Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices 10685 

1 42 U.S.C. 247d–6b 

2As amended by the Pandemic and All-Hazards 

Preparedness Reauthorization Act, Public Law 113– 

5, the Secretary may make determination of a public 

health emergency, or a significant potential for a 

public health emergency, under section 564 of the 

FD&C Act. The Secretary is no longer required to 

make a determination of a public health emergency 

in accordance with section 319 of the PHS Act, 42 

U.S.C. 247d, to support a determination or 

declaration made under section 564 of the FD&C 

Act. 

Washington, DC 20405. ATTN: Ms. 

Hada Flowers/IC 3090–0080, Contract 

Financing Final Payment; (GSA Form 

1142, Release of Claims). 

Instructions: Please submit comments 

only and cite Information Collection 

3090–0080, Contract Financing Final 

Payment; (GSA Form 1142, Release of 

Claims), in all correspondence related to 

this collection. All comments received 

will be posted without change to http:// 

www.regulations.gov, including any 

personal and/or business confidential 

information provided. 

SUPPLEMENTARY INFORMATION: 

A. Purpose 

The General Services Administration 

Acquisition Regulation (GSAR) clause 

552.232–72 requires construction and 

building services contractors to submit 

a release of claims before final payment 

is made to ensure contractors are paid 

in accordance with their contract 

requirements and for work performed. 

GSA Form 1142, Release of Claims is 

used to achieve uniformity and 

consistency in the release of claims 

process. 

B. Annual Reporting Burden 

Respondents: 2000. 

Responses per Respondent: 1. 

Hours per Response: .10. 

Total Burden Hours: 200. 

C. Public Comment 

Public comments are particularly 

invited on: Whether this collection of 

information is necessary and whether it 

will have practical utility; whether our 

estimate of the public burden of this 

collection of information is accurate, 

and based on valid assumptions and 

methodology; ways to enhance the 

quality, utility, and clarity of the 

information to be collected. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat (MVCB), 1800 F 

Street NW., Washington, DC 20405, 

telephone (202) 501–4755. Please cite 

OMB Control No. 3090–0080, Contract 

Financing Final Payment; (GSA Form 

1142, Release of Claims), in all 

correspondence. 

Dated: February 24, 2015. 

Jeffrey A. Koses, 

Director, Office of Acquisition Policy, Office 

of Government-wide Policy. 

[FR Doc. 2015–04116 Filed 2–26–15; 8:45 am] 

BILLING CODE 6820–61–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Determination and Declaration 

Regarding Emergency Use of New In 

Vitro Diagnostics for Detection of 

Enterovirus D68 

AGENCY: Office of the Secretary, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The Secretary of Health and 

Human Services (HHS) is issuing this 

notice pursuant to section 564 of the 

Federal Food, Drug, and Cosmetic 

(FD&C) Act, 21 U.S.C. 360bbb–3. On 

February 6, 2015, the Secretary 

determined that there is a significant 

potential for a public health emergency 

that has a significant potential to affect 

national security or the health and 

security of United States citizens living 

abroad and that involves enterovirus 

D68 (EV–D68). On the basis of this 

determination, she also declared that 

circumstances exist justifying the 

authorization of emergency use of new 

in vitro diagnostics for detection of 

EV–D68 pursuant to section 564 of the 

FD&C Act, subject to the terms of any 

authorization issued under that section. 

DATES: The determination and 

declaration are effective February 6, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Karen Mason, Centers for Disease 

Control and Prevention, 1600 Clifton 

Road MS–A34, Atlanta, GA 30333, 

Telephone (404) 639–1297 (this is not a 

toll free number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under Section 564 of the FD&C Act, 

the Commissioner of the Food and Drug 

Administration (FDA), acting under 

delegated authority from the Secretary 

of HHS, may issue an Emergency Use 

Authorization (EUA) authorizing (1) the 

emergency use of an unapproved drug, 

an unapproved or uncleared device, or 

an unlicensed biological product; or (2) 

an unapproved use of an approved drug, 

approved or cleared device, or licensed 

biological product. Before an EUA may 

be issued, the Secretary of HHS must 

declare that circumstances exist 

justifying the authorization based on 

one of four determinations: (1) A 

determination by the Secretary of 

Homeland Security that there is a 

domestic emergency, or a significant 

potential for a domestic emergency, 

involving a heightened risk of attack 

with a chemical, biological, radiological, 

or nuclear (‘‘CBRN’’) agent or agents; (2) 

the identification of a material threat by 

the Secretary of Homeland Security 

pursuant to section 319F–2 of the Public 

Health Service (PHS) Act 1 sufficient to 

affect national security or the health and 

security of United States citizens living 

abroad; (3) a determination by the 

Secretary of Defense that there is a 

military emergency, or a significant 

potential for a military emergency, 

involving a heightened risk to United 

States military forces of attack with a 

CBRN agent or agents; or (4) a 

determination by the Secretary that 

there is a public health emergency, or a 

significant potential for a public health 

emergency, that affects, or has a 

significant potential to affect national 

security or the health and security of 

United States citizens living abroad, and 

that involves a CBRN agent or agents, or 

a disease or condition that may be 

attributable to such agent or agents.2

Based on any of these four 

determinations, the Secretary of HHS 

may then declare that circumstances 

exist that justify the EUA, at which 

point the FDA Commissioner may issue 

an EUA if the criteria for issuance of an 

authorization under section 564 of the 

FD&C Act are met. The Centers for 

Disease Control and Prevention (CDC), 

HHS, requested that the FDA, HHS, 

issue an EUA for new in vitro 

diagnostics for detection of EV–D68 to 

allow the Department to take 

preparedness measures based on 

information currently available about 

the EV–D68. 

