6972 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 

Atlanta, Georgia 30333, Telephone: (404) 

639–8135. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–02450 Filed 2–6–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: ORR Requirements for Refugee 

Cash Assistance; and Refugee Medical 

Assistance (45 CFR part 400). 

OMB No.: 0970–0036. 

Description: As required by section 

412(e) of the Immigration and 

Nationality Act, the Administration for 

Children and Families (ACF), Office of 

Refugee Resettlement (ORR), is 

requesting the information from Form 

ORR–6 to determine the effectiveness of 

the State cash and medical assistance, 

social services, and targeted assistance 

programs. State-by-State Refugee Cash 

Assistance (RCA) and Refugee Medical 

Assistance (RMA) utilization rates 

derived from Form ORR–6 are 

calculated for use in formulating 

program initiatives, priorities, 

standards, budget requests, and 

assistance policies. ORR regulations 

require that State Refugee Resettlement 

and Wilson-Fish agencies, and local and 

Tribal governments complete Form 

ORR–6 in order to participate in the 

above-mentioned programs. 

Respondents: State Refugee 

Resettlement and Wilson-Fish Agencies, 

local, and Tribal governments. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

ORR–6 ............................................................................................. 50 3 3.88 582 

Estimated Total Annual Burden 

Hours: 582. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden 

information to be collected; and (e) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–02510 Filed 2–6–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0126] 

Authorizations of Emergency Use of In 

Vitro Diagnostic Devices for Detection 

of Ebola Virus; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of three Emergency Use 

Authorizations (EUAs) (the 

Authorizations), one of which was 

amended after initial issuance, for three 

in vitro diagnostic devices for detection 

of the Ebola virus in response to the 

2014 Ebola virus outbreak in West 

Africa. FDA is issuing these 

Authorizations under the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

as requested by BioFire Defense, LLC 

(BioFire Defense) and altona Diagnostics 

GmbH (altona). The Authorizations 

contain, among other things, conditions 

on the emergency use of the authorized 

in vitro diagnostic devices. The 

Authorizations follow 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 Authorizations, 

which include an explanation of the 

reasons for issuance, are reprinted in 

this document. 

DATES: The Authorizations for the 

BioFire FilmArray NGDS BT–E Assay 

and BioFire FilmArray Biothreat-E test 

are effective as of October 25, 2014. The 

Authorization for the altona RealStar®

Ebolavirus RT–PCR Kit 1.0, which was 

amended and reissued on November 26, 

2014, is effective as of November 10, 

2014. 

ADDRESSES: Submit written requests for 

single copies of the EUAs 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 Authorizations may be sent. 

See the SUPPLEMENTARY INFORMATION

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Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6973 

1The Secretary of HHS has delegated the 

authority to issue an EUA under section 564 of the 

FD&C Act to the Commissioner of Food and Drugs. 

2Under to section 564(b)(1) of the FD&C Act, the 

HHS Secretary’s declaration that supports EUA 

issuance must be based on one of four 

determinations, including the identification by the 

Secretary of DHS of a material threat under to 

section 319F–2 of the PHS Act sufficient to affect 

national security or the health and security of U.S. 

citizens living abroad (section 564(b)(1)(D) of the 

FD&C Act). 

section for electronic access to the 

Authorizations. 

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 DHS 

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 

the Department 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 

attributable to such agent or agents; or 

(4) the identification of a material threat 

by the Secretary of DHS under section 

319F–2 of the Public Health Service 

(PHS) Act (42 U.S.C. 247d–6b) sufficient 

to affect national security or the health 

and security of U.S. citizens living 

abroad. 

