Federal Register
Week of April 14, 2014 - April 18, 2014

April 15

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  • No health business-related actions were published.

April 14

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FDA

Notices:

  • The FDA is announcing that a proposed collection of information entitled: Adverse Event Program for Medical Devices (Medical Product Safety Network) has been submitted to OMB for review and clearance.

Among other things, section 519 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i) authorizes FDA to require (1) manufacturers to report medical device-related deaths, serious injuries, and malfunctions, and (2) user facilities to report device-related deaths directly to manufacturers and FDA and serious injuries to the manufacturer. Section 213 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 519(b) of the FD&C Act relating to mandatory reporting by user facilities of deaths, serious injuries, and serious illnesses associated with the use of medical devices. This amendment legislated the replacement of universal user facility reporting by a system that is limited to a. . . subset of user facilities that constitutes a representative profile of user reports for device-related deaths and serious injuries. This amendment is reflected in section 519(b)(5)(A) of the FD&C Act. This legislation provides FDA with the opportunity to design and implement a national surveillance network, composed of well-trained clinical facilities, to provide high-quality data on medical devices in clinical use. This system is called the Medical Product Safety Network (MedSun).

FDA is seeking OMB clearance to continue to use electronic data collection to obtain the information on Form FDA 3500A (approved under OMB control number 0910-0291) related to medical devices and tissue products from the user facilities participating in MedSun, to obtain a demographic profile of the facilities, and for additional questions which will permit FDA to better understand the cause of reported adverse events. Participation in the program is voluntary and currently includes 250 facilities.<em>FR, pages 20887-20888</em>
Week of April 7, 2014 - April 11, 2014

April 11

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CMS

Notices:

  • CMS is seeking comments on an extension of a currently approved collection entitled: Quarterly Statement of Budget for Medical Assistance. We require that each State Medicaid agency quarterly submit the Form CMS-37 via the web-based Medicaid and State Children's Health Insurance Program Budget and Expenditure System (MBES/CBES). Due dates are November 15, February 15, May 15 and August 15 of each fiscal year. The addendum provides a description of forms contained in this package. All submissions represent equally important components of the grant award cycle, but the May and November submissions are particularly significant for budget formulation. The November submission introduces a new fiscal year to the budget cycle and serves as the basis for the formulation of the Medicaid portion of the President's Budget, which is presented to Congress in January. The February and August submissions are used primarily for budget execution in providing interim updates to our Office of Financial Management, the Department of Health and Human Services, the Office of Management and Budget and Congress depending on the scheduling of the national budget review process in a given fiscal year. These submissions provide us with base information necessary to track current year obligations and expenditures in relation to the current year appropriation and to notify senior managers of any impending surpluses or deficits.FR, pages 20209-20211

  • CMS is seeking comments on a revision of a currently approved collection entitled: Health Care Reform Insurance Web Portal Requirements. This information collection is mandated by Sections 1103 and 10102 of the Patient Protection and Affordability Care Act, Public Law 111-148 (ACA). Once all of the information is collected from insurance issuers of major medical health insurance (hereon referred to as issuers) and other affected parties, it will be displayed at http://www.healthcare.gov. Issuers are required to provide information quarterly, and healthcare.gov will be updated on a periodic schedule during each quarter. The information provided will help the general public make educated decisions about organizations providing private health care insurance. We are currently updating a system (hereon referred to as web portal) where state Departments of Insurance and issuers may log in using a custom user ID and password validation. The states may be asked to provide information on issuers in their state and various Web sites maintained for consumers. The issuers will be tasked with providing information on their major medical insurance products and plans. They will ultimately be given the choice to download a basic information template to enter data then upload into the web portal; to manually enter data within the web portal itself; or to submit .xml files containing their information. Once the states and issuers submit their data, they will receive an email notifying them of any errors, and that their submission was received. We are both mandating the issuers verify and update their information on a quarterly basis and requesting that States verify State-submitted information on an annual basis. In the event that an issuer enhances its existing plans, proposes new plans, or deactivates plans, the organization would be required to update the information in the web portal. Changes occurring during the three month quarterly periods will be allowed utilizing effective dates for both the plans and rates associated with the plans.FR, pages 20209-20211

