[Federal Register Volume 83, Number 9 (Friday, January 12, 2018)]
[Proposed Rules]
[Pages 1860-1870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28220]



[[Page 1859]]

Vol. 83

Friday,

No. 9

January 12, 2018

Part VII





 Department of Health and Human Services





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 Semiannual Regulatory Agenda

Federal Register / Vol. 83 , No. 9 / Friday, January 12, 2018 / 
Unified Agenda

[[Page 1860]]


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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 
(E.O.) 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 for Civil Rights--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
227.......................  HIPAA Privacy Rule:                0945-AA08
                             Changing Requirement to
                             Obtain Acknowledgment of
                             Receipt of the Notice of
                             Privacy Practices.
------------------------------------------------------------------------


 Office of the National Coordinator for Health Information Technology--
                           Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
228.......................  Health Information                 0955-AA01
                             Technology:
                             Interoperability and
                             Certification
                             Enhancements (Reg Plan
                             Seq No. 26).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
229.......................  Sunscreen Drug Products            0910-AF43
                             For Over-The-Counter-
                             Human Use; Tentative
                             Final Monograph.
230.......................  Laser Products; Amendment          0910-AF87
                             to Performance Standard.
231.......................  Mammography Quality                0910-AH04
                             Standards Act; Regulatory
                             Amendments (Reg Plan Seq
                             No. 29).
232.......................  Medication Guides; Patient         0910-AH68
                             Medication Information
                             (Reg Plan Seq No. 32).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
233.......................  Postmarketing Safety               0910-AA97
                             Reporting Requirements
                             for Human Drug and
                             Biological Products.
234.......................  Label Requirement for Food         0910-AF61
                             That Has Been Refused
                             Admission Into the United
                             States.
235.......................  Human Subject Protection;          0910-AG48
                             Acceptance of Data From
                             Clinical Investigations
                             for Medical Devices.
236.......................  Food Labeling; Gluten-Free         0910-AH00
                             Labeling of Fermented,
                             Hydrolyzed, or Distilled
                             Foods.
237.......................  Safety and Effectiveness           0910-AH40
                             of Healthcare
                             Antiseptics; Topical
                             Antimicrobial Drug
                             Products for Over-the-
                             Counter Human Use.
------------------------------------------------------------------------


[[Page 1861]]


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
238.......................  Over-the-Counter (OTC)             0910-AF31
                             Drug Review--Cough/Cold
                             (Antihistamine) Products.
239.......................  Over-the-Counter (OTC)             0910-AF35
                             Drug Review--External
                             Analgesic Products.
240.......................  Over-the-Counter (OTC)             0910-AF36
                             Drug Review--Internal
                             Analgesic Products.
241.......................  Over-the-Counter (OTC)             0910-AF38
                             Drug Review--Laxative
                             Drug Products.
242.......................  Over-the-Counter (OTC)             0910-AF45
                             Drug Review--Weight
                             Control Products.
243.......................  Over-the-Counter (OTC)             0910-AG12
                             Drug Review--Pediatric
                             Dosing for Cough/Cold
                             Products.
244.......................  Electronic Distribution of         0910-AG18
                             Prescribing Information
                             for Human Prescription
                             Drugs Including
                             Biological Products.
245.......................  Investigational New Drug           0910-AH07
                             Applications Requirements
                             for Conventional Foods,
                             Dietary Supplements, and
                             Cosmetics.
246.......................  General and Plastic                0910-AH14
                             Surgery Devices: Sunlamp
                             Products.
247.......................  Combinations of                    0910-AH16
                             Bronchodilators With
                             Expectorants; Cold,
                             Cough, Allergy,
                             Bronchodilator, and
                             Antiasthmatic Drug
                             Products for Over-the-
                             Counter Human Use.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
248.......................  Current Good Manufacturing         0910-AB88
                             Practice in
                             Manufacturing, Packing,
                             Labeling, or Holding
                             Operations for Dietary
                             Supplements.
249.......................  Updated Standards for              0910-AG09
                             Labeling of Pet Food.
250.......................  Supplemental Applications          0910-AG94
                             Proposing Labeling
                             Changes for Approved
                             Drugs and Biological
                             Products.
251.......................  Radiology Devices;                 0910-AH03
                             Designation of Special
                             Controls for the Computed
                             Tomography X-Ray System.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
252.......................  CY 2019 Notice of Benefit          0938-AT12
                             and Payment Parameters
                             (CMS-9930-P) (Section 610
                             Review).
253.......................  Regulatory Provisions to           0938-AT23
                             Promote Program
                             Efficiency, Transparency,
                             and Burden Reduction (CMS-
                             3346-P) (Reg Plan Seq No.
                             37).
254.......................  FY 2019 Prospective                0938-AT24
                             Payment System and
                             Consolidated Billing for
                             Skilled Nursing
                             Facilities (SNFs) (CMS-
                             1696-P).
255.......................  Hospital Inpatient                 0938-AT27
                             Prospective Payment
                             System for Acute Care
                             Hospitals and the Long-
                             Term Care Hospital
                             Prospective Payment
                             System and FY 2019 Rates
                             (CMS-1694-P) (Section 610
                             Review) (Reg Plan Seq No.
                             38).
256.......................  CY 2019 Hospital                   0938-AT30
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1695-
                             P) (Section 610 Review).
257.......................  CY 2019 Revisions to               0938-AT31
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1693-P)
                             (Section 610 Review).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
258.......................  Durable Medical Equipment          0938-AT21
                             Fee Schedule, Adjustments
                             to Resume the
                             Transitional 50/50
                             Blended Rates to Provide
                             Relief in Non-Competitive
                             Bidding Areas (CMS-1687-
                             IFC) (Section 610 Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
259.......................  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).
------------------------------------------------------------------------