Once the Secretary of HHS has 

declared that circumstances exist 

justifying an authorization under 

section 564 of the FD&C Act, FDA may 

authorize the emergency use of a drug, 

device, or biological product if the 

Agency concludes that the statutory 

criteria are satisfied. Under section 

564(h)(1) of the FD&C Act, FDA is 

required to publish in the Federal 

Register a notice of each authorization, 

and each termination or revocation of an 

authorization, and an explanation of the 

reasons for the action. Section 564 of the 

FD&C Act permits FDA to authorize the 

introduction into interstate commerce of 

a drug, device, or biological product 

intended for use when the Secretary of 

HHS has declared that circumstances 

exist justifying the authorization of 

emergency use. Products appropriate for 

emergency use may include products 

and uses that are not approved, cleared, 

or licensed under sections 505, 510(k), 

or 515 of the FD&C Act (21 U.S.C. 355, 

360(k), and 360e) or section 351 of the 

PHS Act (42 U.S.C. 262). FDA may issue 

an EUA only if, after consultation with 

the HHS Assistant Secretary for 

Preparedness and Response, the 

Director of the National Institutes of 

Health, and the Director of the CDC (to 

the extent feasible and appropriate 

given the applicable circumstances), 

FDA 1 concludes: (1) That an agent 

referred to in a declaration of emergency 

or threat can cause a serious or lifethreatening disease or condition; (2) 

that, based on the totality of scientific 

evidence available to FDA, including 

data from adequate and well-controlled 

clinical trials, if available, it is 

reasonable to believe that: (A) The 

product may be effective in diagnosing, 

treating, or preventing (i) such disease 

or condition; or (ii) a serious or lifethreatening disease or condition caused 

by a product authorized under section 

564, approved or cleared under the 

FD&C Act, or licensed under section 351 

of the PHS Act, for diagnosing, treating, 

or preventing such a disease or 

condition caused by such an agent; and 

(B) the known and potential benefits of 

the product, when used to diagnose, 

prevent, or treat such disease or 

condition, outweigh the known and 

potential risks of the product, taking 

into consideration the material threat 

posed by the agent or agents identified 

in a declaration under section 

564(b)(1)(D) of the FD&C Act, if 

applicable; (3) that there is no adequate, 

approved, and available alternative to 

the product for diagnosing, preventing, 

or treating such disease or condition; 

and (4) that such other criteria as may 

be prescribed by regulation are satisfied. 

No other criteria for issuance have 

been prescribed by regulation under 

section 564(c)(4) of the FD&C Act. 

Because the statute is self-executing, 

regulations or guidance are not required 

for FDA to implement the EUA 

authority. 

II. EUA Requests for In Vitro Diagnostic 

Devices for Detection of the Ebola Virus 

On September 22, 2006, thenSecretary of DHS, Michael Chertoff, 

determined that the Ebola virus presents 

a material threat against the U.S. 

population sufficient to affect national 

security.2 On August 5, 2014, under 

section 564(b)(1) of the FD&C Act, and 

on the basis of such determination, the 

Secretary of HHS declared 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 section 564 

of the FD&C Act. Notice of the 

declaration of the Secretary was 

published in the Federal Register on 

August 12, 2014 (79 FR 47141). On 

October 22, 2014, BioFire Defense 

submitted complete EUA requests for 

both the BioFire FilmArray NGDS BT– 

E Assay and for the BioFire FilmArray 

Biothreat-E test, and on October 25, 

2014, FDA issued, an EUA for the 

BioFire FilmArray NGDS BT–E Assay 

and an EUA for the BioFire FilmArray 

Biothreat-E test, subject to the terms of 

these authorizations. On October 29, 

2014, altona submitted a complete EUA 

request for the RealStar® Ebolavirus RT– 

PCR Kit 1.0, and on November 10, 2014, 

FDA issued, an EUA for the RealStar®

Ebolavirus RT–PCR Kit 1.0, subject to 

the terms of this authorization. On 

November 26, 2014, in response to a 

request from altona on November 18, 

2014, FDA amended and reissued in its 

entirety the EUA to allow, in addition 

to altona, distributors that are 

authorized by altona to distribute the 

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6974 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 

RealStar® Ebolavirus RT–PCR Kit 1.0 

with certain conditions applicable to 

such authorized distributor(s), and to 

allow the use of the assay under the 

EUA at certain non-U.S. laboratories, 

with certain conditions. The EUA, as 

amended and reissued on November 26, 

2014, which includes an explanation for 

its reissuance, is reprinted in this 

document. Because the November 26, 

2014, Authorization for altona’s Ebola 

assay replaces in its entirety the EUA 

issued on November 10, 2014, the 

original Authorization issued on 

November 10, 2014, is not reprinted in 

this document. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

Authorizations are available on the 

Internet at http://www.regulations.gov. 

