Regulatory Agenda, 58019-58030 [2018-24151]

Download as PDF Vol. 83 Friday, No. 222 November 16, 2018 Part VI Department of Health and Human Services amozie on DSK3GDR082PROD with PROPOSALS6 Semiannual Regulatory Agenda VerDate Sep<11>2014 19:30 Nov 15, 2018 Jkt 247001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\16NOP6.SGM 16NOP6 58020 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; (202) 690– Office of the Secretary 5627. SUPPLEMENTARY INFORMATION: The 21 CFR Ch. I Department of Health and Human Services (HHS) is the Federal 25 CFR Ch. V government’s lead agency for protecting the health of all Americans and 42 CFR Chs. I–V providing essential human services, especially for those who are least able 45 CFR Subtitle A; Subtitle B, Chs. II, to help themselves. HHS enhances the III, and XIII health and well-being of Americans by promoting effective health and human Regulatory Agenda services and by fostering sound, sustained advances in the sciences AGENCY: Office of the Secretary, HHS. ACTION: Semiannual Regulatory Agenda. underlying medicine, public health, and social services. SUMMARY: The Regulatory Flexibility Act This Agenda presents the regulatory of 1980 and Executive Order (E.O.) activities that the Department expects to 12866 require the semiannual issuance undertake in the foreseeable future to of an inventory of rulemaking actions advance this mission. HHS has an under development throughout the agency-wide effort to support the Department, offering for public review Agenda’s purpose of encouraging more summarized information about effective public participation in the forthcoming regulatory actions. regulatory process. For example, to FOR FURTHER INFORMATION CONTACT: Ann encourage public participation, we regularly update our regulatory webpage C. Agnew, Executive Secretary, DEPARTMENT OF HEALTH AND HUMAN SERVICES (https://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 webpage (https:// 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 https:// www.RegInfo.gov. Ann C. Agnew, Executive Secretary to the Department. OFFICE FOR CIVIL RIGHTS—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 254 .................... Nondiscrimination in Health Programs or Activities ......................................................................................... 0945–AA11 OFFICE FOR CIVIL RIGHTS—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 255 .................... 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 Regulation Identifier No. Sequence No. Title 256 .................... 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program. 0955–AA01 FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE amozie on DSK3GDR082PROD with PROPOSALS6 Sequence No. 257 258 259 260 261 262 263 .................... .................... .................... .................... .................... .................... .................... 264 .................... Regulation Identifier No. Title Over-the-Counter (OTC) Drug Review-Cough/Cold (Antihistamine) Products ............................................... Sunscreen Drug Products For Over-The-Counter-Human Use; Tentative Final Monograph ......................... Label Requirement for Food That Has Been Refused Admission Into the United States .............................. Laser Products; Amendment to Performance Standard .................................................................................. Mammography Quality Standards Act; Amendments to Part 900 Regulations (Reg Plan Seq No. 49) ....... Medication Guides; Patient Medication Information ........................................................................................ Testing Standards for Batteries and Battery Management Systems in Electronic Nicotine Delivery Systems. Rule to Revoke Uses of Partially Hydrogenated Oils in Foods ...................................................................... References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. VerDate Sep<11>2014 19:30 Nov 15, 2018 Jkt 247001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\16NOP6.SGM 16NOP6 0910–AF31 0910–AF43 0910–AF61 0910–AF87 0910–AH04 0910–AH68 0910–AH90 0910–AI15 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda 58021 FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 265 .................... 266 .................... Postmarketing Safety Reporting Requirements for Human Drug and Biological Products ............................ Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods ..................................... 0910–AA97 0910–AH00 FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS Sequence No. 267 268 269 270 271 272 .................... .................... .................... .................... .................... .................... 273 .................... 274 .................... 275 .................... 276 .................... 277 .................... Regulation Identifier No. Title Over-the-Counter (OTC) Drug Review—External Analgesic Products ........................................................... Over-the-Counter (OTC) Drug Review—Internal Analgesic Products ............................................................ Over-the-Counter (OTC) Drug Review—Laxative Drug Products ................................................................... Over-the-Counter (OTC) Drug Review—Weight Control Products ................................................................. Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products ..................................... Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products. Sunlamp Products; Amendment to the Performance Standard ...................................................................... General and Plastic Surgery Devices: Sunlamp Products .............................................................................. Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. Acute Nicotine Toxicity Warnings for E-Liquids ............................................................................................... Administration Detention of Tobacco Products ............................................................................................... 0910–AF35 0910–AF36 0910–AF38 0910–AF45 0910–AG12 0910–AG18 0910–AG30 0910–AH14 0910–AH16 0910–AH24 0910–AI05 CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 278 .................... Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (CMS–3347–P) (Section 610 Review) (Reg Plan Seq No. 55). CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1715–P) (Section 610 Review). Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2020 Rates (CMS–1716–P) (Section 610 Review). CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1717–P) (Section 610 Review). 279 .................... 280 .................... 281 .................... 0938–AT36 0938–AT72 0938–AT73 0938–AT74 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 Title 282 .................... 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). CY 2019 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (CMS– 1691–F) (Section 610 Review). CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements;Value-Based Purchasing Model; Quality Reporting Requirements (CMS– 1689–F) (Section 610 Review). CY 2019 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1695–F) (Section 610 Review). CY 2019 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B and the Quality Payment Program (CMS–1693–F) (Section 610 Review). 283 .................... 284 .................... 285 .................... 286 .................... amozie on DSK3GDR082PROD with PROPOSALS6 Regulation Identifier No. Sequence No. 0938–AS21 0938–AT28 0938–AT29 0938–AT30 0938–AT31 CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 287 .................... Durable Medical Equipment Fee Schedule, Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Non-Competitive Bidding Areas (CMS–1687–F) (Section 610 Review). VerDate Sep<11>2014 19:30 Nov 15, 2018 Jkt 247001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\16NOP6.SGM 16NOP6 0938–AT21 58022 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS Title 288 .................... Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2019 Rates (CMS–1694–F) (Completion of a Section 610 Review). FY 2019 Inpatient Psychiatric Facilities Prospective Payment System—Rate and Quality Reporting Updates (CMS–1690–F) (Completion of a Section 610 Review). 