Department of Health and Human Services March 16, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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 and recordkeeping requirements contained in the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA).

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Food and Drug Administration (FDA) has determined the regulatory review period for TYSABRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the availability of an addendum to the report entitled, ``Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Evaluation of In Vitro Test Methods for Detecting Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding and Transcriptional Activation Assays'' [NIH Publication 03-4503]. The addendum describes the rationale for proposed revisions to the original list of recommended reference substances for validation of in vitro estrogen receptor (ER) and androgen receptor (AR) binding and transcriptional activation (TA) assays. The original list was made publicly available in June 2003 (Federal Register, Vol. 68, No. 106, pp. 33171-33172, June 3, 2003). NICEATM requests public comments on the substances proposed as substitutes for six of the 78 substances in the original list. Data are also requested from in vitro and in vivo studies evaluating the estrogenic and androgenic activity of the 78 substances in the revised list of reference substances.

The Food and Drug Administration (FDA) is providing notice of a confidentiality arrangement between the United States Food and Drug Administration and the French Health Products Safety Agency. The purpose of this confidentiality arrangement is to establish mutual commitments to retain the confidentiality of non-public information shared between the agencies.