Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability, 54361-54385 [2017-25010]

Download as PDF 54361 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices The following is a summary of the estimated annual burden hours for recalling firms (manufacturers, processors, and distributors) to comply with the reporting requirements of FDA’s recall regulations, recognizing that there may be a vast difference in the information collection and reporting time involved in different recalls of FDA’s regulated products. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR section Number of responses per respondent Average burden per response Total annual responses Total hours Firm initiated recall (§ 7.46) and recall communications (§ 7.49) .............................................................................. Recall status reports (§ 7.53) ............................................... Termination of a recall (§ 7.55(b)) ....................................... 2,853 2,853 2,853 1 13 1 2,853 37,089 2,853 25 10 10 71,325 370,890 28,530 Total .............................................................................. ........................ ........................ ........................ ........................ 470,745 1 There are no capital costs or operating and maintenance costs associated with this collection of information. I. Total Annual Reporting A. Firm Initiated Recall and Recall Communications We request firms that voluntarily remove or correct foods and drugs (human or animal), cosmetics, medical devices, biologics, and tobacco to immediately notify the appropriate FDA District Office of such actions. The firm is to provide complete details of the recall reason, risk evaluation, quantity produced, distribution information, firms’ recall strategy, and a contact official as well as requires firms to notify their direct accounts of the recall and to provide recipients with a ready means of reporting to the recalling firm. Under these portions of the collection of information, the Agency estimates it will receive 2,853 responses annually based on the average number of recalls over the last 3 fiscal years. The number of responses multiplied by the number of respondents equals 2,853. The average burden hours, 25, multiplied by total number of annual responses equal 71,325. B. Recall Status Reports We request that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall. This request only applies to firms with active recalls, and periodic status reports are estimated to be reported every 2 to 4 weeks. This collection of information will generate approximately 2,853 responses annually, based on the average number of recalls over the last 3 fiscal years, 8,560. The number of respondents multiplied by the number of responses per respondents (13) equals a total number of annual responses of 37,089. The total number of responses, 37,089, multiplied by an average burden hours of 10 per response equals a total of 370,890 total hours. C. Termination of a Recall We provide the firms an opportunity to request in writing that FDA end the recall. The Agency estimates it will receive 2,853 responses annually based on the average number of terminations over the past 3 fiscal years. The total annual responses of 2,853 multiplied by the average burden hours of 10 per response equals a total number of hours of 28,530. II. Total Annual Third-Party Disclosure Burden Recall Communications. We request that firms notify their consignees of the recall and to provide recipients with a ready means of reporting to the recalling firm. Under this portion of the collection of information, the Agency estimates firms will provide 4,433,562 notifications annually based on the number of respondents/consignees (2,853) multiplied by the number of disclosures per respondent (1,554). The total number of hours is 248,279 (based on 4,433,562 multiplied by 0.056 hours). TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of respondents 21 CFR section Recall communications (§ 7.49) ........................................... sradovich on DSK3GMQ082PROD with NOTICES 1 There Number of disclosures per respondent 2,853 1,554 Total annual disclosures 4,433,562 Average burden per disclosure Total hours 0.056 248,279 are no capital costs or operating and maintenance costs associated with this information collections. FDA regulates many different types of products including, but not limited to, medical products, food and feed, cosmetics, and tobacco products. FDA notes that not all third-party disclosures provided by firms to their consignees are similar in nature and may entail different methods and mediums of communication. FDA estimates the burden for third-party disclosure per recall event to be an average of 25 hours. This burden estimate factored out to the average number of consignees per recall VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 (1,554) results in a burden per disclosure estimate of approximate hours (25 hours per recall/1,554 disclosures/recall = 0.056 hours). Dated: November 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–24923 Filed 11–16–17; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–6152] Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability BILLING CODE 4164–01–P PO 00000 AGENCY: Food and Drug Administration, HHS. Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\17NON1.SGM 17NON1 54362 ACTION: Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices Notice. The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Siemens Healthcare Diagnostics, Inc. and Chembio Diagnostic Systems, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) 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 Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, 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 Siemens Healthcare Diagnostics, Inc. is effective as of September 18, 2017; the Authorization for Chembio Diagnostic Systems, Inc. is effective as of September 27, 2017. 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. SUMMARY: sradovich on DSK3GMQ082PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Carmen Maher, 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: VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 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 ensure 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 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 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\17NON1.SGM 17NON1 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 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. sradovich on DSK3GMQ082PROD with NOTICES II. EUA Requests for In Vitro Diagnostic Devices for Detection of the Zika Virus On February 26, 2016, 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 Zika virus. On February 26, 2016, 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 tests for detection of VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 Zika virus and/or diagnosis of Zika virus infection, 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 March 2, 2016 (81 FR 10878). On September 8, 2017, Siemens Healthcare Diagnostics, Inc. requested, and on September 18, 2017, FDA issued, an EUA for the ADVIA Centaur Zika test, subject to the terms of the Authorization. On September 14, 2017, Chembio Diagnostic Systems, Inc. requested, and on September 27, 2017, FDA issued an EUA for the DPP Zika IgM Assay System, subject to the terms of the Authorization. III. Electronic Access An electronic version of this document and the full text of the PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 54363 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 two in vitro diagnostic devices for detection of Zika 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 an explanation of the reasons for issuance, as required by section 564(h)(1) of the FD&C Act: BILLING CODE 4164–01–P E:\FR\FM\17NON1.SGM 17NON1 54364 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 8, 20!7 Matthew Gee, M.Sc. VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Inc. Frm 00049 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.020</GPH> sradovich on DSK3GMQ082PROD with NOTICES Senior M"'n:><Jf'r, ''"'l'.u"w"' Siemens lleal!heare 511 Benedict Avenue N'{ 10591-5097 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54365 )), Zika virus. Pursuant section the basis of such determination, '"<'''''"'""' the authorization concluded that the criteria issuance of this authorization under section of the U.S£. § are met I am the emergency of the ADVI.A Centaur Zika test (as described in the of Authorization section of this leuer CDC Zika virus clinical criteria (e.g., clinical in individuals and/or CDC Zika virus cnlde:mJtOI<D!lJ,cal associated with Zika virus of residence in or travel with active Zika transmission at the time oftravel, or other criteria which Zika virus described in the of Auth<>ri?~tion section of this letter tc• ••.~·'··deteetion of Zika virus inli>Ptiirm authorization. I. Criteria for lssuaru.:e of Authorization the """"!"';'"'" meets the t\et, because I have concluded I have C(lnduded that the t~mcr~<em:v nn;~litflti;re detection of Zika issuance of an authorization that: l, The Zika virus can cause Zika virus intection, a serious or condition to humans infl.