IV. The Authorizations 

Having concluded that the criteria for 

issuance of the Authorizations under 

section 564(c) of the FD&C Act are met, 

FDA has authorized the emergency use 

of certain in vitro diagnostic devices. 

The Authorization for the BioFire 

FilmArray NGDS BT–E Assay issued on 

October 25, 2014, in its entirety (not 

including the authorized versions of the 

fact sheets and other written materials) 

follows and provides an explanation of 

the reasons for its issuance, as required 

by section 564(h)(1) of the FD&C Act: 

BILLING CODE 4164–01–P 

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Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6975 


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Products 

BioFlre LLC 

79 W 4500 S, Suite I. 4 

Salt Lake UT 841 07 

Dear Dr. 

October 2014 

authorization under 

:~n·thnri7ino the emergency use of the 

of Authorization section of this letter 1"'"'-'IJivu 

virus infection or are risk for eXJlosure 

Ebola Zaire virus in the West Africa outbreak in 

epi.deJtnH)lo,gicallisk factors (as described in the of 

for tlle detection ofEbo!a Zaire 
6976 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 


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LLC 

authorization. 

l. Criterilt for lssmmce of Authm·ization 

NGDS BT-E 

(det,~cted in the West Africa outbreak in 

meets the criteria f11r issuance of an authorization under section of 

the Act, because f have concluded that 

The Ebo!a Zaire virus (detected 

vims infected with 

this virus; 

2. 

:u"'""""" anlr~m,ve•lL and available alternative the emergency usc ofthc 

U. of Autboriution 

I have to section 

limited 10 the use ofthe authorized 

DoD the 

'"J>;,nu:>mg Ebola Zaire virus in the West 

of the that the sc,)pe of this authorization is 

NGDS BT ,E laboratories u"'"ls<"'m.v 

virus (de:tecte•l 

cpidc:mh)!o,gicaltisk factors. 

West Africa 

The Author.izcd NGDS BT-E Assay: 

The real-time reverse tr""Q''rir't'''""' 

detection of Ebola Zaire vims de1tec·ted in the 

and 

symptoms ofEbola vims infection or who are at risk for exposure or may have been to 

the Ebola Zaire virus (detected in the West Afnca outbreak in in with 

risk factors. The test consists of nucleic acid extraction follo>ved 

the instrument. 
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6977 


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BioFire LLC 

and 

and Tm parameters could be utlli:cecl 

deteetlon results in an 

The above described NGDS BT-E Assay is authorized to be aeC<Impanied the 

follo"'ing information pertaining to the emergency use, which is authorized to be made 

available to llealtli care and PRtier1ts: 

• Fact Slieet for Health Care Providers: h"f""'"""'ti""' Ntms BT-E Assay 

Results for Ebola 

"' Fact Sbeet for Patients: 

Test for Ebola 

BioFire Defense is also authorized Ut make availablt1 

additional infbrmalion tn the emergenc;.r use of the authorized NODS BT -E 

that is consistent with, and not the terms of this letter of authorization. 

