View Information Collection Request (ICR) Package
Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
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:
0990-0473
ICR Reference No:
202303-0990-001
Status:
Active
Previous ICR Reference No:
202004-0990-004
Agency/Subagency:
HHS/HHSDM
Agency Tracking No:
Title:
Subpart C Research Certification Form
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/12/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/26/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2026
36 Months From Approved
10/31/2023
Responses
65
0
80
Time Burden (Hours)
65
0
80
Cost Burden (Dollars)
0
0
0
Abstract:
The Office for Human Research Protections (OHRP) is requesting a three-year extension of OMB No. 0990-0473, the HHS Subpart C Research Certification Form, currently approved through July 31, 2023. This information collection request includes three new information elements (Name(s) of Institutions Relying on the IRB of Record; Program Officer’s Email Address; and the IRB Determination Regarding the Risk Level of the Study) and clarification in two information elements (Name and address of the IRB of Record Institution; and Contact information for the IRB of record) on the current Subpart C Research Certification Form. The purpose of the Subpart C Research Certification Form is to provide a simplified, standardized procedure for institutions to submit subpart C research certifications to OHRP in order to meet the regulatory requirements for including prisoners in non-exempt human subjects research that is conducted or supported by HHS. The form also simplifies the internal process used by OHRP to review and record such certifications, resulting in faster processing while reducing unnecessary and burdensome staff time. Respondents for this information collection are institutions or organizations which operate the IRB of record that approved the research, or the non-institutional IRBs that serve as the IRB of record.
Authorizing Statute(s):
US Code:
42 USC Section 289
Name of Law: Public Health Service Act
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:
88 FR 16275
03/16/2023
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 39855
06/20/2023
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Subpart C Research Certification Form
0990-0473
HHS Subpart C Certification Form
Subpart C Research Certification Form
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
65
80
0
-15
0
0
Annual Time Burden (Hours)
65
80
0
-15
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:
The annual burden estimates changed compared to the current burden estimates. The changes 7 are due to agency adjustments. The total annual burden in the current OMB-approved information collection (eighty hours and $1,392.80, respectively) is projected to be sixty-five hours and $2,681.25, respectively, in this information collection request.
Annual Cost to Federal Government:
$137,701
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.
No
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
Agency Contact:
Irene Stith-Coleman 240 453-8138 irene.stith-coleman@hhs.gov
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:
06/26/2023
Something went wrong when downloading this file. If you have any questions, please send an email to risc@gsa.gov.