79 FR 245 pgs. 76718-76730 - Regulatory Agenda
Type: PRORULEVolume: 79Number: 245Pages: 76718 - 76730
Pages: 76718, 7671976720, 76721, 76722, 76723, 76724, 76725, 76726, 76727, 76728, 76729, 76730, FR document: [FR Doc. 2014-28964 Filed 12-19-14; 8:45 am]
Agency: Health and Human Services Department
Official PDF Version: PDF Version
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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 (EO) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.
FOR FURTHER INFORMATION CONTACT:
C'Reda J. Weeden, 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 rulemaking activities that the Department expects to undertake in the foreseeable future to advance this mission. The Agenda furthers several Departmental goals, including strengthening health care; advancing scientific knowledge and innovation; advancing the health, safety, and well-being of the American people; increasing efficiency, transparency, and accountability of HHS programs; and strengthening the Nation's health and human services infrastructure and workforce.
HHS has an agency-wide effort to support the Agenda's purpose of encouraging more effective public participation in the regulatory process. For example, to encourage public participation, we regularly update our regulatory Web page ( http://www.HHS.gov/regulations ) which includes links to HHS rules currently open for public comment, and also provides a "regulations toolkit" with background information on regulations, the commenting process, how public comments influence the development of a rule, and how the public can provide effective comments. HHS also actively encourages meaningful public participation in its retrospective review of regulations, through a comment form on the HHS retrospective review Web page ( http://www.HHS.gov/RetrospectiveReview ).
The rulemaking abstracts included in this paper issue of the Federal Register cover, as required by the Regulatory Flexibility Act of 1980, those prospective HHS rulemakings likely to have a significant economic impact on a substantial number of small entities. The Department's complete Regulatory Agenda is accessible online at http://www.RegInfo.gov.
Dated: September 22, 2014.
C'Reda J. Weeden,
Executive Secretary to the Department.
| Sequence No. | Title | Regulation Identifier No. |
|---|---|---|
| 275 | SAMHSA User Fees for Publications | 0930-AA18 |
| Sequence No. | Title | Regulation Identifier No. |
|---|---|---|
| 276 | Over-the-Counter (OTC) Drug Review-Cough/Cold (Antihistamine) Products | 0910-AF31 |
| 277 | Over-the-Counter (OTC) Drug Review-Internal Analgesic Products | 0910-AF36 |
| 278 | Over-the-Counter (OTC) Drug Review-Topical Antimicrobial Drug Products | 0910-AF69 |
| 279 | Abbreviated New Drug Applications and 505(b)(2) | 0910-AF97 |
| 280 | Updated Standards for Labeling of Pet Food | 0910-AG09 |
| 281 | Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Reg Plan Seq No. 48) | 0910-AG10 |
| 282 | Over-the-Counter (OTC) Drug Review-Pediatric Dosing for Cough/Cold Products | 0910-AG12 |
| 283 | Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products | 0910-AG18 |
| 284 | Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Reg Plan Seq No. 49) | 0910-AG35 |
| 285 | Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Reg Plan Seq No. 50) | 0910-AG36 |
| 286 | Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives | 0910-AG59 |
| 287 | Foreign Supplier Verification Program (Reg Plan Seq No. 52) | 0910-AG64 |
| 288 | Format and Content of Reports Intended to Demonstrate Substantial Equivalence | 0910-AG96 |
| 289 | Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods | 0910-AH00 |
| 290 | Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System | 0910-AH03 |
| 291 | Mammography Quality Standards Act; Regulatory Amendments | 0910-AH04 |
| 292 | Investigational New Drug Application Annual Reporting | 0910-AH07 |
| 293 | General and Plastic Surgery Devices: Sunlamp Products | 0910-AH14 |
| References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register . | ||
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| Sequence No. | Title | Regulation Identifier No. |
|---|---|---|
| 294 | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs | 0910-AA49 |
| 295 | Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling | 0910-AF11 |
| 296 | Combinations of Bronchodilators With Nasal Decongestant; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use | 0910-AF33 |
| 297 | Over-the-Counter (OTC) Drug Review-Laxative Drug Products | 0910-AF38 |
| 298 | Laser Products; Amendment to Performance Standard | 0910-AF87 |
| 299 | "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act (Reg Plan Seq No. 53) | 0910-AG38 |
| 300 | Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices | 0910-AG48 |
| 301 | Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines (Reg Plan Seq No. 54) | 0910-AG56 |
| 302 | Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Reg Plan Seq No. 55) | 0910-AG57 |
| 303 | Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (Reg Plan Seq No. 58) | 0910-AG94 |
| 304 | Veterinary Feed Directive (Reg Plan Seq No. 59) | 0910-AG95 |
| 305 | Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use | 0910-AH16 |
