67584 Federal Register / Vol. 69, No. 222 / Thursday, November 18, 2004 / Notices 

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 

Federal Register / Vol. 69, No. 222 / Thursday, November 18, 2004 / Notices 67585

obtained by NCHS, Section 308(d) of the 

Public Health Service Act (42 U.S.C. 

242m(d)) and the NCHS Staff Manual on 

Confidentiality do not permit the release 

of data that are either identified or 

identifiable to persons outside of NCHS. 

In order to preserve privacy and 

confidentiality, details that might 

identify or facilitate the identification of 

persons and organizations participating 

in surveys and data systems are 

suppressed in published data products. 

Examples of data elements that might be 

abridged are geographic identifiers, 

details of sample design, and variables 

such as age or income that might exist 

in other databases. 

Despite the wide dissemination of 

data through publications, CD–ROMs, 

etc., the inability to release files with, 

for instance, lower levels of geography, 

severely limits the utility of some data 

for research, policy, and programmatic 

purposes and sets a boundary on one of 

the goals of the U.S. Department of 

Health and Human Services, i.e., to 

increase our capacity to provide state 

and local area estimates. In pursuit of 

this goal and in response to the research 

community’s interest in restricted data, 

NCHS established the Research Data 

Center (RDC), a mechanism whereby 

researchers can access detailed data files 

in a secure environment, without 

jeopardizing the confidentiality of 

respondents. The RDC provides 

restricted access to NCHS data. The RDC 

also accepts outside data sets. Appendix 

I contains information about some of the 

data sets currently available in the RDC. 

Special requirements for use of nonNCHS data can be found in Appendix 

IV, Project-Specific Requirements.

Authority: Sections 306 and 308 of the 

Public Health Service Act (42 U.S.C. 242k 

and 242m). 

Research Data Center (RDC)—

Operations 

The NCHS RDC is a research facility 

located at the NCHS headquarters in 

Hyattsville, MD, where researchers 

meeting certain qualifications are 

allowed access, under strict supervision, 

to restricted statistical micro data files. 

To gain access to the RDC researchers 

must submit a proposal for review and 

approval. Researchers can use one of 

three access methods (see below): (1) 

Direct access through local computing 

resources in the RDC that accommodate 

visiting researchers; (2) a remote 

program submission system through 

which researchers can submit work to 

be done in the RDC with the output 

returned to them by e-mail; or (3) 

programming services for outside 

researchers provided by RDC staff (see 

below). In all three methods, 

confidential data files remain in the 

RDC where access to unit records is 

restricted, and output is inspected 

before it leaves the RDC. 

As currently designed, the NCHS RDC 

facility in Hyattsville has four user 

workstations and a secure room for the 

RDC printer. In addition, there is office 

space for the RDC staff and long-term 

outside researchers. 

The RDC computers have no 

electronic link either to the NCHS 

network, the CDC–NCHS mainframe, or 

the Internet. The RDC workstations 

consist of Pentium III 933 MHz 

computers running Windows 2000. 

There is sufficient storage on the 

workstations and the server for any 

confidential data. PC–SAS, SUDAAN, 

Watcom Fortran 77, and Stata are 

installed on the workstations, and 

additional programming/analytic 

languages can be added as needed. 

The computers have been configured 

so that removable media such as floppy 

disks are inaccessible to users. All print 

output is routed to a central printer 

which is monitored by RDC staff while 

the RDC is open to external researchers. 

Further, the system’s workstations are 

configured such that researchers are 

given read-only access to requested data 

files and can write only onto the local 

workstation’s hard disk. These 

restrictions ensure that users cannot 

remove information that has not been 

subjected to a review for confidentiality. 

The three methods of access to 

restricted data through the Data Center 

include: 

(1) Guest Researcher (on site)—The 

researcher submits a research proposal 

to the RDC and, upon approval, 

conducts his/her research on site at 

NCHS in the RDC. RDC staff constructs 

the necessary data files before the guest 

researcher arrives and ensure that no 

restricted data leave the facility. Data 

from virtually all of the NCHS data 

collection systems may be made 

available through the RDC. Also 

available are data from other data 

collection systems. 

PC–SAS, SUDAAN, Watcom 

Fortran 77, and Stata are installed on 

the RDC workstations. Other 

programming languages or data analysis 

packages can be made available with 

sufficient lead time. 

Researchers may take the results of 

their analyses off-site only after 

disclosure review by NCHS RDC staff. 

Disclosure review consists of looking for 

tabular cells less than 5, tables with 

geographic variables in any dimension, 

models with geographic variables (or 

variables tantamount to geographic 

variables) as outcome variables, or case 

listings. In general, disclosure review is 

consistent with the guidelines 

published in the NCHS Staff Manual on 

Confidentiality (see Appendix II, 

Requirements for the Release of NCHS 

Micro Data Files). 

(2) Remote Access—Users are able to 

electronically submit analytical 

computer programs using SAS as the 

programming language. After their 

proposals are approved, researchers are 

registered with the RDC remote access 

system and introduced to the 

procedures and programming 

limitations to be followed in accessing 

data. Researchers send programs to the 

RDC and receive output by e-mail. RDC 

staff prepares the requested data files 

which may consist of confidential data 

merged with user data. Both submitted 

programs and output undergo a 

programmed disclosure limitation 

review and are also subject to a manual 

review. Certain procedures and SAS

functions are not allowed (see Appendix 

II, Disallowed SAS Functions, 

Statements, and Procedures for a 

complete list). For example, users 

cannot use PROC TABULATE or PROC 

IML, nor are functions allowed that are 

capable of producing listings of 

individual cases such as LIST and 

PRINT. Additionally, functions that may 

select individual cases are not allowed 

(R_, FIRST., LAST., and others). The 

output is scanned for cells containing 

less than five observations. If any are 

found, not only is that cell suppressed, 

but several additional cells will also be 

suppressed (complementary 

suppression). Alternatively, the 

researcher may be asked to revise and 

resubmit his/her analyses. The job log is 

also scanned with particular attention to 

certain types of error conditions that 

may spawn case listings. Some projects 

are not suitable for the remote access 

method. Stewards of the file/s in 

consultation with RDC staff make this 

determination. 

(3) RDC Staff-Assisted Research: This 

is mainly useful for those planning to 

use statistical software programming 

languages other than SAS or who are 

not able to travel to the RDC facility. 

Under this method, an approved 

researcher e-mails a statistical software 

program to the assigned RDC staff 

person who runs the program and, after 

disclosure review, provides the output 

to the researcher by e-mail. More 

extensive programming services are also 

available. 

