Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 44277 

1For the reasons explained in the third-party 

certification final rule (80 FR 74570 at 74578– 

74579, November 27, 2015), and for consistency 

with the implementing regulations for the thirdparty certification program in 21 CFR parts 1, 11, 

and 16, this notice uses the term ‘‘third-party 

certification body’’ rather than the term ‘‘third-party 

auditor’’ used in section 808(a)(3) of the FD&C Act. 

3. Updated background section that 

includes a brief history of the 

development program and the status of 

product development and clinical data 

to date, if applicable. 

4. Proposed agenda, including 

estimated times needed for discussion 

of each agenda item. 

5. List of questions for discussion 

with a brief summary of each question 

that explains the need or context for the 

question. 

6. Updated programs/shells for 

simulations, if applicable. 

7. Summary of new information that 

is available to support discussions. 

E. Meeting Summaries 

A meeting summary will be sent to 

the sponsor within 60 days of each 

meeting. 

F. Disclosure 

To promote innovation and to provide 

better clarity on the acceptance of 

different types of trial designs, trial 

designs developed through the pilot 

program may be presented by FDA (e.g., 

in a guidance or public workshop) as 

case studies, including while the drug 

studied in the trial has not yet been 

approved by FDA. Accordingly, before 

FDA grants the initial meeting under 

this pilot program, FDA and the sponsor 

must agree on the information that FDA 

may include in these public case 

studies. The specific information to be 

disclosed will depend on the content of 

each application, but FDA intends to 

focus on information that is beneficial to 

advancing the use of CIDs, and those 

elements relevant to the understanding 

of the CID and its potential use in a 

clinical trial intended to support 

regulatory approval. Generally, the 

Agency does not anticipate that the case 

studies will need to include information 

such as molecular structure, the 

sponsor’s name, product name, subjectlevel data, recruitment strategies, 

adverse events, or a complete 

description of study eligibility criteria. 

FDA does anticipate that the following 

information will generally need to be 

disclosed to facilitate discussion of the 

proposed CID: Study endpoints to the 

degree necessary to describe the design 

(e.g., overall survival in the context of 

a time to event analysis), target 

population, sample size and power 

determination, null and alternative 

hypotheses, key operating 

characteristics, assumed rates for 

dichotomous outcomes or mean and 

variance for continuous outcomes, 

simulation objectives, simulation 

scenarios, assumptions (e.g., dropout 

rate, rate of enrollment), modeling 

characteristics, critical study design 

characteristics including any adaptive 

elements (e.g., decision criteria to add/ 

drop a dose, etc.), and, if a Bayesian 

approach, how Bayesian methods are 

being used for design and/or analysis 

purposes. 

It is important that sponsors wishing 

to participate in the pilot program 

identify aspects of the design and 

analysis that they consider nondisclosable and provide a rationale for 

withholding the information. 

Participation in the pilot program, 

including any agreement on information 

disclosure, will be voluntary and at the 

discretion of the sponsor. Sponsors that 

do not wish to make such disclosures 

may seek regulatory input through other 

existing channels. 

IV. Paperwork Reduction Act of 1995 

This notice refers to collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collection of information resulting from 

formal meetings between sponsors or 

applicants and FDA has been approved 

under OMB control number 0910–0429. 

The collection of information in 21 CFR 

part 312 (investigational new drug 

applications) has been approved under 

OMB control number 0910–0014. 

Dated: August 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18801 Filed 8–29–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–4119] 

Food Safety Modernization Act ThirdParty Certification Program User Fee 

Rate for Fiscal Year 2019 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fiscal year (FY) 2019 annual fee rate for 

recognized accreditation bodies and 

accredited certification bodies, and the 

fee rate for accreditation bodies 

applying to be recognized in the thirdparty certification program that is 

authorized by the Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as 

amended by the FDA Food Safety 

Modernization Act (FSMA). We are also 

announcing the fee rate for certification 

bodies that are applying to be directly 

accredited by FDA. 

DATES: This fee is effective October 1, 

2018. 

FOR FURTHER INFORMATION CONTACT: 

Donald Prater, Office of Foods and 

Veterinary Medicine, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 3234, Silver Spring, 

MD 20993, 301–348–3007. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 307 of FSMA, Accreditation 

of Third-Party Auditors, amended the 

FD&C Act to create a new provision, 

section 808, under the same name. 

