Proposed Collection; 60-Day Comment Request; NIMH Data Repositories Data Submission Request; NIMH Data Repositories Data Access and Use Certification
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 Mental Health (NIMH), 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. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301-443-4335 or Email your request, including your address to: email@example.com. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: NIMH Data Repositories (NDR) Data Submission Request, the NIMH Data Repositories Data Access and Use Certification, 0925-0667 Revision; National Institute of Mental Health (NIMH), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Mental Health (NIMH) Data Repositories are a group of Federal data repositories based on an informatics platform for human-subjects research domains related to mental health, initially established as the National Database for Autism Research (NDAR) to support autism-related research. In 2013, NIMH received approval from OMB for use of the NIMH Data Access Request and Use Certification (DUC) Form to meet the unique data access needs of all existing NIMH data repositories, which at the time consisted of NDAR, Pediatric MRI (PedsMRI), and the NIMH Clinical Research Datasets (NCRD)OMB# 0925-0667 (Expiration: 09/30/2016). Now in 2014, two new databases have been added and integrated into the NDAR infrastructure, NDCT and RDoCdb. At this time, NIMH is seeking OMB approval to add an all-purpose NIMH Data Repositories Data Submission Request Form and to add a revised all-purpose NIMH Data Repositories Data Access and Use Certification Form. As the data repositories have matured, and with the introduction of the new databasesnamely NDCT and RDoCdbthe information being collected for data submission has become more complex, rendering an OMB-approved submission form a new necessity. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 221.
Submission for OMB Review; 30-Day Comment Request; NIMH Database of Cognitive Training and Remediation Studies (DCTRS) (NIMH)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 15, 2014, pages 21250-21252 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 Institute of Mental Health (NIMH), 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint To Support Accelerated Approval; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval.'' This guidance is intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the neoadjuvant (preoperative) setting using pathological complete response (pCR) as a surrogate endpoint that could support approval under the accelerated approval regulations. Despite advances in systemic therapy of early-stage breast cancer over the past few decades, there remains a significant unmet medical need for certain high-risk or poor prognosis populations of early-stage breast cancer patients. This guidance is intended to encourage industry innovation and expedite the development of breakthrough therapies to treat high-risk early-stage breast cancer. This guidance finalizes the draft guidance issued May 30, 2012.
Laboratory Site Tours Program
The Food and Drug Administration's (FDA's) Center for Tobacco Products' (CTP) Office of Science is announcing an invitation for participation in its Laboratory Site Tours Program. This program is intended to give CTP staff an opportunity to visit facilities involved in the testing and analysis of tobacco products and tobacco smoke. These visits are intended to provide CTP staff with the opportunity to gain a better understanding of tobacco science and laboratory operations and are not intended as regulatory inspections or facility visits for the purposes of developing Tobacco Product Manufacturing Practice regulations. The purpose of this notice is to invite parties interested in participating in the Laboratory Site Tours Program to submit their requests to CTP.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.