83 FR 44890 - Food for Human Consumption; Export Certificates; Food and Drug Administration Food Safety Modernization Act of 2011; Certification Fees
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 171 (September 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 171 (September 4, 2018)
| Page Range | 44890-44891 | |
| FR Document | 2018-19064 |
[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)] [Notices] [Pages 44890-44891] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19064] ----------------------------------------------------------------------- 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 [[Page 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 155 response to the same request........................... Subsequent certificates for the same product(s) issued 100 in response to the same request........................ ------------------------------------------------------------------------ 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
![44890 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
• Information gathered will not be statement will be submitted to OMB Safety and Applied Nutrition, and PRA
used for the purpose of substantially along with supporting documentation specialists.
informing influential policy decisions; 2 (e.g., a copy of the survey or Respondents to this collection of
and experimental design and stimuli for information may include a wide range
• Information gathered will yield testing). of consumers and other FDA
qualitative findings; the collections will
FDA will submit individual stakeholders such as producers and
not be designed or expected to yield
quantitative collections under this manufacturers who are regulated under
statistical data or used as though the
results are generalizable to the generic clearance to OMB. Individual FDA-regulated food and cosmetic
population of study. quantitative collections will also products, dietary supplements, and
To obtain approval for a collection undergo review by FDA’s Research animal food and feed.
that meets the conditions of this generic Involving Human Subjects Committee, FDA estimates the burden of this
clearance, an abbreviated supporting senior leadership in the Center for Food collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN BY ANTICIPATED DATA COLLECTION METHODS 1
Number of
Number of Total annual
Survey type responses per Total hours
respondents responses
respondent
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
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The total estimated annual burden is announcing the fees we will assess for (Pub. L. 104–134, amended by Pub. L.
10,498 hours. Current estimates are issuing export certificates for food for 104–180) amended sections 801 and 802
based on both historical numbers of human consumption, with the of the Federal Food, Drug, and Cosmetic
participants from past projects as well exception of dietary supplements, Act (the FD&C Act) (21 U.S.C. 381 and
as estimates for projects to be conducted medical foods, and foods for special 382). As a result of the 1996
in the next 3 years. The number of dietary use. The FDA Food Safety amendments, section 801(e)(4) of the
participants to be included in each new Modernization Act (FSMA) of 2011 FD&C Act provides that persons
survey will vary, depending on the authorizes us to charge fees to cover our exporting a drug, animal drug, or device
nature of the compliance efforts and the costs associated with issuing export may request FDA to certify that the
target audience. certificates for food. This notice product meets the requirements of
Dated: August 28, 2018. provides the fee schedule for issuing section 801(e)(1), section 802, or other
Leslie Kux,
these certificates and the basis for the applicable requirements of the FD&C
fees. We have not previously exercised Act. Upon a showing that the product
Associate Commissioner for Policy.
our FSMA authority to collect fees for meets the applicable requirements, the
[FR Doc. 2018–19088 Filed 8–31–18; 8:45 am]
export certificates issued for food for law provides that FDA shall issue
BILLING CODE 4164–01–P human consumption. export certification within 20 days of
DATES: The fees described in this the receipt of a request for such
document for export certificates for food certification. The law also authorizes us
DEPARTMENT OF HEALTH AND
for human consumption, with the to charge up to $175 for each
HUMAN SERVICES
exception of dietary supplements, certification issued within the 20-day
Food and Drug Administration medical foods, and foods for special period.
dietary use, will be effective October 1, In January 2011, section 801(e)(4) of
[Docket No. FDA–2018–N–2700] 2018. the FD&C Act was further amended by
FOR FURTHER INFORMATION CONTACT: Kate FSMA (Pub. L. 111–353) to authorize
Food for Human Consumption; Export FDA to issue, and charge fees for, export
Meck, International Affairs Staff, Center
Certificates; Food and Drug certificates for food. Under section
for Food Safety and Applied Nutrition
Administration Food Safety 801(e)(4)(C) of the FD&C Act, an export
(HFS–550), Food and Drug
Modernization Act of 2011; certification can be made in such form
Administration, 5001 Campus Dr.,
Certification Fees (including a publicly available listing)
College Park, MD 20740, 240–402–2307,
AGENCY: Food and Drug Administration, CFSANExportCertification@fda.hhs.gov. as FDA determines appropriate.
