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