81_FR_61863 81 FR 61690 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability

81 FR 61690 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 173 (September 7, 2016)

Page Range61690-61700
FR Document2016-21353

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 Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as requested by Viracor-IBT Laboratories, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) 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 Secretary of HHS 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 Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

Federal Register, Volume 81 Issue 173 (Wednesday, September 7, 2016) 
[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Pages 61690-61700]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21353]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Authorization of Emergency Use of an In Vitro Diagnostic Device 
for Detection of Zika Virus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 Zika virus in 
response to the Zika virus outbreak in the Americas. FDA issued this 
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) as requested by Viracor-IBT Laboratories, Inc. The Authorization 
contains, among other things, conditions on the emergency use of the 
authorized in vitro diagnostic device. The Authorization follows the 
February 26, 2016, determination by the Secretary of Health and Human 
Services (HHS) 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 
Secretary of HHS 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 Authorization, which includes an explanation of the 
reasons for issuance, is reprinted in this document.

DATES: The Authorization is effective as of July 19, 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

[[Page 61691]]

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.
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    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 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 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 July 7, 2016, Viracor-IBT Laboratories, 
Inc. requested, and on July 19, 2016, FDA issued, an EUA for the Zika 
Virus Real-time RT-PCR test, subject to the terms of the Authorization.

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 Zika virus 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

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    Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21353 Filed 9-6-16; 8:45 am]
 BILLING CODE 4164-01-C

61690 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Number of disclosures Total annual Average burden per 21 CFR Section Total hours respondents per disclosures disclosure respondent 1271.55(a) ................................................................ 1,551 1,422.88 2,206,890 .5 (30 minutes) .......... 1,103,445 1271.60(c) and (d)(2) ............................................... 1,375 416 572,000 .5 (30 minutes) .......... 286,000 1271.290(c) .............................................................. 1,561 1,324.08 2,066,890 .083 (5 minutes) ........ 171,552 1271.290(f) ............................................................... 1,561 1 1,561 1 ................................ 1,561 1271.370(b) and (c) ................................................. 1,561 1,324.08 2,066,890 .25 (15 minutes) ........ 516,723 Total .................................................................. ........................ ........................ ........................ .................................... 2,079,281 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 31, 2016. FD&C Act. The Authorization, which adequate, approved, and available Leslie Kux, includes an explanation of the reasons alternatives. Associate Commissioner for Policy. for issuance, is reprinted in this Section 564(b)(1) of the FD&C Act [FR Doc. 2016–21351 Filed 9–6–16; 8:45 am] document. provides that, before an EUA may be issued, the Secretary of HHS must BILLING CODE 4164–01–P DATES: The Authorization is effective as declare that circumstances exist of July 19, 2016. justifying the authorization based on ADDRESSES: Submit written requests for one of the following grounds: (1) A DEPARTMENT OF HEALTH AND HUMAN SERVICES single copies of the EUA to the Office determination by the Secretary of of Counterterrorism and Emerging Homeland Security that there is a Food and Drug Administration Threats, Food and Drug Administration, domestic emergency, or a significant 10903 New Hampshire Ave., Bldg. 1, potential for a domestic emergency, [Docket No. FDA–2016–N–1486] Rm. 4338, Silver Spring, MD 20993– involving a heightened risk of attack 0002. Send one self-addressed adhesive with a biological, chemical, radiological, Authorization of Emergency Use of an label to assist that office in processing or nuclear agent or agents; (2) a In Vitro Diagnostic Device for your request or include a fax number to determination by the Secretary of Detection of Zika Virus; Availability which the Authorization may be sent. Defense that there is a military AGENCY: Food and Drug Administration, See the SUPPLEMENTARY INFORMATION emergency, or a significant potential for HHS. section for electronic access to the a military emergency, involving a ACTION: Notice. Authorization. heightened risk to U.S. military forces of FOR FURTHER INFORMATION CONTACT: attack with a biological, chemical, SUMMARY: The Food and Drug radiological, or nuclear agent or agents; Administration (FDA) is announcing the Carmen Maher, Office of Counterterrorism and Emerging Threats, (3) a determination by the Secretary of issuance of an Emergency Use HHS that there is a public health Authorization (EUA) (the Authorization) Food and Drug Administration, 10903 emergency, or a significant potential for for an in vitro diagnostic device for New Hampshire Ave., Bldg. 1, Rm. a public health emergency, that affects, detection of the Zika virus in response 4347, Silver Spring, MD 20993–0002, or has a significant potential to affect, to the Zika virus outbreak in the 301–796–8510 (this is not a toll free national security or the health and Americas. FDA issued this number). security of U.S. citizens living abroad, Authorization under the Federal Food, SUPPLEMENTARY INFORMATION: and that involves a biological, chemical, Drug, and Cosmetic Act (the FD&C Act) radiological, or nuclear agent or agents, as requested by Viracor-IBT I. Background or a disease or condition that may be Laboratories, Inc. The Authorization Section 564 of the FD&C Act (21 attributable to such agent or agents; or contains, among other things, U.S.C. 360bbb-3) as amended by the (4) the identification of a material threat conditions on the emergency use of the Project BioShield Act of 2004 (Pub. L. by the Secretary of Homeland Security authorized in vitro diagnostic device. 108–276) and the Pandemic and All- under section 319F–2 of the Public The Authorization follows the February Hazards Preparedness Reauthorization Health Service (PHS) Act (42 U.S.C. 26, 2016, determination by the Secretary Act of 2013 (Pub. L. 113–5) allows FDA 247d–6b) sufficient to affect national of Health and Human Services (HHS) to strengthen the public health security or the health and security of that there is a significant potential for a protections against biological, chemical, U.S. citizens living abroad. public health emergency that has a nuclear, and radiological agents. Among Once the Secretary of HHS has significant potential to affect national other things, section 564 of the FD&C declared that circumstances exist security or the health and security of Act allows FDA to authorize the use of justifying an authorization under U.S. citizens living abroad and that an unapproved medical product or an section 564 of the FD&C Act, FDA may involves Zika virus. On the basis of such unapproved use of an approved medical authorize the emergency use of a drug, determination, the Secretary of HHS product in certain situations. With this device, or biological product if the mstockstill on DSK3G9T082PROD with NOTICES declared on February 26, 2016, that EUA authority, FDA can help assure Agency concludes that the statutory circumstances exist justifying the that medical countermeasures may be criteria are satisfied. Under section authorization of emergency use of in used in emergencies to diagnose, treat, 564(h)(1) of the FD&C Act, FDA is vitro diagnostic tests for detection of or prevent serious or life-threatening required to publish in the Federal Zika virus and/or diagnosis of Zika diseases or conditions caused by Register a notice of each authorization, virus infection, subject to the terms of biological, chemical, nuclear, or and each termination or revocation of an any authorization issued under the radiological agents when there are no authorization, and an explanation of the VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1

Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61691 reasons for the action. Section 564 of the 564, approved or cleared under the Secretary of HHS declared that FD&C Act permits FDA to authorize the FD&C Act, or licensed under section 351 circumstances exist justifying the introduction into interstate commerce of of the PHS Act, for diagnosing, treating, authorization of emergency use of in a drug, device, or biological product or preventing such a disease or vitro diagnostic tests for detection of intended for use when the Secretary of condition caused by such an agent, and Zika virus and/or diagnosis of Zika HHS has declared that circumstances (B) the known and potential benefits of virus infection, subject to the terms of exist justifying the authorization of the product, when used to diagnose, any authorization issued under section emergency use. Products appropriate for prevent, or treat such disease or 564 of the FD&C Act. Notice of the emergency use may include products condition, outweigh the known and determination and declaration of the and uses that are not approved, cleared, potential risks of the product, taking Secretary was published in the Federal or licensed under sections 505, 510(k), into consideration the material threat Register on March 2, 2016 (81 FR or 515 of the FD&C Act (21 U.S.C. 355, posed by the agent or agents identified 10878). On July 7, 2016, Viracor-IBT 360(k), and 360e) or section 351 of the in a declaration under section Laboratories, Inc. requested, and on July PHS Act (42 U.S.C. 262). FDA may issue 564(b)(1)(D) of the FD&C Act, if 19, 2016, FDA issued, an EUA for the an EUA only if, after consultation with applicable; (3) that there is no adequate, Zika Virus Real-time RT–PCR test, the HHS Assistant Secretary for approved, and available alternative to subject to the terms of the Preparedness and Response, the the product for diagnosing, preventing, Authorization. Director of the National Institutes of or treating such disease or condition; Health, and the Director of the Centers and (4) that such other criteria as may III. Electronic Access for Disease Control and Prevention (to be prescribed by regulation are satisfied. An electronic version of this the extent feasible and appropriate No other criteria for issuance have document and the full text of the given the applicable circumstances), been prescribed by regulation under Authorization are available on the FDA1 concludes: (1) That an agent section 564(c)(4) of the FD&C Act. Internet at http://www.regulations.gov. referred to in a declaration of emergency Because the statute is self-executing, or threat can cause a serious or life- regulations or guidance are not required IV. The Authorization threatening disease or condition; (2) for FDA to implement the EUA authority. Having concluded that the criteria for that, based on the totality of scientific issuance of the Authorization under evidence available to FDA, including II. EUA Request for an In Vitro Diagnostic Device for Detection of the section 564(c) of the FD&C Act are met, data from adequate and well-controlled FDA has authorized the emergency use clinical trials, if available, it is Zika Virus On February 26, 2016, the Secretary of of an in vitro diagnostic device for reasonable to believe that: (A) The detection of Zika virus subject to the product may be effective in diagnosing, HHS determined that there is a significant potential for a public health terms of the Authorization. The treating, or preventing (i) such disease Authorization in its entirety (not emergency that has a significant or condition or (ii) a serious or life- including the authorized versions of the potential to affect national security or threatening disease or condition caused fact sheets and other written materials) the health and security of U.S. citizens by a product authorized under section follows and provides an explanation of living abroad and that involves Zika 1 The Secretary of HHS has delegated the virus. On February 26, 2016, under the reasons for its issuance, as required authority to issue an EUA under section 564 of the section 564(b)(1) of the FD&C Act, and by section 564(h)(1) of the FD&C Act: FD&C Act to the Commissioner of Food and Drugs. on the basis of such determination, the BILLING CODE 4164–01–P mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1

