Department of Health and Human Services January 2013 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services, the National Institutes of Health (NIH), has decided, after completion of a Final Supplementary Risk Assessment and a thorough consideration of public comments on the Draft and Final Supplementary Risk Assessment, to implement the Proposed Action, which is identified as the Preferred Alternative in the Final Environmental Impact Statement (EIS). This action reaffirms the NIH's previous decision to partially fund the construction of a state-of-the-art National Biocontainment Laboratory (NBL), the National Emerging Infectious Diseases Laboratories (NEIDL), at the Boston University Medical Campus (BUMC) in Boston, Massachusetts.

Under the provisions 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 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 in writing, request more information on the proposed project, or to obtain a copy of the data collection plans and instruments, contact: Nina Goodman, Public Health Advisor, Office of Communications and Education (OCE), NCI, NIH, 6116 Executive Blvd., Suite 400, Rockville, MD 20892, call non-toll-free number (301) 435- 7789 or email your request, including your address to: goodmann@mail.nih.gov. 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: A Generic Submission For Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources, 0925-0046, Expiration Date 2/28/2013EXTENSION National Cancer Institute, National Institutes of Health (NIH). Need and Use of Information Collection: In order to carry out NCI's legislative mandate to educate and disseminate information about cancer prevention, detection, diagnosis, and treatment to a wide variety of audiences and organizations, it is beneficial for NCI through its Office of Communications and Education (OCE), to pretest NCI communications strategies, concepts, and messages while they are under development. This pretesting, or formative evaluation, helps ensure that the messages, communication materials, and information services created by NCI have the greatest capacity of being received, understood, and accepted by their target audiences. Since NCI's OCE also is responsible for the design, implementation, and evaluation of education programs over the entire cancer continuum, and management of NCI initiatives that address specific challenges in cancer research and treatment, it is also necessary to ensure that customers are satisfied with programs. This customer satisfaction research helps ensure the relevance, utility, and appropriateness of the many educational programs and products that OCE and NCI produce. OCE will use a variety of qualitative (focus groups, interviews) and quantitative (paper, phone, in-person, and web surveys) methodologies to conduct this formative and customer satisfaction research, allowing NCI to: (1) Understand characteristics (attitudes, beliefs, and behaviors) of the intended target audience and use this information in the development of effective communication tools and strategies; (2) use a feedback loop to help refine, revise, and enhance messages, materials, products, and programsensuring that they have the greatest relevance, utility, appropriateness, and impact for/to target audiences; and (3) expend limited program resource dollars wisely and effectively. The participants may include, but are not limited to, cancer patients, their families, the general public, health providers, the media, voluntary groups, scientific and medical organizations (affected public could include individuals or households; businesses or other for profit; not-for-profit institutions; and Federal Government; State, Local, or Tribal Government). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 6,600.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``eCopy Program for Medical Device Submissions.'' The purpose of the guidance is to explain the new electronic copy (eCopy) Program for medical device submissions, which is intended to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version. The guidance describes how FDA has implemented the eCopy Program under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance also provides the standards for a valid eCopy under the FD&C Act and identifies the submission types that must include an eCopy in accordance with these standards for the submission to be processed and accepted for review by FDA. This final guidance will be considered in effect on January 1, 2013, or at the time of publication, whichever is later.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Acceptance and Filing Reviews for Premarket Approval Applications (PMAs).'' The purpose of the acceptance and filing reviews is to make a threshold determination about whether an application is administratively complete. This guidance document is intended to clarify the criteria for accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.