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

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2013. The calendar year 2013 AIC threshold amounts are $140 for ALJ hearings and $1,400 for judicial review.

NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Mound Plant in Miamisburg, Ohio, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Mound Plant. Location: Miamisburg, Ohio. Job Titles and/or Job Duties: All workers potentially exposed to radioactive materials while working at the Mound Plant. Period of Employment: September 1, 1972 through December 31, 1972, and from January 1, 1975 through December 31, 1976.

The Food and Drug Administration (FDA) is postponing the Gastrointestinal Drugs Advisory Committee Meeting scheduled for October 15, 2012. This meeting was announced in the Federal Register of August 16, 2012 (77 FR 49446). The postponement is due to scheduling issues.

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 information collection entitled ``Environmental Impact Considerations.''

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with Oklahoma State University (OSU), Robert M. Kerr Food & Agricultural Products Center (FAPC), is announcing a public workshop entitled ``Food Defense Workshop.'' This public workshop is intended to provide information about food defense as it relates to food facilities such as farms, manufacturers, processors, distributors, retailers, and restaurants. Date and Time: This public workshop will be held on November 7 and 8, 2012, from 7:45 a.m. to 4:15 p.m. Location: The public workshop will be held at the Robert M. Kerr Food & Agricultural Products Center, Oklahoma State University, 148 FAPC, Stillwater, OK 74078-6055. Contact: For information regarding the workshop: David Arvelo, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, Fax: 214-253- 4970, email: david.arvelo@fda.hhs.gov. For information on accommodations: Karen Smith or Andrea Graves at the Robert M. Kerr Food & Agricultural Products Center, Oklahoma State University, 148 FAPC, Stillwater, OK 74078-6055, 405-744-6277, Fax: 405-744-6313, or email: karenl.smith@okstate.edu or andrea.graves@okstate.edu. More information is also available online at https://www.fapc.biz/fooddefense2012.html. Registration: You are encouraged to register by October 31, 2012. The workshop has a registration fee to cover the cost of facilities, materials, speakers, and breaks. The registration fee is $350 for companies with 10 or more employees or $250 for companies with less than 10 employees. Seats are limited; please submit your registration as soon as possible. To register, please complete the online registration form at https://www.fapc.biz/fooddefense2012.html. The workshop will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. Registration will close after the workshop is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 7:45 a.m. Make checks payable to: ``FAPC.'' If you need special accommodations due to a disability, please contact Karen Smith (see Contact) at least 7 days in advance. There are no registration fees for FDA employees. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested after the date of the public workshop by contacting Karen Smith or Andrea Graves (see Contact) at cost plus shipping.

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, will submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for extension of the approved information collection assigned OMB control number 0990-0294, scheduled to expire on September 30, 2012. 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. Deadline: Comments on the ICR must be received within 30 days of the issuance of this notice.

The Food and Drug Administration (FDA) is extending the comment period for the advance notice of proposed rulemaking that appeared in the Federal Register of July 27, 2012. In the advance notice of proposed rulemaking, FDA requested comments regarding potential changes to its regulations relating to records and reports for approved antimicrobial new animal drugs. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Health Resources and Services Administration will be issuing noncompetitive supplemental funding under the Maternal and Child Health Bureau's Epilepsy Program to the Epilepsy Foundation of America (U23MC19824) to support additional evaluation activities.

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 guidance on reagents for detection of specific novel influenza A viruses.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Pre- Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion'' dated September 2012. The guidance document provides blood establishments with recommendations for pre-storage leukocyte reduction of Whole Blood and blood components intended for transfusion, including recommendations for validation and quality control monitoring of the leukocyte reduction process. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2011 and supersedes the FDA memorandum issued on May 29, 1996, entitled ``Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products.''

The Food and Drug Administration (FDA) is issuing this notice to request that patient stakeholders notify FDA of their intention to participate in periodic consultation meetings on process issues related to FDA's patient-focused drug development initiative. This initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). These periodic consultation meetings will address important considerations and challenges in establishing a process for conducting a series of patient-focused drug development meetings that will be useful to both the patient community and FDA. The purpose of this request for notification is to ensure continuity and progress in these discussions by establishing consistent patient stakeholder representation.