Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Virus; Availability, 32140-32157 [2015-13699]

Download as PDF 32140 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices TABLE 3—ESTIMATED ONE-TIME REPORTING BURDEN 1 Number of respondents Guidance document provision Number of responses per respondent Total one-time responses Average burden per response (in hours) Total hours Initial VQIP application ......................................................... Initial VQIP application with re-submissions ........................ 100 100 1 1 100 100 80 100 8,000 10,000 Total One-Time Reporting Burden ............................... ........................ ........................ ........................ ........................ 18,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of responses Guidance document provision Total annual responses Average burden per response (in hours) Total hours Renewal of VQIP application ............................................... 200 1 200 20 4,000 Total Annual Reporting Burden .................................... ........................ ........................ ........................ ........................ 4,000 asabaliauskas on DSK5VPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The draft guidance document allows for food importers to apply for VQIP. We estimate that up to 200 qualified importers will be accepted in the first year of VQIP. We estimate that it will take 80 person-hours to compile all the relevant information and complete the application for the VQIP program. For the purpose of this analysis, we assume that 50 percent of all applications received will require additional information and it would take an additional 20 person-hours by the importer to provide that information. Therefore, we estimate that 100 importers will spend 8,000 hours (80 hours/importer × 100 importers) and 100 importers will spend 10,000 hours (100 hours/importer × 100 importers) to submit their initial VQIP applications for a total one-time reporting burden of 18,000 hours (see table 3). The draft guidance document states that each VQIP participant will submit to FDA a notice of intent to maintain its participation in VQIP and update information on its original application on an annual basis. We expect that each of the expected 200 importers in VQIP would apply to renew their intent to maintain their participation in VQIP. We expect that annual applications to renew participation in VQIP will take significantly less time to prepare than initial applications. We use 25 percent of the amount of effort to prepare and submit the initial application for acceptance in VQIP. Therefore, it is expected that, on average, each VQIP importer will spend 20 hours every year to complete and submit an application for renewal of its VQIP status. The annual burden of completing the renewal application for VQIP status by VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 200 importers is estimated at 4,000 hours (200 applications × 20 hours/ application) (see table 4). For the purposes of the PRA analysis of the draft guidance document, we have estimated costs assuming that, during the annual application process, affected importers will do their paperwork properly and completely the first time. Because we assume that importers will have learned about supporting documentation they need to submit during the initial application process, we have not estimated an additional burden for less than complete annual applications. If we assumed a less consistent outcome, the annual burden might be slightly higher. 1. U.S. Food and Drug Administration. Proposed Analysis of Economic Impacts—Current Good Manufacturing Practice and Hazard Analysis and RiskBased Preventive Controls for Human Food, available under Docket No. FDA– 2011–N–0920. 2. U.S. Food and Drug Administration. Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (78 FR 78014, December 24, 2013). IV. Comments BILLING CODE 4164–01–P Interested persons may submit either electronic comments regarding this draft guidance to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Persons with access to the Internet may obtain this draft guidance at either https://www.fda.gov/Food/ GuidanceRegulation/FSMA/ ucm253380.htm or https:// www.regulations.gov. Use the FDA Web site listed in the previous sentence to Frm 00059 Fmt 4703 VI. References Dated: May 29, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–13706 Filed 6–4–15; 8:45 am] 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. The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations), one of which was amended after initial issuance, for in vitro diagnostic devices for detection of the Ebola virus in response to the Ebola virus outbreak in West Africa. FDA SUMMARY: V. Electronic Access PO 00000 find the most current version of the guidance. Sfmt 4703 E:\FR\FM\05JNN1.SGM 05JNN1 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Corgenix, Inc. (Corgenix), and Cepheid. 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 Authorization for the Corgenix ReEBOVTM Antigen Rapid Test is effective as of February 24, 2015, and was amended and reissued on March 16, 2015. The Authorization for the Cepheid Xpert® Ebola Assay is effective as of March 23, 2015. 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: 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 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 VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 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 Act (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 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 32141 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 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 Homeland Security, Michael Chertoff, determined that the 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. E:\FR\FM\05JNN1.SGM 05JNN1 32142 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 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 February 22, 2015, Corgenix submitted a complete request for, and on February 24, 2015, FDA issued, an EUA for the asabaliauskas on DSK5VPTVN1PROD with NOTICES 2 Under 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). VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 