[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Proposed Rules]
[Pages 43987-43998]
[FR Doc No: 2015-18141]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-N-0146]
RIN 0910-AG66

User Fee Program To Provide for Accreditation of Third-Party
Auditors/Certification Bodies To Conduct Food Safety Audits and To
Issue Certifications

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing this proposed rule to amend the proposed rule, ``Accreditation
of Third-Party Auditors/Certification Bodies to Conduct Food Safety
Audits and to Issue Certifications'' (Accreditation of Third-Party
Auditors proposed rule) and to propose to establish a reimbursement
(user fee) program to assess fees and require reimbursement for the
work performed to establish and administer the system for the
Accreditation of Third-Party Auditors under the FDA Food Safety
Modernization Act (FSMA).

DATES: Submit either electronic or written comments on the proposed
rule by October 7, 2015.

ADDRESSES: You may submit comments by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No.
FDA-2011-N-0146 for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Charlotte A. Christin, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. Introduction
    B. Accreditation of Third-Party Auditors Proposed Rule
    C. Regulatory Use of Certifications Under FSMA
    D. Reimbursement (User Fee) Program Under Section 808(c)(8) of
the FD&C Act
II. Legal Authority
III. Description of the Proposed Rule
    A. Who would be subject to a user fee?
    B. What user fees would be established?
    C. How will FDA notify the public about the fee schedule?
    D. When must the user fee be submitted?
    E. Are user fees refundable?
    F. What are the consequences of not paying a user fee on time?
    G. Possible Exemptions
IV. Preliminary Regulatory Impact Analysis
    A. Introduction
    B. Regulatory Flexibility Act
    C. Unfunded Mandates Reform Act of 1995
    D. Need for This Regulation
V. Paperwork Reduction Act of 1995
VI. Analysis of Environmental Impact
VII. Federalism
VIII. Comments
IX. References

I. Background

A. Introduction

    President Obama signed FSMA (Pub. L. 111-353) into law on January
4, 2011. FSMA enables us to better protect public health by helping to
ensure the safety and security of the U.S. food supply. Among other
things, FSMA gives us important new tools to better ensure the safety
of imported foods, which constitute approximately 15 percent of the
U.S. food supply (including approximately 80 percent of our seafood, 50
percent of our fresh fruit, and 20 percent of our vegetables). One of
these tools is a new program authorized by section 307 of FSMA for
third-party auditing and certification of eligible foreign entities,
including registered foreign food facilities that meet our applicable
requirements.

B. Accreditation of Third-Party Auditors Proposed Rule

    On July 29, 2013, FDA published for public comment in the Federal
Register a proposed rule, ``Accreditation of Third-Party Auditors/
Certification Bodies to Conduct Food Safety Audits and to Issue
Certifications'' (Accreditation of Third-Party Auditors proposed rule)
to establish a program that would provide for accreditation of third-
party auditors/certification bodies (CBs) to conduct food safety audits
of eligible foreign entities (including registered foreign food
facilities), and to issue food and facility certifications (third-party
accreditation program) (78 FR 45782, July 29, 2013). Under this
program, FDA would recognize accreditation bodies (ABs) to accredit
CBs, except for limited circumstances in which we may directly accredit
CBs. The Accreditation of Third-Party Auditors proposed rule contains
eligibility requirements for ABs to qualify for recognition and
requirements that ABs participating in the FDA program must meet, once
recognized. It also contains eligibility requirements for CBs to
qualify for accreditation and requirements that CBs choosing to
participate in the FDA program must meet, once accredited. These
proposed requirements would ensure the competence and independence of
the ABs and CBs participating in the third-party accreditation program.
The Accreditation of Third-Party Auditors proposed rule also provides
for the monitoring and oversight of participating ABs and CBs, and
procedures for removing a CB or an AB from the program. Finally, the
Accreditation of Third-Party Auditors proposed rule proposes
requirements relating to auditing and certification of eligible foreign
entities under the program and for notifying FDA of conditions in an
audited facility that could cause or contribute to a serious risk to
the public health. More information on the Accreditation of Third-Party
Auditors proposed rule can be found on FDA's Web site at http://www.fda.gov/FSMA.
    The comment period on that proposed rule closed on January 27,
2014, and FDA is currently working on the final rule, which will
respond to the comments submitted. Because that rule has not yet been
finalized, this user fee proposed rule is based on the Accreditation of
Third-Party Auditors proposed rule. When this user fee proposed rule is
finalized, this proposed rule will be finalized to align with the
Accreditation of Third-Party Auditors final rule.

