The Federal Register

Proposed Data Collections Submitted for Public Comment and Recommendations

Mon, Nov 24 2003 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 4981210. Send written comments to CDC, Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503, or by fax to (202) 3956974. Written comments should be received within 30 days of this notice.

Proposed Project: Restriction on Travel of Persons (OMB No. 0920 0488)ExtensionNational Center for Infectious Diseases (NCID), Centers for Disease Control and Prevention (CDC).

In 2000, the Food and Drug Administration (FDA) and CDC consolidated regulations related to controlling the spread of communicable diseases. FDA formerly administered the regulations contained in part 1240 of title 21, Code of Federal Regulations, which

Proposed Data Collections Submitted for Public Comment and Recommendations

Mon, Nov 24 2003 11:00:00 GMT

Proposed Project: Evaluation of Customer Satisfaction with the Agency for Toxic Substances and Disease Registry Internet Home Page and Links (OMB No. 09230028)ReinstatementAgency for Toxic Substances and Disease Registry (ATSDR).

ATSDR proposes to conduct customer satisfaction research for its Internet site. Information on the site focuses on prevention of exposure and adverse human health effects and diminished quality of li

Proposed Data Collections Submitted for Public Comment and Recommendations

Mon, Nov 24 2003 11:00:00 GMT

Proposed Project: National Youth Tobacco SurveyNewNational Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). The proposed project is the 2004 national schoolbased National Youth Tobacco Survey. The purpose of this request is to obtain OMB approval to continue a biennial survey among junior and senior high school students attending regular public, private, and C

Proposed Data Collection Submitted for Public Comment and Recommendations

Mon, Nov 24 2003 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 4981210. Send written comments to CDC, Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 or by fax to (202) 3956974. Written comments should be received within 30 days of this notice.

Proposed Project: Data Collection, Management, Reporting, and Evaluation for the Minority AIDS Initiative (MAI)NewNational Center for HIV, STD and Tuberculosis Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC). CDC is requesting OMB approval to collect data to assess the HIV prevention and capacitybuilding activities of communitybased organizations (CBOs) and other notforprofit organizations funded under the MA

Statement of Organization, Functions, and Delegations of Authority

Mon, Nov 24 2003 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 6245662469, dated November 4, 2003) is amended to reflect the consolidation CDC's information technology infrastructure functions into a single organizational component entitled the Information Technology Services Office.

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

Following the title and functional statement for the Office of Security and Emergency Preparedness (CAJ8), Office of the Chief Operating Officer (CAJ), insert the following:

Information Technology Services Office (CAJ9). (1) Develops and coordinates CDCwide plans, budgets, policies, and procedures for information technology (IT) infrastructure services including: desktop computing support, directory serv

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Mon, Nov 24 2003 11:00:00 GMT

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.

Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and

Mon, Nov 24 2003 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 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 focus groups as used by FDA to gauge public opinion. Policymakers can use focus group results to test and refine their ideas so they can conduct further research, as well as, adopt new policies and to allocate or redirect significant resources to support these policies.

Guidance for Industry and Food and Drug Administration Staff; User Fees and Refunds for Premarket Approval

Mon, Nov 24 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``User Fees and Refunds for Premarket Approval Applications.'' This guidance outlines the types of premarket approval applications (PMAs), including supplements and other submissions, that are subject to user fees as well as those that do not have an associated fee. The guidance also identifies industry and FDA actions on these submissions that may result in a partial refund of the fee. The guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

Meeting of the Secretary's Advisory Committee on Human Research Protections

Mon, Nov 24 2003 11:00:00 GMT

Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2), notice is hereby given of the second meeting of the Secretary's Advisory Committee on Human Research Protections (SACHRP). The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the contact person listed below.