16402 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 

(Ebola). Ebola is a type of viral 

hemorrhagic fever that is often fatal in 

humans and nonhuman primates. Ebola 

can spread through human-to-human 

transmission, with infection resulting 

from direct contact (through broken skin 

or mucous membranes) with the blood, 

secretions, droplets, or other body fluids 

of infected people, and indirectly from 

contact with surfaces or items (such as 

needles) contaminated with such fluids. 

With respect to viral hemorrhagic 

fevers, placement on the DNB list and 

associated Lookout record is requested 

for people known or suspected to have 

a viral hemorrhagic fever. Placement 

may also be requested for people 

without symptoms who have been 

exposed to a viral hemorrhagic fever, 

particularly if these individuals intend 

to travel against public health 

recommendations. Even though people 

without symptoms are not infectious, 

these restrictions are requested because 

of the possibility that symptoms could 

develop during travel, particularly long 

international flights. Exposure is 

determined through a CDC risk factor 

assessment using information available 

from a variety of public health, medical 

and other official sources. Examples of 

types of potential exposure to viral 

hemorrhagic fevers contained within the 

CDC risk factor assessment include the 

following. It should be noted that not all 

of these exposures may result in travel 

restrictions. 

• Having been in a country with 

widespread Ebola virus transmission 

within the past 21 days and, although 

having had no known exposures, is 

showing symptoms 

• Percutaneous (e.g., needle stick) or 

mucous membrane exposure to blood 

or body fluids of a person with Ebola 

while the person was showing 

symptoms 

• Exposure to the blood or body fluids 

(including but not limited to feces, 

saliva, sweat, urine, vomit, and 

semen) of a person with Ebola while 

the person was showing symptoms 

without appropriate personal 

protective equipment (PPE) (see 

http://www.cdc.gov/vhf/ebola/hcp/

procedures-for-ppe.html) 

• Laboratory processing of blood or 

body fluids of a person with Ebola 

while the person was showing 

symptoms without appropriate PPE or 

standard biosafety protections 

• Direct contact with a dead body 

without appropriate PPE in a country 

with widespread Ebola virus 

transmission (see http://www.cdc.gov/ 

vhf/ebola/outbreaks/2014-west-africa/

distribution-map.html) 

• Having lived in the immediate 

household and provided direct care to 

a person with Ebola while the person 

was showing symptoms 

• In countries with widespread Ebola 

virus transmission: Direct contact 

while using appropriate PPE with a 

person with Ebola while the person 

was showing symptoms, or with the 

person’s body fluids, or any direct 

patient care in other healthcare 

settings 

• Close contact in households, 

healthcare facilities, or community 

settings with a person with Ebola 

while the person was showing 

symptoms 

Æ Close contact is defined as not 

wearing appropriate PPE within 

approximately 3 feet (1 meter) of a 

person with Ebola while the person 

was showing symptoms 

• Having brief direct contact (e.g., 

shaking hands), while not wearing 

appropriate PPE, with a person with 

Ebola while the person was in the 

early stage of disease 

• In countries without widespread 

Ebola virus transmission: Direct 

contact while using appropriate PPE 

with a person with Ebola while the 

person was showing symptoms 

• Traveled on an aircraft with a person 

with Ebola while the person was 

showing symptoms 

Exposure risk factors, such as those just 

described, will be considered by HHS/ 

CDC in their totality when determining 

whether an individual meets the first 

criteria for placement on the DNB List, 

as described in Section I of this notice. 

HHS/CDC would also consider other 

facts and information it may have to 

make a decision with respect to the 

other criteria, as described in Section I 

of this notice. It should be noted that all 

facts are considered when applying the 

criteria. Again, with the exception of the 

first criteria, not all of the other criteria 

need to be present for HHS/CDC to 

make a request to DHS to have an 

individual placed on DNB and Lookout. 

HHS/CDC would also consider these 

risk factors when assessing an 

individual who has been in a country 

where outbreaks of viral hemorrhagic 

fevers were occurring and refuses to 

comply with a public health assessment, 

and otherwise meets the travel 

restriction criteria. Refusing to comply 

with a public health risk assessment in 

this situation could include refusing to 

provide relevant information that would 

allow public health officials to assess 

the exposure risk. 

