Department of Health and Human Services June 2013 – 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, 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 requirements for reporting and recordkeeping, general and specific requirements, and the availability of sample electronic products for manufacturers and distributors of electronic products.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse, 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 March 27, 2013, pages 18612-18613 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 Institute on Drug Abuse (NIDA), 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. Comments 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.

The Food and Drug Administration (FDA) has determined that CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05%, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for flurandrenolide ointment, 0.025% and 0.05%, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is correcting a document amending the regulations for irradiation of animal feed and pet food that appeared in the Federal Register of May 10, 2013 (78 FR 27303). That document used incorrect style for the strength units describing radiation sources. This correction is being made to improve the accuracy of the animal drug regulations.

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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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 Food and Drug Administration (FDA) is announcing the availability of a final guidance document entitled ``Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products,'' dated June 2013. The final guidance document provides technical and scientific information for sponsors to consider in developing information to support a marketing application for a pen, jet, or related injector device intended for use with drugs or biological products. The marketing application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA) application for the injector alone. For a combination product that includes the injector, the marketing application would typically be a new drug application (NDA) or a biological licensing application (BLA). The guidance announced in this notice finalizes the draft guidance of the same title dated April 2009 and published under Docket No. FDA-2009-D-0179.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the continuing support of a national effort to promote the importance of medication adherence to enhance the health of Americans. Medication adherence is taking medicine as directed to treat an illness or disease in order to get the best health outcome possible for each patient. Nearly three out of four Americans report that they do not take their medication as directed. One in three people never fill their prescriptions. The annual price tag for medication adherence failure is estimated to be $290 billion, and the impact on the medical system and patients from this lack of adherence may result in relapses or recurrences of medical symptoms, increases in hospital visits, or even death. FDA is committed to addressing this issue, which has enormous implications for public health and the U.S. economy, by, in part, continuing its financial and other contributions to a carefully planned, well-executed effective national campaign begun in 2010 by the National Consumers League (NCL) called ``Script Your Future''. To continue and enhance this important public health initiative, the Division of Health Communications (DHC)/Office of Communications (OCOMM)/Center for Drug Evaluation and Research (CDER) in FDA seeks to assist the National Consumers League in the development of new online resources and tools for patients, engagement of public and private partners to build on and complement existing medication adherence programs, education of health care professionals with strategies to share with patients, continuous evaluation of the campaign to enhance and improve it, expansion of public-private partnerships, strengthening of this national forum focused on informing consumers about medication adherence, and tailoring messaging to subpopulations of consumers who may need adaptations or special efforts to inform and educate them.

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On May 29, 2013, the Secretary determined 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 United States citizens living abroad and that involves Middle East respiratory syndrome coronavirus (MERS-CoV). On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Middle East respiratory syndrome coronavirus (MERS-CoV) pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013 that appeared in the Federal Register of April 30, 2013. FDA is correcting the approved strengths of dexmedetomidine hydrochloride injectable solution. This correction is being made to improve the accuracy of the animal drug regulations.