Federal Register
Week of July 21, 2014 - July 25, 2014

July 21

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FDA

Notices:

  • The FDA is announcing that a proposed collection of information entitled: Experimental Study of Direct-to-Consumer (DTC) Promotion Directed at Adolescents has been submitted to OMB for review and clearance.

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. Sponsors for several prescription drug classes market their products directly to vulnerable groups, including adolescents. Such DTC marketing to adolescents raises a variety of potential concerns. Adolescents are a unique audience for DTC drug marketing because their cognitive abilities are different than those of adults, and they are usually dependent on adults for health insurance coverage, health care provider access, and prescription drug payment. Despite this uniqueness, research regarding how adolescents use risk and benefit information for health-related decisions is limited. If considered at all in healthcare communication research, age is typically treated as simply another segment of the audience (Ref. 1), and researchers fail to consider how information processing (how people understand information) in response to advertisement (ad) exposure might differ among adolescents versus older viewers.FR, pages 42333-42337

  • The FDA is announcing that a proposed collection of information entitled: Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring--21 CFR Part 315--(OMB Control Number 0910-0409)—Extension has been submitted to OMB for review and clearance.

FDA is requesting OMB approval of the information collection requirements contained in 21 CFR 315.4, 315.5, and 315.6. These regulations require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of a new diagnostic radiopharmaceutical or of a new indication for use of an approved diagnostic radiopharmaceutical.FR, pages 42337-42338

Week of July 14, 2014 - July 18, 2014

July 18

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CMS

Final Notice:

  • This final notice announces our decision to approve The Compliance Team (TCT) for initial recognition as a national accrediting organization for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.FR, pages 42019-42021

July 16

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FDA

Notices:

  • The FDA is announcing that a proposed collection of information entitled: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (OMB Control Number 0910-0693)—Extension has been submitted to OMB for review and clearance.

The guidance provides recommendations for applicants planning to request waivers or reductions in user fees assessed under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g and 21 U.S.C. 379h) (the FD&C Act). The guidance describes the types of waivers and reductions permitted under the user fee provisions of the FD&C Act, and the procedures for submitting requests for waivers or reductions. It also includes recommendations for submitting information for requests for reconsideration of denials of waiver or reduction requests, and for requests for appeals. The guidance also provides clarification on related issues such as user fee exemptions for orphan drugs.FR, pages 41579-41580

July 15

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FDA

Proposed rule:

  • The FDA is announcing the availability of the draft guidance document entitle: Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics. This guidance is intended to provide greater clarity regarding the principal benefit-risk factors that FDA considers during the review process for a premarket notification (510(k)) submission when there are different technological characteristics between the new device and the legally marketed (predicate device. This draft guidance is not final nor is it in effect at this time.FR, pages 41289-41290

July 14

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CMS

Proposed rule:

  • This proposed rule would revise 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 proposed rule, we describe the proposed 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 proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In this document, we also are proposing changes to the data sources used for expansion requests for physician owned hospitals under the physician self-referral regulations; changes to the underlying authority for the requirement of an admission order for all hospital inpatient admissions and changes to require physician certification for hospital inpatient admissions only for long-stay cases and outlier cases; and changes to establish a three-level appeals process for Medicare Advantage (MA) organizations and Part D sponsors that would be applicable to CMS-identified overpayments associated with data submitted by these organizations and sponsors.FR, pages 40915-41083
Week of July 7, 2014 - July 11, 2014

July 11

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CMS

Notices:

  • CMS is seeking comments on a revision of a currently approved collection entitled: Solicitation for Applications for Medicare Prescription Drug Plan 2015 Contracts. The information will be collected under the solicitation of proposals from PDP, MA-PD, Cost Plan, PACE, and EGWP applicants. We will use the information to ensure that applicants meet our requirements and support the determination of contract awards. Participation in the Part D program is voluntary in nature. Only organizations that are interested in participating in the program will respond to the solicitation. The MA-PDs that voluntarily participate in the Part C program must submit a Part D application and successful bid.FR, pages 40105-40106

