1860 Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / 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 (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

Sequence No. Title Regulation 

Identifier No. 

227 .................... HIPAA Privacy Rule: Changing Requirement to Obtain Acknowledgment of Receipt of the Notice of Privacy Practices.0945–AA08 

OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

228 .................... Health Information Technology: Interoperability and Certification Enhancements (Reg Plan Seq No. 26) .. 0955–AA01 

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

Sequence No. Title Regulation 

Identifier No. 

229 .................... Sunscreen Drug Products For Over-The-Counter-Human Use; Tentative Final Monograph ......................... 0910–AF43 

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

231 .................... Mammography Quality Standards Act; Regulatory Amendments (Reg Plan Seq No. 29) ............................ 0910–AH04 

232 .................... Medication Guides; Patient Medication Information (Reg Plan Seq No. 32) ................................................. 0910–AH68 

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

Sequence No. Title Regulation 

Identifier No. 

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

234 .................... Label Requirement for Food That Has Been Refused Admission Into the United States .............................. 0910–AF61 

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

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

237 .................... Safety and Effectiveness of Healthcare Antiseptics; Topical Antimicrobial Drug Products for Over-theCounter Human Use.0910–AH40 


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FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS

Sequence No. Title Regulation 

Identifier No. 

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

239 .................... Over-the-Counter (OTC) Drug Review—External Analgesic Products ........................................................... 0910–AF35 

240 .................... Over-the-Counter (OTC) Drug Review—Internal Analgesic Products ............................................................ 0910–AF36 

241 .................... Over-the-Counter (OTC) Drug Review—Laxative Drug Products ................................................................... 0910–AF38 

242 .................... Over-the-Counter (OTC) Drug Review—Weight Control Products ................................................................. 0910–AF45 

243 .................... Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products ..................................... 0910–AG12 

244 .................... Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products.0910–AG18 

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

Cosmetics.

0910–AH07 

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

247 .................... Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use.0910–AH16 

FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

248 .................... Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements.0910–AB88 

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

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

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

CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

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

253 .................... Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (CMS–3346– 

P) (Reg Plan Seq No. 37).

0938–AT23 

254 .................... FY 2019 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFs) 

(CMS–1696–P).

0938–AT24 

255 .................... 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) (Reg 

Plan Seq No. 38).

0938–AT27 

256 .................... 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).

0938–AT30 

257 .................... CY 2019 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1693–P) (Section 610 Review).0938–AT31 

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

Sequence No. Title Regulation 

Identifier No. 

258 .................... 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).

0938–AT21 

CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS

Sequence No. Title Regulation 

Identifier No. 

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).

0938–AS21 


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CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

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).

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).

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).

0938–AT03 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Office for Civil Rights (OCR) 

Proposed Rule Stage 

227. • 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: 

andra.wicks@hhs.gov. 

RIN: 0945–AA08 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Office of the National Coordinator for 

Health Information Technology (ONC) 

Proposed Rule Stage 

228. • 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 Overthe-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 Repellent).02/22/07 72 FR 7941 

ANPRM Comment 

Period End.

05/23/07 

NPRM (UVA/ 

UVB).

08/27/07 72 FR 49070 

Action Date FR Cite 

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 End.

09/15/11 

ANPRM (Dosage 

Forms).

06/17/11 76 FR 35669 

ANPRM (Dosage 

Forms) Comment Period 

End.

09/15/11 

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: 

sharon.coleman@fda.hhs.gov. 

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 


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Action Date FR Cite 

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: 

erica.payne@fda.hhs.gov. 

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. • 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: jane.baluss@fda.hhs.gov. 

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: 

anthony.taube@fda.hhs.gov. 

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: 

soma.kalb@fda.hhs.gov. 

RIN: 0910–AG48 

236. Food Labeling; Gluten-Free 

Labeling of Fermented, Hydrolyzed, or 

Distilled Foods 

E.O. 13771 Designation: Regulatory. 


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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: 

carol.dlima@fda.hhs.gov. 

RIN: 0910–AH00 

237. Safety and Effectiveness of 

Healthcare Antiseptics; Topical 

Antimicrobial Drug Products for Overthe-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: 

michelle.jackon@fda.hhs.gov. 

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 

Action Date FR Cite 

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: 

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

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: 

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

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 


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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 and 

Other Labeling).

12/26/06 71 FR 77314 

NPRM Comment 

Period End.

05/25/07 

Final Action (Required Warnings and Other 

Labeling).

04/29/09 74 FR 19385 

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: 

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

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 

Phosphate).

02/11/11 76 FR 7743 

Action Date FR Cite 

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: 

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

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: 

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

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: 

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

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. 


sradovich on DSK3GMQ082PROD with PROPOSALS7
1866 Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Unified Agenda 

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: emily.gebbia@

fda.hhs.gov. 

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: michael.bernstein@fda.hhs.gov. 

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: ebla.aliibrahim@fda.hhs.gov. 

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: 

ian.ostermiller@fda.hhs.gov. 

RIN: 0910–AH14 

247. Combinations of Bronchodilators 

With Expectorants; Cold, Cough, 

Allergy, Bronchodilator, and 

Antiasthmatic Drug Products for Overthe-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: 

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

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 


sradovich on DSK3GMQ082PROD with PROPOSALS7
Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Unified Agenda 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: linda.kahl@fda.hhs.gov. 

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: 

william.burkholder@fda.hhs.gov. 

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: janice.weiner@fda.hhs.gov. 

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: erica.payne@fda.hhs.gov. 

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 costsharing 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: 

lindsey.murtagh@cms.hhs.gov. 

RIN: 0938–AT12 

253. • 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 


sradovich on DSK3GMQ082PROD with PROPOSALS7
1868 Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Unified Agenda 

254. • 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: william.ullman@

cms.hhs.gov. 

RIN: 0938–AT24 

255. • 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. • 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: 

lela.strong@cms.hhs.gov. 

RIN: 0938–AT30 

257. • 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: 

ryan.howe@cms.hhs.gov. 

RIN: 0938–AT31 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Medicare & Medicaid 

Services (CMS) 

Final Rule Stage 

258. • 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: 

alexander.ullman@cms.hhs.gov. 

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, 


sradovich on DSK3GMQ082PROD with PROPOSALS7
Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Unified Agenda 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: 

scott.cooper@cms.hhs.gov. 

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: 

donald.thompson@cms.hhs.gov. 

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: 

ryan.howe@cms.hhs.gov. 

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 


sradovich on DSK3GMQ082PROD with PROPOSALS7
1870 Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Unified Agenda 

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 

[FR Doc. 2017–28220 Filed 1–11–18; 8:45 am] 

BILLING CODE 4150–03–P 


sradovich on DSK3GMQ082PROD with PROPOSALS7