[[Page 1862]]


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
260.......................  Hospital Inpatient                 0938-AS98
                             Prospective Payment
                             Systems for Acute Care
                             Hospitals and the Long-
                             Term Care Hospital
                             Prospective Payment
                             System and Policy Changes
                             and Fiscal Year 2018
                             Rates (CMS-1677-F)
                             (Completion of a Section
                             610 Review).
261.......................  CY 2018 Revisions to               0938-AT02
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Part B;
                             Medicare Shared Savings
                             Program Requirements;
                             Medicare Diabetes
                             Prevention Program (CMS-
                             1676-F) (Completion of a
                             Section 610 Review).
262.......................  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-
                             FC) (Completion of a
                             Section 610 Review).
------------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office for Civil Rights (OCR)

Proposed Rule Stage

227. <bullet> HIPAA Privacy Rule: Changing Requirement To Obtain 
Acknowledgment of Receipt of the Notice of Privacy Practices

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: Health Insurance Portability and Accountability 
(HIPAA) Act of 1996, Pub. L. 104-191
    Abstract: The propsed rule would change the requirement that health 
care providers make a good faith effort to obtain from individuals a 
written acknowledgment of receipt of the provider's notice of privacy 
practices, and if not obtained, to document its good faith efforts and 
the reason the acknowledgment was not obtained.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Andra Wicks, Health Information Privacy Specialist, 
Department of Health and Human Services, Office for Civil Rights, 200 
Independence Avenue SW, Washington, DC 20201, Phone: 202 774-3081, TDD 
Phone: 800 537-7697, Email: <a href="/cdn-cgi/l/email-protection#66070802140748110f050d15260e0e1548010910"><span class="__cf_email__" data-cfemail="89e8e7edfbe8a7fee0eae2fac9e1e1faa7eee6ff">[email protected]</span></a>.
    RIN: 0945-AA08

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office of the National Coordinator for Health Information Technology 
(ONC)

Proposed Rule Stage

228. <bullet> Health Information Technology: Interoperability and 
Certification Enhancements

    Regulatory Plan: This entry is Seq. No. 26 in part II of this issue 
of the Federal Register.
    RIN: 0955-AA01

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

229. Sunscreen Drug Products for Over-the-Counter-Human Use; Tentative 
Final Monograph

    E.O. 13771 Designation: Deregulatory.
    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 proposed rule will address the general recognition of 
safety and effectiveness (GRASE) status of the 16 sunscreen monograph 
ingredients and describe data gaps that FDA believes need to be filled 
in order for FDA to permit the continued marketing of these ingredients 
without submitting new drug applications for premarket review. 
Consistent with the Sunscreen Innovation Act, we also expect to address 
sunscreen dosage forms and maximum SPF values.
    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.
NPRM................................   08/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sharon Coleman, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 22, Room 6212, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 301 796-2490, Fax: 301 796-
9899, Email: <a href="/cdn-cgi/l/email-protection#6a19020b180504440905060f070b042a0c0e0b44020219440d051c"><span class="__cf_email__" data-cfemail="92e1faf3e0fdfcbcf1fdfef7fff3fcd2f4f6f3bcfafae1bcf5fde4">[email protected]</span></a>.
    RIN: 0910-AF43

230. Laser Products; Amendment to Performance Standard

    E.O. 13771 Designation: Regulatory.
    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

[[Page 1863]]

