Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Period for Information Collection Provisions
The Food and Drug Administration (FDA or ``we'') is extending the comment period for the information collection related to the proposed rule on ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' that appeared in the Federal Register of January 16, 2013. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the information collection provisions associated with the rule.
Request for Information: Main Study Design for the National Children's Study
The Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD), National Institutes of Health (NIH), is issuing a Request for Information (RFI) as part of the National Children's Study's (NCS) effort to engage communities and receive public input on specific design questions for incorporation into the Main Study Design of the NCS. The information obtained from RFI responses will be used to guide the construction of decision points or parameters for the Main Study design over the next 12-18 months. This RFI was preceded by a workshop with the National Academy of Sciences which posed similar questions. For background information on this workshop, please visit: http://www.nationalchildrensstudy.gov/research/ workshops/Pages/nationalacademyofsciencesworkshop.aspx.
Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards
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 ``Manufactured Food Regulatory Program Standards.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection involving interviews of pharmaceutical manufacturers who submit new molecular entity (NME) new drug applications (NDAs) and original biologics license applications (BLAs) to FDA under the Program for Enhanced Review Transparency and Communication (``the Program'') during fiscal years (FYs) 2013-2017. The Program is part of the FDA performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA), which allows FDA to collect user fees for the review of human drug and biologics applications for FYs 2013-2017.
Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is issuing this guidance document to describe how to compile and submit the readily available pediatric use information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time.
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure
The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 1, 2010, along with a companion direct final rule. The proposed rule proposed to amend the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. The Agency received significant adverse comment and withdrew the direct final rule. The Agency is issuing this supplemental notice of proposed rulemaking re-proposing the amendments reflecting comments received.
Notice of NIH Consensus Development Conference: Diagnosing Gestational Diabetes Mellitus
The National Institutes of Health (NIH) is holding a conference, titled ``Consensus Development Conference: Diagnosing Gestational Diabetes Mellitus.'' The conference will be open to the public.
Submission of OMB Review; Comment Request (30-Day FRN):
In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collected below. This proposed information collection was previously published in the Federal Register on September 20, 2012 (77 FR 58401) and allowed 60- days for public comment. No public comments were received. 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 March 1, 2011, unless it displays a valid OMB control number. Written comments or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response times, should be directed to the Attention: NIH Desk Officer, Office of Management and Budget, at OIRA_ firstname.lastname@example.org or by fax to 202-395-6974. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Charles L. Hall, Jr., Chief, Pharmaceutical Management Branch, Cancer Therapy Evaluation Program, Division of the Cancer Treatment and Diagnosis, and Centers, National Cancer Institute, Executive Plaza North, Room 7148, 9000 Rockville Pike, Bethesda, MD 20892 or call non-toll-free number 301-496-5725 or Email your request, including your address to: Hallch@mail.nih.gov. Comments regarding this information collection are best assured of having their full effect if received within 30 days following the date of this publication. Proposed Collection: Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer (NCI), OMB No.0925-0613, Expiration Date: 2/28/2013, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The U.S. Food and Drug Administration (FDA) holds the National Cancer Institute (NCI) responsible, as a sponsor of investigational drug trials, for the collection of information about the clinical investigators who participate in these trials and to assure the FDA that systems for accountability are being maintained by investigators in its clinical trials program. The information collected is used to identify qualified investigators and to facilitate the submission and distribution of important information relative to the investigational drug and the response of the patient to that drug. Investigators are physicians who specialize in the treatment of patients with cancer. Data obtained from the Drug Accountability Record is used to track the dispensing of investigational anticancer agents from receipt from the NCI to dispensing or administration to patients. NCI and/or its auditors use this information for compliance purposes. OMB approval is requested for 3 years. There are no costs to the respondents other than their time. The total estimated annualized burden hours are 14,328.
Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I.'' The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), requires FDA to establish and publish criteria to reaccredit or deny reaccreditation to persons accredited by FDA under the FD&C Act to perform premarket review of medical devices. This draft guidance describes the accreditation, reaccreditation, and accreditation withdrawal processes, including criteria that will be considered to accredit, reaccredit, deny accreditation to, and deny reaccreditation to third party reviewers under the Third Party Review Program. The criteria will facilitate international harmonization and, thereby, in the future, allow us to leverage resources with those of regulating bodies in other countries. This draft guidance is not final nor is it in effect at this time.
Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation.'' This guidance provides FDA's recommendations on clinical trial designs for surgical ablation devices intended for the treatment of atrial fibrillation.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2012
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2012, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Medicare Program; Public Meetings in Calendar Year 2013 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2013 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda.
Control of Communicable Disease; Foreign-Requirements for Importers of Nonhuman Primates (NHP)
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is amending regulations for the importation of live nonhuman primates (NHPs) by extending existing requirements for the importation of Macaca fascicularis (cynomolgus), Chlorocebus aethiops (African green), and Macaca mulatta (rhesus) monkeys to all NHPs with the exception of the filovirus testing requirement. Filovirus testing will only be required for Old World NHPs in quarantine that have illness consistent with filovirus infection or that die for any reason other than trauma during quarantine. HHS/CDC is also finalizing a provision to reduce the frequency at which importers of cynomolgus, African green, and rhesus monkeys are required to renew their special permits (from every 180 days to every 2 years). HHS/CDC is incorporating existing guidelines into the regulations and adding new provisions to address the following: NHPs imported as part of an animal act; NHPs imported or transferred by zoological societies; the transfer of NHPs from approved laboratories; and non-live imported NHP products. Finally, HHS/CDC is also requiring that all NHPs be imported only through ports of entry where a HHS/CDC quarantine station is located.
Re-Establishment of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
The U.S. Department of Health and Human Services announces re- establishment of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (hereafter referred to as ``the Advisory Group''). Authorization to re-establish the Advisory Group is given under Executive Order 13631, dated December 7, 2012.
Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning a Genetically Engineered Atlantic Salmon; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for two draft environmental review documents for which a notice of availability appeared in the Federal Register of December 26, 2012. In that notice, FDA made available for comment the Agency's draft environmental assessment (EA) of the proposed conditions of use specified in materials submitted by AquaBounty Technologies, Inc., in support of a new animal drug application (NADA) concerning a genetically engineered (GE) Atlantic salmon and a preliminary finding of no significant impact (FONSI) for those specific conditions of use. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Annual Computational Science Symposium; Conference
The Food and Drug Administration (FDA), in cosponsorship with the Pharmaceutical Users Software Exchange (PhUSE), is announcing a public conference entitled ``The FDA/PhUSE Annual Computational Science Symposium.'' The purpose of the conference is to help the broader community align and share experiences to advance computational science. At the conference, which will bring together FDA, industry, and academia, FDA will update participants on current initiatives, and collaborative project groups will address specific challenges in accessing and reviewing data to support product development. These project groups will focus on solutions and practical ways to implement them.