Department of Health and Human Services March 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice entitled ``Designation of High-Risk Foods for Tracing; Request for Comments and for Scientific Data and Information'' that appeared in the Federal Register of February 4, 2014 (79 FR 6596). In the notice, FDA requested comments and scientific data and information that will help us to implement the section of the FDA Food Safety Modernization Act (FSMA) that requires us to designate high-risk foods. FDA is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is announcing the availability of the Standard Operating Procedure (SOP) for Level 1, Immediately in Effect (IIE) Guidance Documents on Premarket Data Issues. The SOP describes the Center for Devices and Radiological Health's (CDRH's or the Center's) process to clarify and more quickly inform stakeholders when CDRH has changed its expectations relating to, or otherwise has new scientific information that could affect data submitted as part of an Investigational Device Exemption (IDE) or premarket submission, including a Premarket Notification (510(k)), a Premarket Approval (PMA), a Humanitarian Device Exemption (HDE), or combination products containing a device constituent part for which CDRH has jurisdiction that needs to be disseminated in a timely manner.

This proposed notice announces our proposal to renew the Medicare Advantage deeming authority of the National Committee for Quality Assurance (NCQA) for a term of 6 years. This new term of approval would begin October 19, 2014 and end October 18, 2020. This notice announces a 30-day period for public comments on the renewal of the application.

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: (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.

This notice announces the application of the American Association for Laboratory Accreditation (A2LA) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty areas under CLIA. We have determined that the A2LA meets or exceeds the applicable CLIA requirements. We are announcing the approval and granting the A2LA deeming authority for a period of 4 years.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.'' This draft guidance discusses FDA's recommendations for developing the indication and usage statements in the prescribing information for drugs approved under the accelerated approval regulatory pathway (hereafter ``accelerated approval''). The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of December 24, 2013 (78 FR 78014), entitled ``Focused Mitigation Strategies to Protect Food Against Intentional Adulteration'' and its information collection provisions. We are taking this action in response to requests for an extension to allow interested persons an opportunity to fully review and analyze the approaches FDA has proposed for the rule and its potential impact as well as to consider the complexity and if the proposal has the flexibility to address the many types of food operations that will be affected. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Kite Pharma, Inc., which is located in Los Angeles, California to practice the inventions embodied in the following patent applications:

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 Heart, Lung and Blood Institute (NHLBI), 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 on 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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: Dr. Larissa Aviles-Santa, 6701 Rockledge, Epidemiology Branch, Program in Prevention and Population Sciences, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Dr., MSC 7936, Bethesda, MD 20892- 7936, or call non-toll-free number 301-435-0450, or Email your request, including your address to avilessantal@nhlbi.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: The Hispanic Community Health Study/Study of Latinos (HCHS/SOL), Revised, National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose and use of the information collection for this project is to study the prevalence of cardiovascular and pulmonary disease and other chronic diseases, and their risk and protective factors, understand their relationship to all-cause, cardiovascular and pulmonary morbidity and mortality, and understand the role of sociocultural factors (including acculturation) on the prevalence or onset of disease among over 16,400 Hispanics/ Latinos of diverse origins, aged 18-74 years at enrollment, living in four U.S. communities: San Diego, California; Chicago, Illinois; Miami, Florida, and the Bronx, New York. In order to achieve these objectives, the HCHS/SOL had two integrated components: 1. Examination of the cohort following a standardized protocol, which consisted of interviews and clinical measurements to assess physiological and biochemical measurements including DNA/RNA extraction for ancillary genetic research studies. 2. Follow-up of the cohort, which consists of an annual telephone interview to assess vital status, changes in health status and medication intake, and new cardiovascular and pulmonary events (including fatal and non-fatal myocardial infarction and heart failure; fatal and non-fatal stroke; and exacerbation of asthma and chronic obstructive pulmonary disease). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 30,940.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 104 approved new animal drug applications (NADAs) and 5 approved abbreviated new animal drug applications (ANADAs) for implantation or injectable dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the animal drug regulations to remove entries describing conditions of use for new animal drug products for which no NADA is approved, to make minor corrections, and to reflect a current format. This is being done to increase the accuracy and readability of the regulations.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery.'' FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for bipolar electrosurgical vessel sealers intended for use in general surgery. This draft guidance is not final nor is it in effect at this time.

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 the collection of information associated with the criteria and procedures for classifying over-the- counter (OTC) drugs as generally recognized as safe and effective and not misbranded, in accordance with regulations and discussed in the Guidance for Industry ``Time and Extent Applications for Nonprescription Drug Products.''

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 2014. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and therefore, encourages nominations of appropriately qualified candidates from these groups.