Each of the access methods outlined 

above has an associated cost which 

includes equipment and space rental, 

staff overhead, and setup. The staff 

overhead and setup include the time 

and resources necessary for monitoring 

progress, setting up equipment and data 

67586 Federal Register / Vol. 69, No. 222 / Thursday, November 18, 2004 / Notices 

files, disclosure limitation review, and 

file management. Since these reflect 

varying demands on resources, accurate 

cost estimates cannot be given without 

complete knowledge of the proposed 

research. In general, though, the setup 

fee is $500 per day of effort (see Costs 

of Using the RDC, below).

Submission of Research Proposals Using 

NCHS Data 

Researchers must submit proposals 

that are detailed enough in their data 

specifications to permit RDC staff to 

easily determine what data elements are 

required. Prospective researchers are 

encouraged to check with RDC staff 

prior to writing their proposals to 

ensure that the data of interest can be 

made available to them. Researchers 

should develop their proposals in a way 

that facilitates the ability of the RDC 

staff to create the analytic files required 

by the project. Proposals should be 

explicit regarding the variables needed 

as well as any case selection required. 

Only those data items required to 

conduct the proposed analyses will be 

included in the analytic data file and 

the proposals should address why the 

requested data are needed for the 

proposed study. Overly large and 

complex projects or poorly defined 

projects will require extensive 

communication between RDC staff and 

the researchers proposing the project, 

and this can cause the process to move 

slowly. Work to prepare data files can 

be accomplished most expeditiously if 

large, complex projects are subdivided 

into manageable parts and requested 

data are clearly defined. 

Researchers wishing to link data in 

the RDC with external data should 

provide the external data to RDC staff in 

advance of their entry to and use of the 

RDC (a minimum of 7 days prior to the 

approved date for access to the RDC). 

The RDC expects that all researchers 

will adhere to established standards and 

principles for carrying out statistical 

research and analyses. Researchers must 

conduct only those analyses which 

received approval. Failure to comply 

will result in cancellation of the 

research activity and potential 

disbarment from future research 

activities in the RDC. In the case where 

Institutional Review Board (IRB) 

approval is required to conduct 

research, RDC staff will notify relevant 

IRBs of infringements of protocol 

approvals. 

Appendix IV (Project-Specific 

Requirements) contains information on 

submitting a research proposal 

requesting use of data other than those 

produced by NCHS. The format detailed 

below pertains specifically to use of 

NCHS data. If no project specific 

requirements are provided for nonNCHS data, the format below is to be 

used. 

(1) The research proposal must 

contain the following information: 

A. Cover letter. 

B. Project Title. 

C. Abstract: approximately 100–300 

words summarizing the project. 

D. Full personal identification, 

institutional affiliation, mailing 

addresses (including overnight express 

mail address), phone, and e-mail 

address. Applicants who are students 

must append a letter from the 

department chair or advisor stating that 

the applicant is a student working under 

the direction of the department. 

E. Dates of proposed tenure at the 

RDC (or use of the remote access 

system). Proposals requesting remote 

access should include an appendix 

describing the computer and e-mail 

account that will receive output as well 

as the security provisions established 

for them. 

F. Source of funding for the proposed 

project. 

G. Background of study: 

1. Key study questions or hypotheses. 

2. Public health benefits. 

H. A summary of the data 

requirements for the proposed research 

along with an explanation of why the 

data are needed for the proposed study. 

1. Identification of cases to be 

included in the analytic file. 

2. Identification of variables to be 

included in the analytic file. 

3. Data to be supplied by the 

researcher and merged with NCHS or 

other data. 

4. A description of why publicly 

available data are insufficient. 

I. Methods for the study: 

1. Analytic strategy and statistical 

methods to be used. 

2. Software requirements (currently, 

PC–SAS for Windows, Stata, 

SUDAAN, LIMDEP, HLM, SPSS, 

and Watcom Fortran 77 are available 

in the RDC; other languages can be 

made available with sufficient lead 

time). 

J. A description of the output that the 

researcher intends to have reviewed for 

non-disclosure. This should include 

table shells, model equations, or test 

statistics of any output that the 

researcher plans to remove from the 

RDC. This will help the reviewers to 

determine the risk of disclosure.

K. Appendices. 

1. A current resume or Curriculum 

Vitae for each person who will 

participate in the research activity. 

Resumes or CVs must specify 

nationality. 

2. A letter from student applicant’s 

department chair or academic advisor 

stating that student is working under the 

direction of the department. 

3. A data dictionary: a complete 

listing of the specific data requested—

data system, files, years, cases, 

variables, matching or linking variables, 

etc. 

4. A data dictionary for researchersupplied data, if any, to be merged with 

the confidential data. This includes 

identifying the source of the data, 

variable names, variable codes or 

ranges, file layout, number of records, 

and restrictions on NCHS use of the data 

(currently the RDC policy prohibits 

release of merged data to anyone other 

than the prospective researcher). 

5. A description of the computer and 

e-mail system to be used to receive 

output from the remote access system as 

well as the security provisions 

established for them. 

Portions of doctoral proposals or grant 

applications with appropriate 

modifications may suffice for the 

research proposal. 

Proposals to use the Research Data 

Center should be sent to: 

Research Data Center, National Center 

for Health Statistics, 3311 Toledo Road, 

Suite 4113, Hyattsville, MD 20782, 

RDCA@cdc.gov. 

Upon receipt, the Research Proposal 

will be evaluated by a review committee 

convened for that purpose. The Proposal 

Review Committee consists of (at 

minimum) the director of the NCHS 

RDC, the RDC staff liaison, the NCHS 

Confidentiality Officer, and the director 

(or designee) of the NCHS data division 

whose data are requested in the 

proposal. Proposals for use of nonNCHS data undergo review as 

determined by the steward/s of those 

data. 

(2) The following criteria apply to 

proposal review for projects requesting 

use of NCHS data: 

A. Scientific and technical feasibility 

of the project; 

B. Availability of resources at the 

RDC; 

C. Risk of disclosure of restricted 

information; and 

D. For projects using NCHS data, 

whether the proposed project is in 

accordance with the mission of the 

NCHS to provide statistical information 

that will guide actions and policies to 

improve the health of the American 

people.

Researchers should note that approval 

of their application does not constitute 

endorsement by NCHS of the 

substantive, methodological, theoretical, 

or policy relevance or merit of the 

proposed research. NCHS approval only 

Federal Register / Vol. 69, No. 222 / Thursday, November 18, 2004 / Notices 67587

constitutes a judgment that this 

research, as described in the 

application, is not an illegal use of the 

requested data file and that there is high 

probability that the project can be 

successfully done in the RDC. 

