View Information Collection Request (ICR) Package
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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:
0925-0601
ICR Reference No:
201907-0925-003
Status:
Historical Active
Previous ICR Reference No:
201605-0925-003
Agency/Subagency:
HHS/NIH
Agency Tracking No:
19378
Title:
Human Embryonic Stem Cell Line (OD)
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
10/10/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/24/2019
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2022
36 Months From Approved
10/31/2019
Responses
15
0
150
Time Burden (Hours)
255
0
2,550
Cost Burden (Dollars)
0
0
0
Abstract:
This is an extension of 0925-0601, Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research. Executive Order (EO) 13505 states that NIH may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research. The NIH Guidelines for Human Stem Cell Research (Guidelines), implementing the EO, established an NIH Registry of eligible hESC lines that comply with the set of standards described in the Guidelines. The Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research will continue to be used by respondents who have hESC lines and wish for the lines to be approved for use in NIH funded research.
Authorizing Statute(s):
EO: EO 13505 Name/Subject of EO: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells
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
60-day Notice:
Federal Register Citation:
Citation Date:
84 FR 22153
05/16/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 35401
07/23/2019
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Form 2890-Stem Cell
1
Form 2890
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
15
150
0
-135
0
0
Annual Time Burden (Hours)
255
2,550
0
-2,295
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
This an extension even though the number of responses have been reduced substantially. Program indicates that through Form 2890, NIH receives information from institutions about human embryonic stem cell lines that they have derived. NIH then determines whether the embryo donation consent process meets the strict requirements in NIH policy for use of the cell lines by NIH-funded investigators. NIH does not fund the derivation of the cell lines and has no involvement in the decisions that institutions make regarding derivation of new cell lines. In recent years, there have been fewer submissions to NIH about newly derived cell lines.
Annual Cost to Federal Government:
$26,117
Does this IC contain surveys, censuses, or employ statistical methods?
No
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.
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:
Mikia Currie 3014350941
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:
07/24/2019
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