289 .................... DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office for Civil Rights (OCR) Proposed Rule Stage 254. Nondiscrimination in Health Programs or Activities E.O. 13771 Designation: Deregulatory. Legal Authority: Sec. 1557 of the Patient Protection and Affordable Care Act (42 U.S.C. 18116) Abstract: This proposed rule implements Section 1557 of the Patient Protection and Affordable Care Act (PPACA), which prohibits discrimination on the basis of race, color, national origin, sex, age, and disability under any health program or activity, any part of which is receiving Federal financial assistance, including credits, subsidies, or contracts of insurance, or under any program or activity that is administered by an Executive Agency or any entity established under Title l of the PPACA. Timetable: Action Date NPRM .................. Office for Civil Rights (OCR) Completed Actions 255. HIPAA Privacy Rule: Changing Requirement To Obtain Acknowledgment of Receipt of the Notice of Privacy Practices E.O. 13771 Designation: Deregulatory. 19:30 Nov 15, 2018 Reason Merged With 0945–AA00. Date FR Cite 07/27/18 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Andra Wicks, Phone: 202 774–3081, TDD Phone: 800 537– 7697, Email: andra.wicks@hhs.gov. RIN: 0945–AA08 Jkt 247001 0938–AT27 0938–AT32 certification, and reduce burden and costs. Timetable: Action NPRM .................. Date FR Cite 11/00/18 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Michael Lipinski, Director, Regulatory Affairs Division, Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Mary E. Switzer Building, 330 C Street SW, Washington, DC 20201, Phone: 202 690–7151. RIN: 0955–AA01 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage Food and Drug Administration (FDA) Office of the National Coordinator for Health Information Technology (ONC) 10/00/18 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) VerDate Sep<11>2014 Legal Authority: Health Insurance Portability and Accountability (HIPAA) Act of 1996, Pub. L. 104–191 Abstract: This proposed 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. Completed: DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) FR Cite Regulatory Flexibility Analysis Required: Yes. Agency Contact: Luben Montoya, Section Chief, Civil Rights Division, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 800 368–1019, TDD Phone: 800 537–7697, Email: ocrmail@ hhs.gov. RIN: 0945–AA11 amozie on DSK3GDR082PROD with PROPOSALS6 Regulation Identifier No. Sequence No. Proposed Rule Stage 256. 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program E.O. 13771 Designation: Regulatory. Legal Authority: Pub. L. 114–255 Abstract: The rulemaking would implement certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric healthcare providers and reasonable and necessary activities that do not constitute information blocking. The rulemaking would also modify the 2015 Edition health IT certification criteria and Program in additional ways to advance interoperability, enhance health IT PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 257. 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 on a pilot basis. This proposed rule is the result of collaboration under the U.S.Canada Regulatory Cooperation Council 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 Reopening of Administrative Record. Comment Period End. E:\FR\FM\16NOP6.SGM 16NOP6 Date 08/25/00 11/24/00 FR Cite 65 FR 51780 58023 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda Action Date NPRM (Amendment) (Common Cold). FR Cite 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 258. Sunscreen Drug Products for Overthe-Counter-Human Use; Tentative Final Monograph 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 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: amozie on DSK3GDR082PROD with PROPOSALS6 Action Date ANPRM (Sunscreen and Insect Repellent). ANPRM Comment Period End. NPRM (UVA/ UVB). NPRM Comment Period End. Final Action (UVA/ UVB). NPRM (Effectiveness). NPRM (Effectiveness) Comment Period End. ANPRM (Dosage Forms). ANPRM (Dosage Forms) Comment Period End. NPRM .................. 02/22/07 FR Cite 72 FR 7941 05/23/07 08/27/07 72 FR 49070 12/26/07 06/17/11 76 FR 35620 06/17/11 76 FR 35672 09/15/11 06/17/11 76 FR 35669 09/15/11 259. Label Requirement for Food That Has Been Refused Admission Into the United States E.O. 13771 Designation: Deregulatory. 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: On September 18, 2008, FDA issued a proposed rule that would have required owners or consignees to label imported food that was refused entry into the United States. FDA does not plan to finalize the rule. Timetable: Action Date NPRM .................. NPRM Comment Period End. NPRM; Withdrawal. 09/18/08 12/02/08 19:30 Nov 15, 2018 Jkt 247001 FR Cite 73 FR 54106 10/00/18 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 260. Laser Products; Amendment to Performance Standard E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 393 Abstract: On June 24, 2013, FDA issued a proposed rule that would have amended the performance standard for laser products to achieve closer harmonization between the current standard and the amended International Electrotechnical Commission (IEC) standard for laser products and medical laser products. FDA does not plan to finalize the 2013 proposal. Timetable: Action 11/00/18 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Kristen Hardin, Department of Health and Human VerDate Sep<11>2014 Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 22, Room 5491, Silver Spring, MD 20993, Phone: 240 402–4246, Fax: 301 796–9841, Email: kristen.hardin@fda.hhs.gov. RIN: 0910–AF43 Date NPRM .................. NPRM Comment Period End. NPRM; Withdrawal. PO 00000 Frm 00005 06/24/13 09/23/13 FR Cite 78 FR 37723 10/00/18 Fmt 4701 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Erica Payne, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5522, Silver Spring, MD 20993, Phone: 301 796–3999, Fax: 301 847–8145, Email: erica.payne@fda.hhs.gov. RIN: 0910–AF87 261. Mammography Quality Standards Act; Amendments to Part 900 Regulations Regulatory Plan: This entry is Seq. No. 49 in part II of this issue of the Federal Register. RIN: 0910–AH04 262. Medication Guides; Patient Medication Information E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321 et seq.; 42 U.S.C. 262; 42 U.S.C. 264; 21 U.S.C. 371 Abstract: The proposed rule would amend FDA medication guide regulations to require a new form of patient labeling, Patient Medication Information, for submission to and review by the FDA for human prescription drug products and certain blood products used, dispensed, or administered on an outpatient basis. The proposed rule would include requirements for Patient Medication Information development and distribution. The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively. Timetable: Action NPRM .................. Date FR Cite 07/00/19 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Chris Wheeler, Supervisory Project Manager, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD 20993, Phone: 301 796– 0151, Email: chris.wheeler@fda.hhs.gov. RIN: 0910–AH68 263. Testing Standards for Batteries and Battery Management Systems in Electronic Nicotine Delivery Systems E.O. 13771 Designation: Regulatory. Sfmt 4702 E:\FR\FM\16NOP6.SGM 16NOP6 58024 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 371; 21 U.S.C. 387(b); 21 U.S.C. 387(g); 21 U.S.C. 387i Abstract: This rule would propose to establish a product standard to require testing standards for batteries used in electronic nicotine delivery systems (ENDS) and require design protections including a battery management system for ENDS using batteries and protective housing for replaceable batteries. This product standard would protect the safety of users of battery-powered tobacco products and will help to streamline the FDA premarket review process, ultimately reducing the burden on both manufacturers and the Agency. The proposed rule would be applicable to tobacco products that include a nonuser replaceable battery as well as products that include a user replaceable battery. Timetable: Action Date NPRM .................. 09/00/19 amozie on DSK3GDR082PROD with PROPOSALS6 264. • Rule To Revoke Uses of Partially Hydrogenated Oils in Foods E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379(e) Abstract: In the Federal Register of June 17, 2015 (80 FR 34650), we published a declaratory order announcing our final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are generally recognized as safe (GRAS) for any use in human food. In the Federal Register of May 21, 2018 (83 FR 23382), we denied a food additive petition requesting that the food additive regulations be amended to provide for the safe use of PHOs in certain food applications. We are now proposing to update our regulations to remove all mention of partially hydrogenated oils and to revoke all prior sanctioned uses. This rulemaking implements FDA’s findings that the available data demonstrate that PHOs used in food may cause the food to be unsafe. 