82_FR_29992 82 FR 29867 - Authorization of Emergency Use of an Injectable Treatment for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning; Availability

82 FR 29867 - Authorization of Emergency Use of an Injectable Treatment for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 125 (June 30, 2017)

Page Range29867-29883
FR Document2017-13664

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an injectable treatment for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized injectable treatment. The Authorization follows the April 11, 2017, determination by the Department of Health and Human Services (HHS) Secretary 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 nerve agents or certain insecticides (organophosphorus and/or carbamate). On the basis of such determination, the HHS Secretary declared on April 11, 2017, that circumstances exist justifying the authorization of emergency use of injectable treatments for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning, 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 82 Issue 125 (Friday, June 30, 2017) 
[Federal Register Volume 82, Number 125 (Friday, June 30, 2017)]
[Notices]
[Pages 29867-29883]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-13664]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3224]


Authorization of Emergency Use of an Injectable Treatment for 
Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) 
Poisoning; 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 injectable treatment for nerve agent or certain insecticide 
(organophosphorus and/or carbamate) poisoning. FDA issued this 
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as requested by the U.S. Centers for Disease Control and 
Prevention (CDC). The Authorization contains, among other things, 
conditions on the emergency use of the authorized injectable treatment. 
The Authorization follows the April 11, 2017, determination by the 
Department of Health and Human Services (HHS) Secretary 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 nerve agents 
or certain insecticides (organophosphorus and/or carbamate). On the 
basis of such determination, the HHS Secretary declared on April 11, 
2017, that circumstances exist justifying the authorization of 
emergency use of injectable treatments for nerve agent or certain 
insecticide (organophosphorus and/or carbamate) poisoning, 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 April 11, 2017.

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.

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

[[Page 29868]]

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 CDC (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 Injectable Treatment for Nerve Agent or Certain 
Insecticide (Organophosphorus and/or Carbamate) Poisoning

    On April 11, 2017, under section 564(b)(1)(C) of the FD&C Act, 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 nerve agents or certain insecticides 
(organophosphorus and/or carbamate). On April 11, 2017, 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 injectable treatments for nerve agent 
or certain insecticide (organophosphorus and/or carbamate) poisoning, 
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 April 17, 2017 (82 
FR 18152). On March 9, 2017, CDC requested, and on April 11, 2017, FDA 
issued, an EUA for the 2 mg Rafa Atropine Auto-Injector, manufactured 
by Rafa Laboratories Ltd., 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 https://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 injectable treatment for nerve agent 
or certain insecticide (organophosphorus and/or carbamate) poisoning 
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.