C. Regulatory Use of Certifications Under FSMA

    FDA will use certifications issued by accredited CBs in deciding
whether to admit certain imported food into the United States that FDA
has determined poses a food safety risk under section 801(q) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381), and in
deciding whether an importer is eligible to participate in the
Voluntary Qualified Importer Program (VQIP) under section 806(a) of the
FD&C Act (21 U.S.C. 384b(a)) for expedited review and entry of food
imports. These and other potential uses of facility and food
certifications are discussed in more detail in the Federal Register
notice announcing the Accreditation of Third-Party Auditors proposed
rule (78 FR 45782 at 45785 through 45786). On June 5, 2015, FDA
published a notice of availability, ``Draft Guidance for Industry on
the Voluntary Qualified Importer Program for Food Importers and
Guidelines in Consideration of the Burden of the Voluntary Qualified
Importer Program Fee Amounts on Small Business,'' which contains draft
criteria and procedures for VQIP participation (80 FR 32136). The VQIP
draft guidance can be found on FDA's Web site at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm.

D. Reimbursement (User Fee) Program Under Section 808(c)(8) of the FD&C
Act

    Section 808(c)(8) of the FD&C Act (21 U.S.C. 384d(c)(8)),
established by FSMA, requires FDA to establish by regulation a
reimbursement (user fee) program by which we assess fees and require
reimbursement for the work we perform to establish and administer the
third-party accreditation program under section 808 of the FD&C Act. In
this document, we are proposing to establish this user fee program.

II. Legal Authority

    Section 307 of FSMA, Accreditation of Third-Party Auditors, amends
the FD&C Act to create a new provision, section 808, under the same
name. Section 808 of the FD&C Act directs us to establish a new program
for accreditation of third-party auditors conducting food safety audits
and issuing food and facility certifications to eligible foreign
entities (including registered foreign food facilities) that meet our
applicable requirements. Under this provision, we will recognize ABs to
accredit CBs, except for limited circumstances in which we may directly
accredit CBs to participate in the third-party accreditation program.
    Our authority for this proposed rule is derived in part from
section 808(c)(8) of the FD&C Act, which requires us to establish by
regulation a reimbursement (user fee) program by which we assess fees
and require accredited third-party auditors and audit agents to
reimburse us for the work performed to establish and administer the
third-party accreditation program under section 808 of the FD&C Act.
Accordingly, section 808(c)(8) of the FD&C Act authorizes us to assess
fees and require reimbursement from ABs applying for recognition under
section 808 of the FD&C Act, CBs applying for direct accreditation
under section 808 of the FD&C Act, and recognized ABs and accredited
CBs participating in the third-party accreditation program under
section 808 of the FD&C Act.
    Further, section 701(a) (21 U.S.C. 371(a)) authorizes us to issue
regulations for the efficient enforcement of the FD&C Act, including
this proposed rule to establish a user fee program for the third-party
accreditation program under section 808 of the FD&C Act. Thus, FDA has
the authority to issue this proposed rule under sections 808 and 701(a)
of the FD&C Act.

III. Description of the Proposed Rule

    This proposal includes the following: (1) Who would be subject to a
user fee; (2) how user fees would be computed; (3) how FDA would notify
the public about annual fee rates; (4) how the user fee would be
collected; and (5) what the consequences would be for not paying a user
fee.

