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 Department of Health and Human Services [Document Identifier: OS-0990-0260]
 AGENCY: Office of the Secretary, HHS.
 ACTION: Notice.
 SUMMARY: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
 DATES: Comments on the ICR must be received on or before July 26, 2021.
 ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        *www.reginfo.gov/​public/​do/​PRAMain.*
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
 FOR FURTHER INFORMATION CONTACT: *Sherrette.Funn@hhs.gov*
                         or (202) 795-7714. When submitting comments or requesting information, please include the document identifier 0990-0260 and project title for reference.


SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. *Title of the Collection:*
                     Protection of Human Subjects: Assurance of Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent Documentation. *Type of Collection:*
                     Extension with change. OMB No. 0990-0260 Office of the Assistant Secretary for Health, Office for Human Research Protections. *Abstract:*
                     The Office of the Assistant Secretary for Health, Office for Human Research Protections is requesting a three-year extension of the Protection of Human Subjects: Assurance of Compliance with Federal Policy/IRB 
                    ( print page 33320)
                    Review/IRB Recordkeeping/Informed Consent/Consent Documentation, OMB No. 0990-0260. Information reported to the Federal departments and agencies under the Common Rule with respect to a satisfactory assurance is used to ensure that an institution engaged in non-exempt research involving human subjects conducted or supported by a Common Rule department or agency has (1) established adequate administrative policies and procedures for protecting the rights and welfare of human subjects in research, and (2) accepts that responsibility. Other reporting requirements are used to: Assess whether the institution is following the established procedures; ensure that Federal funds are not expended for unapproved human subjects research; and, determine if the approved status of an awarded grant, contract, or cooperative agreement should be reviewed, with the ultimate goal of maintaining or increasing human subject protections. *Likely Respondents:*
                     Institutions, institutional review boards and investigators. Table 1—Estimated Annual Reporting Burden
Common rule provision
Number of 
                             respondents
Number of 
                             responses per respondent
Total annual responses
Average 
                             burden per  
                             response
Total hours.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113 [2018 Requirements]—Incident Reporting, Suspension or Termination of IRB approval Reporting
5,200
1
5,200
1
5,200Total


5,200

5,200
 Table 2—Estimated Annual IRB Recordkeeping Burden
Common rule provision
Number of 
                             respondents
Number of 
                             responses per respondent
Total annual responses
Average 
                             burden per  
                             response
Total hours.115 [Pre-2018 and 2018 Requirement]—Preparation and documentation of IRB activities
6,000
16
96,000
12
1,152,000Total
6,000

96,000

1,152,000
 Table 3—Estimated Annual Third-Party Disclosure Burden
Number of 
                             respondents
Number of disclosures per respondent
Total annual disclosures
Average 
                             burden per  
                             disclosure
Total hours.109(d) [Pre-2018 and 2018 Requirements]—Written notification of IRB approval or disapproval of research
6,000
25
150,000
0.5
75,000.46.116(a) and (b) (Pre-2018 Requirements)/.46.116 (b), (c) and (d) [2018 Requirements]—Elements of informed consent and broad consent
6,000
25
150,000
0.5
75,000.46.116(h)—[2018 Requirements]—Posting clinical trial consent form
100
3
300
0.5
150.117(a) [Pre-2018 and 2018 Requirements]—Documentation of informed consent
6,000
25
150,000
0.5
75,000.117(c)(2) [Pre-2018 and 2018 Requirements]—Written statement about the research when informed consent documentation is waived
6,000
10
60,000
1
60,000Total


510,300

285,150
 Sherrette A. Funn, Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary.


[FR Doc. 2021-13211 Filed 6-23-21; 8:45 am] BILLING CODE 4150-36-P