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    Dated: June 26, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13664 Filed 6-29-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29867 Estimated Total Annual Burden poisoning. FDA issued this an unapproved medical product or an Hours: 258,215. Authorization under the Federal Food, unapproved use of an approved medical In compliance with the requirements Drug, and Cosmetic Act (the FD&C Act), product in certain situations. With this of the Paperwork Reduction Act of 1995 as requested by the U.S. Centers for EUA authority, FDA can help assure (Pub. L. 104–13, 44 U.S.C. Chap 35), the Disease Control and Prevention (CDC). that medical countermeasures may be Administration for Children and The Authorization contains, among used in emergencies to diagnose, treat, Families is soliciting public comment other things, conditions on the or prevent serious or life-threatening on the specific aspects of the emergency use of the authorized diseases or conditions caused by information collection described above. injectable treatment. The Authorization biological, chemical, nuclear, or Copies of the proposed collection of follows the April 11, 2017, radiological agents when there are no information can be obtained and determination by the Department of adequate, approved, and available comments may be forwarded by writing Health and Human Services (HHS) alternatives. to the Administration for Children and Secretary that there is a significant Section 564(b)(1) of the FD&C Act Families, Office of Planning, Research potential for a public health emergency provides that, before an EUA may be and Evaluation, 330 C Street SW., that has a significant potential to affect issued, the Secretary of HHS must Washington DC 20201. Attn: ACF national security or the health and declare that circumstances exist Reports Clearance Officer. Email security of U.S. citizens living abroad justifying the authorization based on address: infocollection@acf.hhs.gov. All and that involves nerve agents or certain one of the following grounds: (1) A requests should be identified by the title insecticides (organophosphorus and/or determination by the Secretary of of the information collection. carbamate). On the basis of such Homeland Security that there is a The Department specifically requests determination, the HHS Secretary domestic emergency, or a significant comments on: (a) Whether the proposed declared on April 11, 2017, that potential for a domestic emergency, collection of information is necessary circumstances exist justifying the involving a heightened risk of attack for the proper performance of the authorization of emergency use of with a biological, chemical, radiological, functions of the agency, including injectable treatments for nerve agent or or nuclear agent or agents; (2) a whether the information shall have certain insecticide (organophosphorus determination by the Secretary of practical utility; (b) the accuracy of the and/or carbamate) poisoning, subject to Defense that there is a military agency’s estimate of the burden of the the terms of any authorization issued emergency, or a significant potential for proposed collection of information; (c) under the FD&C Act. The Authorization, a military emergency, involving a the quality, utility, and clarity of the which includes an explanation of the heightened risk to U.S. military forces of information to be collected; and (d) reasons for issuance, is reprinted in this attack with a biological, chemical, ways to minimize the burden of the document. radiological, or nuclear agent or agents; collection of information on DATES: The Authorization is effective as (3) a determination by the Secretary of respondents, including through the use of April 11, 2017. HHS that there is a public health of automated collection techniques or ADDRESSES: Submit written requests for emergency, or a significant potential for other forms of information technology. single copies of the EUA to the Office a public health emergency, that affects, Consideration will be given to of Counterterrorism and Emerging or has a significant potential to affect, comments and suggestions submitted Threats, Food and Drug Administration, national security or the health and within 60 days of this publication. 10903 New Hampshire Ave., Bldg. 1, security of U.S. citizens living abroad, Rm. 4338, Silver Spring, MD 20993– and that involves a biological, chemical, Robert Sargis, 0002. Send one self-addressed adhesive radiological, or nuclear agent or agents, Reports Clearance Officer. label to assist that office in processing or a disease or condition that may be [FR Doc. 2017–13726 Filed 6–29–17; 8:45 am] attributable to such agent or agents; or your request or include a fax number to (4) the identification of a material threat BILLING CODE 4184–01–P which the Authorization may be sent. by the Secretary of Homeland Security See the SUPPLEMENTARY INFORMATION under section 319F–2 of the Public section for electronic access to the DEPARTMENT OF HEALTH AND Health Service (PHS) Act (42 U.S.C. Authorization. HUMAN SERVICES 247d–6b) sufficient to affect national FOR FURTHER INFORMATION CONTACT: security or the health and security of Food and Drug Administration Carmen Maher, Office of U.S. citizens living abroad. Counterterrorism and Emerging Threats, Once the Secretary of HHS has [Docket No. FDA–2017–N–3224] Food and Drug Administration, 10903 declared that circumstances exist Authorization of Emergency Use of an New Hampshire Ave., Bldg. 1, Rm. justifying an authorization under Injectable Treatment for Nerve Agent 4347, Silver Spring, MD 20993–0002, section 564 of the FD&C Act, FDA may or Certain Insecticide 301–796–8510. authorize the emergency use of a drug, (Organophosphorus and/or SUPPLEMENTARY INFORMATION: device, or biological product if the Carbamate) Poisoning; Availability Agency concludes that the statutory I. Background criteria are satisfied. Under section AGENCY: Food and Drug Administration, Section 564 of the FD&C Act (21 564(h)(1) of the FD&C Act, FDA is HHS. U.S.C. 360bbb–3) as amended by the required to publish in the Federal ACTION: Notice. Project BioShield Act of 2004 (Pub. L. Register a notice of each authorization, 108–276) and the Pandemic and All- and each termination or revocation of an mstockstill on DSK30JT082PROD with NOTICES SUMMARY: The Food and Drug Hazards Preparedness Reauthorization authorization, and an explanation of the Administration (FDA) is announcing the Act of 2013 (Pub. L. 113–5) allows FDA reasons for the action. Section 564 of the issuance of an Emergency Use to strengthen the public health FD&C Act permits FDA to authorize the Authorization (EUA) (the Authorization) protections against biological, chemical, introduction into interstate commerce of for an injectable treatment for nerve nuclear, and radiological agents. Among a drug, device, or biological product agent or certain insecticide other things, section 564 of the FD&C intended for use when the Secretary of (organophosphorus and/or carbamate) Act allows FDA to authorize the use of HHS has declared that circumstances VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1

