Food for Human Consumption; Export Certificates; Food and Drug Administration Food Safety Modernization Act of 2011; Certification Fees, 44890-44891 [2018-19064]
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Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
• 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
Number of
respondents
Survey type
Total annual
responses
Total hours
Cognitive Interviews Screener .........................................................................
Cognitive Interviews .........................................................................................
Pre-test Study Screener ..................................................................................
Pre-testing Study .............................................................................................
Self-administered Surveys/Experimental Studies Screener ............................
Self-Administered Surveys/Experimental Studies ...........................................
720
144
2,400
480
75,000
15,000
1
1
1
1
1
1
720
144
2,400
480
75,000
15,000
60
144
199
120
6,225
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
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.
SUMMARY:
The Food and Drug
Administration (FDA or we) is
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
2 As 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.’’
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:
sradovich on DSK3GMQ082PROD with NOTICES
Number of
responses per
respondent
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:54 Aug 31, 2018
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
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44891
Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
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:
ACTION:
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.
SUMMARY:
TABLE 1—CFSAN FEES FOR FIRST,
SECOND, AND SUBSEQUENT EXPORT
CERTIFICATES
Fee
(dollars)
Type of certificate
First certificate ......................
Second certificate for the
same product(s) issued in
response to the same request .................................
Subsequent certificates for
the same product(s)
issued in response to the
same request ....................
Notice.
Comments on the ICR must be
received on or before October 4, 2018.
DATES:
175
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
ADDRESSES:
155
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
100
comments or requesting information,
please include the document identifier
The fee for issuing the first export
4040–0014–30D and project title for
certificate for food for human
reference.
consumption, with the exception of
dietary supplements, medical foods, and
SUPPLEMENTARY INFORMATION: Interested
foods for special dietary use, will be at
persons are invited to send comments
the maximum allowable amount and
regarding this burden estimate or any
consistent with the export certification
other aspect of this collection of
fees assessed since FY 1997 by other
information, including any of the
FDA Centers that provide export
following subjects: (1) The necessity and
certification for drugs and devices. It is
utility of the proposed information
also consistent with the export
collection for the proper performance of
certification fees assessed by the Center
the agency’s functions; (2) the accuracy
for Veterinary Medicine (CVM) for
certificates for animal food, which CVM of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
began assessing in FY 2016 because the
FSMA amendments to section 801(e)(4)
of the information to be collected; and
of the FD&C Act also apply to animal
(4) the use of automated collection
food. The fees for issuing subsequent
techniques or other forms of information
certificates continue to differ among the technology to minimize the information
Centers, based on varying costs.
collection burden.
Dated: August 28, 2018.
Title of the Collections: Federal
Leslie Kux,
Financial Report (SF–425) and Federal
Associate Commissioner for Policy.
Financial Report Attachment (SF–
[FR Doc. 2018–19064 Filed 8–31–18; 8:45 am]
425A).
BILLING CODE 4164–01–P
Type of Collection: Extension.
OMB No.: 4040–0014.
DEPARTMENT OF HEALTH AND
Abstract: Federal Financial Report
HUMAN SERVICES
(SF–425) and Federal Financial Report
Attachment (SF–425A) are OMB[Document Identifier: OS–4040–0014]
approved collections (4040–0014).
Agency Information Collection
These information collections are used
Request; 30-Day Public Comment
by grant awardees. The ICs expire on
Request
January 31, 2019. We are requesting a
three-year clearance of these collections.
AGENCY: Office of the Secretary, HHS.
sradovich on DSK3GMQ082PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN TABLE
Average
burden hours
per response
Type of
respondent
Federal Financial Report (SF–425) ................................
Federal Financial Report Attachment (SF–425A) ...........
Grant Applicant ..
Grant Applicant ..
100,000
100,000
1
1
1
1
100,000
100,000
Total .........................................................................
............................
200,000
........................
........................
200,000
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Number of
respondents
Number of
responses per
respondent
Forms
Sfmt 4703
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Total
burden hours
]]>Agencies
[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Pages 44890-44891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, [email protected].
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
