Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2016, 46020-46023 [2015-18906]
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46020
Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
This draft guidance establishes
standard dissolution methodology and
specifications that are appropriate for
BCS class 1 and class 3 drugs. The
availability of these standards will
facilitate the rapid development of
dissolution methodology and related
specifications for these classes during
drug development and application
review.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on Dissolution Testing and
Specification Criteria for ImmediateRelease Solid Oral Dosage Forms
Containing Biopharmaceutics
Classification System Class 1 and 3
Drugs. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
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III. The Paperwork Reduction Act of
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This draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
parts 312 and 314 have been approved
under OMB control numbers 0910–0014
and 0910–0001, respectively.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
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ComplianceRegulatoryInformation/
Guidances/default.htm or https://
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Dated: July 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18968 Filed 7–31–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0007]
Food Safety Modernization Act
Domestic and Foreign Facility
Reinspection, Recall, and Importer
Reinspection Fee Rates for Fiscal Year
2016
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2016 fee rates for certain
domestic and foreign facility
reinspections, failures to comply with a
recall order, and importer reinspections
that are authorized by the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the FDA Food Safety
Modernization Act (FSMA). These fees
are effective on October 1, 2015, and
will remain in effect through September
30, 2016.
FOR FURTHER INFORMATION CONTACT:
Jason Lewis, Office of Resource
Management, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rm. 2046,
Rockville, MD 20857, 301–796–5957,
email: Jason.Lewis@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 107 of FSMA (Pub. L. 111–
353) added section 743 to the FD&C Act
(21 U.S.C. 379j–31) to provide FDA with
the authority to assess and collect fees
from, in part: (1) The responsible party
for each domestic facility and the U.S.
agent for each foreign facility subject to
a reinspection, to cover reinspectionrelated costs; (2) the responsible party
for a domestic facility and an importer
who does not comply with a recall
order, to cover food 1 recall activities
associated with such order; and (3) each
importer subject to a reinspection to
cover reinspection-related costs
(sections 743(a)(1)(A), (B), and (D) of the
FD&C Act). Section 743 of the FD&C Act
directs FDA to establish fees for each of
these activities based on an estimate of
1 The term ‘‘food’’ for purposes of this document
has the same meaning as such term in section 201(f)
of the FD&C Act (21 U.S.C. 321(f)).
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100 percent of the costs of each activity
for each year (sections 743(b)(2)(A)(i),
(ii), and (iv)), and these fees must be
made available solely to pay for the
costs of each activity for which the fee
was incurred (section 743(b)(3)). These
fees are effective on October 1, 2015,
and will remain in effect through
September 30, 2016. Section
743(b)(2)(B)(iii) of the FD&C Act directs
FDA to develop a proposed set of
guidelines in consideration of the
burden of fee amounts on small
businesses. As a first step in developing
these guidelines, FDA invited public
comment on the potential impact of the
fees authorized by section 743 of the
FD&C Act on small businesses (76 FR
45818, August 1, 2011). The comment
period for this request ended November
30, 2011. As stated in FDA’s September
2011 ‘‘Guidance for Industry:
Implementation of the Fee Provisions of
Section 107 of the FDA Food Safety
Modernization Act,’’ (https://
www.fda.gov/Food/Guidance
Regulation/GuidanceDocuments
RegulatoryInformation/FoodDefense/
ucm274176.htm), because FDA
recognizes that for small businesses the
full cost recovery of FDA reinspection
or recall oversight could impose severe
economic hardship, FDA intends to
consider reducing certain fees for those
firms. FDA does not intend to issue
invoices for reinspection or recall order
fees until FDA publishes a guidance
document outlining the process through
which firms may request a reduction in
fees.
In addition, as stated in the
September 2011 Guidance, FDA is in
the process of considering various
issues associated with the assessment
and collection of importer reinspection
fees. The fee rates set forth in this notice
will be used to determine any importer
reinspection fees assessed in FY 2016.
II. Estimating the Average Cost of a
Supported Direct FDA Work Hour for
FY 2016
FDA is required to estimate 100
percent of its costs for each activity in
order to establish fee rates for FY 2016.
In each year, the costs of salary (or
personnel compensation) and benefits
for FDA employees account for between
50 and 60 percent of the funds available
to, and used by, FDA. Almost all of the
remaining funds (operating funds)
available to FDA are used to support
FDA employees for paying rent, travel,
utility, information technology, and
other operating costs.
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Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
A. Estimating the Full Cost per Direct
Work Hour in FY 2014
In general, the starting point for
estimating the full cost per direct work
hour is to estimate the cost of a full-time
equivalent (FTE) or paid staff year for
the relevant activity. This is done by
dividing the total funds allocated to the
elements of FDA primarily responsible
for carrying out the activities for which
fees are being collected by the total
FTEs allocated to those activities. For
the purposes of the reinspection and
recall order fees authorized by section
743 of the FD&C Act (the fees that are
the subject of this notice), primary
responsibility for the activities for
which fees will be collected rests with
FDA’s Office of Regulatory Affairs
(ORA). ORA carries out inspections and
other field-based activities on behalf of
FDA’s product centers, including the
Center for Food Safety and Applied
Nutrition (CFSAN) and the Center for
Veterinary Medicine (CVM). Thus, as
the starting point for estimating the full
cost per direct work hour, FDA will use
the total funds allocated to ORA for
CFSAN and CVM related field activities.