29868 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices exist justifying the authorization of prevent, or treat such disease or authorization of emergency use of emergency use. Products appropriate for condition, outweigh the known and injectable treatments for nerve agent or emergency use may include products potential risks of the product, taking certain insecticide (organophosphorus and uses that are not approved, cleared, into consideration the material threat and/or carbamate) poisoning, subject to or licensed under sections 505, 510(k), posed by the agent or agents identified the terms of any authorization issued or 515 of the FD&C Act (21 U.S.C. 355, in a declaration under section under section 564 of the FD&C Act. 360(k), and 360e) or section 351 of the 564(b)(1)(D) of the FD&C Act, if Notice of the determination and PHS Act (42 U.S.C. 262). FDA may issue applicable; (3) that there is no adequate, declaration of the Secretary was an EUA only if, after consultation with approved, and available alternative to published in the Federal Register on the HHS Assistant Secretary for the product for diagnosing, preventing, April 17, 2017 (82 FR 18152). On March Preparedness and Response, the or treating such disease or condition; 9, 2017, CDC requested, and on April Director of the National Institutes of and (4) that such other criteria as may 11, 2017, FDA issued, an EUA for the Health, and the Director of the CDC (to be prescribed by regulation are satisfied. 2 mg Rafa Atropine Auto-Injector, the extent feasible and appropriate No other criteria for issuance have manufactured by Rafa Laboratories Ltd., given the applicable circumstances), been prescribed by regulation under subject to the terms of the FDA 1 concludes: (1) That an agent section 564(c)(4) of the FD&C Act. Authorization. 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 III. Electronic Access threatening disease or condition; (2) for FDA to implement the EUA An electronic version of this that, based on the totality of scientific authority. document and the full text of the evidence available to FDA, including II. EUA Request for an Injectable Authorization are available on the data from adequate and well-controlled Treatment for Nerve Agent or Certain Internet at https://www.regulations.gov. clinical trials, if available, it is Insecticide (Organophosphorus and/or reasonable to believe that: (A) The IV. The Authorization Carbamate) Poisoning product may be effective in diagnosing, Having concluded that the criteria for treating, or preventing (i) such disease On April 11, 2017, under section 564(b)(1)(C) of the FD&C Act, the issuance of the Authorization under or condition; or (ii) a serious or life- section 564(c) of the FD&C Act are met, threatening disease or condition caused Secretary of HHS determined that there is a significant potential for a public FDA has authorized the emergency use by a product authorized under section of an injectable treatment for nerve 564, approved or cleared under the health emergency that has a significant potential to affect national security or agent or certain insecticide FD&C Act, or licensed under section 351 (organophosphorus and/or carbamate) of the PHS Act, for diagnosing, treating, the health and security of U.S. citizens living abroad and that involves nerve poisoning subject to the terms of the or preventing such a disease or Authorization. The Authorization in its agents or certain insecticides condition caused by such an agent; and entirety (not including the authorized (organophosphorus and/or carbamate). (B) the known and potential benefits of versions of the fact sheets and other On April 11, 2017, under section the product, when used to diagnose, written materials) follows and provides 564(b)(1) of the FD&C Act, and on the 1 The Secretary of HHS has delegated the basis of such determination, the an explanation of the reasons for its authority to issue an EUA under section 564 of the Secretary of HHS declared that issuance, as required by section FD&C Act to the Commissioner of Food and Drugs. circumstances exist justifying the 564(h)(1) of the FD&C Act. mstockstill on DSK30JT082PROD with NOTICES VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1

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Page 2 = Dr. Schuchat, CDC emergency response stakeholders, and DoD for preparedness purposes in advance of an actual nerve agent or certain insecticide (organophosphorus and/or carbamate) potsoning event, with the intent that it may be administered by healthcare providers or caregivers, or be self— administered, during an event or post—event for treatment of the muscarimic symptoms of poisoning caused by exposure to these agents_" An EUA is needed to facilitate CDC, emergency response stakeholder, and DoD pre—event planning and preparedness activities related to the use of this unapproved product to enable activities to support rapid administration oftreatment during an actual emergency event involving nerve agents or certain insecticides {organophosphorus and/or carbamate) (e.g., distribution and use of fact sheets about the product, pre—event distribution and stockpiling of an unapproved product, administration of an unapproved product without a preseription, and administration by individuals who are not licensed professionally to administer the product). This EUA is important for emergency response purposes because it enables rapid initiation of treatment with the Rafa Atropine Auto— Injector during a nerve agent or insecticide emergency without FDA and CDC, emergency response stakcholders, or DoD having to take further action with respect to otherwise applicable requirements under federal law. Other atropine auto—injectors previously have been approved by FDA to treat nerve agent and insecticide poisoning in adults and children. However, at the fime of issuance of this EUA, FDA—approved atropine auto—injectors for the treatment of nerve agent or certain insecticide {organophosphorus and/or carbamate) poisoning were not available to replenish the Department‘s Strategic National Stockpile inventory when the products in the current inventory expire." This EUA will help to facilitate the fulffliment of national preparedness and stockpiling requirements and needs for newatropine auto—injectors. Having concluded that the criteria for issuance of this authorizatton under section 564(¢) of the Act (21 U.S.C, § 360bbb—3(c)) are met, 1 am authorizing the emergency use of the Rafa Atropine Auto—Injector (as described in the Seope of Authorization section of this letter {Section [{}) in the specified population (as described in the Scope of Authorization section of this letter (Section 1)) for the initial treatment of muscarinic symptoms of poisoning by susceptiblenerve agents or certain insecticides (organophosphorus and/or carbamate}, subject to the terms of this authorization. This EUA applies in all circumstances when CDC, emergency response stakeholders, and/or DoD reasonably believe that there is a need to store, distribute, and/or administer the authorized Rafa Atropine Auto—Injector without an individual prescription in an emergency because of their constituents" known, suspected, or likely imminent exposure to nerve agents or certain insecticides {organophosphorus and/or carbamate)." * For purposes of this EUA, the term "emergency response stakeholders" refers to CHEMPACK stakeholders (as defined by the Centers for Disease Control and Prevention (CDCyDivision of Strategic National Stockpile (SNS) under the CHEMEPACK prograim), and to other public health, emergency response, and/or other government agencies that receive the authorized Rafa Atropine Auto—Injector through CDC; and that have fegal responsibility and authority for responding to an incident, based on political or geographical boundaries (e.g., city, county, tribal. territorial, State, or Federal), or functional range or sphere of authority {e.g., law enforcement, public health. military health) to prescribe, administer, deliver, distribute, bold, or dispense a medical product during an emergency situation. § Regarding the SNS, see 42 U.S.C, § 2470—6b(a). * For purposes of this EUA, the terms "administer" and "administration"" refer to adminiztration ofthe authorized Rafa Atropine Auto—Injector by healthcare providers and caregivers (as defined tater in this letter) and by individuals administering the authorized Rafa Atropine Auto—Injector to themselves (Le., selCadmintstration) when healthcare

