80_FR_52926 80 FR 52757 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Middle East Respiratory Syndrome Coronavirus; Availability

80 FR 52757 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Middle East Respiratory Syndrome Coronavirus; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 169 (September 1, 2015)

Page Range52757-52766
FR Document2015-21585

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 Middle East Respiratory Syndrome Coronavirus (MERS-CoV). FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by altona Diagnostics GmbH. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the May 29, 2013, determination by the Department of Health and Human Services (HHS) Secretary 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 U.S. citizens living abroad and that involves MERS-CoV. On the basis of such determination, the Secretary of HHS also declared on May 29, 2013, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of MERS-CoV 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.

Federal Register, Volume 80 Issue 169 (Tuesday, September 1, 2015) 
[Federal Register Volume 80, Number 169 (Tuesday, September 1, 2015)]
[Notices]
[Pages 52757-52766]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21585]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3042]


Authorization of Emergency Use of an In Vitro Diagnostic Device 
for Detection of Middle East Respiratory Syndrome Coronavirus; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 Middle East 
Respiratory Syndrome Coronavirus (MERS-CoV). FDA issued this 
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as requested by altona Diagnostics GmbH. The Authorization 
contains, among other things, conditions on the emergency use of the 
authorized in vitro diagnostic device. The Authorization follows the 
May 29, 2013, determination by the Department of Health and Human 
Services (HHS) Secretary 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 U.S. citizens living 
abroad and that involves MERS-CoV. On the basis of such determination, 
the Secretary of HHS also declared on May 29, 2013, that circumstances 
exist justifying the authorization of emergency use of in vitro 
diagnostic devices for detection of MERS-CoV 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 July 17, 2015.

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: Carmen Maher, Acting Assistant 
Commissioner for Counterterrorism Policy and Acting Director, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, 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 
All-Hazards 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

[[Page 52758]]

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 Centers for Disease Control and 
Prevention (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 life-
threatening 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 life-
threatening 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.
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    \1\ The 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.
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    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 Request for an In Vitro Diagnostic Device for Detection of 
MERS-CoV

    On May 29, 2013, under section 564(b)(1)(C) of the FD&C Act (21 
U.S.C. 360bbb-3(b)(1)(C)), the Secretary of HHS 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 U.S. citizens living abroad and that involves MERS-CoV. 
Also on May 29, 2013, 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 diagnostic devices for detection of MERS-CoV, subject to the 
terms of any authorization issued under section 564 of the FD&C Act. 
Notice of the determination and declaration of the Secretary was 
published in the Federal Register on June 5, 2013 (78 FR 33842). On 
June 26, 2015, altona Diagnostics GmbH submitted a complete request 
for, and on July 17, 2015, FDA issued, an EUA for the altona 
Diagnostics GmbH RealStar[supreg] MERS-CoV RT-PCR Kit U.S., subject to 
the terms of the Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the 
Authorization are available on the Internet at http://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the 
Authorization under section 564(c) of the FD&C Act are met, FDA has 
authorized the emergency use of an in vitro diagnostic device for 
detection of MERS-CoV subject to the terms of the Authorization. The 
Authorization 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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[GRAPHIC] [TIFF OMITTED] TN01SE15.010


    Dated: August 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21585 Filed 8-31-15; 8:45 am]
 BILLING CODE 4164-01-C

Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices 52757 procedures, applications for maximum DEPARTMENT OF HEALTH AND Counterterrorism and Emerging Threats, residue limits, clinical trial HUMAN SERVICES Food and Drug Administration, 10903 applications, drug/active substance New Hampshire Ave., Bldg. 1, Rm. master files, or requests for regulatory or Food and Drug Administration 4347, Silver Spring, MD 20993–0002, scientific advice. [Docket No. FDA–2015–N–3042] 301–796–8510 (this is not a toll free number). III. Significance of Guidance Authorization of Emergency Use of an SUPPLEMENTARY INFORMATION: This guidance, developed under the In Vitro Diagnostic Device for VICH process, has been revised to Detection of Middle East Respiratory I. Background conform with FDA’s good guidance Syndrome Coronavirus; Availability Section 564 of the FD&C Act (21 practices regulation (21 CFR 10.115). U.S.C. 360bbb–3) as amended by the AGENCY: Food and Drug Administration, For example, the document has been Project BioShield Act of 2004 (Pub. L. HHS. designated ‘‘guidance’’ rather 108–276) and the Pandemic and All- ACTION: Notice. Hazards Preparedness Reauthorization ‘‘guideline’’. In addition, guidance documents must not include mandatory SUMMARY: The Food and Drug Act of 2013 (Pub. L. 113–5) allows FDA language such as ‘‘shall’’, ‘‘must’’, Administration (FDA) is announcing the to strengthen the public health ‘‘require’’, or ‘‘requirements’’, unless issuance of an Emergency Use protections against biological, chemical, FDA is using these words to describe a Authorization (EUA) (the Authorization) nuclear, and radiological agents. Among statutory or regulatory requirement. The for an in vitro diagnostic device for other things, section 564 of the FD&C guidance represents the current thinking detection of Middle East Respiratory Act allows FDA to authorize the use of of FDA on electronic exchange of Syndrome Coronavirus (MERS-CoV). an unapproved medical product or an documents: Electronic file format. It FDA issued this Authorization under unapproved use of an approved medical does not establish any rights for any the Federal Food, Drug, and Cosmetic product in certain situations. With this person and is not binding on FDA or the Act (the FD&C Act), as requested by EUA authority, FDA can help assure public. You can use an alternative altona Diagnostics GmbH. The that medical countermeasures may be approach if it satisfies the requirements Authorization contains, among other used in emergencies to diagnose, treat, of applicable statutes and regulations. things, conditions on the emergency use or prevent serious or life-threatening of the authorized in vitro diagnostic diseases or conditions caused by IV. Paperwork Reduction Act of 1995 biological, chemical, nuclear, or device. The Authorization follows the This guidance refers to previously May 29, 2013, determination by the radiological agents when there are no approved collections of information Department of Health and Human adequate, approved, and available found in FDA regulations. These Services (HHS) Secretary that there is a alternatives. collections of information are subject to significant potential for a public health Section 564(b)(1) of the FD&C Act review by the Office of Management and emergency that has a significant provides that, before an EUA may be Budget (OMB) under the Paperwork potential to affect national security or issued, the Secretary of HHS must Reduction Act of 1995 (44 U.S.C. 3501– the health and security of U.S. citizens declare that circumstances exist 3520). The collections of information in living abroad and that involves MERS- justifying the authorization based on 21 CFR part 514 have been approved CoV. On the basis of such one of the following grounds: (1) A under OMB control number 0910–0032. determination, the Secretary of HHS determination by the Secretary of also declared on May 29, 2013, that Homeland Security that there is a V. Comments circumstances exist justifying the domestic emergency, or a significant authorization of emergency use of in potential for a domestic emergency, Interested persons may submit either involving a heightened risk of attack electronic comments regarding this vitro diagnostic devices for detection of MERS-CoV subject to the terms of any with a biological, chemical, radiological, document to http://www.regulations.gov or nuclear agent or agents; (2) a or written comments to the Division of authorization issued under the FD&C Act. The Authorization, which includes determination by the Secretary of Dockets Management (see ADDRESSES). It Defense that there is a military is only necessary to send one set of an explanation of the reasons for issuance, is reprinted in this document. emergency, or a significant potential for comments. Identify comments with the a military emergency, involving a docket number found in brackets in the DATES: The Authorization is effective as heightened risk to U.S. military forces of heading of this document. Received of July 17, 2015. attack with a biological, chemical, comments may be seen in the Division ADDRESSES: Submit written requests for radiological, or nuclear agent or agents; of Dockets Management between 9 a.m. single copies of the EUA to the Office (3) a determination by the Secretary of and 4 p.m., Monday through Friday, and of Counterterrorism and Emerging HHS that there is a public health will be posted to the docket at http:// Threats, Food and Drug Administration, emergency, or a significant potential for www.regulations.gov. 10903 New Hampshire Ave., Bldg. 1, a public health emergency, that affects, Rm. 4338, Silver Spring, MD 20993– or has a significant potential to affect, VI. Electronic Access 0002. Send one self-addressed adhesive national security or the health and Persons with access to the Internet label to assist that office in processing security of U.S. citizens living abroad, may obtain the guidance at either your request or include a fax number to and that involves a biological, chemical, which the Authorization may be sent. mstockstill on DSK4VPTVN1PROD with NOTICES http://www.fda.gov/cvm or http:// radiological, or nuclear agent or agents, www.regulations.gov. See the SUPPLEMENTARY INFORMATION or a disease or condition that may be section for electronic access to the attributable to such agent or agents; or Dated: August 26, 2015. Authorization. (4) the identification of a material threat Leslie Kux, FOR FURTHER INFORMATION CONTACT: by the Secretary of Homeland Security Associate Commissioner for Policy. Carmen Maher, Acting Assistant under section 319F–2 of the Public [FR Doc. 2015–21582 Filed 8–31–15; 8:45 am] Commissioner for Counterterrorism Health Service (PHS) Act (42 U.S.C. BILLING CODE 4164–01–P Policy and Acting Director, Office of 247d–6b) sufficient to affect national VerDate Sep<11>2014 20:18 Aug 31, 2015 Jkt 235001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1

