Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices 7473 

Certification/Declaration of Exemption 

Form is the minimum necessary to 

satisfy the assurance and certification 

requirements of Section 491 (a) of the 

Public Health Service Act and HHS 

Regulations for the protection of human 

subjects at 45 CFR 46.103. 

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

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Protection of Human Subjects: Assurance Identification/IRB Certification/

Declaration of Exemption ............................................................................. 12,000 2 30/60 12,000 

Total .......................................................................................................... ........................ ........................ ........................ 12,000 

Darius Taylor, 

Information Collection Clearance Officer. 

[FR Doc. 2015–02649 Filed 2–9–15; 8:45 am] 

BILLING CODE 4150–36–P 

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 

Information.CollectionClearance@

hhs.gov or by calling (202) 690–6162. 

FOR FURTHER INFORMATION CONTACT: 

Information Collection Clearance staff, 

Information.CollectionClearance@

hhs.gov 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

Title Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

.103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent .................. 6,000 39.3 

3 

1 235,980 

.115(a) IRB Recordkeeping ............................................................................. 6,000 15 10 900,000 


rljohnson on DSK3VPTVN1PROD with NOTICES
7474 Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued 

Title Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

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

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–15–0821] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (a) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (b) Evaluate the 

accuracy of the agencies estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; (d) Minimize the burden of 

the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and (e) Assess information 

collection costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

CDC Desk Officer, Office of Management 

and Budget, Washington, DC 20503 or 

by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Quarantine Station Illness Response 

Forms: Airline, Maritime, and Land/

Border Crossing (0920–0821, exp. 08/

31/15)—Revision—National Center for 

Emerging and Zoonotic Infectious 

Diseases, Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

CDC is requesting a revision to a 

currently approved information 

collection, Quarantine Station Illness 

Response Forms: Airline, Maritime, and 

Land/Border Crossing). This revision 

seeks to incorporate the changes that 

resulted from activities undertaken 

during the response to Ebola. These 

changes include two major components, 

both of which have been given previous 

emergency clearance by OMB under 

Control Number 0920–1031 and 0920– 

1034, with an expiration date of April 

30, 2015. As a part of this revision, CDC 

is requesting the full three year approval 

and 12 months of burden for the 

following: 

The incorporation of two public 

health screening forms that are currently 

used to assess risk for Ebola in travelers 

coming to the United States from 

countries experiencing widespread 

transmission of the disease. These forms 

are the United States Traveler Health 

Declaration and a completely revised 

Ebola Entry Screening Risk Assessment 

Form, each given approval from OMB 

under OMB Control No 0920–1031. The 

additional burden requested for the 

English versions of the health 

declaration and the risk assessment 

form, as well as the French and Arabic 

translation guides for the health 

declaration and risk assessment forms, 

is 13,664 hours. 

In this revision, CDC is maintaining 

the ability to use the Ebola Entry 

Screening Risk Assessment Form in the 

event that a traveler is identified as ill 

on a U.S.-bound flight prior to arrival. 

In the no material or non-substantive 

change to a currently approved 

collection granted by OMB on 9/18/

2014, CDC requested 100 respondents 

and 5 hours of burden. Because the risk 

assessment form is more 

comprehensive, it requires more time 

for a traveler to complete the 

assessment. CDC is requesting an 

additional 20 hours of burden for the 

purpose of assessing ill travelers, for a 

total of 25 hours of burden. No 

additional respondents are requested. 

CDC is also requesting the 

incorporation of a telephonic, 

automated survey administered through 

the Interactive Voice Response (IVR) 

phone system, which asks travelers if 

they have developed a fever or any other 

symptoms potentially indicative of 

Ebola exposure (OMB Control No 0920– 

1034). The IVR system would be 

implemented to assist state and local 

public health authorities with active 

monitoring of individuals coming to the 

United States from countries affected by 

the current Ebola outbreak. Use of this 

information collection tool would be 

voluntary and provides a cost- and timesaving mechanism for supporting states 

with their active monitoring 

responsibilities. The additional 12- 

month annualized burden requested for 

the use of the IVR system is 

approximately 71,400 hours. 

No revisions are requested to the Air 

Travel, Maritime Conveyance or Land 

Travel Illness and Death Investigation 

forms or burden associated with these 

forms. The current burden associated 

with these routine information 

collections is 314 hours. 


rljohnson on DSK3VPTVN1PROD with NOTICES