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

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 study, Risk and Benefit Perception Scale Development. The study is designed to test different ways of measuring consumers' benefit and risk perceptions after exposure to direct-to-consumer (DTC) prescription drug advertising.

The Food and Drug Administration (FDA or Agency) is classifying the eyelid weight into class II (special controls). The Agency is exempting the external eyelid weight from premarket notification, but continuing to require premarket notification for implantable eyelid weights in order to provide a reasonable assurance of safety and effectiveness of the device. Both external and implantable eyelid weight devices are subject to special controls. The eyelid weight may be adhered to the outer skin of the upper eyelid (external eyelid weight) or implanted into the upper eyelid (implantable eyelid weight), and is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).

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 on Drug Abuse (NIDA), 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 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: Dr. David Thomas, Director of the NIH Centers of Excellence in Pain Education Program, National Institute on Drug Abuse, 6001 Executive Blvd., Room 3165, Rockville, MD 20852, or call non-toll free number (301) 435-1313, or Email your request, including your address to: dthomas1@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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.

The Health Resources and Services Administration, Department of Health and Human Services, is announcing a decrease in user fees charged to individuals and entities authorized to request information from the National Practitioner Data Bank (NPDB). The new fee will be $3.00 for both continuous and one-time queries and $5.00 for self- queries.

The Department of Health and Human Services (HHS), Administration for Children and Families (ACF) will host a Tribal Consultation to consult on ACF programs and tribal priorities.

This notice reopens the application period and provides information on new dates for the submission of the Comprehensive ESRD Care initiative letters of intent and application. The letter of intent submission date for End-stage Renal Disease Seamless Care Organizations (ESCOs) that include a dialysis facility from a large dialysis organization (LDO) is June 23, 2014, and the submission deadline for the LDO application is June 23, 2014. The letter of intent submission date for ESCOs that include a non-LDO facility is September 15, 2014, and the submission deadline for the non-LDO application is September 15, 2014.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff.'' This guidance is intended, in part, to improve the quality of information submitted by sponsors in an IDE application or supplement to an IDE application and to ensure consistency in the review of those submissions. This draft guidance is intended to clarify FDA's regulations and policies regarding live case presentations using unapproved or uncleared investigational devices in the United States. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or we) 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 information collection provisions in FDA's cosmetic labeling regulations.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the novel influenza A (H7N9) virus (detected in China in 2013). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Quidel Corporation. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the April 19, 2013, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the novel influenza A (H7N9) virus. On the basis of such determination, the Secretary of HHS also declared on April 19, 2013, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the novel influenza A (H7N9) virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

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 the information collection provisions of FDA's regulations for submission of petitions, including food and color additive petitions (including labeling) and Generally Recognized as Safe (GRAS) affirmations, submission of information to a master file in support of petitions, and electronic submission using FDA Form 3503.