Ctsaeval Pia 091710 (2)

06.1 HHS Privacy Impact Assessment NIH NCRR CTSA Study Management System (CTSA-SMS)	Primavera ProSight

PIA SUMMARY

1

The following required questions with an asterisk (*) represent the information necessary to complete the PIA Summary for transmission to the Office of Management and Budget (OMB) and public posting in accordance with OMB Memorandum (M) 03-22.

Note: If a question or its response is not applicable, please answer “N/A” to that question where possible. If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of personally identifiable information (PII). If no PII is contained in the system, please answer questions in the PIA Summary Tab and then promote the PIA to the Senior Official for Privacy who will authorize the PIA. If this system contains PII, all remaining questions on the PIA Form Tabs must be completed prior to signature and promotion.

2	Summary of PIA Required Questions

*Is this a new PIA?

Yes

If this is an existing PIA, please provide a reason for revision:

*1. Date of this Submission:

9/07/2010

*2. OPDIV Name:

NIH

*4. Privacy Act System of Records Notice (SORN) Number (If response to Q.21 is Yes, a SORN number is required for Q.4):

09-25-0200

*5. OMB Information Collection Approval Number:

TBD

*6. Other Identifying Number(s):

Westat internal Project ID 8668

*7. System Name (Align with system item name):

NIH NCRR National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative

Study Management System

*9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed:

	Point of Contact Information
	POC Name	Patricia Newman

*10. Provide an overview of the system:

The CTSA Initiative is directed at transforming the way biomedical research is conducted nationwide by reducing the time it takes for basic science or laboratory discoveries to become treatments for patients, and for those treatments in turn to be incorporated and disseminated throughout community practice.  The CTSA-SMS will include a variety of data to support an evaluation of the first four cohorts of CTSA awardee institutions and the CTSA Consortium. The system stores, processes, and transmits all information related to the study including data submitted by awardees in Non-Competing Continuation Progress Reports (PHS 2590), surveys and responses, staff and agency contact information, study data and reports, and other electronic and hardcopy information.

*13. Indicate if the system is new or an existing one being modified:

New

*17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?

Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. If the information contained in the system ONLY represents federal contact data (i.e., federal contact name, federal address, federal phone number, and federal email address), it does not qualify as PII, according to the E-Government Act of 2002, and the response to Q.17 should be No (only the PIA Summary is required). If the system contains a mixture of federal contact information and other types of PII, the response to Q.17 should be Yes (full PIA is required).

Yes

17a. Is this a GSS PIA included for C&A purposes only, with no ownership of underlying application data? If the response to Q.17a is Yes, the response to Q.17 should be No and only the PIA Summary must be completed.

No

*19. Are records on the system retrieved by 1 or more PII data elements?

Yes

*21. Is the system subject to the Privacy Act? (If the response to Q.19 is Yes, the response to Q.21 must be Yes and a SORN number is required for Q.4)

Yes

*23. If the system shares or discloses PII, please specify with whom and for what purpose(s):

The information contained in this system will not be shared. Only summary information at aggregate levels will be provided. Information stored in the system may be shared in accordance with the guidance in System of Records Notice 09-25-0200.

*30. Please describe in detail: (1) The information the agency will collect, maintain, or disseminate (clearly state if the information contained in the system ONLY represents federal contact data); (2) Why and for what purpose the agency will use the information; (3) Explicitly indicate whether the information contains PII; and (4) Whether submission of personal information is voluntary or mandatory:

The CTSA-SMS collects and maintains a variety of information types. Data submitted to NIH in award applications, Non-Competing Continuation Progress Reports (PHS 2590), and other routine award reporting include award numbers, names, professional email addresses, telephone contact information, and NIH commons ID and person ID. In addition to the identifying information used to locate and contact survey participants, the system will store, process, and transmit basic data respondents volunteer regarding employment, education, and demographics. Information in the CTSA-SMS will be used to provide analytical and policy support to NCRR, assisting NIH in making decisions about current CTSA programming, future funding, and other initiatives to improve clinical and translational science. It may also provide information for NIH’s Government Performance and Results Act (GPRA) report. At least one journal article based on the findings will be developed and submitted for publication. Disclosure of personal information is voluntary.

