Department of Health and Human Services February 2007 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) is seeking comments from the public on its plan to institute a permanent deviation from a policy in the Department of Health and Human Services (HHS), Grants Policy Directive (GPD) 3.01 governing indirect cost recovery for one of its grant programs. The GPD states ``HHS considers activities conducted by grantees that result in indirect charges a necessary and appropriate part of HHS grants, and HHS awarding offices must reimburse their share of these costs.'' Although HRSA typically reimburses grantees for their full share of administrative overhead represented in approved indirect cost rates (which can be up to 50 percent), the agency believes, in the case of its Poison Control Program, that full recovery of overhead expenditures would be detrimental to the poison control centers (PCCs) funded under the program because of the financial instability of PCCs. The purpose of the HRSA Poison Control Centers Stabilization and Enhancement Grant Program is to assist PCCs in achieving financial stability, preventing poisonings and providing treatment recommendations for poisonings. Limiting indirect costs is necessary because many PCCs are located within institutions such as universities and hospitals that have established indirect cost rates in the range of 30 to 50 percent. It is in the best interest of PCCs to limit the indirect cost recovery to 10 percent, leaving 90 percent of the grant funds to achieve the objectives of the grant program. This limitation would be applicable to all awardees of the Poison Control Center Stabilization and Enhancement Grant Programs.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Development of an Electronic System for Reporting Medication Errors and Adverse Drug Events in Primary Care Practice (MEADERS).'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C., 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on December 12th, 2006 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a topical solution of ivermectin.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for veterinary prescription use of fluoxetine hydrochloride chewable tablets for the treatment of canine separation anxiety.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Nuclear Materials and Equipment Corp. (NUMEC)Apollo, Apollo, Pennsylvania, 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: Nuclear Materials and Equipment Corp. (NUMEC)Apollo. Location: Apollo, Pennsylvania. Job Titles and/or Job Duties: All office employees who worked at the Apollo site. Period of Employment: January 1, 1957 through December 31, 1983.

The Food and Drug Administration (FDA) is reopening to February 26, 2007, the comment period for the proposed rule published in the Federal Register of August 29, 2006 (71 FR 51276). The proposed rule would amend the agency's current regulations governing establishment registration and drug listing. The initial comment period was extended (71 FR 63726, October 31, 2006) until January 26, 2007. We recently learned that, on January 26, 2007, the last day of the comment period, technical problems prevented some persons from submitting electronic comments. Therefore, FDA is reopening the comment period until February 26, 2007, to allow interested persons to submit comments for this rulemaking.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for topical use of a gentamicin sulfate and betamethasone valerate topical spray on dogs for the treatment of infected superficial lesions.