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

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending its regulations regarding the prohibition on the sale, or other commercial or public distribution, of viable turtle eggs and live turtles with a carapace length of less than 4 inches to remove procedures for destruction as FDA believes it is not necessary to routinely demand this destruction to achieve the purpose of the regulations. This action will reduce the need for investigator training and the time for the care and humane destruction of these animals.

The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the potential regulation of menthol in cigarettes. FDA is also making available its preliminary scientific evaluation of public health issues related to the use of menthol in cigarettes. The preliminary scientific evaluation indicates there is likely a public health impact of menthol in cigarettes. This ANPRM is seeking comments, including comments on FDA's preliminary evaluation, and data, research, or other information that may inform regulatory actions FDA might take with respect to menthol in cigarettes.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two approved new animal drug applications (NADAs) from Alstoe, Ltd., Animal Health, to Sogeval S.A., and a change of sponsor for an NADA from Nexcyon Pharmaceuticals, Inc. to Elanco Animal Health, A Division of Eli Lilly & Co.

The Food and Drug Administration (FDA) is announcing the availability of a guidance to industry entitled ``Providing Submissions in Electronic FormatPostmarket Non-Expedited ICSRs; Technical Questions and Answers.'' The guidance provides firms with information on the appropriate electronic file format to use when electronically submitting to FDA postmarket non-expedited individual case safety reports (ICSRs) on adverse drug experiences.\1\ The guidance explains that firms that had previously submitted non-expedited ICSRs in an electronic format that is not supported by FDA should contact the Center for Drug Evaluation and Research (CDER) or Center for Biologics and Evaluation and Research (CBER) and resubmit their non-expedited ICSRs in a compatible electronic format.

HRSA currently has nine programs that are funded through competitive grant awards under the Sickle Cell Disease Treatment Demonstration Program. Three of these awards will end on August 31, 2013, prior to the end of the other six awards. HRSA intends to implement a non-competitive extension of the project period for the three grants that will end in 2013. This will allow improved data gathering from each of the grantees in the program, which will be used in a report for Congress that is mandated by the legislation authorizing the grant. In addition, the program will benefit from cost savings realized from having the program completed in a consolidated funding cycle.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the National Institute of Neurological Disorders (NINDS) has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).

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 May 13, Vol. 78, p. 27974 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 Cancer Institute (NCI), 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. For Further Information: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Dorothy Farrell, Center for Strategic Scientific Initiatives, Office of Cancer Nanotechnology Research, National Cancer Institute, 31 Center Drive, Bldg. 31 A, Rm. 10A52, Bethesda, MD 20892 or call non-toll-free number 301-496-5652 or Email your request, including your address to: farrelld@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: National Cancer Institute (NCI) Alliance for Nanotechnology in Cancer Platform Partnership Scientific Progress Reports, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: National Institutes of Health grantees are required to submit interim and final progress reports and other post-award documents associated with the monitoring, oversight, and closeout of an award. This submission represents a request for OMB to approve new program specific progress report guidelines for Cancer Nanotechnology Platform Partnerships (CNPP) awarded by the National Cancer Institute (NCI). The CNPPs are part of the Alliance for Nanotechnology in Cancer, a network of awards funded by NCI to promote the application of nanotechnology to cancer research and care. The proposed guidelines request information about award performance related to trans-Alliance collaboration, scientific milestones, progress towards clinical translation and technology commercialization, and education and outreach efforts. The report also gathers information on leveraged funding, patents and publications. The information is gathered every six months. This information is needed to monitor the performance of this special program within NCI, funded through Requests for Applications (RFA CA-09-013, released May 29, 2009) using the cooperative agreement mechanism (U01). The information will be used to monitor individual award performance and the effectiveness of the program as a whole. The respondents are the Principal Investigators of the awards, along with their institutional business officials. The awards are administered by and the reports reviewed by the Office of Cancer Nanotechnology Research (OCNR), part of the Center for Strategic Scientific Initiatives within NCI. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The estimated annualized burden hours are 72.

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 medical device premarket notification.

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 requirements for premarket approval of medical devices.

HHS is issuing this final rule to clarify how section 340B(e) of the Public Health Service Act (PHSA) will be implemented. The final rule applies section 340B(e) of the PHSA only to drugs transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the orphan drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FFDCA). The final rule also sets forth that it is the responsibility of the 340B covered entity to maintain auditable records that demonstrate compliance with the terms of the orphan drug exclusion requirements. This rule will provide clarity in the marketplace, maintain the 340B savings for newly- eligible covered entities, and protect the financial incentives for manufacturing orphan drugs designated for a rare disease or condition as indicated in the Affordable Care Act and intended by Congress.

The Department of Energy (DOE) has prepared and is making available its portion of the semiannual Unified Agenda of Federal Regulatory and Deregulatory Actions (Agenda) pursuant to Executive Order 12866, ``Regulatory Planning and Review,'' and the Regulatory Flexibility Act.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) proposes to update four sections of its regulations titled ``Distribution of Reference Biological Standards and Biological Preparations'' to update the authority citation and reflect the agency's current name, address, and contact information for fees schedules and terms of payment. These updates will not affect current practices.