 
NPRM Comment Period End.............   09/23/13  .......................
NPRM (Reproposal)...................   10/00/18  .......................
                                     -----------------------------------
Final Action........................           To Be Determined
------------------------------------------------------------------------

    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 5522, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 301 796-3999, Fax: 301 847-
8145, Email: <a href="/cdn-cgi/l/email-protection#b2d7c0dbd1d39cc2d3cbdcd7f2d4d6d39cdadac19cd5ddc4"><span class="__cf_email__" data-cfemail="1c796e757f7d326c7d6572795c7a787d3274746f327b736a">[email protected]</span></a>.
    RIN: 0910-AF87

231. Mammography Quality Standards Act; Regulatory Amendments

    Regulatory Plan: This entry is Seq. No. 29 in part II of this issue 
of the Federal Register.
    RIN: 0910-AH04

232. <bullet> Medication Guides; Patient Medication Information

    Regulatory Plan: This entry is Seq. No. 32 in part II of this issue 
of the Federal Register.
    RIN: 0910-AH68

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

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

    E.O. 13771 Designation: Regulatory.
    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 safety 
reporting regulations for human drugs and biological products including 
blood and blood products in order to better align FDA requirements with 
guidelines of the International Council on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH); 
and to update reporting requirements in light of current 
pharmacovigilance practice and safety information sources and 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 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#83e9e2ede6ade1e2eff6f0f0c3e5e7e2adebebf0ade4ecf5"><span class="__cf_email__" data-cfemail="a9c3c8c7cc87cbc8c5dcdadae9cfcdc887c1c1da87cec6df">[email protected]</span></a>.
    RIN: 0910-AA97

234. Label Requirement for Food That Has Been Refused Admission Into 
the United States

    E.O. 13771 Designation: Fully or Partially Exempt.
    Legal Authority: 15 U.S.C. 1453 to 1455; 21 U.S.C. 321; 21 U.S.C. 
342 and 343; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 42 U.S.C. 
216; 42 U.S.C. 264
    Abstract: The final rule will require owners or consignees to label 
imported food that is refused entry into the United States. The label 
will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the 
label's characteristics (such as its size) and processes for verifying 
that the label has been affixed properly. We are taking this action to 
prevent the introduction of unsafe food into the United States, to 
facilitate the examination of imported food, and to implement section 
308 of the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/18/08  73 FR 54106
NPRM Comment Period End.............   12/02/08  .......................
Final Action........................   07/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Anthony C. Taube, Branch Chief, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Regulatory Affairs, Office of Regional Operations, 12420 Parklawn 
Drive, ELEM-4051, Rockville, MD 20857, Phone: 240 420-4565, Fax: 703 
261-8625, Email: <a href="/cdn-cgi/l/email-protection#472629332f28293e69332632252207212326692f2f3469202831"><span class="__cf_email__" data-cfemail="55343b213d3a3b2c7b2134203730153331347b3d3d267b323a23">[email protected]</span></a>.
    RIN: 0910-AF61

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

    E.O. 13771 Designation: Deregulatory.
    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 generally 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.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/25/13  78 FR 12664
NPRM Comment Period End.............   05/28/13  .......................
Final Action........................   03/00/18  .......................
------------------------------------------------------------------------

    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#c0b3afada1eeaba1aca280a6a4a1eea8a8b3eea7afb6"><span class="__cf_email__" data-cfemail="72011d1f135c19131e10321416135c1a1a015c151d04">[email protected]</span></a>.
    RIN: 0910-AG48

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

    E.O. 13771 Designation: Regulatory.

[[Page 1864]]

    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: FDA was required by statute to establish criteria for the 
voluntary labeling of food as ``gluten-free'' to assist consumers with 
celiac disease who must avoid gluten in their diet. In 2013, FDA issued 
a final rule on gluten-free'' labeling that established criteria for 
when food may be labeled ``gluten-free.'' The final rule included 
methods that FDA would use for testing for the presence of gluten, 
which are appropriate for many food types, but not for fermented and 
hydrolyzed foods. FDA then issued a proposed rule entitled ``Gluten-
Free Labeling of Fermented or Hydrolyzed Foods'' to propose 
requirements for maintenance of certain records that provide 
alternative means for the agency to verify that manufacturers of 
fermented and hydrolyzed foods have complied with the federal criteria 
for foods voluntarily labeled ``gluten-free.''
    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#4a292b382526642e2623272b0a2c2e2b64222239642d253c"><span class="__cf_email__" data-cfemail="e6858794898ac8828a8f8b87a6808287c88e8e95c8818990">[email protected]</span></a>.
    RIN: 0910-AH00

