2000, the Department of Health and Human Services (HHS) has been given the responsibility and resources for conducting analytic epidemiologic investigations of residents of communities in the vicinity of DOE facilities, workers at DOE facilities, and other persons potentially exposed to radiation or to potential hazards from non-nuclear energy production and use. HHS has delegated program responsibility to CDC. Community involvement is a critical part of ATSDR’s and CDC’s energy-related research and activities and input from members of the ORRHES is part of these efforts.

Purpose: The purpose of this meeting is to address issues that are unique to community involvement with the ORRHES, and agency updates.

Matters to be Discussed: Agenda items will include a brief discussion on the ATSDR project management plan and the schedule of Public Health Assessments to be released in FY2005–2006, and updates and recommendations from the Exposure Evaluation, Community Concerns and Communications, and the Health Outcome Data Workgroups, and agency updates.

Agenda items are subject to change as priorities dictate.

Due to programmatic issues that had to be resolved, the Federal Register notice is being published less than fifteen days before the date of the meeting.

Contact Persons for More Information: Marilyn Horton, Designated Federal Official and Committee Management Specialist, Division of Health Assessment and Consultation, ATSDR, 1600 Clifton Road, NE., M/S E–32 Atlanta, Georgia 30333, telephone 1–888–42–ATSDR (28737), fax (404) 498–1744.

The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and ATDSR.

Dated: November 10, 2004.

Alvin Hall,

Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.

[FR Doc. 04–25536 Filed 11–17–04; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Procedures and Costs for Use of the Research Data Center

AGENCY: National Center for Health Statistics, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION: Notice and request for comments.

SUMMARY: This notice provides information about the Research Data Center (RDC) operated by the National Center for Health Statistics (NCHS) within the Centers for Disease Control and Prevention (CDC). The Research Data Center was established in 1998 to provide a mechanism whereby researchers can access detailed data files in a secure environment, without jeopardizing the confidentiality of respondents. Historically, the data files accessed in the RDC have consisted of NCHS survey data. RDC has recently begun accepting data files that were not produced from NCHS survey data. In order to assure that all data files are processed in a consistent manner, the original guidelines for accessing files in the RDC are being reviewed and revised as necessary. As part of the revision process, potential users are being given the opportunity to provide input on how the procedures of the RDC can best serve their research needs. This notice describes how to submit proposals requesting use of the data, mechanisms to access the RDC, requirements, use of outside data sets, costs for using the RDC, and other pertinent topics. We are seeking comments on these procedures and will post the final procedures on the NCHS Web site.

DATES: Submit comments on or before December 9, 2004.

ADDRESSES: Send comments concerning this notice to Ken Harris, National Center for Health Statistics, 3311 Toledo Road, Room 3210, Hyattsville, MD 20782, or e-mail to kwharris@cdc.gov.

FOR FURTHER INFORMATION CONTACT: Ken Harris at (301) 458–4262.

SUPPLEMENTARY INFORMATION:

Operational Procedures for Use of the Research Data Center; National Center for Health Statistics; Centers for Disease Control and Prevention

Table of Contents

Purpose

Background

Research Data Center—Operations

Submission of Research Proposals Using NCHS Data

Researcher—Supplied Data

General Requirements for Guest Researchers

General Requirements for Remote Access

Use of RDC/NCHS

Costs for Using the RDC

Disclosure Review Process

Appendix I—Examples of Data Available through the NCHS RDC

Appendix II—Requirements for the Release of NCHS Micro Data

Appendix III—Disallowed SAS Functions, Statements, and Procedures

Appendix IV—Project-Specific Requirements Vaccine Safety Datalink Files

Appendix V—Agreement Regarding Conditions of Access to Confidential Data in the Research Data Center of the National Center for Health Statistics

Appendix VI—Researcher Affidavit of Confidentiality

Operational Procedures for the Use of the Research Data Center, National Center for Health Statistics (NCHS); Centers for Disease Control and Prevention (CDC)

Purpose

This document provides information about the National Center for Health Statistics’ (NCHS) Research Data Center (RDC), including how to submit proposals requesting use of data, mechanisms to access the RDC, requirements, use of outside data sets, costs for using the RDC, and other pertinent topics. The Guidelines pertain to use of data produced by NCHS and non-NCHS entities. If, after reading these guidelines, you have further questions, you may seek clarification through e-mail (RDCA@cdc.gov) or by contacting Ken Harris at (301) 458–4262 or by e-mail at kwharris@cdc.gov. The procedures described for use of the RDC are under constant review to improve RDC operations and to be responsive to changes in the environment that affect confidentiality protections. Please check the NCHS Web site or contact the RDC to determine if modifications have been made.

Background

In order to advance knowledge on the health and well-being of the nation and its health care system, NCHS and other organizational entities in the Department of Health and Human Services release statistical micro data containing health and related variables. These files allow outside researchers and analysts to develop statistics and conduct independent research. However, any release of data, whether micro data files or the results of statistical analyses, must be consistent with the confidentiality provisions under which the data were collected. For the case of data collected or

Front Matter (R1-R10)

Executive Summary (1-12)

1 Study Background and Contextual Issues (13-24)

2 Description of the Vaccine Safety Datalink (25-32)

3 The Vaccine Safety Datalink Data Sharing Program (33-75)

4 The Vaccine Safety Datalink Research Process and the Release of Preliminary Findings (76-95)

5 Independent Review of Vaccine Safety Datalink Activities (96-103)

Concluding Remarks (104-104)

References (105-110)

Appendix A Committee Biographies (111-114)

Appendix B Glossary (115-116)

Appendix C Acronyms (117-118)

Appendix D Meeting One—Agenda (119-122)

Appendix E Meeting Two—Agenda (123-126)

Appendix F Summary of Public Submissions (127-131)

Appendix G Notice and Request for Comment on Procedures and Costs for Use of the Research Data Center (132-142)