19:30 Nov 15, 2018 Jkt 247001 Action Action Date NPRM .................. FR Cite 06/00/19 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ellen Anderson, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, HFS–265, 4300 River Road, College Park, MD 20740, Phone: 240 402–1309, Email: ellen.anderson@fda.hhs.gov. RIN: 0910–AI15 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 265. Postmarketing Safety Reporting Requirements for Human Drug and Biological Products FR Cite Regulatory Flexibility Analysis Required: Yes. Agency Contact: Darin Achilles, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 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–AH90 VerDate Sep<11>2014 Timetable: 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). Timetable: Action Date NPRM .................. NPRM Comment Period Extended. PO 00000 Frm 00006 03/14/03 06/18/03 Fmt 4701 FR Cite 68 FR 12406 Sfmt 4702 NPRM Comment Period End. NPRM Comment Period Extension End. Final Rule ............ Date FR Cite 07/14/03 10/14/03 05/00/19 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 266. Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods E.O. 13771 Designation: Regulatory. 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 final rule would establish requirements concerning ‘‘gluten-free’’ labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional requirements for the ‘‘gluten-free’’ labeling rule are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as ‘‘gluten-free.’’ Timetable: Action NPRM .................. NPRM Comment Period Reopened. NPRM Comment Period End. NPRM Comment Period Reopened End. NPRM Comment Period Reopened. NPRM Comment Period Reopened End. Final Rule ............ Date 11/18/15 01/22/16 FR Cite 80 FR 71990 81 FR 3751 02/16/16 02/22/16 02/23/16 81 FR 8869 04/25/16 12/00/18 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, 5001 Campus Drive, College E:\FR\FM\16NOP6.SGM 16NOP6 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda Park, MD 20740, Phone: 240 402–2371, Fax: 301 436–2636, Email: carol.dlima@ fda.hhs.gov. RIN: 0910–AH00 Action DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Long-Term Actions 267. 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. The proposed rule will address issues not addressed in previous rulemakings. Timetable: Action Date NPRM .................. FR Cite To Be Determined amozie on DSK3GDR082PROD with PROPOSALS6 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 268. 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 drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses acetaminophen safety. The second VerDate Sep<11>2014 19:30 Nov 15, 2018 Jkt 247001 action addresses products marketed for children under 2 years old and weightand age-based dosing for children’s products. Timetable: Date NPRM (Amendment) (Required Warnings and Other Labeling). NPRM Comment Period End. Final Action (Required Warnings and Other Labeling). Final Action (Correction). Final Action (Technical Amendment). 12/26/06 FR Cite 71 FR 77314 05/25/07 04/29/09 74 FR 19385 06/30/09 74 FR 31177 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 269. 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 Final Action (Granular Psyllium). NPRM (Professional Labeling—Sodium Phosphate). PO 00000 Frm 00007 FR Cite 03/29/07 72 FR 14669 02/11/11 76 FR 7743 Fmt 4701 Sfmt 4702 Action NPRM Comment Period End. Final Rule ............ Date 58025 FR Cite 03/14/11 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 270. 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 final action finalizes the 2005 proposed rule for weight control products containing phenylpropanolamine. Timetable: Action NPRM (Phenylpropanolamine). NPRM Comment Period End. NPRM (Benzocaine). NPRM Comment Period End. Final Action (Phenylpropanolamine). Date 12/22/05 FR Cite 70 FR 75988 03/22/06 03/09/11 76 FR 12916 06/07/11 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 E:\FR\FM\16NOP6.SGM 16NOP6 58026 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda 271. Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/ Cold Products Action 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 NPRM .................. FR Cite 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 amozie on DSK3GDR082PROD with PROPOSALS6 272. 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 to 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264 Abstract: This rule would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products. Timetable: VerDate Sep<11>2014 19:30 Nov 15, 2018 Jkt 247001 Date NPRM .................. NPRM Comment Period Extended. NPRM Comment Period End. NPRM Comment Period Extended End. 12/18/14 03/09/15 FR Cite 79 FR 75506 80 FR 12364 03/18/15 05/18/15 Final Rule ............ To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Michael Bernstein, Supervisory 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, Email: michael.bernstein@fda.hhs.gov. RIN: 0910–AG18 274. 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. Sunlamp products include ultraviolet (UV) lamps and UV tanning beds and booths. 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 use of sunlamp products at young ages, as well as frequently using sunlamp products, both increases 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.This rule would apply device restrictions to sunlamp products. Timetable: 273. Sunlamp Products; Amendment to the Performance Standard E.O. 13771 Designation: Fully or Partially Exempt. Legal Authority: 21 U.S.C. 360ii; 21 U.S.C. 360kk; 21 U.S.C. 393; 21 U.S.C. 371 Abstract: FDA is updating the performance standard for sunlamp products to improve safety, reflect new scientific information, and work towards harmonization with international standards. By harmonizing with the International Electrotechnical Commission, this rule will decrease the regulatory burden on industry and allow the Agency to take advantage of the expertise of the international committees, thereby also saving resources. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Rule ............ 12/22/15 03/21/16 FR Cite 80 FR 79505 06/00/20 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for Devices and Radiological Health, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 66, Room 5454, Silver Spring, MD 20993, Phone: 301 796–5678, Email: ian.ostermiller@ fda.hhs.gov. RIN: 0910–AG30 PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 Action NPRM .................. NPRM Comment Period End. Final Rule ............ Date 12/22/15 03/21/16 FR Cite 80 FR 79493 06/00/20 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for Devices and Radiological Health, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 66, Room 5454, Silver Spring, MD 20993, Phone: 301 796–5678, Email: ian.ostermiller@ fda.hhs.gov. RIN: 0910–AH14 275. 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. E:\FR\FM\16NOP6.SGM 16NOP6 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda Timetable: Action Date NPRM (Amendment). NPRM Comment Period End. Final Action (Technical Amendment). Final Rule ............ 07/13/05 FR Cite 70 FR 40232 11/10/05 03/19/07 72 FR 12730 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 276. Acute Nicotine Toxicity Warnings for E-Liquids E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 331; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 387 Abstract: This rule would establish nicotine exposure warning requirements for liquid nicotine and nicotinecontaining e-liquid(s) that are made or derived from tobacco and intended for human consumption, and potentially for other tobacco products including, but not limited to, novel tobacco products such as dissolvables, lotions, gels, and drinks. This action is intended to protect users and non-users from accidental exposures to nicotinecontaining e-liquids in tobacco products. Timetable: Action Date amozie on DSK3GDR082PROD with PROPOSALS6 NPRM .................. FR Cite 12/00/20 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Courtney Smith, 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: 301 595–1426, Email: ctpregulations@ fda.hhs.gov. RIN: 0910–AH24 277. Administration Detention of Tobacco Products E.O. 13771 Designation: Other. VerDate Sep<11>2014 19:30 Nov 15, 2018 Jkt 247001 Legal Authority: 21 U.S.C. 334; 21 U.S.C. 371 Abstract: The Food and Drug Administration (FDA) is proposing regulations to establish requirements for the administrative detention of tobacco products. This action, if finalized, would allow FDA to administratively detain tobacco products encountered during inspections that an officer or employee conducting the inspection has reason to believe are adulterated or misbranded. The intent of administrative detention is to protect public health by preventing the distribution or use of violative tobacco products until FDA has had time to consider the appropriate action to take and, where appropriate, to initiate a regulatory action. Timetable: Action Date NPRM .................. FR Cite 08/00/20 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Darin Achilles, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 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–AI05 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage 278. Requirements for Long-Term Care Facilities: Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS–3347–P) (Section 610 Review) Regulatory Plan: This entry is Seq. No. 55 in part II of this issue of the Federal Register. RIN: 0938–AT36 279. • CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1715–P) (Section 610 Review) E.O. 13771 Designation: Other. 