  • CMS is seeking comments on a revision of a currently approved collection entitled: Cooperative Agreement to Support Navigators in Federally-facilitated and State Partnership Exchanges. Section 1311(i) of the Affordable Care Act requires Exchanges to establish a Navigator grant program as part of its function to provide consumers with assistance when they need it. Navigators will assist consumers by providing education about and facilitating selection of qualified health plans (QHPs) within Exchanges, as well as other required duties. Section 1311(i) requires that an Exchange operating as of January 1, 2014, must establish a Navigator Program under which it awards grants to eligible individuals or entities who satisfy the requirements to be Exchange Navigators. For Federally-facilitated Exchanges (FFE) and State Partnership Exchanges (SPEs), we will be awarding these grants. Navigator awardees must provide weekly, monthly, quarterly, and annual progress reports to us on the activities performed during the grant period and any sub-awardees receiving funds.FR, pages 20211-20212

  • CMS is seeking comments on a new collection entitled: Improving Quality of Care in Medicaid and CHIP through Increased Access to Preventive Services State Survey. This survey will be used to gain a better understanding of state efforts to increase utilization of preventive services and to develop resources (including educational and outreach resources) to help states increase utilization of preventive services. The results will provide a baseline on regarding coverage of preventive services and will help us identify ways to assist states with materials focusing on prevention and technical assistance.FR, pages 20211-20212

FDA

Notices:

  • The FDA has determined that ZOVIRAX (acyclovir sodium) Injection, equivalent to (EQ) 250 milligrams (mg) base/vial, 500 mg base/vial, and 1gram (g) base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ZOVIRAX (acyclovir sodium) Injection, EQ 250 mg base/vial, 500 mg base/vial, and 1 g base/vial, if all other legal and regulatory requirements are met. FR, pages 20214-20215

April 10

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FDA

Notices:

  • The FDA is announcing an opportunity for public comment on the proposed collection entitled: Medical Devices; Exception From General Requirements for Informed Consent--21 CFR 50.23.

In the Federal Register of June 7, 2006 (71 FR 32827), FDA issued an interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The Agency took this action because it was concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. FR, pages 19915-19917

April 9

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FDA

Notices:

  • The FDA is announcing that a proposed collection of information entitled Food and Drug Administration Generic Rapid Response Surveys has been submitted to OMB for review and clearance.

Section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355), requires that important safety information relating to all human prescription drug products be made available to FDA so that it can take appropriate action to protect the public health when necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the FD&C Act. Under section 519 of the FD&C Act (21 U.S.C. 360i), FDA is authorized to require manufacturers to report medical device-related deaths, serious injuries, and malfunctions to FDA; to require user facilities to report device-related deaths directly to FDA and to manufacturers; and to report serious injuries to the manufacturer. Section 522 of the FD&C Act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct postmarket surveillance of medical devices. Section 705(b) of the FD&C Act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate information regarding medical products or cosmetics in situations involving imminent danger to health or gross deception of the consumer.

Section 903(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)) authorizes the Commissioner of Food and Drugs to implement general powers (including conducting research) to carry out effectively the mission of FDA. These sections of the FD&C Act enable FDA to enhance consumer protection from risks associated with medical products usage that are not foreseen or apparent during the premarket notification and review process. FDA's regulations governing application for Agency approval to market a new drug (21 CFR part 314) and regulations governing biological products (21 CFR part 600) implement these statutory provisions. Currently, FDA monitors medical product related postmarket adverse events via both the mandatory and voluntary MedWatch reporting systems using FDA Forms 3500 and 3500A (OMB control number 0910-0291) and the vaccine adverse event reporting system. FR, page 19618

  • The FDA is withdrawing approval of Bupropion Hydrochloride (HCl) Extended-Release (ER) Tablets, 300 Milligrams (mg) (Bupropion HCl ER Tablets, 300 mg), under abbreviated new drug application (ANDA) 77-715, held by Watson Laboratories, Inc. (Watson), 4955 Orange Dr., Fort Lauderdale, FL 33314. Watson has voluntarily requested that approval for this product be withdrawn and waived its opportunity for a hearing. FR, page 19626