| References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register . | ||
| Sequence No. | Title | Regulation Identifier No. |
|---|---|---|
| 306 | Food Labeling; Revision of the Nutrition and Supplement Facts Labels | 0910-AF22 |
| 307 | Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs | 0910-AF23 |
| 308 | Focused Mitigation Strategies To Protect Food Against Intentional Adulteration | 0910-AG63 |
| 309 | Sanitary Transportation of Human and Animal Food | 0910-AG98 |
| Sequence No. | Title | Regulation Identifier No. |
|---|---|---|
| 310 | Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors | 0910-AF27 |
| 311 | Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements | 0910-AF96 |
| 312 | Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products | 0910-AG81 |
| Sequence No. | Title | Regulation Identifier No. |
|---|---|---|
| 313 | Home Health Agency Conditions of Participation (CMS-3819-F) (Rulemaking Resulting From a Section 610 Review) | 0938-AG81 |
| 314 | Reform of Requirements for Long-Term Care Facilities (CMS-3260-P) (Rulemaking Resulting From a Section 610 Review) (Reg Plan Seq No. 60) | 0938-AR61 |
| 315 | Medicare Shared Savings Program; Accountable Care Organizations (CMS-1461-P) (Section 610 Review) | 0938-AS06 |
| 316 | Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P) (Rulemaking Resulting From a Section 610 Review) | 0938-AS21 |
| 317 | Medicare Clinical Diagnostic Laboratory Test Payment System (CMS-1621-P) | 0938-AS33 |
| 318 | CY 2016 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-P) (Reg Plan Seq No. 63) | 0938-AS40 |
| 319 | Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2016 Rates (CMS-1632-P) (Reg Plan Seq No. 64) | 0938-AS41 |
| 320 | CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1633-P) (Reg Plan Seq No. 65) | 0938-AS42 |
| References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register . | ||
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| Sequence No. | Title | Regulation Identifier No. |
|---|---|---|
| 321 | Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review) | 0938-AQ41 |
| Sequence No. | Title | Regulation Identifier No. |
|---|---|---|
| 322 | Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-F) | 0938-AO91 |
| 323 | Adoption of Operating Rules for HIPAA Transactions (CMS-0036-IFC) | 0938-AS01 |
| Sequence No. | Title | Regulation Identifier No. |
|---|---|---|
| 324 | Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics and CLIA Enforcement Actions for Proficiency Testing Referral (CMS-1443-FC) (Completion of a Section 610 Review) | 0938-AR62 |
| 325 | Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (CMS-1607-F) (Completion of a Section 610 Review) | 0938-AS11 |
| 326 | CY 2015 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-FC) (Section 610 Review) | 0938-AS12 |
| 327 | CY 2015 End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (CMS-1614-F) (Section 610 Review) | 0938-AS13 |
| 328 | CY 2015 Hospital Outpatient Prospective Payment System (PPS) Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1613-FC) (Section 610 Review) | 0938-AS15 |
| 329 | Extension of Payment Adjustment for Low-Volume Hospitals and the Medicare-Dependent Hospital Program Under the FY 2014 Hospital Inpatient Prospective Payment System (CMS-1599-IFC2) (Completion of a Section 610 Review) | 0938-AS18 |
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Proposed Rule Stage
275. SAMHSA User Fees for Publications
Legal Authority: 31 U.S.C. 9701; 31 U.S.C. 1111; EO 8284; EO 11541; Pub. L. 113-76
Abstract: SAMSHA is proposing to implement a modest cost recovery program to partially offset the high costs of distributing its materials to the public. This user fee would apply only to "over-the-limit" non-governmental orders. An "over the limit" order is defined as an order that exceeds either the average weight value (3.75 lbs) or the average number of copies (8). The "non-governmental orders" do not include: SAMHSA's Recovery Month bulk orders; orders by SAMHSA staff for meetings or conferences; and orders from ".gov" and ".mil" addresses. Therefore, it is assumed that SAMHSA would not charge shipping for orders by other Federal, State, and local government agencies. The proposed rule would implement recent legislation allowing the funds collected as part of a user fee for publications and data requests to be available to SAMHSA until expended.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 02/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian Altman, Legislative Director, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Rockville, MD 02857, Phone: 240 276-2009, Email: brian.altman@samhsa.gov.
RIN: 0930-AA18
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Proposed Rule Stage
276. Over-the-Counter (OTC) Drug Review-Cough/Cold (Antihistamine) Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: FDA will be proposing a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients. This proposed rule is the result of collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC) as part of efforts to reduce unnecessary duplication and differences. This pilot exercise will help determine the feasibility of developing an ongoing mechanism for alignment in review and adoption of OTC drug monograph elements.