HHS. SUPPLEMENTARY INFORMATION: This notice focuses on the fees to be
sradovich on DSK3GMQ082PROD with NOTICES
ACTION: Notice. assessed with respect to export
I. Background certificates issued by the Center for
SUMMARY: The Food and Drug In April 1996, the ‘‘FDA Export Food Safety and Applied Nutrition
Administration (FDA or we) is Reform and Enhancement Act of 1996’’ (CFSAN) for food for human
2 As defined in OMB and agency Information dissemination of the information will have or does public policies or important private sector
Quality Guidelines, ‘‘influential’’ means that ‘‘an have a clear and substantial impact on important decisions.’’
agency can reasonably determine that
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![Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 44891
consumption, with the exception of certificates for food for human ACTION: Notice.
dietary supplements, medical foods, and consumption, with the exception of
foods for special dietary use. This notice dietary supplements, medical foods, and SUMMARY: In compliance with the
applies to foods such as produce, grains, foods for special dietary use: requirement of the Paperwork
processed foods, food additives, color Reduction Act of 1995, the Office of the
additives, food contact substances, TABLE 1—CFSAN FEES FOR FIRST, Secretary (OS), Department of Health
generally regarded as safe ingredients, SECOND, AND SUBSEQUENT EXPORT and Human Services, is publishing the
infant formula, and all other foods not CERTIFICATES following summary of a proposed
specifically excluded. Dietary collection for public comment.
supplements, medical foods, and foods Fee
Type of certificate
for special dietary use are excluded (dollars) DATES: Comments on the ICR must be
from this notice. received on or before October 4, 2018.
First certificate ...................... 175
II. Fees To Be Assessed for Export Second certificate for the ADDRESSES: Submit your comments to
Certificates same product(s) issued in OIRA_submission@omb.eop.gov or via
response to the same re- facsimile to (202) 395–5806.
CFSAN estimates the annual costs of quest ................................. 155
the export certification program for food Subsequent certificates for FOR FURTHER INFORMATION CONTACT:
for human consumption, with the the same product(s) Sherrette Funn, Sherrette.Funn@hhs.gov
exception of dietary supplements, issued in response to the or (202) 795–7714. When submitting
medical foods, and foods for special same request .................... 100
comments or requesting information,
dietary use, to be approximately
The fee for issuing the first export please include the document identifier
$975,000 per year for preparing and
certificate for food for human 4040–0014–30D and project title for
issuing export certificates. The costs are
consumption, with the exception of reference.
due to payroll and operating expenses.
Specifically, there are four cost dietary supplements, medical foods, and
SUPPLEMENTARY INFORMATION: Interested
categories for preparing and issuing foods for special dietary use, will be at
persons are invited to send comments
export certificates in general: (1) Direct the maximum allowable amount and
consistent with the export certification regarding this burden estimate or any
personnel for research, review, tracking, other aspect of this collection of
writing, and assembly; (2) an fees assessed since FY 1997 by other
FDA Centers that provide export information, including any of the
information technology system used for
certification for drugs and devices. It is following subjects: (1) The necessity and
tracking and processing certificates; (3)
also consistent with the export utility of the proposed information
billing and collection of fees; and (4)
certification fees assessed by the Center collection for the proper performance of
overhead and administrative support. In
fiscal year (FY) 2017 CFSAN issued for Veterinary Medicine (CVM) for the agency’s functions; (2) the accuracy
approximately 4,072 export certificates certificates for animal food, which CVM of the estimated burden; (3) ways to
for food for human consumption, with began assessing in FY 2016 because the enhance the quality, utility, and clarity
the exception of dietary supplements, FSMA amendments to section 801(e)(4) of the information to be collected; and
medical foods, and foods for special of the FD&C Act also apply to animal (4) the use of automated collection
dietary use. Because CFSAN has not food. The fees for issuing subsequent techniques or other forms of information
been charging fees for issuing these certificates continue to differ among the technology to minimize the information
export certificates, the program has been Centers, based on varying costs. collection burden.
covered by appropriated funds. Dated: August 28, 2018. Title of the Collections: Federal
As mentioned previously, FDA may Leslie Kux, Financial Report (SF–425) and Federal
charge up to $175 for each certificate. Associate Commissioner for Policy. Financial Report Attachment (SF–
Certificates for some of the foods that [FR Doc. 2018–19064 Filed 8–31–18; 8:45 am] 425A).
are the subject of this notice cost us BILLING CODE 4164–01–P
more than $175 to prepare. Subsequent Type of Collection: Extension.
certificates issued for the same OMB No.: 4040–0014.
product(s) in response to the same DEPARTMENT OF HEALTH AND Abstract: Federal Financial Report
request generally cost FDA less than HUMAN SERVICES (SF–425) and Federal Financial Report
$175 to prepare. The fee for all Attachment (SF–425A) are OMB-
[Document Identifier: OS–4040–0014]
subsequent certificates for the same
approved collections (4040–0014).
product(s) issued in response to the Agency Information Collection These information collections are used
same request reflects reduced FDA costs Request; 30-Day Public Comment by grant awardees. The ICs expire on
for preparing those certificates. Request
The following fees will be assessed January 31, 2019. We are requesting a
starting October 1, 2018, for export AGENCY: Office of the Secretary, HHS. three-year clearance of these collections.
ESTIMATED ANNUALIZED BURDEN TABLE
Number of Average
Type of Number of Total
sradovich on DSK3GMQ082PROD with NOTICES
Forms responses per burden hours
respondent respondents burden hours
respondent per response
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
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Document Created: 2018-09-01 02:59:38
Document Modified: 2018-09-01 02:59:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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, [email protected] | |
| FR Citation | 83 FR 44890 |
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