Department of Health and Human Services August 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) held by Ranbaxy Laboratories Ltd., c/o Ranbaxy Inc. (Ranbaxy), 600 College Rd. East, Princeton, NJ 08540. The drug products are no longer marketed, and Ranbaxy has requested that the approval of the applications be withdrawn.

The Agency for Healthcare Research and Quality (AHRQ) requests information from the Public, including diversified stakeholders (health information technology (IT) system developers, including vendors; payers, quality measure developers, end-users, clinicians, health care consumers) regarding current successful strategies and challenges regarding quality measurement enabled by health IT. Quality measurementthe assessment of the timeliness, completeness and appropriateness of preventive services, diagnostic services, and treatment provided in health carehas been most generally conducted via paper chart information capture, manual chart abstraction, and the analysis of administrative claims data. Through this notice, the comment period has been extended. The subject matter content remains unchanged from the original notice which was previously published on July 20, 2012 (www.GPO.gov/fdsys/PKG/FR-2012-07-20/html/2012-17530.htm)

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of U.S. Federal agency responses to ICCVAM test method recommendations on the usefulness and limitations of the LUMI-CELL[supreg] ER (BG1Luc ER TA) test method to identify human estrogen receptor (ER) agonist and antagonist activity of chemicals. ICCVAM forwarded the recommendations to Federal agencies and made these recommendations available to the public (77 FR 8258). ICCVAM agencies responded with their concurrence on the technical aspects of the BG1Luc ER transcriptional activation (TA) test method recommendations and their agreement that the ICCVAM BG1Luc ER TA test method is a validated screening test to identify substances with in vitro ER agonist activity or ER antagonist activity. The U.S. Environmental Protection Agency (EPA) responded that they regard the BG1Luc ER TA test method as an alternative to the Office of Chemical Safety and Pollution Prevention (OCSPP) 890.1300 (Organization for Economic Co-operation and Development [OECD] TG455) test guideline for transcriptional activation currently used in their Endocrine Disruptor Screening Program (EDSP). Several agencies also indicated that they would communicate the ICCVAM recommendations to stakeholders and encourage their appropriate use. Complete Federal agency responses are available at https://iccvam.niehs.nih.gov/methods/endocrine/end eval.htm. The ICCVAM recommendations are provided in the ICCVAM test method evaluation report (ICCVAM, 2011), available at: https:// iccvam.niehs.nih.gov/methods/endocrine/ERTA-TMER.htm.

