Regulatory Agenda, 27125-27135 [2018-11239]

Download as PDF Vol. 83 Monday, No. 112 June 11, 2018 Part VII Department of Health and Human Services daltland on DSKBBV9HB2PROD with PROPOSALS3 Semiannual Regulatory Agenda VerDate Sep<11>2014 20:22 Jun 08, 2018 Jkt 244001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\11JNP7.SGM 11JNP7 27126 Federal Register / Vol. 83, No. 112 / Monday, June 11, 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. underlying medicine, public health, and ACTION: Semiannual regulatory agenda. 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 web C. Agnew, Executive Secretary, DEPARTMENT OF HEALTH AND HUMAN SERVICES page (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 web page (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 83 ...................... HIPAA Privacy Rule: Changing Requirement to Obtain Acknowledgment of Receipt of the Notice of Privacy Practices. Nondiscrimination in Health Programs or Activities ......................................................................................... 84 ...................... 0945–AA08 0945–AA11 OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 85 ...................... Health Information Technology: Certification and Interoperability Enhancements .......................................... 0955–AA01 FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE Sequence No. 86 87 88 89 90 ...................... ...................... ...................... ...................... ...................... 91 ...................... 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 ......................... Mammography Quality Standards Act; Amendments to Part 900 Regulations .............................................. Medication Guides; Patient Medication Information ........................................................................................ Testing Standards for Batteries and Battery Management Systems in Electronic Nicotine Delivery Systems. Administration Detention of Tobacco Products ............................................................................................... 0910–AF31 0910–AF43 0910–AH04 0910–AH68 0910–AH90 0910–AI05 daltland on DSKBBV9HB2PROD with PROPOSALS3 FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE Sequence No. 92 93 94 95 ...................... ...................... ...................... ...................... VerDate Sep<11>2014 Regulation Identifier No. Title Postmarketing Safety Reporting Requirements for Human Drug and Biological Products ............................ Label Requirement for Food That Has Been Refused Admission Into the United States .............................. Laser Products; Amendment to Performance Standard .................................................................................. Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods ..................................... 20:22 Jun 08, 2018 Jkt 244001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\11JNP7.SGM 11JNP7 0910–AA97 0910–AF61 0910–AF87 0910–AH00 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Unified Agenda 27127 FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 96 ...................... 97 ...................... 98 ...................... 99 ...................... 100 .................... 101 .................... 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. Nicotine Exposure Warning and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquids, and Other Tobacco Products. 102 .................... 103 .................... 104 .................... 105 .................... 0910–AF35 0910–AF36 0910–AF38 0910–AF45 0910–AG12 0910–AG18 0910–AG30 0910–AH14 0910–AH16 0910–AH24 FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 106 .................... 107 .................... Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices ............... Safety and Effectiveness of Healthcare Antiseptics; Topical Antimicrobial Drug Products for Over-theCounter Human Use. 0910–AG48 0910–AH40 CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 108 .................... Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (CMS–3346– P). FY 2019 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFs) (CMS–1696–P). Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2019 Rates (CMS–1694–P) (Section 610 Review). CY 2019 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1695–P) (Section 610 Review). CY 2019 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1693–P) (Section 610 Review). 109 .................... 110 .................... 111 .................... 112 .................... 0938–AT23 0938–AT24 0938–AT27 0938–AT30 0938–AT31 CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 113 .................... Durable Medical Equipment Fee Schedule, Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Non-Competitive Bidding Areas (CMS–1687–IFC) (Section 610 Review). 0938–AT21 CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 114 .................... Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (CMS–3295–F) (Rulemaking Resulting From a Section 610 Review). 0938–AS21 daltland on DSKBBV9HB2PROD with PROPOSALS3 CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 115 .................... CY 2019 Notice of Benefit and Payment Parameters (CMS–9930–F) (Completion of a Section 610 Review). VerDate Sep<11>2014 20:22 Jun 08, 2018 Jkt 244001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\11JNP7.SGM 11JNP7 0938–AT12 27128 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Unified Agenda Timetable: DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Action Office for Civil Rights (OCR) Date FR Cite Proposed Rule Stage NPRM .................. 83. HIPAA Privacy Rule: Changing Requirement To Obtain Acknowledgment of Receipt of the Notice of Privacy Practices Regulatory Flexibility Analysis Required: Yes. Agency Contact: Maya Noronha, Special Advisor, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Room 516E, Washington, DC 20201, Phone: 202 568–0028, Email: maya.noronha@hhs.gov. RIN: 0945–AA11 E.O. 13771 Designation: Deregulatory. Legal Authority: Health Insurance Portability and Accountability (HIPAA) Act of 1996, Pub. L. 104–191 Abstract: The propsed rule would change the requirement that health care providers make a good faith effort to obtain from individuals a written acknowledgment of receipt of the provider’s notice of privacy practices, and if not obtained, to document its good faith efforts and the reason the acknowledgment was not obtained. Timetable: Action Date NPRM .................. FR Cite 09/00/18 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Andra Wicks, Health Information Privacy Specialist, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 