*31. Please describe in detail any processes in place to: (1) Notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) Notify and obtain consent from individuals regarding what PII is being collected from them; and (3) How the information will be used or shared. (Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.]):

The CTSA-SMS will be used only to collect survey data, analyze data, and produce reports for the CTSA evaluation study. The CTSA-SMS will be retired upon conclusion of the study. No major changes to the CTSA-SMS affecting disclosure and/or data use are anticipated. In the unlikely event of future major change to the CTSA-SMS affecting status or use of personally identifiable information (PII), privacy notice of consent is provided in writing or via email to affected individuals.

Notification and consent from individuals for collection of PII is provided in the survey: “Pursuant to 5 CFR 1320.5(b), an agency may not conduct or sponsor, and a person is not required to respond to an information collection unless it displays a valid OMB control number. The OMB control number for this collection is 0348-XXXX.”

Each survey is preceded by a message to the individual which specifies why the information is being collected and how it will be used (i.e., The NIH leadership is interested in learning more about the use of CTSA resources.)

*32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII)

Yes

*37. Does the website have any information or pages directed at children under the age of thirteen?

No

*50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN)

Yes

*54. Briefly describe in detail how the PII will be secured on the system using administrative, technical, and physical controls:

Information will be secured on the system through access controls, personnel security awareness and training, regular auditing of information and information management processes, careful monitoring of a properly accredited CTSA-SMS information system, control of changes to the system, by appropriate planning and testing of configuration management and contingency processes, by ensuring that all users of the CTSA-SMS are properly identified and authorized for access and are aware of and acknowledge the system rules of behavior, by ensuring that any contingency or incident is handled expeditiously, properly maintaining the system and regulating the environment it operates in, by controlling media, by evaluating risks and planning for information management and information system operations, by ensuring that the system and any exchange of information is protected, by maintaining the confidentiality and integrity of the CTSA-SMS, and by adhering to the requirements established in the contract and statement of work.

PIA REQUIRE INFORMATION

1	HHS Privacy Impact Assessment (PIA)

The PIA determines if Personally Identifiable Information (PII) is contained within a system, what kind of PII, what is done with that information, and how that information is protected. Systems with PII are subject to an extensive list of requirements based on privacy laws, regulations, and guidance. The HHS Privacy Act Officer may be contacted for issues related to Freedom of Information Act (FOIA) and the Privacy Act. Respective Operating Division (OPDIV) Privacy Contacts may be contacted for issues related to the Privacy Act. The Office of the Chief Information Officer (OCIO) can be used as a resource for questions related to the administrative, technical, and physical controls of the system. Please note that answers to questions with an asterisk (*) will be submitted to the Office of Management and Budget (OMB) and made publicly available in accordance with OMB Memorandum (M) 03-22.

Note: If a question or its response is not applicable, please answer “N/A” to that question where possible.

2	General Information

*Is this a new PIA?

Yes

If this is an existing PIA, please provide a reason for revision:

*1. Date of this Submission:

9/07/10

*2. OPDIV Name:

National Institutes of Health, National Center for Research Resources

3. Unique Project Identifier (UPI) Number for current fiscal year (Data is auto-populated from the System Inventory form, UPI table):

TBD

*4. Privacy Act System of Records Notice (SORN) Number (If response to Q.21 is Yes, a SORN number is required for Q.4):

09-25-0200

*5. OMB Information Collection Approval Number:

TBD

5a. OMB Collection Approval Number Expiration Date:

TBD

*6. Other Identifying Number(s):

Westat internal Project ID 8668

*7. System Name: (Align with system item name)