61692 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices Dear mstockstill on DSK3G9T082PROD with NOTICES EN07SE16.020</GPH> VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1

Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61693 I. Criteria for Issuance of Authorization U. of Authorization mstockstill on DSK3G9T082PROD with NOTICES EN07SE16.021</GPH> VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1

61694 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices The Authorized Zika Virus Real-time RT -PCR test the mstockstill on DSK3G9T082PROD with NOTICES EN07SE16.022</GPH> VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1

Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61695 .. each .. .. .. mstockstill on DSK3G9T082PROD with NOTICES EN07SE16.023</GPH> VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1

61696 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices III. mstockstill on DSK3G9T082PROD with NOTICES EN07SE16.024</GPH> VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1

Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61697 Conditions of Authorization this D. herein. H. mstockstill on DSK3G9T082PROD with NOTICES EN07SE16.025</GPH> VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1

61698 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices luc. M. 0. mstockstill on DSK3G9T082PROD with NOTICES EN07SE16.026</GPH> VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1

Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61699 Authorized laboratories T. v. w. and Authorized Laboratories BB. mstockstill on DSK3G9T082PROD with NOTICES EN07SE16.027</GPH> VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4725 E:\FR\FM\07SEN1.SGM 07SEN1

61700 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices Dated: August 31, 2016. requesting comments related to the Electronic Submissions Leslie Kux, regulatory status of vinpocetine. Submit electronic comments in the Associate Commissioner for Policy. Specifically, we request comments on following way: [FR Doc. 2016–21353 Filed 9–6–16; 8:45 am] our tentative conclusion that • Federal eRulemaking Portal: http:// BILLING CODE 4164–01–C vinpocetine is not a dietary ingredient www.regulations.gov. Follow the and is excluded from the definition of instructions for submitting comments. dietary supplement in the Federal Food, Comments submitted electronically, DEPARTMENT OF HEALTH AND Drug, and Cosmetic Act (FD&C Act). including attachments, to http:// HUMAN SERVICES This action is being taken as part of an www.regulations.gov will be posted to administrative proceeding to determine the docket unchanged. Because your Food and Drug Administration the regulatory status of vinpocetine. All comment will be made public, you are [Docket No. FDA–2016–N–2523] comments submitted by the comment solely responsible for ensuring that your deadline (see DATES) will be accepted as comment does not include any Request for Comment on the Status of part of the official record for this confidential information that you or a mstockstill on DSK3G9T082PROD with NOTICES Vinpocetine proceeding. third party may not wish to be posted, AGENCY: Food and Drug Administration, such as medical information, your or DATES: Submit either electronic or HHS. anyone else’s Social Security number, or written comments on the notice by ACTION: Notice. confidential business information, such November 7, 2016. as a manufacturing process. Please note SUMMARY: The Food and Drug ADDRESSES: You may submit comments that if you include your name, contact EN07SE16.028</GPH> Administration (FDA or we) is as follows: information, or other information that VerDate Sep<11>2014 17:30 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1


Document Created: 2016-09-07 11:50:17
Document Modified: 2016-09-07 11:50:17
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe Authorization is effective as of July 19, 2016.
ContactCarmen 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 Citation81 FR 61690 
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