202 774–3081, TDD Phone: 800 537–7697, Email: andra.wicks@hhs.gov. RIN: 0945–AA08 daltland on DSKBBV9HB2PROD with PROPOSALS3 84. • 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: The 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, or disability under any health program or activity receiving Federal financial assistance, or under any program or activity that is administered by the Department of Health and Human Services or by an entity established under title I of the PPACA. The proposed rule applies the enforcement mechanisms provided for and available under Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.), Title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.), the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.), and Section 504 of the Rehabilitation Act (29 U.S.C. 794). VerDate Sep<11>2014 20:22 Jun 08, 2018 Jkt 244001 07/00/18 Proposed Rule Stage DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office of the National Coordinator for Health Information Technology (ONC) Proposed Rule Stage 85. Health Information Technology: Certification and Interoperability Enhancements E.O. 13771 Designation: Regulatory. Legal Authority: Pub. L. 114–255 Abstract: The rulemaking would update the ONC Health IT Certification Program (Program) by implementing certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (IT) developers, the voluntary certification of health IT for use by pediatric healthcare providers, health information network voluntary attestation to the adoption of a trusted exchange framework and common agreement in support of network-tonetwork exchange, and reasonable and necessary activities that do not constitute information blocking. The rulemaking would also modify the Program through other complementary means to advance health IT certification and interoperability. Timetable: Action Date NPRM .................. FR Cite 09/00/18 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 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 Food and Drug Administration (FDA) 86. Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: FDA will be proposing a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients. This proposed rule is the result of collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC) as part of efforts to reduce unnecessary duplication and differences. This pilot exercise will help determine the feasibility of developing an ongoing mechanism for alignment in review and adoption of OTC drug monograph elements. Timetable: Action Reopening of Administrative Record. Comment Period End. NPRM (Amendment) (Common Cold). Date 08/25/00 FR Cite 65 FR 51780 11/24/00 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 87. Sunscreen Drug Products for Overthe-Counter-Human Use; Tentative Final Monograph E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 Abstract: The proposed rule will address the general recognition of safety and effectiveness (GRASE) status of the 16 sunscreen monograph ingredients and describe data gaps that FDA believes need to be filled in order for FDA to permit the continued marketing of these ingredients without submitting new drug applications for premarket E:\FR\FM\11JNP7.SGM 11JNP7 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Unified Agenda review. Consistent with the Sunscreen Innovation Act, we also expect to address sunscreen dosage forms and maximum SPF values. Timetable: 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 12/00/18 daltland on DSKBBV9HB2PROD with PROPOSALS3 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 Ave., 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 .................. Regulatory Flexibility Analysis Required: Yes. VerDate Sep<11>2014 20:22 Jun 08, 2018 Jkt 244001 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: Date NPRM .................. FR Cite 08/00/18 89. Medication Guides; Patient Medication Information Action 88. Mammography Quality Standards Act; Amendments to Part 900 Regulations E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e); 42 U.S.C. 263b Abstract: FDA is proposing to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA). FDA is taking this action to address changes in mammography technology and mammography processes that have occurred since the regulations were published in 1997 and to address breast density reporting to patient and health care providers. Timetable: Action 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–AH04 FR Cite 02/00/19 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 27129 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 NPRM .................. Date FR Cite 12/00/18 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Colleen Lee, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 71, Room G335, Silver Spring, MD 20993, Phone: 877 287–1373, Email: ctpregulations@ fda.hhs.gov. RIN: 0910–AH90 91. • 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 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 90. Testing Standards for Batteries and Battery Management Systems in Electronic Nicotine Delivery Systems NPRM .................. E.O. 13771 Designation: Regulatory. 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 through a battery management system for ENDS using batteries. This product standard would protect the safety of 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. PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 E:\FR\FM\11JNP7.SGM 11JNP7 11/00/18 27130 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Unified Agenda 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 RIN: 0910–AI05 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 92. Postmarketing Safety Reporting Requirements for Human Drug and Biological Products E.O. 13771 Designation: Regulatory. Legal Authority: 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 242a; 42 U.S.C. 262 and 263; 42 U.S.C. 263a to 263n; 42 U.S.C. 264; 42 U.S.C. 300aa; 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 360b to 360j; 21 U.S.C. 361a; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379e; 21 U.S.C. 381 Abstract: The final rule would amend the postmarketing safety reporting regulations for human drugs and biological products including blood and blood products in order to better align FDA requirements with guidelines of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); and to update reporting requirements in light of current pharmacovigilance practice and safety information sources and enhance the quality of safety reports received by FDA. These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. Premarketing safety reporting requirements were finalized in a separate final rule published on September 29, 2010 (75 FR 59961). This final rule applies to postmarketing safety reporting requirements. Timetable: daltland on DSKBBV9HB2PROD with PROPOSALS3 Action Date NPRM .................. NPRM Comment Period Extended. NPRM Comment Period End. NPRM Comment Period Extension End. Final Rule ............ 