77500 Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 

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. 

Dated: December 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30157 Filed 12–23–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2104] 

Authorizations of Emergency Use of In 

Vitro Diagnostic Devices 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 two Emergency Use 

Authorizations (EUAs) (the 

Authorizations) for two in vitro 

diagnostic devices for detection of the 

Ebola Zaire virus. FDA is issuing these 

Authorizations under the Federal Food, 

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

as requested by the Centers for Disease 

Control and Prevention (CDC). 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 are effective 

as of October 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

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 

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 

attributable to such agent or agents; or 

(4) the identification of a material threat 

by the Secretary of Homeland Security 

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 

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Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 77501 

2Under 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 

DHS Secretary of a material threat under 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). 

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 Zaire 

Virus 

On September 22, 2006, thenSecretary of Homeland Security, 

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 8, 2014, CDC submitted 

complete requests for, and on October 

10, 2014, FDA issued, an EUA for the 

CDC Ebola Virus VP40 Real-time RT– 

PCR Assay and an EUA for the CDC 

Ebola Virus NP Real-time RT–PCR 

Assay, subject to the terms of these 

authorizations. 

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 two CDC in vitro diagnostic devices 

for detection of the Ebola Zaire virus 

subject to the terms of the 

Authorizations. The Authorizations in 

their entirety (not including the 

authorized versions of the fact sheets 

and other written materials) follow and 

provide explanations of the reasons for 

their issuance, as required by section 

564(h)(1) of the FD&C Act. 

BILLING CODE 4164–01–P 

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DEPARTMENT OF HEALTH ANn HU!\1AN SERVICES 

R. MPH 

Director 

Cent<--rs for Disease Control and Prevention 

Clifton Rd, MS D-14 

GA 30333 

Dr. 

October 2014 

1 Pursuant to section 564(h](l} of the Acl U_s_c_ 360bbb-3(b)(l}), tbe HHS ""·-""~ru'c 

supports EVA issuance must be based on one offour detm1ninations, including the idetJ!ifi,cati•on 

of a material threat of the PHS Act sufficie.nt 

security of United of !he 

Department ofHe~lth and Human 

79 Fed. Reg. 
Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 77503 


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Dr, Frieden, Centers 

I. Criteria for Issuance of Autllor.izat:ion 

1. The Ebola Zaire virus can caust: 

humans infected this 

2. Based on the 

that !he CDC Ehola 

instr'ument, may be effective in {b;c;_gnosJllR Ebola Zaire virus, and that the 

no1ten1tial benefits of the CDC Virus NP Real-time RT -PCR when used \¥ilh 

the """'n;f;~,! agrwsing Ebola Zaire virus outweigh the known 

and and 

There is no and available allemative to the emergency 

CDC Ebola Virus NP Real-time RT-PCR for Ebola Zaire 

U. of Authorization 

The Authorized CDC Ebola Virus NP Real-time RT-PCR 

The CDC Ebola Virus NP Real-time RT-PCR a real-time reverse PCR 

for the in vitro detection ofEbola Zaire virus in whole serum, and 

c'"'";'."'"'~ from individuals in affected areas with and symptoms ofEbola virus 

infection and/or risk factors. The CDC Virus NP Real-time RT-PCR 

Assay can also be used with urine a oaweJ1!-Jnaltcl 

whole consists of nucleic acid extraction 

Bead Retriever followed 

7500 Fast Dx Real-Time PCR instrument 

Virus NP Real-lime RT-PCR 

RNA is extracted from 

the M2t!Il\1ax P,.lhm><•n 
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assay C\lntrols: 

function. 

described CDC Ebola Real-time RT-PCR 

FDA entitled "Ebola Virus NP 

which may be revised CDC in consultation with is authorized to be distributed !o and 

used laboratories CDC under !his tl1e fact that il does 

federal law. 

