Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 44891 

consumption, with the exception of 

dietary supplements, medical foods, and 

foods for special dietary use. This notice 

applies to foods such as produce, grains, 

processed foods, food additives, color 

additives, food contact substances, 

generally regarded as safe ingredients, 

infant formula, and all other foods not 

specifically excluded. Dietary 

supplements, medical foods, and foods 

for special dietary use are excluded 

from this notice. 

II. Fees To Be Assessed for Export 

Certificates 

CFSAN estimates the annual costs of 

the export certification program for food 

for human consumption, with the 

exception of dietary supplements, 

medical foods, and foods for special 

dietary use, to be approximately 

$975,000 per year for preparing and 

issuing export certificates. The costs are 

due to payroll and operating expenses. 

Specifically, there are four cost 

categories for preparing and issuing 

export certificates in general: (1) Direct 

personnel for research, review, tracking, 

writing, and assembly; (2) an 

information technology system used for 

tracking and processing certificates; (3) 

billing and collection of fees; and (4) 

overhead and administrative support. In 

fiscal year (FY) 2017 CFSAN issued 

approximately 4,072 export certificates 

for food for human consumption, with 

the exception of dietary supplements, 

medical foods, and foods for special 

dietary use. Because CFSAN has not 

been charging fees for issuing these 

export certificates, the program has been 

covered by appropriated funds. 

As mentioned previously, FDA may 

charge up to $175 for each certificate. 

Certificates for some of the foods that 

are the subject of this notice cost us 

more than $175 to prepare. Subsequent 

certificates issued for the same 

product(s) in response to the same 

request generally cost FDA less than 

$175 to prepare. The fee for all 

subsequent certificates for the same 

product(s) issued in response to the 

same request reflects reduced FDA costs 

for preparing those certificates. 

The following fees will be assessed 

starting October 1, 2018, for export 

certificates for food for human 

consumption, with the exception of 

dietary supplements, medical foods, and 

foods for special dietary use: 

TABLE 1—CFSAN FEES FOR FIRST, 

SECOND, AND SUBSEQUENT EXPORT

CERTIFICATES

Type of certificate Fee 

(dollars) 

First certificate ...................... 175 

Second certificate for the 

same product(s) issued in 

response to the same request ................................. 155 

Subsequent certificates for 

the same product(s) 

issued in response to the 

same request .................... 100 

The fee for issuing the first export 

certificate for food for human 

consumption, with the exception of 

dietary supplements, medical foods, and 

foods for special dietary use, will be at 

the maximum allowable amount and 

consistent with the export certification 

fees assessed since FY 1997 by other 

FDA Centers that provide export 

certification for drugs and devices. It is 

also consistent with the export 

certification fees assessed by the Center 

for Veterinary Medicine (CVM) for 

certificates for animal food, which CVM 

began assessing in FY 2016 because the 

FSMA amendments to section 801(e)(4) 

of the FD&C Act also apply to animal 

food. The fees for issuing subsequent 

certificates continue to differ among the 

Centers, based on varying costs. 

Dated: August 28, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19064 Filed 8–31–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–4040–0014] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before October 4, 2018. 

ADDRESSES: Submit your comments to 

OIRA_submission@omb.eop.gov or via 

facsimile to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When submitting 

comments or requesting information, 

please include the document identifier 

4040–0014–30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collections: Federal 

Financial Report (SF–425) and Federal 

Financial Report Attachment (SF– 

425A). 

Type of Collection: Extension. 

OMB No.: 4040–0014. 

Abstract: Federal Financial Report 

(SF–425) and Federal Financial Report 

Attachment (SF–425A) are OMBapproved collections (4040–0014). 

These information collections are used 

by grant awardees. The ICs expire on 

January 31, 2019. We are requesting a 

three-year clearance of these collections. 

ESTIMATED ANNUALIZED BURDEN TABLE

Forms Type of 

respondent 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

Federal Financial Report (SF–425) ................................ Grant Applicant .. 100,000 1 1 100,000 

Federal Financial Report Attachment (SF–425A) ........... Grant Applicant .. 100,000 1 1 100,000 

Total ......................................................................... ............................ 200,000 ........................ ........................ 200,000 


sradovich on DSK3GMQ082PROD with NOTICES
44892 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 

Terry Clark, 

Office of the Secretary, Asst. Paperwork 

Reduction Act Reports Clearance Officer. 