03/14/03 06/18/03 FR Cite 68 FR 12406 07/14/03 10/14/03 12/00/18 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug VerDate Sep<11>2014 20:22 Jun 08, 2018 Jkt 244001 The amendment is intended to update FDA’s performance standard to reflect advancements in technology. Timetable: 93. 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: The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, ‘‘UNITED STATES: REFUSED ENTRY.’’ The proposal describes the label’s characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107–188). Timetable: NPRM .................. NPRM Comment Period End. NPRM; Withdrawal. Action Date NPRM .................. NPRM Comment Period End. NPRM; Withdrawal. 09/18/08 12/02/08 FR Cite 73 FR 54106 08/00/18 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 94. 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: FDA is proposing to amend the 2013 proposed rule for the performance standard for laser products, which will amend the performance standard for laser products to achieve closer harmonization between the current standard and the recently amended International Electrotechnical Commission (IEC) standard for laser products and medical laser products. PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 Action Date 06/24/13 09/23/13 FR Cite 78 FR 37723 08/00/18 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: erica.payne@fda.hhs.gov. RIN: 0910–AF87 95. 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. 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 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, E:\FR\FM\11JNP7.SGM 11JNP7 27131 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Unified Agenda HFS 820, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402–2371, Fax: 301 436–2636, Email: carol.dlima@fda.hhs.gov. RIN: 0910–AH00 Action DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Long-Term Actions 96. 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 NPRM .......... Date FR Cite To Be Determined daltland on DSKBBV9HB2PROD with PROPOSALS3 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 97. 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 VerDate Sep<11>2014 20:22 Jun 08, 2018 Jkt 244001 acetaminophen safety. The second 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 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 98. 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 PO 00000 Frm 00007 NPRM Comment Period End. Final Rule ............ Date 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 99. Over-the-Counter (OTC) Drug Review—Weight Control Products NPRM (Amendment) (Acetaminophen). Date Final Action (Granular Psyllium). NPRM (Professional Labeling—Sodium Phosphate). Action FR Cite 03/29/07 72 FR 14669 02/11/11 76 FR 7743 Fmt 4701 Sfmt 4702 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\11JNP7.SGM 11JNP7 27132 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Unified Agenda 100. 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 daltland on DSKBBV9HB2PROD with PROPOSALS3 101. 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 20:22 Jun 08, 2018 Jkt 244001 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 103. 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: 102. 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 12/00/19 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 5515, 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 12/00/19 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 5515, Silver Spring, MD 20993, Phone: 301 796–5678, Email: ian.ostermiller@ fda.hhs.gov. RIN: 0910–AH14 104. 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\11JNP7.SGM 11JNP7 27133 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Unified Agenda Timetable: DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 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 105. Nicotine Exposure Warning and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing ELiquids, and Other Tobacco Products 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 and childresistant packaging 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 eliquids in tobacco products Timetable: Action Date daltland on DSKBBV9HB2PROD with PROPOSALS3 NPRM .................. FR Cite 03/00/20 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 VerDate Sep<11>2014 20:22 Jun 08, 2018 Jkt 244001 Food and Drug Administration (FDA) Completed Actions 106. Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices E.O. 13771 Designation: Deregulatory. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C. 360i; 21 U.S.C. 360j; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21 U.S.C. 393; 42 U.S.C. 264; 42 U.S.C. 271; . . . Abstract: This rule updates FDA’s requirements for accepting clinical data used to bring new medical devices to market as part of fulfilling FDA’s mission. While helping to ensure the quality and integrity of clinical trial data and the protection of study participants, this rule should reduce burden on industry by avoiding the need for onsite inspections. This rule parallels the drug regulation, which should further reduce burden by having a harmonized approach. Under this new rule, a device applicant would provide FDA with information about the conduct of their study such as, the research sites where the study was conducted, the investigators who conducted the study, a summary of the protocol, information about how informed consent from the study participants was obtained, and information about the ethics committee that reviewed the study. (If such information is not available, the sponsor may explain why and request a waiver.) Completed: Reason Date Final Action ......... Final Action Effective. 02/21/18 02/21/19 FR Cite 83 FR 7366 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Soma Kalb, Phone: 301 796–6359, Email: soma.kalb@ fda.hhs.gov. RIN: 0910–AG48 107. Safety and Effectiveness of Healthcare Antiseptics; Topical Antimicrobial Drug Products for Overthe-Counter Human Use E.O. 13771 Designation: Regulatory. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360b to 360f; 21 U.S.C. 360j; 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 374 to 375; 21 U.S.C. 379e; 42 U.S.C. 241; 42 U.S.C. 262; . . . PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 Abstract: This rulemaking addresses whether FDA considers certain active ingredients in over-the-counter (OTC) healthcare antiseptic hand wash and healthcare antiseptic products to be generally recognized as safe and effective. If FDA determines that the ingredient is not generally recognized as safe and effective, a manufacturer will not be able to market the product unless it submits and receives approval of a new drug application. Completed: Reason Final Action ......... Final Action Effective. Date 12/20/17 12/20/18 FR Cite 82 FR 60474 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Michelle Jackson, Phone: 301 796–0923, Email: michelle.jackon@fda.hhs.gov. RIN: 0910–AH40 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage 108. Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS–3346–P) E.O. 13771 Designation: Deregulatory. Legal Authority: 42 U.S.C. 263a; 42 U.S.C. 273; 42 U.S.C. 1302; 42 U.S.C. 1320a–7; . . . Abstract: This proposed rule would reform Medicare regulations that are unnecessary, obsolete, or excessively burdensome on healthcare providers and suppliers. This rule would increase the ability of healthcare professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care. Timetable: Action NPRM .................. Date FR Cite 05/00/18 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Alpha-Banu Huq, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, MS: S3–02–01, 7500 Security Boulevard, Baltimore, MD 21244, E:\FR\FM\11JNP7.SGM 11JNP7 27134 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Unified Agenda Phone: 410 786–8687, Email: alpha.huq@cms.hhs.gov. RIN: 0938–AT23 109. FY 2019 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFS) (CMS–1696–P) E.O. 13771 Designation: Deregulatory. Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual proposed rule would update the payment rates used under the prospective payment system for SNFs for fiscal year 2019. The rule also includes proposals for the SNF Quality Reporting Program (QRP) and for the Skilled Nursing Facility ValueBased Purchasing (VBP) Program that will affect Medicare payment to SNFs. Timetable: Action Date NPRM .................. FR Cite 05/00/18 daltland on DSKBBV9HB2PROD with PROPOSALS3 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Bill Ullman, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5–06–27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–5667, Fax: 410 786–0765, Email: william.ullman@ cms.hhs.gov. RIN: 0938–AT24 110. Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2019 Rates (CMS–1694–P) (Section 610 Review) 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 NPRM .................. FR Cite 05/00/18 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Donald Thompson, Deputy Director, Division of Acute Care, VerDate Sep<11>2014 20:22 Jun 08, 2018 Jkt 244001 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 111. CY 2019 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1695–P) (Section 610 Review) E.O. 13771 Designation: 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 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 06/00/18 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 112. CY 2019 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1693–P) (Section 610 Review) E.O. 13771 Designation: 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, 2019. Additionally, this rule proposes updates to the third PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 and future years of the Quality Payment Program. Timetable: Action NPRM .................. Date FR Cite 06/00/18 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ryan Howe, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4–01–15, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–3355, Email: ryan.howe@cms.hhs.gov. RIN: 0938–AT31 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Final Rule Stage 113. Durable Medical Equipment Fee Schedule, Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Non-Competitive Bidding Areas (CMS–1687–IFC) (Section 610 Review) E.O. 13771 Designation: Other. 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 interim final rule with comment period extends the end of the transition period for phasing in adjustments to the fee schedule amounts for certain durable medical equipment (DME) and enteral nutrition paid in areas not subject to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) from June 30, 2016, to December 31, 2016. In addition, this interim final rule with comment period amends the regulation to resume the transition period for items furnished from August 1, 2017, through December 31, 2018. This interim final rule with comment period also makes technical amendments to existing regulations for DMEPOS items and services to exclude infusion drugs used with DME from the DMEPOS CBP. Finally, this interim final rule with comment period also requests information on issues related to adjustments to DMEPOS fee schedules, alternatives for ensuring budget neutrality of oxygen payment classes, and current rules under the DMEPOS CBP. Timetable: E:\FR\FM\11JNP7.SGM 11JNP7 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Unified Agenda Action Date Interim Final Rule FR Cite 05/00/18 Regulatory Flexibility Analysis Required: Undetermined. Agency Contact: Alexander Ullman, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5–07–26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–9671, Email: alexander.ullman@cms.hhs.gov. RIN: 0938–AT21 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Long-Term Actions daltland on DSKBBV9HB2PROD with PROPOSALS3 114. 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 VerDate Sep<11>2014 20:22 Jun 08, 2018 Jkt 244001 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 NPRM .................. NPRM Comment Period End. Final Action ......... 06/16/16 08/15/16 FR Cite 81 FR 39447 06/00/19 Regulatory Flexibility Analysis Required: No. Agency Contact: CDR Scott Cooper, Senior Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S3–01–02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–9465, Email: scott.cooper@cms.hhs.gov. RIN: 0938–AS21 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Completed Actions 115. CY 2019 Notice of Benefit and Payment Parameters (CMS–9930–F) (Completion of a Section 610 Review) Legal Authority: Pub. L. 111–148, title I Abstract: This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform. Timetable: Action NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. Frm 00011 Fmt 4701 Sfmt 9990 Date FR Cite 11/02/17 11/27/17 82 FR 51052 04/17/18 06/18/18 83 FR 16930 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Lindsey Murtagh, Senior Policy Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492–4106, Email: lindsey.murtagh@cms.hhs.gov. RIN: 0938–AT12 [FR Doc. 2018–11239 Filed 6–8–18; 8:45 am] BILLING CODE 4850–03–P E.O. 13771 Designation: Deregulatory. PO 00000 27135 E:\FR\FM\11JNP7.SGM 11JNP7