The above described CDC Ebola Virus NP Real-time R:T-PCR is authorized to be 

accompanied the inforntation to the emergency use, which is 

authorized to be made available to bealtll care and ""H~i.,r•t~· 

.. Fact Sheet for Heaitl1 Care Providers: h• '""''"'"''''~'~"''"' CDC Ebola Virus NP Real-Time 

RT -PCR NP Results 

authorized to make available additional 

of the authorized CDC Ebola NP Real-time RTthe terms ofthis letter of authorization, 

<)f tlu:: that is reasonable believe that the 

Ebola Virus NP Real-th:ne RT-PCR 

detection ofEhola Zaire 

section based on the of scientific 

reasonable to believe that the authorized CDC Ebola Virus 

may effective in the ofEhola Zaire virus infection 

pursuant to section c:"''-''"'" of!he FDA has revievved the scientific info11natlon 
Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 77505 


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This EUA will cease 

the EUA terminated 

section ofthe 

III. Waiver of Certah1 H.cqntremE~nts 

IV. Condit.ions of Authorization 

Pursuant to section 564 

aut!wrization: 

Centers for Disease Control and Prevention 

when 

the criteria set 

HHS declaration that circumstances exist 

Act or when EUA revoked under 

A CDC will distribute the authorized CDC Ebola Virus NP Real-time RT-PCR 

the authorized CDC consultation with 
77506 Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 


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Cnntrol and Preven!ion 

the authorized CDC Ebola 

Care Providers and the 

Sheet tbr Patients. 

NP Real-time 

CDC Ebola 

D. CDC will inform CDC and relevant Ju:alth 

E. CDC will ensure thai laboratories oe~alulfm:a 

Virus NP Real-time RT-PCR have a process in 

results ht:allh care and relevant health ~"''"~, .. :.:~~ 

CDC will maintain reet1rds 

aware. 

CDC is authorized additional intbrrmltion 

ofthe nuthorized CDC Ebola Virus NP Real-time RT-PCR 

and does no! the te1ms of this letter of authorization. 

to FDA :my 

CDC becomes 

CDC may request to the authorized CDC Ebola Virus NP Real-time RT-PCR 

Fact Sheet f(>r Hea.lth Care Providers or the authorized CDC Virus NP Realtime RT·PCR Fact Sheet fbr Patients. Such requests will be made CDC 

consultation with FDA. 

CDC 

K. laboratories CDC will include with repo;1s of the 

M. 

CDC Ehola Virus NP Real-time RT-PCR the autl1orized Fact Sheet fi:1r Health 

Providers and the authorized fact Sheet Patients. Linder 

other methods fbr these Faet Sheets may 

include mass media. 

PCR lnstrument 

the CDCEbola Virus NP Real7500 Fast Dx Real-Time 
Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 77507 


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N. 

CDC and CDC 

P. 

as well as the tenns set 

"""''li'·,hl,. T·""''''"P•m•·nf< set forth in the Act and FDA I'CJtUJlm(JU$, 

to the use oft he 

consistent with the 

in this EUA and the 

R. All ,d, .. rt;.,;"" 

authorized CDC 

state that: 

and 

• This lest has not been FDA cleared or 

• This te.'lt has been au1th0l'lz•ed 

any other viruses or patncrgens; 

.. 

The emergency u.se of the a\lthorized CDC 

described in this letter of authorization 

this authorization. 

Authorization for use 

the detection of Ebola Zaire and not for 

Virus NP Real-time RT·PCR as 

with the conditions and all other terms nf 
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Dr. Prevention 

V. Dtnatiou of Authorization 

ofthe 

Enclosures 
Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 77509 


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DEPARTM.ENT OF HEALTH AND HllMA ... l\1 SERV.IC~::S 

October 2014 

Thomas R, MPH 

Director 

Centers for Disease Control and Prevention 

Clifton MS D-14 

Atlanta, GA 30333 

Dear Dr. Frieden: 

This letter is in response to your that the Food and Administration issue an 

Authorization for emergency use of the Centers for Disease Control and 

Prevention Ebo!a Virus VP40 Real"Hme RT-PCR for the detection of 

Ebola Zaire virus on a instrumem and 

symptoms of Ebola virus infection and/or epJ:de:mt()!og;eal 

pursuant section 564 

concluded that the criteria for issuance of this authorization under section ofthe 

llS.C. are met, I am the emerge11cy use ofthe Ebola 

Virus VP40 Real-time RT-PCR described in the of Authorization section of this 

letter in individuals in affected areas wit11 symptoms of Ebola virus 

epidcmi•Jiogical risk factors described in the of Authorization section 

for the detection of Ebola Zaire virus 

to the terms of this authorization, 
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Prevention 

J.. Criteria for Issua!H'e of Authorization 

2. 