Section 808 of the FD&C Act (21 U.S.C. 

384d) directs FDA to establish a 

program for accreditation of third-party 

certification bodies 1 conducting food 

safety audits and issuing food and 

facility certifications to eligible foreign 

entities (including registered foreign 

food facilities) that meet our applicable 

requirements. Under this provision, we 

established a system for FDA to 

recognize accreditation bodies to 

accredit certification bodies, except for 

limited circumstances in which we may 

directly accredit certification bodies to 

participate in the third-party 

certification program. 

Section 808(c)(8) of the FD&C Act 

directs FDA to establish a 

reimbursement (user fee) program by 

which we assess fees and require 

reimbursement for the work FDA 

performs to establish and administer the 

third-party certification program under 

section 808 of the FD&C Act. The user 

fee program for the third-party 

certification program was established by 

a final rule entitled ‘‘Amendments to 

Accreditation of Third-Party 

Certification Bodies To Conduct Food 

Safety Audits and To Issue 

Certifications To Provide for the User 

Fee Program’’ (81 FR 90186, December 

14, 2016). 

The FSMA FY 2019 third-party 

certification program user fee rate 

announced in this notice is effective on 

October 1, 2018, and will remain in 

effect through September 30, 2019. 

II. Estimating the Average Cost of a 

Supported Direct FDA Work Hour for 

FY 2019 

In each year, the costs of salary (or 

personnel compensation) and benefits 


amozie on DSK3GDR082PROD with NOTICES1
44278 Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 

for FDA employees account for between 

50 and 60 percent of the funds available 

to, and used by, FDA. Almost all of the 

remaining funds (operating funds) 

available to FDA are used to support 

FDA employees for paying rent, travel, 

utility, information technology, and 

other operating costs. 

A. Estimating the Full Cost per Direct 

Work Hour in FY 2019 

Full-time Equivalent (FTE) reflects the 

total number of regular straight-time 

hours—not including overtime or 

holiday hours—worked by employees, 

divided by the number of compensable 

hours applicable to each fiscal year. 

Annual leave, sick leave, compensatory 

time off, and other approved leave 

categories are considered ‘‘hours 

worked’’ for purposes of defining FTE 

employment. 

In general, the starting point for 

estimating the full cost per direct work 

hour is to estimate the cost of an FTE 

or paid staff year. Calculating an 

Agency-wide total cost per FTE requires 

three primary cost elements: Payroll, 

non-payroll, and rent. 

We have used an average of past year 

cost elements to predict the FY 2019 

cost. The FY 2019 FDA-wide average 

cost for payroll (salaries and benefits) is 

$157,731; non-payroll—including 

equipment, supplies, information 

technology, general and administrative 

overhead—is $91,008; and rent, 

including cost allocation analysis and 

adjustments for other rent and rentrelated costs, is $24,400 per paid staff 

year, excluding travel costs. 

Summing the average cost of an FTE 

for payroll, non-payroll, and rent, brings 

the FY 2019 average fully supported 

cost to $273,139 per FTE, excluding 

travel costs. FDA will use this base unit 

fee in determining the hourly fee rate for 

third-party certification user fees for FY 

2019 prior to including travel costs as 

applicable for the activity. 

To calculate an hourly rate, FDA must 

divide the FY 2019 average fully 

supported cost of $273,139 per FTE by 

the average number of supported direct 

FDA work hours in FY 2017—the last 

FY for which data are available. See 

table 1. 

TABLE 1—SUPPORTED DIRECT FDA 

WORK HOURS IN A PAID STAFF

YEAR IN FY 2017 

Total number of hours in a paid 

staff year ............................... 2,080 

Less: 

10 paid holidays .................... ¥80 

20 days of annual leave ....... ¥160 

10 days of sick leave ............ ¥80 

12.5 days of training ............. ¥100 

TABLE 1—SUPPORTED DIRECT FDA 

WORK HOURS IN A PAID STAFF

YEAR IN FY 2017—Continued 

26.5 days of general administration .............................. ¥184 

26.5 days of travel ................ ¥212 

2 hours of meetings per 

week .................................. ¥104 

Net Supported Direct FDA 

Work Hours Available for 

Assignments .................. = 1,160 

Dividing the average fully supported 

FTE cost in FY 2019 ($273,139) by the 

total number of supported direct work 

hours available for assignment in FY 

2017 (1,160) results in an average fully 

supported cost of $235 (rounded to the 

nearest dollar), excluding travel costs, 

per supported direct work hour in FY 

2019. 