Researcher-Supplied Data 

The RDC allows researchers to supply 

their own data to be linked with RDC 

data sets to create merged data sets that 

will be stored in the RDC. The 

researcher-supplied data may consist of 

proprietary data collected and ‘‘owned’’

by the researcher or other publicly 

available data obtained by the 

researcher such as census data. 

Researchers MUST provide RDC staff 

with complete documentation of any 

data proposed to be merged with RDC 

data. Researchers expecting to use 

merged files are responsible for 

interacting with RDC staff to ensure that 

their data can be merged with the data 

resident at the RDC and the format of 

the data is consistent with the RDC data. 

The RDC will accept user data files in 

SAS, Stata, or ASCII format (flat 

files) with variables either columndelimited or column-specific. Other 

formats may also be proposed. RDC staff 

prior to the arrival of the researcher will 

do the merging of researcher-supplied 

data with RDC data sets. Identifying 

information in linking fields will be 

removed after the merge and will not be 

made available to the researchers. 

Owners or stewards of RDC data sets 

make the determination of whether and 

how the resultant merged files would be 

made available to other researchers. For 

RDC files that are owned by NCHS, this 

determination is made by the owners of 

the researcher-supplied data that will be 

merged with the NCHS owned RDC 

files. For files that are NOT owned by 

NCHS, the determination is made by the 

stewards or owners of the RDC files. The 

owners of these files can require that 

any merged files be made available to all 

interested researchers or allow this 

determination to be made by the owners 

of the researcher supplied data. 

The RDC periodically creates and 

maintains backup copies of all computer 

files. Backup files are stored in a secure 

storage area accessible by RDC staff 

only, although they may be made 

available to researchers who need to 

return for additional analyses. These 

backup files will contain user-supplied 

data as well as the merged files. These 

backup files will be destroyed only 

upon the written request of the user. 

General Requirements for Guest 

Researchers 

1. Researchers must work under the 

supervision of RDC staff and only 

during normal working hours (MondayFriday, 8:30 a.m.–5 p.m.). Admittance to 

the RDC will be limited to the 

researchers whose names are included 

in the Research Proposal (Section D). 

Researchers will be required to show 

photo identification before admittance. 

A maximum of 3 collaborating 

researchers can sit at a computer station 

in the RDC. 

2. Computers will be pre-loaded with 

the approved datasets by NCHS staff 

approximately one day prior to the 

external researcher’s use of the RDC. 

Once the analysis is completed, NCHS 

staff will remove the datasets from the 

RDC computer. 

3. Guest researchers must be able to 

conduct their analyses with the software 

specified in their research proposal. 

4. External researchers are not 

allowed to bring documents, manuals, 

books, etc., that may enable them to 

identify and disclose confidential 

information they access in the RDC. 

Neither are they allowed to bring into 

the RDC cell phones, pagers, or other 

devices which would enable them to 

communicate with persons outside of 

the RDC. 

5. All logs will be printed or 

electronically archived and will be kept 

by NCHS. NCHS will retain only the 

programs and procedures run by 

external researchers. The logs will not 

include results from their research. 

6. All computer output generated by 

statistical programs and all hand-written 

notes based on such computer output 

are subject to disclosure review by 

NCHS staff before removal from the 

RDC. Output is restricted to summary 

tables of geographic or patient-level data 

(e.g., line listings of diagnoses by study 

identifier will be prohibited). 

7. Guest researchers may not save 

output, files, or programs to 

transportable electronic media. RDC 

staff can copy output or programs to 

transportable media, if requested. 

8. Researchers proposing multiple 

analyses that employ multiple data sets 

will have access to only one dataset at 

a time. Under no circumstances will 

researchers be permitted any 

opportunity to merge datasets on their 

own.

General Requirements for Remote 

Access 

1. Researchers must register an e-mail 

address that is credibly secure. 

Although programs can be sent to the 

RDC from any address, results will 

always be returned to the registered email address. 

2. Data requests must be in the form 

of SAS programs (Version 8.2). 

However, certain SAS commands/

statements are not allowed through 

remote access. A list of such commands/

statements is included in Appendix III. 

This list is periodically reviewed and 

may be modified as necessary. The 

SAS program must be in plain ASCII

format. 

3. During the first week of 

registration, researchers’ data requests 

are executed in a manual mode, 

requiring RDC staff to review the 

program and resulting output before its 

release. During this period, remote 

access is available only during normal 

working hours. After the first week, 

researchers may submit data requests 

any time (day or night) and receive 

prompt response, except when the CDC 

e-mail system is down or when the 

remote access system is taken off-line 

for maintenance. 

4. The remote access system does not 

allow users to write permanent datasets 

in its disk space. Jobs that attempt to 

create permanent datasets or files are 

flagged, terminated, and an error 

message is sent to the researcher. 

5. The remote access system limits 

researchers’ time and storage. No single 

program is allowed more than one hour 

to complete execution or to generate 

output in access of 1.5 MB. 

6. With one exception, macros are not 

allowed through the remote access 

system. The exception, GLIMIX, 

requires special permission. 

Use of the RDC 

In order to get access to restricted data 

files in the RDC, researchers must 

include in their proposals a signed 

‘‘Agreement Regarding Conditions of 

Access to Confidential Data in the 

Research Data Center for the National 

Center for Health Statistics.’’ (Appendix 

V) All researchers participating on an 

approved project must sign the 

agreement—which clearly states the 

penalties for violating the conditions of 

agreement. In addition, each researcher 

must sign an ‘‘Affidavit of 

Confidentiality.’’ (Appendix VI) The 

RDC reserves the right to terminate any 

project at any time that it deems that an 

investigator’s actions will compromise 

confidentiality or ethical standards of 

behavior in a research environment. 