Agencies

[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Unknown Section]
[Pages 27125-27135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11239]



[[Page 27125]]

Vol. 83

Monday,

No. 112

June 11, 2018

Part VII





Department of Health and Human Services





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Semiannual Regulatory Agenda

Federal Register / Vol. 83 , No. 112 / Monday, June 11, 2018 / 
Unified Agenda

[[Page 27126]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

25 CFR Ch. V

42 CFR Chs. I-V

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


Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual regulatory agenda.

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

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

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

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services 
(HHS) is the Federal government's lead agency for protecting the health 
of all Americans and providing essential human services, especially for 
those who are least able to help themselves. HHS enhances the health 
and well-being of Americans by promoting effective health and human 
services and by fostering sound, sustained advances in the sciences 
underlying medicine, public health, and social services.
    This Agenda presents the regulatory activities that the Department 
expects to undertake in the foreseeable future to advance this mission. 
HHS has an agency-wide effort to support the Agenda's purpose of 
encouraging more effective public participation in the regulatory 
process. For example, to encourage public participation, we regularly 
update our regulatory web page (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 web page (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
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
83........................  HIPAA Privacy Rule:                0945-AA08
                             Changing Requirement to
                             Obtain Acknowledgment of
                             Receipt of the Notice of
                             Privacy Practices.
84........................  Nondiscrimination in               0945-AA11
                             Health Programs or
                             Activities.
------------------------------------------------------------------------


 Office of the National Coordinator for Health Information Technology--
                           Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
85........................  Health Information                 0955-AA01
                             Technology: Certification
                             and Interoperability
                             Enhancements.
------------------------------------------------------------------------


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
86........................  Over-the-Counter (OTC)             0910-AF31
                             Drug Review--Cough/Cold
                             (Antihistamine) Products.
87........................  Sunscreen Drug Products            0910-AF43
                             For Over-The-Counter-
                             Human Use; Tentative
                             Final Monograph.
88........................  Mammography Quality                0910-AH04
                             Standards Act; Amendments
                             to Part 900 Regulations.
89........................  Medication Guides; Patient         0910-AH68
                             Medication Information.
90........................  Testing Standards for              0910-AH90
                             Batteries and Battery
                             Management Systems in
                             Electronic Nicotine
                             Delivery Systems.
91........................  Administration Detention           0910-AI05
                             of Tobacco Products.
------------------------------------------------------------------------


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
92........................  Postmarketing Safety               0910-AA97
                             Reporting Requirements
                             for Human Drug and
                             Biological Products.
93........................  Label Requirement for Food         0910-AF61
                             That Has Been Refused
                             Admission Into the United
                             States.
94........................  Laser Products; Amendment          0910-AF87
                             to Performance Standard.
95........................  Food Labeling; Gluten-Free         0910-AH00
                             Labeling of Fermented,
                             Hydrolyzed, or Distilled
                             Foods.
------------------------------------------------------------------------


[[Page 27127]]


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
96........................  Over-the-Counter (OTC)             0910-AF35
                             Drug Review--External
                             Analgesic Products.
97........................  Over-the-Counter (OTC)             0910-AF36
                             Drug Review--Internal
                             Analgesic Products.
98........................  Over-the-Counter (OTC)             0910-AF38
                             Drug Review--Laxative
                             Drug Products.
99........................  Over-the-Counter (OTC)             0910-AF45
                             Drug Review--Weight
                             Control Products.
100.......................  Over-the-Counter (OTC)             0910-AG12
                             Drug Review--Pediatric
                             Dosing for Cough/Cold
                             Products.
101.......................  Electronic Distribution of         0910-AG18
                             Prescribing Information
                             for Human Prescription
                             Drugs Including
                             Biological Products.
102.......................  Sunlamp Products;                  0910-AG30
                             Amendment to the
                             Performance Standard.
103.......................  General and Plastic                0910-AH14
                             Surgery Devices: Sunlamp
                             Products.
104.......................  Combinations of                    0910-AH16
                             Bronchodilators With
                             Expectorants; Cold,
                             Cough, Allergy,
                             Bronchodilator, and
                             Antiasthmatic Drug
                             Products for Over-the-
                             Counter Human Use.
105.......................  Nicotine Exposure Warning          0910-AH24
                             and Child-Resistant
                             Packaging for Liquid
                             Nicotine, Nicotine-
                             Containing E-Liquids, and
                             Other Tobacco Products.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
106.......................  Human Subject Protection;          0910-AG48
                             Acceptance of Data From
                             Clinical Investigations
                             for Medical Devices.
107.......................  Safety and Effectiveness           0910-AH40
                             of Healthcare
                             Antiseptics; Topical
                             Antimicrobial Drug
                             Products for Over-the-
                             Counter Human Use.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
108.......................  Regulatory Provisions to           0938-AT23
                             Promote Program
                             Efficiency, Transparency,
                             and Burden Reduction (CMS-
                             3346-P).
109.......................  FY 2019 Prospective                0938-AT24
                             Payment System and
                             Consolidated Billing for
                             Skilled Nursing
                             Facilities (SNFs) (CMS-
                             1696-P).
110.......................  Hospital Inpatient                 0938-AT27
                             Prospective Payment
                             System for Acute Care
                             Hospitals and the Long-
                             Term Care Hospital
                             Prospective Payment
                             System and FY 2019 Rates
                             (CMS-1694-P) (Section 610
                             Review).
111.......................  CY 2019 Hospital                   0938-AT30
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1695-
                             P) (Section 610 Review).
112.......................  CY 2019 Revisions to               0938-AT31
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1693-P)
                             (Section 610 Review).
------------------------------------------------------------------------