  • CMS is seeking comments on a revision of a currently approved collection entitled: Part C-Medicare Advantage and 1876 Cost Plan Expansion Application. The information will be collected under the solicitation of Part C applications from MA, EGWP Plan, and Cost Plan applicants and will be used to ensure that applicants meet our requirements and support the determination of contract awards. Participation in all programs is voluntary in nature; only organizations that are interested in participating in the program will respond to the solicitation. The MA-PDs that voluntarily participate in the Part C program must submit a Part D application and successful bid.FR, pages 40105-40106

  • CMS is seeking comments on an extension of a currently approved collection entitled: Medicaid Drug Rebate Program Forms. We develop the rebate amount per drug unit from information supplied by the drug manufacturers and distributes these data to the states. States then must report quarterly to the drug manufacturers and report to us the total number of units of each dosage form/strength of their covered outpatient drugs reimbursed during a quarter and the rebate amount to be refunded. This report is due within 60 days of the end of each calendar quarter. The information in the report is based on claims paid by the state Medicaid agency during a calendar quarter. Form CMS-R-144 (Quarterly Report Data) is required from states quarterly to report utilization for any drugs paid for during that quarter. Form CMS-368 (Administrative Data) is required only in those instances where a change to the original data submittal is necessary.FR, pages 40106-40107

Proposed Rules:

  • This rule proposes to update and make revisions to the End-Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2015. This rule also proposes to set forth requirements for the ESRD quality incentive program (QIP), including payment years (PYs) 2017 and 2018. This rule also proposes to make a technical correction to remove outdated terms and definitions. In addition, this rule proposes to set 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); make alternative payment rules for DME and enteral nutrition under the Medicare DMEPOS CBP; clarify the statutory Medicare hearing aid coverage exclusion and specify devices not subject to the hearing aid exclusion; update 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; clarify the Change of Ownership (CHOW) and provides for an exception to the current requirements; revise the appeal provisions for termination of a contract and notification to beneficiaries under the Medicare DMEPOS CBP, and add a technical change related to submitting bids for infusion drugs under the Medicare DMEPOS CBP.FR, pages 40207-40315

  • This major proposed 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. See the Table of Contents for a listing of the specific issues addressed in this proposed rule.FR, pages 40317-40540

CMS

Notices:

  • The FDA is announcing the availability of a draft guidance for industry entitled: Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act. On March 23, 2010, the Patient Protection and Affordable Care Act (ACA) was signed into law. The Secretary of Health and Human Services has delegated authority to FDA to issue guidance to identify the information to be submitted under section 6004 and oversee and make arrangements for the collection of such information. FDA is issuing this draft guidance to provide information to assist persons submitting drug sample information under ACA section 6004, and to advise industry of an updated compliance policy. This draft guidance revises the draft compliance policy guide issued on April 3, 2012.FR, pages 40109-40111

  • The FDA is announcing the availability of a draft guidance for industry entitled: ANDA Submissions--Amendments and Easily Correctable Deficiencies Under GDUFA.'' The guidance document is intended to assist applicants in preparing to submit to FDA amendments to abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by explaining how the Generic Drug User Fee Amendments of 2012 (GDUFA) performance metric goals apply to these submissions. When finalized, this guidance will replace the December 2001 guidance for industry entitled “Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications'' in consideration of the new amendment review tier system and performance goals under GDUFA.FR, pages 40111-40112

July 10

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  • No health business-related actions were published.

July 9

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FDA

Notices:

  • The FDA is seeking comment on a proposed collection entitled: Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)--(OMB Control Number 0910-0616)--Extension

    The information required under section 402(j)(5)(B) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) is submitted in the form of a certification, Form FDA 3674, which accompanies applications and submissions currently submitted to FDA and is already approved by OMB. The OMB control numbers and expiration dates for submitting FDA 3674 under the following parts are: 21 CFR parts 312 and 314 (human drugs) are 0910-0014, expiring April 30, 2015, and 0910-0001, expiring September 30, 2014; 21 CFR parts 312 and 601 (biological products) are 0910-0014 and 0910-0338, expiring January 31, 2017; 21 CFR parts 807 and 814 (devices) are 0910-0120, expiring January 31, 2017, and 0910-0231, expiring January 31, 2017.FR, pages 38905-38908

  • The FDA is announcing the availability of a draft document entitled: Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products'' dated July 2014. The draft guidance document provides sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical development.FR, pages 38905-38908