NIH NCRR National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative Study Management System

8. System Location: (OPDIV or contractor office building, room, city, and state)

	System Location:
	OPDIV or contractor office building	Westat Inc. 1600 Research Blvd.
	Room
	City	Rockville
	State	MD

*9. System Point of Contact (POC). The System POC is the person to whom questions about the system and the responses to this PIA may be addressed:

	Point of Contact Information
	POC Name	Patricia Newman

The following information will not be made publicly available:

	POC Title	Program Analyst
	POC Organization	NIH/NCRR
	POC Phone	301-435-0864
	POC Email	pnewman@mail.nih.gov

*10. Provide an overview of the system: (Note: The System Inventory form can provide additional information for child dependencies if the system is a GSS)

The CTSA Initiative is directed at transforming the way biomedical research is conducted nationwide by reducing the time it takes for basic science or laboratory discoveries to become treatments for patients, and for those treatments in turn to be incorporated and disseminated throughout community practice.  The CTSA-SMS will include a variety of data to support an evaluation of the first four cohorts of CTSA awardee institutions and the CTSA Consortium. The system stores, processes, and transmits all information related to the study including data submitted by awardees in Non-Competing Continuation Progress Reports (PHS 2590), surveys and responses, staff and agency contact information, study data and reports, and other electronic and hardcopy information.

SYSTEM CHARACTERIZATION AND DATA CATEGORIZATION

1	System Characterization and Data Configuration

11. Does HHS own the system?

Yes

11a. If no, identify the system owner:

12. Does HHS operate the system? (If the system is operated at a contractor site, the answer should be No)

No

12a. If no, identify the system operator:

Westat Inc.

1600 Research Blvd, Rockville, MD 20850

*13. Indicate if the system is new or an existing one being modified:

New

14. Identify the life-cycle phase of this system:

Requirements Phase

15. Have any of the following major changes occurred to the system since the PIA was last submitted?

No

	Please indicate “Yes” or “No” for each category below:	Yes/No
	Conversions	No
	Anonymous to Non-Anonymous	No
	Significant System Management Changes	No
	Significant Merging	No
	New Public Access	No
	Commercial Sources	No
	New Interagency Uses	No
	Internal Flow or Collection	No
	Alteration in Character of Data	No

16. Is the system a General Support System (GSS), Major Application (MA), Minor Application (child) or Minor Application (stand-alone)?

Minor application

*17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII within any database(s), record(s), file(s) or website(s) hosted by this system?

Yes

Note: This question seeks to identify any, and all, personal information associated with the system. This includes any PII, whether or not it is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or other legislation. If the information contained in the system ONLY represents business contact data (i.e., business contact name, business address, business phone number, and business email address), it does not qualify as PII, according to the E-Government Act of 2002, and the response to Q.17 should be No (only the PIA Summary is required). If the system contains a mixture of business contact information and other types of PII, the response to Q.17 should be Yes (full PIA is required).

Please indicate "Yes" or "No" for each PII category. If the applicable PII category is not listed, please use the Other field to identify the appropriate category of PII.

	Categories:	Yes/No
	Name (for purposes other than contacting federal employees)	Yes
	Date of Birth	No
	Social Security Number (SSN)	No
	Photographic Identifiers	No
	Driver’s License	No
	Biometric Identifiers	No
	Mother’s Maiden Name	No
	Vehicle Identifiers	No
	Personal Mailing Address	Yes
	Personal Phone Numbers	Yes
	Medical Records Numbers	No
	Medical Notes	No
	Financial Account Information	No
	Certificates	No
	Legal Documents	No
	Device Identifiers	No
	Web Uniform Resource Locator(s) (URL)	No
	Personal Email Address	Yes
	Education Records	No
	Military Status	No
	Employment Status	Yes
	Foreign Activities	No
	Other	Yes

17a. Is this a GSS PIA included for C&A purposes only, with no ownership of underlying application data? If the response to Q.17a is Yes, the response to Q.17 should be No and only the PIA Summary must be completed.

