building 71, Room 
G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 
287-1373, Fax: 877 287-1426, Email: <a href="/cdn-cgi/l/email-protection#bad9cecac8dfddcfd6dbced3d5d4c9fadcdedb94d2d2c994ddd5cc"><span class="__cf_email__" data-cfemail="3e5d4a4e4c5b594b525f4a5751504d7e585a5f1056564d10595148">[email protected]</span></a>.
    RIN: 0910-AG96

112. Investigational New Drug Application Annual Reporting

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 
U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355(i); 21 U.S.C. 371(a); 42 
U.S.C. 262(a)
    Abstract: This proposed rule would revise the requirements 
concerning annual reports submitted to investigational new drug 
applications (INDs) by replacing the current annual reporting 
requirement with a requirement that is generally consistent with the 
format, content, and timing of submission of the development safety 
update report devised by the International Conference on Harmonization 
of Technical Requirements for Registration of Pharmaceuticals for Human 
Use (ICH).
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   04/05/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ebla Ali Ibrahim, Project Manager, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Building 51, Room 6302, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3691, Email: 
<a href="/cdn-cgi/l/email-protection#284d4a44490649444105414a5a49404145684e4c490640405b064f475e"><span class="__cf_email__" data-cfemail="9afff8f6fbb4fbf6f3b7f3f8e8fbf2f3f7dafcfefbb4f2f2e9b4fdf5ec">[email protected]</span></a>.
    RIN: 0910-AH07

113. Requirements for Tobacco Product Manufacturing Practice

    Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387b; 21 U.S.C. 387f
    Abstract: FDA is proposing requirements that govern the methods 
used in, and the facilities and controls used for, the pre-production 
design validation, manufacture, packing, and storage of tobacco 
products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   03/19/13  78 FR 16824
ANPRM Comment Period End............   05/20/13
ANPRM Withdrawn.....................   08/01/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Darin Achilles, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Document Control Center, Building 71, Room G335, 
Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 301 595-1426, Email: 
<a href="/cdn-cgi/l/email-protection#1c7f686c6e797b69707d687573726f5c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="56352226243331233a37223f39382516303237783e3e2578313920">[email protected]</span></a>.
    RIN: 0910-AH22

114. Use of Ozone Depleting Substances (Section 610 Review)

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 335; 21 
U.S.C. 342; 21 U.S.C. 346a; 21 U.S.C. 348; 21 U.S.C. 351; 21 U.S.C. 
352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 361; 21 U.S.C. 371; 21 
U.S.C. 372; 21 U.S.C. 374; 15 U.S.C. 402; 15 U.S.C. 409
    Abstract: The Food and Drug Administration (FDA or the Agency) is 
proposing to amend its regulation (21 CFR 2.125) on uses of ozone-
depleting substances (ODSs), including chlorofluorocarbons (CFCs), to 
remove designations for certain products as essential uses under the 
Clean Air Act. Essential-use products are exempt from FDA's ban on the 
use of CFC propellants in FDA-regulated products and the Environmental 
Protection Agency's (EPA's) ban on the use of CFCs and other ODSs in 
pressurized dispensers. This action, if finalized, will remove 
essential use exemptions for sterile aerosol talc administered 
intrapleurally by thoracoscopy for human use, metered-dose atropine 
sulfate aerosol human drugs administered by oral inhalation, and 
anesthetic drugs for topical use on accessible mucous membranes of 
humans where a cannula is used for application. FDA is proposing this 
action because alternative products that do not use ODSs are now 
available and because

[[Page 40285]]

these products are no longer being marketed in approved versions that 
contain ODSs. On June 29, 2015, FDA published a notice and request for 
comment concerning its tentative conclusion that these products are no 
longer an essential use under the Clean Air Act (80 FR 36937). The 
Agency received no comments concerning removal of essential use 
designations for sterile aerosol talc and metered-dose atropine 
sulfate, and is proposing to remove these designations by direct final 
rule and a companion proposed rule in the event adverse comments are 
received. FDA received one comment concerning removal of anesthetic 
drugs for topical use in response to its 2015 notice and request for 
comment, and is proposing to remove this exemption through a separate 
notice. Because these products are not currently sold in the approved 
form, no significant economic impact is anticipated.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   06/30/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Daniel Orr, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Building 51, 
Room 5199, 10993 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 
240 402-0979, Email: <a href="/cdn-cgi/l/email-protection#2246434c4b474e0c4d5050624446430c4a4a510c454d54"><span class="__cf_email__" data-cfemail="7511141b1c10195b1a0707351311145b1d1d065b121a03">[email protected]</span></a>.
    RIN: 0910-AH36