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


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


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
115.......................  CY 2019 Notice of Benefit          0938-AT12
                             and Payment Parameters
                             (CMS-9930-F) (Completion
                             of a Section 610 Review).
------------------------------------------------------------------------


[[Page 27128]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office for Civil Rights (OCR)

Proposed Rule Stage

83. HIPAA Privacy Rule: Changing Requirement To Obtain Acknowledgment 
of Receipt of the Notice of Privacy Practices

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

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

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Andra Wicks, Health Information Privacy Specialist, 
Department of Health and Human Services, Office for Civil Rights, 200 
Independence Avenue SW, Washington, DC 20201, Phone: 202 774-3081, TDD 
Phone: 800 537-7697, Email: [email protected].
    RIN: 0945-AA08

84.  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: The 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, 
or disability under any health program or activity receiving Federal 
financial assistance, or under any program or activity that is 
administered by the Department of Health and Human Services or by an 
entity established under title I of the PPACA. The proposed rule 
applies the enforcement mechanisms provided for and available under 
Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.), 
Title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.), 
the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.), and 
Section 504 of the Rehabilitation Act (29 U.S.C. 794).
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Maya Noronha, Special Advisor, Department of Health 
and Human Services, Office for Civil Rights, 200 Independence Avenue 
SW, Room 516E, Washington, DC 20201, Phone: 202 568-0028, Email: 
[email protected].
    RIN: 0945-AA11

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

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

Proposed Rule Stage

85. Health Information Technology: Certification and Interoperability 
Enhancements

    E.O. 13771 Designation: Regulatory.
    Legal Authority: Pub. L. 114-255
    Abstract: The rulemaking would update the ONC Health IT 
Certification Program (Program) by implementing certain provisions of 
the 21st Century Cures Act, including conditions and maintenance of 
certification requirements for health information technology (IT) 
developers, the voluntary certification of health IT for use by 
pediatric healthcare providers, health information network voluntary 
attestation to the adoption of a trusted exchange framework and common 
agreement in support of network-to-network exchange, and reasonable and 
necessary activities that do not constitute information blocking. The 
rulemaking would also modify the Program through other complementary 
means to advance health IT certification and interoperability.
    Timetable:

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

    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)

Food and Drug Administration (FDA)

Proposed Rule Stage

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

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: FDA will be proposing a rule to add the common cold 
indication to certain over-the-counter (OTC) antihistamine active 
ingredients. This proposed rule is the result of collaboration under 
the U.S.-Canada Regulatory Cooperation Council (RCC) as part of efforts 
to reduce unnecessary duplication and differences. This pilot exercise 
will help determine the feasibility of developing an ongoing mechanism 
for alignment in review and adoption of OTC drug monograph elements.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Reopening of Administrative Record..   08/25/00  65 FR 51780
Comment Period End..................   11/24/00  .......................
NPRM (Amendment) (Common Cold)......   11/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Adams-King, Regulatory Health Project 
Manager, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO 22, Room 
5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 
796-3713, Fax: 301 796-9899, Email: [email protected].
    RIN: 0910-AF31

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

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The proposed rule will address the general recognition of 
safety and effectiveness (GRASE) status of the 16 sunscreen monograph 
ingredients and describe data gaps that FDA believes need to be filled 
in order for FDA to permit the continued marketing of these ingredients 
without submitting new drug applications for premarket

[[Page 27129]]

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................................   12/00/18  .......................
------------------------------------------------------------------------

    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 Ave., WO 22, Room 5491, Silver Spring, MD 
20993, Phone: 240 402-4246, Fax: 301 796-9841, Email: 
[email protected].
    RIN: 0910-AF43

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

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e); 
42 U.S.C. 263b
    Abstract: FDA is proposing to amend its regulations governing 
mammography. The amendments would update the regulations issued under 
the Mammography Quality Standards Act of 1992 (MQSA). FDA is taking 
this action to address changes in mammography technology and 
mammography processes that have occurred since the regulations were 
published in 1997 and to address breast density reporting to patient 
and health care providers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/00/18  .......................
------------------------------------------------------------------------

    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-AH04

89. 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................................   02/00/19  .......................
------------------------------------------------------------------------

    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

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

    E.O. 13771 Designation: Regulatory.
    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 through a 
battery management system for ENDS using 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................................   12/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Colleen Lee, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, WO 71, Room G335, Silver Spring, MD 20993, Phone: 877 
287-1373, Email: [email protected].
    RIN: 0910-AH90

91.  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 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................................   11/00/18  .......................
------------------------------------------------------------------------

    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].

