Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40057 

under OMB control number 0910–0733 

is available at https://www.fda.gov/ucm/ 

groups/fdagov-public/@fdagov-drugsgen/documents/document/ 

ucm269919.pdf; 21 CFR parts 50 and 56 

under OMB control number 0910–0755; 

the guidance for industry entitled 

‘‘Expedited Programs for Serious 

Conditions—Drugs and Biologics’’ 

under OMB control number 0910–0765 

is available at https://www.fda.gov/ 

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/ 

UCM358301.pdf; and the ICH guidance 

for industry entitled ‘‘E6(R2) Good 

Clinical Practice: Integrated Addendum 

to ICH E6(R1)’’ under OMB control 

number 0910–0843 is available at 

https://www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

UCM464506.pdf. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm, or https://

www.regulations.gov. 

Dated: August 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17273 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–2455] 

Patient-Focused Drug Development 

Guidance: Methods To Identify What Is 

Important to Patients and Select, 

Develop, or Modify Fit-for-Purpose 

Clinical Outcome Assessments; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

2-day public workshop to convene a 

discussion on methodological 

approaches that may be used to identify 

what is most important to patients and 

caregivers with respect to burden of 

disease, burden of treatment, and the 

benefits and risks in the management of 

the patient’s disease, and best practices 

for selecting, developing, or modifying 

fit-for-purpose clinical outcome 

assessments (COAs) to measure the 

patient experience in clinical trials. This 

workshop will inform development of 

patient-focused drug development 

guidance as required by the 21st 

Century Cures Act (Cures Act) and as 

part of commitments made by FDA 

under the sixth authorization of the 

Prescription Drug User Fee Act (PDUFA 

VI). FDA will publish discussion 

documents approximately 1 month 

before the workshop date. FDA is 

interested in seeking information and 

comments on the approaches proposed 

in the discussion documents. FDA is 

also interested in input on examples, 

which could be illustrated in the draft 

guidance, where the approaches 

proposed in the discussion document 

have been successfully applied. 

DATES: The public workshop will be 

held on October 15 and 16, 2018, from 

9 a.m. to 5 p.m. Submit either electronic 

or written comments on this public 

workshop by December 14, 2018. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

ADDRESSES: The public workshop will 

be held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. Workshop updates, 

agenda, and discussion documents will 

be made available at: https://

www.fda.gov/Drugs/NewsEvents/ 

ucm607276.htm prior to the workshop. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before December 14, 2018. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of December 14, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–2455 for ‘‘Patient-Focused Drug 

Development Guidance: Methods to 

Identify What is Important to Patients 

and Select, Develop or Modify Fit-forPurpose Clinical Outcome Assessments; 

Public Workshop; Request for 

Comments.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 


sradovich on DSK3GMQ082PROD with NOTICES
40058 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Meghana Chalasani, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1146, 

Silver Spring, MD 20993–0002, 240– 

402–6525, Fax: 301–847–8443, 

Meghana.Chalasani@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This public workshop is intended to 

support FDA implementation of 

requirements for guidance development 

under section 3002 of the Cures Act 

(Pub. L. 114–255) and to meet a 

performance goal included in the sixth 

authorization of PDUFA VI. Section 

3002 of Title III Subtitle A of the Cures 

Act directs FDA to develop patientfocused drug development guidance to 

address a number of areas including 

methodological approaches that may be 

used to develop and identify what is 

most important to patients with respect 

to burden of disease, burden of 

treatment, and the benefits and risks in 

the management of the patient’s disease; 

and approaches to identifying and 

developing methods to measure impacts 

to patients that will help facilitate 

collection of patient experience data in 

clinical trials. 

In addition, FDA committed to meet 

certain performance goals under PDUFA 

VI. This reauthorization, part of the FDA 

Reauthorization Act of 2017 signed by 

the President on August 18, 2017, 

includes a number of performance goals 

and procedures that are documented in 

the PDUFA VI Commitment Letter, 

which is available at https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

UCM511438.pdf. These goal 

commitments were developed in 

consultation with patient and consumer 

advocates, healthcare professionals, and 

other public stakeholders, as part of 

negotiations with regulated industry. 