[top] 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) | 09/00/15 |
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
277. Over-the-Counter (OTC) Drug Review-Internal Analgesic Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371; 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 and Other Labeling) | 12/26/06 | 71 FR 77314 |
| NPRM Comment Period End | 05/25/07 | |
| Final Action (Required Warnings and Other Labeling) | 04/29/09 | 74 FR 19385 |
| Final Action (Correction) | 06/30/09 | 74 FR 31177 |
| Final Action (Technical Amendment) | 11/25/09 | 74 FR 61512 |
| NPRM (Amendment) (Pediatric) | 10/00/15 | |
| NPRM (Amendment) (Acetaminophen) | 12/00/15 |
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
278. Over-the-Counter (OTC) Drug Review-Topical Antimicrobial Drug Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: 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 addresses antimicrobial agents in healthcare antiseptic products.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM (Healthcare) | 06/17/94 | 59 FR 31402 |
| Comment Period End | 12/15/95 | |
| NPRM (Consumer Hand Wash Products) | 12/17/13 | 78 FR 76443 |
| NPRM (Healthcare Antiseptic) | 04/00/15 |
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-AF69
279. Abbreviated New Drug Applications and 505(b)(2)
Legal Authority: Pub. L. 108-173, title XI; 21 U.S.C. 355; 21 U.S.C. 371
Abstract: This proposed rule would make changes to certain procedures for Abbreviated New Drug Applications and related applications to patent certifications, notice to patent owners and application holders, the availability of a 30-month stay of approval, amendments and supplements, and the types of bioavailability and bioequivalence data that can be used to support these applications.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 11/00/14 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice L. Weiner, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6268, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, Email: janice.weiner@fda.hhs.gov.
RIN: 0910-AF97
280. Updated Standards for Labeling of Pet Food
Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 110-85, sec 1002(a)(3)
Abstract: FDA is proposing updated standards for the labeling of pet food that include nutritional and ingredient information, as well as style and formatting standards. FDA is taking this action to provide pet owners and animal health professionals more complete and consistent information about the nutrient content and ingredient composition of pet food products.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 04/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: William Burkholder, Veterinary Medical Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 2642 (MPN-4, HFV-228), 7519 Standish Place, Rockville, MD 20855, Phone: 240 453-6865, Email: william.burkholder@fda.hhs.gov.
RIN: 0910-AG09
281. Current Good Manufacturing Practice and Hazard Analysis and R-Based Preventive Controls for Food for Animals
Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of the Federal Register .
[top] RIN: 0910-AG10
282. Over-the-Counter (OTC) Drug Review-Pediatric Dosing for Cough/Cold Products
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 | 10/00/15 |
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
283. Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264
Abstract: This rule would require electronic package inserts for human drug and biological prescription products with limited exceptions, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 11/00/14 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Megan Velez, Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO 32, Room 4249, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-9301, Email: megan.velez@fda.hhs.gov.
RIN: 0910-AG18
284. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Regulatory Plan: This entry is Seq. No. 49 in part II of this issue of the Federal Register .
RIN: 0910-AG35
285. Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Regulatory Plan: This entry is Seq. No. 50 in part II of this issue of the Federal Register .
RIN: 0910-AG36
286. Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives
Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 387; The Family Smoking Prevention and Tobacco Control Act
Abstract: The Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, requires the Food and Drug Administration to promulgate regulations that require the testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents, that the Agency determines should be tested to protect the public health.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 05/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Carol Drew, 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-AG59
287. Foreign Supplier Verification Program
Regulatory Plan: This entry is Seq. No. 52 in part II of this issue of the Federal Register .
RIN: 0910-AG64
288. Format and Content of Reports Intended to Demonstrate Substantial Equivalence
Legal Authority: 21 U.S.C. 387e(j); 21 U.S.C. 387j(a); secs 905(j) and 910(a) of the Federal Food, Drug, and Cosmetic Act
Abstract: This regulation would establish the format and content of reports intended to demonstrate substantial equivalence. This regulation also would provide information as to how the Agency will review and act on these submissions.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 07/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Gerie Voss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 301 595-1426, Email: ctpregulations@fda.hhs.gov.
RIN: 0910-AG96
289. Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods
Legal Authority: Sec 206 of the Food Allergen Labeling and Consumer Protection Act; 21 U.S.C. 343(a)(1); 21 U.S.C. 321(n); 21 U.S.C. 371(a)
Abstract: This proposed rule would establish requirements concerning compliance for using a "gluten-free" labeling claim for those foods for which there is no scientifically valid analytical method available that can reliably detect and accurately quantify the presence of 20 parts per million (ppm) gluten in the food.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 01/00/15 |
Regulatory Flexibility Analysis Required: Yes.
