Agency Information Collection Activities: Proposed Collection; Comment Request; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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 reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in FDA's regulations on foreign clinical studies not conducted under an investigational new drug application (IND).
Richard Stowell: Debarment Order
The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Richard Stowell for a period of 3 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Stowell was convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21 U.S.C. 335a(l)(1)(B)), of three felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Stowell was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of December 14, 2012, Mr. Stowell had not responded. Mr. Stowell's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products
The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.
Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.'' This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators. This guidance provides FDA's responses to the most frequently asked questions regarding financial disclosure by clinical investigators. The guidance announced in this notice finalizes the draft guidance of the same title dated May 2011 and replaces the guidance entitled, ``Guidance for Industry: Financial Disclosure by Clinical Investigators,'' dated March 2001.
Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma'' dated February 2013. The guidance document recognizes the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 1.2 dated September 2012, as an acceptable mechanism that is consistent with FDA's requirements and recommendations for collecting Source Plasma donor history information. The Plasma Protein Therapeutics Association (PPTA) Source Plasma donor history questionnaires and accompanying materials (SPDHQ documents) will provide blood establishments that collect Source Plasma with a specific process for administering questions to Source Plasma donors to determine their eligibility to donate. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2011.
Request for Public Comment on the Proposed Adoption of Administration for Native Americans Program Policies and Procedures
Pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, the Administration for Native Americans (ANA) is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, general statements of policy, and rules of agency procedure or practice, and to give notice of the final adoption of such changes at least 30 days before the changes become effective. In accordance with notice requirements of NAPA, ANA herein describes its proposed interpretive rules, general statements of policy, and rules of agency procedure or practice as they relate to the Fiscal Year (FY) 2013 Funding Opportunity Announcements (FOA) for the following programs: (1) Social and Economic Development Strategies (hereinafter referred to as SEDS); (2) Native Asset Building Initiative (hereinafter referred to as NABI); (3) Sustainable Employment and Economic Development Strategies (hereinafter referred to as SEEDS); (4) Native Language Preservation and Maintenance (hereinafter referred to as Language Preservation); (5) Native Language Preservation and MaintenanceEsther Martinez Initiative (hereinafter referred to as LanguageEMI); and 6) Environmental Regulatory Enhancement (hereinafter referred to as ERE). This notice of public comment also provides additional information about ANA's plan for administering the programs.
Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-2013; Public Conference
The Food and Drug Administration (FDA), in cosponsorship with the Drug Information Association (DIA), is announcing a public conference entitled ``Seventh Annual DIA/FDA Statistics Forum2013.'' The purpose of the conference is to discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. This meeting is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians and clinical investigators who are involved in the development of new drugs and biologics. A primary focus for this meeting will be to establish an ongoing dialogue regarding FDA's ``Critical Path'' initiativeemphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data and measuring the progress being made in designing and implementing innovative solutions.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-May 1, 2013
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, May 1, 2013. 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 selected genetic tests for cancer diagnosis (for cancers of unknown primary site and for cervical cytology findings of uncertain clinical significance). This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated March 2013. The draft guidance document provides revised recommendations for screening and testing of donors and management of donations based on screening tests for syphilis. The draft guidance is intended for blood establishments that collect Whole Blood or blood components, including Source Plasma. The guidance announced in this notice replaces the draft guidance entitled, ``Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis,'' dated June 2003. In addition, the draft guidance, when finalized, is intended to supersede the FDA memorandum to registered blood establishments dated December 12, 1991, entitled, ``Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing.''