July 8

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FDA

Notices:

  • The FDA is reopening the comment period for the notice entitled: Center for Drug Evaluation and Research Use of Innovative Packaging, Storage, and/or Disposal Systems to Address the Misuse and Abuse of Opioid Analgesics, which published in the Federal Register of April 9, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments. Comments are due by August 7, 2014. FR, pages 38541-38542

July 7

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CMS

Proposed Rule:

  • This proposed rule would update the Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective Jan. 1, 2015. As required by the Affordable Care Act, this rule implements the second year of the four-year phase-in of the rebasing adjustments to the HH PPS payment rates. This rule provides information on our efforts to monitor the potential impacts of the rebasing adjustments and the Affordable Care Act mandated face-to-face encounter requirement. This rule also proposes: Changes to simplify the face-to-face encounter regulatory requirements; changes to the HH PPS case-mix weights; changes to the home health quality reporting program requirements; changes to simplify the therapy reassessment timeframes; a revision to the Speech-Language Pathology (SLP) personnel qualifications; minor technical regulations text changes; and limitations on the reviewability of the civil monetary penalty provisions. Finally, this proposed rule also discusses Medicare coverage of insulin injections under the HH PPS, the delay in the implementation of ICD-10-CM, and solicits comments on a HH value-based purchasing (HH VBP) model. Comments are due Sept. 2, 2014.FR, pages 38365-38420

HHS

Notices:

  • The FDA is announcing an opportunity for public comment on the proposed collection entitled: Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics.

The guidance document provides information concerning cooperative manufacturing arrangements applicable to biological products subject to licensure under section 351 of the Public Health Service Act (42 U.S.C. 262). The guidance addresses several types of manufacturing arrangements (i.e., short supply arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and contract manufacturing arrangements) and describes certain reporting and recordkeeping responsibilities, associated with these arrangements, including the following: (1) Notification of all important proposed changes to production and facilities; (2) notification of results of tests and investigations regarding or possibly impacting the product; (3) notification of products manufactured in a contract facility; and (4) standard operating procedures.FR, pages 38318-38319

Week of June 30, 2014 - July 4, 2014

July 3

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CMS

Notice:

  • CMS is seeking comments on a revision of a currently approved collection entitled: Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program. Section 302 of the MMA amended section 1847 of the Social Security Act (the Act) to require the implementation of the DMEPOS competitive bidding program. The Act provided the program requirements for the submission of bids in establishing payment rates and the awarding of contracts; provided the requirements for mergers and acquisitions; and a requirement for the Secretary to re-compete contracts not less often than once every 3 years. The MMA also requires the Secretary to re-compete contracts not less often than once every 3 years. The Round 1 Rebid contract period for all product categories except mail-order diabetic supplies expired on December 31, 2013. (Round 1 Rebid contracts for mail-order diabetic testing supplies ended on December 31, 2012.) The competition for the Round 1 Re-compete began in August of 2012. The Round 1 Re-compete contracts and prices became effective on January 1, 2014 and will expire on December 31, 2016. Round 2 and National Mail-Order contracts and prices will expire on June 30, 2016.FR, pages 38033-38034

July 2

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FDA

Notice:

  • The FDA is announcing the availability of a guidance entitled Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act. The guidance announces the Agency's intention with regard to enforcement of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to regulate entities that compound drugs, now that the FD&C Act has been amended by the Drug Quality and Security Act (DQSA). The guidance reflects the Agency's current thinking on the issues addressed by the guidance. FR, pages 37742-37743

  • The FDA is announcing the availability of a draft guidance for industry entitled Current Good Manufacturing Practice--Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance describes FDA's current expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with FDA as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in accordance with provisions added by the Drug Quality and Security Act DQSA). FDA is also soliciting public input on specific potential alternative approaches regarding certain CGMP requirements. These potential approaches are explained in detail in the draft guidance. FR, pages 37743-37747