  • The FDA is announcing the availability of a draft guidance for industry entitled Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs. This guidance discusses how applicants for low molecular weight heparin (LMWH) products should provide information on impurities and the potential impact on immunogenicity. Comments are due June 9. 2014. FR, pages 19621-19622

April 8

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CMS

Notices:

  • In accordance with the requirements of the Privacy Act of 1974, CMS is establishing a new System of Records (SOR) titled, “Hospice Item Set (HIS) System,” System No. 09-70-0548. The new system will support the collection of data required for the Hospice Quality Reporting Program (HQRP) pursuant to Section 3004(c) of the Patient Protection and Affordable Care Act of 2010 (ACA) (Pub. L. 111-148), which amended the Social Security Act (the Act) (42 U.S.C. 1814(i)). HIS is a standardized, patient-level data collection vehicle consisting of data elements confirming that the appropriate assessments were made and inquiries or concerns were addressed for each patient at the time of admission for the following domains of care: (1) Pain; (2) Respiratory Status; (3) Medications; (4) Patient Preferences; and (5) Beliefs & Values. FR, pages 19341-19344

April 7

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FDA

Notices:

  • The FDA has determined that SKELAXIN (metaxalone) Tablets, 400 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SKELAXIN (metaxalone) Tablets, 400 mg, if all other legal and regulatory requirements are met. FR, page 19102
Week of March 31, 2014 - April 4, 2014

April 4

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CMS

Notices:

  • CMS is seeking comments on a revision of a currently approved collection entitled: Fee-for-Service Recovery Audit Prepayment Review Demonstration and Prior Authorization Demonstration. On July 23, 2012, the Office of Management and Budget approved the collections required for two demonstrations of prepayment review and prior authorization. The first demonstration allows Medicare Recovery Auditors to review claims on a pre-payment basis in certain States. The second demonstration established a prior authorization program for Power Mobility Device claims in certain States. FR, pages 18913-18914

  • CMS is seeking comments on a reinstatement with change of a currently approved collection entitled: Psychiatric Unit Criteria Work Sheet and Supporting Regulations. Certain hospital units are excluded from the Medicare Prospective Payment System (PPS). The exclusion of units is not optional on the part of the provider but is required by section 1886(d)(1)(B) of the Social Security Act. That section excludes psychiatric hospitals, rehabilitation hospitals, hospitals whose inpatients are predominantly individuals under 18 years of age (children's hospitals), and psychiatric and rehabilitation units which are a distinct part of a hospital. FR, pages 18915-18916

  • CMS is seeking comments on a disclosure for the In-Office Ancillary Services Exception. Physicians who provide certain imaging services (magnetic resonance imaging, computed tomography, and positron emission tomography) under the in-office ancillary services exception to the physician self-referral prohibition are required to create the disclosure notice as well as the list of other imaging suppliers to be provided to the patient. The patient will then be able to use the disclosure notice and list of suppliers in making an informed decision about his or her course of care for the imaging service. The physician must maintain a record of the disclosure in the patient's medical record. If we were investigating the referrals of a physician providing advanced imaging services under the in-office ancillary services exception, we would review the written disclosure in order to determine if the physician satisfied the requirement. FR, pages 18915-18916

FDA

Notices:

  • The FDA is announcing the availability of the guidance entitled: Types of Communication During the Review of Medical Device Submissions. The purpose of this guidance is to update the Agency's approach to Interactive Review and other additional types of communication, to reflect FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed to in connection with the Medical Device User Fee Amendments of 2012 (MDUFA III). These new Agency communication commitments are to increase the efficiency of the review process. FR, pages 18918-18919

April 3

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HHS

Notices:

  • HHS, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to comment on the “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). This collection was developed as part of a Federal Governmentwide effort to streamline the process for seeking feedback from the public on service delivery, This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection. Consideration will be given to all comments received by June 2, 2014. FR, pages 18 18692-18693

April 2

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CMS

Notices:

