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