[ATSDR] Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0923-22BJ Symptom Diary	Form and Instruction	Unchanged	Available
Form 0923-22BJ Child 3-6 Symptom Diary	Form and Instruction	Unchanged	Repair queued
Form 0923-22BJ Child Follow-up Survey	Form and Instruction	Unchanged	Available
Form 0923-22BJ Child 3-6 Follow-up Survey Online	Form and Instruction	Unchanged	Repair queued
Form 0923-22BJ Child Follow-up Survey	Form and Instruction	Unchanged	Available
Form 0923-22BJ Child 3-6 Follow-up Survey Paper	Form and Instruction	Unchanged	Repair queued
Form 0923-22BJ Child Initial Survey	Form and Instruction	Unchanged	Available
Form 0923-22BJ Child 3-6 Initial Survey	Form and Instruction	Unchanged	Repair queued
Form 0923-22BJ Symptom Diary	Form and Instruction	Unchanged	Available
Form 0923-22BJ Child 7-17 Symptom Diary	Form and Instruction	Unchanged	Repair queued
Form 0923-0064 Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses Child (< 18 years of age) Follow-up	Form and Instruction	Modified	Available
Form 0923-0064 Appx D _Child Follow-up Survey REDCap (Online)	Form and Instruction	Modified	Repair queued
Form 0923-0064 Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses Child (< 18 years of age) Follow-up	Form and Instruction	Modified	Available
Form 0923-0064 Appx D_ Follow-up Child Survey (Word)	Form and Instruction	Modified	Repair queued
Form 0923-0064 Parental Permission Form (<18 years of age), Child Assent Form (7 to <18 years), and Initial Child Survey (<18 years of age)	Form and Instruction	Modified	Available
Form 0923-0064 Appx B_ Parental Permission, Child Assent, and Initial Survey (paper) – Child 7-17 Initial Survey	Form and Instruction	Modified	Repair queued
Form 0923-22BJ Symptom Diary	Form and Instruction	Unchanged	Available
Form 0923-22BJ Adult Symptom Diary	Form and Instruction	Unchanged	Repair queued
Form 0923-0064 Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses Adult (≥ 18 years of age) Follow-up	Form and Instruction	Modified	Available
Form 0923-0064 Appx C_ Adult Follow-up Survey Online	Form and Instruction	Modified	Available
Form 0923-0064 Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses Adult (≥ 18 years of age) Follow-up	Form and Instruction	Modified	Available
Form 0923-0064 Appx C _Follow-up Adult Survey (Word)	Form and Instruction	Modified	Repair queued
Form 0923-0064 Consent to Take Part in a Research Study and Initial Survey (Adult ≥ 18 years of age)	Form and Instruction	Modified	Available
Form 0923-0064 Appx A _Adult Initial Survey & Consent	Form and Instruction	Modified	Repair queued
0923-0064 Change Request Justification 20221208.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2022-12-13	Repair queued
1 - 2 SSB_PFAS and Viral Infections_20220729.docx	Supporting Statement B	Uploaded 2022-08-01	Repair queued
1 - 1 SSA_PFAS Viral Infections_20220729.docx	Supporting Statement A	Uploaded 2022-08-01	Available
1 - 3 List of Attachments_20220729.docx	Supplementary Document	Uploaded 2022-08-01	Available
Protocol_PFAS Viral Infections_20220729.docx	Supplementary Document	Uploaded 2022-08-01	Repair queued
P_ApndxL_NonResponseMessage_11092021.docx	Supplementary Document	Uploaded 2022-01-07	Repair queued
P_ApndxK_PrivacyActStmnt_11092021.docx	Supplementary Document	Uploaded 2022-01-07	Available
P_ApndxJ_ChldAssntCopy.docx	Supplementary Document	Uploaded 2022-12-14	Repair queued
P_ApndxI_PrntlPrmssnCopy.docx	Supplementary Document	Uploaded 2022-12-13	Repair queued
P_ApndxH_AdltCnsntCopy.docx	Supplementary Document	Uploaded 2022-12-13	Available
P_ApndxG2_RcrtmntCmms.docx	Supplementary Document	Uploaded 2022-12-14	Available
P_ApndxG1_PEATTCoverLttr_20220729.docx	Supplementary Document	Uploaded 2022-08-01	Repair queued
P_ApndxG_RcrtmntLttr.docx	Supplementary Document	Uploaded 2022-12-14	Repair queued
P_ApndxF_SmmryImmuneEffcts_06202022.docx	Supplementary Document	Uploaded 2022-08-01	Available
AttG_DataMngmtPlan_STARS Summary.docx	Supplementary Document	Uploaded 2022-01-07	Available
AttF_Data Use Agreement Template_01042022.pdf	Supplementary Document	Uploaded 2022-01-07	Repair queued
AttE_MOP_PFAS Viral Infections_01042022.docx	Supplementary Document	Uploaded 2022-01-07	Available
1 - AttD_IRB approval.docx	Supplementary Document	Uploaded 2022-01-07	Repair queued
AttC_PIA CPO signed.pdf	Supplementary Document	Uploaded 2022-08-01	Available
1 - AttB1_60D PblcCmmntsAgncyRespns.docx	Supplementary Document	Uploaded 2022-01-07	Available
1 - AttB_60D FRN PFAS Viral Infection.pdf	Supplementary Document	Uploaded 2022-01-07	Available
1 - AttA_Authorizing Legislation.docx	Supplementary Document	Uploaded 2022-01-07	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
251063	Child 3-6 Symptom Diary	Form and Instruction	Unchanged	Symptom Diary
251063	Child 3-6 Symptom Diary	Form and Instruction	Unchanged
251062	Child 3-6 Follow-up Survey Online	Form and Instruction	Unchanged	Child Follow-up Survey
251062	Child 3-6 Follow-up Survey Online	Form and Instruction	Unchanged
251061	Child 3-6 Follow-up Survey Paper	Form and Instruction	Unchanged	Child Follow-up Survey
251061	Child 3-6 Follow-up Survey Paper	Form and Instruction	Unchanged
251060	Child 3-6 Initial Survey	Form and Instruction	Unchanged	Child Initial Survey
251060	Child 3-6 Initial Survey	Form and Instruction	Unchanged
251059	Child 7-17 Symptom Diary	Form and Instruction	Unchanged	Symptom Diary
251059	Child 7-17 Symptom Diary	Form and Instruction	Unchanged
251058	Appx D _Child Follow-up Survey REDCap (Online)	Form and Instruction	Modified	Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses Child (< 18 years of age) Follow-up
251058	Appx D _Child Follow-up Survey REDCap (Online)	Form and Instruction	Modified
251057	Appx D_ Follow-up Child Survey (Word)	Form and Instruction	Modified	Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses Child (< 18 years of age) Follow-up
251057	Appx D_ Follow-up Child Survey (Word)	Form and Instruction	Modified
251056	Appx B_ Parental Permission, Child Assent, and Initial Survey (paper) – Child 7-17 Initial Survey	Form and Instruction	Modified	Parental Permission Form (<18 years of age), Child Assent Form (7 to <18 years), and Initial Child Survey (<18 years of age)
251056	Appx B_ Parental Permission, Child Assent, and Initial Survey (paper) – Child 7-17 Initial Survey	Form and Instruction	Modified
251055	Adult Symptom Diary	Form and Instruction	Unchanged	Symptom Diary
251055	Adult Symptom Diary	Form and Instruction	Unchanged
251054	Appx C_ Adult Follow-up Survey Online	Form and Instruction	Modified	Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses Adult (≥ 18 years of age) Follow-up
251054	Appx C_ Adult Follow-up Survey Online	Form and Instruction	Modified
251053	Appx C _Follow-up Adult Survey (Word)	Form and Instruction	Modified	Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses Adult (≥ 18 years of age) Follow-up
251053	Appx C _Follow-up Adult Survey (Word)	Form and Instruction	Modified
251052	Appx A _Adult Initial Survey & Consent	Form and Instruction	Modified	Consent to Take Part in a Research Study and Initial Survey (Adult ≥ 18 years of age)
251052	Appx A _Adult Initial Survey & Consent	Form and Instruction	Modified