237. Safety and Effectiveness of Healthcare Antiseptics; Topical 
Antimicrobial Drug Products for Over-the-Counter Human Use

    E.O. 13771 Designation: Regulatory.
    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. 360b-360f; 21 U.S.C. 371; 21 U.S.C. 374 
to 375; 21 U.S.C. 379e; 21 U.S.C. 360j; 42 U.S.C. 241; 42 U.S.C. 262; 
21 U.S.Cl. 360hh-360ss; . . .
    Abstract: This rulemaking addresses whether FDA considers certain 
active ingredients in over the counter (OTC) healthcare antiseptic hand 
wash and healthcare 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................................   05/01/15  80 FR 25166
NPRM Comment Period End.............   10/28/15  .......................
Final Action........................   01/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Michelle Jackson, Department of Health and Human 
Services, Food and Drug Administration, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993, Phone: 301 796-0923, Email: 
<a href="/cdn-cgi/l/email-protection#f69b9f959e939a9a93d89c97959d9998b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="bad7d3d9d2dfd6d6df94d0dbd9d1d5d4fadcdedb94d2d2c994ddd5cc">[email protected]</span></a>.
    RIN: 0910-AH40

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

238. Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) 
Products

    E.O. 13771 Designation: Deregulatory.
    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)......   11/00/18  .......................
------------------------------------------------------------------------

    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#4b212a2522282e652a2f2a2638662022252c0b2d2f2a65232338652c243d"><span class="__cf_email__" data-cfemail="4a202b2423292f642b2e2b2739672123242d0a2c2e2b64222239642d253c">[email protected]</span></a>.
    RIN: 0910-AF31

239. Over-the-Counter (OTC) Drug Review--External Analgesic Products

    E.O. 13771 Designation: Regulatory.
    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 final 
action addresses the 2003 proposed rule on patches, plasters, and 
poultices.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Adams-King, Regulatory 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, Email: 
<a href="/cdn-cgi/l/email-protection#cca6ada2a5afa9e2ada8ada1bfe1a7a5a2ab8caaa8ade2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="462c27282f2523682722272b356b2d2f282106202227682e2e3568212930">[email protected]</span></a>.
    RIN: 0910-AF35

240. Over-the-Counter (OTC) Drug Review--Internal Analgesic Products

    E.O. 13771 Designation: Regulatory.
    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

[[Page 1865]]

drugs meeting the conditions of the monograph, or having an approved 
new drug application, may be legally marketed. The action addresses 
acetaminophen safety.
    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) (Acetaminophen)....           To Be Determined
------------------------------------------------------------------------

    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#751f141b1c16105b1411141806581e1c1b12351311145b1d1d065b121a03"><span class="__cf_email__" data-cfemail="96fcf7f8fff5f3b8f7f2f7fbe5bbfdfff8f1d6f0f2f7b8fefee5b8f1f9e0">[email protected]</span></a>.
    RIN: 0910-AF36

241. Over-the-Counter (OTC) Drug Review--Laxative Drug Products

    E.O. 13771 Designation: Regulatory.
    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. 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 
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 Rule..........................           To Be Determined
------------------------------------------------------------------------

    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#660c07080f0503480702070b154b0d0f080126000207480e0e1548010910"><span class="__cf_email__" data-cfemail="fb919a9592989ed59a9f9a9688d69092959cbb9d9f9ad5939388d59c948d">[email protected]</span></a>.
    RIN: 0910-AF38

242. Over-the-Counter (OTC) Drug Review--Weight Control Products

    E.O. 13771 Designation: Regulatory.
    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 final 
rule finalizes the 2005 proposed rule for weight control products 
containing phenylpropanolamine. The second final rule will finalize the 
proposed rule for weight control products containing benzocaine.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Phenylpropanolamine)..........   12/22/05  70 FR 75988
NPRM Comment Period End.............   03/22/06  .......................
NPRM (Benzocaine)...................   03/09/11  76 FR 12916
NPRM Comment Period End.............   06/07/11
                                     -----------------------------------
Final Action (Phenylpropanolamine)..           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Adams-King, Regulatory 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, Email: 
<a href="/cdn-cgi/l/email-protection#1e747f70777d7b307f7a7f736d33757770795e787a7f3076766d30797168"><span class="__cf_email__" data-cfemail="f49e959a9d9791da9590959987d99f9d9a93b4929095da9c9c87da939b82">[email protected]</span></a>.
    RIN: 0910-AF45

243. Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/
Cold Products

    E.O. 13771 Designation: Regulatory.
    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................................           To Be Determined
------------------------------------------------------------------------

    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#8ee4efe0e7edeba0efeaefe3fda3e5e7e0e9cee8eaefa0e6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="3258535c5b51571c5356535f411f595b5c55725456531c5a5a411c555d44">[email protected]</span></a>.
    RIN: 0910-AG12

244. Electronic Distribution of Prescribing Information for Human 
Prescription Drugs Including Biological Products

    E.O. 13771 Designation: Other.
    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.