Statistical micro data files are 

collections of data from individual units 

such as persons or providers. Statistical 

agencies world wide are bound by 

ethical and legal requirements to 

preserve the privacy of individual 

respondents and the confidentiality of 

data provided to the agency by them or 

otherwise pertaining to them. As 

mentioned earlier, confidentiality 

protection at NCHS is governed by 

Section 308(d) of the Public Health

67588 Federal Register / Vol. 69, No. 222 / Thursday, November 18, 2004 / Notices 

Service Act (42 U.S.C. 242m). This 

section states that: 

No information, if an establishment or 

person supplying the information or 

described in it is identifiable, obtained 

in the course of activities undertaken or 

supported under section 304, 306, or 

307 may be used for any purpose other 

than the purpose for which it was 

supplied unless such establishment or 

person has consented (as determined 

under regulations of the Secretary) to its 

use for such other purpose and in the 

case of information obtained in the 

course of health statistical or 

epidemiological activities under section 

304 or 306, such information may not be 

published or released in other form if 

the particular establishment or person 

supplying the information or described 

in it is identifiable unless such 

establishment or person has consented 

(as determined under regulations of the 

Secretary) to its publication or release in 

other form. 

Having read and familiarized 

themselves with the Researcher 

Affidavit of Confidentiality, including 

Section 308(d) of the Public Health 

Service Act (42 U.S.C. 242m) (see 

below), researchers agree: 

1. To make no copies of any files or 

portions of files to which they are 

granted access except those authorized 

by NCHS Research Data Center staff. 

2. To return to RDC staff all NCHS 

restricted materials with which they 

may be provided during the conduct of 

their research at NCHS and other 

materials as requested. 

3. Not to use ANY technique in an 

attempt to learn the identity of any 

person, establishment, or sampling unit 

not identified on public use data files. 

4. To hold in strictest confidence the 

identification of any establishment or 

individual that may be inadvertently 

revealed in any documents or 

discussion, or analysis. Such 

inadvertent identification revealed in 

their analyses will be immediately 

brought to the attention of RDC staff. 

5. Not to remove any printouts, 

electronic files, documents, or media 

until they have been scanned for 

disclosure risk by RDC staff. 

6. Not to remove from NCHS any 

written notes pertaining to the 

identification of any establishment, 

individual, or geographic area that may 

be revealed in the conduct of their 

research at NCHS. 

7. To the inspection of any material 

they may bring to or remove from the 

NCHS Research Data Center. 

8. To comport themselves in a manner 

consistent with principles and 

standards appropriate to a scientific 

research establishment. 

Appendix V Agreement Regarding 

Conditions of Access to Confidential 

Data in the Research Data Center of the 

National Center for Health Statistics, 

signed by all investigators on the 

project, must be submitted with the 

initial proposal. 

Deliberate violation of any of these 

conditions may result in cancellation of 

the data access, and the researcher may 

be escorted from the premises by the 

duly authorized Federal protection 

service on duty at NCHS. The researcher 

may also be barred from any future use 

of the RDC upon review and 

determination by the Director of NCHS 

that this is necessary to protect the 

integrity and confidentiality of the RDC. 

The RDC technical monitor will 

perform a disclosure review and must 

provide approval to the researcher 

before removal of any data from the 

RDC, whether it is in electronic or paper 

form. Any violation by the researcher 

may be punishable by fine or 

imprisonment for up to 5 years or both 

under Title 18 U.S.C. 1001. 

As noted above, the RDC contains 

work stations with computers preloaded by NCHS staff with the requested 

dataset(s) to be analyzed with statistical 

software. External researchers must 

schedule time for use of the RDC, pay 

the appropriate user fees, and abide by 

the standard practices of the RDC. 

Among the requirements is a restriction 

on equipment that can be brought into 

the RDC, signing agreements to maintain 

confidentiality, and submitting to 

review of all results for any potential 

breaches in confidentiality. 

Costs for Using the RDC 

Time in the RDC can be scheduled in 

increments ranging from a consecutive 

2-day minimum to a consecutive 10-day 

maximum. Extensions can be negotiated 

with RDC staff subject to scheduling 

requirements. Scheduling time at the 

RDC is on a first-come, first-served 

basis. 

Researchers using the NCHS RDC will 

be charged for space and equipment 

rental and staff time necessary for 

supervision, disclosure limitation 

review, maintenance of computer 

facilities (including both hardware and 

software), and the creation and 

maintenance of data files required by 

the researcher. The cost per project (or 

creation of an analytic file) is given in 

the table below:

Guest Researcher (on site) ...................................................................... $200 per day (2-day minimum). 

Remote Access ......................................................................................... $500 per month for files with less than 130,000 records. 

$1,000 per month for files with 130,000 records or more. 

$500 per year for selected standard files.* 

* There are selected files that have been developed for repeat and multiple users which require minimal set up procedures and involve 

minimal content changes to the file when preparing for different users. For that reason, charges for accessing these files are considerably 

less expensive than the regular fees. Two files fall under this category: the contextual data file for the National Survey of Family Growth 

(NSFG–CDF) and the Polio file for the National Health Interview Survey (NHIS–Polio). The cost for accessing standard files of this type 

will be published as the files are developed. 

There is a minimum setup charge of 

$500 per day for new file creation. An 

additional $500 per day is charged as 

needed for file creations and for special 

handling, such as the merging of 

additional data or creating custom file 

formats. 

More complex projects may require 

discussion between the researcher and 

RDC staff to determine the cost of file 

creation. Researchers are encouraged to 

develop their proposals in a way that 

facilitates the ability of the RDC staff to 

create the analytic files required by the 

project. Proposals should be explicit 

regarding the variables needed as well 

as any case selection required. Overly 

large and complex projects will require 

extensive communication between RDC 

staff and the researchers proposing the 

project, and this can cause the process 

to move slowly. Work to prepare data 

files can be accomplished most 

expeditiously if large, complex projects 

are subdivided into manageable parts. 

Payment is expected in advance of the 

use of the RDC. A cashier’s check or 

money order made payable to NCHS 

RDC must be received seven business 

days prior to the start date scheduled for 

use of the RDC. Payments should be 

mailed to: NCHS RDC, Attn: RDC 

Director, 3311 Toledo Road, Suite 4113, 

Hyattsville, MD 20782. 

Disclosure Review Process 

The disclosure review process in the 

RDC is centered on a rigorously 

Federal Register / Vol. 69, No. 222 / Thursday, November 18, 2004 / Notices 67589

conducted research base. Briefly, RDC 

staff, either independently or in 

collaboration with staff from other areas 

of the NCHS, other government 

agencies, and non-governmental 

researchers, conduct research into the 

use of technological and statistical 

advances to develop and refine 

additional methods to access restricted 

data such as the use of the internet or 

encrypted data, assessment of disclosure 

risk through statistical and automated 

procedures, and the use of disclosure 

limitation methodologies (e.g., statistical 

noise) to enable the release of otherwise 

restricted data files. The results of these 

research activities are applied to 

disclosure review activities in the RDC. 