52758 Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices security or the health and security of evidence available to FDA, including potential to affect national security or U.S. citizens living abroad. data from adequate and well-controlled the health and security of U.S. citizens Once the Secretary of HHS has clinical trials, if available, it is living abroad and that involves MERS- declared that circumstances exist reasonable to believe that: (A) The CoV. Also on May 29, 2013, under justifying an authorization under product may be effective in diagnosing, section 564(b)(1) of the FD&C Act and section 564 of the FD&C Act, FDA may treating, or preventing (i) such disease on the basis of such determination, the authorize the emergency use of a drug, or condition; or (ii) a serious or life- Secretary of HHS declared that device, or biological product if the threatening disease or condition caused circumstances exist justifying the Agency concludes that the statutory by a product authorized under section authorization of emergency use of in criteria are satisfied. Under section 564, approved or cleared under the vitro diagnostic devices for detection of 564(h)(1) of the FD&C Act, FDA is FD&C Act, or licensed under section 351 MERS-CoV, subject to the terms of any required to publish in the Federal of the PHS Act, for diagnosing, treating, authorization issued under section 564 Register a notice of each authorization, or preventing such a disease or of the FD&C Act. Notice of the and each termination or revocation of an condition caused by such an agent; and determination and declaration of the authorization, and an explanation of the (B) the known and potential benefits of Secretary was published in the Federal reasons for the action. Section 564 of the the product, when used to diagnose, Register on June 5, 2013 (78 FR 33842). FD&C Act permits FDA to authorize the prevent, or treat such disease or On June 26, 2015, altona Diagnostics introduction into interstate commerce of condition, outweigh the known and GmbH submitted a complete request for, a drug, device, or biological product potential risks of the product, taking and on July 17, 2015, FDA issued, an intended for use when the Secretary of into consideration the material threat EUA for the altona Diagnostics GmbH HHS has declared that circumstances posed by the agent or agents identified RealStar® MERS-CoV RT–PCR Kit U.S., exist justifying the authorization of in a declaration under section subject to the terms of the emergency use. Products appropriate for 564(b)(1)(D) of the FD&C Act, if Authorization. emergency use may include products applicable; (3) that there is no adequate, and uses that are not approved, cleared, approved, and available alternative to III. Electronic Access or licensed under sections 505, 510(k), the product for diagnosing, preventing, An electronic version of this or 515 of the FD&C Act (21 U.S.C. 355, or treating such disease or condition; document and the full text of the 360(k), and 360e) or section 351 of the and (4) that such other criteria as may Authorization are available on the PHS Act (42 U.S.C. 262). FDA may issue be prescribed by regulation are satisfied. Internet at http://www.regulations.gov. an EUA only if, after consultation with No other criteria for issuance have the HHS Assistant Secretary for been prescribed by regulation under IV. The Authorization Preparedness and Response, the section 564(c)(4) of the FD&C Act. Because the statute is self-executing, Having concluded that the criteria for Director of the National Institutes of issuance of the Authorization under Health, and the Director of the Centers regulations or guidance are not required for FDA to implement the EUA section 564(c) of the FD&C Act are met, for Disease Control and Prevention (to FDA has authorized the emergency use the extent feasible and appropriate authority. of an in vitro diagnostic device for given the applicable circumstances), II. EUA Request for an In Vitro detection of MERS-CoV subject to the FDA 1 concludes: (1) That an agent Diagnostic Device for Detection of terms of the Authorization. The referred to in a declaration of emergency MERS-CoV Authorization in its entirety (not or threat can cause a serious or life- including the authorized versions of the On May 29, 2013, under section threatening disease or condition; (2) fact sheets and other written materials) 564(b)(1)(C) of the FD&C Act (21 U.S.C. that, based on the totality of scientific follows and provides an explanation of 360bbb–3(b)(1)(C)), the Secretary of 1 The Secretary of HHS has delegated the HHS determined that there is a the reasons for its issuance, as required authority to issue an EUA under section 564 of the significant potential for a public health by section 564(h)(1) of the FD&C Act: FD&C Act to the Commissioner of Food and Drugs. emergency that has a significant BILLING CODE 4164–01–P mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 20:18 Aug 31, 2015 Jkt 235001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1

Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices 52759 DEPARTMENT OF HEALTH&. HUMAN SERVICES Public Health Service Food and Drug Admini$tration Silver MO 20993 2015 ofblboJ:atory as "CLIA Laboratories!' Prenaredn:ess Reaulhori:r11tion Pub. L No. 13-5, undor seclion the Secretary may make a determination heallh emel'gency, or of a sig~lifi<:mt mstockstill on DSK4VPTVN1PROD with NOTICES East EN01SE15.003</GPH> VerDate Sep<11>2014 20:18 Aug 31, 2015 Jkt 235001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4725 E:\FR\FM\01SEN1.SGM 01SEN1

52760 Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices Page 2 Dr. Cramer, altona Diagnostics GmbH t Criteria rot lssuanee•ofAnthoriution I.llave 'oonclud.ed tbatthe emergency use of the Rea!Star® .M1i&:s~c·ov '""' ..,.,..., presunlpQVe <!et~X:tionof ly[E:R$~CoV afi•m1thodiation·under sectiotl5(i4(1:>) lhave concluded, purSll:ant to section564( ljm:ited to the use.oflhe .authoriziil RealSia mstockstill on DSK4VPTVN1PROD with NOTICES EN01SE15.004</GPH> VerDate Sep<11>2014 20:18 Aug 31, 2015 Jkt 235001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4725 E:\FR\FM\01SEN1.SGM 01SEN1

Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices 52761 Cnun~~r. altona Diagnostics GmbH Forward ptilncr: - Reverse primer: PI 359 S653 • Forward pril:ner: • Reverseprimer: PI357 l'l"'Jtfl(l' 8652 mstockstill on DSK4VPTVN1PROD with NOTICES EN01SE15.005</GPH> VerDate Sep<11>2014 20:18 Aug 31, 2015 Jkt 235001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4725 E:\FR\FM\01SEN1.SGM 01SEN1

52762 Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices RT-PCR The fun;~tioltiali1ty of the MERS-CoV Real::>tar··· MERS-CoV • • MERS-CoV RT-PCR lJI:agr1os1tics ""'"'"'H and any authorized distributor(s) '.v'""'""''" addlii:!c,nal infornr1atiion r~r:tttuJtg to the emergency use ootexoeed, mstockstill on DSK4VPTVN1PROD with NOTICES EN01SE15.006</GPH> VerDate Sep<11>2014 20:18 Aug 31, 2015 Jkt 235001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4725 E:\FR\FM\01SEN1.SGM 01SEN1

Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices 52763 Page 5- This will cease to be ,.fl.,rtim• the EUA is ter:nm1ate:ct IlL Waiver of Certain Requirements • • Conditions of Authorization of the altona Diagnostics GmbH aud Authorized Distributor(s) B. mstockstill on DSK4VPTVN1PROD with NOTICES EN01SE15.007</GPH> VerDate Sep<11>2014 20:18 Aug 31, 2015 Jkt 235001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4725 E:\FR\FM\01SEN1.SGM 01SEN1

52764 Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices G. authorization. altona Diagnostics GmbH I. authorized distributor(s). J. mstockstill on DSK4VPTVN1PROD with NOTICES EN01SE15.008</GPH> VerDate Sep<11>2014 20:18 Aug 31, 2015 Jkt 235001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4725 E:\FR\FM\01SEN1.SGM 01SEN1

Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices 52765 AU labi.11'aklry f!ers\1!Tnelusmg the RealStar® MERS·CoV alt~na. [liagllo~ti~ GmJ>H•. AnyAntlmrized Distdbo.t~r{s)~ ct.IAHigh· eomplexity Labnridoriest and Similarly Qualified Non41.S. Laboratories \villltltl.isEUIA are maintained ll.l1tU notified h~v FI:>A fol'itlspectil)!l upon request • mstockstill on DSK4VPTVN1PROD with NOTICES EN01SE15.009</GPH> VerDate Sep<11>2014 20:18 Aug 31, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4725 E:\FR\FM\01SEN1.SGM 01SEN1

52766 Federal Register / Vol. 80, No. 169 / Tuesday, September 1, 2015 / Notices Dated: August 26, 2015. DATES: Submit either electronic or Chemistry, Manufacturing, and Controls Leslie Kux, written comments on Agency guidances (CMC) Technical Sections’’ giving Associate Commissioner for Policy. at any time. interested persons until December 19, [FR Doc. 2015–21585 Filed 8–31–15; 8:45 am] ADDRESSES: Submit written requests for 2014, to comment on the draft guidance. BILLING CODE 4164–01–C single copies of the guidance to the FDA received one comment on the draft Policy and Regulations Staff (HFV–6), guidance and that comment was Center for Veterinary Medicine, Food considered as the guidance was DEPARTMENT OF HEALTH AND and Drug Administration, 7519 Standish finalized. The guidance announced in HUMAN SERVICES Pl., Rockville, MD 20855. Send one self- this notice finalizes the draft guidance addressed adhesive label to assist that dated October 2014. Food and Drug Administration office in processing your requests. See GFI #227 provides recommendations [Docket No. FDA–2014–D–1492] the SUPPLEMENTARY INFORMATION section to sponsors submitting CMC data for electronic access to the guidance Two-Phased Chemistry, document. submissions to CVM to support Manufacturing, and Controls Technical Submit electronic comments on the approval of a new animal drug or Sections; Guidance for Industry; guidance to http://www.regulations.gov. abbreviated new animal drug. The two- Availability Submit written comments on the phased process allows for two separate guidance to the Division of Dockets CMC submissions, each with its own AGENCY: Food and Drug Administration, review clock, and each including Management (HFA–305), Food and Drug HHS. complete appropriate CMC information Administration, 5630 Fishers Lane, Rm. ACTION: Notice. 1061, Rockville, MD 20852. that is available for review at the time SUMMARY: The Food and Drug FOR FURTHER INFORMATION CONTACT: of submission. The guidance specifies Administration (FDA) is announcing the Heather Longstaff, Center for Veterinary the technical details of how the process availability of a guidance for industry Medicine (HFV–145), Food and Drug works, the review clocks, the (GFI) #227 entitled ‘‘Two-Phased Administration, 7500 Standish Pl., information that is appropriate for each Chemistry, Manufacturing, and Controls Rockville, MD 20855, 240–402–0651, technical section submission, and the heather.longstaff@fda.hhs.gov. possible review outcomes. The guidance mstockstill on DSK4VPTVN1PROD with NOTICES (CMC) Technical Sections.’’ The guidance provides recommendations to SUPPLEMENTARY INFORMATION: also includes CVM’s recommendations sponsors submitting chemistry, for meetings between the Division of manufacturing, and controls (CMC) data I. Background Manufacturing Technologies and the submissions to the Center of Veterinary In the Federal Register of October 20, sponsor during this process to ensure Medicine (CVM) to support approval of 2014 (79 FR 62635) FDA published the concurrence with the approach used for a new animal drug or abbreviated new notice of availability for a draft guidance the CMC technical section. EN01SE15.010</GPH> animal drug. for industry #227 entitled ‘‘Two-Phased VerDate Sep<11>2014 20:18 Aug 31, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1


Document Created: 2018-02-26 10:04:57
Document Modified: 2018-02-26 10:04:57
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe Authorization is effective as of July 17, 2015.
ContactCarmen Maher, Acting Assistant Commissioner for Counterterrorism Policy and Acting Director, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993- 0002, 301-796-8510 (this is not a toll free number).
FR Citation80 FR 52757 
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