  • CMS is seeking comment on an extension of a currently approved collection entitled: Medicare Advantage Chronic Care Improvement Program (CCIP) and Quality Improvement (QI) Project Reporting Tools. Medicare Advantage Organizations (MAOs) are required to have an ongoing quality improvement (QI) program that meets our requirements and includes at least one chronic care improvement program (CCIP) and one QI project. Every MAO must have a QI program that monitors and identifies areas where implementing appropriate interventions would improve patient outcomes and patient safety. Information collected using the CCIP and QIP reporting tools is an integral resource for oversight, monitoring, compliance, and auditing activities necessary to ensure high quality value-based health care for Medicare beneficiaries. FR, pages 18554-18555

  • CMS is seeking comment on reinstatement with change of a previously approved information collection entitled: Rate Increase Disclosure and Review Reporting Requirements. Section 1003 of the Affordable Care Act adds a new section 2794 of the PHS Act which directs the Secretary of the Department of Health and Human Services (the Secretary), in conjunction with the states, to establish a process for the annual review of “unreasonable increases in premiums for health insurance coverage.” The statute provides that health insurance issuers must submit to the Secretary and the applicable state justifications for unreasonable premium increases prior to the implementation of the increases. Section 2794 also specifies that beginning with plan years beginning in 2014, the Secretary, in conjunction with the states, shall monitor premium increases of health insurance coverage offered through an Exchange and outside of an Exchange. Section 2794 directs the Secretary to ensure the public disclosure of information and justification relating to unreasonable rate increases. The regulation therefore develops a process to ensure the public disclosure of all such information and justification. Section 2794 requires that health insurance issuers submit justification for an unreasonable rate increase to CMS and the relevant state prior to its implementation. Additionally, section 2794 requires that rate increases effective in 2014 (submitted for review in 2013) be monitored by the Secretary, in conjunction with the states. To those ends the regulation establishes various reporting requirements for health insurance issuers, including a Preliminary Justification for a proposed rate increase, a Final Justification for any rate increase determined by a state or CMS to be unreasonable, and a notification requirement for unreasonable rate increases which the issuer will not implement. FR, pages 18554-18555

FDA

Notices:

  • The FDA has determined that PREZISTA (darunavir) tablets, 400 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for darunavir tablets, 400 mg, if all other legal and regulatory requirements are met. FR, pages 18558-18559

  • The FDA has determined that NIMOTOP (Nimodipine) Capsules, 30 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of the abbreviated new drug applications (ANDAs) that refer to imodipine capsules, 30 mg, and it will allow FDA to approve ANDAs that refer to this drug as long as they meet relevant legal and regulatory requirements. FR, pages 18558-18559

April 1

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FDA

Notices:

  • The FDA is announcing the availability of a guidance for industry entitled “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.'' The guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities (outsourcing facility) under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Quality and Security Act (DQSA). Entities that elect to register as outsourcing facilities must pay certain fees to be considered outsourcing facilities. This guidance describes the annual establishment fee, the reinspection fee, annual adjustments to fees required by law, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee.FR, pages 18297-18299

March 31

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FDA

Notices:

  • The FDA is announcing the availability of a guidance for the public, FDA advisory committee members, and staff, entitled Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers. The FDA is issuing the guidance to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA procedures regarding public availability of information regarding certain financial interests and waivers granted by FDA to permit individuals to participate in an advisory committee meeting. This guidance replaces the guidance of the same title dated March 2012.FR, pages 18032-18033
Week of March 24, 2014 - March 28, 2014

March 27

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FDA

Notices:

  • The FDA is seeking comments on a proposed collection of information entitled: Reports of Corrections and Removals of Medical Devices and Radiation Emitting Products--(OMB Control Number 0910-0359)--Extension

I. Reports of Corrections and Removals

Under Sec. 806.10 (21 CFR 806.10), each device manufacturer or importer shall submit a written report to FDA of any action initiated to correct or remove a device to reduce a risk to health posed by the device or to remedy a violation of the Federal Food, Drug, and Cosmetic Act caused by the device, which may present a risk to health within 10 working days of initiating the correction or removal. Under Sec. 806.20(a) (21 CFR 806.20(a)), each device manufacturer or importer of a device who initiates a correction or removal of a device that is not required to be reported to FDA shall keep a record of the correction or removal. FDA currently accepts by mail reports of corrections and removals (806 reports) associated with medical and radiation emitting products regulated by the Center for Devices and Radiological Health (CDRH) under part 806.FR, pages 17549-17551