The determination of a significant 

potential for a public health emergency, 

and the declaration that circumstances 

exist justifying emergency use of new in 

vitro diagnostics for detection of 

EV–D68 by the Secretary of HHS, as 

described below, enable the FDA 

Commissioner to issue an EUA for in 

vitro diagnostics for detection of 

EV–D68 for emergency use under 

section 564 of the FD&C Act. 

II. Determination by the Secretary of 

Health and Human Services 

On February 6, 2015, pursuant to 

section 564 of the FD&C Act, I 

determined that there is a significant 

potential for a public health emergency 

that has a significant potential to affect 

national security or the health and 

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10686 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices 

security of United States citizens living 

abroad and that involves EV–D68. 

III. Declaration of the Secretary of 

Health and Human Services 

Also on February 6, 2015, on the basis 

of my determination of a significant 

potential for a public health emergency 

that has a significant potential to affect 

national security or the health and 

security of United States citizens living 

abroad and that involves EV–D68, I 

declared that circumstances exist 

justifying the authorization of 

emergency use of new in vitro 

diagnostics for detection of EV–D68 

pursuant to section 564 of the FD&C 

Act, subject to the terms of any 

authorization issued under that section. 

Notice of the EUAs issued by the FDA 

Commissioner pursuant to this 

determination and declaration will be 

provided promptly in the Federal 

Register as required under section 564 

of the FD&C Act. 

Dated: February 6, 2015. 

Sylvia M. Burwell, 

Secretary. 

[FR Doc. 2015–04121 Filed 2–26–15; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Secretary’s Advisory 

Committee on Human Research 

Protections 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: Pursuant to Section 10(a) of 

the Federal Advisory Committee Act, 

U.S.C. Appendix 2, notice is hereby 

given that the Secretary’s Advisory 

Committee on Human Research 

Protections (SACHRP) will hold a 

meeting that will be open to the public. 

Information about SACHRP and the full 

meeting agenda will be posted on the 

SACHRP Web site at: http://

www.dhhs.gov/ohrp/sachrp/mtgings/

index.html. 

DATES: The meeting will be held on 

Tuesday, March 24, 2015, from 8:30 

a.m. until 5:00 p.m. and Wednesday, 

March 25, 2015, from 8:30 a.m. until 

4:30 p.m. 

ADDRESSES: Fishers Lane Conference 

Center, Terrace Level, 5635 Fishers 

Lane, Rockville, Maryland 20852. 

FOR FUTHER INFORMATION CONTACT: Jerry 

Menikoff, M.D., J.D., Director, Office for 

Human Research Protections (OHRP), or 

Julia Gorey, J.D., Executive Director, 

SACHRP; U.S. Department of Health 

and Human Services, 1101 Wootton 

Parkway, Suite 200, Rockville, 

Maryland 20852; 240–453–8141; fax: 

240–453–6909; email address: 

SACHRP@hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authority of 42 U.S.C. 217a, Section 222 

of the Public Health Service Act, as 

amended, SACHRP was established to 

provide expert advice and 

recommendations to the Secretary of 

Health and Human Services, through 

the Assistant Secretary for Health, on 

issues and topics pertaining to or 

associated with the protection of human 

research subjects. 

The meeting will open to the public 

at 8:30 a.m., on Tuesday, March 24. 

Following opening remarks from Dr. 

Jerry Menikoff, Executive Secretary of 

SACHRP and OHRP Director, and Dr. 

Jeffrey Botkin, SACHRP Chair, Dr. 

Botkin and invited speakers will discuss 

issues surrounding the use of newborn 

dried bloodspots in research. The 

Subpart A Subcommittee (SAS) report 

will follow; SAS will discuss draft 

recommendations on the research uses 

of newborn dried bloodspots and the 

Newborn Screening Saves Lives 

Reauthorization Act of 2014. SAS was 

established by SACHRP in October 2006 

and is charged with developing 

recommendations for consideration by 

SACHRP regarding the application of 

subpart A of 45 CFR part 46 in the 

current research environment. 

In the afternoon of March 24, the 

Subcommittee on Harmonization (SOH) 

will present their report; SOH was 

established by SACHRP at its July 2009 

meeting and charged with identifying 

and prioritizing areas in which 

regulations and/or guidelines for human 

subjects research adopted by various 

agencies or offices within HHS would 

benefit from harmonization, 

consistency, clarity, simplification and/ 

or coordination. SOH will present 

recommendations on the research use of 

‘‘big data’’ and the intersection of the 

HHS and FDA regulations. 

On March 25, the SOH will discuss 

the return of individual research results 

with special considerations regarding 

HIPAA and CLIA; this will be followed 

by presentation of SOH 

recommendations on the FDA draft 

guidance ‘‘General Clinical 

Pharmacology Considerations for 

Pediatric Studies for Drugs and 

Biologics.’’ The meeting will adjourn at 

4:30 p.m. March 25, 2015. Time for 

public comment sessions will be 

allotted both days. 

Public attendance at the meeting is 

limited to space available. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify one of 

the designated SACHRP points of 

contact at the address/phone number 

listed above at least one week prior to 

the meeting. Pre-registration is required 

for participation in the on-site public 

comment session; individuals may preregister the day of the meeting. 

Individuals who would like to submit 

written statements should email or fax 

their comments to SACHRP at 

SACHRP@hhs.gov at least five business 

days prior to the meeting. 

Dated: February 23, 2015. 

Jerry Menikoff, 

Executive Secretary, Secretary’s Advisory 

Committee on Human Research Protections, 

Director, Office for Human Research 

Protections. 

[FR Doc. 2015–04120 Filed 2–26–15; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–1696 and CMS– 

10417] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates 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 

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