Department of Health and Human Services January 29, 2010 – Federal Register Recent Federal Regulation Documents

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 November 9, 2009, (Vol. 74, No. 215, p. 57684) and allowed 60-days for public comment. Two public comments were received. The first comment, received November 11, 2009, questioned the purpose and safety of clinical trials conducted outside of the United States. An e-mail response was sent on January 6, 2010, acknowledging the commenter's concern. The response noted that the NCI's Clinical Trials Reporting Program is an information collection activity intended to assist the NCI in management of the NCI's clinical trials portfolio, which is global in nature. The response further stated that while CTRP is not directly related to the conduct of a clinical trial, the NCI hopes to use the information to facilitate routine review of safety, efficacy, and administrative data reported from on-going cancer trials. On January 6, 2010, the same commenter sent a subsequent comment concerning corruption in clinical trials conducted by large pharmaceutical companies. The NCI sent an e-mail response on January 8, 2010, thanking the commenter for her additional comments and noting that they would be taken into consideration.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Lawrence Livermore National Laboratory, Livermore, California, 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:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Janssen Pharmaceutica NV. The NADA provides for use of miconazole nitrate, polymixin B sulfate, and prednisolone acetate for the treatment of otitis externa in dogs.