I have pursuant to section that it is reasonable to believe that the 

known and benefits ofthe authorized NGDS BT-E 

uulllUJ<twJn. when used for detection ofEbola Zaire virus ,-~W~'W" 

AtTica outbreak in the known and risks of such a P""""'''""· 

diagmlsis of Ebola Zaire virus the A itimt 

ofthe Act. The FDA has reviewed 
6978 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 


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must be 

and may not 

Authorization and the Conditions of Authorizati<m to the 

tem1s of this EUA and under the circumstances set forth in the ofDHS's detemTination 

described above and the of HHS's declaration umler section 

the NODS BT-E described above is authorizt-'d to Ebola Zaire virus 

the West Afiica outbreak in infection in individuals with 

cease to be effective 

is te11ninaled under 

ofthe Act. 

m. Waiver of Certain 

.lam the 

duration ofthis EUA: 

IV. Conditions of Atlfhorfzation 

HHS declaration 

A.ct or when the EUA 

NODS BT-E 

Pursuant to section 564 oftl1e Act, I am establishing the ro!!ovvmg conditions on this 

authorization: 

!he 
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6979 


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LLC 

.Bio.Fire Defense 

with 

authorized 

!O lHboratorics ·'~·~'";n,,n,,,,J 

R BioFire Defense DoD the authorized 

NGDS BT~E 

NGDS BT-E 

Care Providers authorized 

Fact Sheet for Patients. 

C BloFire Defense will make available on ils website the authorized 

Assay Fact Sheet for Health Care Providers and the aut!mrized 

Sheet for Patients. 

DoD and rc!.cvant 

NGDS BTNGDS BT-E 

health 

BioFirc Defense vv.iU !rack to FDA under21 CFR Part 803. 

G. a process BioFire Defense will maintain ret:ords ofdeviee 

usage. 

H. BioFire Defense will collect intonmnion on the "'~'""~'"'"Q'"'"' to 

FDA occurrence or ll1lse ""·'"'.;"" 

Defense becomes avvare. 

L BioFire Defense is authorized available additional infom1ation 

~'A'''"~'"'" use of the NGDS BT-E that 

not exceed, the 

BioFire Defense may to the authorized 

Fact She.et for Health Care Providers the authorized >•llnH~rr:ul 

Shet~t for Patients. Such ro•m••ct<· will be made BioFire Defense in consultation 

with FDA. 

Laboratories 

K Laboratories 

NGDSBT-E 

authorized Fact 

methods for 

media. 

by DoD 

DoD 'NiH include with of the results ofthe 

the authorizt,-d Fact Sheet fin Health Care Providers and the 

for Patients. Under 

these Fact Sheets may be 

DoD the NGDS on 
6980 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 


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infonnation 

smst,c:cte:d occurrence 

DoD 

Defense and laborat(Wics A,,.,.;m'''''"'; 

associated \Vilh this 

made available to FDi~ 

results to 

will be 

• ~u~ 

laboratories 

fbr the deteetim1 ofEbola Zaire 

and fbr any other 

,. This test is authorized lx1r the duuttkm of the declaration 

the authorization of the t':l:nergency use of in 

ofEbola Zaire virus under section !) ofthe 

unless tl1e authorization is terminated or revoked sooner. 

matter to !he use ofthe authorized 

may represent or suggest that this test is safe or effective tiJr the 

West Africa outbreak in 

emergency use of the authorized NGDS BT-E 

must the ctmdilions and all other tenns 

V. Duration of Authorization 
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6981 

The Authorization for the BioFire 

FilmArray Biothreat-E test issued 

October 25, 2014, in its entirety (not 

including the authorized versions of the 

fact sheets and other written materials) 

follows and provides an explanation of 

the reasons for its issuance, as required 

by section 564(h)(1) of the FD&C Act: 


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6982 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 


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OF IU:ALTH ANU HOMAN SERVICES 

October 

BloFire 

79 W 4500 S, Suite 14 

Salt Lake 84 I 07 

Dear Dr. 
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6983 


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the lenns of 

I. Critet·ia for Issuance <)f Authorization 

IA'fl"""'""' meets the criteria fbr issuance 

I have concluded that 

I_ The Ebola Zaire virus \ u.;tc<.:lcu can cause Ebola 

"'''-""'"''"+""'"'" diseaSl~ or condition to humans infedcd with virus 

virus: 

when used \vith the 

the Atl·lca outbreak in 

and 

U. of Authorization 

l have pursuant section 

limited to the use of the authorized 

Ctlm-ple:xl1'Y Laboratories for 

Afi-ica outbreak in 

with ••n•d•-··•ni" 