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 PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 58027 make other policy changes to payment under Medicare Part B. These changes would apply to services furnished beginning January 1, 2020. Additionally, this rule proposes updates to the Quality Payment Program. Timetable: Action NPRM .................. Date FR Cite 06/00/19 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Marge Watchorn, Deputy 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: 410 786–4361, Email: marge.watchorn@cms.hhs.gov. RIN: 0938–AT72 280. • Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2020 Rates (CMS–1716–P) (Section 610 Review) E.O. 13771 Designation: Other. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual proposed rule would revise the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems. In addition, the rule proposes to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers. Timetable: Action NPRM .................. Date FR Cite 04/00/19 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–AT73 E:\FR\FM\16NOP6.SGM 16NOP6 58028 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda 281. • CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1717–P) (Section 610 Review) E.O. 13771 Designation: Other. 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. This proposed rule would also update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Timetable: Action Date NPRM .................. FR Cite 06/00/19 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Marjorie Baldo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4–03–06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–4617, Email: marjorie.baldo@cms.hhs.gov. RIN: 0938–AT74 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns. Timetable: Action NPRM .................. NPRM Comment Period End. Final Action—To Be Merged With 0938–AS59 and 0938–AT23. amozie on DSK3GDR082PROD with PROPOSALS6 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 Jkt 247001 81 FR 39447 06/00/19 283. CY 2019 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (CMS–1691–F) (Section 610 Review) E.O. 13771 Designation: Regulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395d(d); 42 U.S.C. 1395f(b); 42 U.S.C 1395g Abstract: This annual final rule updates the bundled payment system for ESRD facilities by January 1, 2019. The rule also updates the quality incentives in the ESRD program and implements changes to the DMEPOS competitive bidding program. Timetable: Action 282. 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) 19:30 Nov 15, 2018 06/16/16 08/15/16 FR Cite 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 Final Rule Stage VerDate Sep<11>2014 Date Date NPRM .................. NPRM Comment Period End. Final Action ......... 07/19/18 09/10/18 FR Cite 83 FR 34304 11/00/18 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janae James, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5–05–27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–0801, Email: janae.james@cms.hhs.gov. RIN: 0938–AT28 PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 284. CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Value-Based Purchasing Model; Quality Reporting Requirements (CMS–1689–F) (Section 610 Review) E.O. 13771 Designation: Other. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1315a; 42 U.S.C. 1395(hh) Abstract: This annual final rule updates the payment rates under the Medicare prospective payment system for home health agencies. In addition, this rule finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model and to the Home Health Quality Reporting Program (HH QRP). Timetable: Action NPRM .................. NPRM Comment Period End. Final Action ......... Date 07/12/18 08/31/18 FR Cite 83 FR 32340 11/00/18 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: C5–08–28, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–0456, Email: hillary.loeffler@cms.hhs.gov. RIN: 0938–AT29 285. CY 2019 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1695–F) (Section 610 Review) E.O. 13771 Designation: Deregulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual final rule would 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 finalizes changes to the ambulatory surgical center payment system list of services and rates. This rule updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Timetable: Action NPRM .................. E:\FR\FM\16NOP6.SGM 16NOP6 Date 07/31/18 FR Cite 83 FR 37046 58029 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda Action Date NPRM Comment Period End. Final Action ......... FR Cite 09/24/18 11/00/18 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Marjorie Baldo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4–03–06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–4617, Email: marjorie.baldo@cms.hhs.gov. RIN: 0938–AT30 286. CY 2019 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B and the Quality Payment Program (CMS–1693–F) (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, 2019. Additionally, this rule updates the Quality Payment Program. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Action ......... 07/27/18 09/10/18 FR Cite amozie on DSK3GDR082PROD with PROPOSALS6 Centers for Medicare & Medicaid Services (CMS) Centers for Medicare & Medicaid Services (CMS) Long-Term Actions Completed Actions 287. Durable Medical Equipment Fee Schedule, Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Non-Competitive Bidding Areas (CMS–1687–F) (Section 610 Review) 288. Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2019 Rates (CMS–1694–F) (Completion of a 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) and 16008 Abstract: This final rule follows the interim final rule that published May 11, 2018, and extended 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, the rule amended the regulation to resume the transition period for items furnished from August 1, 2017, through December 31, 2018. The rule also made technical amendments to existing regulations for DMEPOS items and services to exclude infusion drugs used with DME from the DMEPOS CBP. Timetable: Action 11/00/18 19:30 Nov 15, 2018 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 83 FR 35704 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Marge Watchorn, Deputy 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: 410 786–4361, Email: marge.watchorn@cms.hhs.gov. RIN: 0938–AT31 VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Jkt 247001 Date Interim Final Rule Interim Final Rule Comment Period End. Final Action ......... 05/11/18 07/09/18 FR Cite 83 FR 21912 05/00/21 Regulatory Flexibility Analysis Required: Yes. 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 PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 E.O. 13771 Designation: Deregulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual final rule revises 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. In addition, the rule establishes new requirements or revises existing requirements for quality reporting by specific Medicare providers. Timetable: Action NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. Date FR Cite 05/07/18 06/25/18 83 FR 20164 08/17/18 10/01/18 83 FR 41144 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–AT27 289. FY 2019 Inpatient Psychiatric Facilities Prospective Payment System—Rate and Quality Reporting Updates (CMS–1690–F) (Completion of a Section 610 Review) E.O. 13771 Designation: Deregulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395f; 42 U.S.C. 1395g; 42 U.S.C. 1395hh; . . . Abstract: This annual final rule updates the prospective payment rates and quality reporting requirements for inpatient psychiatric facilities (IPF) with discharges beginning on October 1, 2018. This rule also includes updates to the IPF Quality Reporting Program. Timetable: E:\FR\FM\16NOP6.SGM 16NOP6 58030 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Unified Agenda Action Date amozie on DSK3GDR082PROD with PROPOSALS6 NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. VerDate Sep<11>2014 FR Cite 05/08/18 06/26/18 83 FR 21104 08/06/18 10/01/18 83 FR 38576 19:30 Nov 15, 2018 Jkt 247001 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Sherlene Jacques, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5–05–27, 7500 Security Blvd., Baltimore, MD PO 00000 Frm 00012 Fmt 4701 Sfmt 9990 21244, Phone: 410 786–0510, Email: sherlene.jacques@cms.hhs.gov. RIN: 0938–AT32 [FR Doc. 2018–24151 Filed 11–15–18; 8:45 am] BILLING CODE 4150–03–P E:\FR\FM\16NOP6.SGM 16NOP6