A. Who would be subject to a user fee?

    In determining what user fees to establish, FDA considered the
obligations the Agency would have under the Accreditation of Third-
Party

Auditors proposed rule and the parties that would be participating in
the third-party accreditation program. FDA is likely to perform a
significant amount of work reviewing applications for recognition of
ABs, even where FDA denies an application (see proposed 21 CFR 1.631).
Reviewing renewal applications is also a source of cost to FDA, but
that will likely take fewer resources than reviewing original
applications for recognition. FDA will also perform a significant
amount of work to monitor recognized ABs, which may include onsite
assessments of statistically significant numbers of CBs accredited by
the recognized AB and onsite audits of eligible entities that such CBs
certified (see proposed Sec.  1.633). FDA also will perform a
significant amount of work to periodically evaluate the performance of
each accredited CB to determine whether it continues to comply with the
requirements for participation (see proposed Sec.  1.662).
    In certain circumstances, FDA would consider applications from CBs
for direct accreditation (see proposed Sec.  1.670). This application
review, and any subsequent monitoring and renewal application review,
would add to FDA's program costs.
    FDA tentatively concludes that there are four main groups to whom
costs should be attributed for the purposes of charging fees:
     ABs submitting applications or renewal applications for
recognition in the third-party accreditation program;
     Recognized ABs participating in the third-party
accreditation program subject to FDA monitoring activities;
     CBs submitting applications or renewal applications for
direct accreditation; and
     Accredited CBs (whether accredited by recognized ABs or by
FDA through direct accreditation) participating in the third-party
accreditation program subject to FDA monitoring activities.
    These are the parties identified in proposed Sec.  1.700.
    We note that under this proposed rule, FDA's collection of fees
through the proposed user fee program would not recover all costs
associated with the establishment and administration of the third-party
accreditation program under section 808 of the FD&C Act. Other FDA
costs include those involving reconsiderations of certain regulatory
decisions such as denial of an application for recognition or waiver
request (see proposed Sec.  1.691), reviewing waiver requests (see
proposed Sec.  1.663), revocation of recognition of ABs or withdrawal
of accreditation of CBs (see proposed Sec.  1.634 and Sec.  1.664), and
maintaining a Web site listing recognized ABs and accredited CBs (see
proposed Sec.  1.690). Additionally, FDA would bear general initial
startup costs, mainly due to training new employees and establishing an
IT system to support the new third-party accreditation program.
    FDA requests comment on whether any of the costs to FDA of the
third-party accreditation program that are not accounted for in this
proposed rulemaking should be paid for through user fees collected
under section 808(c)(8) of the FD&C Act, and if so, to whom should the
fees be charged and how should the fees be calculated (e.g., the
estimated average cost of processing a waiver request, per hour of
FDA's work to determine whether to revoke recognition of an AB or
withdraw accreditation of a CB, a flat annual fee to recognized ABs and
accredited CBs to cover maintenance of the Web site).

B. What user fees would be established?

    Proposed Sec.  1.705 would establish application fees and annual
fees. The proposed rule would establish application fees for ABs
applying for recognition (proposed Sec.  1.705(a)(1)), recognized ABs
submitting renewal applications (proposed Sec.  1.705(a)(2)), CBs
applying for direct accreditation (proposed Sec.  1.705(a)(3)), and CBs
applying for renewal of direct accreditation (proposed Sec.
1.705(a)(4)). The proposed rule would establish annual fees for
recognized ABs (proposed Sec.  1.705(b)(1)), CBs directly accredited by
FDA (proposed Sec.  1.705(b)(2)), and CBs accredited by recognized ABs
(proposed Sec.  1.705(b)(3)). The application fees would fund our
review of the applications. The annual fees would support relevant
monitoring activities.
1. Application Fee for ABs Applying for Recognition
    Under proposed Sec.  1.705(a)(1), ABs applying for recognition
would be subject to an application fee for the estimated average cost
of the work FDA performs in reviewing and evaluating applications for
recognition of ABs. The average cost of the work FDA performs in
reviewing and evaluating one application for recognition of an AB would
be estimated by: (1) Estimating the number of hours, on average, it
would take a full-time federal employee (FTE) to review and evaluate an
application for recognition and (2) multiplying that estimate by the
fully supported FTE hourly rates calculated by the Agency for the
applicable fiscal year.
    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 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 the Office of Regulatory
Affairs (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 calculate an hourly rate of a fully supported FTE (i.e., an
hourly rate that takes into account the direct work performed by FTEs
and the work performed by indirect and supporting FTEs), FDA would
first calculate the average cost of the direct work performed by an FTE
per year and multiply that average annual cost of the work performed by
an FTE by 1.43 (10 total FTEs divided by 7 direct FTEs). FDA would then
divide the fully supported cost of an FTE per year by the average
number of supported direct FDA work hours in that year an average FTE
is available for work assignment (which excludes, e.g., annual leave,
sick leave, and trainings).
    For example, in fiscal year (FY) 2013, a recent fiscal year for
which data is available, the estimated average cost of an FTE doing
Center for Food Safety and Applied Nutrition (CFSAN) and Center for
Veterinary Medicine (CVM) related field activities work was $216,543,
excluding the cost of inspection travel. Multiplying $216,543 by 1.43
results in an average fully supported cost of $309,657 per FTE,
excluding travel costs. Dividing this average fully supported cost of
an FTE in FY 2013 by the total number of supported direct work hours
available for assignment per FTE (1,600 hours) results in an average
fully supported cost of $194 per supported direct work hour in FY 2013,
excluding travel costs.
    In this example, to estimate the inflation-adjusted average fully
supported cost for FY 2015, we use the method set forth in the
Prescription Drug User Fee Act provisions of the FD&C Act (21 U.S.C.
379h), the statutory method for inflation adjustment in the FD&C Act
that FDA has used consistently in setting user fees. FDA previously
determined the FY 2014

