Pia

Save

Privacy Impact Assessment Form
v 1.21
Status

Form Number

Form Date

Question

Answer

1

OPDIV:

CDC/ATSDR/OIA/TS

2

PIA Unique Identifier:

TBD

2a Name:

06/02/21

Evaluating the Association between Serum Concentrations of Pe
General Support System (GSS)
Major Application

3

The subject of this PIA is which of the following?

Minor Application (stand-alone)
Minor Application (child)
Electronic Information Collection
Unknown

3a

Identify the Enterprise Performance Lifecycle Phase
of the system.

Development
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 Health Scientist

POC Name

Melanie Buser

POC Organization ATSDR/OIA/TS
POC Email

wyf9@cdc.gov

POC Phone

770-488-3311
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

Page 1 of 8

Save
8c

Briefly explain why security authorization is not
required

The study will use multiple CDC authorized systems for the
collection, storage, and analysis of data.

10

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

N/A

11 Describe the purpose of the system.

In 2019 and 2020, the Agency for Toxic Substances and Disease
Registry (ATSDR) conducted statistically based biomonitoring
PFAS exposure assessments (EAs) in eight communities that
had documented exposures to PFAS in drinking water. ATSDR
also supported two EAs that were designed to test the PFAS
Exposure Assessment Technical Tools (PEATT). PFAS
concentrations were measured in serum collected from EA and
PEATT assessment participants. During the same period,
ATSDR initiated a health study at the Pease International
Tradeport that included measurement of participants’ PFAS
serum concentrations. This follow-up study will recruit
participants from the above studies who have existing PFAS
serum measurements. The proposed study will assess the
association between PFAS serum concentrations and the selfreported frequency of various groups of symptoms of viral
infection (as a marker for susceptibility to viral infection).

The system will collect and maintain the following types of
information:
Participant Info (name, email, mailing address, phone number,
date of birth)
Demographic (age, height, weight, smoking history, relevant
Describe the type of information the system will
underlying medical conditions, etc.)
collect, maintain (store), or share. (Subsequent
12
questions will identify if this information is PII and ask Exposure (work, school, and commuting that increase risk of
exposure to virus; contact with exposed individuals, etc.)
about the specific data elements.)
Symptoms (symptoms, date of onset, testing, etc.)
Internal CDC users will be authenticated by CDC's Active
Directory system. Survey participants will be authenticated by
NCEZID's RedCap survey system. Both systems are CDC
authorized.

Page 2 of 8

Save

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 use surveys to evaluate the association between
serum PFAS concentrations and selected acute viral illnesses. It
will collect the data described above either through paperbased surveys or online using an approved CDC system. These
survey results will be linked to existing serum PFAS measures
that were collected from previous ATSDR-funded studies using
name and date of birth.
Participant information will be used to contact survey
participants, send reminders, confirm the identity of the
participants and to ensure that the data from this study are
correctly linked to the PFAS serum levels collected in a
previous study. Participant information will not be shared
outside of the purposes of this study.
Demographic information and exposure information are
needed as these represent potential confounders in the
association between PFAS serum levels and viral infections.
Symptom information is needed as this provides the main
outcome data for this survey-based study.
Study participants will be members of the public who have
known exposures to PFAS. Identified data from this study will
not be shared. Deidentified demographic, exposure, and
symptom information will be disseminated through abstracts,
professional meeting presentations and manuscripts for
publication in peer reviewed journals.
Yes

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

Indicate the type of PII that the system will collect or
15
maintain.

No
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

demographic info

Exposure

Other...

Symptoms

Other...

Employees
Public Citizens
16

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

Business Partners/Contacts (Federal, state, local agencies)
Vendors/Suppliers/Contractors
Patients
Other

Page 3 of 8

Save
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)

500-4,999
The primary purpose of the PII is for sending participants
access to surveys (either through mailing or email addresses)
and to link survey data to previously collected PFAS serum
levels.
There is no secondary purpose for the PII in the system.

20 Describe the function of the SSN.

N/A

20a Cite the legal authority to use the SSN.

N/A

ATSDR and NCEH are authorized to conduct this study under
the 1980 Comprehensive Environmental Response,
Identify legal authorities governing information use Compensation, and Liability Act (CERCLA), as amended by the
21
1986 Superfund Amendments and Reauthorization Act (SARA)
and disclosure specific to the system and program.
(42 U.S.C. 9601, 9604), and the Public Health Service Act
Section 301 (42 U.S.C. 241) and Section 311 (42 U.S.C. 243),
respectively.
22

Yes

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

No
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.