The most recent FY with available data
was FY 2014. In that year, FDA
obligated a total of $669,055,119 for
ORA in carrying out the CFSAN and
CVM related field activities work,
excluding the cost of inspection travel.
In that same year, the number of ORA
staff primarily conducting the CFSAN
and CVM related field activities was
3,016 FTEs or paid staff years. Dividing
$669,055,119 by 3,016 FTEs results in
an average cost of $221,835 per paid
staff year, excluding travel costs.
Not all of the FTEs required to
support the activities for which fees will
be collected are conducting direct work
such as inspecting or reinspecting
facilities, examining imports, or
monitoring recalls. Data collected over a
number of years and used consistently
in other FDA user fee programs (e.g.,
under the Prescription Drug User Fee
Act (PDUFA) and the Medical Device
User Fee and Modernization Act) show
that every seven FTEs who perform
direct FDA work require three indirect
and supporting FTEs. These indirect
and supporting FTEs function in budget,
facility, human resource, information
technology, planning, security,
administrative support, legislative
liaison, legal counsel, program
management, and other essential
program areas. On average, two of these
indirect and supporting FTEs are
located in ORA or the FDA center where
the direct work is being conducted, and
one of them is located in the Office of
the Commissioner. To get the fully
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supported cost of an FTE, FDA needs to
multiply the average cost of an FTE by
1.43, to take into account the indirect
and supporting functions. The 1.43
factor is derived by dividing the 10 fully
supported FTEs by 7 direct FTEs. In FY
2014, the average cost of an FTE was
$221,835. Multiplying this amount by
1.43 results in an average fully
supported cost of $317,224 per FTE,
excluding the cost of inspection travel.
To calculate an hourly rate, FDA must
divide the average fully supported cost
of $317,224 per FTE by the average
number of supported direct FDA work
hours. See table 1.
46021
compounded inflation rate for FYs 2015
and 2016, therefore, is 4.150 percent (1
plus 2.0813 percent times 1 plus 2.0266
percent).
Increasing the FY 2014 average fully
supported cost per supported direct
FDA work hour of $198 (excluding
inspection travel costs) by 4.150 percent
yields an inflationary adjusted
estimated cost of $206 per a supported
direct work hour in FY 2016, excluding
inspection travel costs. FDA will use
this base unit fee in determining the
hourly fee rate for reinspection and
recall order fees for FY 2016 prior to
including domestic or foreign travel
costs as applicable for the activity.
In FY 2014, ORA spent a total of
TABLE 1—SUPPORTED DIRECT FDA
WORK HOURS IN A PAID STAFF YEAR $4,536,206 for domestic regulatory
inspection travel costs and General
Services Administration Vehicle costs
Total number of hours in a paid
staff year ...................................
2,080 related to FDA’s CFSAN and CVM field
Less:
activities programs. The total ORA
10 paid holidays ........................
80 domestic travel costs spent is then
20 days of annual leave ...........
160 divided by the 10,392 CFSAN and CVM
10 days of sick leave ................
80 domestic inspections, which averages a
10 days of training ....................
80
total of $437 per inspection. These
2 hours of meetings per week ..
80
inspections average 31.64 hours per
inspection. Dividing $437 per
Net Supported Direct FDA
inspection by 31.64 hours per
Work Hours Available for
Assignments ......................
1,600 inspection results in a total and an
additional cost of $14 per hour spent for
Dividing the average fully supported
domestic inspection travel costs in FY
cost of an FTE in FY 2014 ($317,224) by 2014. To adjust $14 for inflationary
the total number of supported direct
increases in FY 2015 and FY 2016, FDA
work hours available for assignment
must multiply it by the same inflation
(1,600) results in an average fully
factor mentioned previously in this
supported cost of $198 (rounded to the
document (1.04150), which results in an
nearest dollar), excluding inspection
estimated cost of $15 dollars per paid
travel costs, per supported direct work
hour in addition to $206 for a total of
hour in FY 2014—the last FY for which
$221 per paid hour ($206 plus $15) for
data are available.
each direct hour of work requiring
B. Adjusting FY 2014 Costs for Inflation domestic inspection travel. FDA will
use these rates in charging fees in FY
To Estimate FY 2016 Costs
2016 when domestic travel is required.