In this notice, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces fees for vessel sanitation inspections for Fiscal Year (FY) 2013. These inspections are conducted by HHS/CDC's Vessel Sanitation Program (VSP). VSP helps the cruise line industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly inspections and, when necessary, re-inspection.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``ASTM International-FDA Workshop on Absorbable Medical Devices: Lessons Learned From Correlations of Bench Testing and Clinical Performance.'' FDA is co-sponsoring the workshop together with ASTM International, an organization responsible for the development and delivery of international voluntary consensus standards for engineered products, including medical devices. The purpose of this public workshop is to provide a forum for highlighting and discussing the use of absorbable materials in medical devices across a broad range of indications with the aim of defining successful and unsuccessful methods to predict clinical performance. The main topics to be discussed include identification of test methods for establishing correlations between in vitro and in vivo degradation of absorbable implant devices, and the interaction of mechanical loading and mechanical performance with degradation. While there will be an emphasis on cardiovascular indications as part of a panel session, characterization techniques and experiences from both cardiovascular as well as non-cardiovascular devices will be discussed and are encouraged. Date and Time: The public workshop will be held on November 28, 2012, from 8:30 a.m. to 5 p.m. EST. Location: The public workshop will be held at the FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD, 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation / ucm241740.htm. Contact Person: Maureen Dreher, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, Bldg. 62, rm. 2110, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2505, Fax: 301-796-9932, email: Maureen.dreher@fda.hhs.gov; or Erica Takai, CDRH, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6353, Fax: 301-796-9959, email: erica.takai@fda.hhs.gov. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by November 13, 2012. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the workshop will be provided beginning at 8 a.m. If you need special accommodations due to a disability, please contact Cindy Garris, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4321, Silver Spring, MD, 20993-0002, 301-796-5861, email: cynthia.garris@fda.hhs.gov, at least 7 days in advance of the workshop. To register for the public workshop, please visit FDA's Medical Devices News & EventsWorkshops & Conferences calendar at https:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Maureen Dreher or Erica Takai to register (see Contact Person). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by November 13, 2012, 5 p.m. EST. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after November 23, 2012. If you have never attended a Connect Pro event before, test your connection at https:// collaboration.fda.gov/common/help/en/support/meetingtest.htm. To get a quick overview of the Connect Pro program, visit https:// www.adobe.com/go/connectprooverview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Requests for Oral Presentations: This public workshop includes presentations in topic-focused sessions. If you wish to present at the workshop, please submit an abstract at: https://www.astm.org/ f04wkshp1112.htm. FDA has included general topics in this document. Following the close of the call for abstracts, FDA and ASTM International members of the workshop organizing committee will determine the amount of time allotted to each presenter, the approximate time each oral presentation is to begin, and will select and notify participants by October 1, 2012. All requests to make oral presentations must be received by the close of the call for abstracts on September 1, 2012. If selected for presentation, any presentation materials must be emailed to Maureen Dreher (see Contact Person) no later than November 23, 2012. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Comments: FDA is holding this public workshop through co- sponsorship with ASTM International to obtain information on test methods for establishing correlations between in vitro and in vivo degradation of absorbable devices. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is December 28, 2012. Regardless of attendance at the public workshop, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 or electronic comments to https://www.regulations.gov. It is only necessary to send one set of comments. Please identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConfere nces/ default.htm. (Select this public workshop from the posted events list).

This document corrects a technical error that appeared in the notice published in the July 24, 2012 Federal Register (77 FR 43329) entitled ``State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals (QIs) for FY 2012.''

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 24, 2012 (77 FR 31028) and allowed 60-days for public comment. One public comment was received on May 24 wondering why that taxpayers' dollars are being spent on research. An email response was sent on May 25, 2012 that stated the comments will be taken into consideration. The purpose of this notice is to allow an additional 30 days for public comment. The 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. Proposed Collection: Title: Collection of Customer Service, Demographic, and Smoking/Tobacco Use Information from the National Cancer Institute's Cancer Information Service (CIS) Clients (NCI). Type of Information Collection Request: Revision of currently approved collection 0925-0208. Need and Use of Information Collection: The National Cancer Institute's Cancer Information Service (CIS) provides the latest information on cancer, clinical trials, and tobacco cessation in English and Spanish. Clients are served by calling 1-800- 4-CANCER for cancer information; 1-877-44U-QUIT for smoking cessations services; using the NCI's LiveHelp, a Web-based chat service; using NCI's Contact Us page on www.cancer.gov; and using NCI's Facebook page. CIS currently conducts a brief survey of a sample of telephone and LiveHelp clients at the end of usual servicea survey that includes three customer service and twelve demographic questions (age, sex, race, ethnicity, education, household income, number in household, and five questions about health care/coverage). Characterizing clients and how they found out about the CIS is essential to customer service, program planning, and promotion. The NCI also conducts a survey of individuals using the CIS's smoking cessation servicesa survey that includes 20 smoking/tobacco use ``intake'' questions that serve as a needs assessment that addresses smoking history, previous quit attempts, and motivations to quit smoking. An additional question is used with callers who want to receive proactive call-back services. Responses to these questions enable Information Specialists to provide effective individualized counseling. The NCI's CIS also responds to cancer-related inquiries to its Facebook page and its Contact Us form on www.cancer.gov but does not collect customer service or demographic questions on these access channels. Frequency of Response: Once. Affected Public: Individuals or households. Type of Respondents: People with cancer; their relatives and friends; and general public, including smokers/tobacco users. Annualized estimates for numbers of respondents and respondent burden are presented in Table 1.

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 pretesting of tobacco communications.