ReEBOVTM Antigen Rapid Test, subject to the terms of the Authorization. On March 16, 2015, in response to a request from Corgenix on March 10, 2015, FDA amended and reissued in its entirety the EUA to allow, in addition to Corgenix, distributors that are authorized by Corgenix to distribute the ReEBOVTM Antigen Rapid Test, with certain conditions applicable to such authorized distributor(s), subject to the terms of this Authorization. This EUA, as amended and reissued on March 16, 2015, which includes an explanation for its reissuance, is reprinted in this document. Because the March 16, 2015, Authorization for Corgenix’s assay replaces in its entirety the EUA issued on February 24, 2015, the original Authorization issued on February 24, 2015, is not reprinted in this document. On February 26, 2015, Cepheid submitted a complete request for, and on March 23, 2015, FDA issued, an EUA for the Xpert® Ebola Assay, subject to the terms of this Authorization. PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 III. Electronic Access Electronic versions of these documents and the full text of the Authorizations are available on the Internet at https://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 in vitro diagnostic devices for detection of the Ebola virus subject to the terms of the Authorizations. The Authorization for the Corgenix ReEBOVTM Antigen Rapid Test issued on March 16, 2015, 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 E:\FR\FM\05JNN1.SGM 05JNN1 VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 32143 EN05JN15.000</GPH> asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 32144 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices Inc. I. Criteria for Issuance of Authorization I have concluded that the emergency use of the ReEBOVTM "'"'"''"'.. detection ofEbola West sp<~cified pu,Jut<>uuu meets the criteria the Act, because I have concluded that: virus this of scientific evidence available to Based on the Test be effective in dlagn<lSIIJig that the ReEBOVTM \""'""'""in the West Africa outbreak in and that the known and vvto~lnldl benefits of the ReEBOVTM Test for Ebola Zaire tae:tectca in the West Africa outbreak in vv•,,;;wcm1 risks of such and 3. There is no ad<:quate, 1'1!'11\rm,,.n and available alternative to the emerg;en<:y use of the ReEBOVTM Ehola Zaire virus in the West Africa outbreak in II. of Authorization VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.001</GPH> section limited to the authorized ReEBOVTM detection ofEbola Zaire virus the West and virus infection in ""''~innrt·inn asabaliauskas on DSK5VPTVN1PROD with NOTICES I have Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 32145 cw::nst~mc~'s when is detem1ined to be more than use of an authorized Ebola virus which has been demonstrated to be more sensitive in the Ebola Zaire virus. The authorized ReEBOVTM Test not intended for use for """"'""'uK, such The ReEBOV™ authorized for Test ReEBOVTM Test consists of a sellt~c{mtatined, disp,osable GIJJtStii)K-ronrnar lateral flow test that includes an internal process Control Line. •·v••v"''"K llPJ)Jicatictn clinical and insertion into the test tube con1tairling the reagent SJ)eCiU'Ie(l, tO bind n~l4iCIT>J~rli<~ll'~ The ReEBOVTM ru'"''"'" • The Process Control was the Ebola Zaire nP.rthrrnAI'I VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.002</GPH> asabaliauskas on DSK5VPTVN1PROD with NOTICES The above described ReEBOVTM ru,,..,,,u mu"m''~<. authorized FDA entitled "ReEBQVTM 32146 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices <H'<lU<I.Ul<:i at which may be revised to laboratories and facilities "d~"'~~~'"tel v .,,~u, 1JIJ"'"• the fact that it does not meet certain law. described ReEBOVTM • Fact Sheet for Health Care Fact Sheet for Patients: As described in section IV authorized to make available authorized ReEBOVTM terms of this Jetter Test <~nrhtt'"'" I have concluded, pursuant to section ofthc based on the of scientific evidence available to that it is reasonable to believe that the authorized ReEBOVTM Test may be effective in the ofEbola Zaire virus in the West infection pursuant to section Africa outbreak in of the Act. FDA has reviewed the scientific information available to FDA conclusions described in section I and concludes that '"'"'"'"'J"'" Ebola Zaire virus in the West Africa outbreak in the criteria set forth in section of the The emergency use of the authorized ReEBOV™ consistent and may not the terms of this and Conditions asabaliauskas on DSK5VPTVN1PROD with NOTICES described above and the VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 to determination of HHS's corresportdir1g declaration under Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.003</GPH> Authorization of this EUA and under the circumstances set forth in the ""''""t"'"'' Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 32147 This will cease to effective when the HHS declaration that circumstances the EUA is tenninated under section or when the section ofthe I am the duration of this EUA: IV. Conditions of Authorization Pursuant to section 564 of the authorization: Inc. and its authorized dis~trilbutor(s) {m:cltJtdlllg treatment centers and for infection the authorized for Health Care Providers and the authorized ReEBOV™ Sheet for Patients. 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.004</GPH> VerDate Sep<11>2014 Inc. and its authorized win distribute the authorized ReEBQVTM Test with the authorized as may be revised Inc. in consultation with to laboratories and facilities and for Ebola infection treatment centers and B. asabaliauskas on DSK5VPTVN1PROD with NOTICES A. 32148 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices and relevant herein, health autlnorJity(i of COllO!l!OllS E. will ensure laboratories and facilities for Ebola infection (in<:ludling the authorized ReEBOVTM n.HUII.:.m health care protes:siOilats r. J. Inc. will communicate to its authorized made to this EUA and its authorized ac!:on1pa111ying instructions for K. Inc. to the authorized ReEBOV'M Test Fact Sheet for Care or the authorized ReEBOVfM Test Fact Sheet for Patients. Such requests will be made consultation with FDA L. for use with the be made 803. VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.005</GPH> asabaliauskas on DSK5VPTVN1PROD with NOTICES Laboratories and Facilities Adleqillately EQUiJJtpetll, ···p~•"~'" Ebola Infection Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 32149 Inc. Test the aut.nv'""''"' Care Providers and the authorized Fact Sheet for Patients. Under other methods for these Fact Sheets include mass media. 