'H'"'"u'''" alternative the emerge.ney use of the 

dl1tj!;l:los1ng Ebola Zaire virus in West Afiica 

oftbe Act, that the scope of ti1is authorization is 

Biotlm:at-E lest Moderate and 

detection ofEbola Zaire virus {dcrtected 

and symptoms of Eoola 

The Autborb:ed Biotbreat·E test: 

Biothreat-E test 
6984 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 


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LLC 

Once a clinical takes about 5 minutes to 

l hour. 

the automated test, which 

The Biolhreat-E test includes !he 

RNA Process Control is a 

process to demonstrate !hal 

successfuL The 

assay control: 

BioFire Defense in consultation with FDA, is authorized to 

CLIA Moderate and Laboratories under th1s 

it does not meet certain federal law. 

The ab!we described FilmArray Biothreat-E test is authorized to be aeco:mpanied the 

tolllm.viiU! information to the emergency use, V1lhicll is authorized to be made 

available tn health care professionals and patients: 

• Fact Sheet. for Health Care Providers: Jnterpreting 

Results for Ebola 

" Fact Sheet for Patiellts: 

Test for Ebola 

BioFire Defense is also authorized 

Biothreat~E Test 

'""""'" .... '" infonnation to the emergency use ofthe authorized BiodJreat-E 

consistent and docs no! the temu; of this letter of authmization. 

of the Act, that it is reasonable to believe that the 

Biothreat-E test in the ~..,,.~ .... vu 

have concluded, pursuant to section of the Act, based on the 

evidence available to FDA. that reasonable to believe that the authorized 

Biothreat-E test may be ell'eetive .i11 ofEbola Zaire vims (de:tected 

Africa outbreak in infection pursuant of the 

rHv"'"""n the scientific information av<mame 
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6985 


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BioFirc LLC 

to the 

tenus oft!1is EUA and under the circumstances set t'i.Jt1h in the <.!,.,.,.,,,,.., 

described above and the ofHHS's declaration under section 

Blothreat-E test described above is authorized to Ebolu Zaire virus 

will cease to be etfcetivc 

the EllA is tem1inatcd under section 

ofthe Act. 

and S}1nptoms 

HHS dcch1ration that circumstance~; exi:st 

of the Aet or v.rhen the EllA revoked under 

Biothrcat-E the duration 

under 21 CFR Part 820 with respect io the 

storage, and distribution ofthe Biothreat-E test. 

IV, Conditions of Authorization 

BioFire Defense 

~t'\'"'"''"'"''·'h' limitations on the use of the 

available 

.,.,.,.m;, • .,rr,,,.,t., under 21 CFR 

conditions on this 

A. BioFire Defense wfll distribute the authorized Biothreat-E test with the 

B. BioFire Defense will 

authorized 

authorized 

BioFlre Defense in consultation with FDA, 

rnnw.l••>•iht laboratories. 

CLIA Moderate and Laboratories the 

Biothreat-E test Fact Sheet tor Health Care Providers and tl1e 

Fact Sheet fbr Patients. 
6986 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 


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D. 

BinFire Defense, 

BioFire Defense 

Sheet f{1r Health 

Patients. 

herein. 

Laboratories m1d 

E. Bk)Fire Defense will ensure that CUA Moderate and 

H. 

the authorized 

BioFire Defense vvill track events and report to FDA CFR Part 803. 

Detl~nse will maintain records of device 

usage. 

BioFire Defense is authtlrized to make available additional 

emergency use of the authorized Biothrcat-E 

does not exceed, the tenus of this letter of authorization. 

and report to 

of•vhich BioFire 

l BioFire Detensemay 

Sheet for Health Care """""'"'"" 

BioFire Defense in consultation with FDA. 

mass media. 

