Department of Health and Human Services January 14, 2016 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection entitled ``Young Men who have Sex with Men (YMSM) Study Thailand''. CDC is requesting a three-year approval for this new project.

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, the 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 to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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*: Rebecca Ferrer, Program Director, Basic Biobehavioral and Psychological Sciences Branch, Behavioral Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Dr., Rockville MD 20852. or call non-toll-free number (240) 276-6914 or Email your request, including your address to: ferrerra@mail.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: Self-affirmation Construct Validity, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This information collection, seeks to refine a theory about how self-competence and values play a role in defensive responses to health communications. Although theoretically-driven research has shown that self- affirmationa process by which individuals reflect on values that are important to themcan improve responses to health and cancer communications, the ``active ingredient'' (or mechanisms underlying effectiveness) of self-affirmations is unknown. Self-affirmation is a potent means of augmenting the effectiveness of threatening health communications. Individuals tend to be defensive against information suggesting their behavior puts them at risk for disease or negative health. Previous evidence suggests that self-affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, intentions to engage in preventive behavior, and actual behavioral change. Understanding the mechanisms that explain these robust effects would yield evidence important for dissemination, including ways to refine self-affirmation interventions and make them more potent, which could change the ways that public health messages are constructed. This research can inform NCI scientific priorities and investments in self-affirmation research. The results of the information collection will be used to further develop and improve self-affirmation theory. These findings may allow future researchers to develop and test cancer prevention interventions. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 717.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry.'' The guidance document provides blood collecting establishments and manufacturers of plasma derivatives with comprehensive recommendations intended to minimize the possible risk of transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) from blood and blood products. The guidance amends the guidance document entitled ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated May 2010 (2010 guidance) by finalizing and incorporating the recommendations from the draft document entitled ``Draft Guidance for Industry: Amendment to 'Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products''' dated June 2012 (2012 draft guidance).