Section J.1 of the commitment letter, 

‘‘Enhancing the Incorporation of the 

Patient’s Voice in Drug Development 

and Decision-Making,’’ (https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

UCM511438.pdf) outlines work, 

including the development of a series of 

guidance documents and associated 

public workshops to facilitate the 

advancement and use of systematic 

approaches to collect and utilize robust 

and meaningful patient and caregiver 

input that can more consistently inform 

drug development, and, as appropriate, 

regulatory decision making. 

Prior to the issuance of each guidance, 

as part of the development, FDA will 

conduct a public workshop to gather 

input from the wider community of 

patients, patient advocates, academic 

researchers, expert practitioners, drug 

developers, and other stakeholders. 

II. Purpose and Scope of Meeting 

FDA is announcing a 2-day public 

workshop to convene a discussion on: 

(1) Methodological approaches that may 

be used to develop and identify what is 

most important to patients and 

caregivers with respect to burden of 

disease, burden of treatment, and the 

benefits and risks in the management of 

the patient’s disease and (2) best 

practices for selecting, developing, or 

modifying fit-for-purpose COAs to 

measure the patient experience in 

clinical trials. The purpose of this 

public workshop is to obtain feedback 

from stakeholders on: (1) Methods to 

identify what is important to patients; 

(2) best practices for eliciting 

information on which aspects of disease 

symptoms, signs, impacts, and other 

issues are important and meaningful to 

patients; (3) measuring symptoms, signs, 

impacts and other issues of a disease or 

condition in a meaningful way; and (4) 

selecting, developing, or modifying fitfor-purpose COAs to measure the 

patient experience in clinical trials. 

FDA is seeking information and 

comments from a broad range of 

stakeholders, including patients, patient 

advocates, academic and medical 

researchers, expert practitioners, drug 

developers, and other interested 

persons. FDA will publish discussion 

documents outlining the topic areas that 

will be addressed in the draft guidances. 

These documents will be published 

approximately 1 month before the 

workshop date on the website at: 

https://www.fda.gov/Drugs/NewsEvents/ 

ucm607276.htm. FDA is interested in 

seeking information and comments on 

the approaches and considerations 

proposed in the discussion documents. 

FDA is also interested in seeking 

information and comments on 

additional examples, which could be 

included in guidance, where the 

approaches proposed in the discussion 

document have been successfully 

applied. After this public workshop, 

FDA will take into consideration the 

stakeholder input from the workshop 

and the public docket and publish draft 

guidance(s). 

III. Participating in the Public 

Workshop 

Registration: Interested parties are 

encouraged to register early. To register 

electronically, please visit: https://

pfddmethods.eventbrite.com. 

Registration for in-person attendance 

will close on October 10, 2018. 

Registration for the webcast will remain 

open until the day of the meeting. 

Persons without access to the internet 

can call 240–402–6525 to register. If you 

are unable to attend the meeting in 

person, you can register to view a live 

webcast of the meeting. You will be 

asked to indicate in your registration if 

you plan to attend in person or via the 

webcast. Seating will be limited, so 

early registration is recommended. 

Registration is free and will be on a firstcome, first-served basis. However, FDA 

may limit the number of participants 

from each organization based on space 

limitations. Registrants will receive 

confirmation once they have been 

accepted. Onsite registration on the day 

of the meeting will be based on space 

availability. 

If you need special accommodations 

because of a disability, please contact 

Meghana Chalasani (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the meeting. 

Request for Oral Presentations: There 

will be time allotted during the 

workshop for open public comment. 

Sign-up for this session will be on a 

first-come, first-served basis on the day 

of the workshop. Individuals and 


sradovich on DSK3GMQ082PROD with NOTICES
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