Department of Health and Human Services March 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.'' The guidance encourages manufacturers of medically necessary drug products (MNPs) and components to develop production plans in the event of an emergency that results in high absenteeism at one or more production facilities. The purpose of the guidance is to provide to industry considerations for developing plans for these types of emergencies, as well as to discuss the Center for Drug Evaluation and Research's (CDER's) intended approach to assist in avoiding drug product shortages that may have a negative impact on the national public health during such emergencies.

The Food and Drug Administration (FDA) has determined ROCEPHIN (ceftriaxone sodium) Injection, 250 milligrams (mg), 500mg, 1 gram (g), 2g, and 10g base/vial, approved under new drug application (NDA) 050585, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for any of these products if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to cardiovascular outcomes expected from such blood pressure reduction. However, blood pressure control is well established as beneficial in preventing serious cardiovascular events, and inadequate treatment of hypertension is acknowledged as a significant public health problem. The Agency believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling.

The Food and Drug Administration (FDA) is reopening until June 30, 2011, the comment period for the notice of public meeting, published in the Federal Register of August 9, 2010 (75 FR 47820), entitled ``Generic Drug User Fee; Public Meeting; Request for Comments.'' In that notice, FDA announced a public meeting that took place on September 17, 2010, to gather stakeholder input on the development of a generic drug user fee program. FDA is reopening the comment period for the expected duration of the active negotiation phase to ensure that all interested stakeholders have the opportunity to share their views on the matter.

The Department of Health and Human Services published a notice in the Federal Register of March 4, 2011, announcing a call for comment on the draft report of the Adult Immunization Working Group to the National Vaccine Advisory Committee. It was announced that the draft report and recommendations could be found on the Web at https:// www.hhs.gov/nvpo/nvac/subgroups/adultimmunization. The Web address where the draft report and recommendations can be found is https:// www.hhs.gov/nvpo/nvac/subgroups/adultimmunization.html.

This interim final rule with comment period implements section 203 of the Medicare and Medicaid Extenders Act of 2010 relating to the treatment of teaching hospitals that are members of the same Medicare graduate medical education affiliated groups for the purpose of determining possible full-time equivalent resident cap reductions.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``FDA Food Safety Modernization Act: Title IIIA New Paradigm for Importers.'' The purpose of the public meeting is to provide interested persons an opportunity to discuss implementation of the import safety provisions of the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is seeking information on importer verification, the Voluntary Qualified Importer Program, import certifications for food, and third-party accreditation. In a separate notice published elsewhere in this issue of the Federal Register, FDA is announcing a public hearing to provide stakeholders the opportunity to discuss FDA's use of international comparability assessments as a mechanism to enhance the safety of imported foods and animal feed and lessons learned through equivalence determinations. The public hearing will include a separate discussion of FDA's efforts to gather information from regulators in other countries regarding the regulatory policies, practices, and programs they currently use to ensure the safety of foods and animal feed imported into their countries.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 026'' (Recognition List Number: 026), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Interactive Diet and Activity Tracking in AARP (iDATA): Biomarker Based Validation Study. Type of Information Collection Request: New. Need and Use of Information Collection: The AARP-based study is one component of a multi-center biomarker validation study project involving two other large cohorts in the United States. The iDATA study involves large cohorts and provides the necessary sample size to evaluate the measurement error structure of the diet and physical activity assessment instruments and the heterogeneity of the measurement error structure across multiple and diverse study populations. The iDATA study will include 1,500 participants from the NIH-AARP Diet and Health Study and current AARP membership. The data collection instruments adhere to The Public Health Service Act, which provides authority to the Risk Factor Monitoring and Methods Branch in the Division of Cancer Control and Population Sciences and the Division of Cancer Epidemiology and Genetics. Both divisions work to reduce cancer in the U.S. population by establishing and supporting programs for the detection, diagnosis, prevention and treatment of cancer; and by collecting, identifying, analyzing and disseminating information on cancer research, diagnosis, prevention and treatment. Dietary and physical activity data will be gathered using the instruments as detailed below. In addition, biospecimen and clinic data will be also gathered. Frequency of Response: Monthly. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 50-74). The annual reporting burden is provided for each study component as shown in the table below. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Drug Abuse (NIDA), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on medical device labeling regulations.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This revised draft guidance provides recommendations to applicants considering whether to request a waiver or reduction in user fees. This guidance is a revision of the draft guidance entitled ``Draft Interim Guidance Document for Waivers of and Reductions in User Fees,'' issued July 16, 1993.

The National Institute for Occupational Safety and Health (NIOSH), CDC, HHS, in collaboration with the National Truck Equipment Association, Ambulance Manufacturers Division (NTEA-AMD) has developed a series of proposed ambulance component test standards. One such standard, AMD STANDARD 026Seat, Seat Mount and Occupant Restraint Dynamic TestProposed (draft), seeks to improve occupant and seat retention during crash conditions. As a part of the standard development process, NIOSH will be conducting a series of tests to evaluate existing, redesigned, and/or new seating to validate the test methods proposed. It is anticipated testing will be conducted in up to three phases over approximately 15 months. NIOSH will contract with an independent test facility and provide funding for all testing, instrumentation, data collection, and data analysis. Prospective industry partners will provide the following test assets: Seating, seat retention devices, and occupant restraints. This project has three key goals: (1) To validate test and data collection methodologies proposed in AMD 026 (draft) to support standard development; (2) to support and facilitate the transition of the industry from the current seating design parameters to those proposed in SAE J2917 Surface Vehicle Recommended Practice, Occupant Restraint and Equipment Mounting IntegrityFrontal Impact System-Level Ambulance Patient Compartment, published May 2010, and SAE J2956 Surface Vehicle Recommended Practice, Occupant Restraint and Equipment Mounting IntegritySide Impact System-Level Ambulance Patient Compartment (draft); and, (3) to develop the design and production ``cost-of-change'' to meet the proposed design parameters.

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee''). The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the currently available evidence regarding the outcomes associated with the use of unilateral and bilateral cochlear implant technology for hearing loss. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).