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

The Food and Drug Administration (FDA) is correcting notices concerning FDA's determination of the regulatory review period for PRISTIQ that appeared in the Federal Registers of August 31, 2010 (75 FR 53314) and September 2, 2010 (75 FR 53969). The documents omitted docket number FDA-2009-E-0086. This document corrects those omissions. Because the comment period for the notices closed on February 28, 2011, FDA is reopening the comment period to allow interested parties to submit comments or petitions to docket number FDA-2009-E-0086.

This document is a request for comments on opportunities to more effectively align benefits and incentives to prevent cost-shifting and improve access to care under the Medicare and Medicaid programs for individuals with both Medicare and Medicaid (``dual eligibles''). The document also reflects CMS' commitment to the general principles of the President's Executive Order released January 18, 2011, entitled ``Improving Regulation and Regulatory Review.''

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on March 14, 2011 (76 FR 13647) and allowed 60-days for public comment. There were no public comments in response to the notice. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. 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.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of gonadotropin releasing factor-diphtheria toxoid conjugate by subcutaneous injection for temporary immunological castration (suppression of testicular function) and reduction of boar taint in intact male pigs intended for slaughter.

The Food and Drug Administration (FDA) has determined that XIBROM (bromfenac ophthalmic solution) 0.09% was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for bromfenac ophthalmic solution 0.09% if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This proposed notice with comment period acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for critical access hospitals (CAHs) that wish to participate in the Medicare or Medicaid programs. Section 1865(a)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic Testing.'' This draft guidance document provides industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for C. trachomatis and/or N. gonorrhoeae screening and diagnostic testing using nucleic acid based assays. This draft guidance is not final nor is it in effect at this time.