No

18. Please indicate the categories of individuals about whom PII is collected, maintained, disseminated and/or passed through. Note: If the applicable PII category is not listed, please use the Other field to identify the appropriate category of PII. Please answer "Yes" or "No" to each of these choices (NA in other is not applicable).

	Categories:	Yes/No
	Employees	Yes
	Public Citizen	Yes
	Patients	No
	Business partners/contacts (Federal, state, local agencies)	Yes
	Vendors/Suppliers/Contractors	Yes
	Other	Yes

*19. Are records on the system retrieved by 1 or more PII data elements?

Yes

Please indicate "Yes" or "No" for each PII category. If the applicable PII category is not listed, please use the Other field to identify the appropriate category of PII.

	Categories:	Yes/No
	Name (for purposes other than contacting federal employees)	Yes
	Date of Birth	No
	SSN	No
	Photographic Identifiers	No
	Driver’s License	No
	Biometric Identifiers	No
	Mother’s Maiden Name	No
	Vehicle Identifiers	No
	Personal Mailing Address	No
	Personal Phone Numbers	No
	Medical Records Numbers	No
	Medical Notes	No
	Financial Account Information	No
	Certificates	No
	Legal Documents	No
	Device Identifiers	No
	Web URLs	No
	Personal Email Address	No
	Education Records	No
	Military Status	No
	Employment Status	No
	Foreign Activities	No
	Other	Yes

20. Are 10 or more records containing PII maintained, stored or transmitted/passed through this system?

Yes

*21. Is the system subject to the Privacy Act? (If the response to Q.19 is Yes, the response to Q.21 must be Yes and a SORN number is required for Q.4)

Yes

21a. If yes but a SORN has not been created, please provide an explanation.

INFORMATION SHARING PRACTICES

1	Information Sharing Practices

22. Does the system share or disclose PII with other divisions within this agency, external agencies, or other people or organizations outside the agency?

No

	Please indicate “Yes” or “No” for each category below:	Yes/No
	Name (for purposes other than contacting federal employees)	No
	Date of Birth	No
	SSN	No
	Photographic Identifiers	No
	Driver’s License	No
	Biometric Identifiers	No
	Mother’s Maiden Name	No
	Vehicle Identifiers	No
	Personal Mailing Address	No
	Personal Phone Numbers	No
	Medical Records Numbers	No
	Medical Notes	No
	Financial Account Information	No
	Certificates	No
	Legal Documents	No
	Device Identifiers	No
	Web URLs	No
	Personal Email Address	No
	Education Records	No
	Military Status	No
	Employment Status	No
	Foreign Activities	No
	Other	No

*23. If the system shares or discloses PII please specify with whom and for what purpose(s):

The information contained in this system will not be shared. Only summary information at aggregate levels will be provided. Information stored in the system may be shared in accordance with the guidance in System of Records Notice 09-25-0200.

24. If the PII in the system is matched against PII in one or more other computer systems, are computer data matching agreement(s) in place?

No

25. Is there a process in place to notify organizations or systems that are dependent upon the PII contained in this system when major changes occur (i.e., revisions to PII, or when the system is replaced)?

No

26. Are individuals notified how their PII is going to be used?

Yes

26a. If yes, please describe the process for allowing individuals to have a choice. If no, please provide an explanation.

A Privacy Act notification statement is included in the CTSA- SMS at the point at which personal information is requested by NIH or provided by an individual.

27. Is there a complaint process in place for individuals who believe their PII has been inappropriately obtained, used, or disclosed, or that the PII is inaccurate?

Yes

27a. If yes, please describe briefly the notification process. If no, please provide an explanation.

Individuals can contact the project at any time to redress their grievances and make any corrections.

Information regarding this process is available in the documentation provided to the participant. The notification procedure is detailed in the System of Record Notice.

