[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Pages 7473-7474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02650]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier HHS-0990-0260-60D]


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the Assistant Secretary for Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, the Office of the Secretary, Department of 
Health and Human Services (HHS), announces plans to submit an 
Information Collection Request (ICR), described below, to the Office of 
Management and Budget (OMB). The ICR is for extending the use of the 
approved information collection assigned OMB control number 0990-0260, 
which expires on April 30, 2015. Prior to submitting that ICR to OMB, 
OS seeks comments from the public regarding the burden estimate, below, 
or any other aspect of the ICR.

DATES: Comments on the ICR must be received on or before April 13, 
2015.

ADDRESSES: Submit your comments to 
[email protected] or by calling (202) 690-6162.

FOR FURTHER INFORMATION CONTACT: Information Collection Clearance 
staff, [email protected] or (202) 690-6162.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the document identifier 0990-0260 for 
reference.
    Information Collection Request Title: Protection of Human Subjects: 
Assurance of Compliance with Federal Policy/IRB Review/IRB 
Recordkeeping/Informed Consent/Consent Documentation-Extension--0990-
0260, Assistant Secretary for Health, Office for Human Research 
Protections.
    Abstract: Section 491(a) of Public Law 99-158 states that the 
Secretary of HHS shall by regulation require that each entity applying 
for HHS support (e.g., a grant, contract, or cooperative agreement) to 
conduct research involving human subjects submit to HHS assurances 
satisfactory to the Secretary that it has established an institutional 
review board (IRB) to review the research in order to ensure protection 
of the rights and welfare of the human research subjects. IRBs are 
boards, committees, or groups formally designated by an entity to 
review, approve, and have continuing oversight of research involving 
human subjects.
    Pursuant to the requirement of the Public Law 99-158, HHS 
promulgated regulations at 45 CFR part 46, subpart A, the basic HHS 
Policy for the Protection of Human Subjects. The June 18, 1991 adoption 
of the common Federal Policy (56 FR 28003) by 15 departments and 
agencies implements a recommendation of the President's Commission for 
the Study of Ethical Problems in Medicine and Biomedical and Behavioral 
Research which was established on November 9, 1974, by Public Law 95-
622. The Common Rule is based on HHS regulations at 45 CFR part 46, 
subpart A, the basic HHS Policy for the Protection of Human Subjects.
    Need and Proposed Use of the Information: The information collected 
through the Protection of Human Subjects: Assurance Identification/IRB 
Certification/Declaration of Exemption Form Protection of Human 
Subjects: Assurance of Compliance with Federal Policy/IRB Review/IRB 
Recordkeeping/Informed Consent/Consent Documentation collection 
requirement is the minimum necessary to satisfy the assurance, 
certification, reporting, disclosure, documentation and recordkeeping 
requirements of Section 491(a) of the Public Health Service Act and HHS 
Regulations for the protection of human subjects at 45 CFR part 46.
    Likely Respondents: Research institutions engaged in HHS-conducted 
or --supported research involving human subjects. Institutional use of 
the form is also relied upon by other federal departments and agencies 
that have codified or follow the Federal Policy for the Protection of 
Human Subjects (Common Rule).

                                    Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                      Title                         respondents    responses per   response  (in       hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
.103(b)(4), .109(d)IRB Actions, .116 and .117              6,000            39.3               1         235,980
 Informed Consent...............................                               3
.115(a) IRB Recordkeeping.......................           6,000              15              10         900,000

[[Page 7474]]

 
.103(b)(5) Incident Reporting, .113 Suspension             6,000             0.5           45/60           2,250
 or Termination Reporting.......................
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............       1,138,230
----------------------------------------------------------------------------------------------------------------

    OS specifically requests comments on (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.

Darius Taylor,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2015-02650 Filed 2-9-15; 8:45 am]
BILLING CODE 4150-36-P