Pia

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Privacy Impact Assessment Form
v 1.21
Status

Form Number

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

TBD

2a Name:

02/14/20

Assessment of Potential Exposure from Private Wells for Drinkin
General Support System (GSS)
Major Application

3

Minor Application (stand-alone)

The subject of this PIA is which of the following?

Minor Application (child)
Electronic Information Collection
Unknown

3a

Identify the Enterprise Performance Lifecycle Phase
of the system.

Planning
Yes

3b Is this a FISMA-Reportable system?

4

Does the system include a Website or online
application available to and for the use of the general
public?

5

Identify the operator.

6

Point of Contact (POC):

7

Is this a new or existing system?

8

Does the system have Security Authorization (SA)?

No
Yes
No
Agency
Contractor
POC Title

Environmental Epidemiologist

POC Name

Johnni Daniel

POC Organization DEHSP
POC Email

[email protected]

POC Phone

770-488-3415
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

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8c

Briefly explain why security authorization is not
required

The exposure study will utilize several CDC authorized systems
for data collection, storage, and processing.

10

Describe in further detail any changes to the system
that have occurred since the last PIA.

N/A
The purpose of this Generic ICR is to respond to state and local
areas that request assistance with assessing potential
exposure to contaminants in drinking water from private wells
in their jurisdiction.

11 Describe the purpose of the system.

An example of a prior study conducted by CDC that has yielded
information used to reduce exposures is the Navajo study
where NCEH provided technical assistance (OMB approval was
not needed) to assess the health risks associated with drinking
water from various sources used by the Navajo Nation
(2007-2011). The investigation identified contaminants,
including uranium, in these drinking water sources. Based on
this information, the Navajo Nation Environmental Protection
Agency (NNEPA) and Navajo Nation Division of Health
(NNDOH) collaborated to develop a consumer awareness
campaign to help people understand sources of drinking water
contamination, learn where to get safe drinking water, and
learn how to protect the quality of water stored at home.
Having a generic mechanism in place will facilitate a faster
processing and clearance of information collection approvals
requested by NCEH and partners.
This is an extension GenICR which is needed to continue the
work conducted during the original ICR approval period.
During the approval period, one GenIC has been generated to
respond to three state health department (New Hampshire,
New Mexico, and Connecticut) requests in assisting with
assessing potential exposure to arsenic and uranium in
residential private wells used for drinking water.

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The study will collect, maintain, and store the information
below:
Participant Contact Information (name, mailing address, email,
phone number)
De-identified Demographic Data (date of birth, sex, height,
weight)
Laboratory Results (creatinine concentrations in urine, arsenic
and uranium in urine, arsenic and uranium in water)
Surveys (diet, drinking water, bathing, employment, lifestyle
factors, and recreational activities)
Other (StudyID)

Describe the type of information the system will
collect, maintain (store), or share. (Subsequent
12
questions will identify if this information is PII and ask All information in the system will be stored for at least six years,
about the specific data elements.)
but no longer than ten years after the end of the study
depending on the program need for scientific, legal or business
reference.
The study will be sharing de-identified data with the
requesting agency in areas in which the study is being
conducted. The requesting agency will use the data to support
response activities.
Users will be authenticated via CDC's Secure Access
Management System (SAMS) and CDC's Active Directory (AD).
SAMS and AD are both authorized CDC information systems.

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Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.

The study will enroll participants with potential exposure to
drinking water contaminants in private wells. Participants will
be members of the general public in affected areas that are at
least 18 years of age, use private wells for drinking water,
willing to receive and return a tap water sampling kit and urine
specimen kit or to provide a blood specimen, and willing to
answer survey questions. They will be enrolled from the
geographic area of concern as defined by the requesting
agency. The types of information that will be collected and
maintained about these participants are participant contact
information, demographic information, laboratory results,
surveys and study ID. Any information shared about the
participants with the requesting agency or other external
entities will be de-identified. Information in the system will be
regularly retrieved by the participant's name when participants
contact the study for follow up appointments, at those
appointments, or for the status of their labs.
Users will be authenticated via CDC's Secure Access
Management System (SAMS) and CDC's Active Directory (AD).
SAMS and AD are both authorized CDC information systems.
The study will collect, maintain, and store the information
below:
Participant Contact Information (name, mailing address, email,
phone number)
De-identified Demographic Data (date of birth, sex, height,
weight)
Laboratory Results (creatinine concentrations in urine, arsenic
and uranium in urine, arsenic and uranium in water)
Surveys (diet, drinking water, bathing, employment, lifestyle
factors, and recreational activities)
Other (StudyID)

14 Does the system collect, maintain, use or share PII?

Yes
No

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15

Indicate the type of PII that the system will collect or
maintain.