V. Provisions of This Notice 

HHS/CDC will make requests of DHS 

based on the criteria in this notice 

effective immediately. Individuals who 

have had their travel temporarily 

restricted as a result of placement on the 

DNB list and associated Lookout records 

may submit a written response to the 

Director, Division of Global Migration 

and Quarantine, if they believe that 

HHS/CDC has erred in its public health 

request to DHS. The response should be 

addressed to: Director, Division of 

Global Migration and Quarantine, 

ATTN: Travel Restriction and 

Intervention Activity, Centers for 

Disease Control and Prevention, 1600 

Clifton Road, MS E–03, Atlanta, GA 

30329. Responses may also be faxed to 

CDC at (404) 718–2158 or emailed to 

travelrestrictions@cdc.gov. 

As part of the response, individuals 

should include the reference number 

listed in the notification letter they 

received and any facts or other evidence 

indicating why they believe that HHS/ 

CDC’s public health request was made 

in error. 

The policy and program operations 

described above will become effective 

on March 27, 2015. 

Dated: March 24, 2015. 

Sylvia M. Burwell, 

Secretary. 

[FR Doc. 2015–07118 Filed 3–26–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0908] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Clinical Trial Sponsors: Establishment 

and Operation of Clinical Trial Data 

Monitoring Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the collection of information concerning 

the establishment and operation of 

clinical trial data monitoring 

committees. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 16403 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 26, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance for Clinical Trial Sponsors: 

Establishment and Operation of 

Clinical Trial Data Monitoring 

Committees—(OMB Control Number 

0910–0581)—Extension 

Sponsors are required to monitor 

studies evaluating new drugs, biologics, 

and devices (21 CFR 312.50 and 312.56 

for drugs and biologics, and 21 CFR 

812.40 and 812.46 for devices). Various 

individuals and groups play different 

roles in clinical trial monitoring. One 

such group is a data monitoring 

committee (DMC), appointed by a 

sponsor to evaluate the accumulating 

outcome data in some trials. A clinical 

trial DMC is a group of individuals with 

pertinent expertise that reviews on a 

regular basis accumulating data from 

one or more ongoing clinical trials. The 

DMC advises the sponsor regarding the 

continuing safety of current trial 

subjects and those yet to be recruited to 

the trial, as well as the continuing 

validity and scientific merit of the trial. 

The guidance document referenced in 

this document is intended to assist 

sponsors of clinical trials in determining 

when a DMC is needed for monitoring 

a study, and how such committees 

should operate. The guidance addresses 

the roles, responsibilities, and operating 

procedures of DMCs, describes certain 

reporting and recordkeeping 

responsibilities, including the 

following: (1) Sponsor reporting to FDA 

on DMC recommendations related to 

safety; (2) standard operating 

procedures (SOPs) for DMCs; (3) DMC 

meeting records; (4) sponsor notification 

to the DMC regarding waivers; and (5) 

DMC reports based on meeting minutes 

to the sponsor. 

1. Sponsor Reporting to FDA on DMC 

Recommendations Related to Safety 

The requirement of the sponsor to 

report DMC recommendations related to 

serious adverse events in an expedited 

manner in clinical trials of new drugs 

(section 312.32(c)(21 CFR 312.32(c))) 

would not apply when the DMC 

recommendation is related to an excess 

of events not classifiable as serious. 

Nevertheless, the Agency recommends 

in the guidance that sponsors inform 

FDA about all recommendations related 

to the safety of the investigational 

product whether or not the adverse 

event in question meets the definition of 

‘‘serious.’’ 

2. SOPs for DMCs 

In the guidance, FDA recommends 

that sponsors establish procedures to do 

the following things: 

• Assess potential conflicts of interest 

of proposed DMC members; 

• Ensure that those with serious 

conflicts of interest are not included in 

the DMC; 

• Provide disclosure to all DMC 

members of any potential conflicts that 

are not thought to impede objectivity 

and, thus, would not preclude service 

on the DMC; 

• Identify and disclose any 

concurrent service of any DMC member 

on other DMCs of the same, related, or 

competing products; 

• Ensure separation, and designate a 

different statistician to advise on the 

management of the trial, if the primary 

trial statistician takes on the 

responsibility for interim analysis and 

reporting to the DMC; and 

• Minimize the risks of bias that are 

associated with an arrangement under 

which the primary trial statistician takes 

on the responsibility for interim 

analysis and reporting to the DMC, if it 

appears infeasible or highly impractical 

for any other statistician to take over 

responsibilities related to trial 

management. 