H. Scope of Authorization 

! have pursuant to section of the Act, that the scope of this authorization is 

limited to the use ofthe authorized CDC Eboia Virus VP40 Real-time RT-PCR 

laboratories CDC t!1r the detection of Ebola Zaire virus in 

individuals in affected areas >Vith and symptoms ofEbola virus infection and/or 

risk factors. 

Tbe Authodzed CDC Ebola Virus VP40 Rea!~timc RT-PCR. 

The CDC Ebola Virus VP40 Real-time RT-PCR tran:scrlr:1tase PCR 

serum, alld 

S\~:nnton1s ofEbola virus 

Real-time RT -I'CR 

cm:ml!1tctH)!l with a pa.tu:nt.-m:atcnea 

The CDC Ebola Virus VP40 Real-time RT-PCR consists of two nrl1m<>.r'fnr.rm<'! 

RNA is extracted from whole blood collected with 

the ""·"'""""-"" Pal:ho:tl'en 

3 No other criteria prescribed Act 
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The CDC Ebola Virus assay controls: 

for PCR reagent fllllction. 

nu•cleiasc·!rl~e water) added 

PCR reagent function and cross~ 

cross-contamination. 

be human RNAse P gene 

and ex tractJ on, 

EBOV VP40 rRT-PCR !o control for spe,cm1en 

The above described CDC Ebola Real-time RT-PCR when labeled 

FDA entitled "Ebola Virus VP40 Real-Time RTwhich may 

CDC in consultation with FDA, authorized to be dist!ibuted to and used 

CDC under this EllA, the fact that it does not meet 

federal law, 

The above de:;cribed CDC Ebola Virus VP40 Real-time RT-PCR is autltor.ized to be 

the informatim1 to the emet>gency use, wbk.h is 

made available to bealth care and nn'""''~~· 

"' .Fact Sheet for Health Ca.re Providers: 

RT~PCR VP40 

information 

RT~PCR 

authorization, 

authorized make available additional 

ofthe authorized CDC .Ebola Virus VP40 Real-time 

does not the terms of this letter of 

pursuant lo section Act, that it is reasonable to bel.ieve that the 

benefits of the authorized CDC Ebola Virus VP40 Real-time RT -PCR 

1 .. v'""""'u", when used for detection ofEbola Zaire 

J>Oiten~!lal risks of such a 

I have concluded, pursuant to section of the based the of scientific 

evidence available to reasonable to beHeve that the authorized CDC Ebola Virus 
77512 Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 


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4 Dr. Frieden, and Prevention 

Seclrctmv of DIIS's 

co1rrct>oondJit12 declaration under 

described above is 

individuals in affected areas with and 

t:pituc.muJJO.~lc<~J 1isk factors. 

EUA cease to he when the HHS declaration that circumstances exist to 

EUA is tem1inated under of the Act or when the EllA revoked 

section of the Act. 

Ill Waiver of Certain Requirements 

for the CDC Ehola Virus VP40 Re11l-time RT-PCR 

IV. Conditions of Authorization 

Pursuant to section 564 ofthe 

authorization: 

Centers for Disease Control and Prevention 

fbr t11e intended 

"'""'!'"""'directions fnr use US.C. 

anltlrooriate limitations the use ofthe 

and any available 

me1uumg reqruir•emcmts under 21 CFR 

conditions nn this 

A, CDC will distribute the authorized CDC Ebola Virus VP40 Real-time RT-PCR 

with the authorized CDC in consultation with 

to '"'""'""-'"" 
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and Prevention 

the authorized CDC VP40 Real-lime 

Care Providers and the~"''""~,.,.,, CDC Ebola 

Fact Sheet for Patients. 

laboratories CDC and relevant 

m"'m""'"' the tenns and conditions herein. 

E. CDC will ensure that laboratories 

Virus VP40 Real-time RT·PCR 

results to health 

F. CDC will track adverse events 

G. a process 

H. CDC will collect infbm1ation 

woiJ"'"'""' occurrence of J:alse 

aware. 

FDA under 21 CFR Part 

CDC will maintain 

health 

usage. 