Agencies

[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)]
[Unknown Section]
[Pages 58019-58030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24151]



[[Page 58019]]

Vol. 83

Friday,

No. 222

November 16, 2018

Part VI





Department of Health and Human Services





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Semiannual Regulatory Agenda

Federal Register / Vol. 83 , No. 222 / Friday, November 16, 2018 / 
Unified Agenda

[[Page 58020]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

25 CFR Ch. V

42 CFR Chs. I-V

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


Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual Regulatory Agenda.

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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 webpage (https://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 webpage (https://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 https://www.RegInfo.gov.

Ann C. Agnew,
Executive Secretary to the Department.

              Office for Civil Rights--Proposed Rule Stage
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                                                           Regulation
       Sequence No.                    Title             Identifier No.
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254.......................  Nondiscrimination in               0945-AA11
                             Health Programs or
                             Activities.
------------------------------------------------------------------------


               Office for Civil Rights--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
255.......................  HIPAA Privacy Rule:                0945-AA08
                             Changing Requirement to
                             Obtain Acknowledgment of
                             Receipt of the Notice of
                             Privacy Practices.
------------------------------------------------------------------------


 Office of the National Coordinator for Health Information Technology--
                           Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
256.......................  21st Century Cures Act:            0955-AA01
                             Interoperability,
                             Information Blocking, and
                             the ONC Health IT
                             Certification Program.
------------------------------------------------------------------------


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
257.......................  Over-the-Counter (OTC)             0910-AF31
                             Drug Review-Cough/Cold
                             (Antihistamine) Products.
258.......................  Sunscreen Drug Products            0910-AF43
                             For Over-The-Counter-
                             Human Use; Tentative
                             Final Monograph.
259.......................  Label Requirement for Food         0910-AF61
                             That Has Been Refused
                             Admission Into the United
                             States.
260.......................  Laser Products; Amendment          0910-AF87
                             to Performance Standard.
261.......................  Mammography Quality                0910-AH04
                             Standards Act; Amendments
                             to Part 900 Regulations
                             (Reg Plan Seq No. 49).
262.......................  Medication Guides; Patient         0910-AH68
                             Medication Information.
263.......................  Testing Standards for              0910-AH90
                             Batteries and Battery
                             Management Systems in
                             Electronic Nicotine
                             Delivery Systems.
264.......................  Rule to Revoke Uses of             0910-AI15
                             Partially Hydrogenated
                             Oils in Foods.
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


[[Page 58021]]


              Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
265.......................  Postmarketing Safety               0910-AA97
                             Reporting Requirements
                             for Human Drug and
                             Biological Products.
266.......................  Food Labeling; Gluten-Free         0910-AH00
                             Labeling of Fermented,
                             Hydrolyzed, or Distilled
                             Foods.
------------------------------------------------------------------------


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
267.......................  Over-the-Counter (OTC)             0910-AF35
                             Drug Review--External
                             Analgesic Products.
268.......................  Over-the-Counter (OTC)             0910-AF36
                             Drug Review--Internal
                             Analgesic Products.
269.......................  Over-the-Counter (OTC)             0910-AF38
                             Drug Review--Laxative
                             Drug Products.
270.......................  Over-the-Counter (OTC)             0910-AF45
                             Drug Review--Weight
                             Control Products.
271.......................  Over-the-Counter (OTC)             0910-AG12
                             Drug Review--Pediatric
                             Dosing for Cough/Cold
                             Products.
272.......................  Electronic Distribution of         0910-AG18
                             Prescribing Information
                             for Human Prescription
                             Drugs Including
                             Biological Products.
273.......................  Sunlamp Products;                  0910-AG30
                             Amendment to the
                             Performance Standard.
274.......................  General and Plastic                0910-AH14
                             Surgery Devices: Sunlamp
                             Products.
275.......................  Combinations of                    0910-AH16
                             Bronchodilators With
                             Expectorants; Cold,
                             Cough, Allergy,
                             Bronchodilator, and
                             Antiasthmatic Drug
                             Products for Over-the-
                             Counter Human Use.
276.......................  Acute Nicotine Toxicity            0910-AH24
                             Warnings for E-Liquids.
277.......................  Administration Detention           0910-AI05
                             of Tobacco Products.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
278.......................  Requirements for Long-Term         0938-AT36
                             Care Facilities:
                             Regulatory Provisions to
                             Promote Program
                             Efficiency, Transparency,
                             and Burden Reduction (CMS-
                             3347-P) (Section 610
                             Review) (Reg Plan Seq No.
                             55).
279.......................  CY 2020 Revisions to               0938-AT72
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1715-P)
                             (Section 610 Review).
280.......................  Hospital Inpatient                 0938-AT73
                             Prospective Payment
                             System for Acute Care
                             Hospitals and the Long-
                             Term Care Hospital
                             Prospective Payment
                             System and FY 2020 Rates
                             (CMS-1716-P) (Section 610
                             Review).
281.......................  CY 2020 Hospital                   0938-AT74
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1717-
                             P) (Section 610 Review).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


        Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
282.......................  Hospital and Critical              0938-AS21
                             Access Hospital (CAH)
                             Changes to Promote
                             Innovation, Flexibility,
                             and Improvement in
                             Patient Care (CMS-3295-F)
                             (Rulemaking Resulting
                             From a Section 610
                             Review).
283.......................  CY 2019 Changes to the End-        0938-AT28
                             Stage Renal Disease
                             (ESRD) Prospective
                             Payment System, Quality
                             Incentive Program,
                             Durable Medical
                             Equipment, Prosthetics,
                             Orthotics, and Supplies
                             (DMEPOS) (CMS-1691-F)
                             (Section 610 Review).
284.......................  CY 2019 Home Health                0938-AT29
                             Prospective Payment
                             System Rate Update and CY
                             2020 Case-Mix Adjustment
                             Methodology
                             Refinements;Value-Based
                             Purchasing Model; Quality
                             Reporting Requirements
                             (CMS-1689-F) (Section 610
                             Review).
285.......................  CY 2019 Hospital                   0938-AT30
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1695-
                             F) (Section 610 Review).
286.......................  CY 2019 Revisions to               0938-AT31
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B and the Quality
                             Payment Program (CMS-1693-
                             F) (Section 610 Review).
------------------------------------------------------------------------


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


[[Page 58022]]