CUA Moderate and 

Biotluent-E test on 

<m~tw;;"rn Lahotatt>ries wlll include wlth 

the authorized Fact Sheet 

tbt· Patients. 

these Fact Sheets may he 

~on1Pl,exi't'v Laboratories will the 

instrument. 

M. CUA Moderate and Comp1exitv Laboratories will have a process in fQr 

other 

''"""'-tmo test results to health care and relevant health authorities, as 

CL!A M<>derate and Laboratories will collect infimnation on the 

""'rt"'""~'""" ofthc and re.port 10 Bit>Fil·e Dt~fense any occurrence 

false n"''""''"p of which become 
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6987 


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Biof.'iri' Defi'USi' and CLIA !VIoderate and 

--···r···-···-,, Laboratories ensure that 

any records associated with this EllA are '""""'·""'"'u FDA. Such 

records will be made available to FDA for m~;pe,C!1(m 

Conditions Related to 

" This rest has been authmized 

the West Al1ica (m!brcak in 

" This test is authorized 

the authorization 

Ebola Zaire virus 

unlcs$ the authorization 

f11r the detection of Ebola Zaire virus , • ., .. __ ., __ in 

and no! fi.1r any other viruses 

matter the 

that this test is safe 

Aft'ica outbreak in 

for the 

Biothreat-E test described in this letter of 

with the conditions and all other terms of this authmization, 
6988 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 

The Authorization for the RealStar®

Ebolavirus RT–PCR Kit 1.0, originally 

issued on November 10, 2014, as 

amended and reissued in its entirety on 

November 26, 2014, (not including the 

authorized versions of the fact sheets 

and other written materials) follows and 

provides an explanation of the reasons 

for its issuance, as required by section 

564(h)(1) of the FD&C Act, and its 

amendment: 


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Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6989 


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DEPARTJI.lENT OF HEALTH & HllMAN SERVICES 
6990 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 


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2 Dr. Sven Cramer, altona Diag;ao~;ti{:s GmbH 

concluded that the criteria fhr issua11ee 

I U.S.C. <>nilhnri"·'"" the emergency of the '"''mcaru 

Eholavirus RT-PCR Kit 1.0 of Authorization section of this letter 

in individuals with and symptoms of Ehola virus infection in with 

''"""'''""' risk factors (as described nf Authorization section ofthis letter 

the detection of RNA from Ebolaviruses 

"""lii'i~r~ non~U.S. to terms of this 

authorization. 

t Criteria for Issuance of Authorization 

2. 

Ebolaviruses can cause serious or llt•e-tilm::al<lni.ngdisease or 

condition to humans infected \Vith this 

of scientific evidence <lvailable to FDA, it is reasonable to believe 

that the Ebolav!rus RT-PCR Kit 1 when used with the"'"'";;''"" 

may be effective in u•v'"'"~~'"'·"' 

henel1ts of the '"""'':""'' 

instruments thr uu'l5"""'"'l5 

and available altemative to 

Kit for Ebolavirus int;,.,.,ti:nn 

U. of Authorizat.ion 
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6991 


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-Dr, Sven GmbH 

The Authorized E:twhwirus RT-PCR Kit Ul: 

the CFX9()TM 

includes 

"n''"'"'~~ RT-PCR inhib.itkln and 

Ebolavirus RT-PC:R Kit 

The internal Control contains a defined copy number of an molecule 

with no any other kno\vn sctJUcnccs. lt has to be added to the nucleic acid 

and reverse and detected in to the 

RNA. The fimction oftlu: internal C:<)ntml is 

real-time RT-.PCR results 

The PCR water is to usec.i 

fimction is to indicate contamination 

The "Positive Control 

target sequence usc{j 

Ebolavirus RNA. 

cont1'0I for 

PCR detection system, 

wl1ich nu1y be revised 

to be distributed tn and 

under this 

federal law. 