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Page 4 — Dr. Schuchat, CDC the Rafa Atropine Auto—Injector, which may be authorized by FDA in consultation with, and with concurrence of, the Division of Neurology Products (DNPYOffice of Drug Evaluation 1 (ODE1 YOffice of New Drugs (ONDY/Center for Drug Evaluation and Research {CDER), the Counter—Terrorism and Emergenicy Coordination Staff (CTECSY/Office of the Center Director (OCDYCDER, and the Office of Counterterrorism and. Emerging Threats (OCETyOffice of the Chief Scientist (OCSY/Office of the Commissioner (OC)." Theauthorized Rafa Atropine Auto—Injector is a self—contained unit specially designed for automatic healthcare provider, ‘" caregiver,"* or individual (i:e., self} administration. Each pre— filled auto—injector provides a single dose of atropine. When activated, the authorized 2 mg Rafa Atropine Auto—Injector dispenses 1.67 mg atropine base (equivalent to 2 mg atropine sulfate) in 0.7 mL. of sterile pyrogen—free solution through a single needle for rapid intramuscutar (IM) administration. The authorized 2 mg Rafa Atropine Auto—Injector, and any other strengths that are authorized at a later time under this EUA, are authorized to be distributed by CDC, emergency response stakeholders, and DoD for pre—event storage and further redistribution, if appropriate, and for post—event storage, distribution, and admimstration, when packaged in the authorized manufacturer packaging and with the authorized labeling (e.g., the labels on each auto—infjector and box carton, including expiration date, National Drug Code, National Stock Number if needed, bar code, and lot number: and fact sheets), despite the fact that they may not contain information on the prescription label that otherwise would be required under section 503(b)(2) of the Act (21 U.S.C. § 353(b)(2)) {e.g., name and address ofdispenser; serial number; date of prescription or of its filling: name of prescriber; name of patient, if stated on prescription; agent that antagonizes the muscarine—like actions of acetylcholine and other choline esters. Atropine inhibits the muscarmic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves, on smooth muscles, which respond to endogenous acetyleholine but are not so innervated, and on brain. As with other antimuscarinic agents, the major—action of atropine is a competitive or surmountable antagonism, which can be overcome byincreasing the concentration of acetylcholine at receptor sites of the effector organ (e.g.. by using anticholinesterase agents. which inhibit the enzymatic destruction of acetylcholine}. When atropime and pralidoxime (2—PAM)are co—administered, survival is improved due to their synergistic effects. *On the date of fssuance of this EUA, the 0.5 mg Rafa Atropine Auto—Infector and 1 mg Rafa Atropine Auto— Injector were not authorized for use under this EUA. However, CDC may request authorization under this EUA of the 0.5 mg—and t mg strengths at a later time. If FDA authorizes use of the 05 mg and 1 mg strengths based oma review of the scientific data, communication about such authorization will be posted on FDA‘s EUA website at the time of amendment of this EUA (e.g., through a memorandum and updated EUA Fact Sheets) Htps. dang metgin i TCopptertenns ues 68 ho. For purposes of this EUA, the term "healthcare provider" includes (i) healthcare professionals who are acting within their professional scope of practice; (i) healthcare professionals who might otherwise be acting outside of their professional scope of practice in administering the authorized Rafa Atropine Auto—Injector (e.g., physicians not licensed in the state: certain emergencymedical technicians, paramedics, physician assistants. nurses, pharmacists, éic.); and (iny other responders (e.2.. firefighters}. To the extent feasible and appropriate, healthcare providers should be acting under the authority of the applicable emergency response stakeholders authority and official emergencyresponse plans when administering the authorized product. " For purposes of this EUA, the term "caregiver" includes individuals who are not healthcare providers as defined in this EUA (e.g.. public health agencystaff, military service members, volunteers, agents, contractors, family members, co—workers, bystanders, etc.}, but who might beithe only available individual to admimister the Rata Atropine Auto—Injector to an individual exhibiting symptoms of nerve agent or certain insecticide {organophosphoras and/or carbamate) potsoning (e.2.; if the demand for patient care exceeds the capacity of avatlable bealthcare providers during an emergency response).. To the extent feasible and appropriate, caregivers should be acting under the authority of the applicable emergency response stakeholder‘s official emergency response plans when receiving and adminisicring the authoriged product.

