The Federal Register

Proposed Data Collections Submitted for Public Comment and Recommendations

Thu, Jan 29 2004 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call the CDC Reports Clearance Officer on (404) 4981210.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques

Public Notice

Thu, Jan 29 2004 11:00:00 GMT

This is a request for information only. It is not a request for proposal and does not commit the government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the government and will not be returned.

The Centers for Disease Control and Prevention (CDC), National Center for Infectious Disease (NCID), Division of Bacterial and Mycotic Diseases (DBMD) through its component Branches has lead technical responsibility for a number of Category A, B and C bioterrorism agents and their associated toxins (Bacillus anthracis, Clostridium botulinum, Brucella sps., Burkholderia sps., Staphylococcus entertoxin B, other food or waterborne bacterial pathogens, and other bacterial agents). DBMD uses epidemiologic, laboratory, clinical, and biostatistical sciences to control and prevent bacterial and mycotic infectious disease. The Division also conducts applied research in a variety of settings, and translates

Statement of Organization, Functions, and Delegations of Authority

Thu, Jan 29 2004 11:00:00 GMT

Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 6777276, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 68 FR 6245662459, dated November 4, 2003) is amended to reorganize the Management Analysis and Services Office, Office of the Chief Operating Officer.

Section CB, Organization and Functions, is hereby amended as follows:

Revise the functional statement for the Management Analysis and Services
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Office (CAJ6), Office of the Chief Operating Officer (CAJ), by deleting item (1) and inserting the following: (1) Plans, coordinates, and provides CDCwide management and information services in the following areas: policy development and consultation, studies and surveys, delegations of authorities, organizations and functions, Privacy Act, confidentiality management, records management, Paperwork

Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular

Thu, Jan 29 2004 11:00:00 GMT

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
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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 requirements relating to FDA regulations for establishment registration and listing for human cells, tissues, and cellular and tissuebased products (HCT/Ps) and the associated Form FDA 3356 used to report establishment registration and listing information.

Determination of Regulatory Review Period for Purposes of Patent Extension; FROVA

Thu, Jan 29 2004 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for FROVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of two applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of two patents that claims that human drug product.

Determination of Regulatory Review Period for Purposes of Patent Extension; REMODULIN

Thu, Jan 29 2004 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for REMODULIN 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 that claims that human drug product.

Record of Decision--Construction and Operation of an Integrated Research Facility by the National Institutes of

Thu, Jan 29 2004 11:00:00 GMT

The National Institute of Allergy and Infectious Diseases (NIAID), a component of NIH, will be the occupant of the facility, which will contain Intramural NIAID biosafety level 2, 3, and 4 laboratory and animal research facilities for conducting biodefense and emerging infectious disease research. NIAID's biodefense mission is different but complementary to USAMRIID's. The selected action best satisfies NIH's needs and the biodefense research goals of NIAID and USAMRIID. Moreover, it fosters increased interagency collaboration between NIH and U.S. Army scientists by building on the already well established formal cooperation that exists between these two organizations. NIH will incorporate design and operational safeguards in the facility to protect laboratory workers and local residents from possible harmful effects related to the operation of the facility, however remote these occurrences may be. This action also allows NIH to address a critical national shortage in biosafety level4 (BSL4