3. DMC Meeting Records 

The Agency recommends in the 

guidance that the DMC or the group 

preparing the interim reports to the 

DMC maintain all meeting records. This 

information should be submitted to FDA 

with the clinical study report (section 

314.50(d)(5)(ii) (21 CFR 

314.50(d)(5)(ii))). 

4. Sponsor Notification to the DMC 

Regarding Waivers 

The sponsor must report to FDA 

certain serious and unexpected adverse 

events in drugs and biologics trials 

(section 312.32) and unanticipated 

adverse device effects in the case of 

device trials (section 812.150(b)(1) (21 

CFR 812.150(b)(1))). The Agency 

recommends in the guidance that 

sponsors notify DMCs about any 

waivers granted by FDA for expedited 

reporting of certain serious events. 

5. DMC Reports of Meeting Minutes to 

the Sponsor 

The Agency recommends in the 

guidance that DMCs should issue a 

written report to the sponsor based on 

the DMC meeting minutes. Reports to 

the sponsor should include only those 

data generally available to the sponsor. 

The sponsor may convey the relevant 

information in this report to other 

interested parties, such as study 

investigators. Meeting minutes or other 

information that include discussion of 

confidential data would not be provided 

to the sponsor. 

Description of Respondents: The 

submission and data collection 

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16404 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 

recommendations described in this 

document affect sponsors of clinical 

trials and DMCs. 

Burden Estimate: Table 1 of this 

document provides the burden estimate 

of the annual reporting burden for the 

information to be submitted in 

accordance with the guidance. Table 2 

of this document provides the burden 

estimate of the annual recordkeeping 

burden for the information to be 

maintained in accordance with the 

guidance. Table 3 of this document 

provides the burden estimate of the 

annual third-party disclosure burden for 

the information to be submitted in 

accordance with the guidance. 

Reporting, Recordkeeping, and ThirdParty Disclosure Burdens: Based on 

information from FDA review divisions, 

FDA estimates there are approximately 

740 clinical trials with DMCs regulated 

by the Center for Biologics Evaluation 

and Research, the Center for Drug 

Evaluation and Research, and the Center 

for Devices and Radiological Health. 

FDA estimates that the average length of 

a clinical trial is 2 years, resulting in an 

annual estimate of 370 clinical trials. 

Because FDA has no information on 

which to project a change in the use of 

DMCs, FDA estimates that the number 

of clinical trials with DMCs will not 

change significantly. For purposes of 

this information collection, FDA 

estimates that each sponsor is 

responsible for approximately 10 trials, 

resulting in an estimated 37 sponsors 

that are affected by the guidance 

annually. 

Based on information provided to 

FDA by sponsors that have typically 

used DMCs for the kinds of studies for 

which this guidance recommends them, 

FDA estimates that the majority of 

sponsors have already prepared SOPs 

for DMCs, and only a minimum amount 

of time is necessary to revise or update 

them for use for other clinical studies. 

FDA receives very few requests for 

waivers regarding expedited reporting of 

certain serious events; therefore, FDA 

has estimated one respondent per year 

to account for the rare instance a request 

may be made. Based on FDA’s 

experience with clinical trials using 

DMCs, FDA estimates that the sponsor 

on average would issue two interim 

reports per clinical trial to the DMC. 

FDA estimates that the DMCs would 

hold two meetings per year per clinical 

trial resulting in the issuance of two 

DMC reports of meeting minutes to the 

sponsor. One set of both of the meeting 

records should be maintained per 

clinical trial. 

The ‘‘Average Burden per Response’’ 

and ‘‘Average Burden per 

Recordkeeping’’ are based on FDA’s 

experience with comparable 

recordkeeping and reporting provisions 

applicable to FDA regulated industry. 

The ‘‘Average Burden per Response’’ 

includes the time the respondent would 

spend reviewing, gathering, and 

preparing the information to be 

submitted to the DMC, FDA, or the 

sponsor. The ‘‘Average Burden per 

Recordkeeping’’ includes the time to 

record, gather, and maintain the 

information. 

The information collection provisions 

in the guidance for 21 CFR 312.30, 

312.32, 312.38, 312.55, and 312.56 have 

been approved under OMB Control No. 