Researchers may take the results of 

their analyses off-site after disclosure 

review by RDC staff. Disclosure review 

consists of looking for tabular cells less 

than 5, tables with geographic variables 

in any dimension, models with 

geographic variables (or variables 

tantamount to geographic variables) as 

outcome variables, or line listings. In 

general, disclosure review is consistent 

with the guidelines published in the 

NCHS Staff Manual on Confidentiality 

(see Appendix II, Requirements for the 

Release of Micro Data). 

RDC staff review data summaries to 

assure maintenance of respondent 

confidentiality. In no case may any table 

contain cells with fewer than 5 

observations. If found, these small cells 

are suppressed, generally by obliterating 

the cell. To assure that small cells 

cannot be calculated from the other cells 

in the same row or column, staff makes 

illegible the totals for the rows and 

columns corresponding to the small 

cell. Once disclosure review is 

completed, researchers receive a 

photocopy of the final tabulations. 

RDC staff when reviewing crosstabulations for small cell use the 

following procedures: 

1. Shred all tables having fewer than 

five total observations (table total); 

2. Shred all tables having fewer than 

five observations in each cell ; 

3.If the table passes the first two 

criteria, RDC staff will review the table 

one row at a time; 

4. Make illegible all counts and 

percents for cells with four or fewer 

observations;

5. If one row cell is <5, that cell and 

at least one other row cell will be 

suppressed; if two or more row cells are 

each <5, each will be suppressed, but 

the row total need not be suppressed 

because the suppressed row cells cannot 

be determined; 

6. If one column cell is <5, that cell 

and at least one other column cell will 

be suppressed; if two or more column 

cells are each <5, each will be 

suppressed, but the column total need 

not be suppressed because the 

suppressed column cells cannot be 

determined; 

7. Row (or column) total is suppressed 

ONLY if it (i.e., total) is <5; since the 

cells that are <5 (row or column as 

appropriate) are suppressed, user cannot 

determine their values by knowing the 

row (or column) total. 

RDC staff will use best practices in 

determining whether data are 

identifiable and will be conservative in 

their decisions. RDC decisions are final 

and not subject to negotiation by 

researchers. 

Publication 

For NCHS files, any published 

material derived from the data should 

acknowledge NCHS as the source and 

should include a disclaimer that credits 

any analyses, interpretations, or 

conclusions reached by the author 

(recipient of the file) to that author and 

not to NCHS, which is responsible only 

for the initial data. Researchers who 

want to publish a technical description 

of the data should make a reasonable 

effort to ensure that the description is 

consistent with that published by 

NCHS.

Appendix I—Examples of NCHS Data 

Available Through the NCHS RDC 

National Health Interview Survey—Data 

from the core and supplements for survey 

years 1987–2002 are available for merging 

user-supplied data at the state and county 

levels (note that RDC users do not have 

access to county FIPS codes; these are 

replaced with randomly assigned dummy 

codes). Additionally, state data files may be 

made available for analysis and reporting. 

National Survey of Family Growth—

Contextual Data File—The 1995 NSFG has 

available sets of contextual variables at the 

state, county, census tract, and block-group 

levels for the residence of the respondents in 

1990, 1993, and 1995. 

Third National Health and Nutrition 

Examination Survey (1988–1994)—Data from 

NHANES III are available with state and 

county identifiers (there are restrictions on 

the use and reporting of geographic units). 

NCHS survey data, including vital 

statistics, Longitudinal Study on Aging, and 

other data files with restricted information 

(sample design information, lower levels of 

geography, etc.) can be made available as 

requested and needed. 

Appendix II—Requirements for the Release 

of NCHS Micro Data Files 

The following rules apply to all files 

released by NCHS which contain any 

information about individual persons or 

establishments, except where the supplier of 

information was told, prior to his giving the 

information, that the information would be 

made public: 

A. Before any new or revised micro data 

files are published, they, together with their 

full documentation, must be approved for 

publication by the Confidentiality Officer 

who will rely upon assistance from the NCHS 

Disclosure Review Board in reaching 

decisions. 

B. The file must not contain any detailed 

information about the subject that could 

facilitate identification and that is not 

essential for research purposes (e.g., exact 

date of the subject’s birth, excessive detail for 

occupation, extreme values of income and 

age, detailed race or ethnicity for small and 

highly visible groups—and other 

characteristics that would make an 

individual or establishment easier to 

identify). It is recommended that the 

following be consulted concerning possible 

techniques that would permit the maximum 

amount of information to be released 

consistent with sound principles of statistical 

disclosure limitation: The Confidentiality 

and Data Access Committee’s Checklist on 

Disclosure Potential of Data (http://

www.fcsm.gov/committees/cdac/

checklist_799.doc) and Statistical Policy 

Working Paper 22, Report on Statistical 

Disclosure Limitation Methodology. Office of 

Information and Regulatory Affairs, Office of 

Management and Budget (http://

www.fcsm.gov/working-papers/wp22.html).

C. Geographic places that have fewer than 

100,000 people are not to be identified on the 

file. Depending upon the statistical structure 

of a file and other circumstances, a higher 

figure may be employed. It is the 

responsibility of the program proposing the 

data release to determine the disclosure risk 

associated with the proposed minimum size 

of geographic areas to be identified. 

D. Characteristics of an area are not to 

appear on the file if they would uniquely 

identify an area of fewer than 100,000 people 

(e.g., a variable describing the size of a 

Metropolitan Area in which a respondent 

was interviewed providing for a category of 

fewer than 100,000 in a file where Region is 

also provided). 

E. Information on the drawing of the 

sample which might assist in identifying a 

respondent must not be released outside the 

Center. Thus, the identities of primary 

sampling units are not to be made available 

outside the Research Data Center except in 

limited circumstances and as approved by 

the Confidentiality Officer. When such 

circumstances require the disclosure of the 

identity of areas in which data collection 

activities take place, the survey manager 

must insure that all information for this 

survey proposed for release takes into 

account the greater risk of identification 

because of this exception. The decision as to 

whether PSU identities are to be made public 

should be made before data are collected and 

plans for data release finalized.

Appendix III—Disallowed SAS Functions, 

Statements, and Procedures 

The list below is used by the RDC remote 

access system to scan user-submitted 

programs for functions, statements, and 

procedures that may result in an 

unauthorized disclosure. Any user-submitted 

program that contains one or more of these 

67590 Federal Register / Vol. 69, No. 222 / Thursday, November 18, 2004 / Notices 

keywords is automatically rejected, and the 

user is asked to correct the problem and 

resubmit the program. Because the remote 

access system is an automated system, the 

RDC does not and cannot make any 

exceptions. This list may change pending 

development of additional methodologies.

r_word 

add 

print 

obs 

firstobs 

first. 

last. 

