7472 Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices 

document identifier HHS–OS–0990– 

0390–30D for reference. 

Information Collection Request Title: 

Challenge and Prize Competition 

Solicitations 

Abstract: In 2011, Federal agencies 

including HHS were given prize 

authority for administering challenges 

and competitions. Challenges and 

competitions enable the Assistant 

Secretary for Administration, HHS to 

tap into the expertise and creativity of 

the public in new ways. In order for 

HHS to quickly and effectively launch 

competitions on a continual basis, HHS 

seeks an extension on currently 

approved generic clearance to collect 

information for these challenges and 

competitions, which will generally 

include first name, last name, email, 

city, state and when applicable other 

demographic information. 

The information collected will be 

used to understand whether the 

participant has met the technical 

requirements for the challenge, assist in 

the technical review and judging of the 

solutions that are provided, and 

understand the impact and 

consequences of administering the 

competition and developing solutions 

for submission. Information may be 

collected during the competition or after 

its completion. 

Need and Proposed Use of the 

Information 

Challenges and competitions enable 

HHS to tap into the expertise and 

creativity of the public in new ways. 

HHS has sponsored challenges and 

competitions in a wide variety of areas 

such as recruitment efforts, health data 

applications and other types of data, 

development of novel technologies, and 

communications to increase public 

participation and solicit new ideas on a 

wide array of topics important to the 

agencies mission. HHS’s goal is to 

engage a broader number of 

stakeholders who are inspired to work 

on some of our most pressing health 

issues, thus supporting a new ecosystem 

of scientists, developers, and 

entrepreneurs who can continue to 

innovate for public health. The generic 

clearance is necessary for HHS to 

quickly and effectively launch 

competitions on a continual basis. 

Likely Respondents: Likely 

respondents include individuals, 

businesses, and state and local 

governments who choose to participate 

in a challenge or competition hosted by 

HHS. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Individuals or Households ............................................................................... 1000 1 1/6 166.6 

Organizations ................................................................................................... 1000 1 1/6 166.6 

Businesses ....................................................................................................... 1000 1 1/6 166.6 

State, territory, tribal or local governments ..................................................... 60 1 1/6 10 

Total .......................................................................................................... ........................ ........................ ........................ 510 

Darius Taylor, 

Information Collection Clearance Officer. 

[FR Doc. 2015–02652 Filed 2–9–15; 8:45 am] 

BILLING CODE 4150–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

[Document Identifier HHS–OS–0990–0263– 

30–D] 

Agency Information Collection 

Activities; Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, has submitted an 

Information Collection Request (ICR), 

described below, to the Office of 

Management and Budget (OMB) for 

review and approval. The ICR is for 

renewal of the approved information 

collection assigned OMB control 

number 0990–0263, scheduled to expire 

on March 31, 2015 Comments submitted 

during the first public review of this ICR 

will be provided to OMB. OMB will 

accept further comments from the 

public on this ICR during the review 

and approval period. 

DATES: Comments on the ICR must be 

received on or before March 12, 2015. 

ADDRESSES: Submit your comments to 

OIRA_submission@omb.eop.gov or via 

facsimile to (202) 395–5806. 

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 OMB 

control number 0990–0263 and 

document identifier HHS–OS–30D for 

reference. 

Information Collection Request Title: 

Protection of Human Subjects: 

Assurance Identification/IRB 

Certification/Declaration of Exemption 

Form—Extension OMB No. 0990–0263, 

Assistant Secretary for Health, Office for 

Human Research Protections. 

Abstract: The Office for Human 

Research Protections is requesting a 

three year extension of the Protection of 

Human Subjects: Assurance 

Identification/IRB Certification/

Declaration of Exemption Form. That 

form is designed to promote uniformity 

among departments and agencies, and to 

help ensure common means of 

ascertaining institutional review board 

certifications and other reporting 

requirements relating to the protection 

of human subjects in research. The 

Federal Policy for the Protection of 

Human Subjects, known as the Common 

Rule, requires that before engaging in 

non-exempt human subjects research 

that is conducted or supported by a 

Common Rule department or agency, 

each institution must: (1) Hold an 

applicable assurance of compliance 

[Section 103(a)]; and (2) certify to the 

awarding department or agency that the 

application or proposal for research has 

been reviewed and approved by an IRB 

designated in the assurance [Sections 

103(b) and (f)]. 

Need and Proposed Use of the 

Information: The information collected 

through the Protection of Human 

Subjects: Assurance Identification/IRB 


rljohnson on DSK3VPTVN1PROD with NOTICES
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