Page 5 —Dr. Schuchat, CDC directions for use and cautionarystatements, if contained in the prescription}. The authorized Rafa Atropine Auto—Injector is authorized to be administered without a prescripthion and by healthcare providers, caregivers, and individuals (1.¢., to oneself) under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law. The authorized Rafa Atropine Auto—Injector is authorized to be accompanied by the authorized manufacturer‘s labeling (e.g., the labels on each auto—injector and box carton} developed in consultation with FDA and CDC. Thequthorized Rafa Atropine Auto—Injector is also authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made svailable to healtheare providers, caregivers, and individuals/patients‘" to facilitate understanding of nerve agent and certain insecticide {organophosphorus and/or carbamate} poisoning, the risks and benefits of the Rafa Atropine Auto—Injector, and proper medication administration: * Fact Sheet for Healthcare Providers: Use of the 2 mg Rafa Atropine Auto—Injector for Initial Treatment of Nerve Agent or Certain Insecticide {Organophosphorus and/or Carbamate) Poisoning * Fact Sheet for Patients and Caregivers: Use of the 2 mg Rafa Atropine Auto— Injector for Initial Treatment of Nerve Agent or Certain Insecticide {(Organophosphorus and/or Carbamate) Poisoning Other Fact Sheets developed by CDC and/or by DoD (e.g., specifically for DoD purposes) in consultation with, and with concurrence of, DNP/ODE1/ONDNVCDER, CTECS/OCDYCDER, and OCET/OCS/OC may be authorized to accompany the above described Rafa Atropine Auto— Injector and to be made available to healthcare providers, caregivers, and individuals/patients, as appropriate. As described in Section IV below, CDC and DoD are also authorized to make available additional information relating to the emergency use of the authorized Rafa Atropine Auto— Injector that is reasonably conststent with, and does not exceed, the terms of this letter of authorization. Authorized Rafa Atropine Auto—Injectors are authorized to have their manufacturer labeled expiry dating extended. by DNP/ODE1/OND/CDER, CTECS/OCIDYCDER, and OCET/OCS/OC based on scientific data supporting such an extension. I have concluded, pursuant to section 564(d)(2) ofthe Act, that it is reasonable to believe that the known and potential benefits ofthe authorized Rafa Atropine Auto—Injector in the specified population, when used for the initial treatment of musearinic symptoms of poisoning by susceptible nerve agents or certain insecticides (organophosphorus and/or carbamate}) and used consistently with the Scope of Authorization of this letter (Section 11}, outweigh the known and The authorized Fact Sheet for Patients and Caregivers includes information for {i) patients to whom the authorized Rafa Afropine Auto—Injector is administered byhealthcare providers or caregivers, (#) individuals who may need to selF—administer the authorized Rafa Atropine Auto—Injector, and (fii) caregivers who may need to administer the authorized Rafa Atropine Auto—Injector to individuals,

Page 6— Dr. Schuchat, CDC potential risks of such a product. 1 have concluded, pursuant to section 564(d)(3) ofthe Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized Rafa Atropine Auto—Injector may be effective in the initial treatment of muscarinic symptoms of poisoning by susceptible nerve agents or certain insecticides {organophosphorus and/or carbamate), when used consistently with the Scope of Authorization of this letter (Section [1), pursuant to section S64(c)(2)(A) of the Act. FDA has reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section 1 above, and concludes that the authorized Rafa Atropine Auto—Infector, when used for the initial treatment of muscarinic symptoms of poisoning by susceptible nerve agents or certain insecticides (organophosphorus and/or carbamate) in the specified population (as described in the Scope of Authorization of this letter [Section I1}), meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness. The emergency use of the authorized Rafa Atropine Auto—Injector underthis EUA must be consistent with, and may notexceed, the terms of this letter, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section TV). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS‘s determination described above and the Secretary of HHS‘s corresponding declaration under section 564(b)(1), the Rafa Atropine Auto—Injector described above is authorized for the initial treatment of muscarinic symptoms of poisoning by susceptible nerve agents or certain imsecticides {organophosphorus and/or carbamate) in the specified population. This EUA will cease to be effective when the HHS declaration that cireumstances exist to justify the EUA is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act. I{, Waiver of Coertain Requirements This letter authorizes use of Rafa Atropine Auto—Injectors as previously manufactured by Rafa under U.S. Government contract as of the date of this letter, as well as authorized Rafa Atropine Auto—Injfectors that may be manufactured by Rafa under U.S. Government contract after such date, insofar as the informational visit and testing completed on production quality products provide reasonable assurance that the methods used in, and the facilities and controls used for, the manufacturing, processing; labeling, and packing ofthe authorized Rafa Atropine Auto— Injector are adequate to preserve its identity, strength, quality, and purity for use of the product under this EUA The authorized Rafa Atropine Auto—Injector should be held in accordance with the manufacturer‘s labeled and appropriate product storage conditions for the product (1.e., ambient temperature, 25°C (77°F), with excursions permitted to 15°C—30°C (59°F—86°F)}. In addition, the USP allows for a brief excursion to higher temperatures (1e., up to 24 hours at up to 40°C {104°F)). However, to ensure the defivery and availability ofthe authorized Rafa Atropine Auto—Injector in the event of a nerve agent or certain insecticide {organophosphorus and/or carbamate) emergency and a decision on the part of CDC, an emergency response stakeholder(s), or DoD to distribute and administer the product under the terms of this EUA, the authorized Rafa Atropine Auto—Injector may require transportation and/or temporary storage for rapid