~ted with the 7 Based t'l!l the of scientific evidence available to FDA, it that the A.DVIA Centaur reasonable to believe '"''"rr•v"''' and available a!ternati ve to the emergency use of the clla:gnos1ngZika virus infection. VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.021</GPH> sradovich on DSK3GMQ082PROD with NOTICES l !3·5. under section of a sign ill can! 54366 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 3 Mr. Gee. Siemens Healtheare U. of Authm·izatiou authori:r.atlon Act. that the •>~""'"';.,"''!laboratories lor the Centaur Zika test CDC Zika antibodies The Authorized AJlVIA Cenhmr Zika Tt·st P!l1JertH1naten~:d serum CDC Zika virus clinical criteria CDC Zika virus with active Zika virus Zika transmission at the time may be '"'''"~t~··1 The ADVIA Centaur Zika test is of the ADVIA Centaur Zika Ab and ADVIA Centaur Zika assays. All AOVIA Centaur Zika Ab reactive must be tested with the ADVIA Centaur Zika assay. ADVIA Centaur Zika Ab In the first pass, coated fromthe Th.: anti·Zika antibodies earnm·ed with aeridinium fimnaL antibodies resl::tsoendled. ln the second the Solid Phase are detected addition of NSJ '-'~"'"'··---H for chemiluminescent detection. In from the antibodies are washt:d and In the seeond pass, the amhLIKa Solid Phase is detected the ""'"'"'·""ofNS! labeled with acridinium ester (Lite fin chemi!uminescent detection, VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4725 AD VIA Centaur E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.022</GPH> sradovich on DSK3GMQ082PROD with NOTICES The AD VIi\. Centaur Zika test includes use ofthe ADVIA Centaur XP XPT and other authorized instruments. Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 4 Mr. .. calibrators; control AD VIA Centaur ZHm test "' • " • • 54367 ADVIA Centaur ZikaM ADV!A Centaur ZikaM ADVIA Centaur ZikaM Cal!i1:ratl)l' ..... ~l>ti!llt'u Value Card ami ADVIA Centaur ZikaM Master ADVIA Centaur ZikaM control control as~ng11ed value card and barcode labels Control and barcode labels ADV.IA Centaur Zika test the or additional materials and reagents com11110111Y used in dlnicallaboratories and that are described in the authori:?.ed AD VIA Centaur Instructions fhr The above described i\DVIA Centaur Zika test when labeled FDA entitled ·'ADVIA Centaur Zika test" the information ""'rt"'inirm healthcare ADVlA Centaur • Fact Sheet for Healthcare • Fact Sheet for Patients: U!'lde:rst~mdin)l VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Siemens Healthcare Frm 00052 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.023</GPH> sradovich on DSK3GMQ082PROD with NOTICES Other Fact Sheets deve!OO<:!'d with concurrence the Chief Scientist Results 54368 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 5 described in Section IV below, ~~{~m~~ns make available additional infimnation ADVlA Centaur Zika test that of authorizFltinn. pursuant to of the Acl, !hat it reasonable to believe that the known and benefits ofthe authorized AD VIA Centaur Zika when used for have pursuant to section of the Act based on the ofscicntit1c evidence available to FDA, that it is reasonable to believe that the authorized ADVIA Centaur of recent Zika virus when used Zika test may be effective in the of of this letter tn section with the ofthe Act has reviewed the scicntille inthmuuion available to FDA. '""'"'''""' Section I above, and concludes Centaur Zika test, when used to Zika virus infection in the described in the of of this letter set tl:1rth in section ""'II"'" um! the conclusions described The emergency usc of the authorized ADVIA Centaur Zika test under this consistent and may not exceed, the terms ofthis letter, the Audt<)rization and the Conditions of Authori:tlttion IV). to the tenns of this EUA and under the circumstances set forth in the HHS's detennination described above and the ofHHS's declaration under section ). to Zika virus infection in the AD VIA Centaur Zika test described above is individuals CDC Zika time the Waivea· of Certain the duration of sradovich on DSK3GMQ082PROD with NOTICES the VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.024</GPH> m. will cease to be effective when the HHS declaration !hat c!r•cmnstan<:es of the Act when the Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54369 !l.k Gee, Siemens Healthcare Uu!gnostics Inc. (2! LLS.C. on the usc of the device ''"'""''"'" and any available infom1ation re~:an:iin·g "'""t;·,,."'""'"'" under 21 CFR IV. Conditions of Authorization Pursuant to section 564 ofthe .Act, I am '"''·""''"'" this authoriz<llkm: A. Siemens Healthcare and authorized to authorized authorized ADVIA Centaur Zika laboratories. Siemens Healthcare vti>i':HVM''"~ to the authorized Siemens Healthcare Dillgnostlcs in Such requests 'vvi!l be made consultation with, and Ct)ncurrence ot: Dlv1D/OIRJCDRH. [t Siemens Heahheare and its authorized to authorized