""''"M"'" control for the RT-PCR reaction. its 

RT-PCR reagents. 

Kit 1.0, when labeled ,.,~,,,~;,,.,..,. 

Ebolavirus RT-PCR Kit l 
6992 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 


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4 -- Dr. Sven Cramer, 

Tl1e above desedbed I<:boJavi.ru:s RT~PCR Kit 1.0 is auUwdzed to be 

the information to the entcrgeney use, which is 

aut.l:u:n·ized to be ntlldc a:vailable to health care and """i"nt~ 

.. Fact Sheet for Health Care Providers: Ebolavirus RT-PCR 

Kit Ul Results 

• Fact Sbeet for Patients: 

PCR Kit 1.0 

As described in Section lV altona GmbH and its authorized 

available additional information to the ''''"'"'"'""''"'"v 

Ebolavims RT-PCR Kit 1.0 that is consistent 

the terms of this letter 

co.nd.uded. pursuant to section of the based on the 

that is reasonable to believe that the authorized ._<::m.:nm 

the ofinfcction 

pursuant to section The FDA has reviewed the scientific intt1nnalion 

availuhle to FDA the int(Jrmation ~"T"'""'""' the conclusions described in Section I 

and concludes that the authorized Ebnlavinas RT~PCR Kit w!1en used to 

dmll:m:1se inteetinn with Ebolaviruses in the meets the criteria set forth in 

of the Aot efrectivencss. 

declaration under 

,;,,c, . .~.;r.F''' ab<rve is authorized to d!~tgnose 

and symptoms of Ebola 

This EUA \Viii cease to be effective when the HHS declaration that circumstances exist 

the EUA is terminated under section oftlle Acl or when the ElJA is revoked under 

seetion ofthe Act. 

the Ebolavirus RT-PCR Kit LO 
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6993 


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tV. Conditions of Authorization 

Pursuant to section 564 of the lam the conditions this 

D. 

will toCL!A 

non-U.S. laboratories the authorized 

Fact Sheet for Health Care Providers and the 

Ebolavirus RT-PCR Kit 1.0 Fact Sheet forPatients. 

will ensure that CLIA 

a process altona 

will maintain records of device usage. 
6994 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 


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H. altona GmbH and 

available additional mton111ation 

Ebo!avi.r11s RT·PCR Kit LO 

tenns of this letter of authorization. 

altona Diagnostics GmbH 

GmbH 

and communicate to 

be made to this 

instructions for 

make 

emergency use ofthe. authorized 

is consistent and tl1e 

with C<)py 

:su,.,::;~:::uuem amendments that 

ac<:on1pBIIlYing materials 

!o the authorized 

Providers the "111 ""''""""' 

Ebolavirus RT-PCR Kit l Fact Sheet for Patients. Sueh rt'<Jtlt,sts will be 

K altona 

803. 

'-'""15 .. ..,.,,,,. . ., GmbH in consultation with FDA. 

adverse <rvents and report FDA under 21 CFR Part 

CUA High Complexity Laboratories and Sintilady Qualified Non-U.S. Labon1.tories 

laboratories wilJ 

include with reports results of the Ebolavirus RT -PCR Kil .0 the 

authorized Fact Sheet ibr Health Care Providers and the authorized Fact Sheet for 

Patients. Under other methods 

Fact Sheets may be 

real-time system. 

Laboratories and non-U$. laboratories will 

''"'""'"'"'" test results to health care and re.!evant 
Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 6995 


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Dr. Sven GmbH 

CLIA 

Non-U.S. Laboratories 

CLIA 

and m.m-U.S. laboratories will ensure that any records 

associated with tl1is EUA are maintained until notit1cd FDA Such records '"·ill be 

made available to FDA for upon request. 

Conditions Related to 

R. 