u — y sz Page 7 —Dr. Schuchat, CDC administration without the capacity to maintain labeled storage conditions in the midst of the response. During such scenarios, the authorized Rafa Atropine Auto—Injector may be stored with temperature excursions up to 40°C (104°F) for a total period of up to 7 days. Significant excursions from the labeled storage conditions should be documented to the extent practicable given the circumstances ofan emergency. IV, Conditions of Authorization Pursuant to section 564 of the Act, 1 am establishing the following conditions on this suthorization: CDC A. CDC will distribute the authorized Rafa Atropine Auto— Injector under its direction to theextent such decisions are consistent with and do not exeeed the terms of this letter, including distribution with the authorized labeling. Through a process of inventory control, CDC will maintain records regarding distribution under its direction of the authorized Rafa Atropine Auto—Injector (1.e., lot numbers, quantity, receiving site, receipt date). . CDC will—ensure that the terms of this EUA are made available to emergency response stakeholders and DoD through appropriate means.,"" CDC will provide authorized emergency response stakeholders and DoD a copy ofthis letter of authorization, and communicate to emergency response stakeholders and DoD any subsequent amendments that might be made to this letter of authorization and its authorized accompanying materials (eg., Fact Sheets). . CDC will make available to emergency response stakeholders and DoD through appropriate means the authorized Rafa Atropine Auto—Injector Fact Sheet for Healthcare Providers, the authorized Rafa Atropine Auto—Injector Fact Sheet for Patients and Caregivers, and anyother Fact Sheets for emergency response stakeholders that FDA may authorize, as well as any authorized amendments thereto. CDHC may request changes to the authorized Rafa Atropine Auto—Injector Fact Sheet for Healthcare Providers and the authorized Rafa Atropine Auto—Injector Fact Sheet for Patients and Caregivers and may request the development of addiGional Fact Sheets. Such requests will be made by CDC in consultation with, and require concurrence of, DNP/ODET/OND/CDER, CTECSYOCIYCDER, and GOCET/OCS/OC. CDHBCis authorized to issue additional recommendations and instructions related to the emergency use ofthe authorized Rafa Atropine Auto—Injector as described in this letter ofauthorization, to the extent that additional recommendations and instructions are necessary to meet public health needs during an event involving susceptible nerve agents or certain insecticides (organophosphorus and/or carbamate) and are reasonably consistent with the authorized emergency use ofthe product. " For example, through hard copy, web posting. and/or mass media.

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Page 9 —— Dr. Schuchat, CDC accompanying materials (e.g., Fact Sheets), through appropriate means. M. Emergency response stakeholders will inform their applicable healthcare providers that the authorized Rafa Atropine Auto—Injector may be used only for the initial treatment of the muscarinie symptoms of poisoning by susceptible nerve agents or certain insecticides (organophosphorus and/or carbamate) in the specified population. N. Emergency response stakeholders will ensure that their applicable healthcare providers administering the authorized Rafa Atropine Auto—Injector will abide by any procedures regarding—drug accountability issued by CDC and/or their respective institutions, Through a process of inventory control, emergency response stakeholders will O maintain records of product usage (i.e., lot number, quantity, receiving site, receipt date, and administration date), product storage, and disposition of the authorized product and will maintain records regarding further distribution {if permissible) under their direction of the authorized Rafa Atropine Auto—Injector product. P. Emergency response stakeholders will, consistent with any applicable CDC and/or junsdictional procedures, be responsible for authorizing their applicable healthcare providers to administer the authorized Rafa Atropine Auto—Injector in accordance with the terms of this letter of authorization, including instructing their applicable healthcare providers about the terms of this letter of authorization with regard to pre—event storage and distribution and post—event storage, distribution, and administration, and for instructing them about the means through which they are to obtain the authornized Rafa Atropine Auto—Injector. 15 Emergency response stakeholders will include with the authorized Rafa Atropine & Auto—Injector the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients and Caregivers, and any other Fact Sheets for emergency response stakeholders that FDA may authonze, as well as any authorized amendments thereto. Under exigent circumstances, these Fact Sheets may be disseminated through other appropriate means (e.g., web posting, mass media).. With the exception of DoD— specific Fact Sheets (see Condition FF), changes to the authorized Fact Sheets may be made only by CDC in consultation with, and require concurrence of, DNP/ODEL/OND/CDER, CTECS/OCDYCDER, and QOCET/OCS/OC, R. Emergency response stakeholders will train their applicable healtheare providers on the use of the authorized Rafa Atropine Auto—Injector in accordance with this EUA and any applicable institutional procedures or protocols. In the event of an emergency during which the authorized Rafa Atropine Auto—Injector may need to be administered by caregivers and/or be self—administered, emergency response stakeholders will inform such caregivers and individuals about the use of the authorized product (e.g., by providing them with the Fact Sheet for Patients and Caregivers and/or just—in—time * An emergency response stakeholder may also, if permifted by CDC, distribute the authorized product to other public or private entities acting as the agents or delegates of the emergency response stakeholder as part of a public health or medical response. If such distribution occurs, the emergency response stakeholder will be responsible for ensuring that the authorized agents and/or detegates adhere to the emergency response stakeholder conditions and any applicable healthcare provider conditions provided in this letter of authorization.