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
288.......................  Hospital Inpatient                 0938-AT27
                             Prospective Payment
                             System for Acute Care
                             Hospitals and the Long-
                             Term Care Hospital
                             Prospective Payment
                             System and FY 2019 Rates
                             (CMS-1694-F) (Completion
                             of a Section 610 Review).
289.......................  FY 2019 Inpatient                  0938-AT32
                             Psychiatric Facilities
                             Prospective Payment
                             System--Rate and Quality
                             Reporting Updates (CMS-
                             1690-F) (Completion of a
                             Section 610 Review).
------------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office for Civil Rights (OCR)

Proposed Rule Stage

254. Nondiscrimination in Health Programs or Activities

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: Sec. 1557 of the Patient Protection and Affordable 
Care Act (42 U.S.C. 18116)
    Abstract: This proposed rule implements Section 1557 of the Patient 
Protection and Affordable Care Act (PPACA), which prohibits 
discrimination on the basis of race, color, national origin, sex, age, 
and disability under any health program or activity, any part of which 
is receiving Federal financial assistance, including credits, 
subsidies, or contracts of insurance, or under any program or activity 
that is administered by an Executive Agency or any entity established 
under Title l of the PPACA.
    Timetable:

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

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Luben Montoya, Section Chief, Civil Rights 
Division, Department of Health and Human Services, Office for Civil 
Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 800 
368-1019, TDD Phone: 800 537-7697, Email: [email protected].
    RIN: 0945-AA11

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office for Civil Rights (OCR)

Completed Actions

255. 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: This proposed 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.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Merged With 0945-AA00...............   07/27/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Andra Wicks, Phone: 202 774-3081, TDD Phone: 800 
537-7697, Email: [email protected].
    RIN: 0945-AA08

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

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

Proposed Rule Stage

256. 21st Century Cures Act: Interoperability, Information Blocking, 
and the ONC Health IT Certification Program

    E.O. 13771 Designation: Regulatory.
    Legal Authority: Pub. L. 114-255
    Abstract: The rulemaking would implement certain provisions of the 
21st Century Cures Act, including conditions and maintenance of 
certification requirements for health information technology (IT) 
developers under the ONC Health IT Certification Program (Program), the 
voluntary certification of health IT for use by pediatric healthcare 
providers and reasonable and necessary activities that do not 
constitute information blocking. The rulemaking would also modify the 
2015 Edition health IT certification criteria and Program in additional 
ways to advance interoperability, enhance health IT certification, and 
reduce burden and costs.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Michael Lipinski, Director, Regulatory Affairs 
Division, Department of Health and Human Services, Office of the 
National Coordinator for Health Information Technology, Mary E. Switzer 
Building, 330 C Street SW, Washington, DC 20201, Phone: 202 690-7151.
    RIN: 0955-AA01

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Proposed Rule Stage

Food and Drug Administration (FDA)

257. 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 on a pilot basis. This proposed rule is the result of 
collaboration under the U.S.-Canada Regulatory Cooperation Council 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

[[Page 58023]]

 
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: [email protected].
    RIN: 0910-AF31

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM (Sunscreen and Insect            02/22/07  72 FR 7941
 Repellent).
ANPRM Comment Period End............   05/23/07
NPRM (UVA/UVB)......................   08/27/07  72 FR 49070
NPRM Comment Period End.............   12/26/07
Final Action (UVA/UVB)..............   06/17/11  76 FR 35620
NPRM (Effectiveness)................   06/17/11  76 FR 35672
NPRM (Effectiveness) Comment Period    09/15/11
 End.
ANPRM (Dosage Forms)................   06/17/11  76 FR 35669
ANPRM (Dosage Forms) Comment Period    09/15/11
 End.
NPRM................................   11/00/18
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Kristen Hardin, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 10903 New Hampshire Avenue, WO 22, Room 5491, Silver Spring, 
MD 20993, Phone: 240 402-4246, Fax: 301 796-9841, Email: 
[email protected].
    RIN: 0910-AF43

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

    E.O. 13771 Designation: Deregulatory.
    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: On September 18, 2008, FDA issued a proposed rule that 
would have required owners or consignees to label imported food that 
was refused entry into the United States. FDA does not plan to finalize 
the rule.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/18/08  73 FR 54106
NPRM Comment Period End.............   12/02/08
NPRM; Withdrawal....................   10/00/18
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AF61

260. Laser Products; Amendment to Performance Standard

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 
393
    Abstract: On June 24, 2013, FDA issued a proposed rule that would 
have amended the performance standard for laser products to achieve 
closer harmonization between the current standard and the amended 
International Electrotechnical Commission (IEC) standard for laser 
products and medical laser products. FDA does not plan to finalize the 
2013 proposal.
    Timetable:

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

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Erica Payne, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, 
Room 5522, Silver Spring, MD 20993, Phone: 301 796-3999, Fax: 301 847-
8145, Email: [email protected].
    RIN: 0910-AF87

261. Mammography Quality Standards Act; Amendments to Part 900 
Regulations

    Regulatory Plan: This entry is Seq. No. 49 in part II of this issue 
of the Federal Register.
    RIN: 0910-AH04

262. Medication Guides; Patient Medication Information

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 21 U.S.C. 321 et seq.; 42 U.S.C. 262; 42 U.S.C. 
264; 21 U.S.C. 371
    Abstract: The proposed rule would amend FDA medication guide 
regulations to require a new form of patient labeling, Patient 
Medication Information, for submission to and review by the FDA for 
human prescription drug products and certain blood products used, 
dispensed, or administered on an outpatient basis. The proposed rule 
would include requirements for Patient Medication Information 
development and distribution. The proposed rule would require clear and 
concisely written prescription drug product information presented in a 
consistent and easily understood format to help patients use their 
prescription drug products safely and effectively.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/00/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Chris Wheeler, Supervisory Project Manager, 
Department of Health and Human Services, Food and Drug Administration, 
10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD 
20993, Phone: 301 796-0151, Email: [email protected].
    RIN: 0910-AH68

263. Testing Standards for Batteries and Battery Management Systems in 
Electronic Nicotine Delivery Systems

    E.O. 13771 Designation: Regulatory.