[[Page 1866]]

    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/18/14  79 FR 75506
NPRM Comment Period Extended........   03/09/15  80 FR 12364
NPRM Comment Period End.............   03/18/15  .......................
NPRM Comment Period Extended End....   05/18/15  .......................
                                     -----------------------------------
Final Rule..........................           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Emily Gebbia, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, 
Room 6226, Silver Spring, MD 20993, Phone: 240 402-0980, Email: 
<a href="/cdn-cgi/l/email-protection#42272f2b2e3b6c252720202b23022426236c2a2a316c252d34"><span class="__cf_email__" data-cfemail="91f4fcf8fde8bff6f4f3f3f8f0d1f7f5f0bff9f9e2bff6fee7">[email protected]</span></a>.
    Michael Bernstein, Regulatory Counsel, Department of Health and 
Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, WO 51, Room 6240, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993-0002, Phone: 301 796-3478, Fax: 301 847-8440, 
Email: <a href="/cdn-cgi/l/email-protection#8be6e2e8e3eaeee7a5e9eef9e5f8ffeee2e5cbedefeaa5e3e3f8a5ece4fd"><span class="__cf_email__" data-cfemail="315c58525950545d1f5354435f424554585f715755501f5959421f565e47">[email protected]</span></a>.
    RIN: 0910-AG18

245. Investigational New Drug Applications Requirements for 
Conventional Foods, Dietary Supplements, and Cosmetics

    E.O. 13771 Designation: Deregulatory.
    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: Researchers conducting studies of FDA-regulated products 
involving human subjects must, in some circumstances, meet requirements 
set out in FDA's Investigational New Drug (IND) Application 
regulations. The proposed rule would exempt sponsors of certain studies 
that evaluate a drug use of a product that is lawfully marketed as a 
conventional food, dietary supplement, or cosmetic from being required 
to submit an IND application under circumstances when the study does 
not present a potential for significant risk to the health, safety, or 
welfare of the human subjects. The proposed rule is intended to broaden 
the regulatory criteria for studies exempt from IND requirements and 
provide clarity and consistency regarding when studies evaluating drug 
uses of products that are lawfully marketed as conventional foods, 
dietary supplements, or cosmetics are subject to IND review. The 
proposed rule would also streamline some IND application requirements 
for certain studies that do not qualify for the new exemption.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................           To Be Determined
------------------------------------------------------------------------

    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#f491969895da95989dd99d9686959c9d99b4929095da9c9c87da939b82"><span class="__cf_email__" data-cfemail="6b0e09070a450a0702460209190a0302062b0d0f0a45030318450c041d">[email protected]</span></a>.
    RIN: 0910-AH07

246. General and Plastic Surgery Devices: Sunlamp Products

    E.O. 13771 Designation: Regulatory.
    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..........................           To Be Determined
------------------------------------------------------------------------

    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#2148404f0f4e525544534c484d4d4453614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="751c141b5b1a06011007181c19191007351311145b1d1d065b121a03">[email protected]</span></a>.
    RIN: 0910-AH14

247. Combinations of Bronchodilators With Expectorants; Cold, Cough, 
Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-
Counter Human Use

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective, 
and not misbranded. After a final monograph (i.e. final rule) is 
issued, only OTC drugs meeting the conditions of the monograph, or 
having an approved new drug application, may be legally marketed. These 
actions address cough/cold drug products containing an oral 
bronchodilator (ephedrine and its salts) in combination with any 
expectorant.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Amendment)....................   07/13/05  70 FR 40232
NPRM Comment Period End.............   11/10/05  .......................
Final Action (Technical Amendment)..   03/19/07  72 FR 12730
                                     -----------------------------------
Final Rule..........................           To Be Determined
------------------------------------------------------------------------

    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#bdd7dcd3d4ded893dcd9dcd0ce90d6d4d3dafddbd9dc93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="0c666d62656f69226d686d617f216765626b4c6a686d2264647f226b637a">[email protected]</span></a>.
    RIN: 0910-AH16

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

248. Current Good Manufacturing Practice in Manufacturing, Packing, 
Labeling, or Holding Operations for Dietary Supplements

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 343; 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

[[Page 1867]]

