View Information Collection Request (ICR) Package
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Burden
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Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0923-0044
ICR Reference No:
201407-0923-001
Status:
Historical Active
Previous ICR Reference No:
201309-0923-001
Agency/Subagency:
HHS/TSDR
Agency Tracking No:
20576
Title:
Biomonitoring of Great Lakes Populations Program
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:
08/28/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/19/2014
Terms of Clearance:
Prior terms of clearance apply.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2015
10/31/2015
10/31/2015
Responses
7,981
0
7,906
Time Burden (Hours)
1,025
0
1,000
Cost Burden (Dollars)
0
0
0
Abstract:
We are requesting approval to re-contact, re-screen, and re-collect blood and urine specimens and questionnaire responses for 25 previously enrolled study participants (shoreline anglers) attributed to the Detroit River area. During the analysis of serum samples, the National Center for Environmental Health Division of Laboratory Sciences informed our program that external contamination of 25 samples collected from these participants occurred due to equipment failure. The reason for repeating the questionnaire and urine sample is to chronologically align information collected on exposure parameters per responses to the questionnaire and the body burden measurements of all analytes.
Authorizing Statute(s):
PL:
Pub.L. 111 - 88 1
Name of Law: Dept of Interior, Environment, and Related Agencies Act of 2010
US Code:
42 USC 9604
Name of Law: CERCLA
US Code:
42 USC 9626
Name of Law: Superfund Act of 1986
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
25
IC Title
Form No.
Form Name
MI Biomonitoring Questionnaire
none
MI Biomonitoring Questionnaire
MI Contact Information Sheet
none
MI Contact Info Sheet
MI Informed Consent
none
MI Consent
MI Scheduling Questionnaire
none
MI Scheduling Questionnaire
MI Screener
none
MI screener
MN Clinic Visit Form
none
MN Clinic Visit
MN Consent
none
MN Consent
MN Contact Information
none
MN Contact Information
MN Participant Questionnaire
none
MN Participant Questionnaire
MN Participation Record
none
MN Participation Record
MN Recruitment Script
none
MN Recruitment Script
MN Refusal Questions
none
MN Refusal Questions
Mi Informed Consent for Repeat Appointments
0923-0044
Att2_MI_Consent 20140724
Michigan Biomonitoring of Great Lakes Populations
0923-0044
Att3_MI_BiomQs_20120619
Michigan Department of Community Health Telephone Questions for Scheduling (repeated appointments)
0923-0044
Att1_MI_PhoneQs 20140724
NY - Network Questions - Burmese
none, none
NY Network Questions - Burmese
,
Network Questions - Burmese translation
NY Consent
none
NY Consent
NY Consent - Burmese
none, none
NY Consent - Burmese
,
NY Consent - Burmese translation
NY Interview - Burmese
none, none
NY Interview - Burmese
,
Interview - Burmese translation
NY Mail-in Screener
none
NY Mail-in Screener
NY Nonresponder Script
none
NY Nonresponder Script
NY Online Screener
none
NY Online Screener
NY Questionnaire
none
NY Questionnaire
NY Responder Script
none
NY Responder Script
NY Screener - Burmese
none, none
NY Screener - Burmese
,
Screener - Burmese translation
ICR Summary 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
7,981
7,906
0
75
0
0
Annual Time Burden (Hours)
1,025
1,000
0
25
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
We are requesting approval to re-contact, re-screen, and re-collect blood and urine specimens, and questionnaire responses for 25 previously enrolled study participants (shoreline anglers) attributed to the Detroit River area. During the analysis of serum samples, the National Center for Environmental Health Division of Laboratory Sciences informed our program that external contamination of 25 samples collected from these participants occurred due to equipment failure. The reason for repeating the questionnaire and urine sample is to chronologically align information collected on exposure parameters per responses to the questionnaire and the body burden measurements of all analytes. We are requesting an increase of 26 burden hours for Year 2 only.
Annual Cost to Federal Government:
$3,800,000
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
Yes
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?
Uncollected
Agency Contact:
Catina Conner 4046394775
Common Form ICR:
No
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:
08/19/2014
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