ICR Details

OMB Control No: 0923-0064	ICR Reference No: 202212-0923-001
Status: Historical Active	Previous ICR Reference No: 202208-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-0064-23BK
Title: [ATSDR] Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/03/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/15/2022
Terms of Clearance: Previous terms continue: We appreciate ATSDR's agreement to include a non-substantive change if ATSDR adds an additional question about a second flu shot.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2025	09/30/2025	09/30/2025
Responses	9,510	0	9,510
Time Burden (Hours)	9,908	0	9,908
Cost Burden (Dollars)	0	0	0

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Abstract: Minor changes have been made to multiple forms and the body of the protocol. The protocol itself has had no changes since OMB approval. The changes in the appendices are largely minor (e.g., dates to align when the study will actually start). These changes are documented below, along with justifications. We are not asking for any changes to the number of annual responses, or the number of burden hours requested. This study will assess the association between serum-PFAS levels and self-reported frequency of various groups of symptoms of viral infection (as a marker for susceptibility to viral infections). ATSDR will collect information through 5 surveys administered quarterly over the course of a year. Participants (anticipated n=4,075) will be asked about symptoms prospectively, as well as COVID information prospectively and retrospectively. Survey data will be linked to serum-PFAS levels that have been previously collected for ATSDR PFAS cohorts via survival analysis.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 17600	04/05/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 974	01/07/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 12

table that charts list of burden

IC Title	Form No.	Form Name
Adult Symptom Diary	0923-22BJ	Symptom Diary
Appx A _Adult Initial Survey & Consent	0923-0064	Consent to Take Part in a Research Study and Initial Survey (Adult ≥ 18 years of age)
Appx B_ Parental Permission, Child Assent, and Initial Survey (paper) – Child 7-17 Initial Survey	0923-0064	Parental Permission Form (<18 years of age), Child Assent Form (7 to <18 years), and Initial Child Survey (<18 years of age)
Appx C _Follow-up Adult Survey (Word)	0923-0064	Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses Adult (≥ 18 years of age) Follow-up
Appx C_ Adult Follow-up Survey Online	0923-0064	Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses Adult (≥ 18 years of age) Follow-up
Appx D _Child Follow-up Survey REDCap (Online)	0923-0064	Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses Child (< 18 years of age) Follow-up
Appx D_ Follow-up Child Survey (Word)	0923-0064	Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses Child (< 18 years of age) Follow-up
Child 3-6 Follow-up Survey Online	0923-22BJ	Child Follow-up Survey
Child 3-6 Follow-up Survey Paper	0923-22BJ	Child Follow-up Survey
Child 3-6 Initial Survey	0923-22BJ	Child Initial Survey
Child 3-6 Symptom Diary	0923-22BJ	Symptom Diary
Child 7-17 Symptom Diary	0923-22BJ	Symptom Diary

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ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	9,510	9,510	0	0	0	0
Annual Time Burden (Hours)	9,908	9,908	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $322,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 12/15/2022

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