    Abstract: The Food and Drug Administration published a final rule 
in the Federal Register of June 25, 2007 (72 FR 34752), on current good 
manufacturing practice (CGMP) regulations for dietary supplements. FDA 
also published an Interim Final Rule in the same Federal Register (72 
FR 34959) that provided a procedure for requesting an exemption from 
the final rule requirement that the manufacturer conduct at least one 
appropriate test or examination to verify the identity of any component 
that is a dietary ingredient. This IFR allows for submission to, and 
review by, FDA of an alternative to the required 100 percent identity 
testing of components that are dietary ingredients, provided certain 
conditions are met. This IFR also establishes a requirement for 
retention of records relating to the FDA's response to an exemption 
request.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   10/18/17  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Linda Kahl, Phone: 240 402-2784, Fax: 240-402-2657, 
Email: <a href="/cdn-cgi/l/email-protection#4a2623242e2b64212b22260a2c2e2b64222239642d253c"><span class="__cf_email__" data-cfemail="0e6267606a6f20656f66624e686a6f2066667d20696178">[email protected]</span></a>.
    RIN: 0910-AB88

249. Updated Standards for Labeling of Pet Food

    E.O. 13771 Designation: Other.
    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.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   11/22/17  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: William Burkholder, Phone: 240 402-5900, Email: 
<a href="/cdn-cgi/l/email-protection#a7d0cecbcbcec6ca89c5d2d5cccfc8cbc3c2d5e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="d4a3bdb8b8bdb5b9fab6a1a6bfbcbbb8b0b1a694b2b0b5fabcbca7fab3bba2">[email protected]</span></a>.
    RIN: 0910-AG09

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

    E.O. 13771 Designation: Other.
    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.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   09/29/17  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice L. Weiner, Phone: 301 796-3601, Fax: 301 
847-8440, Email: <a href="/cdn-cgi/l/email-protection#f59f949b9c9690db82909c9b9087b5939194db9d9d86db929a83"><span class="__cf_email__" data-cfemail="f8929996919b9dd68f9d91969d8ab89e9c99d690908bd69f978e">[email protected]</span></a>.
    RIN: 0910-AG94

251. Radiology Devices; Designation of Special Controls for the 
Computed Tomography X-Ray System

    E.O. 13771 Designation: Other.
    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 are necessary to provide reasonable assurance 
of the safety and effectiveness of a class II CT X-ray system.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   09/29/17  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Erica Blake-Payne, Phone: 301 796-3999, Fax: 301 
847-8145, Email: <a href="/cdn-cgi/l/email-protection#e08592898381ce9081998e85a0868481ce888893ce878f96"><span class="__cf_email__" data-cfemail="2643544f45470856475f484366404247084e4e5508414950">[email protected]</span></a>.
    RIN: 0910-AH03

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

252. CY 2019 Notice of Benefit and Payment Parameters (CMS-9930-P) 
(Section 610 Review)

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: Pub. L. 111-148, Title I
    Abstract: This proposed rule sets forth payment parameters and 
provisions related to the risk adjustment and risk adjustment data 
validation programs; cost-sharing parameters and cost-sharing 
reductions; and user fees for Federally-facilitated Exchanges and 
State-based Exchanges on the Federal platform. It proposes changes that 
would enhance the role of States related to essential health benefits 
and qualified health plan (QHP) certification; and would provide States 
with additional flexibility in the operation and establishment of 
Exchanges, including the Small Business Health Options Program (SHOP) 
Exchanges. It includes proposed changes to the required functions of 
the Small Business Health Options Programs; actuarial value for stand-
alone dental plans; the rate review program; the medical loss ratio 
program; eligibility and enrollment; exemptions; and other related 
topics.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/17  .......................
------------------------------------------------------------------------

    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#dcb0b5b2b8afb9a5f2b1a9aea8bdbbb49cbfb1aff2b4b4aff2bbb3aa"><span class="__cf_email__" data-cfemail="97fbfef9f3e4f2eeb9fae2e5e3f6f0ffd7f4fae4b9ffffe4b9f0f8e1">[email protected]</span></a>.
    RIN: 0938-AT12

253. <bullet> Regulatory Provisions To Promote Program Efficiency, 
Transparency, and Burden Reduction (CMS-3346-P)

    Regulatory Plan: This entry is Seq. No. 37 in part II of this issue 
of the Federal Register.
    RIN: 0938-AT23

[[Page 1868]]

254. <bullet> FY 2019 Prospective Payment System and Consolidated 
Billing for Skilled Nursing Facilities (SNFS) (CMS-1696-P)