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

115. CY 2018 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1676-P) (Section 
610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    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, 2018.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ryan Howe, Director, Division of Practitioner 
Services, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Center for Medicare, MS: C4-01-15, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-3355, Email: 
<a href="/cdn-cgi/l/email-protection#1f6d667e71317770687a5f7c726c3177776c31787069"><span class="__cf_email__" data-cfemail="d0a2a9b1befeb8bfa7b590b3bda3feb8b8a3feb7bfa6">[email protected]</span></a>.
    RIN: 0938-AT02

116. CY 2018 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1678-P) (Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual proposed rule would revise the Medicare 
hospital outpatient prospective payment system to implement statutory 
requirements and changes arising from our continuing experience with 
this system. The 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................................   06/00/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Lela Strong, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-05-13, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-3213, Email: 
<a href="/cdn-cgi/l/email-protection#84e8e1e8e5aaf7f0f6ebeae3c4e7e9f7aaececf7aae3ebf2"><span class="__cf_email__" data-cfemail="83efe6efe2adf0f7f1ecede4c3e0eef0adebebf0ade4ecf5">[email protected]</span></a>.
    RIN: 0938-AT03

117. <bullet> CY 2019 Notice of Benefit and Payment Parameters (CMS-
9930-P) (Section 610 Review)

    Legal Authority: Pub. L. 111-148.
    Abstract: This proposed rule would set forth payment parameters and 
provisions related to the risk adjustment programs; cost sharing 
parameters and cost-sharing reductions; and user fees for Federally-
Facilitated Exchanges. It would also provide additional standards for 
several other Affordable Care Act programs.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Lindsey Murtagh, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Consumer Information and Insurance 
Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 
492-4106, Email: <a href="/cdn-cgi/l/email-protection#ff9396919b8c9a86d1928a8d8b9e9897bf9c928cd197978cd1989089"><span class="__cf_email__" data-cfemail="036f6a6d6770667a2d6e76717762646b43606e702d6b6b702d646c75">[email protected]</span></a>.
    RIN: 0938-AT12

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

118. Hospital Inpatient Prospective Payment System for Acute Care 
Hospitals and the Long-Term Care Hospital Prospective Payment System 
and FY 2018 Rates (CMS-1677-P) (Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; Pub. L. 114-255
    Abstract: This annual final rule would revise the Medicare hospital 
inpatient and long-term care hospital prospective payment systems for 
operating and capital-related costs. This rule implements changes 
arising from our continuing experience with these systems.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/28/17  82 FR 19796
NPRM Comment Period End.............   06/13/17
Final Action........................   08/00/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Donald Thompson, Deputy Director, Division of Acute 
Care, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-08-06, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: 
<a href="/cdn-cgi/l/email-protection#07636869666b6329736f686a7774686947646a74296f6f7429606871"><span class="__cf_email__" data-cfemail="14707b7a7578703a607c7b7964677b7a547779673a7c7c673a737b62">[email protected]</span></a>.
    RIN: 0938-AS98


[[Page 40286]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

119. Hospital and Critical Access Hospital (CAH) Changes To Promote 
Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-F) 
(Rulemaking Resulting from a Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr
    Abstract: This final rule updates the requirements that hospitals 
and critical access hospitals (CAHs) must meet to participate in the 
Medicare and Medicaid programs. These final requirements are intended 
to conform the requirements to current standards of practice and 
support improvements in quality of care, reduce barriers to care, and 
reduce some issues that may exacerbate workforce shortage concerns.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/16/16  81 FR 39447
NPRM Comment Period End.............   08/15/16
Final Action........................   06/00/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: CDR Scott Cooper, Senior Technical Advisor, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Clinical Standards and Quality, Mail Stop 
S3-01-02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
9465, Email: <a href="/cdn-cgi/l/email-protection#9ceffff3e8e8b2fff3f3ecf9eedcfff1efb2f4f4efb2fbf3ea"><span class="__cf_email__" data-cfemail="fd8e9e928989d39e92928d988fbd9e908ed395958ed39a928b">[email protected]</span></a>.
    RIN: 0938-AS21

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

120. Imaging Accreditation (CMS-3309-P)

    Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1102
    Abstract: This proposed rule would establish standards for imaging 
accreditation for advanced diagnostic imaging services. These proposed 
standards would address qualifications for clinical personnel, 
standards to ensure that suppliers have established policies and 
procedures governing the use of equipment in furnishing the technical 
component of advanced diagnostic imaging, and the establishment and 
maintenance of a quality assurance and quality control program to 
ensure reliability, clarity and accuracy of the diagnostic images. This 
proposed rule would also address oversight of CMS approved accrediting 
organizations with imaging accreditation programs.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   03/23/17  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sonia Swancy, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Clinical Standards and Quality, MS: S3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
8445, Email: <a href="/cdn-cgi/l/email-protection#f0839f9e9991de8387919e9389b0939d83de989883de979f86"><span class="__cf_email__" data-cfemail="b7c4d8d9ded699c4c0d6d9d4cef7d4dac499dfdfc499d0d8c1">[email protected]</span></a>.
    RIN: 0938-AS62