[FR Doc. 2018–19084 Filed 8–31–18; 8:45 am] 

BILLING CODE 4151–AE–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

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 grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; SEP–6: NCI 

Clinical and Translational R21 & Omnibus 

R03. 

Date: October 4, 2018. 

Time: 7:30 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 

Contact Person: Eduardo E. Chufan, Ph.D., 

Scientific Review Officer, Research 

Technology and Contract Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, Room 7W254, Bethesda, MD 20892– 

9750, 240–276–7975, chufanee@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; SEP–9: NCI 

Clinical and Translational R21 and Omnibus 

R03. 

Date: October 23, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute, Shady 

Grove, 9609 Medical Center Drive, Room 

7W114, Rockville, MD 20850 (Telephone 

Conference Call). 

Contact Person: Jeffrey E. DeClue, Ph.D., 

Scientific Review Officer, Research 

Technology and Contract Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, Room 7W114, Bethesda, MD 20892– 

9750, 240–276–6371, decluej@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Initial Review Group; Subcommittee 

I—Transition to Independence. 

Date: October 24–25, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The William F. Bolger Center, 9600 

Newbridge Drive, Potomac, MD 20854. 

Contact Person: Delia Tang, MD, Scientific 

Review Officer, Research Programs Review 

Branch, Division of Extramural Activities, 

National Cancer Institute, NIH, 9609 Medical 

Center Drive, Room 7W602, Bethesda, MD 

20892–9750, 240–276–6456, tangd@

mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; SEP–8: NCI 

Clinical and Translational R21 and Omnibus 

R03. 

Date: November 1–2, 2018. 

Time: 6:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Reed A. Graves, Ph.D., 

Scientific Review Officer, Research 

Technology and Contract Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, Room 7W106, Bethesda, MD 20892– 

9750, 240–276–6384, gravesr@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; HIV/AIDS 

and the Tumor Niche. 

Date: November 13, 2018. 

Time: 11:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute, Shady 

Grove, 9609 Medical Center Drive, Room 

7W618, Rockville, MD 20850 (Telephone 

Conference Call). 

Contact Person: Mukesh Kumar, Ph.D., 

Scientific Review Officer, Research Programs 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 7W618, 

Bethesda, MD 20892–9750, 240–276–6611, 

mukesh.kumar3@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: August 28, 2018. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–19051 Filed 8–31–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of HHS-Certified 

Laboratories and Instrumented Initial 

Testing Facilities Which Meet Minimum 

Standards To Engage in Urine Drug 

Testing for Federal Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies federal 

agencies of the laboratories and 

Instrumented Initial Testing Facilities 

(IITF) currently certified to meet the 

standards of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs (Mandatory Guidelines). 

A notice listing all currently HHScertified laboratories and IITFs is 

published in the Federal Register 

during the first week of each month. If 

any laboratory or IITF certification is 

suspended or revoked, the laboratory or 

IITF will be omitted from subsequent 

lists until such time as it is restored to 

full certification under the Mandatory 

Guidelines. 

If any laboratory or IITF has 

withdrawn from the HHS National 

Laboratory Certification Program (NLCP) 

during the past month, it will be listed 

at the end and will be omitted from the 

monthly listing thereafter. 

This notice is also available on the 

internet at http://www.samhsa.gov/ 

workplace. 

FOR FURTHER INFORMATION CONTACT: 

Charles LoDico, Division of Workplace 

Programs, SAMHSA/CSAP, 5600 

Fishers Lane, Room 16N02C, Rockville, 

Maryland 20857; 240–276–2600 (voice). 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) notifies federal agencies 

of the laboratories and Instrumented 

Initial Testing Facilities (IITF) currently 

certified to meet the standards of the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(Mandatory Guidelines). The Mandatory 

Guidelines were first published in the 

Federal Register on April 11, 1988 (53 

FR 11970), and subsequently revised in 

the Federal Register on June 9, 1994 (59 

FR 29908); September 30, 1997 (62 FR 

51118); April 13, 2004 (69 FR 19644); 

November 25, 2008 (73 FR 71858); 

December 10, 2008 (73 FR 75122); April 

30, 2010 (75 FR 22809); and on January 

23, 2017 (82 FR 7920). 

The Mandatory Guidelines were 

initially developed in accordance with 


sradovich on DSK3GMQ082PROD with NOTICES