Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug, 29883 [C1-2017-10818]

Download as PDF Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices Dated: June 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2017–13664 Filed 6–29–17; 8:45 am] [Docket No. FDA–2016–N–0969] Food and Drug Administration BILLING CODE 4164–01–P Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus AGENCY: Food and Drug Administration ACTION: [Docket No. FDA–2013–N–0523] Correction In notice document 2017–10818 appearing on pages 24351 through 24356 in the issue of Friday, May 26, make the following correction: On page 24351, in the third column, under the DATES heading, in the third line ‘‘June 26, 2017’’ should read ‘‘July 25, 2017’’. mstockstill on DSK30JT082PROD with NOTICES [FR Doc. C1–2017–10818 Filed 6–29–17; 8:45 am] VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 SUPPLEMENTARY INFORMATION: Notice. The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Roche Molecular Systems, Inc. for the LightMix® Zika rRT–PCR Test. FDA revoked this Authorization on March 13, 2017, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Roche Molecular Systems, Inc. by letter dated March 10, 2017. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document. SUMMARY: Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug BILLING CODE 1505–01–D Food and Drug Administration, HHS. The Authorization is revoked as of March 13, 2017. 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 DATES: PO 00000 Frm 00063 Fmt 4703 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: 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). Sfmt 4703 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 26, 2016, FDA issued an EUA to Roche Molecular Systems, Inc. for the LightMix® Zika rRT–PCR Test, 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. Under section 564(g)(2), the Secretary of Health and Human Services may revoke an EUA if, among other things, the criteria for issuance are no E:\FR\FM\30JNN1.SGM 30JNN1 EN30JN17.269</GPH> DEPARTMENT OF HEALTH AND HUMAN SERVICES 29883

Agencies

[Federal Register Volume 82, Number 125 (Friday, June 30, 2017)]
[Notices]
[Page 29883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: C1-2017-10818]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0523]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Applications for Food and Drug Administration Approval 
To Market a New Drug

Correction

    In notice document 2017-10818 appearing on pages 24351 through 
24356 in the issue of Friday, May 26, make the following correction:
    On page 24351, in the third column, under the DATES heading, in the 
third line ``June 26, 2017'' should read ``July 25, 2017''.

[FR Doc. C1-2017-10818 Filed 6-29-17; 8:45 am]
 BILLING CODE 1505-01-D