Social Security Number

Date of Birth

Name

Photographic Identifiers

Driver's License Number

Biometric Identifiers

Mother's Maiden Name

Vehicle Identifiers

E-Mail Address

Mailing Address

Phone Numbers

Medical Records Number

Medical Notes

Financial Account Info

Certificates

Legal Documents

Education Records

Device Identifiers

Military Status

Employment Status

Foreign Activities

Passport Number

Taxpayer ID

Other...

Surveys

Other...

Lab results included in
medical notes

Other...

Employees
Public Citizens
16

Business Partners/Contacts (Federal, state, local agencies)

Indicate the categories of individuals about whom PII
is collected, maintained or shared.

Vendors/Suppliers/Contractors
Patients
Other

17 How many individuals' PII is in the system?

18 For what primary purpose is the PII used?

19

Describe the secondary uses for which the PII will be
used (e.g. testing, training or research)

100-499
To contact study participants with reminders and information
about the study, for the informed consent process and to send
participants' their lab testing results.
None

20 Describe the function of the SSN.

The study will not collect, store, or share SSN.

20a Cite the legal authority to use the SSN.

NA

21

Identify legal authorities governing information use Public Health Service Act, Section 301, “Research and
and disclosure specific to the system and program.
investigation,” (42 U.S.C. 241)

22

Are records on the system retrieved by one or more
PII data elements?

Yes
No

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Published:
Identify the number and title of the Privacy Act
System of Records Notice (SORN) that is being used
22a
to cover the system or identify if a SORN is being
developed.

SORN 09-20-0136 “Epidemiologic Studies and Su

Published:
Published:
In Progress
Directly from an individual about whom the
information pertains
In-Person
Hard Copy: Mail/Fax
Email
Online
Other
Government Sources

23

Within the OPDIV
Other HHS OPDIV
State/Local/Tribal
Foreign
Other Federal Entities
Other

Identify the sources of PII in the system.

Non-Government Sources
Members of the Public
Commercial Data Broker
Public Media/Internet
Private Sector
Other
23a

Identify the OMB information collection approval
number and expiration date.

24 Is the PII shared with other organizations?

0920-1173 and 03/31/2020
Yes
No
Within HHS

Identify with whom the PII is shared or disclosed and
24a
for what purpose.

Other Federal
Agency/Agencies
State or Local
Agency/Agencies
Private Sector

Describe any agreements in place that authorizes the
information sharing or disclosure (e.g. Computer
24b Matching Agreement, Memorandum of
Understanding (MOU), or Information Sharing
Agreement (ISA)).

De-identified information will be shared with requesting
agencies.
As part of the required "Data Management Plan," if sharing is
required NCEH will share data sets with external entities via
data use agreements (DUA) with each data recipient.

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Describe the procedures for accounting for
24c
disclosures

Procedures for accounting for disclosures are detailed in the
study's manual of procedures. Typically, this will be a manual
process where the program keeps track of disclosures in a
spreadsheet.

Describe the process in place to notify individuals
25 that their personal information will be collected. If
no prior notice is given, explain the reason.

Participants sign a consent form on order to participate in the
study. The consent form notifies the individual that their
information will be collected, for what purpose, and
information they will receive back from the study.

26

Voluntary

Is the submission of PII by individuals voluntary or
mandatory?

Mandatory

Describe the method for individuals to opt-out of the
collection or use of their PII. If there is no option to
Individuals who wish to opt out may decline taking part in the
27
object to the information collection, provide a
study.
reason.
Describe the process to notify and obtain consent
from the individuals whose PII is in the system when
major changes occur to the system (e.g., disclosure
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe
why they cannot be notified or have their consent
obtained.

NCEH will contact the study principal investigator (PI) (per
consent form) via email, telephone, and/or mail when major
changes to the study occur to obtain consent from the study
participants.
Individuals that have a concern that their PII has been
inappropriately used, obtained, or disclosed, OR that their PII is
inaccurate should contact the study PI and data manager using
contact information in the study’s SORN or consent form.

Describe the process in place to resolve an
individual's concerns when they believe their PII has
29 been inappropriately obtained, used, or disclosed, or
that the PII is inaccurate. If no process exists, explain
why not.

