Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40059 

1 In the case of a determination by the Secretary 

of Defense, the Secretary of HHS shall determine, 

within 45 calendar days of such determination, 

whether to make a declaration under section 

564(b)(1) of the FD&C Act, and, if appropriate, shall 

promptly make such a declaration. 

organizations with common interests are 

urged to consolidate or coordinate, and 

request time for a joint presentation. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public workshop. 

Transcripts: As soon as a transcript is 

available, FDA will post it at https://

www.fda.gov/Drugs/NewsEvents/ 

ucm607276.htm. 

Dated: August 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17272 Filed 8–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3009] 

Authorization of Emergency Use of a 

Freeze Dried Plasma Treatment for 

Hemorrhage or Coagulopathy During 

an Emergency Involving Agents of 

Military Combat; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of an Emergency Use 

Authorization (EUA) (the Authorization) 

for a freeze dried plasma treatment for 

hemorrhage or coagulopathy during an 

emergency involving agents of military 

combat (e.g., firearms, projectiles, and 

explosive devices) when plasma is not 

available for use or when the use of 

plasma is not practical. FDA issued this 

Authorization under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act), as 

requested by the U.S. Department of 

Defense (DoD). The Authorization 

contains, among other things, 

conditions on the emergency use of the 

authorized treatment. The Authorization 

follows the June 7, 2018, determination 

by the Deputy Secretary of Defense that 

there is a military emergency or 

significant potential for a military 

emergency, involving a heightened risk 

to U.S. military forces of an attack with 

an agent or agents that may cause, or are 

otherwise associated with an 

imminently life-threatening and specific 

risk to those forces. The Deputy 

Secretary of Defense further stated that, 

more specifically, U.S. forces are now 

deployed in multiple locations where 

they serve at heightened risk of an 

enemy attack with agents of military 

combat, including firearms, projectiles, 

and explosive devices, that may cause 

major and imminently life-threatening 

combat casualties involving 

uncontrolled hemorrhage. On the basis 

of such determination, the Department 

of Health and Human Services (HHS) 

Secretary declared on July 9, 2018, that 

circumstances exist justifying the 

authorization of emergency use of freeze 

dried plasma for the treatment of 

hemorrhage or coagulopathy during an 

emergency involving agents of military 

combat (e.g., firearms, projectiles, and 

explosive devices) when plasma is not 

available for use or when the use of 

plasma is not practical, 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 9, 2018. 

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: 

Michael Mair, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4340, 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), the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5), 21st 

Century Cures Act (Pub. L. 114–255), 

and Public Law 115–92 (2017), allows 

FDA to strengthen the public health 

protections against biological, chemical, 

nuclear, and radiological agents and 

other agents that may cause, or are 

otherwise associated with, an 

imminently life-threatening and specific 

risk to U.S. military forces. 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 and other agents that 

may cause, or are otherwise associated 

with, an imminently life-threatening 

and specific risk to U.S. military forces 

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, 

including personnel operating under the 

authority of title 10 or title 50, United 

States Code, of attack with (i) a 

biological, chemical, radiological, or 

nuclear agent or agents; or (ii) an agent 

or agents that may cause, or are 

otherwise associated with, an 

imminently life-threatening and specific 

risk to U.S. military forces; 1 (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 


sradovich on DSK3GMQ082PROD with NOTICES
40060 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 

2The 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. 

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 

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), 

512, or 515 of the FD&C Act (21 U.S.C. 

355, 360(k), 360b, and 360e) or section 

351 of the PHS Act (42 U.S.C. 262), or 

conditionally approved under section 

571 of the FD&C Act (21 U.S.C. 360ccc). 

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 2 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; (4) 

in the case of a determination described 

in section 564(b)(1)(B)(ii), that the 

request for emergency use is made by 

the Secretary of Defense; and (5) that 

such other criteria as may be prescribed 

by regulation are satisfied. 

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 a Freeze Dried 

Plasma Treatment for Hemorrhage or 

Coagulopathy During an Emergency 

Involving Agents of Military Combat 

When Plasma Is Not Available for Use 

or When the Use of Plasma Is Not 

Practical 

On June 7, 2018, the Deputy Secretary 

of Defense determined that ‘‘there is a 

military emergency or significant 

potential for a military emergency, 

involving a heightened risk to U.S. 

military forces of an attack with an 

agent or agents that may cause, or are 

otherwise associated with an 

imminently life-threatening and specific 

risk to those forces.’’ The Deputy 

Secretary of Defense further stated that, 

‘‘[m]ore specifically, U.S. [f]orces are 

now deployed in multiple locations 

where they serve at heightened risk of 

an enemy attack with agents of military 

combat, including firearms, projectiles, 

and explosive devices, that may cause 

major and imminently life-threatening 

combat casualties involving 

uncontrolled hemorrhage.’’ On July 9, 

2018, 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 freeze dried plasma 

for the treatment of hemorrhage or 

coagulopathy during an emergency 

involving agents of military combat 

(e.g., firearms, projectiles, and explosive 

devices) when plasma is not available 

for use or when the use of plasma is not 

practical, subject to the terms of any 

authorization issued under section 564 

of the FD&C Act. Notice of the 

declaration of the Secretary of HHS was 

published in the Federal Register on 

July 16, 2018 (83 FR 32884) and a 

correction was published in the Federal 

Register on July 31, 2018 (83 FR 36941). 

