Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability, 39653-39672 [2016-14380]

Download as PDF Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: sradovich on DSK3TPTVN1PROD with NOTICES I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA has approved for marketing the medical device ZILVER PTX DRUG VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 ELUTING PERIPHERAL STENT. ZILVER PTX DRUG ELUTING PERIPHERAL STENT is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameters from 4 millimeters (mm) to 9 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient. Subsequent to this approval, the USPTO received a patent term restoration application for ZILVER PTX DRUG ELUTING PERIPHERAL STENT (U.S. Patent No. 6,299,604) from Cook Medical Technologies, LLC, and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated March 25, 2014, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of ZILVER PTX DRUG ELUTING PERIPHERAL STENT represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for ZILVER PTX DRUG ELUTING PERIPHERAL STENT is 3,075 days. Of this time, 2,180 days occurred during the testing phase of the regulatory review period, while 895 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: June 16, 2004. FDA has verified the applicant’s claim that the date the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective was June 16, 2004. 2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): June 4, 2010. FDA has verified the applicant’s claim that the premarket approval application (PMA) for ZILVER PTX DRUG ELUTING PERIPHERAL STENT (PMA P100022) was initially submitted June 4, 2010. 3. The date the application was approved: November 14, 2012. FDA has verified the applicant’s claim that PMA P100022 was approved on November 14, 2012. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 39653 This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,826 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: June 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–14356 Filed 6–16–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–1486] Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika 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) for two in vitro diagnostic devices for detection of 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 Focus Diagnostics, Inc., and altona Diagnostics GmbH. The Authorizations contain, SUMMARY: E:\FR\FM\17JNN1.SGM 17JNN1 39654 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices sradovich on DSK3TPTVN1PROD with NOTICES 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 Department of Health and Human Services (HHS) Secretary that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the HHS Secretary 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 explanations of the reasons for issuance, are reprinted in this document. DATES: The Authorization for Focus Diagnostics, Inc., is effective as of April 28, 2016, and the Authorization for altona Diagnostics GmbH is effective as of May 13, 2016. 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. SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) as amended by the Project BioShield Act of 2004 (Pub. L. 108–276) and the Pandemic and AllHazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help assure that medical countermeasures may be VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 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), PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 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 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 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\17JNN1.SGM 17JNN1 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices sradovich on DSK3TPTVN1PROD with NOTICES 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 April 26, 2016, Focus Diagnostics, Inc., requested, and on April 28, 2016, FDA issued, an EUA for the Zika Virus RNA Qualitative Real- VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 Time RT–PCR test, subject to the terms of the Authorization. On May 11, 2016, altona Diagnostics GmbH requested, and on May 13, 2016, FDA issued, an EUA for the RealStar® Zika Virus RT–PCR Kit U.S., subject to the terms of the Authorization. III. Electronic Access An electronic version of this document and the full text of the Authorizations are available on the Internet at https://www.regulations.gov. PO 00000 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 explanations of the reasons for their issuance, as required by section 564(h)(1) of the FD&C Act. BILLING CODE 4164–01–P Frm 00032 Fmt 4703 Sfmt 4703 39655 E:\FR\FM\17JNN1.SGM 17JNN1 39656 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.007</GPH> sradovich on DSK3TPTVN1PROD with NOTICES Dear Mr. Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39657 I. Criteria for Issuance of Authorization L VerDate Sep<11>2014 16:48 Jun 16, 2016 of Authorization Jkt 238001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.008</GPH> sradovich on DSK3TPTVN1PROD with NOTICES II. VerDate Sep<11>2014 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.009</GPH> sradovich on DSK3TPTVN1PROD with NOTICES 39658 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39659 VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.010</GPH> sradovich on DSK3TPTVN1PROD with NOTICES Control 39660 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices am the PCR IV. Conditions of Authorization VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.011</GPH> sradovich on DSK3TPTVN1PROD with NOTICES Focus Dililltll:oslics, Inc. Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39661 D. CFR Part H. VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.012</GPH> sradovich on DSK3TPTVN1PROD with NOTICES L 39662 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices Authorized Laboratories RT- VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.013</GPH> sradovich on DSK3TPTVN1PROD with NOTICES Conditions Related to Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39663 VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.014</GPH> sradovich on DSK3TPTVN1PROD with NOTICES V. Duration or Authorization 39664 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.015</GPH> sradovich on DSK3TPTVN1PROD with NOTICES Dear Dr. Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39665 I. Criteria for Issuance of Authorization VerDate Sep<11>2014 16:48 Jun 16, 2016 of Authorization Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.016</GPH> sradovich on DSK3TPTVN1PROD with NOTICES 11. 39666 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.017</GPH> sradovich on DSK3TPTVN1PROD with NOTICES Zika Virus RT-PCR Kit Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39667 • • PCR Kit U.S. VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.018</GPH> sradovich on DSK3TPTVN1PROD with NOTICES authori7~tion. 39668 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices III. Waiver of Certain .. IV. Conditions of Authorization VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.019</GPH> sradovich on DSK3TPTVN1PROD with NOTICES altona Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39669 D. E. G. VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.020</GPH> sradovich on DSK3TPTVN1PROD with NOTICES I. 39670 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices L. 0. P. and under I CFR VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.021</GPH> sradovich on DSK3TPTVN1PROD with NOTICES Authorized Laboratories Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39671 and Authorized l,aboratorics Conditions Related to X. • test • • VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4725 E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.022</GPH> sradovich on DSK3TPTVN1PROD with NOTICES • 39672 Dated: June 13, 2016. Leslie Kux, Associate Commissioner for Policy. guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 16, 2016. [FR Doc. 2016–14380 Filed 6–16–16; 8:45 am] BILLING CODE 4164–01–C ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Electronic Submissions Food and Drug Administration [Docket No. FDA–2007–D–0369] Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances 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 additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft sradovich on DSK3TPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 You may submit comments as follows: Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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): Division of Dockets Management (HFA–305), Food PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2007–D–0369 for ‘‘Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 https:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover E:\FR\FM\17JNN1.SGM 17JNN1 EN17JN16.023</GPH> Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices

Agencies

[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39653-39672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14380]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1486]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of two Emergency Use Authorizations (EUAs) (the 
Authorizations) for two in vitro diagnostic devices for detection of 
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 Focus Diagnostics, Inc., and altona 
Diagnostics GmbH. The Authorizations contain,

[[Page 39654]]

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 Department of Health and Human Services 
(HHS) Secretary that there is a significant potential for a public 
health emergency that has a significant potential to affect national 
security or the health and security of U.S. citizens living abroad and 
that involves Zika virus. On the basis of such determination, the HHS 
Secretary 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 explanations of the reasons 
for issuance, are reprinted in this document.

DATES: The Authorization for Focus Diagnostics, Inc., is effective as 
of April 28, 2016, and the Authorization for altona Diagnostics GmbH is 
effective as of May 13, 2016.

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.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) 
allows FDA to strengthen the public health protections against 
biological, chemical, nuclear, and radiological agents. Among other 
things, section 564 of the FD&C Act allows FDA to authorize the use of 
an unapproved medical product or an unapproved use of an approved 
medical product in certain situations. With this EUA authority, FDA can 
help assure that medical countermeasures may be used in emergencies to 
diagnose, treat, or prevent serious or life-threatening diseases or 
conditions caused by biological, chemical, nuclear, or radiological 
agents when there are no adequate, approved, and available 
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (1) 
A determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack with a biological, 
chemical, radiological, or nuclear agent or agents; (2) a determination 
by the Secretary of Defense that there is a military emergency, or a 
significant potential for a military emergency, involving a heightened 
risk to U.S. military forces of attack with a biological, chemical, 
radiological, or nuclear agent or agents; (3) a determination by the 
Secretary of HHS that there is a public health emergency, or a 
significant potential for a public health emergency, that affects, or 
has a significant potential to affect, national security or the health 
and security of U.S. citizens living abroad, and that involves a 
biological, chemical, radiological, or nuclear agent or agents, or a 
disease or condition that may be attributable to such agent or agents; 
or (4) the identification of a material threat by the Secretary of 
Homeland Security under section 319F-2 of the Public Health Service 
(PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or 
the health and security of U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist 
justifying an authorization under section 564 of the FD&C Act, FDA may 
authorize the emergency use of a drug, device, or biological product if 
the Agency concludes that the statutory criteria are satisfied. Under 
section 564(h)(1) of the FD&C Act, FDA is required to publish in the 
Federal Register a notice of each authorization, and each termination 
or revocation of an authorization, and an explanation of the reasons 
for the action. Section 564 of the FD&C Act permits FDA to authorize 
the introduction into interstate commerce of a drug, device, or 
biological product intended for use when the Secretary of HHS has 
declared that circumstances exist justifying the authorization of 
emergency use. Products appropriate for emergency use may include 
products and uses that are not approved, cleared, or licensed under 
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue 
an EUA only if, after consultation with the HHS Assistant Secretary for 
Preparedness and Response, the Director of the National Institutes of 
Health, and the Director of the Centers for Disease Control and 
Prevention (to the extent feasible and appropriate given the applicable 
circumstances), FDA \1\ concludes: (1) That an agent referred to in a 
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of 
scientific evidence available to FDA, including data from adequate and 
well-controlled clinical trials, if available, it is reasonable to 
believe that: (A) The product may be effective in diagnosing, treating, 
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under 
section 564, approved or cleared under the FD&C Act, or licensed under 
section 351 of the PHS Act, for diagnosing, treating, or preventing 
such a disease or condition caused by such an agent; and (B) the known 
and potential benefits of the product, when used to diagnose, prevent, 
or treat such disease or condition, outweigh the known and potential 
risks of the product, taking into consideration the material threat 
posed by the agent or agents identified in a declaration under section 
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no 
adequate, approved, and available alternative to the product for 
diagnosing, preventing, or treating such disease or condition; and (4) 
that such other criteria as may be prescribed by regulation are 
satisfied.
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    \1\ The Secretary of HHS has delegated the authority to issue an 
EUA under section 564 of the FD&C Act to the Commissioner of Food 
and Drugs.
---------------------------------------------------------------------------

    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 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

[[Page 39655]]

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 April 26, 2016, Focus Diagnostics, Inc., requested, and on 
April 28, 2016, FDA issued, an EUA for the Zika Virus RNA Qualitative 
Real-Time RT-PCR test, subject to the terms of the Authorization. On 
May 11, 2016, altona Diagnostics GmbH requested, and on May 13, 2016, 
FDA issued, an EUA for the RealStar[supreg] Zika Virus RT-PCR Kit U.S., 
subject to the terms of the Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the 
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 
explanations of the reasons for their issuance, as required by section 
564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

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    Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14380 Filed 6-16-16; 8:45 am]
 BILLING CODE 4164-01-C

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