Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of Zika Virus, 38636-38638 [2019-16881]

Download as PDF jspears on DSK3GMQ082PROD with NOTICES 38636 Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices systems, population, analytes) for the types of assessments discussed in item (1)(b)(i) above? Please describe the rationale for any design considerations proposed. (2) Evaluating the Pharmacokinetics in Organ Impairment (a) Under what circumstances are organ impairment assessments for oligonucleotide therapeutics warranted or not warranted for: (i) Renal function (ii) hepatic function (b) In circumstances where organ impairment assessments are warranted: (i) What types of assessments are suitable for renal and/or hepatic impairment and why (e.g., dedicated clinical studies, population pharmacokinetic analyses)? Please discuss the advantages, challenges, and limitations with each type of assessment. (ii) What are the study design considerations (e.g., study population) for the types of assessments discussed in item (2)(b)(i) above for renal and/or hepatic impairment? Please describe the rationale for any design considerations proposed. (3) Evaluating Immunogenicity (a) Under what circumstances are immunogenicity assessments of oligonucleotide therapeutics warranted or not warranted? (b) In circumstances where immunogenicity assessments are warranted: What types of assessments are suitable and why (e.g., antibodies against other components of the formulation, antibodies against a newly created ‘‘splice-altered’’ protein, neutralizing titers, cytokine measurements)? Please discuss the advantages, challenges, and limitations with each type of assessment. (4) Evaluating QT Prolongation (a) Under what circumstances are cardiac electrophysiology assessments warranted or not warranted in the evaluation of oligonucleotide therapeutics? (b) In circumstances where cardiac electrophysiology assessments are warranted: What types of assessments are suitable and why (e.g., hERG inhibition assay, thorough QT assessment) in nonclinical or clinical studies? Please discuss the advantages, challenges, and limitations with each type of assessment. (5) With regard to the four questions above, when a sponsor seeks to rely on previously generated data and information that it owns or to which it has a right of reference, what scientific findings may be applied across the VerDate Sep<11>2014 16:49 Aug 06, 2019 Jkt 247001 sponsor’s oligonucleotide therapeutics with shared characteristics (e.g., similar backbone modifications)? FDA will consider all information and comments submitted. III. Electronic Access Persons with access to the internet may obtain relevant clinical pharmacology guidances at https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents. Dated: August 2, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–16880 Filed 8–6–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–3277] Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of Zika Virus AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to InBios International, Inc. (InBios), for the ZIKV Detect 2.0 IgM Capture ELISA. FDA revoked this Authorization on May 23, 2019, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in consideration of the De Novo classification request granted to the InBios ZIKV Detect 2.0 IgM Capture ELISA as a Class II device under the generic name Zika virus serological reagents on May 23, 2019. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document. SUMMARY: The Authorization is revoked as of May 23, 2019. ADDRESSES: Submit written requests for single copies of the revocation 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 selfaddressed adhesive label to assist that office in processing your request or include a fax number to which the revocation may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocation. DATES: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993–0002, 240–402–8155 (this is not a toll free number). SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) as amended by the Project BioShield Act of 2004 (Pub L. 108–276) and the Pandemic and AllHazards Preparedness Reauthorization Act of 2013 (Pub L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among 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. On August 17, 2016, FDA issued an EUA to InBios for the ZIKV Detect 2.0 IgM Capture ELISA, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on October 28, 2016 (81 FR 75092), as required by section 564(h)(1) of the FD&C Act. In response to requests from InBios, the EUA was amended on March 27, 2017, and May 18, 2018. Under section 564(g)(2) of the FD&C Act, the Secretary of Health and Human Services (HHS) may revoke an EUA if, among other things, the criteria for issuance are no longer met. II. EUA Criteria for Issuance No Longer Met On March 23, 2019, FDA revoked the EUA for the InBios ZIKV Detect 2.0 IgM Capture ELISA because the criteria for issuance were no longer met. Under section 564(c)(3) of the FD&C Act, an EUA may be issued only if FDA concludes there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition. The InBios ZIKV Detect 2.0 IgM Capture ELISA had a De Novo classification request granted as a Class II device under the generic name Zika virus serological reagents on May 23, 2019 (https://www.accessdata.fda.gov/cdrh_ docs/pdf18/DEN180069.pdf). FDA has concluded that this is an adequate, approved, and available alternative for diagnosing Zika virus infection. III. Electronic Access An electronic version of this document and the full text of the revocation are available on the internet at https://www.regulations.gov/. E:\FR\FM\07AUN1.SGM 07AUN1 Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices IV. The Revocation Having concluded that the criteria for revocation of the Authorization under section 564(g) of the FD&C Act are met, FDA has revoked the EUA for the InBios ZIKV Detect 2.0 IgM Capture ELISA. The revocation in its entirety follows 38637 and provides an explanation of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act. BILLING CODE 4164–01–P VerDate Sep<11>2014 16:49 Aug 06, 2019 Jkt 247001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4725 E:\FR\FM\07AUN1.SGM 07AUN1 EN07AU19.000</GPH> jspears on DSK3GMQ082PROD with NOTICES Dear 38638 Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices [FR Doc. 2019–16881 Filed 8–6–19; 8:45 am] BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3771] Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability AGENCY: Food and Drug Administration, jspears on DSK3GMQ082PROD with NOTICES HHS. VerDate Sep<11>2014 18:14 Aug 06, 2019 Jkt 247001 ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency’s annual report entitled ‘‘Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.’’ Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. FOR FURTHER INFORMATION CONTACT: Kathy Weil, Center for Drug Evaluation and Research, Food and Drug SUMMARY: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5367, Silver Spring, MD 20993–0002, 301–796–0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: E:\FR\FM\07AUN1.SGM 07AUN1 EN07AU19.001</GPH> Dated: August 1, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy.