[[Page 58024]]

    Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 371; 21 U.S.C. 
387(b); 21 U.S.C. 387(g); 21 U.S.C. 387i
    Abstract: This rule would propose to establish a product standard 
to require testing standards for batteries used in electronic nicotine 
delivery systems (ENDS) and require design protections including a 
battery management system for ENDS using batteries and protective 
housing for replaceable batteries. This product standard would protect 
the safety of users of battery-powered tobacco products and will help 
to streamline the FDA premarket review process, ultimately reducing the 
burden on both manufacturers and the Agency. The proposed rule would be 
applicable to tobacco products that include a non-user replaceable 
battery as well as products that include a user replaceable battery.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Darin Achilles, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, 
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, 
Fax: 301 595-1426, Email: [email protected].
    RIN: 0910-AH90

264.  Rule To Revoke Uses of Partially Hydrogenated Oils in 
Foods

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379(e)
    Abstract: In the Federal Register of June 17, 2015 (80 FR 34650), 
we published a declaratory order announcing our final determination 
that there is no longer a consensus among qualified experts that 
partially hydrogenated oils (PHOs) are generally recognized as safe 
(GRAS) for any use in human food. In the Federal Register of May 21, 
2018 (83 FR 23382), we denied a food additive petition requesting that 
the food additive regulations be amended to provide for the safe use of 
PHOs in certain food applications. We are now proposing to update our 
regulations to remove all mention of partially hydrogenated oils and to 
revoke all prior sanctioned uses. This rulemaking implements FDA's 
findings that the available data demonstrate that PHOs used in food may 
cause the food to be unsafe.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/19
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ellen Anderson, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, HFS-265, 
4300 River Road, College Park, MD 20740, Phone: 240 402-1309, Email: 
[email protected].
    RIN: 0910-AI15

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

265. 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).
    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..........................   05/00/19
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AA97

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

    E.O. 13771 Designation: Regulatory.
    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 final rule would establish requirements concerning 
``gluten-free'' labeling for foods that are fermented or hydrolyzed or 
that contain fermented or hydrolyzed ingredients. These additional 
requirements for the ``gluten-free'' labeling rule are needed to help 
ensure that individuals with celiac disease are not misled and receive 
truthful and accurate information with respect to fermented or 
hydrolyzed foods labeled as ``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 End....   02/22/16
NPRM Comment Period Reopened........   02/23/16  81 FR 8869
NPRM Comment Period Reopened End....   04/25/16
Final Rule..........................   12/00/18
------------------------------------------------------------------------

    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, 5001 Campus Drive, 
College

[[Page 58025]]

Park, MD 20740, Phone: 240 402-2371, Fax: 301 436-2636, Email: 
[email protected].
    RIN: 0910-AH00

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

267. 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. The proposed rule will address issues not addressed in 
previous rulemakings.
    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: 
[email protected].
    RIN: 0910-AF35

268. 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 drugs meeting the conditions of the monograph, or 
having an approved new drug application, may be legally marketed. The 
first action addresses acetaminophen safety. The second action 
addresses products marketed for children under 2 years old and weight- 
and age-based dosing for children's products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Amendment) (Required Warnings    12/26/06  71 FR 77314
 and Other Labeling).
NPRM Comment Period End.............   05/25/07
Final Action (Required Warnings and    04/29/09  74 FR 19385
 Other Labeling).
Final Action (Correction)...........   06/30/09  74 FR 31177
Final Action (Technical Amendment)..   11/25/09  74 FR 61512
                                     -----------------------------------
NPRM (Amendment) (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: [email protected].
    RIN: 0910-AF36

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

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective, 
and not misbranded. After a final monograph (i.e., final rule) is 
issued, only OTC drugs meeting the conditions of the monograph, or 
having an approved new drug application, may be legally marketed. The 
final rule listed will address the professional labeling for sodium 
phosphate drug products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Final Action (Granular Psyllium)....   03/29/07  72 FR 14669
NPRM (Professional Labeling--Sodium    02/11/11  76 FR 7743
 Phosphate).
NPRM Comment Period End.............   03/14/11
                                     -----------------------------------
Final Rule..........................           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Adams-King, Regulatory Health Project 
Manager, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO 22, Room 
5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 
796-3713, Fax: 301 796-9899, Email: [email protected].
    RIN: 0910-AF38

270. 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 final 
action finalizes the 2005 proposed rule for weight control products 
containing phenylpropanolamine.
    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: 
[email protected].
    RIN: 0910-AF45

[[Page 58026]]

271. 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: [email protected].
    RIN: 0910-AG12

272. 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 to 
353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21 
U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42 
U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264
    Abstract: This rule would require electronic package inserts for 
human drug and biological prescription products with limited 
exceptions, in lieu of paper, which is currently used. These inserts 
contain prescribing information intended for healthcare practitioners. 
This would ensure that the information accompanying the product is the 
most up-to-date information regarding important safety and efficacy 
issues about these products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   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: Michael Bernstein, Supervisory 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, 
Email: [email protected].
    RIN: 0910-AG18

273. Sunlamp Products; Amendment to the Performance Standard

    E.O. 13771 Designation: Fully or Partially Exempt.
    Legal Authority: 21 U.S.C. 360ii; 21 U.S.C. 360kk; 21 U.S.C. 393; 
21 U.S.C. 371
    Abstract: FDA is updating the performance standard for sunlamp 
products to improve safety, reflect new scientific information, and 
work towards harmonization with international standards. By harmonizing 
with the International Electrotechnical Commission, this rule will 
decrease the regulatory burden on industry and allow the Agency to take 
advantage of the expertise of the international committees, thereby 
also saving resources.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/22/15  80 FR 79505
NPRM Comment Period End.............   03/21/16  .......................
Final Rule..........................   06/00/20  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for 
Devices and Radiological Health, Department of Health and Human 
Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 
66, Room 5454, Silver Spring, MD 20993, Phone: 301 796-5678, Email: 
[email protected].
    RIN: 0910-AG30

274. 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. Sunlamp products include ultraviolet (UV) lamps and UV 
tanning beds and booths. 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 use of sunlamp products at young ages, as well as 
frequently using sunlamp products, both increases 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.This rule would apply device 
restrictions to sunlamp products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/22/15  80 FR 79493
NPRM Comment Period End.............   03/21/16  .......................
Final Rule..........................   06/00/20  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for 
Devices and Radiological Health, Department of Health and Human 
Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 
66, Room 5454, Silver Spring, MD 20993, Phone: 301 796-5678, Email: 
[email protected].
    RIN: 0910-AH14

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

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

[[Page 58027]]

    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: [email protected].
    RIN: 0910-AH16

276. Acute Nicotine Toxicity Warnings for E-Liquids

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 331; 21 U.S.C. 
371; 21 U.S.C. 374; 21 U.S.C. 387
    Abstract: This rule would establish nicotine exposure warning 
requirements for liquid nicotine and nicotine-containing e-liquid(s) 
that are made or derived from tobacco and intended for human 
consumption, and potentially for other tobacco products including, but 
not limited to, novel tobacco products such as dissolvables, lotions, 
gels, and drinks. This action is intended to protect users and non-
users from accidental exposures to nicotine-containing e-liquids in 
tobacco products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/20  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Courtney Smith, 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: 301 595-1426, Email: [email protected].
    RIN: 0910-AH24

277. Administration Detention of Tobacco Products

    E.O. 13771 Designation: Other.
    Legal Authority: 21 U.S.C. 334; 21 U.S.C. 371
    Abstract: The Food and Drug Administration (FDA) is proposing 
regulations to establish requirements for the administrative detention 
of tobacco products. This action, if finalized, would allow FDA to 
administratively detain tobacco products encountered during inspections 
that an officer or employee conducting the inspection has reason to 
believe are adulterated or misbranded. The intent of administrative 
detention is to protect public health by preventing the distribution or 
use of violative tobacco products until FDA has had time to consider 
the appropriate action to take and, where appropriate, to initiate a 
regulatory action.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/00/20  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Darin Achilles, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, 
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, 
Fax: 301 595-1426, Email: [email protected].
    RIN: 0910-AI05