& 

%

nocol 

report 

pctn 

pctsum 

tabulate 

iml 

nofreq 

nocum 

browse 

editor 

summary 

list 

put 

file 

r_

plot 

PROC DATASET: 

-Copy 

-Delete 

-Rename 

-Repair 

-Append 

-List 

Compress 

Pointobs 

multi part data set names

In addition to the above disallowed 

statements and functions, users of the remote 

access system cannot use any statements or 

functions that write permanent data files to 

the hard disk.

Appendix IV—Project-Specific Requirements 

Vaccine Safety Datalink (VSD) Project 

The VSD was established to allow the 

Centers for Disease Control and Prevention 

(CDC) to carefully monitor vaccine safety in 

the United States. The VSD, a large-linked 

database, contains medical and 

immunization information on more than six 

million people annually. Information 

available in the database includes basic 

demographic information, managed care 

organization (MCO) enrollment, dates of 

vaccination, and medical visits. The VSD is 

a collaborative project involving CDC and 

several large MCOs. Information from the 

VSD is used by CDC to conduct vaccine 

safety studies. 

Recognition of the need for improved 

monitoring of vaccine safety prompted the 

CDC to initiate the VSD project in 1990. This 

project currently involves partnerships with 

MCOs to continually monitor vaccine safety. 

All vaccines administered within a MCO are 

recorded and include vaccine type, date of 

vaccination, concurrent vaccinations (those 

given during the same visit), the 

manufacturer, lot number and injection site. 

Medical visits are also recorded which can be 

used to monitor for potential adverse events 

resulting from immunization. The VSD 

project allows for planned vaccine safety 

studies as well as timely investigations of 

emerging hypotheses. At present, the VSD 

project is examining potential associations 

between vaccines and a number of serious 

conditions. Data from the VSD also are used 

to test new vaccine safety hypotheses that 

result from the medical literature, signals 

from the Vaccine Adverse Events Reporting 

System (VAERS), changes in the 

immunization schedule, the introduction of 

new vaccines, or recommendations from the 

Institute of Medicine (IOM) and Advisory 

Committee on Immunization Practices (ACIP) 

recommendations. This project is a powerful 

and cost-effective tool for the on-going 

evaluation of vaccine safety. It should be 

noted that the MCOs, as owners of the data, 

have broad decision-making authority over 

data release, as specified in CDC’s contract 

with America’s Health Insurance Plans 

(AHIP). In addition, MCOs have a recognized 

need and right to protect proprietary data. 

In August 2002, CDC’s National 

Immunization Program (NIP) and its 

managed care partners created a data sharing 

program to allow limited access to VSD data 

through the NCHS RDC with confidentiality 

protection under Sec. 308(d) of the Public 

Health Service Act (42 U.S.C. 242m). 

Proposals requesting use of VSD data 

undergo a review by the MCOs’ Institutional 

Review Board(s) (MCO IRB) in addition to a 

review by RDC staff. After approval of their 

research proposal and payment of fees for the 

associated costs, researchers are able to 

independently analyze data from the VSD. 

Two types of VSD data may be accessed at 

the RDC by an external researcher: 

1. Analytic datasets created from the VSD 

data files that reside at CDC to conduct new 

vaccine safety studies: 

The VSD data files are comprised of several 

separate data sets derived from computerized 

data sources from seven participating VSD 

MCOs. The VSD data files contain data 

through December 31, 2000 and include 

information such as vaccinations, hospital 

discharge and other diagnoses, and 

demographic characteristics. With these data, 

an external researcher may conduct a new 

vaccine safety study in order to test his/her 

vaccine safety hypothesis. The external 

researcher may request only the variables 

that are found in the VSD data Files (as listed 

in the data dictionary). 

To assist researchers, CDC makes available 

at its Web site: (1) A list of recommended 

scientific references relevant to conducting 

research using large linked databases such as 

the VSD data files and (2) a data dictionary 

that lists all the variables contained in the 

VSD data files available for new vaccine 

safety research (http://www.cdc.gov/nip/

vacsafe/vsd/default.htm#data). 

Proposals for analyses of new vaccine 

safety studies using data from the VSD data 

files should include only those specific 

variables that are needed to conduct the 

proposed analyses, including a brief 

explanation with justification for use of these 

variables. 

Data contained in the VSD data files have 

been created from MCO administrative data 

which are not solely collected for the 

purpose of scientific research. It should be 

noted then that potential data discrepancies 

and varying degrees of data quality that are 

specific to such types of data do exist and 

typically are not resolvable with data that are 

available in the RDC. 

2. Final datasets from published VSD 

studies: 

External researchers who would like to 

perform a reanalysis of a published VSD 

study performed by VSD investigators may 

request the final dataset for the specific study 

they wish to re-analyze. Data collected for the 

final datasets of the published studies may 

include additional variables not listed in the 

data dictionary that is referenced above; 

therefore, the RDC will provide the external 

researcher with the necessary data dictionary 

for the requested dataset(s). No additional 

source or ‘‘raw’’ data are available for 

reanalysis of published VSD studies. 

In general, VSD studies published after 

August 2002 are available for reanalysis. 

However, since many studies were published 

prior to the establishment of the CDC data 

sharing policy, some of the earlier published 

VSD study datasets may not be available for 

re-analysis for the following reasons: 

• Some IRBs mandate that datasets be 

destroyed after research is completed. 

• Principal investigator may no longer be 

affiliated with VSD or the collaborating 

MCOs; therefore, the location of the dataset 

is unknown. 

• Rapidly changing technology can mean 

that data are on obsolete media. 

Following receipt of a proposal for a 

reanalysis, the RDC will verify that the data 

variables requested from the published study 

are available. If these data are not available 

(for one or more of the reasons stated above), 

the RDC will notify the external researcher. 

Documentation for variables and datasets 

used in VSD studies completed after August 

2002 are maintained according to the CDC 

data sharing policy regarding archival of data 

that are available on the Web at http://

www.cdc.gov/od/ads/pol-385.htm.

All proposals requesting use of VSD data 

should contain the following information: 

A. Project Title. 

B. Name of proposed investigator and 

collaborators (RDC rules limit number of 

persons at a work station to 3 at a time). 

C. Name of point of contact, address, 

telephone number, and e-mail address. 

D. Summary of proposed study (i.e., 

background, reasons for conducting the 

study, public health benefits). 