Agencies

[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38636-38638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3277]


Revocation of Authorization of Emergency Use of an In Vitro 
Diagnostic Device for Detection and/or Diagnosis of Zika Virus

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorization (EUA) (the Authorization) 
issued to InBios International, Inc. (InBios), for the ZIKV Detect 2.0 
IgM Capture ELISA. FDA revoked this Authorization on May 23, 2019, 
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in 
consideration of the De Novo classification request granted to the 
InBios ZIKV Detect 2.0 IgM Capture ELISA as a Class II device under the 
generic name Zika virus serological reagents on May 23, 2019. The 
revocation, which includes an explanation of the reasons for 
revocation, is reprinted in this document.

DATES: The Authorization is revoked as of May 23, 2019.

ADDRESSES: Submit written requests for single copies of the revocation 
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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 240-402-8155 (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. On August 17, 2016, FDA issued 
an EUA to InBios for the ZIKV Detect 2.0 IgM Capture ELISA, subject to 
the terms of the Authorization. Notice of the issuance of the 
Authorization was published in the Federal Register on October 28, 2016 
(81 FR 75092), as required by section 564(h)(1) of the FD&C Act. In 
response to requests from InBios, the EUA was amended on March 27, 
2017, and May 18, 2018. Under section 564(g)(2) of the FD&C Act, the 
Secretary of Health and Human Services (HHS) may revoke an EUA if, 
among other things, the criteria for issuance are no longer met.

II. EUA Criteria for Issuance No Longer Met

    On March 23, 2019, FDA revoked the EUA for the InBios ZIKV Detect 
2.0 IgM Capture ELISA because the criteria for issuance were no longer 
met. Under section 564(c)(3) of the FD&C Act, an EUA may be issued only 
if FDA concludes there is no adequate, approved, and available 
alternative to the product for diagnosing, preventing, or treating the 
disease or condition. The InBios ZIKV Detect 2.0 IgM Capture ELISA had 
a De Novo classification request granted as a Class II device under the 
generic name Zika virus serological reagents on May 23, 2019 (https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180069.pdf). FDA has 
concluded that this is an adequate, approved, and available alternative 
for diagnosing Zika virus infection.

III. Electronic Access

    An electronic version of this document and the full text of the 
revocation are available on the internet at https://www.regulations.gov/.

[[Page 38637]]

IV. The Revocation

    Having concluded that the criteria for revocation of the 
Authorization under section 564(g) of the FD&C Act are met, FDA has 
revoked the EUA for the InBios ZIKV Detect 2.0 IgM Capture ELISA. The 
revocation in its entirety follows and provides an explanation of the 
reasons for revocation, as required by section 564(h)(1) of the FD&C 
Act.
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[[Page 38638]]


[GRAPHIC] [TIFF OMITTED] TN07AU19.001


    Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16881 Filed 8-6-19; 8:45 am]
BILLING CODE 4164-01-C

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