To adjust the hourly rate for FY 2016,
In FY 2014, ORA spent a total of
FDA must estimate the cost of inflation
$3,209,009 on 255 foreign inspection
in each year for FY 2015 and FY 2016.
trips related to FDA’s CFSAN and CVM
FDA uses the method prescribed for
field activities programs, which
estimating inflationary costs under the
averaged a total of $12,584 per foreign
PDUFA provisions of the FD&C Act
inspection trip. These trips averaged 3
(section 736(c)(1) (21 U.S.C. 379h(c)(1)), weeks (or 120 paid hours) per trip.
the statutory method for inflation
Dividing $12,584 per trip by 120 hours
adjustment in the FD&C Act that FDA
per trip results in a total and an
has used consistently. FDA previously
additional cost of $105 per paid hour
determined the FY 2015 inflation rate to spent for foreign inspection travel costs
be 2.0813; this rate was published in the in FY 2014. To adjust $105 for
FY 2015 PDUFA user fee rates notice in inflationary increases in FY 2015 and
the Federal Register of August 1, 2014
FY 2016, FDA must multiply it by the
(79 FR 44807). Utilizing the method set
same inflation factor mentioned
forth in section 736(c)(1) of the FD&C
previously in this document (1.04150),
Act, FDA has calculated an inflation
which results in an estimated cost of
rate of 2.0266 percent for FY 2016, and
$109 dollars per paid hour in addition
FDA intends to use this inflation rate to to $206 for a total of $315 per paid hour
make inflation adjustments for FY 2016
($206 plus $109) for each direct hour of
for several of its user fee programs; the
work requiring foreign inspection travel.
derivation of this rate is published in
FDA will use these rates in charging fees
the Federal Register in the FY 2016
in FY 2016 when foreign travel is
notice for the PDUFA user fee rates. The required.
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Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
facility subject to a reinspection’’ to
cover reinspection-related costs.
Section 743(a)(2)(A)(i) of the FD&C
Fee rates Act defines the term ‘‘reinspection’’
Fee category
for FY
with respect to domestic facilities as ‘‘1
2016
or more inspections conducted under
section 704 subsequent to an inspection
Hourly rate if domestic travel is
conducted under such provision which
required .....................................
$221
identified non-compliance materially
Hourly rate if foreign travel is required ........................................
315 related to a food safety requirement of
th[e] Act, specifically to determine
whether compliance has been achieved
III. Fees for Reinspections of Domestic
to the Secretary’s satisfaction.’’
or Foreign Facilities Under Section
The FD&C Act does not contain a
743(a)(1)(A)
definition of ‘‘reinspection’’ specific to
A. What will cause this fee to be
foreign facilities. In order to give
assessed?
meaning to the language in section
743(a)(1)(A) of the FD&C Act to collect
The fee will be assessed for a
fees from the U.S. agent of a foreign
reinspection conducted under section
facility subject to a reinspection, the
704 of the FD&C Act (21 U.S.C. 374) to
Agency is using the following definition
determine whether corrective actions
of ‘‘reinspection’’ for purposes of
have been implemented and are
assessing and collecting fees under
effective and compliance has been
section 743(a)(1)(A), with respect to a
achieved to the Secretary of Health and
foreign facility, ‘‘1 or more inspections
Human Services’ (the Secretary) (and,
conducted by officers or employees duly
by delegation, FDA’s) satisfaction at a
designated by the Secretary subsequent
facility that manufactures, processes,
to such an inspection which identified
packs, or holds food for consumption
non-compliance materially related to a
necessitated as a result of a previous
food safety requirement of the FD&C
inspection (also conducted under
Act, specifically to determine whether
section 704) of this facility, which had
compliance has been achieved to the
a final classification of Official Action
Secretary’s (and, by delegation, FDA’s)
Indicated (OAI) conducted by or on
satisfaction.’’
behalf of FDA, when FDA determined
This definition allows FDA to fulfill
the non-compliance was materially
the mandate to assess and collect fees
related to food safety requirements of
from the U.S. agent of a foreign facility
the FD&C Act. FDA considers such non- in the event that an inspection reveals
compliance to include non-compliance
non-compliance materially related to a
with a statutory or regulatory
food safety requirement of the FD&C
requirement under section 402 of the
Act, causing one or more subsequent
FD&C Act (21 U.S.C. 342) and section
inspections to determine whether
403(w) of the FD&C Act (21 U.S.C.
compliance has been achieved to the
343(w)). However, FDA does not
Secretary’s (and, by delegation, FDA’s)
consider non-compliance that is
satisfaction. By requiring the initial
materially related to a food safety
inspection to be conducted by officers
requirement to include circumstances
or employees duly designated by the
where the non-compliance is of a
Secretary, the definition ensures that a
technical nature and not food safety
foreign facility would be subject to fees
related (e.g., failure to comply with a
only in the event that FDA, or an entity
food standard or incorrect font size on
designated to act on its behalf, has made
a food label). Determining when nonthe requisite identification at an initial
compliance, other than under sections
inspection of non-compliance materially
402 and 403(w) of the FD&C Act, is
related to a food safety requirement of
materially related to a food safety
the FD&C Act. The definition of
requirement of the FD&C Act may
‘‘reinspection-related costs’’ in section
depend on the facts of a particular
743(a)(2)(B) of the FD&C Act relates to
situation. FDA intends to issue guidance both a domestic facility reinspection
to provide additional information about and a foreign facility reinspection, as
the circumstances under which FDA
described in section 743(a)(1)(A).
would consider non-compliance to be
B. Who will be responsible for paying
materially related to a food safety
this fee?
requirement of the FD&C Act.