Describe the process in place for periodic reviews of
PII contained in the system to ensure the data's
30
integrity, availability, accuracy and relevancy. If no
processes are in place, explain why not.

31

Identify who will have access to the PII in the system
and the reason why they require access.

The individual may be directed to contact the PI or data
manager to identify the record and specify the information
being contested, the corrective action sought, and the reasons
for requesting the correction, along with supporting
information to show how the record is inaccurate, incomplete,
untimely, or irrelevant. If an incident has occurred, the PI or
data manager will report the potential incident to the CDC
Security Incident Response Team and the Privacy Officer. The
data manager will serve as the POC to resolve the individual's
concerns.
There is no process in place for periodic reviews of the PII.
Once laboratory results are reported to the study participants,
data will be de-identified and used for analysis.
Users

To contact study participants during
study activities and to provide

Administrators

To provide access to users as needed.

Developers
Contractors
Others

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Describe the procedures in place to determine which
The study PI will determine the level of access for each user
32 system users (administrators, developers,
depending on their role in the study.
contractors, etc.) may access PII.
Describe the methods in place to allow those with
33 access to PII to only access the minimum amount of
information necessary to perform their job.
Identify training and awareness provided to
personnel (system owners, managers, operators,
contractors and/or program managers) using the
34
system to make them aware of their responsibilities
for protecting the information being collected and
maintained.
Describe training system users receive (above and
35 beyond general security and privacy awareness
training).

Due to the small number of study participants, all users with
access to PII will have access to all study participants' PII.

Study staff will all go through annual security awareness
training.

We will provide instructions to users about how to manage
data security and privacy protections and will require all study
staff and direct contractors to receive training on their roles
and responsibilities, as outlined in the study's Manual of
Procedures. The study's Rules of Behavior will be signed and
reviewed by all research staff.

Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?

Yes
No

Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.

Retention and destruction of PII in the study is determined
using Records Control Schedule CDC RG-0442, Scientific and
Research Project Records, Minor Research Records
Authorized Disposition: Maintain at least six years, but no
longer than ten years after the retirement of the system
depending on the program need for scientific, legal or business
reference, then delete/destroy.

Describe, briefly but with specificity, how the PII will
38 be secured in the system using administrative,
technical, and physical controls.

PII will be secured using the following administrative controls:
Rules of Behavior, Manual of Procedures, NDAs, and DUAs.
PII will be secured using the following technical controls: file
level and whole disk encryption, e-Auth Level 3, and access
control lists in multiple authorized CDC IT systems.
PII will be secured using the following physical controls:
controlled physical access, guards, key card access, and locked
rooms.

REVIEWER QUESTIONS: The following section contains Reviewer Questions which are not to be filled out unless the user is an OPDIV
Senior Officer for Privacy.

Reviewer Questions
1

Are the questions on the PIA answered correctly, accurately, and completely?

Answer
Yes
No

Reviewer
Notes
2

Does the PIA appropriately communicate the purpose of PII in the system and is the purpose
justified by appropriate legal authorities?

Yes
No

Reviewer
Notes

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Reviewer Questions
3

Do system owners demonstrate appropriate understanding of the impact of the PII in the
system and provide sufficient oversight to employees and contractors?

Answer
Yes
No

Reviewer
Notes
4

Does the PIA appropriately describe the PII quality and integrity of the data?

Yes
No

Reviewer
Notes
5

Is this a candidate for PII minimization?

Yes
No

Reviewer
Notes
6

Does the PIA accurately identify data retention procedures and records retention schedules?

Yes
No

Reviewer
Notes
7

Are the individuals whose PII is in the system provided appropriate participation?

Yes
No

Reviewer
Notes
8

Does the PIA raise any concerns about the security of the PII?

Yes
No

Reviewer
Notes
9

Is applicability of the Privacy Act captured correctly and is a SORN published or does it need
to be?

Yes
No

Reviewer
Notes
10

Is the PII appropriately limited for use internally and with third parties?

Yes
No

Reviewer
Notes
11

Does the PIA demonstrate compliance with all Web privacy requirements?

Yes
No

Reviewer
Notes
12

Were any changes made to the system because of the completion of this PIA?

Yes
No

Reviewer
Notes

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General Comments

OPDIV Senior Official
for Privacy Signature

Jarell
Oshodi -S

Digitally signed by Jarell
HHS Senior
Oshodi -S
Agency Official
Date: 2020.02.25
for Privacy
16:50:25 -05'00'

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