Department of Health and Human Services March 2014 – Federal Register Recent Federal Regulation Documents

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

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 Allergy and Infectious Diseases (NIAID), 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: Jacquelyn Burns, Office for Policy in Clinical Research Operations, DAIDS, NIAID, 6700B Rockledge Drive, Room 4118, Bethesda, MD 20852, or call non-toll- free number 301-402-0143, or Email your request, including your address to: Jburns@niaid.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: Assessment of DAIDS Training Resources, 0925- New, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). Need and Use of Information Collection: This is a new data collection in order to assess the efficacy of training resources and their impact on NIAID-supported and/or sponsored research operations. The generic OMB clearance will allow collecting information about the knowledge, attitudes, and behaviors from target audiences (e.g., research staff) to help improve and inform these training resources. Information collected will be used to determine the future direction for training resources, including which resources should be continued, enhanced, added, or discontinued in order to utilize resources efficiently. Findings will provide data to inform and guide the optimal development, dissemination, and revisions to improve NIAID trainings and resources. Various types of data will be collected, including post- assessment tests, questionnaires, interviews, and focus groups. Post- assessment tests will be administered at the time of the trainings to assess trainees' immediate knowledge gained, as well as reactions and satisfaction to the content. Select trainees will be queried at later time points (e.g., three-months, six-months) after they have participated in a training to understand if they have been able to apply their knowledge at the workplace, and identify facilitators or hindrances to implementing this new knowledge. The assessment team will conduct repeated data collections for these select trainees to determine any changes throughout time. In order to obtain information beyond self-reported data, select managers and supervisors will also be queried to assess if they have observed any changes in their staff after attending trainings, and if the work environment is conducive for trainees to implement knowledge from trainings. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 847.

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 recommendations to applicants considering whether to request a waiver or reduction in user fees.

The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on the issues and challenges associated with the collection, analysis, and availability of demographic subgroup data in applications for approval of FDA-regulated human medical products.

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 December 20, 2013 page 77138 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 Heart, Lung and Blood Institute (NHLBI), 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.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The updated information is consistent with current data on the associations between nutrients and chronic diseases or health-related conditions, reflects current public health conditions in the United States, and corresponds to new information on consumer behavior and consumption patterns. We are proposing to update the list of nutrients that are required or permitted to be declared; provide updated Daily Reference Values and Reference Daily Intake values that are based on current dietary recommendations from consensus reports; amend requirements for foods represented or purported to be specifically for children under the age of 4 years and pregnant and lactating women and establish nutrient reference values specifically for these population subgroups; and revise the format and appearance of the Nutrition Facts label.

The Food and Drug Administration (FDA or we) is proposing to amend the definition of a single-serving container; require dual-column labeling for certain containers; update and modify several reference amounts customarily consumed (RACCs or reference amounts); add several food products and food product categories to the reference amounts customarily consumed per eating occasion for the general food supply; amend the label serving size for breath mints; and make technical amendments to various aspects of the serving size regulations. These actions are being taken, in part, in response to recommendations of the 2003 FDA Obesity Working Group and FDA's recognition that portion sizes have changed since the original serving size regulations were published in 1993. This proposal also discusses six citizen petitions. The intended effect of this rulemaking is to provide consumers with more accurate and up-to-date information on serving sizes.