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

278. Requirements for Long-Term Care Facilities: Regulatory Provisions 
To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-
3347-P) (Section 610 Review)

    Regulatory Plan: This entry is Seq. No. 55 in part II of this issue 
of the Federal Register.
    RIN: 0938-AT36

279.  CY 2020 Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Medicare Part B (CMS-1715-P) 
(Section 610 Review)

    E.O. 13771 Designation: Other.
    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, 2020. Additionally, this rule 
proposes updates to the Quality Payment Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/19  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Marge Watchorn, Deputy 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: 410 786-4361, 
Email: [email protected].
    RIN: 0938-AT72

280.  Hospital Inpatient Prospective Payment System for Acute 
Care Hospitals and the Long-Term Care Hospital Prospective Payment 
System and FY 2020 Rates (CMS-1716-P) (Section 610 Review)

    E.O. 13771 Designation: Other.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual proposed rule would revise the Medicare 
hospital inpatient and long-term care hospital prospective payment 
systems for operating and capital-related costs. This proposed rule 
would implement changes arising from our continuing experience with 
these systems. In addition, the rule proposes to establish new 
requirements or revise existing requirements for quality reporting by 
specific Medicare providers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/00/19  .......................
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0938-AT73

[[Page 58028]]

281.  CY 2020 Hospital Outpatient PPS Policy Changes and 
Payment Rates and Ambulatory Surgical Center Payment System Policy 
Changes and Payment Rates (CMS-1717-P) (Section 610 Review)

    E.O. 13771 Designation: Other.
    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. This proposed rule would also update and 
refine the requirements for the Hospital Outpatient Quality Reporting 
(OQR) Program and the ASC Quality Reporting (ASCQR) Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/19  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Marjorie Baldo, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-4617, Email: 
[email protected].
    RIN: 0938-AT74

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

282. 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, 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--To Be Merged With 0938-  06/00/19  .......................
 AS59 and 0938-AT23.
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AS21

283. CY 2019 Changes to the End-Stage Renal Disease (ESRD) Prospective 
Payment System, Quality Incentive Program, Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies (DMEPOS) (CMS-1691-F) (Section 610 
Review)

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395d(d); 42 U.S.C. 
1395f(b); 42 U.S.C 1395g
    Abstract: This annual final rule updates the bundled payment system 
for ESRD facilities by January 1, 2019. The rule also updates the 
quality incentives in the ESRD program and implements changes to the 
DMEPOS competitive bidding program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/19/18  83 FR 34304
NPRM Comment Period End.............   09/10/18  .......................
Final Action........................   11/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janae James, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C5-05-27, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-0801, Email: 
[email protected].
    RIN: 0938-AT28

284. CY 2019 Home Health Prospective Payment System Rate Update and CY 
2020 Case-Mix Adjustment Methodology Refinements; Value-Based 
Purchasing Model; Quality Reporting Requirements (CMS-1689-F) (Section 
610 Review)

    E.O. 13771 Designation: Other.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1315a; 42 U.S.C. 
1395(hh)
    Abstract: This annual final rule updates the payment rates under 
the Medicare prospective payment system for home health agencies. In 
addition, this rule finalizes changes to the Home Health Value-Based 
Purchasing (HHVBP) Model and to the Home Health Quality Reporting 
Program (HH QRP).
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/12/18  83 FR 32340
NPRM Comment Period End.............   08/31/18  .......................
Final Action........................   11/00/18
------------------------------------------------------------------------

    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: C5-08-28, 7500 
Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0456, Email: 
[email protected].
    RIN: 0938-AT29

285. CY 2019 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1695-F) (Section 610 Review)

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual final rule would 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 
finalizes changes to the ambulatory surgical center payment system list 
of services and rates. 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................................   07/31/18  83 FR 37046

[[Page 58029]]

 
NPRM Comment Period End.............   09/24/18
Final Action........................   11/00/18
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Marjorie Baldo, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-4617, Email: 
[email protected].
    RIN: 0938-AT30

286. CY 2019 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B and the Quality Payment 
Program (CMS-1693-F) (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, 2019. Additionally, this rule updates 
the Quality Payment Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/27/18  83 FR 35704
NPRM Comment Period End.............   09/10/18  .......................
Final Action........................   11/00/18
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Marge Watchorn, Deputy 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: 410 786-4361, 
Email: [email protected].
    RIN: 0938-AT31

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

287. Durable Medical Equipment Fee Schedule, Adjustments To Resume the 
Transitional 50/50 Blended Rates To Provide Relief in Non-Competitive 
Bidding Areas (CMS-1687-F) (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) and 16008
    Abstract: This final rule follows the interim final rule that 
published May 11, 2018, and extended 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, the rule amended the regulation to 
resume the transition period for items furnished from August 1, 2017, 
through December 31, 2018. The rule also made technical amendments to 
existing regulations for DMEPOS items and services to exclude infusion 
drugs used with DME from the DMEPOS CBP.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   05/11/18  83 FR 21912
Interim Final Rule Comment Period      07/09/18  .......................
 End.
Final Action........................   05/00/21
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    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: 
[email protected].
    RIN: 0938-AT21

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

288. Hospital Inpatient Prospective Payment System for Acute Care 
Hospitals and the Long-Term Care Hospital Prospective Payment System 
and FY 2019 Rates (CMS-1694-F) (Completion of a Section 610 Review)

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual final rule revises 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. In addition, 
the rule establishes new requirements or revises existing requirements 
for quality reporting by specific Medicare providers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/07/18  83 FR 20164
NPRM Comment Period End.............   06/25/18  .......................
Final Action........................   08/17/18  83 FR 41144
Final Action Effective..............   10/01/18
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0938-AT27

289. FY 2019 Inpatient Psychiatric Facilities Prospective Payment 
System--Rate and Quality Reporting Updates (CMS-1690-F) (Completion of 
a Section 610 Review)

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395f; 42 U.S.C. 1395g; 
42 U.S.C. 1395hh; . . .
    Abstract: This annual final rule updates the prospective payment 
rates and quality reporting requirements for inpatient psychiatric 
facilities (IPF) with discharges beginning on October 1, 2018. This 
rule also includes updates to the IPF Quality Reporting Program.
    Timetable:

[[Page 58030]]



------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/08/18  83 FR 21104
NPRM Comment Period End.............   06/26/18  .......................
Final Action........................   08/06/18  83 FR 38576
Final Action Effective..............   10/01/18
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sherlene Jacques, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C5-05-27, 7500 Security 
Blvd., Baltimore, MD 21244, Phone: 410 786-0510, Email: 
[email protected].
    RIN: 0938-AT32

[FR Doc. 2018-24151 Filed 11-15-18; 8:45 am]
 BILLING CODE 4150-03-P

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