09-19-0001 Records of Persons Exposed or Poten

Published:
Published:
In Progress

Page 4 of 8

Save
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.

OMB pacakge is currently undergoing review.
Yes

24 Is the PII shared with other organizations?

No
Within HHS
Other Federal
Agency/Agencies
State or Local
Agency/Agencies

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

Private Sector
Describe any agreements in place that authorizes the
information sharing or disclosure (e.g. Computer
Information from this study will not be shared. No information
24b Matching Agreement, Memorandum of
sharing agreements are in place or anticipated.
Understanding (MOU), or Information Sharing
Agreement (ISA)).
24c

Describe the procedures for accounting for
disclosures

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.
26

Is the submission of PII by individuals voluntary or
mandatory?

N/A
Consent packages will be included with the recruitment level
and will notify individuals that their information will be
collected.
Voluntary
Mandatory

Page 5 of 8

Save
Describe the method for individuals to opt-out of the
collection or use of their PII. If there is no option to
Participants may opt-out by declining to participate 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
There is no process to notify and obtain consent from the
28 and/or data uses have changed since the notice at
individuals PII in the system. This PII was already collected
the time of original collection). Alternatively, describe during a previous study.
why they cannot be notified or have their consent
obtained.
Individuals, who believe their PII has been inappropriately
obtained, used, or disclosed, or that the PII is inaccurate,
should contact the point of contact (POC) as identified in the
sign-in sheet and consent form. They will be directed to
Describe the process in place to resolve an
identify the record and specify the information being
individual's concerns when they believe their PII has contested, the corrective action sought, and the reasons for
29 been inappropriately obtained, used, or disclosed, or requesting the correction, along with supporting information
that the PII is inaccurate. If no process exists, explain to show how the record is inaccurate, incomplete, untimely, or
why not.
irrelevant. The POC will make a determination as to the next
steps that should be taken to address the individual's concerns.
If an incident has occurred, the PI will report the potential
incident to the Centers for Disease Control and Prevention
(CDC) Security Incident Response Team and Privacy Officer.
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.

PII was collected during a previous ATSDR-funded study. Upon
enrollment in this follow-up study, individuals will be able to
correct any errors in PII.
Users
Administrators

31

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

Administrators will need to have
access to PII in order to send links to

Developers
Contractors
Others

Describe the procedures in place to determine which The study's principal investigator (PI) determines who will have
32 system users (administrators, developers,
access to PII. The PI will configure the permissions each user
contractors, etc.) may access PII.
will receive for accessing study data.
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.

Only ATSDR project staff will have access to PII during online
data collection. PII will be deleted as soon as the online survey
results are received.

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.

Study staff will complete CDC's annual security awareness
training and sign associated rules of behavior.

Describe training system users receive (above and
35 beyond general security and privacy awareness
training).

Users receive no additional training beyond general security
and privacy awareness training.

Page 6 of 8

Save
Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?
Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.

Yes
No
Records are retained, disposed, stored, handled, and viewed in
accordance with the ATSDR Comprehensive Records Control
Schedule (B-371), GSR 20.2c& d, and GSR 20.6. Current
procedures allow the system manager to keep the records for
20 years unless needed for further study.
The PII in the system is secured using a layered approach with
appropriate administrative, technical, and physical controls,
being implemented.

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

The administrative controls educate system users of their
responsibility to protect PII and legally bind them to do so.
These controls include signed rules of behavior , nondisclosure agreements, CDC privacy and security awareness
training, and records management training. Records are
maintained according to CDC record control policies and
procedures.
The technical controls, implemented by the system, act to
either allow access to system PII data only to approved users or
to make PII data unreadable outside of the system. These
controls include encryption, authentication, firewalls, intrusion
detection systems, and anti-malware systems.
The physical controls, implemented by the system, restrict
access to CDC buildings and areas housing computers used by
this system. These controls include guards, identification
badges, key cards, locked doors, cipher locks, fences, alarms
and closed circuit TV.

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

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

Yes

No

Reviewer
Notes
3

No

Reviewer
Notes
4

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

Yes
No

Page 7 of 8

Save
Reviewer Questions

Answer

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

General Comments

OPDIV Senior Official
for Privacy Signature

Jarell
Oshodi -S

Digitally signed by Jarell
HHS Senior
Oshodi -S
Agency Official
Date: 2021.06.03
for Privacy
12:30:35 -04'00'

Page 8 of 8