Vol. 82 Thursday, 

No. 163 August 24, 2017 

Part VII 

Department of Health and Human Services 

Semiannual Regulatory Agenda 

mstockstill on DSK30JT082PROD with PROPOSALS7

40278 Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Unified Agenda 

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

Sequence No. Title Regulation 

Identifier No. 

92 ...................... Removal of 2 CFR Subsection 376.147 (Rulemaking Resulting From a Section 610 Review) ................ 0991–AC08 

93 ...................... Uniform Administrative Requirements, Costs Principles and Adult Requirements (45 CFR 75) (Rulemaking Resulting From a Section 610 Review).0991–AC09 

SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

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

Facilities for Children and Youth.

0930–AA10 

95 ...................... Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements ...................................... 0930–AA22 

CENTERS FOR DISEASE CONTROL AND PREVENTION—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

96 ...................... Establishment of Minimum Standards for Birth Certificates ............................................................................ 0920–AA46 

FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

97 ...................... Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices ............... 0910–AG48 

98 ...................... Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods ..................................... 0910–AH00 

99 ...................... Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-theCounter Human Use (Healthcare Antiseptic).0910–AH40 

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Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Unified Agenda 40279 

FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS

Sequence No. Title Regulation 

Identifier No. 

100 .................... Postmarketing Safety Reporting Requirements for Human Drug and Biological Products ............................ 0910–AA97 

101 .................... Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products ............................................. 0910–AF31 

102 .................... Laser Products; Amendment to Performance Standard .................................................................................. 0910–AF87 

103 .................... Updated Standards for Labeling of Pet Food .................................................................................................. 0910–AG09 

104 .................... Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products ....... 0910–AG94 

105 .................... Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System ........... 0910–AH03 

106 .................... General and Plastic Surgery Devices: Sunlamp Products .............................................................................. 0910–AH14 

FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

107 .................... Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements ...................... 0910–AC53 

108 .................... Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Second Phase.0910–AG20 

109 .................... Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives 0910–AG59 

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

Components.

0910–AG70 

111 .................... Format and Content of Reports Intended To Demonstrate Substantial Equivalence ..................................... 0910–AG96 

112 .................... Investigational New Drug Application Annual Reporting ................................................................................. 0910–AH07 

113 .................... Requirements for Tobacco Product Manufacturing Practice ........................................................................... 0910–AH22 

114 .................... Use of Ozone Depleting Substances (Section 610 Review) ........................................................................... 0910–AH36 

CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

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).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).

0938–AT03 

117 .................... CY 2019 Notice of Benefit and Payment Parameters (CMS–9930–P) (Section 610 Review) ....................... 0938–AT12 

CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

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).0938–AS98 

CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS

Sequence No. Title Regulation 

Identifier No. 

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).

0938–AS21 

CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

120 .................... Imaging Accreditation (CMS–3309–P) ............................................................................................................. 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).

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).

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).0938–AS81 

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40280 Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Unified Agenda 

CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS—Continued 

Sequence No. Title Regulation 

Identifier No. 

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).

0938–AS82 

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: 

paolo.delvecchio@samhsa.hhs.gov. 

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: brian.altman@samhsa.gov. 

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 

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

soma.kalb@fda.hhs.gov. 

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: 

carol.dlima@fda.hhs.gov. 

RIN: 0910–AH00. 

99. Safety and Effectiveness of 

Consumer Antiseptics; Topical 

Antimicrobial Drug Products for Overthe-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: 

pranvera.ikonomi@fda.hhs.gov. 

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 

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40282 Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Unified Agenda 

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: jane.baluss@fda.hhs.gov. 

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: 

janice.adams-king@fda.hhs.gov. 

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: 

erica.payne@fda.hhs.gov. 

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: william.burkholder@

fda.hhs.gov. 

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: janice.weiner@fda.hhs.gov. 

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 

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

erica.payne@fda.hhs.gov. 

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: 

ian.ostermiller@fda.hhs.gov. 

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 highpressure 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: patrick.raulerson@fda.hhs.gov. 

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: 

paula.katz@fda.hhs.gov. 

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, 

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40284 Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Unified Agenda 

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: ctpregulations@

fda.hhs.gov. 

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: brian.hasselbalch@

fda.hhs.gov. 

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: paula.katz@

fda.hhs.gov. 

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: ctpregulations@

fda.hhs.gov. 

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: ebla.aliibrahim@fda.hhs.gov. 

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: 

ctpregulations@fda.hhs.gov. 

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 

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

daniel.orr@fda.hhs.gov. 

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: 

ryan.howe@cms.hhs.gov. 

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: 

lela.strong@cms.hhs.gov. 

RIN: 0938–AT03 

117. • 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: 

lindsey.murtagh@cms.hhs.gov. 

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: 

donald.thompson@cms.hhs.gov. 

RIN: 0938–AS98 

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40286 Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Unified Agenda 

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: 

scott.cooper@cms.hhs.gov. 

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: 

sonia.swancy@cms.hhs.gov. 

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: 

molly.macharris@cms.hhs.gov. 

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: james.sharp@cms.hhs.gov. 

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: 

hillary.loeffler@cms.hhs.gov. 

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 

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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: 

ryan.howe@cms.hhs.gov. 

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: 

lela.strong@cms.hhs.gov. 

RIN: 0938–AS82 

[FR Doc. 2017–16920 Filed 8–23–17; 8:45 am] 

BILLING CODE 4150–03–P 

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