81 FR 44616 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 131 (July 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 131 (July 8, 2016)
| Page Range | 44616-44626 | |
| FR Document | 2016-16176 |
[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)] [Notices] [Pages 44616-44626] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16176] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1206] Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Ebola Zaire virus in response to the Ebola virus outbreak in West Africa. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Biocartis NV. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health [[Page 44617]] and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of Ebola virus, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document. DATES: The Authorization is effective as of May 26, 2016. ADDRESSES: Submit written requests for single copies of the EUA to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorization. FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993- 0002, 301-796-8510 (this is not a toll free number). SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help assure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives. Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a biological, chemical, radiological, or nuclear agent or agents; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security under section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or the health and security of U.S. citizens living abroad. Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k), and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA \1\ concludes: (1) That an agent referred to in a declaration of emergency or threat can cause a serious or life- threatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) The product may be effective in diagnosing, treating, or preventing (i) such disease or condition; or (ii) a serious or life- threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; and (4) that such other criteria as may be prescribed by regulation are satisfied. --------------------------------------------------------------------------- \1\ The Secretary of HHS has delegated the authority to issue an EUA under section 564 of the FD&C Act to the Commissioner of Food and Drugs. --------------------------------------------------------------------------- No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. Because the statute is self- executing, regulations or guidance are not required for FDA to implement the EUA authority. II. EUA Request for an In Vitro Diagnostic Device for Detection of the Ebola Zaire Virus On September 22, 2006, then-Secretary of DHS, Michael Chertoff, determined that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security \2\. On August 5, 2014, under section 564(b)(1) of the FD&C Act and on the basis of such determination, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of Ebola virus, subject to the terms of any authorization issued under section 564 of the FD&C Act. Notice of the declaration of the Secretary was published in the Federal Register on [[Page 44618]] August 12, 2014 (79 FR 47141). On May 2, 2016, Biocartis NV submitted a complete request for, and on May 26, 2016, FDA issued, an EUA for the IdyllaTM Ebola Virus Triage Test, subject to the terms of the Authorization. --------------------------------------------------------------------------- \2\ Under section 564(b)(1) of the FD&C Act, the HHS Secretary's declaration that supports the EUA issuance must be based on one of four determinations, including the identification by the DHS Secretary of a material threat under section 319F-2 of the PHS Act sufficient to affect national security or the health and security of U.S. citizens living abroad (section 564(b)(1)(D) of the FD&C Act. --------------------------------------------------------------------------- III. Electronic Access An electronic version of this document and the full text of the Authorization are available on the Internet at http://www.regulations.gov. IV. The Authorization Having concluded that the criteria for issuance of the Authorization under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of an in vitro diagnostic device for detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) subject to the terms of the Authorization. The Authorization in its entirety (not including the authorized versions of the fact sheets and other written materials) follows and provides an explanation of the reasons for its issuance, as required by section 564(h)(1) of the FD&C Act: BILLING CODE 4164-01-P [[Page 44619]] [GRAPHIC] [TIFF OMITTED] TN08JY16.000 [[Page 44620]] [GRAPHIC] [TIFF OMITTED] TN08JY16.001 [[Page 44621]] [GRAPHIC] [TIFF OMITTED] TN08JY16.002 [[Page 44622]] [GRAPHIC] [TIFF OMITTED] TN08JY16.003 [[Page 44623]] [GRAPHIC] [TIFF OMITTED] TN08JY16.004 [[Page 44624]] [GRAPHIC] [TIFF OMITTED] TN08JY16.005 [[Page 44625]] [GRAPHIC] [TIFF OMITTED] TN08JY16.006 [[Page 44626]] [GRAPHIC] [TIFF OMITTED] TN08JY16.007 Dated: July 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-16176 Filed 7-7-16; 8:45 am] BILLING CODE 4164-01-C
![44616 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices
it satisfies the requirements of the V. Other Issues for Consideration calculated using only analytical results
applicable statutes and regulations. The Agency invites comments on the without taking into account prevalence
draft guidance document entitled ‘‘Use in a population, it is sometimes called
III. Electronic Access ‘‘technical’’ PPV (TPPV) to distinguish it
of Standards in FDA Regulatory
Persons interested in obtaining a copy Oversight of Next Generation from prevalence-based PPV. What are
of the draft guidance may do so by Sequencing (NGS)-Based In Vitro the benefits and weaknesses to assessing
downloading an electronic copy from Diagnostics (IVDs) Used for Diagnosing NGS-based test accuracy using TPPV in
the Internet. A search capability for all Germline Diseases,’’ in general, and on addition to PPA and NPA, or instead of
Center for Devices and Radiological the following questions, in particular: NPA?