29878 Federal Register/Vol. 82, No. 125 /Friday, June 30, 2017 /Notices Page 10— Dr. Schuchat, CDC training, instructing healthcare providers how to inform patients and caregivers, etc.). to the extent feasible given the emergency circumstances."" Emergency resporise stakeholders will track adverse events and report to FDA in accordance with the Fact Sheet for Healthcare Providers (Me., complete the MedWateh or by calling 1—800—FDA—1088; submitted reports should state that the Rafa Atropine Auto—Injector was used under an EUA and should provide the strength (eg., 2 mg} that was administered), to the extent feasible given the emergency circumstances. Emergency response stakeholders will conduct any follow—up requested by FDA and/or CDHC regarding adverse events, to the extent feasible given the emergency circumstances. Emergency response stakeholders will track and communicate, to the extent appropriate, any expiry dating extensions of the authorized Rafa Atropine Auto— Injector that FDA may authorize, and that CDC may cornmunicate, under this EUA and any conditions related to such extensions under this EUA, Emergency response stakeholders will maintain adequate records regarding the expiry dates by which authorized Rafa Atropine Auto—Injector may be used. Emergency response stakeholders will ensure that any records associated with this EUA are maintained until notified by CDC and/or FDA. Such records will be made availableto FDA and/or CDC for inspection upoft requiest. Healthcare Providers Conducting Activities under the Direction of Emergeglcy Response Stakeholders with Respect to the Authorized Rafa Atropine Auto—Injector ‘ V. Healthcare providers conducting activities under the direction of emergency response stakeholders with respect to the authorized Rafa Atropine Auto—Injector will be aware of this letter, including the terms and any authorized amendments thereto. Healthcare providers willread the authorized Fact Sheet for Healthcare Providers prior to admtnistering the authorized Rafa Atropine Auto—Injector, to the extent feasible given the emergencycircumstances, . Healthcare providers administering the authorized Rafa Atropine Auto—Injector will # ensure that the authorized Fact Sheet for Patients and Caregivers has been made available to patients and/or caregivers through approptiate means, to the extent feasible given the emergency circumstances. In the event of an emergency during which the authorized Rafa Atropine Auto—Injector may need to be administered by caregivers and/or be self— administered, healthcare providers will inform such caregivers and individuals about the use of the authorized product (e.g., by providing them with the Fact Sheet for Patients * As described earlier in this tetrer of authorization, it is contemplated during some response—scenarios that the authorized Rafa Atropine Auto—Injector may need to be administered by caregivers or be self—administered. _ The Conditions of Authorization for healthcare providers conducting—activities under the direction of emergencyresponse stakeholders with respect to the authorized Rafa Atropine Auto—Injector do not apply to DoD.. DoD—specific Conditions of Authorization are provided below.

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u — y sz Page 12 — Dr. Schuchat, CDC EEB. DoD will make available through applicable DoD communication channels and procedures the authorized Rafa Atropine Auto—Infector Fact Sheets and/or guthorized DoD—specific Rafa Atropine Auto—Injector Fact Sheet(s), as well as any authorized amendments thereto. Underexigent circumstances, other appropriate means for disseminating these Fact Sheets may be used. FFE, DoBD may request the development and use of a Fact Sheet(s) for DoD— specific purposes for the authorized 2 mg Rafa Atropinie Auto—Injector. Such requests will be made by DoD in consultation with, and require concurrence of, DNP/ODELV/OND/CDER, CTECS/OCD/CDER, and OCET/OCS/OC, DoD will inform CDC ofsuch requests. Changes to any authorized DoD—specific Rafa Atropine Auto—Injector Fact Sheets may be made only by DoD in consultation with, and require concurrence of, DNP/ODEL/OND/CDER, CTECS/OCD/ACDER, and QOCET/OCS/OC. DoD will also inform CDC of such changes. Such DoD—specific Rafa Atropine Auto—Injector Fact Sheets will not beused by non—DoD emergency response stakeholders. GG. DoD will be responsible for authorizing components acting as part of a DoD response to administer the authorized Rafa Atropine Auto—Injector in accordance with the terms of this EUA, including instructing such components about the terms of this EUA with regard to pre—event storage and distribution and post—event storage, distribution, and administration, and for instructing them about the means through which they are to obtain and use the authorized Rafa Atropine Auto—Injector. HH. DoD is authorized to issue additional recommendations and instructions related to the DoD—specific emergency use ofthe authorized Rafa Atropine Auto— Injector as described in this letter of authorization, to the extent that additional recommendations and instructions are necessary to meet military needs during an event involving susceptible nerve agents or certain insecticides {organophosphorus and/or carbamate) and are reasonably consistent with the authorized emergency use of the product. IL, DoPD will train applicable DoD components and/or personnel on the use ofthe authorized Rafs Atropine Auto—Injector in accordance with this EUA and any applicable DoD procedures or protocols. JJ. DoD, through applicable DoD components, will track adverse events and report to?DA (eg.. by completmg the MLdWatch FDA Form 3500 online at (avaflabie at htt%-ww m.uw{iai‘ifdapow ecripts meduw? iocdex .ctm action=reporting RafaAtmpme Auto-lnjecmr wasusaé under an EUA and should provide the strength (1.e., 2 mg) that was administered), to the extent feasible given the emergency cireumstances. DoD will conduct any follow—up requested by FDA and/or CDC regarding adverse events, to the extent feasible given the