Under section 743(a)(1)(A) of the
The FD&C Act states that this fee is to
FD&C Act, FDA is directed to assess and be paid by the responsible party for each
collect fees from ‘‘the responsible party
domestic facility (as defined in section
for each domestic facility (as defined in
415(b) of the FD&C Act) and by the U.S.
section 415(b) (21 U.S.C. 350d(b))) and
agent for each foreign facility (section
the United States agent for each foreign
743(a)(1)(A) of the FD&C Act). This is
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TABLE 2—FSMA FEE SCHEDULE FOR
FY 2016
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the party to whom FDA will send the
invoice for any fees that are assessed
under this section.
C. How much will this fee be?
The fee is based on the number of
direct hours spent on such
reinspections, including time spent
conducting the physical surveillance
and/or compliance reinspection at the
facility, or whatever components of
such an inspection are deemed
necessary, making preparations and
arrangements for the reinspection,
traveling to and from the facility,
preparing any reports, analyzing any
samples or examining any labels if
required, and performing other activities
as part of the OAI reinspection until the
facility is again determined to be in
compliance. The direct hours spent on
each such reinspection will be billed at
the appropriate hourly rate shown in
table 2 of this document.
IV. Fees for Non-Compliance With a
Recall Order Under Section 743(a)(1)(B)
A. What will cause this fee to be
assessed?
The fee will be assessed for not
complying with a recall order under
section 423(d) (21 U.S.C. 350l(d)) or
section 412(f) of the FD&C Act (21
U.S.C. 350a(f)) to cover food recall
activities associated with such order
performed by the Secretary (and by
delegation, FDA) (section 743(a)(1)(B) of
the FD&C Act). Non-compliance may
include the following: (1) Not initiating
a recall as ordered by FDA; (2) not
conducting the recall in the manner
specified by FDA in the recall order; or
(3) not providing FDA with requested
information regarding the recall, as
ordered by FDA.
B. Who will be responsible for paying
this fee?
Section 743(a)(1)(B) of the FD&C Act
states that the fee is to be paid by the
responsible party for a domestic facility
(as defined in section 415(b) of the
FD&C Act) and an importer who does
not comply with a recall order under
section 423 or under section 412(f) of
the FD&C Act. In other words, the party
paying the fee would be the party that
received the recall order.
C. How much will this fee be?
The fee is based on the number of
direct hours spent on taking action in
response to the firm’s failure to comply
with a recall order. Types of activities
could include conducting recall audit
checks, reviewing periodic status
reports, analyzing the status reports and
the results of the audit checks,
conducting inspections, traveling to and
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Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
from locations, and monitoring product
disposition. The direct hours spent on
each such recall will be billed at the
appropriate hourly rate shown in table
2 of this document.
V. How must the fees be paid?
An invoice will be sent to the
responsible party for paying the fee after
FDA completes the work on which the
invoice is based. Payment must be made
within 90 days of the invoice date in
U.S. currency by check, bank draft, or
U.S. postal money order payable to the
order of the Food and Drug
Administration. Detailed payment
information will be included with the
invoice when it is issued.
VI. What are the consequences of not
paying these fees?
Under section 743(e)(2) of the FD&C
Act, any fee that is not paid within 30
days after it is due shall be treated as a
claim of the U.S. Government subject to
provisions of subchapter II of chapter 37
of title 31, United States Code.
Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18906 Filed 7–31–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2596]
Understanding Potential Intervention
Measures To Reduce the Risk of
Foodborne Illness From Consumption
of Cheese Manufactured From
Unpasteurized Milk
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for comments
and for scientific data and information.
ACTION:
The Food and Drug
Administration (FDA or we) is
requesting comments and scientific data
and information that would assist us in
identifying and evaluating intervention
measures that might have an effect on
the presence of bacterial pathogens in
cheeses manufactured from
unpasteurized milk. We are taking this
action in light of scientific data on
potential health risks associated with
consumption of cheese made from
unpasteurized milk.
DATES: Submit either electronic or
written comments and scientific data
and information by November 2, 2015.
ADDRESSES: Submit electronic
comments and scientific data and
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SUMMARY:
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information to https://
www.regulations.gov. Submit written
comments and scientific data and
information to Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Andrew Yeung, Center for Food Safety
and Applied Nutrition (HFS–316), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835, 240–402–1541, andrew.yeung@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A 2012 review of outbreaks of
foodborne illness that occurred in the
United States between 1993 and 2006
that were attributed to dairy products
determined that more than 50 percent of
the outbreaks reviewed in the study
involved cheese, with the remaining
outbreaks being attributable to fluid
milk (Ref. 1). Forty-two percent of the
65 cheese-associated outbreaks (i.e., 27
outbreaks) were attributable to products
manufactured from unpasteurized milk,
even though the contribution of
unpasteurized dairy products to all
dairy product consumption in the
United States during the time period
under study was estimated at below 1
percent (on a weight or volume base)
(Ref. 1). The 65 analyzed outbreaks due
to cheese made from unpasteurized milk
resulted in 641 associated illnesses with
131 hospitalizations (i.e., a
hospitalization rate of more than 20
percent). Pathogens associated with
these outbreaks included Listeria
monocytogenes, Escherichia coli (E.
coli) O157, Salmonella, and others (Ref.