    E.O. 13771 Designation: Fully or Partially Exempt.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual proposed rule would update the payment rates 
used under the prospective payment system for SNFs for fiscal year 
2019.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Bill Ullman, Technical Advisor, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare, MS: C5-06-27, 7500 Security Boulevard, Baltimore, 
MD 21244, Phone: 410 786-5667, Fax: 410 786-0765, Email: 
<a href="/cdn-cgi/l/email-protection#b2c5dbdededbd3df9cc7dededfd3dcf2d1dfc19cdadac19cd5ddc4"><span class="__cf_email__" data-cfemail="691e000505000804471c0505040807290a041a4701011a470e061f">[email protected]</span></a>.
    RIN: 0938-AT24

255. <bullet> Hospital Inpatient Prospective Payment System for Acute 
Care Hospitals and the Long-Term Care Hospital Prospective Payment 
System and FY 2019 Rates (CMS-1694-P) (Section 610 Review)

    Regulatory Plan: This entry is Seq. No. 38 in part II of this issue 
of the Federal Register.
    RIN: 0938-AT27

256. <bullet> CY 2019 Hospital Outpatient PPS Policy Changes and 
Payment Rates and Ambulatory Surgical Center Payment System Policy 
Changes and Payment Rates (CMS-1695-P) (Section 610 Review)

    E.O. 13771 Designation: Fully or Partially Exempt.
    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................................   06/00/18  .......................
------------------------------------------------------------------------

    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#731f161f125d0007011c1d1433101e005d1b1b005d141c05"><span class="__cf_email__" data-cfemail="e9858c8588c79a9d9b86878ea98a849ac781819ac78e869f">[email protected]</span></a>.
    RIN: 0938-AT30

257. <bullet> CY 2019 Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Medicare Part B (CMS-1693-P) 
(Section 610 Review)

    E.O. 13771 Designation: Fully or Partially Exempt.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual proposed rule would revise payment polices 
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, 2019.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/18  .......................
------------------------------------------------------------------------

    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#7d0f041c135315120a183d1e100e5315150e531a120b"><span class="__cf_email__" data-cfemail="16646f7778387e79617356757b65387e7e6538717960">[email protected]</span></a>.
    RIN: 0938-AT31

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

258. <bullet> Durable Medical Equipment Fee Schedule, Adjustments To 
Resume the Transitional 50/50 Blended Rates To Provide Relief in Non-
Competitive Bidding Areas (CMS-1687-IFC) (Section 610 Review)

    E.O. 13771 Designation: Fully or Partially Exempt.
    Legal Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)); Pub. L. 
114-255, sec. 5004(b), 16007(a), 16008
    Abstract: This interim final rule with comment period extends the 
end of the transition period for phasing in adjustments to the fee 
schedule amounts for certain durable medical equipment (DME) and 
enteral nutrition paid in areas not subject to the Durable Medical 
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive 
Bidding Program (CBP) from June 30, 2016, to December 31, 2016. In 
addition, this interim final rule with comment period amends the 
regulation to resume the transition period for items furnished from 
August 1, 2017, through December 31, 2018. This interim final rule with 
comment period also makes technical amendments to existing regulations 
for DMEPOS items and services to exclude infusion drugs used with DME 
from the DMEPOS CBP. Finally, this interim final rule with comment 
period also requests information on issues related to adjustments to 
DMEPOS fee schedules, alternatives for ensuring budget neutrality of 
oxygen payment classes, and current rules under the DMEPOS CBP.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   11/00/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Undetermined.
    Agency Contact: Alexander Ullman, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C5-07-26, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-9671, Email: 
<a href="/cdn-cgi/l/email-protection#6908050c1108070d0c1b471c0505040807290a041a4701011a470e061f"><span class="__cf_email__" data-cfemail="88e9e4edf0e9e6ecedfaa6fde4e4e5e9e6c8ebe5fba6e0e0fba6efe7fe">[email protected]</span></a>.
    RIN: 0938-AT21

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

259. 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)

    E.O. 13771 Designation: Regulatory.
    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,

[[Page 1869]]

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#483b2b273c3c662b2727382d3a082b253b6620203b662f273e"><span class="__cf_email__" data-cfemail="3340505c47471d505c5c43564173505e401d5b5b401d545c45">[email protected]</span></a>.
    RIN: 0938-AS21

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

260. Hospital Inpatient Prospective Payment Systems for Acute Care 
Hospitals and the Long-Term Care Hospital Prospective Payment System 
and Policy Changes and Fiscal Year 2018 Rates (CMS-1677-F) (Completion 
of a Section 610 Review)