[[Page 27130]]

    RIN: 0910-AI05

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

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

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 242a; 42 
U.S.C. 262 and 263; 42 U.S.C. 263a to 263n; 42 U.S.C. 264; 42 U.S.C. 
300aa; 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 
355; 21 U.S.C. 360; 21 U.S.C. 360b to 360j; 21 U.S.C. 361a; 21 U.S.C. 
371; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379e; 21 U.S.C. 381
    Abstract: The final rule would amend the postmarketing safety 
reporting regulations for human drugs and biological products including 
blood and blood products in order to better align FDA requirements with 
guidelines of the International Council on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH); 
and to update reporting requirements in light of current 
pharmacovigilance practice and safety information sources and enhance 
the quality of safety reports received by FDA. These revisions were 
proposed as part of a single rulemaking (68 FR 12406) to clarify and 
revise both premarketing and postmarketing safety reporting 
requirements for human drug and biological products. Premarketing 
safety reporting requirements were finalized in a separate final rule 
published on September 29, 2010 (75 FR 59961). This final rule applies 
to postmarketing safety reporting requirements.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/14/03  68 FR 12406
NPRM Comment Period Extended........   06/18/03  .......................
NPRM Comment Period End.............   07/14/03  .......................
NPRM Comment Period Extension End...   10/14/03  .......................
Final Rule..........................   12/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 6278, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3469, Fax: 301 
847-8440, Email: [email protected].
    RIN: 0910-AA97

93. 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: The final rule will require owners or consignees to label 
imported food that is refused entry into the United States. The label 
will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the 
label's characteristics (such as its size) and processes for verifying 
that the label has been affixed properly. We are taking this action to 
prevent the introduction of unsafe food into the United States, to 
facilitate the examination of imported food, and to implement section 
308 of the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).
    Timetable:

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

    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

94. 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: FDA is proposing to amend the 2013 proposed rule for the 
performance standard for laser products, which will amend the 
performance standard for laser products to achieve closer harmonization 
between the current standard and the recently amended International 
Electrotechnical Commission (IEC) standard for laser products and 
medical laser products. The amendment is intended to update FDA's 
performance standard to reflect advancements in technology.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/24/13  78 FR 37723
NPRM Comment Period End.............   09/23/13  .......................
NPRM; Withdrawal....................   08/00/18  .......................
------------------------------------------------------------------------

    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

95. 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........   02/22/16  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,

[[Page 27131]]

HFS 820, 5100 Paint Branch Parkway, College 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

96. 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

97. 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

98. 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

99. 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 27132]]

100. 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

101. 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

102. 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..........................   12/00/19  .......................
------------------------------------------------------------------------

    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 5515, Silver Spring, MD 20993, Phone: 301 796-5678, Email: 
[email protected].
    RIN: 0910-AG30

103. 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..........................   12/00/19  .......................
------------------------------------------------------------------------

    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 5515, Silver Spring, MD 20993, Phone: 301 796-5678, Email: 
[email protected].
    RIN: 0910-AH14

104. 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 27133]]

    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

105. Nicotine Exposure Warning and Child-Resistant Packaging for Liquid 
Nicotine, Nicotine-Containing E-Liquids, and Other Tobacco Products

    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 and 
child-resistant packaging 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................................   03/00/20  .......................
------------------------------------------------------------------------

    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

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

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

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 
U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C. 
360i; 21 U.S.C. 360j; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21 
U.S.C. 393; 42 U.S.C. 264; 42 U.S.C. 271; . . .
    Abstract: This rule updates FDA's requirements for accepting 
clinical data used to bring new medical devices to market as part of 
fulfilling FDA's mission. While helping to ensure the quality and 
integrity of clinical trial data and the protection of study 
participants, this rule should reduce burden on industry by avoiding 
the need for on-site inspections. This rule parallels the drug 
regulation, which should further reduce burden by having a harmonized 
approach. Under this new rule, a device applicant would provide FDA 
with information about the conduct of their study such as, the research 
sites where the study was conducted, the investigators who conducted 
the study, a summary of the protocol, information about how informed 
consent from the study participants was obtained, and information about 
the ethics committee that reviewed the study. (If such information is 
not available, the sponsor may explain why and request a waiver.)
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Action........................   02/21/18  83 FR 7366
Final Action Effective..............   02/21/19  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Soma Kalb, Phone: 301 796-6359, Email: 
[email protected].
    RIN: 0910-AG48

