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

Forms and Documents

Document Name	Status
Form 0923-22BJ Child 3-6 Symptom Diary Form and Instruction	Unchanged
Form 0923-22BJ Child 3-6 Follow-up Survey Online Form and Instruction	Modified
Form 0923-22BJ Child 3-6 Follow-up Survey Paper Form and Instruction	Unchanged
Form 0923-22BJ Child 3-6 Initial Survey Form and Instruction	Modified
Form 0923-22BJ Child 7-17 Symptom Diary Form and Instruction	Unchanged
Form 0923-22BJ Child 7-17 Follow-up Survey Online Form and Instruction	Modified
Form 0923-22BJ Child 7-17 Follow-up Survey Paper Form and Instruction	Unchanged
Form 0923-22BJ Child 7-17 Initial Survey Form and Instruction	Modified
Form 0923-22BJ Adult Symptom Diary Form and Instruction	Unchanged
Form 0923-22BJ Adult Follow-up Survey Online Form and Instruction	Modified
Form 0923-22BJ Adult Follow-up Survey Paper Form and Instruction	Unchanged
Form 0923-22BJ Adult Initial Survey Form and Instruction	Modified
1 - 2 SSB_PFAS and Viral Infections_20220729.docx Supporting Statement B	2022-08-01
1 - 1 SSA_PFAS Viral Infections_20220729.docx Supporting Statement A	2022-08-01
1 - 3 List of Attachments_20220729.docx Supplementary Document	2022-08-01
Protocol_PFAS Viral Infections_20220729.docx Supplementary Document	2022-08-01
P_ApndxL_NonResponseMessage_11092021.docx Supplementary Document	2022-01-07
P_ApndxK_PrivacyActStmnt_11092021.docx Supplementary Document	2022-01-07
P_ApndxJ_ChldAssentFormCopy_11092021.docx Supplementary Document	2022-01-07
P_ApndxI_ParentalPermissionFormCopy_20220729.docx Supplementary Document	2022-08-01
P_ApndxH_AdltConsentFormCopy_20220729.docx Supplementary Document	2022-08-01
P_ApndxG2_RecruitmentComms_11092021.docx Supplementary Document	2022-01-07
P_ApndxG1_PEATTCoverLttr_20220729.docx Supplementary Document	2022-08-01
P_ApndxG_RecruitmentLetter_11092021.docx Supplementary Document	2022-01-07
P_ApndxF_SmmryImmuneEffcts_06202022.docx Supplementary Document	2022-08-01
AttG_DataMngmtPlan_STARS Summary.docx Supplementary Document	2022-01-07
AttF_Data Use Agreement Template_01042022.pdf Supplementary Document	2022-01-07
AttE_MOP_PFAS Viral Infections_01042022.docx Supplementary Document	2022-01-07
1 - AttD_IRB approval.docx Supplementary Document	2022-01-07
AttC_PIA CPO signed.pdf Supplementary Document	2022-08-01
1 - AttB1_60D PblcCmmntsAgncyRespns.docx Supplementary Document	2022-01-07
1 - AttB_60D FRN PFAS Viral Infection.pdf Supplementary Document	2022-01-07
1 - AttA_Authorizing Legislation.docx Supplementary Document	2022-01-07

IC Document Collections

IC ID	Document Title	Status
251063	Child 3-6 Symptom Diary Form and Instruction	Unchanged
251062	Child 3-6 Follow-up Survey Online Form and Instruction	Modified
251061	Child 3-6 Follow-up Survey Paper Form and Instruction	Unchanged
251060	Child 3-6 Initial Survey Form and Instruction	Modified
251059	Child 7-17 Symptom Diary Form and Instruction	Unchanged
251058	Child 7-17 Follow-up Survey Online Form and Instruction	Modified
251057	Child 7-17 Follow-up Survey Paper Form and Instruction	Unchanged
251056	Child 7-17 Initial Survey Form and Instruction	Modified
251055	Adult Symptom Diary Form and Instruction	Unchanged
251054	Adult Follow-up Survey Online Form and Instruction	Modified
251053	Adult Follow-up Survey Paper Form and Instruction	Unchanged
251052	Adult Initial Survey Form and Instruction	Modified

ICR Details

OMB Control No:	ICR Reference No: 202208-0923-001
Status: Received in OIRA	Previous ICR Reference No: 202112-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-22BJ
Title: 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: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/02/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	9,510	0
Time Burden (Hours)	9,908	0
Cost Burden (Dollars)	0	0

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Abstract: 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

IC Title	Form No.	Form Name
Adult Follow-up Survey Online	0923-22BJ	Adult Follow-up Survey RedCap
Adult Follow-up Survey Paper	0923-22BJ	Adult Follow-up Survey
Adult Initial Survey	0923-22BJ	Adult Initial Survey
Adult Symptom Diary	0923-22BJ	Symptom Diary
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 Follow-up Survey Online	0923-22BJ	Child Follow-up Survey
Child 7-17 Follow-up Survey Paper	0923-22BJ	Child Follow-up Survey
Child 7-17 Initial Survey	0923-22BJ	Child Initial Survey
Child 7-17 Symptom Diary	0923-22BJ	Symptom Diary

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ICR Summary of Burden

	Total Request	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	0	0	9,510	0	0
Annual Time Burden (Hours)	9,908	0	0	9,908	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a New collection.

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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: 08/02/2022

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