0. Laboratories and facilities ade:qu11tely e<JUUJoe,c!. infection for renortmo and Laboratories and Facilities~--·-,.--··-~. for Ebola Infection K and laboratories and for Ebola infection treatment centers will ensure that any records associated with this are maintained until notified FDA. Such records will be made available to FDA upon Conditions Related to to the use of the the Fact and S. All VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.006</GPH> asabaliauskas on DSK5VPTVN1PROD with NOTICES the aooUCllLble Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES The Authorization for the Cepheid Xpert® Ebola Assay issued on March 23, 2015, in its entirety (not including the VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 authorized versions of the fact sheets and other written materials) follows and provides an explanation of the reasons PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 for its issuance, as required by section 564(h)(1) of the FD&C Act: E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.007</GPH> 32150 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 32151 &HUMAN March Dear Dr. VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.008</GPH> asabaliauskas on DSK5VPTVN1PROD with NOTICES De1:>art:ment of Homeland ~,r·un:ttt of the Public Health Service United oftheAct ~PC•1"PT!>1"U of the that 32152 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 2 Dr. James F. of Authorization section of this for the (detected in the West Africa outbreak in I. Criteria for Issuance of Authorization I have concluded that the emergenc:v use of the detection ofEbola virus in the West Africa outbreak in POlllll<:U.ICin meets the criteria issuance of an authorization under section have concluded that: 1. virus this 2. and available alternative to the of the dlagmJSllllgEbola Zaire in the West Africa 3. II. of Authorization the scope of this authorization is in CLIA Moderate and "'~u'"a'"'" non-U.S. laboratories for the detection of (detected in the West Africa outbreak in with and ,;u.,llw'·'""'n with epraermologlcal The Authorized is an automated test intended VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.009</GPH> asabaliauskas on DSK5VPTVN1PROD with NOTICES EDTA venous whole blood specinlen:s. Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 32153 3 - Dr. James F. and transfer the inactivated virus to the AU ext:rac:tto:n, "''up:•u"~"'"'"u, and detection are automated. • Probe federal law. is authorized to be aec:onmaxuf~Cl authorized to be Results Sheet Patients: described in section IV to make available additional VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.010</GPH> asabaliauskas on DSK5VPTVN1PROD with NOTICES that 32154 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 4 Dr. James F. reasonable to believe that the in the specific~d poputlatJon, (de:tected in the West This EUA will cease to be effective when the HHS declaration that circumstances the EUA is terminated under section of the Act or when the EUA is revoked under of the Act section III. Waiver of Certain I am EUA: the duration of this VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.011</GPH> asabaliauskas on DSK5VPTVN1PROD with NOTICES IV. Conditions of Authorization Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 32155 5 Dr. James F. Pursuant to section 564 of the authorization: B. id and any authorized Ebola Fact Fact Sheet for Health for Patients. will make available on their wel1sit,es Providers Moderate and non-U.S. laboratories and relevant inc:ludling the terms and conditions quallifi1~d dis1tributo:r(s) will ensure that CLIA Moderate non-U.S. laboratories the atu.uv:"""'''"' reporting test results to health F. a process control, '""'"l"m''" and any authorized dis:tril:>utor(s) will maintain records of device usage. and any authorized distributor(s) and report to FDA any suspec:ted or \JCilJHClU and any dis1tri1'1utor(s) become aware. G. •v•·•v.,u, are authorized to make av:lila:hle adcliti<mal emer!!:eru:y use ofthe authorized the terms of this I. and VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.012</GPH> asabaliauskas on DSK5VPTVN1PROD with NOTICES instructions for 32156 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices 6 Dr. James F. K. Care request or the authorized Such requests will be made L. the addition of other spe:cmum will be made Such FDA and report FDA under21 CFR CLIA Moderate and Laboratories CLIA Moderate and laboratories will authorized Patients. Under these Fact Sheets may be 0. P. CLIA Moderate and laboratories will collect inf:r.rn-,,.t;,,, or apJ>rOJlriately trained on the use of the and use apJ>fOJ>riate la1botato.ry hartdli11g this kit. Sv<ztPcnM .... ,.... t .....; .... VerDate Sep<11>2014 and CLIA Moderate and Laboratories or non-U.S.laboratories will ensure any records associated with this EUA are maintained until notified FDA. Such records made available to FDA for upon request. 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4725 E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.013</GPH> asabaliauskas on DSK5VPTVN1PROD with NOTICES R. Jli:qtriihutor·s. and CLIA Moderate and or,., .. ,.. .,,,.,. Ou:alillied Non-U.S. Laboratories Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices [FR Doc. 2015–13699 Filed 6–4–15; 8:45 am] Food and Drug Administration [Docket No. FDA–2013–D–0286] BILLING CODE 4164–01–C asabaliauskas on DSK5VPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of SUMMARY: VerDate Sep<11>2014 18:31 Jun 04, 2015 Jkt 235001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). Fax written comments on the collection of information by July 6, 2015. DATES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the title. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: E:\FR\FM\05JNN1.SGM 05JNN1 EN05JN15.014</GPH> Dated: May 29, 2015. Leslie Kux, Associate Commissioner for Policy. 32157

