13854 Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices 

for people with intellectual disabilities: 

(A) Expansion of educational 

opportunities; (B) promotion of 

homeownership; (C) assurance of 

workplace integration; (D) improvement 

of transportation options; (E) expansion 

of full access to community living; and 

(F) increasing access to assistive and 

universally designed technologies. 

Dated: March 11, 2015. 

Aaron Bishop, 

Commissioner, Administration on Intellectual 

and Developmental Disabilities. 

[FR Doc. 2015–06085 Filed 3–16–15; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; NINDS Center Core (P30) 

and Research Resource (R24) Review. 

Date: April 17, 2015. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Plaza Hotel, 10 Thomas 

Circle NW., Washington, DC 20005. 

Contact Person: Natalia Strunnikova, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, Division of Extramural 

Research, NINDS/NIH/DHHS/Neuroscience 

Center, 6001 Executive Boulevard, Suite 

3208, MSC 9529, Bethesda, MD 20892–9529, 

301–402–0288, natalia.strunnikova@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: March 11, 2015. 

Carolyn Baum, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05968 Filed 3–16–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1206] 

Authorization of Emergency Use of an 

In Vitro Diagnostic Device for 

Detection of Ebola Zaire Virus; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of an Emergency Use 

Authorization (EUA) (the Authorization) 

for an in vitro diagnostic device for 

detection of the Ebola Zaire virus in 

response to the 2014 Ebola virus 

outbreak in West Africa. FDA is issuing 

this Authorization under the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act), as requested by Roche 

Molecular Systems, Inc. (Roche). The 

Authorization contains, among other 

things, conditions on the emergency use 

of the authorized in vitro diagnostic 

device. The Authorization follows the 

September 22, 2006, determination by 

then-Secretary of the Department of 

Homeland Security (DHS), Michael 

Chertoff, that the Ebola virus presents a 

material threat against the U.S. 

population sufficient to affect national 

security. On the basis of such 

determination, the Secretary of Health 

and Human Services (HHS) declared on 

August 5, 2014, that circumstances exist 

justifying the authorization of 

emergency use of in vitro diagnostics for 

detection of Ebola virus subject to the 

terms of any authorization issued under 

the FD&C Act. The Authorization, 

which includes an explanation of the 

reasons for issuance, is reprinted in this 

document. 

DATES: The Authorization is effective as 

of December 23, 2014. 

ADDRESSES: Submit written requests for 

single copies of the EUA to the Office 

of Counterterrorism and Emerging 

Threats, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 1, 

rm. 4338, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request or include a fax number to 

which the Authorization may be sent. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the 

Authorization. 

FOR FURTHER INFORMATION CONTACT: 

Luciana Borio, Assistant Commissioner 

for Counterterrorism Policy, Office of 

Counterterrorism and Emerging Threats, 

and Acting Deputy Chief Scientist, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 1, rm. 4340, 

Silver Spring, MD 20993–0002, 301– 

796–8510 (this is not a toll free number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5) allows FDA 

to strengthen the public health 

protections against biological, chemical, 

nuclear, and radiological agents. Among 

other things, section 564 of the FD&C 

Act allows FDA to authorize the use of 

an unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. With this 

EUA authority, FDA can help assure 

that medical countermeasures may be 

used in emergencies to diagnose, treat, 

or prevent serious or life-threatening 

diseases or conditions caused by 

biological, chemical, nuclear, or 

radiological agents when there are no 

adequate, approved, and available 

alternatives. 

Section 564(b)(1) of the FD&C Act 

provides that, before an EUA may be 

issued, the Secretary of HHS must 

declare that circumstances exist 

justifying the authorization based on 

one of the following grounds: (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 biological, chemical, radiological, 

or nuclear agent or agents; (2) 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 U.S. military forces of 

attack with a biological, chemical, 

radiological, or nuclear agent or agents; 

(3) a determination by the Secretary of 

HHS 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 U.S. citizens living abroad, 

and that involves a biological, chemical, 

radiological, or nuclear agent or agents, 

or a disease or condition that may be 

mstockstill on DSK4VPTVN1PROD with NOTICES