L CDC authorized to make available additional infonnatinn 

ofthe authorized CDC Ebola Virus VP40 Real-time RT-PCR 

to the eme:rgenc:f' llSC 

that consistent 

and does not the terms of this letter of authorization. 

CDC may to authorized CDC Ebola Virus VP40 Real-time RT·PCR 

Fact for Health Care Pmvidcrs or the authorized CDC Ebola Virus VP40 

Real-time RT-PCR Fact Sheet for Patients. Such requests be made CDC in 

consultation with FDA 

CDC 

K. laboratories CDC will include with reports of the results ofthe 

CDC Ebola Vims VP40 Real-time RT-PCR the authorized Fact Sheet 1br Health 

Care Providets and tlie authorized Fact Sl1eet Patients. Under 

other methods for these Fact Sheets may 

include mass media, 

L the CDC Ebola V!ms VP40 RealPCR instrument 

laboratories '"'""W"'"'" 

results to health care nrc)!e~>sHmals 

7500 Fast Dx Real-Time 
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Dr. Frieden, Centers and Prevention 

RT-PCR 

eQlJlpmen! when 

CDC 

P. CDC at>d laboratories CDC will ensure that any records 

associated with this EUA are maintained until notified FDA. records will be 

made available to FDA upon request 

Conditions Related to 

., Authmizatiou for use UU<<OU!OU laboratories Ut::>lglll:iltO\J 

for the detection of Ebola Zaire and for 

., This lest is authorized tlte duration of the declaration that circumstances exist 

~'""' ,,.,,. the authorization Olllllll:OSitlCS fM detection 

virus under section 

unless the authorization is terminated or revoked :sooner. 

No ""'"'"'"""1rna matter to the use ofthe authorized 

CDC Ebola Virus VP40 Real-time RT-PCR may represent or suggest that this test is safe 

The emergency use oftbe authmized CDC Ebola Virus VP40 Real-time RT-PCR as 

described in this letter of authorization with the conditions and other tenns of 

!his authorization. 
Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 77515 

Dated: December 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30108 Filed 12–23–14; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Bioequivalence Recommendations for 

Methylphenidate Hydrochloride 

Extended-Release Oral Suspension; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Bioequivalence 

Recommendations for Methylphenidate 

Hydrochloride Extended-Release Oral 

Suspension.’’ The recommendations 

provide specific guidance on the design 

of bioequivalence (BE) studies to 

support abbreviated new drug 

applications (ANDAs) for 

methylphenidate hydrochloride (HCl) 

extended-release oral suspension. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by February 23, 

2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Kris 

Andre ́, Center for Drug Evaluation and 

Research (HFD–600), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4726, Silver Spring, 

MD 20993–0002, 240–402–7959. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry, 

‘‘Bioequivalence Recommendations for 

Specific Products,’’ which explained the 

process that would be used to make 

product-specific BE recommendations 

available to the public on FDA’s Web 

site at http://www.fda.gov/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/default.htm. As 

described in that guidance, FDA 

adopted this process as a means to 

develop and disseminate productspecific BE recommendations and 

provide a meaningful opportunity for 

the public to consider and comment on 

those recommendations. This notice 

announces the availability of draft BE 

recommendations for methylphenidate 

HCl extended-release oral suspension. 

New drug application 202100 for 

Quillivant XR (methylphenidate HCl) 

extended-release oral suspension was 

initially approved by FDA in September 

2012. There are no approved ANDAs for 

this product. FDA is now issuing a draft 

guidance for industry on BE 

recommendations for generic 

methylphenidate HCl extended-release 

oral suspension (Draft Methylphenidate 

HCl Oral Suspension BE 

Recommendations). 

In August 2014, Pfizer, Inc., 

manufacturer of the reference listed 

drug, Quillivant XR, submitted a citizen 

petition requesting that FDA establish 

certain BE requirements for any new 

drug product that references Quillivant 

XR and seeks approval by means of 

demonstrating BE to Quillivant XR 

(Docket No. FDA–2014–P–1269). FDA is 

reviewing the issues raised in the 

petition. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the design of BE studies to support 

ANDAs for methylphenidate HCl 

extended-release oral suspension. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 


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