Department of Health and Human Services July 15, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Substantial Equivalence Reports: Manufacturer Requests for Extensions or To Change the Predicate Tobacco Product.'' This draft guidance provides information to tobacco product manufacturers about FDA's policies on manufacturer requests for extensions of time to respond to deficiencies that FDA has identified, and manufacturer requests to change the predicate tobacco product, in substantial equivalence (SE) reports.

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 1, 2014 (Volume 79, Number 62), page 18300, 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 Office of Intramural Research (OIR), National Institutes of Health (NIH), 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 sent 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.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.'' The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The draft guidance provides the Agency's recommendations and requirements for informed consent to assure the protection of the rights and welfare of human subjects in clinical investigations.

The Food and Drug Administration (FDA or we) is correcting a final rule that appeared in the Federal Register of June 10, 2014. The final rule revised our infant formula regulations by establishing requirements for current good manufacturing practices, including audits; establishing requirements for quality factors; and amending our quality control procedures, notification, and record and reporting requirements for infant formula. We issued the final rule to provide greater protection of infants who consume infant formula products. In this document, we correct some errors that appeared in the preamble to the final rule.

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), 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, or request more information on the proposed project, contact: Brenda Kostelecky, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W276, Rockville MD, 20850 or call non-toll-free number 240-276-5585 or Email your request, including your address to: brenda.kostelecky@nih.gov. 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: Evaluation of Cancer Control Leadership Forums at the Center for Global Health (CGH) (NCI), 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This submission is a request for OMB to approve the Cancer Control Leadership Forums. These workshops are organized and funded by the National Cancer Institute's CGH in conjunction with various partners ranging from foreign Ministries of Health and research institutions, to international non- governmental organizations (NGOs) and U.S. academic institutions. The goal of the U.S. National Cancer Institute (NCI) Cancer Control Leadership Forums is to increase the capacity of participating countries to initiate or enhance cancer control planning and implementation in their respective countries. The Forums are an opportunity for countries to exchange experiences and ideas about creating and implementing comprehensive cancer control plans. The proposed evaluation requests information about the outcomes of the forums including (1) status of cancer control planning and implementation in each participating country, (2) outcomes related to the action plans (e.g. developing written materials, completion of action items, resources and support acquired),(3) successes and challenges related to the action plans, and (4) new cancer control partnerships and networks. Baseline information regarding the status of cancer control planning and implementation will be collected 3 months prior to the Forums in order to inform the development of each Forum. The evaluation information will be collected 3-24 months after each forum and is needed to evaluate the effectiveness of these workshops in order to inform future programming and funding decisions. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 108.