[top] Agency Contact: Felicia Billingslea, Director, Food Labeling and Standard Staff, Department of Health and Human Services, Food and Drug
RIN: 0910-AH00
290. Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System
Legal Authority: 21 U.S.C. 360c
Abstract: The proposed rule would establish special controls for the computed tomography (CT) X-ray system. A CT X-ray system is a diagnostic X-ray imaging system intended to produce cross-sectional images of the body through use of a computer to reconstruct an image from the same axial plane taken at different angles. High doses of ionizing radiation can cause acute (deterministic) effects such as burns, reddening of the skin, cataracts, hair loss, sterility, and, in extremely high doses, radiation poisoning. The design of a CT X-ray system should balance the benefits of the device ( i.e., the ability of the device to produce a diagnostic quality image) with the known risks ( e.g., exposure to ionizing radiation). FDA is establishing proposed special controls, which, when combined with the general controls, would provide reasonable assurance of the safety and effectiveness of a class II CT X-ray system.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 09/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Erica Blake, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4426, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-8145, Email: erica.blake@fda.hhs.gov.
RIN: 0910-AH03
291. Mammography Quality Standards Act; Regulatory Amendments
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, such as breast density reporting, that have occurred since the regulations were published in 1997.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 04/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-8145, Email: nancy.pirt@fda.hhs.gov.
RIN: 0910-AH04
292. Investigational New Drug Application Annual Reporting
Legal Authority: 21 U.S.C. 355(i); 21 U.S.C. 371(a)
Abstract: This proposed rule would revise the requirements concerning annual reports submitted to investigational new drug applications (INDs) by replacing the current annual reporting requirement with a requirement that is consistent with the format, content, and timing of submission of the development safety update report devised by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 09/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Peter A. Taschenberger, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 6312, Silver Spring, MD 20993, Phone: 301 796-0018, Fax: 301 847-3529, Email: peter.taschenberger@fda.hhs.gov.
RIN: 0910-AH07
293. General and Plastic Surgery Devices: Sunlamp Products
Legal Authority: 21 U.S.C. 360j(e)
Abstract: This proposed rule would apply device restrictions to sunlamp products.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 03/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Paul Gadiock, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, W0-66, Room 4432, Silver Spring, MD 20993-0002, Phone: 301 796-5736, Fax: 301 847-8145, Email: paul.gadiock@fda.hhs.gov.
RIN: 0910-AH14
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Final Rule Stage
294. Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs
Legal Authority: 21 U.S.C. 321 and 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355 to 356c; 21 U.S.C. 360 and 360b; 21 U.S.C. 360c to 360f; 21 U.S.C. 360h to 360j; 21 U.S.C. 371 and 374; 21 U.S.C. 379e and 381; 21 U.S.C. 393; 15 U.S.C. 1451 to 1561; 42 U.S.C. 262 and 264; 42 U.S.C. 271
Abstract: The rule will reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, including certain biological drugs, and animal drugs. These regulations contain information on when, how, and where to register drug establishments and list drugs, and what information must be submitted. They also address National Drug Codes.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 08/29/06 | 71 FR 51276 |
| NPRM Comment Period End | 02/26/07 | |
| Final Action | 10/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: David Joy, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, WO 51, Room 6254, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-2242, Email: david.joy@fda.hhs.gov.
[top] RIN: 0910-AA49
295. Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling
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 final rule will amend the content and format of the "Pregnancy," "Labor and delivery," and "Nursing mothers" subsections of the "Use in Specific Populations" section of regulations regarding the labeling for human prescription drug and biological products to better communicate risks.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 05/29/08 | 73 FR 30831 |
| NPRM Comment Period End | 08/27/08 | |
| Final Action | 11/00/14 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Kathy Schreier, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., WO51, Rm. 6246, Silver Spring, MD 20993, Phone: 301 796-3432, Email: kathy.schreier@fda.hhs.gov .
RIN: 0910-AF11
296. Combinations of Bronchodilators With Nasal Decongestant; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
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 oral nasal decongestant.
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 Action (Oral Bronchodilator & Oral Nasal Decongestant) | 07/00/15 |
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-AF33
297. Over-the-Counter (OTC) Drug Review-Laxative Drug Products
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360 to 360a; 21 U.S.C. 371 to 371a
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph ( i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final rule listed will address the professional labeling for sodium phosphate drug products.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| Final Action (Granular Psyllium) | 03/29/07 | 72 FR 14669 |
| NPRM (Professional Labeling-Sodium Phosphate) | 02/11/11 | 76 FR 7743 |
| NPRM Comment Period End | 03/14/11 | |
| Final Action (Professional Labeling-Sodium Phosphate) | 10/00/15 |
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
298. Laser Products; Amendment to Performance Standard
Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 393
Abstract: The regulation will amend the performance standard for laser products to achieve closer harmonization between the current standard and the 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 | |
| Final Action | 10/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-8145, Email: nancy.pirt@fda.hhs.gov.
RIN: 0910-AF87
299. "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act
Regulatory Plan: This entry is Seq. No. 53 in part II of this issue of the Federal Register .
RIN: 0910-AG38
300. Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C. 360i; 21 U.S.C. 360j; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21 U.S.C. 393; 42 U.S.C. 264; 42 U.S.C. 271; . . .