" Laboratories and 

f(Jr the detection of RNA fh.Jl11 Ebolaviruses (such 

lincludi.rm the Zaire cbolavirus strain Africa 

Tai Forest ebolavirus, and 

Reston other viruses or 

., This test aut11orizcd for the duration of the declaration that circumstances exist 

the authorization ofthe emergeuey use of in for detection 

virus Utlder section of the ), 

unless the authorization terminated m revoked sooner. 

or matter to the use of the authmizerl 

Ebolavin1s RT-PCR Kit l may represent nr suggest that this test is saie or effective 

'""!;;'"''"" of infection with Ebolavirus. 

The emergency use of the authorized Ebolavirus RT-PCR Kit l described in this 

letter ofauthorizalion must the conditions and all other terms of this authmization. 
6996 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 

Dated: February 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02467 Filed 2–6–15; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0354] 

Guidance for Industry: Questions and 

Answers Regarding the Effect of 

Section 4205 of the Patient Protection 

and Affordable Care Act of 2010 on 

State and Local Menu and Vending 

Machine Labeling Laws; Withdrawal of 

Guidance 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the withdrawal of a 

guidance entitled ‘‘Guidance for 

Industry: Questions and Answers 

Regarding the Effect of Section 4205 of 

the Patient Protection and Affordable 

Care Act of 2010 on State and Local 

Menu and Vending Machine Labeling 

Laws,’’ dated August 2010. We are 

taking this action because the policies 

stated in the guidance have been 

superseded by our issuance of final 

rules on menu and vending machine 

labeling. 

DATES: February 9, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Felicia B. Billingslea, Center for Food 

Safety and Applied Nutrition (HFS– 

820), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 240–402–2371. 

SUPPLEMENTARY INFORMATION: In a notice 

published in the Federal Register of 

August 25, 2010 (75 FR 52427), we 

announced the availability of a guidance 

entitled ‘‘Guidance for Industry: 

Questions and Answers Regarding the 

Effect of Section 4205 of the Patient 

Protection and Affordable Care Act of 

2010 on State and Local Menu and 

Vending Machine Labeling Laws.’’ The 

guidance stated that we were issuing the 

guidance to: (1) Ensure that industry 

and State and local governments 

understand the immediate effects of the 

law, and (2) clarify the effect of section 

4205 of the Patient Protection and 

Affordable Care Act of 2010 on State 

and local menu and vending machine 

labeling laws. 

We are withdrawing this guidance 

because we recently issued two final 

rules entitled ‘‘Food Labeling; Nutrition 

Labeling of Standard Menu Items in 

Restaurants and Similar Retail Food 

Establishments’’ and ‘‘Food Labeling; 

Calorie Labeling of Articles of Food in 

Vending Machines’’ (see 79 FR 71156 

(December 1, 2014) and 79 FR 71259 

(December 1, 2014), respectively). The 

preambles for these final rules discuss 

issues relating to Federalism and to 

federal preemption of State and local 

laws and reflect our latest thinking on 

those issues. Consequently, the 

guidance no longer reflects our current 

thinking insofar as the law’s effect on 

State and local menu and vending 

machine labeling laws is concerned. 

Dated: February 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02526 Filed 2–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0798] 

Medical Device Data Systems, Medical 

Image Storage Devices, and Medical 

Image Communication Devices; Mobile 

Medical Applications: Guidances for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of two guidance documents. 

FDA is issuing ‘‘Medical Device Data 

Systems, Medical Image Storage 

Devices, and Medical Image 

Communication Devices’’ to inform 

manufacturers, distributors, and other 

entities that the Agency does not intend 

to enforce compliance with regulatory 

requirements for Medical Device Data 

Systems (MDDS) and two similar 

radiology device types due to the low 

risk they pose to patients and the 

importance they play in advancing 

digital health. FDA is also issuing an 

updated version of the guidance 

document ‘‘Mobile Medical 

Applications,’’ originally issued on 

September 25, 2013, that has been 

edited to be consistent with the MDDS 

guidance document. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: An electronic copy of the 

guidance document is available for 


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