1). All of these pathogens can cause
significant illness and even death.
FDA and Health Canada recently
collaborated on the development of a
model to evaluate the impact of factors,
such as the microbiological status of
milk used in cheese production, various
cheese manufacturing steps, conditions
during distribution and storage, and
cross-contamination during processing
and handling, on the public health risk
of listeriosis from consumption of softripened cheese. Elsewhere in this issue
of the Federal Register, we are
announcing the release of the ‘‘Joint
Food and Drug Administration/Health
´
Canada—Sante Canada Quantitative
Assessment of the Risk of Listeriosis
From Soft-Ripened Cheese
Consumption in the United States and
Canada’’ (the FDA/Health Canada QRA)
(Ref. 2).
FDA establishes food standards of
identity, to promote honesty and fair
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46023
dealing in the interest of consumers,
under the authority set forth in section
401 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
341). Some of these standards of
identity (e.g., the standard of identity for
soft-ripened cheese in § 133.182 (21 CFR
133.182)) permit the manufacture of
cheese from unpasteurized milk. These
standards of identity specify that the
process for cheese manufactured from
unpasteurized milk include an aging
period. A typical aging period is not less
than 60 days at not less than 35 °F (see
§ 133.182(a) in the standard of identity
for soft-ripened cheese).
The aging period for cheese
manufactured from unpasteurized milk
was presumed to act as a control
measure to reduce the risk that
pathogens would be present when the
cheese was consumed. However, the
available data and information raise
questions about the safety of cheese
manufactured from unpasteurized milk,
even when aged. For example, research
has demonstrated that pathogens such
as E. coli O157:H7 can survive a 60-day
aging period in a hard cheese such as
Cheddar cheese (Refs. 3 and 4). In
addition, a 1997 memorandum from a
subcommittee of the National Advisory
Committee on Microbiological Criteria
for Foods stated that the scientific
literature confirms that pathogens can
survive the 60-day aging process for
cheeses manufactured using
unpasteurized milk (Ref. 5). More
recently, the results of the FDA/Health
Canada QRA suggest that the 60-day
aging period for soft-ripened cheese may
increase the risk of listeriosis from
consumption of soft-ripened cheese by
allowing more time for L.
monocytogenes, if present, to multiply
(rather than decrease) as the softripened cheese ages (Ref. 6).
FDA recognizes that there is broad
diversity in cheese manufacturing
operations and approaches and that
many factors go into ensuring the safety
of the food. Many types of raw milk
cheeses are made using traditional
methods that require a successful
balance involving the quality of the
milk, the equipment, and the
environment, including ensuring the
presence of bacteria critical to the
nature of the cheese while preventing
the introduction or growth of pathogens.
In issuing this call for data and
information, we are particularly
interested in learning more about the
standards and practices in use by the
growing artisanal cheese manufacturing
community.
E:\FR\FM\03AUN1.SGM
03AUN1
Agencies
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46020-46023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18906]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0007]
Food Safety Modernization Act Domestic and Foreign Facility
Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal
Year 2016
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
fiscal year (FY) 2016 fee rates for certain domestic and foreign
facility reinspections, failures to comply with a recall order, and
importer reinspections that are authorized by the Federal Food, Drug,
and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety
Modernization Act (FSMA). These fees are effective on October 1, 2015,
and will remain in effect through September 30, 2016.
FOR FURTHER INFORMATION CONTACT: Jason Lewis, Office of Resource
Management, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rm. 2046, Rockville, MD 20857, 301-796-5957, email:
Jason.Lewis@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 107 of FSMA (Pub. L. 111-353) added section 743 to the FD&C
Act (21 U.S.C. 379j-31) to provide FDA with the authority to assess and
collect fees from, in part: (1) The responsible party for each domestic
facility and the U.S. agent for each foreign facility subject to a
reinspection, to cover reinspection-related costs; (2) the responsible
party for a domestic facility and an importer who does not comply with
a recall order, to cover food \1\ recall activities associated with
such order; and (3) each importer subject to a reinspection to cover
reinspection-related costs (sections 743(a)(1)(A), (B), and (D) of the
FD&C Act). Section 743 of the FD&C Act directs FDA to establish fees
for each of these activities based on an estimate of 100 percent of the
costs of each activity for each year (sections 743(b)(2)(A)(i), (ii),
and (iv)), and these fees must be made available solely to pay for the
costs of each activity for which the fee was incurred (section
743(b)(3)). These fees are effective on October 1, 2015, and will
remain in effect through September 30, 2016. Section 743(b)(2)(B)(iii)
of the FD&C Act directs FDA to develop a proposed set of guidelines in
consideration of the burden of fee amounts on small businesses. As a
first step in developing these guidelines, FDA invited public comment
on the potential impact of the fees authorized by section 743 of the
FD&C Act on small businesses (76 FR 45818, August 1, 2011). The comment
period for this request ended November 30, 2011. As stated in FDA's
September 2011 ``Guidance for Industry: Implementation of the Fee
Provisions of Section 107 of the FDA Food Safety Modernization Act,''
(https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm274176.htm),
because FDA recognizes that for small businesses the full cost recovery
of FDA reinspection or recall oversight could impose severe economic
hardship, FDA intends to consider reducing certain fees for those
firms. FDA does not intend to issue invoices for reinspection or recall
order fees until FDA publishes a guidance document outlining the
process through which firms may request a reduction in fees.