121. Merit-Based Incentive Payment System (MIPS) and Alternative 
Payment Models (APMS) in Medicare Fee-For-Service (CMS-5517-FC) 
(Completion of a Section 610 Review)

    Legal Authority: Pub. L. 114-10, sec. 101
    Abstract: This rule implements provisions of the Medicare Access 
and CHIP Reauthorization Act (MACRA) related to MIPS and APMs. Section 
101 of MACRA authorizes a new MIPS, which repeals the Medicare 
sustainable growth rate and improves Medicare payments for physician 
services. MACRA consolidates the current programs of the Physician 
Quality Reporting System, the Value-Based Modifier, and the Electronic 
Health Records Incentive Program into one program, MIPS, that 
streamlines and improves on the three distinct incentive programs. 
Additionally, MACRA authorizes incentive payments for providers who 
participate in eligible APMs.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/09/16  81 FR 28161
NPRM Comment Period End.............   06/27/16
Final Action........................   11/04/16  81 FR 77088
Final Action Effective..............   01/01/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Molly MacHarris, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Clinical Standards & Quality, MS: S3-02-
01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4461, 
Email: <a href="/cdn-cgi/l/email-protection#0e636162627720636f6d666f7c7c677d4e6d637d2066667d20696178"><span class="__cf_email__" data-cfemail="066b696a6a7f286b67656e6774746f7546656b75286e6e7528616970">[email protected]</span></a>.
    James Sharp, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Center for 
Medicare & Medicaid Innovation Center, MS: WB-06-05, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-7388, Email: 
<a href="/cdn-cgi/l/email-protection#5e343f333b2d702d363f2c2e1e3d332d7036362d70393128"><span class="__cf_email__" data-cfemail="e88289858d9bc69b80899a98a88b859bc680809bc68f879e">[email protected]</span></a>.
    RIN: 0938-AS69

122. CY 2017 Home Health Prospective Payment System Rate Update; Home 
Health Value-Based Purchasing Model; and Home Health Quality Reporting 
Requirements (CMS-1648-F) (Completion of a Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual rule updates the 60-day national episode 
rate, the national per-visit rates used to calculate low utilization 
payment adjustments (LUPAs), and outlier payments under the Medicare 
prospective payment system for home health agencies. The rule also 
updates the provisions of the Home Health Value-Based Purchasing 
(HHVBP) program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/05/16  81 FR 43714
NPRM Comment Period End.............   08/26/16
Final Action........................   11/03/16  81 FR 76702
Final Action Effective..............   01/01/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Hillary Loeffler, Director, Division of Home Health 
and Hospice, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Medicare, MS: C5-07-22, 7500 
Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0456, Email: 
<a href="/cdn-cgi/l/email-protection#e68e8f8a8a87949fc88a898380808a8394a6858b95c88e8e95c8818990"><span class="__cf_email__" data-cfemail="462e2f2a2a27343f682a292320202a233406252b35682e2e3568212930">[email protected]</span></a>.
    RIN: 0938-AS80

123. CY 2017 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1654-F) 
(Completion of a Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; Pub. L. 114-10
    Abstract: This annual rule revises payment policies under the 
Medicare physician fee schedule, and make other policy changes to 
payment under

[[Page 40287]]

Medicare Part B. These changes apply to services furnished beginning 
January 1, 2017.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/15/16  81 FR 46162
NPRM Comment Period End.............   09/06/16
Final Action........................   11/15/16  81 FR 80170
Final Action Effective..............   01/01/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ryan Howe, Director, Division of Practitioner 
Services, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Center for Medicare, MS: C4-01-15, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-3355, Email: 
<a href="/cdn-cgi/l/email-protection#cebcb7afa0e0a6a1b9ab8eada3bde0a6a6bde0a9a1b8"><span class="__cf_email__" data-cfemail="4c3e352d226224233b290c2f213f6224243f622b233a">[email protected]</span></a>.
    RIN: 0938-AS81

124. CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1656-FC) (Completion of a Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual rule revises the Medicare hospital outpatient 
prospective payment system to implement statutory requirements and 
changes arising from our continuing experience with this system. The 
rule describes changes to the amounts and factors used to determine 
payment rates for services. In addition, the rule changes the 
ambulatory surgical center payment system list of services and rates.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/14/16  81 FR 45604
NPRM Comment Period End.............   09/06/16
Final Action........................   11/14/16  81 FR 79562
Final Action Effective..............   01/01/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Lela Strong, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-05-13, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-3213, Email: 
<a href="/cdn-cgi/l/email-protection#503c353c317e2324223f3e3710333d237e3838237e373f26"><span class="__cf_email__" data-cfemail="59353c3538772a2d2b36373e193a342a7731312a773e362f">[email protected]</span></a>.
    RIN: 0938-AS82

[FR Doc. 2017-16920 Filed 8-23-17; 8:45 am]
 BILLING CODE 4150-03-P


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