44890 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 

2As defined in OMB and agency Information 

Quality Guidelines, ‘‘influential’’ means that ‘‘an 

agency can reasonably determine that 

dissemination of the information will have or does 

have a clear and substantial impact on important 

public policies or important private sector 

decisions.’’ 

• Information gathered will not be 

used for the purpose of substantially 

informing influential policy decisions; 2

and 

• Information gathered will yield 

qualitative findings; the collections will 

not be designed or expected to yield 

statistical data or used as though the 

results are generalizable to the 

population of study. 

To obtain approval for a collection 

that meets the conditions of this generic 

clearance, an abbreviated supporting 

statement will be submitted to OMB 

along with supporting documentation 

(e.g., a copy of the survey or 

experimental design and stimuli for 

testing). 

FDA will submit individual 

quantitative collections under this 

generic clearance to OMB. Individual 

quantitative collections will also 

undergo review by FDA’s Research 

Involving Human Subjects Committee, 

senior leadership in the Center for Food 

Safety and Applied Nutrition, and PRA 

specialists. 

Respondents to this collection of 

information may include a wide range 

of consumers and other FDA 

stakeholders such as producers and 

manufacturers who are regulated under 

FDA-regulated food and cosmetic 

products, dietary supplements, and 

animal food and feed. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN BY ANTICIPATED DATA COLLECTION METHODS 1

Survey type Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Total hours 

Cognitive Interviews Screener ......................................................................... 720 1 720 60 

Cognitive Interviews ......................................................................................... 144 1 144 144 

Pre-test Study Screener .................................................................................. 2,400 1 2,400 199 

Pre-testing Study ............................................................................................. 480 1 480 120 

Self-administered Surveys/Experimental Studies Screener ............................ 75,000 1 75,000 6,225 

Self-Administered Surveys/Experimental Studies ........................................... 15,000 1 15,000 3,750 

Total .......................................................................................................... ........................ ........................ ........................ 10,498 

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

The total estimated annual burden is 

10,498 hours. Current estimates are 

based on both historical numbers of 

participants from past projects as well 

as estimates for projects to be conducted 

in the next 3 years. The number of 

participants to be included in each new 

survey will vary, depending on the 

nature of the compliance efforts and the 

target audience. 

Dated: August 28, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19088 Filed 8–31–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2700] 

Food for Human Consumption; Export 

Certificates; Food and Drug 

Administration Food Safety 

Modernization Act of 2011; 

Certification Fees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the fees we will assess for 

issuing export certificates for food for 

human consumption, with the 

exception of dietary supplements, 

medical foods, and foods for special 

dietary use. The FDA Food Safety 

Modernization Act (FSMA) of 2011 

authorizes us to charge fees to cover our 

costs associated with issuing export 

certificates for food. This notice 

provides the fee schedule for issuing 

these certificates and the basis for the 

fees. We have not previously exercised 

our FSMA authority to collect fees for 

export certificates issued for food for 

human consumption. 

DATES: The fees described in this 

document for export certificates for food 

for human consumption, with the 

exception of dietary supplements, 

medical foods, and foods for special 

dietary use, will be effective October 1, 

2018. 

FOR FURTHER INFORMATION CONTACT: Kate 

Meck, International Affairs Staff, Center 

for Food Safety and Applied Nutrition 

(HFS–550), Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2307, 

CFSANExportCertification@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In April 1996, the ‘‘FDA Export 

Reform and Enhancement Act of 1996’’ 

(Pub. L. 104–134, amended by Pub. L. 

104–180) amended sections 801 and 802 

of the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 381 and 

382). As a result of the 1996 

amendments, section 801(e)(4) of the 

FD&C Act provides that persons 

exporting a drug, animal drug, or device 

may request FDA to certify that the 

product meets the requirements of 

section 801(e)(1), section 802, or other 

applicable requirements of the FD&C 

Act. Upon a showing that the product 

meets the applicable requirements, the 

law provides that FDA shall issue 

export certification within 20 days of 

the receipt of a request for such 

certification. The law also authorizes us 

to charge up to $175 for each 

certification issued within the 20-day 

period. 

In January 2011, section 801(e)(4) of 

the FD&C Act was further amended by 

FSMA (Pub. L. 111–353) to authorize 

FDA to issue, and charge fees for, export 

certificates for food. Under section 

801(e)(4)(C) of the FD&C Act, an export 

certification can be made in such form 

(including a publicly available listing) 

as FDA determines appropriate. 

This notice focuses on the fees to be 

assessed with respect to export 

certificates issued by the Center for 

Food Safety and Applied Nutrition 

(CFSAN) for food for human 


sradovich on DSK3GMQ082PROD with NOTICES
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