Health guidance documents is available 1. Does the draft guidance content 5. Are the minimum performance
at http://www.fda.gov/MedicalDevices/ adequately address the analytical thresholds presented in this draft
DeviceRegulationandGuidance/ performance of targeted and whole guidance appropriate, or are alternative
GuidanceDocuments/default.htm, and exome human DNA sequencing (WES) thresholds more appropriate? Are there
for Center for Biologics Evaluation and NGS-based tests intended to aid in the ‘‘best ways’’ to determine acceptable
Research guidance documents is diagnosis of individuals with suspected thresholds for each metric? Are there
available at http://www.fda.gov/ germline diseases or other conditions performance metrics that do not require
BiologicsBloodVaccines/ (referred to as ‘‘NGS-based tests for minimum thresholds? Are there test
germline diseases’’ or ‘‘NGS-based tests’’ scenarios where minimum thresholds
GuidanceCompliance
in the guidance)? For example, do the are not useful or relevant?
RegulatoryInformation/Guidances/
recommendations outlined in the draft 6. How can bias and over-fitting be
default.htm. Guidance documents are
guidance adequately address the minimized or accounted for if known
also available at http://
analytical performance of NGS-based ‘‘reference’’ samples are used as
www.regulations.gov. Persons unable to
tests used as an aid in diagnosis of comparators in accuracy studies?
download an electronic copy of ‘‘Use of
Standards in FDA Regulatory Oversight patients with signs and symptoms of Dated: July 5, 2016.
of Next Generation Sequencing (NGS)- developmental delay or intellectual Leslie Kux,
Based In Vitro Diagnostics (IVDs) Used disability, undiagnosed diseases, or Associate Commissioner for Policy.
for Diagnosing Germline Diseases’’ may hereditary cancer syndromes? If not, [FR Doc. 2016–16201 Filed 7–7–16; 8:45 am]
send an email request to CDRH- what additional test design, BILLING CODE 4164–01–P
Guidance@fda.hhs.gov to receive an development, or validation activities are
electronic copy of the document. Please necessary for analytical validation of
use the document number 16009 to such tests? Are there specific DEPARTMENT OF HEALTH AND
identify the guidance you are indications within this broad intended HUMAN SERVICES
requesting. use that require different or additional
test design, development, or validation Food and Drug Administration
IV. Paperwork Reduction Act of 1995 activities from those described in the
[Docket No. FDA–2014–N–1206]
draft guidance?
This guidance refers to previously 2. Do the recommendations in the
approved collections of information Authorization of Emergency Use of an
draft guidance adequately address the In Vitro Diagnostic Device for
found in FDA regulations. These analytical validation of NGS-based tests
collections of information are subject to Detection of Ebola Zaire Virus;
that use targeted panels or WES? Availability
review by the Office of Management and Targeted sequencing panels? Are there
Budget (OMB) under the Paperwork differences between the use of targeted AGENCY: Food and Drug Administration,
Reduction Act of 1995 (44 U.S.C. 3501– panels and WES that were not HHS.
3520). The collections of information in adequately distinguished in the ACTION: Notice.
21 CFR part 807, subpart E, regarding recommendations described in the draft
premarket notification submissions, guidance? SUMMARY: The Food and Drug
have been approved under OMB control 3. The recommendations in this Administration (FDA) is announcing the
number 0910–0120; the collections of document focus on WES and targeted issuance of an Emergency Use
information in 21 CFR part 801 and 21 NGS-based tests for germline diseases. Authorization (EUA) (the Authorization)
CFR 809.10, regarding labeling, have Are the recommendations outlined in for an in vitro diagnostic device for
been approved under OMB control the guidance sufficient to address detection of the Ebola Zaire virus in
number 0910–0485; the collections of analytical validation for whole genome response to the Ebola virus outbreak in
information in 21 CFR part 814, sequencing (WGS) NGS-based tests for West Africa. FDA issued this
subparts A through E, regarding germline diseases? If not, what Authorization under the Federal Food,
premarket approval, have been additional test design, development, Drug, and Cosmetic Act (the FD&C Act),
approved under OMB control number and validation activities are needed to as requested by Biocartis NV. The
0910–0231; the collections of address the analytical validation of such Authorization contains, among other
information in 21 CFR part 820, tests? things, conditions on the emergency use
regarding the quality system regulation, 4. Accuracy is generally described of the authorized in vitro diagnostic
have been approved under OMB control using an agreement, typically positive device. The Authorization follows the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
number 0910–0073; and the collections and negative percent agreement (PPA September 22, 2006, determination by
of information in the guidance and NPA), between a new test and an then-Secretary of the Department of
document ‘‘Requests for Feedback on accepted reference method. For NGS- Homeland Security (DHS), Michael
Medical Device Submissions: The Pre- based tests, positive predictive value Chertoff, that the Ebola virus presents a
Submission Program and Meetings with (PPV) may be a more meaningful metric material threat against the U.S.
Food and Drug Administration Staff’’ than NPA when calculating the population sufficient to affect national
have been approved under OMB control likelihood that a variant call detected by security. On the basis of such
number 0910–0756. the test is a true positive. If PPV is determination, the Secretary of Health
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Document Created: 2016-07-08 00:17:29
Document Modified: 2016-07-08 00:17:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The Authorization is effective as of May 26, 2016. | |
| 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). | |
| FR Citation | 81 FR 44616 |
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