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\1\ The term ``food'' for purposes of this document has the same
meaning as such term in section 201(f) of the FD&C Act (21 U.S.C.
321(f)).
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In addition, as stated in the September 2011 Guidance, FDA is in
the process of considering various issues associated with the
assessment and collection of importer reinspection fees. The fee rates
set forth in this notice will be used to determine any importer
reinspection fees assessed in FY 2016.
II. Estimating the Average Cost of a Supported Direct FDA Work Hour for
FY 2016
FDA is required to estimate 100 percent of its costs for each
activity in order to establish fee rates for FY 2016. In each year, the
costs of salary (or personnel compensation) and benefits for FDA
employees account for between 50 and 60 percent of the funds available
to, and used by, FDA. Almost all of the remaining funds (operating
funds) available to FDA are used to support FDA employees for paying
rent, travel, utility, information technology, and other operating
costs.
[[Page 46021]]
A. Estimating the Full Cost per Direct Work Hour in FY 2014
In general, the starting point for estimating the full cost per
direct work hour is to estimate the cost of a full-time equivalent
(FTE) or paid staff year for the relevant activity. This is done by
dividing the total funds allocated to the elements of FDA primarily
responsible for carrying out the activities for which fees are being
collected by the total FTEs allocated to those activities. For the
purposes of the reinspection and recall order fees authorized by
section 743 of the FD&C Act (the fees that are the subject of this
notice), primary responsibility for the activities for which fees will
be collected rests with FDA's Office of Regulatory Affairs (ORA). ORA
carries out inspections and other field-based activities on behalf of
FDA's product centers, including the Center for Food Safety and Applied
Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Thus,
as the starting point for estimating the full cost per direct work
hour, FDA will use the total funds allocated to ORA for CFSAN and CVM
related field activities. The most recent FY with available data was FY
2014. In that year, FDA obligated a total of $669,055,119 for ORA in
carrying out the CFSAN and CVM related field activities work, excluding
the cost of inspection travel. In that same year, the number of ORA
staff primarily conducting the CFSAN and CVM related field activities
was 3,016 FTEs or paid staff years. Dividing $669,055,119 by 3,016 FTEs
results in an average cost of $221,835 per paid staff year, excluding
travel costs.
Not all of the FTEs required to support the activities for which
fees will be collected are conducting direct work such as inspecting or
reinspecting facilities, examining imports, or monitoring recalls. Data
collected over a number of years and used consistently in other FDA
user fee programs (e.g., under the Prescription Drug User Fee Act
(PDUFA) and the Medical Device User Fee and Modernization Act) show
that every seven FTEs who perform direct FDA work require three
indirect and supporting FTEs. These indirect and supporting FTEs
function in budget, facility, human resource, information technology,
planning, security, administrative support, legislative liaison, legal
counsel, program management, and other essential program areas. On
average, two of these indirect and supporting FTEs are located in ORA
or the FDA center where the direct work is being conducted, and one of
them is located in the Office of the Commissioner. To get the fully
supported cost of an FTE, FDA needs to multiply the average cost of an
FTE by 1.43, to take into account the indirect and supporting
functions. The 1.43 factor is derived by dividing the 10 fully
supported FTEs by 7 direct FTEs. In FY 2014, the average cost of an FTE
was $221,835. Multiplying this amount by 1.43 results in an average
fully supported cost of $317,224 per FTE, excluding the cost of
inspection travel.
To calculate an hourly rate, FDA must divide the average fully
supported cost of $317,224 per FTE by the average number of supported
direct FDA work hours. See table 1.
Table 1--Supported Direct FDA Work Hours in a Paid Staff Year
------------------------------------------------------------------------
------------------------------------------------------------------------
Total number of hours in a paid staff year................... 2,080
Less:
10 paid holidays........................................... 80
20 days of annual leave.................................... 160
10 days of sick leave...................................... 80
10 days of training........................................ 80
2 hours of meetings per week............................... 80
----------
Net Supported Direct FDA Work Hours Available for 1,600
Assignments.............................................
------------------------------------------------------------------------
Dividing the average fully supported cost of an FTE in FY 2014
($317,224) by the total number of supported direct work hours available
for assignment (1,600) results in an average fully supported cost of
$198 (rounded to the nearest dollar), excluding inspection travel
costs, per supported direct work hour in FY 2014--the last FY for which
data are available.