laboratories the authorized ADV.!A Centaur Zika tesl Fact Sheet fbr Hca.lthcare Providers the authorized ADVIA Centaur Zika Fact Sheet tbr Patients, and any additional ADVlA Centaur Zika test Fact Sheets for Healtheare Prnv.iders and Patients that OCETlOCS/OC and Dl\ltDI'O!R!CDRH autl1orize. (' Siemens Healtheare "''.'"'""'"'""' {)rl their websitcs the nmnm'l7('fl Providers and the authorized and any additional AD VIA Centaur Sheets Healthcare Pmviders and Patients that OCET/OCSIOC and DJvtDfOIR/CDRH may authorize. VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.025</GPH> sradovich on DSK3GMQ082PROD with NOTICES D. Siemens Heahhcarc and its authori?ed '"''''""'''' will infonn of this EUA. health ·mtfmr•'"' authoriz£d laboratories and relevant the terms and conditions herein. 54370 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices Healthcare Di<lgnostics lnc. authorized dis:trilJut,or(.s) AIJVIA Centaur healthcare nrn,vlcters lmlhn'''"''d G. Siemens Healthcare information on the report to FDA any and authorized will collect ofthe test Siemens Healthcare will occurrence of lalsc and talse resulls and ~•gm!Jtc<uudeviations from the established characteristics ofthe test of which Siemens Healthcare becomes aware. authorized to of the authorized ten11s ofthis H. Siemens Healthcare make available ADVV\ Centaur lika letter of authoriztltion. L Siemens llealthcare ADVIA Centaur Zika lest. "'"'"""'"' authorized l Siemens Healthcare amendments that materials K. Siemens He:llthcaw Centaur Zika test Zika test I mmnn'il ms~h requests listed in this condition in consultation DMD/()IRJCDRlL ~~ 'u"'""'u~<•uuuwi!l be made Siemens Hcaltheare concurrence of. OCEl:tOCS/OC and VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.026</GPH> sradovich on DSK3GMQ082PROD with NOTICES L, Siemens .He<'llthcare may request the addition of other instruments l{)r use \Vith the authorized AD VIA Centaur Zika tesL Such requests will be lllilde Siemens Heatthcarc in consultation with, and concurrence DMD/OIR/CDRll. Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices Siemens 54371 Heailh,~arc t'hr with the '"'' ...·""''"·''·" Siemens Healt!u:at·e DMD/OIR/CDRIL with, and types for Siemens J!ealthcare may request the addition of other use with the authorized i\DVIA Centaur Zika test Such requests will be made Siemens Healthcare in consultation and concurrence DJ\.10/0lRlC:DRH. 0. Siemens Healthcare may request the addition of other materials fbr use with the authorized ADVIA Centaur Zika test Such requests >viii he made in consultation Siemens liealt.hcare and DMDlOIR/CDRH. P. SieJnens Healtheare m!!.nostH:s may request substitution tbt· or authorized materials in the process of the human 'u"'"'·"'" Siemens Heallhcare DilU!Il:osl.ics D!vtD/OIR/CDRH~ Siemens Healthcare CFR Part 803. of the ADVJA Centaur R. Siemens Healtheare will evaluate the of characterized clinical Zika test with any FDA-recommended or established After D!'viD/OIR/CDRl I's "'">rim.,·n~ and will subn1it that data to review of and concurrence with the data, Sicmen$ Hcalthcare will in consultation and with concurrence ol~ DMD/OIR/CDRR to reflect the additional S. Siemens llealthcare will test with any FDA-recommended reft~rencc of the ADVI,.\ Centaur Zika After submission to FDA and t~m1currence to of the ADVIA Centau.r 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00056 on a semi-annm~l basis. Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.027</GPH> sradovich on DSK3GMQ082PROD with NOTICES Siemens Healthcare Zika test ami report to VerDate Sep<11>2014 with the data, Siemens Hca!thcarc the additional 54372 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices Authorized Laboratories reports of the results ADVIA Centaur Hea!theare Providers authorized Fact Shee! tor Patients. and additional Centaur Zika test Sheets for Hea!theare Providers and Patients that OCETlOCS/OC and DMD/OIR/CDRH may authorize. Linder other v. each collected alonu~;ide .,,.,..,.;,,"''"' '""~,,.;..,,,,," or >vith other authorized ~~c·~'M·'-~" Y. \\lithin the United States and its territories, authorized laboratories all Zika Positive results to Siemens Healthcarc ~n'"!.!.'"'~'"""· Authorized laboratories the l!nal int,,,..,,,.,,;,nio Zika Positive, for antibodies to Zika antibodies to Zika virus). described in the Instructions document, to healthC<!fC nrrwt,rH•t·~ Authorized laboratories will have results . addilional VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00057 to Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.028</GPH> sradovich on DSK3GMQ082PROD with NOTICES BR Authorized laboratories will hcalthcare nwrn.