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; Pub. L. 114-255; 
. . .
    Abstract: We are revising the Medicare hospital inpatient 
prospective payment systems (IPPS) for operating and capital-related 
costs of acute care hospitals to implement changes arising from our 
continuing experience with these systems for FY 2018. Some of these 
changes implement certain statutory provisions contained in the Pathway 
for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving 
Medicare Post-Acute Care Transformation Act of 2014, the Medicare 
Access and CHIP Reauthorization Act of 2015, the 21st Century Cures 
Act, and other legislation. We also are making changes relating to the 
provider-based status of Indian Health Service (IHS) and Tribal 
facilities and organizations and to the low-volume hospital payment 
adjustment for hospitals operated by the IHS or a Tribe. In addition, 
we are providing the market basket update that will apply to the rate-
of-increase limits for certain hospitals excluded from the IPPS that 
are paid on a reasonable cost basis subject to these limits for FY 
2018. We are updating the payment policies and the annual payment rates 
for the Medicare prospective payment system (PPS) for inpatient 
hospital services provided by long-term care hospitals (LTCHs) for FY 
2018.
    In addition, we are establishing new requirements or revising 
existing requirements for quality reporting by specific Medicare 
providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, 
and inpatient psychiatric facilities). We also are establishing new 
requirements or revising existing requirements for eligible 
professionals (EPs), eligible hospitals, and critical access hospitals 
(CAHs) participating in the Medicare and Medicaid Electronic Health 
Record (EHR) Incentive Programs. We are updating policies relating to 
the Hospital Value-Based Purchasing (VBP) Program, the Hospital 
Readmissions Reduction Program, and the Hospital-Acquired Condition 
(HAC) Reduction Program.
    We also are making changes relating to transparency of accrediting 
organization survey reports and plans of correction of providers and 
suppliers; electronic signature and electronic submission of the 
Certification and Settlement Summary page of the Medicare cost reports; 
and clarification of provider disposal of assets.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/28/17  82 FR 19796
NPRM Comment Period End.............   06/13/17
Final Action........................   08/14/17  82 FR 37990
Final Action Effective..............   10/01/17
------------------------------------------------------------------------

    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#ec8883828d8088c2988483819c9f8382ac8f819fc284849fc28b839a"><span class="__cf_email__" data-cfemail="e6828988878a82c8928e898b96958988a6858b95c88e8e95c8818990">[email protected]</span></a>.
    RIN: 0938-AS98

261. CY 2018 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B; Medicare Shared Savings Program 
Requirements; Medicare Diabetes Prevention Program (CMS-1676-F) 
(Completion of a Section 610 Review)

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual final rule revises payment polices under the 
Medicare physician fee schedule, and makes other policy changes to 
payment under Medicare Part B. These changes apply to services 
furnished beginning January 1, 2018.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/21/17  82 FR 33950
NPRM Comment Period End.............   09/11/17
Final Action........................   11/15/17  82 FR 52976
Final Action Effective..............   01/01/18
------------------------------------------------------------------------

    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#76040f1718581e19011336151b05581e1e0558111900"><span class="__cf_email__" data-cfemail="611318000f4f090e160421020c124f0909124f060e17">[email protected]</span></a>.
    RIN: 0938-AT02

262. CY 2018 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1678-FC) (Completion of a Section 610 Review)

    E.O. 13771 Designation: Fully or Partially Exempt.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; Pub. L. 114-255
    Abstract: This annual final rule revises the Medicare hospital 
outpatient prospective payment system (OPPS) and the Medicare 
ambulatory surgical center (ASC) payment system for CY 2018 to 
implement changes arising from our continuing experience with these 
systems and certain provisions under the 21st Century Cures Act. In 
this rule, we describe the changes to the amounts and factors used to 
determine the payment rates for Medicare services paid under the OPPS 
and those paid under the ASC payment system. In addition, this rule 
updates and refines the requirements for the Hospital Outpatient 
Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) 
Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/20/17  82 FR 33558
NPRM Comment Period End.............   09/11/17
Final Action........................   11/13/17  82 FR 52356
Final Action Effective..............   01/01/18
------------------------------------------------------------------------


[[Page 1870]]

    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#167a737a773865626479787156757b65387e7e6538717960"><span class="__cf_email__" data-cfemail="d7bbb2bbb6f9a4a3a5b8b9b097b4baa4f9bfbfa4f9b0b8a1">[email protected]</span></a>.
    RIN: 0938-AT03

[FR Doc. 2017-28220 Filed 1-11-18; 8:45 am]
 BILLING CODE 4150-03-P


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