[top] Abstract: This rule will amend FDA's regulations on acceptance of data from clinical investigations for medical devices to require that clinical investigations conducted outside the United States in support of a premarket approval application, humanitarian device exemption application, an investigational device exemption
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 02/25/13 | 78 FR 12664 |
| NPRM Comment Period End | 05/28/13 | |
| Final Action | 01/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Sheila Anne Brown, Policy Analyst, Investigational Device Exemptions Staff, Department of Health and Human Services, Food and Drug Administration, WO 66, Room 1651, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6563, Fax: 301 847-8120, Email: sheila.brown@fda.hhs.gov .
RIN: 0910-AG48
301. Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines
Regulatory Plan: This entry is Seq. No. 54 in part II of this issue of the Federal Register .
RIN: 0910-AG56
302. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
Regulatory Plan: This entry is Seq. No. 55 in part II of this issue of the Federal Register .
RIN: 0910-AG57
303. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
Regulatory Plan: This entry is Seq. No. 58 in part II of this issue of the Federal Register .
RIN: 0910-AG94
304. Veterinary Feed Directive
Regulatory Plan: This entry is Seq. No. 59 in part II of this issue of the Federal Register .
RIN: 0910-AG95
305. • Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph ( i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. These actions address cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM (Amendment) | 07/13/05 | 70 FR 40232 |
| NPRM Comment Period End | 11/10/05 | |
| Final Action (Technical Amendment) | 03/19/07 | 72 FR 12730 |
| Final Action | 07/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Adams-King, Regulatory Health Project Manager, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.
RIN: 0910-AH16
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Long-Term Actions
306. Food Labeling; Revision of the Nutrition and Supplement Facts Labels
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: FDA is amending the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. This rule will modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label.
Timetable :
| Action | Date | FR Cite |
|---|---|---|
| ANPRM | 07/11/03 | 68 FR 41507 |
| ANPRM Comment Period End | 10/09/03 | |
| Second ANPRM | 04/04/05 | 70 FR 17008 |
| Second ANPRM Comment Period End | 06/20/05 | |
| Third ANPRM | 11/02/07 | 72 FR 62149 |
| Third ANPRM Comment Period End | 01/31/08 | |
| NPRM | 03/03/14 | 79 FR 11879 |
| NPRM Comment Period End | 06/02/14 | |
| Final Action | 03/00/16 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Blakeley Fitzpatrick, Interdisciplinary Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-830), HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, Phone : 240 402-5429, Email : nutritionprogramstaff@fda.hhs.gov .
RIN: 0910-AF22
307. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
Abstract: FDA is amending its labeling regulations for foods to provide updated Reference Amounts Customarily Consumed (RACCs) for certain food categories. This rule would provide consumers with nutrition information based on the amount of food that is customarily consumed, which would assist consumers in maintaining healthy dietary practices. In addition to updating certain RACCs, FDA is also amending the definition of single-serving containers; amending the label serving size for breath mints; and providing for dual-column labeling, which would provide nutrition information per serving and per container or unit, as applicable, under certain circumstances.
Timetable :
| Action | Date | FR Cite |
|---|---|---|
| ANPRM | 04/04/05 | 70 FR 17010 |
| ANPRM Comment Period End | 06/20/05 | |
| NPRM | 03/03/14 | 79 FR 11989 |
| NPRM Comment Period End | 06/02/14 | |
| Final Action | 03/00/16 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Cherisa Henderson, Nutritionist, Department of Health and Human Services, Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, Phone : 240 402-5429, Fax : 301 436-1191, Email : nutritionprogramstaff@fda.hhs.gov .
[top] RIN: 0910-AF23
308. Focused Mitigation Strategies To Protect Food Against Intentional Adulteration
Legal Authority: 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350g; 21 U.S.C. 350i; 21 U.S.C. 371; 21 U.S.C. 374; Pub. L. 111-353
Abstract: This rule would require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act to address hazards that may be intentionally introduced by acts of terrorism. These food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation.
Timetable :
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 12/24/13 | 78 FR 78014 |
| NPRM Comment Period Extended | 03/25/14 | 79 FR 16251 |
| NPRM Comment Period End | 03/31/14 | |
| NPRM Comment Period Extended End | 06/30/14 | |
| Final Rule | 05/00/16 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Jody Menikheim, Supervisory General Health Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-005), 5100 Paint Branch Parkway, College Park, MD 20740, Phone : 240 402-1864, Fax : 301 436-2633, Email : fooddefense@fda.hhs.gov .
RIN: 0910-AG63
309. Sanitary Transportation of Human and Animal Food
Legal Authority: 21 U.S.C. 350e; 21 U.S.C. 373; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 371; . . .
Abstract: This rule would establish requirements for shippers, carriers by motor vehicle or rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated.