0910–0014; 21 CFR 314.50 has been 

approved under OMB Control No. 0910– 

0001; and 21 CFR 812.35 and 812.150 

have been approved under OMB Control 

No. 0910–0078. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section of guidance/reporting activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

5. Sponsor reporting to FDA on DMC recommendations related to safety ......................... 37 1 37 0.50 (30 min.) 18.5 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Section of guidance/recordkeeping activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per 

recordkeeping 

Total hours 

4.1. and 6.4 SOPs for DMCs ................................. 37 1 37 8 296 

4.4.3.2. DMC meeting records ............................... 370 1 370 2 740 

Total ................................................................ ............................ ............................ .......................... .......................... 1,036 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Section of guidance/disclosure activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

4.4.1.2. Sponsor notification to the DMC regarding waivers ....................................................... 1 1 1 0.25 

(15 minutes) 0 .25 

4.4.3.2. DMC reports of meeting minutes to the 

sponsor ............................................................. 370 2 740 1 740 

Total .............................................................. ............................ ............................ .......................... .......................... 740 .25 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 16405 

Dated: March 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07009 Filed 3–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–15–15UX: Docket No. CDC–2015– 

0011] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing efforts to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on proposed and/or 

continuing information collections, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on ‘‘Continuing and New 

International and U.S. Data Collections 

from the 2014 CDC Ebola Virus Disease 

Emergency Response’’. Under the 

current 60-day Federal Register Notice, 

the CDC is announcing its intention to 

seek three-year OMB approval to 

continue several Ebola-related 

information collections beyond their 

current emergency expiration dates and 

to conduct newly proposed information 

collections within international borders 

of Ebola-affected West African countries 

and within the domestic borders of 

State, Territorial and Local (STL) public 

health authorities in the U.S. These 

existing ‘‘source’’ information 

collections and new information 

collection requests (ICRs) will be 

submitted under four ‘‘destination’’ 

ICRs for Office of Management and 

Budget (OMB) approval. 

DATES: Written comments must be 

received on or before May 26, 2015. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2015– 

0011, by any of the following methods: 

• Federal eRulemaking Portal: 

Regulation.gov. Follow the instructions 

for submitting comments. 

• Mail: Leroy A. Richardson, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE., MS– 

D74, Atlanta, Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. All relevant comments 

received will be posted without change 

to Regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

Regulations.gov. 

Please note: All public comment 

should be submitted through the 

Federal eRulemaking portal 

(Regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact the Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE., MS–D74, Atlanta, 

Georgia 30329; phone: 404–639–7570; 

Email: omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology; and (e) estimates of capital 

or start-up costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. 

Proposed Project 

Continuing and New International 

and U.S. Data Collections from the 2014 

CDC Ebola Virus Disease Emergency 

Response—New—National Center for 

Emerging and Zoonotic Infectious 

Diseases (NCEZID), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

The international outbreak of Ebola 

virus disease (EVD) in West Africa 

began March 10, 2014. The initial cases 

were from southern Guinea, near its 

rural border with Liberia and Sierra 

Leone. Highly mobile populations 

contributed to increasing waves of 

person-to-person transmission of EVD 

that occurred in multiple countries in 

West Africa. The Centers for Disease 

Control and Prevention (CDC) 

Emergency Operations Center (EOC) 

was activated on July 9, 2014, to help 

coordinate technical assistance and 

control activities with international 

partners and to deploy teams of public 

health experts to the affected countries. 

The operations turned to the United 

States (U.S.) when the first imported 

case of EVD was diagnosed in Texas on 

September 30, 2014. In response, on 

October 11, 2014, the CDC Quarantine 

Stations and the Department of 

Homeland Security (DHS) Customs and 

Border Patrol (CBP) mobilized to screen, 

detect, and refer arriving travelers who 

were potential persons at risk for EVD 

to appropriate state, territorial, and local 

(STL) authorities. The CDC also 

increased its commitment to support 

STL public health authorities to combat 

and control the spread of EVD within 

their jurisdictions. 

Thus in 2014, the CDC used OMB 

emergency clearance procedures to 

initiate and expedite multiple urgently 

needed information collections in West 

Africa, at U.S. ports of entry, and within 

STL jurisdictions. These procedures 

allowed the agency to accomplish its 

primary mission on many fronts to 

quickly prevent public harm, illness, 

mstockstill on DSK4VPTVN1PROD with NOTICES