Department of Health and Human Services June 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Mirwaiss Aminzada from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Aminzada was convicted of a felony under Federal law for conduct relating to the regulation of a drug product. Mr. Aminzada was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Aminzada failed to request a hearing. Mr. Aminzada's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

The Indian Health Service published a document in the Federal Register on June 5, 2015 for the FY 2015 New and Competing Continuation Funding Announcement for the Dental Preventive and Clinical Support Centers Program. The notice contained incorrect dates.

This notice extends the application submission deadline for organizations to participate in the Oncology Care Model (OCM) beginning in 2016. The new deadline for receipt of online applications from payers and practices is 5:00 p.m. Eastern Daylight Time (EDT) on June 30, 2015. Only those payers and practices that submitted timely, complete Letters of Intent (LOIs) are eligible to apply to participate in OCM, and only the submission of web-based applications will be accepted.

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 (the 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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``Demo Day for the 2014 FDA Food Safety Challenge.'' The 2014 FDA Food Safety Challenge (https:// www.foodsafetychallenge.com) is a prize competition under the America COMPETES Reauthorization Act of 2010 which granted us (and other federal Agencies) broad authority to conduct prize competitions to spur innovation, solve tough problems, and advance our core mission. The purpose of the public meeting is for each of the five challenge finalists to present their concepts to the judges for selection of one or more winners.

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 must publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's procedures for early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use, including bioengineered food plants.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.'' This guidance discusses FDA recommendations for the size, shape, and other physical attributes of generic tablets and capsules intended to be swallowed intact. FDA is concerned that differences in these physical characteristics between generic drugs and the originator drug could affect patient outcomes.

This NPRM proposes to update Head Start program performance standards, last revised in 1998, to meet Congress's requirements and improve the quality of Head Start. In the Improving Head Start for School Readiness Act of 2007, Congress instructed the Office of Head Start to update its performance standards by regulation and ``ensure that any such revisions in the standards [do] not result in the elimination of or any reduction in quality, scope, or types of health, educational, parental involvement, nutritional, social, or other services.'' The proposed performance standards incorporate extensive consultation with experts and findings from scientific research, reflect best practices, lessons from program input and innovation, integrate recommendations from the Secretary's Advisory Committee Final Report on Head Start Research and Evaluation, and reflect this Administration's deep commitment to improving the school readiness of young children. The proposed program performance standards will improve the quality of services, reduce bureaucratic burden on programs, and improve regulatory clarity and transparency. They provide a clear road map for current and prospective grantees to provide high quality Head Start services and to strengthen the outcomes of the children and families they serve.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use.'' The purpose of this workshop is to receive input from stakeholders and discuss approaches to the study of non-microbial biomarkers for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for establishing appropriate comparator methods and clinically relevant performance standards for non-microbial based in vitro diagnostics for infection.

This document is a request for information regarding specific aspects of the regulatory policies and standards that may be applied to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (hair specimen). The original comment close date was June 29, 2015. We are extending the date to July 29, 2015 to allow for additional comments.

The Health and Human Services Department (HHS) is correcting a final rule that appeared in the Federal Register of December 6, 2012. The document modified the dispensing requirements buprenorphine and buprenorphine combination products approved by the Food and Drug Administration (FDA) for opioid dependence and used in federally certified and registered opioid treatment programs. In particular, this rule allows opioid treatment programs more flexibility in dispensing take-home supplies of buprenorphine after the assessment and documentation of a patient's responsibility and stability to receive opioid addiction treatment medication. However, an inadvertent removal of paragraphs was made. This correction reinstates the missing paragraphs.

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 February 11, 2015, pages 7619-7620 and allowed 60-days for public comment. One public comment was 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.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Based on the available scientific evidence and the findings of expert scientific panels, the Food and Drug Administration (FDA or we) has made a final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially-produced trans fatty acids (IP-TFA) are generally recognized as safe (GRAS) for any use in human food. This action responds, in part, to citizen petitions we received, and we base our determination on available scientific evidence and the findings of expert scientific panels establishing the health risks associated with the consumption of trans fat.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). 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.