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Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices 29883 Dated: June 26, 2017. DEPARTMENT OF HEALTH AND include a fax number to which the Anna K. Abram, HUMAN SERVICES revocation may be sent. See the Deputy Commissioner for Policy, Planning, SUPPLEMENTARY INFORMATION section for Legislation, and Analysis. Food and Drug Administration electronic access to the revocation. [FR Doc. 2017–13664 Filed 6–29–17; 8:45 am] [Docket No. FDA–2016–N–0969] FOR FURTHER INFORMATION CONTACT: BILLING CODE 4164–01–P Carmen Maher, Office of Revocation of Authorization of Counterterrorism and Emerging Threats, Emergency Use of an In Vitro Food and Drug Administration, 10903 DEPARTMENT OF HEALTH AND Diagnostic Device for Detection of Zika New Hampshire Ave., Bldg. 1, Rm. HUMAN SERVICES Virus 4347, Silver Spring, MD 20993–0002, 301–796–8510 (this is not a toll free Food and Drug Administration AGENCY: Food and Drug Administration, number). HHS. SUPPLEMENTARY INFORMATION: ACTION: Notice. [Docket No. FDA–2013–N–0523] I. Background SUMMARY: The Food and Drug Agency Information Collection Administration (FDA) is announcing the Section 564 of the FD&C Act (21 Activities: Proposed Collection; revocation of the Emergency Use U.S.C. 360bbb–3) as amended by the Comment Request; Applications for Authorization (EUA) (the Authorization) Project BioShield Act of 2004 (Pub. L. Food and Drug Administration issued to Roche Molecular Systems, Inc. 108–276) and the Pandemic and All- Approval To Market a New Drug for the LightMix® Zika rRT–PCR Test. Hazards Preparedness Reauthorization FDA revoked this Authorization on Act of 2013 (Pub. L. 113–5) allows FDA Correction to strengthen the public health March 13, 2017, under the Federal Food, Drug, and Cosmetic Act (the protections against biological, chemical, In notice document 2017–10818 nuclear, and radiological agents. Among appearing on pages 24351 through FD&C Act), as requested by Roche Molecular Systems, Inc. by letter dated other things, section 564 of the FD&C 24356 in the issue of Friday, May 26, Act allows FDA to authorize the use of make the following correction: March 10, 2017. The revocation, which includes an explanation of the reasons an unapproved medical product or an On page 24351, in the third column, for revocation, is reprinted in this unapproved use of an approved medical under the DATES heading, in the third document. product in certain situations. On August line ‘‘June 26, 2017’’ should read ‘‘July 26, 2016, FDA issued an EUA to Roche 25, 2017’’. DATES: The Authorization is revoked as Molecular Systems, Inc. for the of March 13, 2017. LightMix® Zika rRT–PCR Test, subject to [FR Doc. C1–2017–10818 Filed 6–29–17; 8:45 am] ADDRESSES: Submit written requests for the terms of the Authorization. Notice of BILLING CODE 1505–01–D single copies of the revocation to the the issuance of the Authorization was mstockstill on DSK30JT082PROD with NOTICES Office of Counterterrorism and published in the Federal Register on Emerging Threats, Food and Drug October 28, 2016 (81 FR 75092), as Administration, 10903 New Hampshire required by section 564(h)(1) of the Ave., Bldg. 1, Rm. 4338, Silver Spring, FD&C Act. Under section 564(g)(2), the MD 20993–0002. Send one self- Secretary of Health and Human Services addressed adhesive label to assist that may revoke an EUA if, among other office in processing your request or things, the criteria for issuance are no EN30JN17.269</GPH> VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1


Document Created: 2017-06-30 06:02:00
Document Modified: 2017-06-30 06:02:00
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 April 11, 2017.
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.
FR Citation82 FR 29867 
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