·t.rl•''"" Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54373 Authorized laboratories \Vill collect intbrmation on the "''1rfi''""'"'"'" Centaur Zika test and DMDIOIR/CDRH {via and Authorized Siemens Uealthcare lli:ilglms;tic!>, Its Authorized l.aboratories authorized records associated with this made available to FDA notified request FF. All and matter to the use of the authoriz.ed ADVlA Centaur Zika test shall be consistent ·with the authorized Fact Sheets the 1em1s set fhrth in this EllA and the and FDA GG. use of the that This aulhori zed This test has laboratories: virus infection This tesl has been and r\ot for any other i'l>t tbe duration of the declaration that ernergcncy usc of in m""'" v""'' the authorization vitro tests for detection ofZika virus and/or infection under of the Act, 21lLS.C Zika virus l ), VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.029</GPH> sradovich on DSK3GMQ082PROD with NOTICES unless the authorization is terminated or revoked sooner. 54374 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices or ADVIA Centaur Zika test may l'<'l''r"~"'nl dil~IUIOS!S tlf virus ini'Cct.ion. ''""'~''"'~rwv usc of the authori:t:ed ADVIA Centaur Zika \Vlth !hC <;VJIIUIUUIII:'I V. DuratiGn of AutbGrization This \Vill be efTectivc until the declaration that circumstances the authorization of the emergency use vitro tests for detection of Zi.ka virus and/or u"'lS''u"'" of Zika virus infection is terrninated under section ofthc Act the EUA is revoked under section VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.030</GPH> sradovich on DSK3GMQ082PROD with NOTICES Enclosures Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54375 3661 Horseblock Road Medford, NY 11763 Dearfl,k with active transmission at the time of travel. or other Zika virus laboratories in the United States that are certified under the to Amcndzncnts of 1988 ~·'''~'''¥" 26, 2016, pursuant to section the of Health and Human Services fi1r a health emergency that has a 360bbbtbere is a ~X1t.el11lia! to affect VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.031</GPH> sradovich on DSK3GMQ082PROD with NOTICES comple.~ity 54376 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices issued under concluded that the criteria 1\lr issuance ofthis authorization under section of the are met l the emergency use of the DPP Zika ofAutl1orization section ofthis letter (Section (as described in the m<:etimg CDC Zika virus clinical criteria a of clinical and Zika virus criteria of residence in or travel to a with active Zika transmis;lion at the ep:tacmil)!Ogtcat criteria tor which Zika virus may be mcuclltc•:tJ for I he rm~sum!Jiti the terms of I. Criteria for Issuance of Authorization concluded thai the emergency use ofthe DPP Zika detection ofZika virus meets the criteria for issuance of an authori:ration under section have concluded that: '""'~"'"""1 I. fhc Zika vims can cause Zika virus conditim1 to humans infected with the virus; 1. 3. There is no '"''"'Y'·'"'~'· "'""''"'·'•'··• and available altcmmive to the emergency use of the DPP Zika Zika virus infection. As amended by the Pandcmk and All·Ha?l'!rds Preparedness Reauthnrizatkm Act. Pub. ofthe Act, the Secretary may determination of a public health""'"'""''"'" lbr a public health em~rgem;y. VerDate Sep<11>2014 18:32 Nov 16, 2017 mul D····laralh!Jt l?.e£aniii1JIJCn11!<'<'l?FlCV Jkt 244001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.032</GPH> sradovich on DSK3GMQ082PROD with NOTICES Df'itt'rl•iilli11ilm under sect k111 <lh signifkam Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54377 Inc. U. of Allthorization authorit,ation is "m""'"'"''t~laboratories for ···~-"Ub CDC Zika of residence in or Del"itlltn1l~d" nh,nrirlm,~ and/or test results for other for the the latest of Zika ·virus Tbe Authori.zed JlPP Zika "'"'"'"'''"m'n"'""' lateral ""•·•tv'tl"'~ nmv assay in human serum orEDTA '"''"''''"''' • s•nec•m,ens and otlu~r area <md a area in the test·control wind0\1/ ofthe test device. 'I'he reagent tbr the detection of ZIK V based on human that colored ~.;vlt!~::~.;•~::u and then diluted with belbre \llell# l ofthe DPP Zika Test Device. The ;;:ne:cm!lcn ammcmv~mnmtng the TEST colored antibodies bound to the TEST colored COJI1jugal.e and detection is nPt·fi"'"""'l authorized instruments, that uses ass:av·-so;ecu sradovich on DSK3GMQ082PROD with NOTICES line and measure color VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 itto area will capture the the Chcmhio DPP Micro Reader, or other the presence of the control '""'""''"'Q the results in the TEST Frm 00062 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.033</GPH> membrane and is delivered 54378 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices Mr. Inc. \Vith a or invalid result consideration of test lnnrith'""' for the dHIJ.;Il.