B. Adjusting FY 2017 Travel Costs for 

Inflation To Estimate FY 2019 Travel 

Costs 

To adjust the hourly rate for FY 2019, 

FDA must estimate the cost of inflation 

in each year for FY 2018 and FY 2019. 

FDA uses the method prescribed for 

estimating inflationary costs under the 

Prescription Drug User Fee Act 

(PDUFA) provisions of the FD&C Act 

(section 736(c)(1) (21 U.S.C. 379h(c)(1)), 

the statutory method for inflation 

adjustment in the FD&C Act that FDA 

has used consistently. FDA previously 

determined the FY 2018 inflation rate to 

be 1.6868 percent; this rate was 

published in the FY 2018 PDUFA user 

fee rates notice in the Federal Register 

(82 FR 43244, September 14, 2017). 

Utilizing the method set forth in section 

736(c)(1) of the FD&C Act, FDA has 

calculated an inflation rate of 1.6868 

percent for FY 2018 and 1.7708 percent 

for FY 2019, and FDA intends to use 

this inflation rate to make inflation 

adjustments for FY 2019 for several of 

its user fee programs; the derivation of 

this rate is published in the Federal 

Register in the FY 2019 notice for the 

PDUFA user fee rates (83 FR 37504 at 

37505, August 1, 2018). The 

compounded inflation rate for FYs 2018 

and 2019, therefore, is 1.034875 (or 

3.4875 percent) (1 plus 1.6868 percent 

times 1 plus 1.7708 percent). 

The average fully supported cost per 

supported direct FDA work hour, 

excluding travel costs, of $235 already 

takes into account inflation as the 

calculation above is based on FY 2019 

predicted costs. FDA will use this base 

unit fee in determining the hourly fee 

rate for third-party certification program 

fees for FY 2019 prior to including 

travel costs as applicable for the 

activity. For the purpose of estimating 

the fee, we are using the travel cost rate 

for foreign travel because we anticipate 

that the vast majority of onsite 

assessments made by FDA under this 

program will require foreign travel. In 

FY 2017, the Office of Regulatory Affairs 

spent a total of $2,566,050 on 480 

foreign inspection trips related to FDA’s 

Center for Food Safety and Applied 

Nutrition and Center for Veterinary 

Medicine field activities programs, 

which averaged a total of $5,346 per 

foreign inspection trip. These trips 

averaged 3 weeks (or 120 paid hours) 

per trip. Dividing $5,346 per trip by 120 

hours per trip results in a total and an 

additional cost of $45 (rounded to the 

nearest dollar) per paid hour spent for 

foreign inspection travel costs in FY 

2017. To adjust $45 for inflationary 

increases in FY 2018 and FY 2019, FDA 

must multiply it by the same inflation 

factor mentioned previously in this 

document (1.034875 or 3.4875 percent), 

which results in an estimated cost of 

$47 (rounded to the nearest dollar) per 

paid hour in addition to $235 for a total 

of $282 per paid hour ($235 plus $47) 

for each direct hour of work requiring 

foreign inspection travel. FDA will use 

these rates in charging fees in FY 2019 

when travel is required for the thirdparty certification program. 