B. Adjusting FY 2014 Costs for Inflation To Estimate FY 2016 Costs
To adjust the hourly rate for FY 2016, FDA must estimate the cost
of inflation in each year for FY 2015 and FY 2016. FDA uses the method
prescribed for estimating inflationary costs under the PDUFA provisions
of the FD&C Act (section 736(c)(1) (21 U.S.C. 379h(c)(1)), the
statutory method for inflation adjustment in the FD&C Act that FDA has
used consistently. FDA previously determined the FY 2015 inflation rate
to be 2.0813; this rate was published in the FY 2015 PDUFA user fee
rates notice in the Federal Register of August 1, 2014 (79 FR 44807).
Utilizing the method set forth in section 736(c)(1) of the FD&C Act,
FDA has calculated an inflation rate of 2.0266 percent for FY 2016, and
FDA intends to use this inflation rate to make inflation adjustments
for FY 2016 for several of its user fee programs; the derivation of
this rate is published in the Federal Register in the FY 2016 notice
for the PDUFA user fee rates. The compounded inflation rate for FYs
2015 and 2016, therefore, is 4.150 percent (1 plus 2.0813 percent times
1 plus 2.0266 percent).
Increasing the FY 2014 average fully supported cost per supported
direct FDA work hour of $198 (excluding inspection travel costs) by
4.150 percent yields an inflationary adjusted estimated cost of $206
per a supported direct work hour in FY 2016, excluding inspection
travel costs. FDA will use this base unit fee in determining the hourly
fee rate for reinspection and recall order fees for FY 2016 prior to
including domestic or foreign travel costs as applicable for the
activity.
In FY 2014, ORA spent a total of $4,536,206 for domestic regulatory
inspection travel costs and General Services Administration Vehicle
costs related to FDA's CFSAN and CVM field activities programs. The
total ORA domestic travel costs spent is then divided by the 10,392
CFSAN and CVM domestic inspections, which averages a total of $437 per
inspection. These inspections average 31.64 hours per inspection.
Dividing $437 per inspection by 31.64 hours per inspection results in a
total and an additional cost of $14 per hour spent for domestic
inspection travel costs in FY 2014. To adjust $14 for inflationary
increases in FY 2015 and FY 2016, FDA must multiply it by the same
inflation factor mentioned previously in this document (1.04150), which
results in an estimated cost of $15 dollars per paid hour in addition
to $206 for a total of $221 per paid hour ($206 plus $15) for each
direct hour of work requiring domestic inspection travel. FDA will use
these rates in charging fees in FY 2016 when domestic travel is
required.
In FY 2014, ORA spent a total of $3,209,009 on 255 foreign
inspection trips related to FDA's CFSAN and CVM field activities
programs, which averaged a total of $12,584 per foreign inspection
trip. These trips averaged 3 weeks (or 120 paid hours) per trip.
Dividing $12,584 per trip by 120 hours per trip results in a total and
an additional cost of $105 per paid hour spent for foreign inspection
travel costs in FY 2014. To adjust $105 for inflationary increases in
FY 2015 and FY 2016, FDA must multiply it by the same inflation factor
mentioned previously in this document (1.04150), which results in an
estimated cost of $109 dollars per paid hour in addition to $206 for a
total of $315 per paid hour ($206 plus $109) for each direct hour of
work requiring foreign inspection travel. FDA will use these rates in
charging fees in FY 2016 when foreign travel is required.
[[Page 46022]]
Table 2--FSMA Fee Schedule for FY 2016
------------------------------------------------------------------------
Fee rates
Fee category for FY
2016
------------------------------------------------------------------------
Hourly rate if domestic travel is required................... $221
Hourly rate if foreign travel is required.................... 315
------------------------------------------------------------------------
III. Fees for Reinspections of Domestic or Foreign Facilities Under
Section 743(a)(1)(A)
A. What will cause this fee to be assessed?
The fee will be assessed for a reinspection conducted under section
704 of the FD&C Act (21 U.S.C. 374) to determine whether corrective
actions have been implemented and are effective and compliance has been
achieved to the Secretary of Health and Human Services' (the Secretary)
(and, by delegation, FDA's) satisfaction at a facility that
manufactures, processes, packs, or holds food for consumption
necessitated as a result of a previous inspection (also conducted under
section 704) of this facility, which had a final classification of
Official Action Indicated (OAI) conducted by or on behalf of FDA, when
FDA determined the non-compliance was materially related to food safety
requirements of the FD&C Act. FDA considers such non-compliance to
include non-compliance with a statutory or regulatory requirement under
section 402 of the FD&C Act (21 U.S.C. 342) and section 403(w) of the
FD&C Act (21 U.S.C. 343(w)). However, FDA does not consider non-
compliance that is materially related to a food safety requirement to
include circumstances where the non-compliance is of a technical nature
and not food safety related (e.g., failure to comply with a food
standard or incorrect font size on a food label). Determining when non-
compliance, other than under sections 402 and 403(w) of the FD&C Act,
is materially related to a food safety requirement of the FD&C Act may
depend on the facts of a particular situation. FDA intends to issue
guidance to provide additional information about the circumstances
under which FDA would consider non-compliance to be materially related
to a food safety requirement of the FD&C Act.