  • The FDA is seeking comments on a proposed collection of information entitled: Electronic Records; Electronic Signatures--(OMB Control Number 0910-0303)--Extension

    FDA regulations in part 11 (21 CFR part 11) provide criteria for acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records. Under these regulations, records and reports may be submitted to FDA electronically provided the Agency has stated its ability to accept the records electronically in an Agency-established public docket and that the other requirements of part 11 are met.FR, pages 17551-17552

March 27

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FDA

Notices:

  • The FDA is announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of abbreviated new drug applications (ANDAs) from multiple sponsors for prescription pain medications containing more than 325 milligrams (mg) of acetaminophen. The basis for this proposal is that the agency has determined that fixed-combination prescription drugs containing more than 325 mg of acetaminophen per dosage unit (tablet or capsule) do not provide a sufficient margin of safety to protect the public against the serious risk of acetaminophen-induced liver injury.FR, pages 17156-17163

  • The FDA is withdrawing approval of 108 abbreviated new drug applications (ANDAs) for prescription pain medications containing more than 325 milligrams (mg) of acetaminophen. The holders of these ANDAs have voluntarily requested that approval of these applications be withdrawn and have waived their opportunity for a hearing. Effective March 27, 2014. FR, pages 17163-17168

March 26

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FDA

Notices:

  • The FDA is announcing that a collection of information entitled: Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use has been approved by OMB under the Paperwork Reduction Act of 1995. FR, page 16799

  • The FDA is announcing the availability of the Standard Operating Procedure (SOP) for Level 1, Immediately in Effect (IIE) Guidance Documents on Premarket Data Issues. The SOP describes the Center for Devices and Radiological Health's (CDRH's or the Center's) process to clarify and more quickly inform stakeholders when CDRH has changed its expectations relating to, or otherwise has new scientific information that could affect data submitted as part of an Investigational Device Exemption (IDE) or premarket submission, including a Premarket Notification (510(k)), a Premarket Approval (PMA), a Humanitarian Device Exemption (HDE), or combination products containing a device constituent part for which CDRH has jurisdiction that needs to be disseminated in a timely manner. FR, page 16801

March 25

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CMS

Notices:

  • CMS is seeking comments on an extension of a currently approved collection entitled: Organ Procurement Organization/Histocompatibility Laboratory Cost Report. We are requesting an extension of the Form CMS 216-94, Organ Procurement Organization (OPO)/Histocompatibility Laboratory Cost Report. These cost reports are filed annually by freestanding OPO and Histocompatibility Lab providers participating in the Medicare program to determine the reasonable costs incurred to furnish treatment for renal transplant patients. FR, pages 16336-16337

  • CMS is seeking comments on an extension of a currently approved collection entitled: Healthcare Common Procedure Coding System (HCPCS)--Level II Code Modification Request Process. Each year, in the United States, health care insurers process over 5 billion claims for payment. For Medicare and other health insurance programs to ensure that these claims are processed in an orderly and consistent manner, standardized coding systems are essential. The Healthcare Common Procedure Coding System (HCPCS) Level II Code Set is one of the standard code sets used for this purpose. Level II of the HCPCS, also referred to as alpha-numeric codes, is a standardized coding system that is used primarily to identify products, supplies, and services not included in the CPT codes, such as ambulatory services and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) when used in the home or outpatient setting. The HCPCS codeset has been maintained and distributed via modifications of codes, modifiers and descriptions, as a direct result of data received from applicants. The HCPCS codeset maintenance is an ongoing process, as changes are implemented and updated annually; therefore, the process requires continual collection of information from applicants on an annual basis. As new technology evolves and new devices, drugs and supplies are introduced to the market, applicants submit applications to us requesting modifications to the HCPCS Level II codeset. FR, pages 16336-16337