()S!S DPP Zika materials and instruments. or other authorized materials and instruments: control materials tbe nrt\\fli'ii>rl .. DPP Zi.ka other authorized with !he test; Control Padc DPP Zika Reactive Contmt DPP Nonreactive insert The assay controls are used to the user's to results. and federal eo11tml the use of additional materials and :n1.~.w:4rv latiOflitOJ•ies and that arc described in the authorized DPP The above described DPP Zika authorized FDA entitled "DPP Zika and "DPP Zika when labeled with the " "DPP Micro Reader. "DPP Zika Rcicrcnce Instructions. not meet certain otherwise Chembin in consultation with, and v.·ith concurrence of, the Division of Devices Vitro and Health KaiJHltog!ctu l1eal!h sradovich on DSK3GMQ082PROD with NOTICES MI!Ct\JOW,IO~~Y VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.034</GPH> lle revised Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 5 54379 Mr. rmu"m''"' entcrJ~~:ertcv information aulht1rized to be ac<:ornp<mu~d use. which is authorized available to healthcam Otht~r Fact Sheets Chembio in em1sultation with. and with concurrence the Office of Counterterrorism and Threats of the Chief Scientist of the Commissioner and DMD!OIR/CDRII may be authorized to ac<x1mpany the above described DPP Zika Assay and 10 be made available to healthcare and "'"""''"'· described in Section IV below. Chembio is also authorized to make available additional to the emergency authorized DPP Zika that consistent ;vith, and does no! the 1em1s of this letter inihnmttion detection of this letter '~"•V"'~" the known I have concluded, pursuant to section of the Act based on the ofsdentific evidence available to that it is reasonable to believe that the authorized DPI' Zika of recent Zika vims infection. when used may be e!Tcctive in the of Authorization ofthis letter pursuant to section VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.035</GPH> sradovich on DSK3GMQ082PROD with NOTICES "'"'?'"'"~'"'" ust~ of the authorized DPP Zika consistent '"''ilh. and may no! exceed, the terms ofthis letter. ami the Conditions of Authorization t() the Authorization tenns of this EUA and under the circumstances set t(ll1h in the of HHS's determination described above and the of HHS's declaration under section ). the DPP Zika Zika virus infection in individuals a of clinical and '""""''""'" associated with Zika virus and/or CDC Zika virus criteria of residence in ot travel transmission at the time oftmveL or other be 54380 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices EUA will cease to be et!ectivc when the IHIS declaration that circumstances exist to the EUA is tcm1inated under st.-ction of the Act when the is revoked of the Act under section m. Waiver of Certain I am the duration of this EUA: ir.-m .. nt< the DPP Zika the under 21 CrR Part 820 with respect to the storage, and distribution of the DPP Zika .. and any available intormatit1n """'"""d''"" under2l CFR ne1rli\:rrn::lrl<'<' IV. Conditions of Authorization Pursuant to section 564 of the Act, f am '""'""''"'"m~" the this authorization: conditions on will distribute the authorized DPI' Zika to authorized laboratories. Chcmbio be made Such DMD/OIR/CDRH. '""ill It Chembio and its aulhmizcd to authorized la!:lOratories the authorized DPP Zika tbr Hcalthcare Providers and the authorized DPP Zika Fact Sheet fhr Patients. and additional DPP Zika fact Sheets !or Heal!hcare Providers and Patients that OCET/OCS/OC and DMD/OJR/CDRH may authorize" VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.036</GPH> sradovich on DSK3GMQ082PROD with NOTICES C Chembio and i!s authorized will make available on their \vcbsites the authorized DPP Zika Fact Sheet tor Hcalthcare Providers and the authorized DPP Zika Fact Sheet fbr Patients, and any additional DPP Zika Sheets l'br Healtheare Providers and Patients that OCET/OCS/OC and D!VlO/OIR/CDRH may authorize. Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54381 7 ?v1r. D. will inform authorized labmatories and the Ct'lndi t ions Chembio and its authorized authorized DPP Zika resulls to healthcare ·~··"·"'"'"'"" a process will controL Chemblo and its authorized maintain records of device usage. G. Chembio and its authorized will collect information on the""'''''{'',""''"' ofthe assay. Chembio will report to FDA any occurrence of false and false results and deviations from the established '"''rtr'r"'""'''"' characteristics of the Chembio and its authorized infonnation that "'"''""''"'arc authorized to 1nake of the authorized DPP the terms auth~lrization. L Chembio and its authorized Control Pack control material or other authorized comml materials for same time the DPP Zika at the Cbembio authorized K. Chembio will be Chembio may request the authorized DPP Zika Sheet for Hea.lthcare and the authorized DPP Zlka Sheet for Patients. Chembio may also Sheets for Healtheare Providers and Patients, !IPI'ropri~ne, and ma}' request such Fact Sheets. All such requests listed in condition <}f authorization will be OCET/OCSlOC made Chembio in consultation with, <md VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.037</GPH> sradovich on DSK3GMQ082PROD with NOTICES and DrviD/OlR/CDRII. 