Department of Health and Human Services January 12, 2005 – Federal Register Recent Federal Regulation Documents

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 regulations requiring the distribution of patient labeling, called Medication Guides, for certain products that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication information.

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Research Services, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. 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. Proposed Collection: Title: Request for Generic Clearance to collect public comments on the Proposed Standards of Care Regulations covering chimpanzees in the federally supported Chimpanzee Sanctuary System. Type of Information Collection Request: New. Need and Use of Information Collection: The Chimpanzee Health Improvement, Maintenance, and Protection Act of 2000 (Public Law 106-551) requires the Secretary of the Department of Health and Human Services to develop Standards of Care Regulations for chimpanzees in the Sanctuary System. The Act further requires the Secretary to publish the proposed standards in the Federal Register to provide a 60 day period for public comment on the proposed standards. Following receipt of public comments, NCRR/NIH will consider these comments in preparing the final regulations for the sanctuary system. The public includes members of the general population, interested communities (local, regional, and national organizations), and non-profit business entities. Input from the public will allow the NCRR/NIH staff to receive critical review of the standards from different stakeholders, provide a review and analyses of the burden estimated by the government, and help assure that the proposed standards are necessary and current. Frequency of Response: One time event. Affected Public: Non-profit entities serving as a contractor to the government to operate and maintain the federally supported Chimpanzee Sanctuary System. Type of Respondents: Non-profit businesses that possess qualified staff and resources needed to develop, operate, and maintain several hundred chimpanzees. Estimated number of respondents: 1-3. Number Respondents per Response: 1-3. Average Burden Hours Per Response: 15.4. Burden Hours Requested: 186.95. Total annualized cost to respondents is estimated at $8412.75. There is no capital, operating, and/or maintenance costs to report.