Timetable :
| Action | Date | FR Cite |
|---|---|---|
| ANPRM | 04/30/10 | 75 FR 22713 |
| ANPRM Comment Period End | 08/30/10 | |
| NPRM | 02/05/14 | 79 FR 7005 |
| NPRM Comment Period Extended | 05/23/14 | 79 FR 29699 |
| NPRM Comment Period End | 05/31/14 | |
| NPRM Comment Period Extended End | 07/30/14 | |
| Final Rule | 03/00/16 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone : 240 402-2022, Fax : 301 346-2632, Email : michael.kashtock@fda.hhs.gov .
RIN: 0910-AG98
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Completed Actions
310. Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records And Reports; and Quality Factors
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 350a; 21 U.S.C. 371
Abstract: The Food and Drug Administration (FDA) is revising its infant formula regulations to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 07/09/96 | 61 FR 36154 |
| NPRM Comment Period End | 12/06/96 | |
| NPRM Comment Period Reopened | 04/28/03 | 68 FR 22341 |
| NPRM Comment Period Extended | 06/27/03 | 68 FR 38247 |
| NPRM Comment Period End | 08/26/03 | |
| NPRM Comment Period Reopened | 08/01/06 | 71 FR 43392 |
| NPRM Comment Period End | 09/15/06 | |
| Interim Final Rule | 02/10/14 | 79 FR 7934 |
| Interim Final Rule Comment Period End | 03/27/14 | |
| Final Action | 06/10/14 | 79 FR 33057 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Leila Beker, Biologist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-850), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1451, Email: leila.beker@fda.hhs.gov .
RIN: 0910-AF27
311. Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355 to 355a; 21 U.S.C. 356 to 356c; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379k-l; 21 U.S.C. 379aa; 21 U.S.C. 381; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264; . . .
Abstract: The final rule would amend FDA's postmarketing safety reporting regulations for human drug and biological products to require that mandatory safety reports submitted to the Agency be transmitted in an electronic format that FDA can process, review, and archive. The rule will allow the Agency to review safety reports more quickly, to identify emerging safety problems, and disseminate safety information more rapidly in support of FDA's public health mission. The amendments also would be a key element in harmonizing FDA's postmarketing safety reporting regulations with international and International Harmonization Standards standards for the electronic submission of safety information.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| ANPRM | 11/05/98 | 63 FR 59746 |
| ANPRM Comment Period End | 02/03/99 | |
| NPRM | 08/21/09 | 74 FR 42184 |
| NPRM Comment Period End | 11/19/09 | |
| Final Action | 06/10/14 | 79 FR 33072 |
[top] Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Reena Raman, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6238, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-7577, Fax: 301 847-8440, Email: reena.raman@fda.hhs.gov .
RIN: 0910-AF96
312. Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387s; Pub. L. 111-31
Abstract: This rule will require manufacturers and importers of tobacco products to submit certain market share data to FDA. USDA currently collects such data, but its program sunsets at the end of September 2014, and USDA will cease collection of this information. FDA is taking this action so that it may continue to calculate market share percentages needed to compute user fees.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 05/31/13 | 78 FR 32581 |
| NPRM Comment Period End | 08/14/13 | |
| Final Action | 07/10/14 | 79 FR 39302 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Annette L. Marthaler, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 877 287-1426, Email: ctpregulations@fda.hhs.gov .
RIN: 0910-AG81
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Proposed Rule Stage
313. Home Health Agency Conditions of Participation (CMS-3819-F) (Rulemaking Resulting From a Section 610 Review)
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395x; 42 U.S.C. 1395cc(a); 42 U.S.C. 1395hh; 42 U.S.C. 1395bb
Abstract: This final rule revises the existing Conditions of Participation that Home Health Agencies must meet to participate in the Medicare program. The new requirements focus on the actual care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our efforts to improve patient safety and achieve broad-based improvements in the quality of care furnished through Federal programs, while at the same time reducing procedural burdens on providers.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 03/10/97 | 62 FR 11005 |
| NPRM Comment Period End | 06/09/97 | |
| Second NPRM | 10/09/14 | 79 FR 61163 |
| Second NPRM Comment Period End | 12/08/14 | |
| Final Action | 10/00/17 |
Regulatory Flexibility Analysis Required: No.
Agency Contact: Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards & Quality, MS: S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6617, Email: danielle.shearer@cms.hhs.gov .
RIN: 0938-AG81
314. Reform of Requirements for Long-Term Care Facilities (CMS-3260-P) (Rulemaking Resulting From a Section 610 Review)
Regulatory Plan: This entry is Seq. No. 60 in part II of this issue of the Federal Register .
