Protection of Human Subjects: Common Rule (56 FR 28003)

ICR 201203-0990-003

OMB: 0990-0260

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2012-03-28
ICR Details
0990-0260 201203-0990-003
Historical Active 200812-0990-001
HHS/HHSDM
Protection of Human Subjects: Common Rule (56 FR 28003)
Extension without change of a currently approved collection   No
Regular
Approved without change 04/27/2012
Retrieve Notice of Action (NOA) 03/28/2012
  Inventory as of this Action Requested Previously Approved
04/30/2015 36 Months From Approved 04/30/2012
328,980 0 328,980
1,138,230 0 1,138,230
0 0 0

The Common Rule (56 FR 27003) establishes Federal policy for the protection of human subjects of Federally conducted or sponsored research. The common rule, published in 1991, requires applicant and awardee institutions to establish procedures to report, disclose and maintain required informaiton including informed consent and assurance of the establishment of an Institutional Review Board.

PL: Pub.L. 99 - 158 491(a) Name of Law: Protection of Human Rights
   US Code: 42 USC 289 Name of Law: IRB
   EO: EO 12333 Name/Subject of EO: Common Rule
  
None

Not associated with rulemaking

  77 FR 4819 01/31/2012
77 FR 18820 03/28/2012
No

  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 328,980 328,980 0 0 0 0
Annual Time Burden (Hours) 1,138,230 1,138,230 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,992,000
No
No
No
No
No
Uncollected
Sherrette Funn-Coleman 2026905683

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
03/28/2012


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