  • CMS is seeking comments on a new collection entitled: Community First Choice Option Evaluation. This project is an evaluation of the implementation and progress of the Community First Choice (CFC) Option. The results of the study will be included in the final Report to Congress, to be delivered by the Secretary of Health and Human Services in 2015. The project is designed to assist us along with the Congress in our understanding of: States' CFC implementation plans, the effectiveness of the CFC Option on individuals receiving home- and community-based attendant care, and States' spending on long-term services and supports. Researchers will request data from States approved for CFC via a data from and semi-structured interviews. Information obtained will be used to better understand CFC program design, the targeted patient population, and intended outcomes. At this time, we have only approved California's program. To provide comparative information to the Secretary, researchers will also collect data from States that have decided not to pursue the CFC option. Data will be analyzed and developed into a report to Congress which will evaluate the effectiveness of the CFC option, the program's impact on participants' physical and emotional health, and a comparative analysis of the costs of community-based services and those provided in institutional settings. FR, pages 16337-16338

FDA

Notices:

  • The FDA is announcing the availability of a draft guidance for industry entitled: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway. This draft guidance discusses FDA's recommendations for developing the indication and usage statements in the prescribing information for drugs approved under the accelerated approval regulatory pathway (hereafter “accelerated approval”). The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved. Comments are due by May 27, 2014. FR, pages 16344-16345

  • The FDA is proposing to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also proposing changes unrelated to the new FDASIA requirements to update its regulations governing classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation. Comments are due by April 24, 2014. FR, pages 16252-16265

March 24

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FDA

Notices:

  • The FDA is announcing an opportunity for public comment on the proposed collection of information entitled: Application for FDA Approval To Market a New Drug--(OMB Control Number 0910-0001)--Extension

    Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(a)), a new drug may not be commercially marketed in the United States, imported, or exported from the United States, unless an approval of an application filed with FDA under section 505(b) or 505(j) if the act is effective with respect to such drug. Under the FD&C Act, it is the sponsor's responsibility to provide the information needed by FDA to make a scientific and technical determination whether the product is safe and effective for use. Comments are due by May 23, 2014. FR, pages 16003-16007

  • The FDA is announcing an opportunity for public comment on the proposed collection of information entitled: Additional Criteria and Procedures for Classifying OTC Drugs as Generally Recognized as Safe and Effective and Not Misbranded--21 CFR 330.14 (OMB Control Number 0910-0688)--Extension

    In the Federal Register of January 23, 2002 (67 FR 3060), we established regulations in Sec. 330.14 (21 CFR 330.14) providing additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded (2002 time and extent application (TEA) final rule). These regulations state that OTC drug products introduced into the U.S. market after the OTC drug review began and OTC drug products without any marketing experience in the United States can be evaluated under the monograph process if the conditions (e.g., active ingredients) meet certain “time and extent'' criteria outlined in Sec. 330.14(b). The regulations allow a TEA to be submitted to us by any party for our consideration to include new conditions in the OTC drug monograph system. TEAs must provide evidence described in Sec. 330.14(c) demonstrating that the condition is eligible for inclusion in the monograph system. (Section 330.14(d) specifies the number of copies and address for submission of a TEA.) If a condition is found eligible, any interested parties can submit safety and effectiveness information as explained in Sec. 330.14(f). Safety and effectiveness data includes the data and information listed in 21 CFR 330.10(a)(2), a listing of all serious adverse drug experiences that may have occurred, and an official or proposed compendial monograph. We published the Guidance for Industry “Time and Extent Applications for Nonprescription Drug Products'' in September 2011. Comments are due by May 23, 2014. FR, pages 16007-16008

  • The FDA is announcing the availability of the draft guidance entitled: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery. FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for electrosurgical devices intended for use in general surgery. Comments are due June 23, 2014. FR, pages 16008-16009

  • The FDA is announcing the availability of the draft guidance entitled “Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery.” FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for bipolar electrosurgical vessel sealers intended for use in general surgery. This draft guidance is not final nor is it in effect at this time. Comments are due June 23, 2014. FR, pages 16009-16010

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