E. Specific hypothesis for new vaccine 

safety studies to be investigated or title of 

published VSD study to be reanalyzed. 

F. Proposed methodology for new vaccine 

safety studies or the specification of the 

methods used in published VSD studies: 

1. Definition of the study population of 

interest and type of study to be conducted: 

a. Descriptive studies: specify the variables 

and values for those variables to be used to 

select the study population. 

b. Case-control studies: specify criteria for 

cases and controls. 

c. Cohort studies: specify criteria for the 

exposed and unexposed population. 

d. For all new vaccine safety studies, 

please include the following information as 

Federal Register / Vol. 69, No. 222 / Thursday, November 18, 2004 / Notices 67591

part of the definition of the study population 

of interest: 

i. Adult or Pediatric data (0–17 or 18+). 

ii. Study years of interest (i.e. 199X–2000). 

Please note the study years available vary by 

HMO site. 

iii. How the study population will be 

selected from the VSD data files based on 

available fields in the VSD data dictionary. 

2. Specification of the variables that will be 

required including: 

a. Exposures: Specific criteria defining 

exposures based on the VSD data dictionary 

should be included. For instance, specific 

vaccines given within 14 days of the outcome 

of interest. 

b. Outcomes: Specific criteria defining 

those outcomes based on the VSD data 

dictionary should be included. For instance, 

specific ICD–9 codes for outcomes of interest 

and type of health care encounter 

(hospitalization, outpatient encounter, 

emergency room visit). 

c. Person Time or Enrollment: Specify 

criteria to determine calculation of person 

time, follow-up time, or MCO enrollment 

restrictions. 

d. Confounding or control variables, 

including: 

1. Demographic information. 

2. Pre-existing or co-morbid conditions. 

3. Concurrent vaccinations. 

4. MCO Site. 

e. Other required variables to perform the 

proposed analysis. 

G.Proposed analytic strategies. 

The RDC staff will notify the external 

researcher whether his/her proposal is 

complete and whether the requested 

variables are available. If all the requested 

data variables can be located for the proposed 

new vaccine safety studies or proposed 

reanalysis, review of the proposal by the 

appropriate MCO IRBs takes place. In 

compliance with federal law and regulations, 

access by external researchers to a portion of 

the VSD data files or to datasets from VSD 

published studies requires review and 

approval by the appropriate IRBs of the 

relevant MCOs. The MCO IRBs have the 

responsibility to protect the confidentiality 

and privacy of their members’ medical 

records and to adhere to the rules and 

regulations applicable to their respective 

institution(s). Consequently, each of the MCO 

IRBs must review any request for access to 

the VSD data files that contain information 

on its MCO members. Any appeal by the 

requestor of an IRB decision must follow the 

national, federal procedures for IRBs. CDC is 

not involved in the MCO IRB process at any 

time. General information pertaining to the 

rules and regulations of IRB submission can 

be found at http://www.cdc.gov/od/ads/

hsr2.htm/.

Submission of Proposals to MCO IRBs 

Review of a proposal submitted by an 

external researcher by a MCO IRB does not 

imply that CDC approves or endorses the 

external researcher’s proposed research. IRB 

applications may require a more detailed 

description of the proposed vaccine safety 

study and may vary according to individual 

IRB requirements. Furthermore, various IRBs 

may have different time lines for submission 

of proposals for review. Each IRB may have 

specific policies or requirements for data 

sharing that have not been adopted by the 

other MCO IRBs. These policies may include 

required collaboration with an MCO 

investigator, fees associated with the IRB 

review process, or differing criteria for the 

IRB review process. 

MCO IRBs will use their established 

procedures and time lines to review the 

proposed research and to consider any 

appeals. As a rule, IRBs attempt to inform 

researchers as to the status of their proposals. 

Approval for access to MCO data contained 

within the VSD data files does not indicate 

approval for obtaining additional data 

contained within the MCO’s member medical 

records or elsewhere, if such data are not 

contained within the VSD data files that 

reside in the RDC. 

For new vaccine safety studies, it is 

possible that an external researcher will 

receive approval for access to VSD data from 

some, but not all, relevant IRBs. If this 

occurs, then the dataset(s) needed to conduct 

the new vaccine safety study will still be 

created, but only with data from the MCOs 

whose IRBs approved access. VSD data sets 

for new vaccine safety studies must contain 

data from two or more MCOs’ data. Access 

will not be provided to data from only one 

MCO. For reanalysis of a published VSD 

study, all relevant IRBs from the MCOs that 

participated in the published study must 

approve the proposal for reanalysis; therefore 

if one or more IRBs do not approve access to 

VSD data used in the published study, the 

final dataset cannot be provided. 

Once the external researcher has received 

a response from all of the appropriate IRBs, 

the RDC will begin the process of creating or 

formatting the approved dataset(s). The RDC 

will not create or prepare the dataset(s) until 

it receives copies of all final IRB dispositions.

Publication of Research Using VSD Data 

When an external researcher has 

completed his/her work at the RDC and 

wishes to publish research results and 

findings using VSD data, there are specific 

requirements that must be followed: 

• External researchers are required to 

submit a copy of these data sharing 

guidelines with any manuscript submitted to 

a journal. 

• External researchers are required to 

submit (to the journal) a copy of the 

Confidentiality Agreement he/she signed 

prior to conducting research at the RDC. 

• Disclaimers must be included in the 

manuscript which state: 

The research was conducted using data 

from the Vaccine Safety Datalink Project, 

through the data sharing program at the 

Centers for Disease Control and Prevention. 

• Any published material using VSD data 

must acknowledge CDC as the original data 

source. 

• Additionally, disclaimers must be 

included that state: 

The analysis, interpretations, and 

conclusions are the responsibility of the 

authors and do not represent the views and 

opinions of the CDC, the Federal 

Government, or the managed care 

organization providing the data. 

Appendix V—Agreement Regarding 

Conditions of Access to Confidential Data in 

the Research Data Center of the National 

Center for Health Statistics 

I lllllllllll (please print 

name) am aware that the information 

contained in the (name of data file) has been 

provided to NCHS in accordance with the 

provisions of Section 308(d) of the Public 

Health Service Act (42 U.S.C. 242m), with 

the assurance that it will be used only for 

health statistical reporting and analysis and 

will not be published or released in 

identifiable form. I am also aware that I can 

be held legally liable for any harm incurred 

by individuals or establishments who have 

provided or are described in the information 

contained in the above work files to which 

I will have access. 