28. Are there processes in place for periodic reviews of PII contained in the system to ensure the data’s integrity, availability, accuracy and relevancy?

Yes

28a. If yes, please describe briefly the review process. If no, please provide an explanation.

PII is reviewed biennially as part of the preparation for contacting and interviewing the participants.

29. Are there rules of conduct in place for access to PII on the system?

Yes

Please indicate "Yes," "No," or "N/A" for each category. If yes, briefly state the purpose for each user to have access:

	Users with access to PII	Yes/No/N/A	Purpose
	User	Yes	Project staff members have access to the IIF in order to contact participants.
	Administrators	Yes	Manage Westat resources supporting or included in the CTSA-SMS.
	Developers	Yes	Extract and utilize participant information for phone, mail, and email contacts and other routine information management tasks.
	Contractors	Yes	Westat, a contracted research organization, is conducting the study.
	Other	No

*30. Please describe in detail: (1) The information the agency will collect, maintain, or disseminate (clearly state if the information contained in the system ONLY represents federal contact data); (2) Why and for what purpose the agency will use the information; (3) Explicitly indicate whether the information contains PII; and (4) Whether submission of personal information is voluntary or mandatory:

The CTSA-SMS collects and maintains a variety of information types. Data submitted to NIH in award applications, Non-Competing Continuation Progress Reports (PHS 2590), and other routine award reporting include award numbers, names, professional email addresses, telephone contact information, and NIH commons ID and person ID. In addition to the identifying information used to locate and contact survey participants, the system will store, process, and transmit basic data respondents volunteer regarding employment, education, and demographics. Information in the CTSA-SMS will be used to provide analytical and policy support to NCRR, assisting NIH in making decisions about current CTSA programming, future funding, and other initiatives to improve clinical and translational science. It may also provide information for NIH’s Government Performance and Results Act (GPRA) report. At least one journal article based on the findings will be developed and submitted for publication. Disclosure of personal information is voluntary.

*31. Please describe in detail any processes in place to: (1) Notify and obtain consent from the individuals whose PII is in the system when major changes occur to the system (e.g., disclosure and/or data uses have changed since the notice at the time of the original collection); (2) Notify and obtain consent from individuals regarding what PII is being collected from them; and (3) How the information will be used or shared. (Note: Please describe in what format individuals will be given notice of consent [e.g., written notice, electronic notice, etc.])

The CTSA-SMS will be used only to collect survey data, analyze data, and produce reports for the CTSA evaluation study. The CTSA-SMS will be retired upon conclusion of the study. No major changes to the CTSA-SMS affecting disclosure and/or data use are anticipated. In the unlikely event of future major change to the CTSA-SMS affecting status or use of personally identifiable information (PII), privacy notice of consent is provided in writing or via email to affected individuals.

Notification and consent from individuals for collection of PII is provided in the survey: “Pursuant to 5 CFR 1320.5(b), an agency may not conduct or sponsor, and a person is not required to respond to an information collection unless it displays a valid OMB control number. The OMB control number for this collection is 0348-XXXX.”

Each survey is preceded by a message to the individual which specifies why the information is being collected and how it will be used (i.e., The NIH leadership is interested in learning more about the use of CTSA resources.)

WEBSITE HOSTING PRACTICES

1	Website Hosting Practices

*32. Does the system host a website? (Note: If the system hosts a website, the Website Hosting Practices section is required to be completed regardless of the presence of PII)

Yes

	Please indicate “Yes” or “No” for each type of site below. If the system hosts both Internet and Intranet sites, indicate “Yes” for “Both” only.	Yes/ No	If the system hosts an Internet site, please enter the site URL. Do not enter any URL(s) for Intranet sites.
	Internet	Yes	TBD
	Intranet	Yes
	Both	Yes

33. Does the system host a website that is accessible by the public and does not meet the exceptions listed in OMB M-03-22?