On July 9, 2018, DoD requested, and on 

July 9, 2018, FDA issued, an EUA for 

Pathogen-Reduced Leukocyte-Depleted 

Freeze Dried Plasma manufactured by 

the Centre de Transfusion Sanguine des 

Arme ́es (CTSA) (for purposes of this 

EUA, ‘‘French FDP’’), 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 a freeze dried plasma treatment for 

the treatment of hemorrhage or 

coagulopathy during an emergency 

involving agents of military combat 

(e.g., firearms, projectiles, and explosive 

devices) when plasma is not available 

for use or when the use of plasma is not 

practical, 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 

issuance, as required by section 

564(h)(1) of the FD&C Act. 

BILLING CODE 4164–01–P 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40061 


sradovich on DSK3GMQ082PROD with NOTICESEN13AU18.001</GPH>
40062 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 


sradovich on DSK3GMQ082PROD with NOTICESEN13AU18.002</GPH>
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40063 


sradovich on DSK3GMQ082PROD with NOTICESEN13AU18.003</GPH>

Criteria for IssuaJitce of Authorization 

II. Authorization 
40064 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 


sradovich on DSK3GMQ082PROD with NOTICESEN13AU18.004</GPH>

The 
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40065 


sradovich on DSK3GMQ082PROD with NOTICESEN13AU18.005</GPH>
40066 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 


sradovich on DSK3GMQ082PROD with NOTICESEN13AU18.006</GPH>

Ill. Waiver of 

IV. Conditions of Authorization 

DoD 
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40067 


sradovich on DSK3GMQ082PROD with NOTICESEN13AU18.007</GPH>

B. 

L 
40068 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 


sradovich on DSK3GMQ082PROD with NOTICESEN13AU18.008</GPH>
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40069 


sradovich on DSK3GMQ082PROD with NOTICESEN13AU18.009</GPH>

.. 
40070 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 

Dated: August 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17303 Filed 8–10–18; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2876] 

Fougera Pharmaceuticals, Inc., et al.; 

Withdrawal of Approval of 20 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 20 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The holders of the 

applications notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Approval is withdrawn as of 

September 12, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Trang Tran, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 1671, Silver Spring, 

MD 20993–0002, 240–402–7945, 

Trang.Tran@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

holders of the applications listed in the 

table have informed FDA that these drug 

products are no longer marketed and 

have requested that FDA withdraw 

approval of the applications under the 

process described in § 314.150(c) (21 

CFR 314.150(c)). The applicants have 

also, by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 060133 ...................... Chloramphenicol Ophthalmic Ointment, 1% ................... Fougera Pharmaceuticals, Inc., 60 Baylis Rd., P.O. Box 

2006, Melville, NY 11747. 

ANDA 060572 ...................... Mycolog II (nystatin and triamcinolone acetonide) Ointment USP, 100,000 units/gram (g) and 0.1%.Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., 

P.O. Box 4310, Morgantown, WV 26504. 

ANDA 061107 ...................... Hydrocortisone Acetate and Neomycin Sulfate Ointment, 0.5%/0.5% and 1.5%/0.5%.Fougera Pharmaceuticals, Inc.. 

ANDA 061988 ...................... Polycillin (ampicillin) Capsules, 250 milligrams (mg) and 

500 mg.

Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 

08543. 

ANDA 072097 ...................... Cap-Profen (ibuprofen) Tablets USP, 200 mg (White) ... L. Perrigo Co., 515 Eastern Ave., Allegan, MI 49010. 

ANDA 072098 ...................... Ibuprofen Tablets, 200 mg (Brown) ................................ Do. 

ANDA 074334 ...................... Vecuronium Bromide for Injection, 10 mg/vial and 20 

mg/vial.

Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 

19044. 

ANDA 074874 ...................... Pentoxifylline Extended-Release Tablets, 400 mg ......... Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, 

Inc., 425 Privet Rd., Horsham, PA 19044. 


sradovich on DSK3GMQ082PROD with NOTICESEN13AU18.010</GPH>