Agencies

[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Pages 32140-32157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13699]


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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 two Emergency Use Authorizations (EUAs) (the 
Authorizations), one of which was amended after initial issuance, for 
in vitro diagnostic devices for detection of the Ebola virus in 
response to the Ebola virus outbreak in West Africa. FDA

[[Page 32141]]

issued these Authorizations under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act), as requested by Corgenix, Inc. (Corgenix), and 
Cepheid. 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 Authorization for the Corgenix ReEBOVTM Antigen 
Rapid Test is effective as of February 24, 2015, and was amended and 
reissued on March 16, 2015. The Authorization for the Cepheid 
Xpert[supreg] Ebola Assay is effective as of March 23, 2015.

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: 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 Act 
(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 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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, then-Secretary of Homeland Security, Michael 
Chertoff, determined that the

[[Page 32142]]

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 February 22, 2015, Corgenix submitted a complete 
request for, and on February 24, 2015, FDA issued, an EUA for the 
ReEBOVTM Antigen Rapid Test, subject to the terms of the 
Authorization. On March 16, 2015, in response to a request from 
Corgenix on March 10, 2015, FDA amended and reissued in its entirety 
the EUA to allow, in addition to Corgenix, distributors that are 
authorized by Corgenix to distribute the ReEBOVTM Antigen 
Rapid Test, with certain conditions applicable to such authorized 
distributor(s), subject to the terms of this Authorization. This EUA, 
as amended and reissued on March 16, 2015, which includes an 
explanation for its reissuance, is reprinted in this document. Because 
the March 16, 2015, Authorization for Corgenix's assay replaces in its 
entirety the EUA issued on February 24, 2015, the original 
Authorization issued on February 24, 2015, is not reprinted in this 
document. On February 26, 2015, Cepheid submitted a complete request 
for, and on March 23, 2015, FDA issued, an EUA for the Xpert[supreg] 
Ebola Assay, subject to the terms of this Authorization.
---------------------------------------------------------------------------

    \2\ Under 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).
---------------------------------------------------------------------------

III. Electronic Access

    Electronic versions of these documents and the full text of the 
Authorizations are available on the Internet at https://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 in vitro diagnostic devices for 
detection of the Ebola virus subject to the terms of the 
Authorizations. The Authorization for the Corgenix ReEBOVTM 
Antigen Rapid Test issued on March 16, 2015, 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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    The Authorization for the Cepheid Xpert[supreg] Ebola Assay issued 
on March 23, 2015, 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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    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13699 Filed 6-4-15; 8:45 am]
 BILLING CODE 4164-01-C
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