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

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360b to 360f; 21 U.S.C. 360j; 21 U.S.C. 
360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 374 to 375; 21 U.S.C. 379e; 42 
U.S.C. 241; 42 U.S.C. 262; . . .
    Abstract: This rulemaking addresses whether FDA considers certain 
active ingredients in over-the-counter (OTC) healthcare antiseptic hand 
wash and healthcare antiseptic products to be generally recognized as 
safe and effective. If FDA determines that the ingredient is not 
generally recognized as safe and effective, a manufacturer will not be 
able to market the product unless it submits and receives approval of a 
new drug application.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Action........................   12/20/17  82 FR 60474
Final Action Effective..............   12/20/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Michelle Jackson, Phone: 301 796-0923, Email: 
[email protected].
    RIN: 0910-AH40

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

108. Regulatory Provisions To Promote Program Efficiency, Transparency, 
and Burden Reduction (CMS-3346-P)

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 42 U.S.C. 263a; 42 U.S.C. 273; 42 U.S.C. 1302; 42 
U.S.C. 1320a-7; . . .
    Abstract: This proposed rule would reform Medicare regulations that 
are unnecessary, obsolete, or excessively burdensome on healthcare 
providers and suppliers. This rule would increase the ability of 
healthcare professionals to devote resources to improving patient care 
by eliminating or reducing requirements that impede quality patient 
care or that divert resources away from furnishing high quality patient 
care.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Alpha-Banu Huq, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Clinical Standards and Quality, MS: S3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244,

[[Page 27134]]

Phone: 410 786-8687, Email: [email protected].
    RIN: 0938-AT23

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

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual proposed rule would update the payment rates 
used under the prospective payment system for SNFs for fiscal year 
2019. The rule also includes proposals for the SNF Quality Reporting 
Program (QRP) and for the Skilled Nursing Facility Value-Based 
Purchasing (VBP) Program that will affect Medicare payment to SNFs.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Bill Ullman, Technical Advisor, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare, MS: C5-06-27, 7500 Security Boulevard, Baltimore, 
MD 21244, Phone: 410 786-5667, Fax: 410 786-0765, Email: 
[email protected].
    RIN: 0938-AT24

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

    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................................   05/00/18  .......................
------------------------------------------------------------------------

    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

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

    E.O. 13771 Designation: 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 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................................   06/00/18  .......................
------------------------------------------------------------------------

    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[email protected].
    RIN: 0938-AT30

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

    E.O. 13771 Designation: 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, 2019. Additionally, this rule 
proposes updates to the third and future years of the Quality Payment 
Program.
    Timetable:

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

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ryan Howe, Director, Division of Practitioner 
Services, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Center for Medicare, MS: C4-01-15, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-3355, Email: 
[email protected].
    RIN: 0938-AT31

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

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

    E.O. 13771 Designation: Other.
    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 interim final rule with comment period extends the 
end of the transition period for phasing in adjustments to the fee 
schedule amounts for certain durable medical equipment (DME) and 
enteral nutrition paid in areas not subject to the Durable Medical 
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive 
Bidding Program (CBP) from June 30, 2016, to December 31, 2016. In 
addition, this interim final rule with comment period amends the 
regulation to resume the transition period for items furnished from 
August 1, 2017, through December 31, 2018. This interim final rule with 
comment period also makes technical amendments to existing regulations 
for DMEPOS items and services to exclude infusion drugs used with DME 
from the DMEPOS CBP. Finally, this interim final rule with comment 
period also requests information on issues related to adjustments to 
DMEPOS fee schedules, alternatives for ensuring budget neutrality of 
oxygen payment classes, and current rules under the DMEPOS CBP.
    Timetable:

[[Page 27135]]



------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   05/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Undetermined.
    Agency Contact: Alexander Ullman, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C5-07-26, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-9671, Email: 
[email protected].
    RIN: 0938-AT21

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

 Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

114. 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........................   06/00/19  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: CDR Scott Cooper, Senior Technical Advisor, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Clinical Standards and Quality, Mail Stop 
S3-01-02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
9465, Email: [email protected].
    RIN: 0938-AS21

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

 Centers for Medicare & Medicaid Services (CMS)

Completed Actions

115. CY 2019 Notice of Benefit and Payment Parameters (CMS-9930-F) 
(Completion of a Section 610 Review)

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: Pub. L. 111-148, title I
    Abstract: This final rule sets forth payment parameters and 
provisions related to the risk adjustment and risk adjustment data 
validation programs; cost-sharing parameters; and user fees for 
Federally-facilitated Exchanges and State-based Exchanges on the 
Federal platform.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/02/17  82 FR 51052
NPRM Comment Period End.............   11/27/17  .......................
Final Action........................   04/17/18  83 FR 16930
Final Action Effective..............   06/18/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Lindsey Murtagh, Senior Policy Advisor, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Consumer Information and Insurance Oversight, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 301 492-4106, Email: 
[email protected].
    RIN: 0938-AT12

[FR Doc. 2018-11239 Filed 6-8-18; 8:45 am]
 BILLING CODE 4850-03-P

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