Note: OMB M-03-22 Attachment A, Section III, Subsection C requires agencies to post a privacy policy for websites that are accessible to the public, but provides three exceptions: (1) Websites containing information other than "government information" as defined in OMB Circular A-130; (2) Agency intranet websites that are accessible only by authorized government users (employees, contractors, consultants, fellows, grantees); and (3) National security systems defined at 40 U.S.C. 11103 as exempt from the definition of information technology (see section 202(i) of the E-Government Act.).

Yes

34. If the website does not meet one or more of the exceptions described in Q. 33 (i.e., response to Q. 33 is "Yes"), a website privacy policy statement (consistent with OMB M-03-22 and Title II and III of the E-Government Act) is required. Has a website privacy policy been posted?

Yes

35. If a website privacy policy is required (i.e., response to Q. 34 is “Yes”), is the privacy policy in machine-readable format, such as Platform for Privacy Preferences (P3P)?

Yes

35a. If no, please indicate when the website will be P3P compliant:

36. Does the website employ tracking technologies?

Yes

	Please indicate “Yes”, “No”, or “N/A” for each type of cookie below:	Yes/No/N/A
	Web Bugs	No
	Web Beacons	No
	Session Cookies	Yes
	Persistent Cookies	No
	Other	No

*37. Does the website have any information or pages directed at children under the age of thirteen?

No

37a. If yes, is there a unique privacy policy for the site, and does the unique privacy policy address the process for obtaining parental consent if any information is collected?

38. Does the website collect PII from individuals?

Yes

	Please indicate “Yes” or “No” for each category below:	Yes/No
	Name (for purposes other than contacting federal employees)	Yes
	Date of Birth	No
	SSN	No
	Photographic Identifiers	No
	Driver's License	No
	Biometric Identifiers	No
	Mother's Maiden Name	No
	Vehicle Identifiers	No
	Personal Mailing Address	Yes
	Personal Phone Numbers	Yes
	Medical Records Numbers	No
	Medical Notes	No
	Financial Account Information	No
	Certificates	No
	Legal Documents	No
	Device Identifiers	No
	Web URLs	No
	Personal Email Address	Yes
	Education Records	No
	Military Status	No
	Employment Status	Yes
	Foreign Activities	No
	Other: Employer Name, NIH commons ID, NIH account ID, Job specialty	Yes

39. Are rules of conduct in place for access to PII on the website?

Yes

40. Does the website contain links to sites external to HHS that owns and/or operates the system?

No

40a. If yes, note whether the system provides a disclaimer notice for users that follow external links to websites not owned or operated by HHS.

ADMINISTRATIVE CONTROLS

1	Administrative Controls

Note: This PIA uses the terms “Administrative,” “Technical” and “Physical” to refer to security control questions—terms that are used in several Federal laws when referencing security requirements.

41. Has the system been certified and accredited (C&A)?

No. The system will be authorized in 2010.

41a. If yes, please indicate when the C&A was completed (Note: The C&A date is populated in the System Inventory form via the responsible Security personnel):

41b. If a system requires a C&A and no C&A was completed, is a C&A in progress?

Yes

42. Is there a system security plan for this system?

Yes

43. Is there a contingency (or backup) plan for the system?

Yes

44. Are files backed up regularly?

Yes

45. Are backup files stored offsite?

Yes

46. Are there user manuals for the system?

Yes

47. Have personnel (system owners, managers, operators, contractors and/or program managers) using the system been trained and made aware of their responsibilities for protecting the information being collected and maintained?

Yes

48. If contractors operate or use the system, do the contracts include clauses ensuring adherence to privacy provisions and practices?

Yes

49. Are methods in place to ensure least privilege (i.e., “need to know” and accountability)?

Yes

49a. If yes, please specify method(s):

There are user roles defined for the CTSA-SMS. These roles ensure that access privileges are narrowly defined, and that only those staff members that need certain types of access are granted that access. In addition to limiting functions, physical access controls limit access to the system.

