Department of Health and Human Services March 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). Method, metallic reduction, glucose (urinary, non-quantitative) test systems in a reagent tablet format are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

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 a proposed information collection request entitled ``HIV Knowledge, Beliefs, Attitudes, and Practices of Providers in the Southeast (K-BAP Study)''. CDC is requesting a three-year approval for new data collection to identify areas of HIV prevention knowledge and practice strengths and deficits among primary care providers, in order to target limited HIV prevention resources to achieve the greatest reduction in new HIV infections and optimize HIV clinical care in clinical settings. The target population will be primary care providers practicing in high- prevalence metropolitan statistical geographic areas with large at-risk African American populations.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0406, scheduled to expire on April 30, 2016. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

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 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: Anthony Dickherber, NCI Center for Strategic Scientific Initiatives, 31 Center Drive, Rm10A33, Bethesda, MD 20892 or call non-toll-free number 301- 547-9980 or Email your request, including your address to: dickherberaj@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: Surveys and Interviews to Support an Evaluation of the Innovative Molecular Analysis Technologies (IMAT) Program (NCI), 0925-0720, Expiration Date 5/31/2016EXTENSION, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of the proposed evaluation is to pursue a comprehensive process and outcome assessment of the 15-year old Innovative Molecular Analysis Technologies (IMAT) program. While the program consistently offers promising indicators of success, the full program has not been evaluated since 2008, and never in as comprehensive a manner as has been formulated in the current evaluation plan. An outcome evaluation of the long-standing National Cancer Institute's (NCI) IMAT program presents a rich and unique opportunity likely to serve institutes across the National Institutes of Health (NIH), and perhaps other federal agencies, considering the costs and benefits of directing resources towards supporting technology development. An award through the NIH Evaluation Set-Aside program to support this evaluation, for which NIH-wide relevance is a principle element of determining merit for support, is testament to this. The evaluation serves as an opportunity to gauge the impact of investments in technology development and also to assess the strengths and weaknesses of phased innovation award mechanisms. Prior approval from OMB allowed for extensive surveys and interviews already, and this extension is requested to accommodate unforeseen delays in collecting the remaining information. Like all institutes and centers (ICs) of the NIH, NCI seeks opportunities for improving their programs' utility for the broad continuum of researchers, clinicians and ultimately patients. NCI Acting Director Douglas Lowy and other leadership across NCI, as well as the NCI Board of Scientific Advisors, will be the primary users of the evaluation results. Findings are primarily intended for considering the long-term strategy to support innovative technology development and how to more efficiently translate emerging capabilities through such technologies into the promised benefits for cancer research and clinical care. Interviews with grantees, program officers, review officers, and other NIH awardees make up a crucial component of the evaluation plan and will largely follow set survey protocols. Specific near-term aims include the use of this information to consider the utility of continued investment through existing solicitations and in strategic planning generally for institute support for innovative technology development. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 233.

This notice sets forth final changes to the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to incorporate the recommendations of the Institute of Medicine (IOM) regarding human gene transfer protocols, as initially outlined by the NIH Office of Science Policy (OSP) in a Federal Register notice issued on October 16, 2015 (80 FR 62543). Following the solicitation of public comment on its original proposal, the NIH is amending the NIH Guidelines in the following areas: (A) The criteria for selecting protocols for in-depth review and public discussion by the NIH Recombinant DNA Advisory Committee (RAC), (B) the process by which human gene transfer protocols are reviewed and registered with the NIH, and (C) the streamlining of the NIH protocol submission requirements under Appendix M-I-A of the NIH Guidelines. In a continuing effort to harmonize with the Food and Drug Administration (FDA) regulations, a change is being made to the reporting requirement for additional clinical trial sites allowing for a delay of 30 days to submit appropriate documentation. The changes set forth in this notice do not affect the responsibility of the Principal Investigator to submit documentation to his or her local oversight bodies and to the NIH, nor do they affect the requirement to submit appropriate documentation to the NIH when new clinical trial sites are registered. The changes also do not affect the responsibility of a Principal Investigator (or a delegated clinical trial sponsor) to submit appropriate and timely follow up information to the NIH as outlined in the NIH Guidelines (e.g., protocol amendments, serious adverse events, annual reports with cumulative safety data).

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Milton W. Chu, M.D., proposing that the color additive regulations be amended to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper as orientation marks for intraocular lenses.

The Food and Drug Administration (FDA) is announcing a public conference, to be held in cosponsorship with the Parenteral Drug Association (PDA), entitled ``Aligning Manufacturing Goals with Patient Needs through Successful Innovation and Compliance.'' The conference will cover current issues affecting the industry as well as explore strategies to facilitate the development and continuous improvement of safe and effective medical products. The conference establishes a unique forum to discuss the foundations, emerging technologies, and innovations in regulatory science, as well as the current quality and compliance areas of concerns. Meeting participants will hear from FDA and industry speakers about the requirements and best practices to consider while implementing robust quality systems in order to deliver the best quality product.

The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is proposing these devices be banned.

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 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 a proposed information collection project entitled ``Formative Research to Develop HIV Social Marketing Campaigns for Healthcare Providers.'' CDC seeks a three-year approval to collect data from health care providers in order to develop timely, relevant, clear, and engaging materials that will support patient-provider communications related to HIV prevention.

The Food and Drug Administration (FDA) is announcing we have filed a petition, submitted by Global Nutrition International, proposing that the food additive regulations be amended to provide for the safe use of calcium butyrate as a source of energy in dairy cattle feed.