Under section 743(a)(1)(A) of the FD&C Act, FDA is directed to
assess and collect fees from ``the responsible party for each domestic
facility (as defined in section 415(b) (21 U.S.C. 350d(b))) and the
United States agent for each foreign facility subject to a
reinspection'' to cover reinspection-related costs.
Section 743(a)(2)(A)(i) of the FD&C Act defines the term
``reinspection'' with respect to domestic facilities as ``1 or more
inspections conducted under section 704 subsequent to an inspection
conducted under such provision which identified non-compliance
materially related to a food safety requirement of th[e] Act,
specifically to determine whether compliance has been achieved to the
Secretary's satisfaction.''
The FD&C Act does not contain a definition of ``reinspection''
specific to foreign facilities. In order to give meaning to the
language in section 743(a)(1)(A) of the FD&C Act to collect fees from
the U.S. agent of a foreign facility subject to a reinspection, the
Agency is using the following definition of ``reinspection'' for
purposes of assessing and collecting fees under section 743(a)(1)(A),
with respect to a foreign facility, ``1 or more inspections conducted
by officers or employees duly designated by the Secretary subsequent to
such an inspection which identified non-compliance materially related
to a food safety requirement of the FD&C Act, specifically to determine
whether compliance has been achieved to the Secretary's (and, by
delegation, FDA's) satisfaction.''
This definition allows FDA to fulfill the mandate to assess and
collect fees from the U.S. agent of a foreign facility in the event
that an inspection reveals non-compliance materially related to a food
safety requirement of the FD&C Act, causing one or more subsequent
inspections to determine whether compliance has been achieved to the
Secretary's (and, by delegation, FDA's) satisfaction. By requiring the
initial inspection to be conducted by officers or employees duly
designated by the Secretary, the definition ensures that a foreign
facility would be subject to fees only in the event that FDA, or an
entity designated to act on its behalf, has made the requisite
identification at an initial inspection of non-compliance materially
related to a food safety requirement of the FD&C Act. The definition of
``reinspection-related costs'' in section 743(a)(2)(B) of the FD&C Act
relates to both a domestic facility reinspection and a foreign facility
reinspection, as described in section 743(a)(1)(A).
B. Who will be responsible for paying this fee?
The FD&C Act states that this fee is to be paid by the responsible
party for each domestic facility (as defined in section 415(b) of the
FD&C Act) and by the U.S. agent for each foreign facility (section
743(a)(1)(A) of the FD&C Act). This is the party to whom FDA will send
the invoice for any fees that are assessed under this section.
C. How much will this fee be?
The fee is based on the number of direct hours spent on such
reinspections, including time spent conducting the physical
surveillance and/or compliance reinspection at the facility, or
whatever components of such an inspection are deemed necessary, making
preparations and arrangements for the reinspection, traveling to and
from the facility, preparing any reports, analyzing any samples or
examining any labels if required, and performing other activities as
part of the OAI reinspection until the facility is again determined to
be in compliance. The direct hours spent on each such reinspection will
be billed at the appropriate hourly rate shown in table 2 of this
document.
IV. Fees for Non-Compliance With a Recall Order Under Section
743(a)(1)(B)
A. What will cause this fee to be assessed?
The fee will be assessed for not complying with a recall order
under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C
Act (21 U.S.C. 350a(f)) to cover food recall activities associated with
such order performed by the Secretary (and by delegation, FDA) (section
743(a)(1)(B) of the FD&C Act). Non-compliance may include the
following: (1) Not initiating a recall as ordered by FDA; (2) not
conducting the recall in the manner specified by FDA in the recall
order; or (3) not providing FDA with requested information regarding
the recall, as ordered by FDA.
B. Who will be responsible for paying this fee?
Section 743(a)(1)(B) of the FD&C Act states that the fee is to be
paid by the responsible party for a domestic facility (as defined in
section 415(b) of the FD&C Act) and an importer who does not comply
with a recall order under section 423 or under section 412(f) of the
FD&C Act. In other words, the party paying the fee would be the party
that received the recall order.
C. How much will this fee be?
The fee is based on the number of direct hours spent on taking
action in response to the firm's failure to comply with a recall order.
Types of activities could include conducting recall audit checks,
reviewing periodic status reports, analyzing the status reports and the
results of the audit checks, conducting inspections, traveling to and
[[Page 46023]]
from locations, and monitoring product disposition. The direct hours
spent on each such recall will be billed at the appropriate hourly rate
shown in table 2 of this document.
V. How must the fees be paid?
An invoice will be sent to the responsible party for paying the fee
after FDA completes the work on which the invoice is based. Payment
must be made within 90 days of the invoice date in U.S. currency by
check, bank draft, or U.S. postal money order payable to the order of
the Food and Drug Administration. Detailed payment information will be
included with the invoice when it is issued.
VI. What are the consequences of not paying these fees?
Under section 743(e)(2) of the FD&C Act, any fee that is not paid
within 30 days after it is due shall be treated as a claim of the U.S.
Government subject to provisions of subchapter II of chapter 37 of
title 31, United States Code.
Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18906 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P