TABLE 2—FSMA FEE SCHEDULE FOR

FY 2019 

Fee category 

Fee rates 

for 

FY 2019 

Hourly rate without travel ......... $235 

Hourly rate if travel is required 282 

III. Fees for Accreditation Bodies and 

Certification Bodies in the Third-Party 

Certification Program Under Section 

808(c)(8) of the FD&C Act 

The third-party certification program 

assesses application fees and annual 

fees. In FY 2019, the only fees that 

could be collected by FDA under 

section 808(c)(8) of the FD&C Act are 

the initial application fee for 

accreditation bodies seeking 

recognition, the annual fee for 

recognized accreditation bodies, the 

annual fee for certification bodies 

accredited by a recognized accreditation 

body, and the initial application fee for 

a certification body seeking direct 

accreditation from FDA. Table 3 

provides an overview of the fees for FY 

2019. 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 44279 

TABLE 3—FSMA THIRD-PARTY CERTIFICATION PROGRAM USER FEE

SCHEDULE FOR FY 2019 

Fee category 

Fee rates 

for 

FY 2019 

Initial Application Fee for Accreditation Body Seeking 

Recognition ........................... $38,211 

Annual Fee for Recognized Accreditation Body .................... 1,775 

Annual Fee for Accredited Certification Body ........................ 2,219 

Initial Application Fee for a Certification Body Seeking Direct 

Accreditation from FDA ......... 38,211 

A. Application Fee for Accreditation 

Bodies Applying for Recognition in the 

Third-Party Certification Program Under 

Section 808(c)(8) of the FD&C Act 

Section 1.705(a)(1) (21 CFR 

1.705(a)(1)) establishes an application 

fee for accreditation bodies applying for 

initial recognition that represents the 

estimated average cost of the work FDA 

performs in reviewing and evaluating 

initial applications for recognition of 

accreditation bodies. 

The fee is based on the fully 

supported FTE hourly rates and 

estimates of the number of hours it 

would take FDA to perform relevant 

activities. These estimates represent 

FDA’s current thinking, and as the 

program evolves, FDA will reconsider 

the estimated hours. We estimate that it 

would take, on average, 60 person-hours 

to review an accreditation body’s 

submitted application, 48 person-hours 

for an onsite performance evaluation of 

the applicant (including travel and other 

steps necessary for a fully supported 

FTE to complete an onsite assessment), 

and 45 person-hours to prepare a 

written report documenting the onsite 

assessment. 

FDA employees are likely to review 

applications and prepare reports from 

their worksites, so we use the fully 

supported FTE hourly rate excluding 

travel, $235/hour, to calculate the 

portion of the user fee attributable to 

those activities: $235/hour × (60 hours 

+ 45 hours) = $24,675. FDA employees 

will likely travel to foreign countries for 

the onsite performance evaluations 

because most accreditation bodies are 

anticipated to be located in foreign 

countries. For this portion of the fee we 

use the fully supported FTE hourly rate 

for work requiring travel, $282/hour, to 

calculate the portion of the user fee 

attributable to those activities: $282/ 

hour × 48 hours (i.e., two fully 

supported FTEs × ((2 travel days × 8 

hours) + (1 day onsite × 8 hours))) = 

$13,536. The estimated average cost of 

the work FDA performs in total for 

reviewing an initial application for 

recognition for an accreditation body 

based on these figures would be $24,675 

+ $13,536 = $38,211. Therefore, the 

application fee for accreditation bodies 

applying for recognition in FY 2019 will 

be $38,211. 

B. Annual Fee for Accreditation Bodies 

Participating in the Third-Party 

Certification Program Under Section 

808(c)(8) of the FD&C Act 

To calculate the annual fee for each 

recognized accreditation body, FDA 

takes the estimated average cost of work 

FDA performs to monitor performance 

of a single recognized accreditation 

body and annualizes that over the 

average term of recognition. At this time 

we assume an average term of 

recognition of 5 years. We also assume 

that FDA will monitor 10 percent of 

recognized accreditation bodies onsite. 

As the program proceeds, we will adjust 

the term of recognition as appropriate. 

We estimate that for one performance 

evaluation of a recognized accreditation 

body, it would take, on average (taking 

into account that not all recognized 

accreditation bodies would be 

monitored onsite), 24 hours for FDA to 

conduct records review, 8 hours to 

prepare a report detailing the records 

review and onsite performance 

evaluation, and 4.8 hours of onsite 

performance evaluation (i.e., 10 percent 

× two fully supported FTEs × ((2 travel 

days × 8 hours)) + (1 day onsite × 8 

hours))). Using the fully supported FTE 

hourly rates in table 2, the estimated 

average cost of the work FDA performs 

to monitor performance of a single 

recognized accreditation body would be 

$7,520 ($235/hour × (24 hours + 8 

hours)) plus $1,354 ($282/hour × 4.8 

hours), which is $8,874. Annualizing 

this amount over 5 years would lead to 

an annual fee for recognized 

accreditation bodies of $1,775 for FY 

2019. 