RIN: 0938-AR61
315. Medicare Shared Savings Program; Accountable Care Organizations (CMS-1461-P) (Section 610 Review)
Legal Authority: PL-111-148, sec 3022
Abstract: This proposed rule addresses changes to the Medicare Shared Savings Program (Shared Savings Program), including provisions relating to the payment of Accountable Care Organizations (ACOs) participating in the Shared Savings Program. Under the Shared Savings Program, providers of services and suppliers that participate in an ACO continue to receive traditional Medicare fee for service (FFS) payments under Parts A and B and are eligible for additional payments from the ACO if they meet specified quality and savings requirements.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 11/00/14 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Terri Postma, Medical Officer, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C5-15-24, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4169, Email: terri.postma@cms.hhs.gov .
RIN: 0938-AS06
316. Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P) (Rulemaking Resulting From a Section 610 Review)
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr
Abstract: This proposed rule would update the requirements that hospitals and CAHs must meet to participate in the Medicare and Medicaid programs. These proposals 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 | 03/00/15 |
Regulatory Flexibility Analysis Required: Yes.
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
317. • Medicare Clinical Diagnostic Laboratory Test Payment System (CMS-1621-P)
Legal Authority: Pub. L. 113-93, sec 216
[top] Abstract: Under section 216 of the Protecting Access to Medicare Act of 2014, this proposed rule would require Medicare payment for clinical laboratory tests to be based on private payor rates beginning January 1, 2017. Beginning January 1, 2016, and every 3 years thereafter (or, annually, for certain laboratory tests), applicable laboratories must report to CMS the amount they are
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 12/00/14 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Anne Hauswald, Director, Division of Ambulatory Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, Mail Stop C4-01-26, 7500 Security Blvd., Baltimore, MD 21244, Phone: 410 786-4546, Email: anne-e-tayloe.hauswald@cms.hhs.gov .
Valerie Miller, Deputy Director, Division of Ambulatory Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, Mail Stop C4-01-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4535, Email: valerie.miller@cms.hhs.gov .
RIN: 0938-AS33
318. • CY 2016 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-P)
Regulatory Plan: This entry is Seq. No. 63 in part II of this issue of the Federal Register .
RIN: 0938-AS40
319. • Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2016 Rates (CMS-1632-P)
Regulatory Plan: This entry is Seq. No. 64 in part II of this issue of the Federal Register .
RIN: 0938-AS41
320. • CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1633-P)
Regulatory Plan: This entry is Seq. No. 65 in part II of this issue of the Federal Register .
RIN: 0938-AS42
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
321. Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review)
Legal Authority: Pub. L. 111- 48, secs 2501, 2503, 3301(d)(2); Pub. L. 111-152, sec 1206; Pub. L. 111-8, sec 221
Abstract: This final rule revises requirements pertaining to Medicaid reimbursement for covered outpatient drugs to implement provisions of the Affordable Care Act. This rule also revises other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 02/02/12 | 77 FR 5318 |
| NPRM Comment Period End | 04/02/12 | |
| Final Action | 04/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Wendy Tuttle, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, Mail Stop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-8690, Email: wendy.tuttle@cms.hhs.gov .
RIN: 0938-AQ41
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Long-Term Actions
322. Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-F)
Legal Authority: 42 U.S.C. 1821; 42 U.S.C. 1861ff (3)(B)(i)(ii); 42 U.S.C. 1913(c)(1) et al
Abstract: This rule finalizes emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers to ensure that they adequately plan for both natural and man-made disasters and coordinate with Federal, State, tribal, regional, and local emergency preparedness systems. This rule ensures providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 12/27/13 | 78 FR 79082 |
| NPRM Comment Period Extended | 02/21/14 | 79 FR 9872 |
| NPRM Comment Period End | 03/31/14 | |
| Final Action | 12/00/16 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Graham, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clincial Standards and Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-1850, Phone: 410 786-8020, Email: janice.graham@cms.hhs.gov .
RIN: 0938-AO91
323. Adoption of Operating Rules for HIPAA Transactions (CMS-0036-IFC)
Legal Authority: Pub. L. 104-191, sec 1104
Abstract: Under the Affordable Care Act, this interim final rule adopts operating rules for HIPAA transactions for health care claims or equivalent encounter information, enrollment and disenrollment of a health plan, health plan premium payments, and referral certification and authorization.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| Interim Final Rule | 11/00/15 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Geanelle Herring, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Administrative Simplification Group, Office of E-Health Standards and Services, Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4466, Email: geanelle.herring@cms.hhs.gov .