54382 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices ~L request the addition of other instruments ft•r use with the authorized Such requests \Viii be made Chembio in eonsultaliQn com::urrence of, D!VfD/()!R/CDIUL Chembi" DPP Zika and Chembio request the addition of oiher reagents fin with the authorized Zika Such requests will be made Chembio in consultation with. and concurrence ot: D!'v1D/OIR/CDRI!. 0. Chembio may request the addition of other types for use with the authori7:ed DPP Zika Such requests will be made Chembio in consultation with. and DMD/OlRlCDRH. the addition of other control materials fbr u~"e with the Such will be made Chcmbio in P. consultation Chembio may substitution for enrnu'"'~ to the authorized materials used in the dctcctil.m process of the human anti·Zika in the Such requests will be made Chcmbio in consultation \Vi!h, R. Chembio ;viii track adverse events and report to FDA undcr2l CFR Part 803. S. Chembio will evaluate the Assay with any of characterized clinical and FDA-recommended or established will submit that data to FDA After DMD/OIRlCDRH's revie\V of and Chcmbio will its in commltalion with, and '""ith concurrence to reflect the additional T. Chcmbio \lv'i!l with any FDArecommended l"cfet·encc to FDA and DMD/OIR/CDRH's review ofand concurrence with the data, Chembio will its to reJ:1eet the additional of the DPP Zika Chembio will track the D!'v1D/OIR/CDRH 011 a semi-annual and report to V Authorized laboratories will include with reports of the results of the DPP Zika the authorized Fact Sheet f<Jr Healtheare Providers and the authorized Fact for and any additional DPP Zika Fact Sheets tor Hcalthearc Providers and Patients ahat OCETIOCS/OC and DMDlOIR/CDRH may authorize. Under other methods VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.038</GPH> sradovich on DSK3GMQ082PROD with NOTICES mlllerial. Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices these Fact Sheets may be 54383 may include mass media. X. !fnon-senm1 ~'""'"""''"'" laboratories Authorized laboratories must read the results ofthe DPP Zika authorized instruments. DPP Micro Reader or on inrm·"'""' the results DPP Zika terl'itories. authorized la!1,or!ttm!les Zika to Chembio. l. to ensure report all 1~)r reactive results described in !he Instructions BB. Authorized laboratories \\~ll have hcalthcare ami re.lcvant to CC Authorized laboratories will collect information on the J~c~·tmmance and DMD/OIR/CDRH (via email .:. ·'"·'·"'·'·····' and VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.039</GPH> sradovich on DSK3GMQ082PROD with NOTICES in accordance with the assay must also be trained in of the DPP Zika 54384 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices and Authorized Laboratories Chembio. its authorized records associated with this will be made available to FDA and authorized laboratories will ensure that. an.Y maintained until notified FDA. Such records inspel:Ll(m upon request matter the use of the Assay shall be consistent with the authorized Fact '"""'"""'· as well as the terms set torth in this and the FF. in the Act and FDA re~::cuwmons. 00. All and ""'''",.,''""''"'r authorized DPP Zika state that: for This test has been authorized " This test has been authorized and not tor <my other viruses or patMJ;en.s; authorized virus intection the authorization oft he emergency usc of in tests t(Jr detection of Zika virus and/or of Zika virus ). l) of!hc Act, 21 U.S. C. infection under section unless the authorization is tem1ina1cd or revoked sooner. vitro matter to the use safe authorized eflective for the of the authorized DPP Zika as described this letter must with the conditions and all olher tenns ofthis authorization, •"m<'r<J't".lu'v use •H""'i'mh."'" V. Duration of Authorization VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4725 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.040</GPH> sradovich on DSK3GMQ082PROD with NOTICES the This EUA will be efl:cctive until the declaration that cireurnstanecs authorization ofthe ''"'~'r''"""'" usc vilro tests for detection of Zika virus and/or <mtgnos11s of Zika virus is terminated under section ofthe Act or the EU A is revoked under section of the Dated: November 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–25010 Filed 11–16–17; 8:45 am] BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–6159] Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ‘‘Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.’’ The draft guidance, when finalized, will provide stakeholders engaged in the development of regenerative medicine therapies with FDA’s current thinking on the expedited development and review of these products. The draft guidance describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions (referred to in the draft guidance as serious conditions), including those products designated as regenerative advanced therapies (which FDA refers to as ‘‘regenerative medicine advanced therapy’’ (RMAT) designation); describes how the Center for Biologics Evaluation and Research (CBER) will work with sponsors and encourage flexibility in clinical trial design to facilitate the development of data to demonstrate the safety and effectiveness of regenerative medicine therapies being developed to address sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 unmet medical needs in patients with serious or life-threatening diseases or conditions; and describes the opportunities for sponsors of regenerative medicine therapies to interact with CBER review staff. DATES: Submit either electronic or written comments on the draft guidance by February 15, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 54385 Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2017–D–6159 for ‘‘Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 E:\FR\FM\17NON1.SGM 17NON1 EN17NO17.041</GPH> Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices

Agencies

[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54361-54385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6152]


Authorizations of Emergency Use of In Vitro Diagnostic Devices 
for Detection of Zika Virus; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 54362]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of two Emergency Use Authorizations (EUAs) (the 
Authorizations) for in vitro diagnostic devices for detection of the 
Zika virus in response to the Zika virus outbreak in the Americas. FDA 
issued these Authorizations under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act), as requested by Siemens Healthcare Diagnostics, 
Inc. and Chembio Diagnostic Systems, Inc. The Authorizations contain, 
among other things, conditions on the emergency use of the authorized 
in vitro diagnostic devices. The Authorizations follow the February 26, 
2016, determination by the Secretary of Health and Human Services (HHS) 
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 
Zika virus. On the basis of such determination, the Secretary of HHS 
declared on February 26, 2016, that circumstances exist justifying the 
authorization of emergency use of in vitro diagnostic tests for 
detection of Zika virus and/or diagnosis of Zika virus infection, 
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 Siemens Healthcare Diagnostics, Inc. is 
effective as of September 18, 2017; the Authorization for Chembio 
Diagnostic Systems, Inc. is effective as of September 27, 2017.

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, 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 ensure 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 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

[[Page 54363]]

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 
Zika Virus

    On February 26, 2016, 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 Zika virus. 
On February 26, 2016, 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 tests for detection of Zika virus and/or diagnosis of 
Zika virus infection, 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 
March 2, 2016 (81 FR 10878). On September 8, 2017, Siemens Healthcare 
Diagnostics, Inc. requested, and on September 18, 2017, FDA issued, an 
EUA for the ADVIA Centaur Zika test, subject to the terms of the 
Authorization. On September 14, 2017, Chembio Diagnostic Systems, Inc. 
requested, and on September 27, 2017, FDA issued an EUA for the DPP 
Zika IgM Assay System, subject to the terms of the Authorization.

III. Electronic Access

    An electronic version of this document 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 two in vitro diagnostic devices for 
detection of Zika 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 an 
explanation of the reasons for issuance, as required by section 
564(h)(1) of the FD&C Act:
BILLING CODE 4164-01-P

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    Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-25010 Filed 11-16-17; 8:45 am]
 BILLING CODE 4164-01-C