C. Annual Fee for Certification Bodies 

Accredited by a Recognized 

Accreditation Body in the Third-Party 

Certification Program Under Section 

808(c)(8) of the FD&C Act 

To calculate the annual fee for a 

certification body accredited by a 

recognized accreditation body, FDA 

takes the estimated average cost of work 

FDA performs to monitor performance 

of a single certification body accredited 

by a recognized accreditation body and 

annualizes that over the average term of 

accreditation. At this time we assume an 

average term of accreditation of 4 years. 

This fee is based on the fully supported 

FTE hourly rates and estimates of the 

number of hours it would take FDA to 

perform relevant activities. We estimate 

that FDA would conduct, on average, 

the same activities, for the same amount 

of time to monitor certification bodies 

accredited by a recognized accreditation 

body as we would to monitor an 

accreditation body recognized by FDA. 

Using the fully supported FTE hourly 

rates in table 2, the estimated average 

cost of the work FDA performs to 

monitor performance of a single 

accredited certification body would be 

$7,520 ($235/hour × (24 hours + 8 

hours)) plus $1,354 ($282/hour × 4.8 

hours), which is $8,874. Annualizing 

this amount over 4 years would lead to 

an annual fee for accredited certification 

bodies of $2,219 for FY 2019. 

D. Initial Application Fee for 

Certification Bodies Seeking Direct 

Accreditation From FDA in the ThirdParty Certification Program Under 

Section 808(c)(8) of the FD&C Act 

Section 1.705(a)(3) establishes an 

application fee for certification bodies 

applying for direct accreditation from 

FDA that represents the estimated 

average cost of the work FDA performs 

in reviewing and evaluating initial 

applications for direct accreditation of 

certification bodies. 

The fee is based on the fully 

supported FTE hourly rates and 

estimates of the number of hours it 

would take FDA to perform relevant 

activities. These estimates represent 

FDA’s current thinking, and as the 

program evolves, FDA will reconsider 

the estimated hours. We estimate that it 

would take, on average, 60 person-hours 

to review a certification body’s 

submitted application, 48 person-hours 

for an onsite performance evaluation of 

the applicant (including travel and other 

steps necessary for a fully supported 

FTE to complete an onsite assessment), 

and 45 person-hours to prepare a 

written report documenting the onsite 

assessment. 

FDA employees are likely to review 

applications and prepare reports from 

their worksites, so we use the fully 

supported FTE hourly rate excluding 

travel, $235/hour, to calculate the 

portion of the user fee attributable to 

those activities: $235/hour × (60 hours 

+ 45 hours) = $24,675. FDA employees 

will likely travel to foreign countries for 

the onsite performance evaluations 

because most certification bodies are 

anticipated to be located in foreign 

countries. For this portion of the fee we 

use the fully supported FTE hourly rate 

for work requiring travel, $282/hour, to 

calculate the portion of the user fee 

attributable to those activities: $282/ 


amozie on DSK3GDR082PROD with NOTICES1
44280 Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 

hour × 48 hours (i.e., two fully 

supported FTEs × ((2 travel days × 8 

hours) + (1 day onsite × 8 hours))) = 

$13,536. The estimated average cost of 

the work FDA performs in total for 

reviewing an initial application for 

direct accreditation of a certification 

body based on these figures would be 

$24,675 + $13,536 = $38,211. Therefore, 

the application fee for certification 

bodies applying for direct accreditation 

from FDA in FY 2019 will be $38,211. 

IV. Estimated Fees for Accreditation 

Bodies and Certification Bodies in 

Other Fee Categories for FY 2019 

Section 1.705(a) also establishes 

application fees for recognized 

accreditation bodies submitting renewal 

applications and certification bodies 

applying for renewal of direct 

accreditation. Section 1.705(b) also 

establishes annual fees for certification 

bodies directly accredited by FDA. 

