Department of Health and Human Services August 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance entitled ``Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)'' dated July 2007.

The Food and Drug Administration (FDA) is announcing that it has reorganized the Center for Drug Evaluation and Research (CDER) by establishing four new Divisions under the Office of Generic Drugs. This reorganization includes the organization and their substructure components as listed in this document. This document is announcing the availability of the Staff Manual Guide that explains the details of this reorganization.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This guidance provides recommendations to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an appropriate scientific approach during product design and developmentas well as during manufacturing and product life-cycle managementto ensure that the amount of residual drug substance at the end of the labeled use period is minimized. The guidance is applicable to investigational new drug applications, new drug applications, abbreviated new drug applications, and supplemental new drug applications for TDDS, TMDS, and topical patch products.

This proposed rule would implement provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). The Affordable Care Act expands access to health insurance through improvements in Medicaid, the establishment of Affordable Insurance Exchanges (``Exchanges''), and coordination between Medicaid, the Children's Health Insurance Program (CHIP), and Exchanges. This proposed rule would implement sections of the Affordable Care Act related to Medicaid and CHIP eligibility, enrollment simplification, and coordination. In addition, this proposed rule also sets out the increased Federal Medical Assistance Percentage (FMAP) rates and the related conditions and requirements that will be available for State medical assistance expenditures relating to ``newly eligible'' individuals and certain medical assistance expenditures in ``expansion States'' beginning January 1, 2014, including a proposal of three alternative methodologies to use for purposes of applying the appropriate FMAP for expenditures in accordance with section 2001 of the Affordable Care Act.

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 reporting requirements associated with extra label drug use in animals.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Procedures for Handling Section 522 Postmarket Surveillance Studies.'' This guidance document is intended to assist device manufacturers subject to a section 522 postmarket surveillance order imposed by FDA by providing an overview of section 522 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), procedural information on how to fulfill section 522 obligations, and recommendations on the format, content, and review of postmarket surveillance study submissions. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Ventricular bypass (assist) device; pacemaker repair or replacement material; and female condom. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Design Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document is intended to provide guidance to those involved in designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing a public workshop entitled: ``Mobile Medical Applications Draft Guidance.'' The purpose of the workshop is to provide a forum for discussion with FDA and to encourage public comment on the following topics: FDA's recently issued draft guidance document entitled ``Mobile Medical Applications,'' how FDA should approach accessories and particularly mobile medical applications that are accessories to other medical devices, and standalone software that provides clinical decision support. Date and Time: The public workshop will be held on September 12 and 13, 2011. Submit electronic and written comments by October 19, 2011. Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Contact Person: Bakul Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5456, Silver Spring, MD 20993, 301-796-5528, Bakul.Patel@fda.hhs.gov. Registration and Requests for Oral Presentations: Registration is free and will be on a first-come, first-served basis. Persons interested in attending this workshop must register online by 5 p.m. on September 9, 2011. For those without Internet access, please call the contact person to register. Early registration is recommended because seating is limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. Non-U.S. citizens are subject to additional security screening, and they should register as soon as possible. If you need special accommodations due to a disability, please contact Susan Monahan (e-mail: Susan.Monahan@fda.hhs.gov or phone: 301- 796-5661) no later than September 9, 2011. This workshop will also be provided via webcast. Persons interested in participating by webcast must register online by 5 p.m. on September 9, 2011. Early registration is recommended because webcast connections are limited. Organizations are requested to register all participants, but view using one connection per location. Webcast participants will be sent connection requirements. To register for the public workshopwhether attending in person or for the webcastplease visit https://www.fda.gov/ MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to the FDA Medical Devices News & EventsWorkshops & Conferences calendar and select this public workshop from the posted events list). Please provide complete contact information for each attendee, including name, title, affiliation, address, e-mail, telephone, and FAX number. Registrants will receive confirmation once they have been accepted. You will be notified if you are on a waitlist. This workshop includes a public comment session. During online registration you may indicate if you wish to make an oral presentation during a public comment session at the public workshop, and which topic you wish to address in your presentation. FDA has included topics for comment in this document. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin. All requests to make oral presentations, as well as presentation materials, must be sent to the contact person by September 9, 2011. Comments: Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments until October 19, 2011. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. 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.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), 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 24, 2011, Vol 76, 100, page 30177-30178, and allowed 60 days for public comment. One request for the draft instruments was received from the public. These were provided to the requestor. 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.

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), conducted an analysis to determine classification criteria using results from 3-animal tests that would provide eye hazard classification equivalent to testing conducted in accordance with current U.S. Federal Hazardous Substances Act (FHSA) regulations, which require the use of 6 to 18 animals. The results showed that using a classification criterion of at least 1 positive animal in a 3-animal test to identify eye hazards will provide the same or greater level of eye hazard classification as current FHSA requirements, while using 50% to 83% fewer animals. ICCVAM developed draft recommendations based on the results of this analysis. NICEATM invites public comments on these draft ICCVAM recommendations.