RIN: 0938-AS01
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Completed Actions
324. Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics and CLIA Enforcement Actions for Proficiency Testing Referral (CMS-1443-FC) (Completion of a Section 610 Review)
Legal Authority: Pub. L. 111-148, sec 10501
Abstract: This final rule establishes methodology and payment rates for a prospective payment system (PPS) for Federally qualified health center (FQHC) services under Medicare Part B beginning on October 1, 2014, in compliance with the statutory requirement of the Affordable Care Act. This rule also establishes a policy which would allow rural health clinics (RHCs) to contract with nonphysician practitioners when statutory requirements for employment of nurse practitioners and physician assistants are met, and makes other technical and conforming changes to the RHC and FQHC regulations. Finally, this rule makes changes to the Clinical Laboratory Improvement Amendments (CLIA) regulations regarding enforcement actions for proficiency testing referral.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 09/23/13 | 78 FR 58386 |
| NPRM Comment Period End | 11/18/13 | |
| Final Rule | 05/02/14 | 79 FR 25436 |
| Comment Period End | 07/01/14 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Corinne Axelrod, Health Insurance Specialist, Hospital and Ambulatory Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5620, Email: corinne.axelrod@cms.hhs.gov .
RIN: 0938-AR62
325. Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (CMS-1607-F) (Completion of a Section 610 Review)
Legal Authority: sec 1886(d) of the Social Security Act
Abstract: This final rule revises the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This rule implements changes arising from our continuing experience with these systems.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 05/14/14 | 79 FR 27977 |
| NPRM Comment Period End | 06/30/14 | |
| Final Action | 08/22/14 | 79 FR 49853 |
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: C4-01-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: donald.thompson@cms.hhs.gov .
RIN: 0938-AS11
326. CY 2015 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-FC) (Section 610 Review)
Legal Authority: Social Security Act, secs 1102, 1871 and 1848
Abstract: This final rule addresses changes to the physician fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 07/11/14 | 79 FR 40318 |
| NPRM Comment Period End | 09/02/14 | |
| Final Action | 11/13/14 | 79 FR 67548 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Kathy Bryant, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-01-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3448, Email: kathy.bryant@cms.hhs.gov .
RIN: 0938-AS12
327. CY 2015 End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (CMS-1614-F) (Section 610 Review)
Legal Authority: Social Security Act, sec 1834(a)(1)(6); MIPPA, sec 153(b)
Abstract: This final rule updates and makes revisions to the End-Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2015. This rule also sets forth requirements for the ESRD quality incentive program (QIP), including payment years (PYs) 2017 and 2018. This rule also makes a technical correction to remove outdated terms and definitions. In addition, this rule sets forth the methodology for adjusting Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment amounts using information from the Medicare DMEPOS Competitive Bidding Program (CBP); makes alternative payment rules for DME and enteral nutrition under the Medicare DMEPOS CBP; clarifies the statutory Medicare hearing aid coverage exclusion and specifies devices not subject to the hearing aid exclusion; updates the definition of minimal self-adjustment regarding what specialized training is needed by suppliers to provide custom fitting services if they are not certified orthotists; clarifies the Change of Ownership (CHOW) and provides for an exception to the current requirements; revises the appeal provisions for termination of a contract and notification to beneficiaries under the Medicare DMEPOS CBP, and adds a technical change related to submitting bids for infusion drugs under the Medicare DMEPOS CBP.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 07/11/14 | 79 FR 40208 |
| NPRM Comment Period End | 09/02/14 | |
| Final Action | 11/06/14 | 79 FR 66120 |
| Final Action Effective | 01/01/15 |
Regulatory Flexibility Analysis Required: Yes.
[top] Agency Contact: Michelle Cruse, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, Mail Stop C5-05-27, 7500 Security Boulevard, Baltimore,
RIN: 0938-AS13
328. CY 2015 Hospital Outpatient Prospective Payment System (PPS) Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1613-FC) (Section 610 Review)
Legal Authority: sec 1833 of the Social Security Act
Abstract: This final rule revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2015 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this rule, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this rule updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| NPRM | 07/14/14 | 79 FR 40916 |
| NPRM Comment Period End | 09/02/14 | |
| Final Action | 11/13/14 | 79 FR 66770 |
| Final Action Effective | 01/01/15 |
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-AS15
329. Extension of Payment Adjustment for Low-Volume Hospitals and the Medicare-Dependent Hospital Program Under the FY 2014 Hospital Inpatient Prospective Payment System (CMS-1599-IFC2) (Completion of a Section 610 Review)
Legal Authority: Pub. L. 113-67, secs 1105 and 1106
Abstract: This interim final rule implements changes to the payment adjustment for low-volume hospitals and to the Medicare-dependent hospital program under the hospital inpatient prospective payment systems for FY 2014 (through March 31, 2014) in accordance with sections 1105 and 1106, respectively, of the Pathway for SGR Reform Act of 2013.
Timetable:
| Action | Date | FR Cite |
|---|---|---|
| Interim Final Rule | 03/18/14 | 79 FR 15022 |
| Interim Final Rule Comment Period End | 05/12/14 | |
| Merged With 0938-AS11 | 06/01/14 |
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michele Hudson, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-10-07, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5490, Email: michele.hudson@cms.hhs.gov .
RIN: 0938-AS18
[FR Doc. 2014-28964 Filed 12-19-14; 8:45 am]
BILLING CODE 4150-24-P