Although we will not be collecting 

these other fees in FY 2019, for 

transparency and planning purposes, we 

have provided an estimate of what these 

fees would be for FY 2019 based on the 

fully supported FTE hourly rates for FY 

2019 and estimates of the number of 

hours it would take FDA to perform 

relevant activities as outlined in the 

Final Regulatory Impact Analysis for the 

Third-Party Certification Regulation. 

Table 4 provides an overview of the 

estimated fees for other fee categories. 

TABLE 4—ESTIMATED FEE RATES FOR

OTHER FEE CATEGORIES UNDER

THE FSMA THIRD-PARTY CERTIFICATION PROGRAM

Fee category 

Estimated 

fee rates 

for 

FY 2019 

Renewal application fee for recognized accreditation body ... $21,350 

Renewal application fee for directly accredited certification 

body ...................................... 28,999 

Annual fee for certification body 

directly accredited by FDA .... 21,056 

V. How must the fee be paid? 

Accreditation bodies seeking initial 

recognition must submit the application 

fee with the application. 

For recognized accreditation bodies 

and accredited certification bodies, an 

invoice will be sent annually. Payment 

must be made within 30 days of the 

invoice date. Detailed payment 

information will be included with the 

invoice when it is issued. 

VI. What are the consequences of not 

paying this fee? 

The consequences of not paying these 

fees are outlined in 21 CFR 1.725. If 

FDA does not receive an application fee 

with an application for recognition, the 

application will be considered 

incomplete and FDA will not review the 

application. If a recognized 

accreditation body fails to submit its 

annual user fee within 30 days of the 

due date, we will suspend its 

recognition. If the recognized 

accreditation body fails to submit its 

annual user fee within 90 days of the 

due date, we will revoke its recognition. 

If an accredited certification body fails 

to pay its annual fee within 30 days of 

the due date, we will suspend its 

accreditation. If the accredited 

certification body fails to pay its annual 

fee within 90 days of the due date, we 

will withdraw its accreditation. 

Dated: August 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18802 Filed 8–29–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel, NIBIB Team-based 

R25 Review (2019/01). 

Date: September 24, 2018. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute of Biomedical Imaging and 

Bioengineering, 6707 Democracy Blvd., Suite 

920, Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Ruixia Zhou, Ph.D., 

Scientific Review Officer, National Institute 

of Biomedical Imaging and Bioengineering, 

National Institutes of Health, 6707 

Democracy Blvd., Suite 957, Bethesda, MD 

20892, 301–496–4773, zhour@mail@nih.gov. 

Dated: August 23, 2018. 

David D. Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–18769 Filed 8–29–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Toxicology Program Board of 

Scientific Counselors; Announcement 

of Meeting; Request for Comments 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

next meeting of the National Toxicology 

Program (NTP) Board of Scientific 

Counselors (BSC). The BSC, a federally 

chartered, external advisory group 

composed of scientists from the public 

and private sectors, will review and 

provide advice on programmatic 

activities. This meeting is by webcast 

only and is open to the public. 

Registration is requested for oral 

comment and is required to access the 

webcast. Information about the meeting 

and registration are available at http:// 

ntp.niehs.nih.gov/go/165. 

DATES: 

Meeting: October 9, 2018; 1:00—4:00 

p.m. (EDT). 

Written Public Comment 

Submissions: Deadline is October 1, 

2018. 

Oral Comments: Deadline is October 

1, 2018. 

Registration to view the webcast: 

Deadline October 9, 2018. 

Registration to view the meeting via 

the webcast is required. 

ADDRESSES: 

Meeting Webpage: The preliminary 

agenda, registration, and other meeting 

materials are at http://ntp.niehs.nih.gov/ 

go/165. 

Webcast: The meeting will be 

webcast; the URL will be provided to 

those who register for viewing. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Mary Wolfe, Designated Federal Official 

for the BSC, Office of Liaison, Policy 

and Review, Division of NTP, NIEHS, 

P.O. Box 12233, K2–03, Research 

Triangle Park, NC 27709. Phone: 984– 

287–3209, Fax: 301–451–5759, Email: 

wolfe@niehs.nih.gov. Hand Deliver/ 

Courier address: 530 Davis Drive, Room 

K2130, Morrisville, NC 27560. 


amozie on DSK3GDR082PROD with NOTICES1