Accountability is assured through strict authentication and authorization and the use of audit logs that exist for applications, systems and network infrastructure components.

*50. Are there policies or guidelines in place with regard to the retention and destruction of PII? (Refer to the C&A package and/or the Records Retention and Destruction section in SORN):

Yes

50a. If yes, please provide some detail about these policies/practices:

CTSA-SMS records are retained and disposed of under the authority of the NIH Records Control Schedule contained in NIH Manual Chapter 1743 "Keeping and Destroying Records" and NARA guidance on electronic information systems.

TECHNICAL CONTROLS

1	Technical Controls

51. Are technical controls in place to minimize the possibility of unauthorized access, use, or dissemination of the data in the system?

Yes

	Please indicate “Yes” or “No” for each category below:	Yes/No
	User Identification	Yes
	Passwords	Yes
	Firewall	Yes
	Virtual Private Network (VPN)	Yes
	Encryption	Yes
	Intrusion Detection System (IDS)	Yes
	Common Access Cards (CAC)	Yes
	Smart Cards	No
	Biometrics	No
	Public Key Infrastructure (PKI)	Yes

52. Is there a process in place to monitor and respond to privacy and/or security incidents?

Yes

52a. If yes, please briefly describe the process:

Westat Systems group is responsible for monitoring and responding to any security incident in collaboration with the CTSA project group. The systems group employs various tools like Snort, regularly scheduled internal and external agency network vulnerability scans etc. to stay on top of any security threat. All privacy and/or security incidents, or suspected incidents, must be reported promptly to the NIH IRT, the NCRR ISSO, and the NCRR Project Officer. Suspected and confirmed incidents are reported and responded to in accordance with DHHS policy and procedures.

PHYSICAL ACCESS

1	Physical Access

53. Are physical access controls in place?

Yes

	Please indicate “Yes” or “No” for each category below:	Yes/No
	Guards	Yes
	Identification Badges	Yes
	Key Cards	Yes
	Cipher Locks	Yes
	Biometrics	No
	Closed Circuit TV (CCTV)	Yes

*54. Briefly describe in detail how the PII will be secured on the system using administrative, technical, and physical controls:

Information will be secured on the system through access controls, personnel security awareness and training, regular auditing of information and information management processes, careful monitoring of a properly accredited CTSA-SMS information system, control of changes to the system, by appropriate planning and testing of configuration management and contingency processes, by ensuring that all users of the CTSA-SMS are properly identified and authorized for access and are aware of and acknowledge the system rules of behavior, by ensuring that any contingency or incident is handled expeditiously, properly maintaining the system and regulating the environment it operates in, by controlling media, by evaluating risks and planning for information management and information system operations, by ensuring that the system and any exchange of information is protected, by maintaining the confidentiality and integrity of the CTSA-SMS, and by adhering to the requirements established in the contract and statement of work.

APPROVAL/DEMOTION

1	System Information

System Name:

2	PIA Reviewer Approval/Promotion or Demotion

Promotion/Demotion:

Comments:

Approval/Demotion Point of Contact:

Date:

3	Senior Official for Privacy Approval/Promotion or Demotion

Promotion/Demotion:

Comments:

4	OPDIV Senior Official for Privacy or Designee Approval

Please print the PIA and obtain the endorsement of the reviewing official below. Once the signature has been collected, retain a hard copy for the OPDIV's records. Submitting the PIA will indicate the reviewing official has endorsed it

This PIA has been reviewed and endorsed by the OPDIV Senior Official for Privacy or Designee (Name and Date):

Name: __________________________________ Date: ________________________________________

	Name:
	Date:

5	Department Approval to Publish to the Web

Approved for web publishing
Date Published:
Publicly posted PIA URL or no PIA URL explanation:

PIA % COMPLETE

1	PIA Completion

PIA Percentage Complete:

PIA Missing Fields: