46164 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 

1Press Release, Board of Governors of the Federal 

Reserve System, Agencies issue final rule regarding 

the treatment of certain municipal securities as 

high-quality liquid assets (August 22, 2018), 

available at https://www.federalreserve.gov/ 

newsevents/pressreleases/bcreg20180822a.htm. 

reports that detail funding 

vulnerabilities. 

Legal authorization and 

confidentiality: The Board’s Legal 

Division has determined that the FR 

2052a is authorized pursuant to section 

5 of the Bank Holding Company Act (12 

U.S.C. 1844), section 8 of the 

International Banking Act (12 U.S.C. 

3106), and section 165 of the DoddFrank Wall Street Reform and Consumer 

Protection Act (Dodd-Frank Act) (12 

U.S.C. 5365) and are mandatory. Section 

5(c) of the Bank Holding Company Act 

authorizes the Board to require BHCs to 

submit reports to the Board regarding 

their financial condition. Section 8(a) of 

the International Banking Act subjects 

FBOs to the provisions of the Bank 

Holding Company Act. Section 165 of 

the Dodd-Frank Act requires the Board 

to establish prudential standards for 

certain BHCs and FBOs, which include 

liquidity requirements. 

Financial institution information 

required by the FR 2052a is collected as 

part of the Board’s supervisory process. 

Therefore, such information is entitled 

to confidential treatment under 

Exemption 8 of the Freedom of 

Information Act (FOIA) (5 U.S.C. 

552(b)(8)). In addition, the institution 

information provided by each 

respondent would not be otherwise 

available to the public and its disclosure 

could cause substantial competitive 

harm. Accordingly, it is entitled to 

confidential treatment under the 

authority of exemption 4 of the FOIA (5 

U.S.C. 552(b)(4)), which protects from 

disclosure trade secrets and commercial 

or financial information. 

Current Actions: The Economic 

Growth, Regulatory Relief, and 

Consumer Protection Act (EGRRCPA), 

enacted on May 24, 2018, amended 

various provisions of banking law to 

eliminate or reduce statutory and 

regulatory requirements on certain 

banking organizations. Section 403 of 

EGRRCPA provides that the federal 

banking agencies shall treat certain 

municipal obligations as ‘‘high quality 

liquid assets’’ (HQLA) for purposes of 

their liquidity regulations, and must 

amend those regulations to reflect this 

new treatment within 90 days of the 

enactment of EGRRCPA. The federal 

banking agencies, on August 22, 2018, 

issued an interim final rule 1 amending 

their liquidity regulations (the 

‘‘Liquidity IFR’). The current FR 2052a 

instructions are inconsistent with the 

provisions of EGRRCPA. The Board has 

revised the FR 2052a to provide that 

respondents are permitted to report 

investment grade municipal obligations 

as HQLA, consistent with EGRRCPA 

and the Liquidity IFR. In order for the 

FR 2052a to reflect section 403 of 

EGRRCPA, which became effective 

immediately when EGRRCPA was 

signed on May 24, 2018, the Board 

cannot comply with the normal 

clearance process and still receive the 

June 30, 2018, financial data in a timely 

manner. Therefore, the Board has 

determined that the revision to the FR 

2052a described above must be 

instituted quickly and public 

participation in the approval process 

would substantially interfere with the 

Board’s ability to perform its statutory 

obligations arising from EGRRCPA. 

Board of Governors of the Federal Reserve 

System, September 6, 2018. 

Michele Taylor Fennell, 

Assistant Secretary of the Board. 

[FR Doc. 2018–19675 Filed 9–11–18; 8:45 am] 

BILLING CODE 6210–01–P 

FEDERAL RETIREMENT THRIFT 

INVESTMENT BOARD 

Board Meeting; 77 K St. NE, 

Washington, DC; 10th Floor; 

September 17, 2018; 8:30 a.m. 

Open Session 

1. Approval of the Minutes of the 

August 27, 2018 Board Meeting 

2. Monthly Reports 

(a) Participant Activity 

(b) Investment Policy 

(c) Legislative Report 

3. FY 19 Budget Review and Approval 

4. Vendor Risk Management Update 

5. Capital Market and L Fund Update 

6. IT Update 

Closed Session 

Information covered under 5 U.S.C. 

552b(c)(4) and (c)(9)(B). 

CONTACT PERSON FOR MORE INFORMATION: 

Kimberly Weaver, Director, Office of 

External Affairs, (202) 942–1640. 

Dated: September 7, 2018. 

Dharmesh Vashee, 

Deputy General Counsel, Federal Retirement 

Thrift Investment Board. 

[FR Doc. 2018–19833 Filed 9–11–18; 8:45 am] 

BILLING CODE 6760–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0908] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 12, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0581. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 46165 

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 and 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 

(§ 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 (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 

(§ 312.32) and unanticipated adverse 

device effects in the case of device trials 

(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 the Respondents: The 

submission and data collection 

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, 


daltland on DSKBBV9HB2PROD with NOTICES
46166 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 

312.32, 312.38, 312.55, and 312.56 have 

been approved under OMB control 

number 0910–0014; 21 CFR 314.50 has 

been approved under OMB control 

number 0910–0001; and 21 CFR 812.35 

and 812.150 have been approved under 

OMB control number 0910–0078. 

In the Federal Register of May 31, 

2018 (83 FR 25015), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of the 

information collection 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 minutes) .. 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 

responses 

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. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: September 6, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19799 Filed 9–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1960] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; MedWatch: The 

Food and Drug Administration Medical 

Products Reporting Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 12, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0291 and 

title ‘‘MedWatch: The Food and Drug 

Administration Medical Products 

Reporting Program.’’ Also include the 

FDA docket number found in brackets 

in the heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

MedWatch: The FDA Medical Products 

Reporting Program 

OMB Control Number 0910–0291— 

Revision 

This information collection supports 

FDA’s MedWatch safety information 

and adverse event reporting program. 

Members of the public use FDA’s 

MedWatch system to report adverse 

events, product problems, errors with 

the use of a human medical product, or 

when evidence of therapeutic failure is 

suspected or identified in clinical use. 


daltland on DSKBBV9HB2PROD with NOTICES