  • The FDA is preparing to develop a list of bulk drug substances (active ingredients) that may be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), although they are neither the subject of a United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. In response to a notice published in the Federal Register of December 4, 2013, interested groups and individuals previously nominated a wide variety of substances for this list. However, many of those nominations either were for a substance that is already the subject of a USP monograph or a component of an FDA-approved drug, were not for bulk drug substances used in compounding as active ingredients, or did not include sufficient information to justify inclusion of the nominated substance on the list. To improve the efficiency of the process for developing the list of bulk drug substances that may be used to compound drug products under section 503A, FDA is providing more detailed information on what it needs to evaluate a nomination. Because the deadline for nominations has passed, FDA is reopening the nomination process so that interested persons can submit nominations of bulk drug substances that are not the subject of a USP or NF monograph or a component of an FDA-approved drug. Interested persons will also have the opportunity to provide adequate support to justify placement of the substances on the list. Bulk drug substances that were previously nominated will not be further considered unless they are renominated and those nominations are adequately supported. Substances that are already eligible for use in compounding or that are not adequately supported will not be placed on the list. FR, pages 37747-37750

  • The FDA is preparing to develop a list of bulk drug substances (active ingredients) that may be used to compound drug products in accordance with section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) concerning outsourcing facilities. In response to a notice published in the Federal Register of December 4, 2013, interested groups and individuals previously nominated a wide variety of substances for this list. However, many of those nominations were not for bulk drug substances used in compounding as active ingredients, and none included sufficient information to justify inclusion of the nominated substances on the list. To improve the efficiency of the process for developing the list of bulk drug substances that may be used to compound drug products under section 503B of the FD&C Act, FDA is providing more detailed information on what it needs to evaluate a nomination. Because the deadline for nominations has passed, FDA is reopening the nomination process so that interested persons can submit nominations of bulk drug substances and provide adequate support to justify placing the substances on the list. Bulk drug substances that were previously nominated will not be further considered unless they are renominated and adequately supported. Substances that are not adequately supported will not be placed on the list.FR, pages 37750-37754

Proposed Rule:

  • The FDA is proposing to amend its regulations to revise the list of drug products that may not be compounded under the exemptions provided by the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the drug products have been withdrawn or removed from the market after the drug products or components of such drug products were found to be unsafe or not effective. Specifically, the proposed rule would add 25 drug products to this list of drug products and modify the description of one drug product on this list to add an exception. These revisions are necessary because new information has come to the Agency's attention since March 8, 1999, when FDA published the original list as a final rule. FDA is also withdrawing the previous proposed rule regarding additions to this list (see the Federal Register of January 4, 2000).FR, pages 37750-37754

HHS

Final Rule:

  • In the October 30, 2013 issue of the Federal Register (78 FR 65046), HHS published a final rule entitled, “Program Integrity: Exchange, Premium Stabilization Programs, and Market Standards; Amendments to the HHS Notice of Benefit and Payment Parameters for 2014.” The effective date was December 30, 2013. This correcting amendment corrects technical and typographical errors identified in the October 30, 2013 final rule. FR, pages 37661-37662

July 1

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FDA

Notice:

  • The FDA is posting its draft Strategic Priorities FY 2014-2018 document to ensure that the public has an opportunity to comment on this document. The purpose of this document is to outline FDA's strategic intentions and plans for the next 4 years. This document identifies five cross-cutting strategic priorities and four core mission goals that will guide efforts to achieve FDA's public health mission and to fulfill its role in supporting the larger mission and strategic goals of the Department of Health and Human Services. The five cross-cutting strategic priorities are: (1) Regulatory science, (2) globalization, (3) safety and quality, (4) smart regulation, and (5) stewardship. The four core mission goals are: (1) Enhance oversight of FDA-regulated products, (2) improve and safeguard access to FDA-regulated products to benefit health, (3) promote better informed decisions about the use of FDA-regulated products, and (4) strengthen organizational excellence and accountability.FR, pages 37332-37333

HHS

Proposed Rule:

  • This proposed rule would specify additional options for annual eligibility redeterminations and renewal and re-enrollment notice requirements for qualified health plans offered through the exchange, beginning with annual redeterminations for coverage for plan year 2015. In particular, this proposed rule would provide additional flexibility for Marketplaces, including the ability for Marketplaces to propose unique approaches that meet the specific needs of their State, while streamlining the consumer experience. Comments are due by July 28, 2014. FR, pages 37262-37269

June 30

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  • No health business-related actions were published.

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