Having read and familiarized myself with 

the Researcher Affidavit of Confidentiality, 

including Section 308(d) of the Public Health 

Service Act (42 U.S.C. 242m) (attached), I 

agree: 

1. To make no copies of any files or 

portions of files to which I am granted access 

except those authorized by NCHS Research 

Data Center staff. 

2. To return to RDC staff all NCHS 

restricted materials with which I may be 

provided during the conduct of my research 

at NCHS and other materials as requested.

3. Not to use ANY technique in an attempt 

to learn the identity of any person, 

establishment, or sampling unit not 

identified on public use data files. 

4. To hold in strictest confidence the 

identification of any establishment or 

individual that may be inadvertently 

revealed in any documents or discussion, or 

analysis. Such inadvertent identification 

revealed in my analysis will be immediately 

brought to the attention of RDC staff. 

5. Not to remove any printouts, electronic 

files, documents, or media until they have 

been scanned for disclosure risk by RDC staff. 

6. Not to remove from NCHS any written 

notes pertaining to the identification of any 

establishment, individual, or geographic area 

that may be revealed in the conduct of my 

research at NCHS. 

7. To the inspection of any material I may 

bring to or remove from the NCHS Research 

Data Center. 

8. To comport myself in a manner 

consistent with the principles and standards 

appropriate to a scientific research 

establishment. 

Deliberate violation of any of these 

conditions may result in cancellation of the 

data access agreement, and the researcher 

may be escorted from the premises by the 

duly authorized Federal protection service on 

duty at NCHS. The researcher may also be 

barred from any future use of the RDC upon 

review and determination by the Director of 

NCHS that this is necessary to protect the 

integrity and confidentiality of the RDC. 

lllllllllllllllllllll

Researcher’s Signature 

lllllllllllllllllllll

Date 

lllllllllllllllllllll

NCHS Witness 

lllllllllllllllllllll

Date

67592 Federal Register / Vol. 69, No. 222 / Thursday, November 18, 2004 / Notices 

Appendix VI—Researcher Affidavit of 

Confidentiality 

I certify that no confidential data or 

information viewed or otherwise obtained 

while I am a researcher in the National 

Center for Health Statistics (NCHS) Research 

Data Center (RDC) will be removed from 

NCHS. Further, I understand that NCHS will 

perform a disclosure review and must 

provide approval to me before I remove any 

data from the RDC, whether they are in 

electronic or paper form. I acknowledge 

NCHS Confidentiality Statute, Sec. 308(d) of 

the Public Health Service Act (42 U.S.C. 

242m) stated below and fully understand my 

legal obligations to NCHS to protect all 

confidential data. Further, I understand that 

any violation may be punishable by fine or 

imprisonment for up to 5 years or both under 

Title 18 U.S.C. 1001. 

NCHS Confidentiality Statute—No 

information, if an establishment or person 

supplying the information or described in it 

is identifiable, obtained in the course of 

activities undertaken or supported under 

section 304, 306, or 307 may be used for any 

purpose other than the purpose for which it 

was supplied unless such establishment or 

person has consented (as determined under 

regulations of the Secretary) to its use for 

such other purpose and in the case of 

information obtained in the course of health 

statistical or epidemiological activities under 

section 304 or 306, such information may not 

be published or released in other form if the 

particular establishment or person supplying 

the information or described in it is 

identifiable unless such establishment or 

person has consented (as determined under 

regulations of the Secretary) to its publication 

or release in other form. 

Title 18 U.S.C. 1001—Deliberately making 

a false statement in any matter within the 

jurisdiction of any Department or Agency of 

the Federal Government violates Title 18 

U.S.C. 1001 and is punishable by a fine or 

up to 5 years in prison or both.

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Researcher’s Signature

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Date

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NCHS Witness

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Date

Dated: November 9, 2004. 

James D. Seligman, 

Associate Director for Program Services, 

Centers for Disease Control and Prevention.

[FR Doc. 04–25537 Filed 11–17–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Oncologic Drugs Advisory Committee; 

Notice of Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public.

Name of Committee: Oncologic Drugs 

Advisory Committee.

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues.

Date and Time: The meeting will be 

held on December 1, 2004, from 8 a.m. 

to 5 p.m.

Location: Holiday Inn, Kennedy/

Adams Ballroom, 8777 Georgia Ave., 

Silver Spring, MD.

Contact Person: Johanna M. Clifford, 

Center for Drug Evaluation and Research 

(HFD–21), Food and Drug 

Administration, 5600 Fishers Lane, (for 

express delivery, 5630 Fishers Lane, rm. 

1093) Rockville, MD 20857, 301–827–

7001, Fax: 301–827–6776, e-mail: 

cliffordj@cder.fda.gov, or FDA Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512542. Please call the Information 

Line for up-to-date information on this 

meeting.

Agenda: The committee will discuss 

these items: (1) New drug application 

(NDA) 21–673, proposed trade name 

CLOLAR (clofarabine) Ilex Products, 

Inc., proposed indication for the 

treatment of pediatric patients 1 to 21 

years old with refractory or relapsed 

acute leukemias, and (2) NDA 21–600, 

proposed trade name MARQIBO 

(vincristine sulfate liposome injection) 

Inex Pharmaceuticals Corp., proposed 

indication for the treatment of patients 

with aggressive non-Hodgkin’s 

lymphoma previously treated with at 

least two combination chemotherapy 

regimens.

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person by November 23, 2004. Oral 

presentations from the public will be 

scheduled between approximately 10:30 

a.m. and 11 a.m., and between 

approximately 2:30 p.m. and 3 p.m. 

Time allotted for each presentation may 

be limited. Those desiring to make 

formal oral presentations should notify 

the contact person before November 23, 

2004, and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation.

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets.

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Trevelin 

Prysock at 301–827–7001 at least 7 days 

in advance of the meeting.

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2).

Dated: November 9, 2004.

Sheila Dearybury Walcoff,

Associate Commissioner for External 

Relations.

[FR Doc. 04–25530 Filed 11–17–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the meeting of the 

Advisory Committee to the Director, 

National Institutes of Health (NIH). 

The meeting will be open to the 

public as indicated below, 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 

in advance of the meeting. 

A portion of the meeting will be 

closed to the public in accordance with 

the provisions set forth in the 

Government in the Sunshine Act, 

sections 552b(c)(6) and 552b(c)(9)(B), 

Title 5 U.S.C., as amended, because the 

disclosure of which would constitute a 

clearly unwarranted invasion of 

personal property and the premature 

disclosure of information and the 

discussions are likely to significantly