inflation adjustment factor to be 2.20 percent (78 FR 46980, August 2,
2013), and the inflation adjustment factor for the FY 2015 to be 2.0813
percent (79 FR 44807, August 1, 2014). The inflation adjustment factor
for FY 2015 (2.0813 percent) is compounded by adding 1 and then
multiplying by 1 plus the inflation adjustment factor for FY 2014 (2.20
percent), which equals a compounded inflation adjustment factor of
1.043271 (rounded) (1.020813 x 1.0220). After adjusting for inflation,
the estimated cost of $192 per supported direct work hour in FY 2013
increases to $202 per supported direct work hour in FY 2015.
    For the purposes of providing a sense of the fee we are proposing,
in this document we use $202 as the base unit fee in determining the
hourly fee rate, prior to including domestic or foreign travel costs as
applicable for the activity.
    When travel is required, we would have one hourly rate for domestic
travel and one hourly rate for foreign travel. To calculate an hourly
rate of a fully supported FTE including travel costs, FDA would
calculate the additional cost per hour spent on travel (taking into
account domestic and foreign travel, as applicable), adjust for
inflation, and add this amount to the base unit fee.
    For the purposes of providing a sense of the fee we are proposing,
in this document we demonstrate calculation of additional costs per
hour spent on travel using information from ORA's inspection trips
related to FDA's CFSAN and CVM field activities programs. In FY 2013,
ORA spent a total of $2,797,656 on 235 foreign inspection trips related
to FDA's CFSAN and CVM field activities programs which averaged a total
of $11,905 per trip. The average paid hours per trip was 120 hours.
Dividing $11,905 per trip by the average paid hours per trip (120
hours) results in a total and an additional cost of $99 per paid hour
spent for foreign inspection travel costs in FY 2013. To adjust for
inflationary increases in FY 2014 and FY 2015, we multiply $99 by the
compounded inflation adjustment factor previously mentioned in this
document (1.04327), which results in an adjusted estimated additional
cost of $103 per paid hour spent for foreign inspection travel costs in
FY 2015. We then add $103 to $202 (base unit fee) to get a total of
$305 per paid hour for each direct hour of work requiring foreign
inspection travel.
    In addition, in FY 2013, ORA spent a total of $4,687,907 on 11,779
domestic regulatory inspection trips related to FDA's CFSAN and CVM
activities programs which averaged a total of $398 per inspection.
Dividing $398 by the average number of hours per inspection (27.91
hours) results in an additional cost of $14 per hour spent for domestic
inspection travel costs in FY 2013. To adjust for inflationary
increases in FY 2014 and FY 2015, we multiply $14 by the compounded
inflation adjustment factor previously mentioned in this document
(1.04327), which results in an adjusted estimated additional cost of
$15 per paid hour spent for domestic inspection travel costs in FY
2015. We then add $15 to $202 (base unit fee) to get a total of $217
per paid hour for each direct hour of work requiring domestic
inspection travel.
    To provide a sense of the fee we are proposing, we calculate an
estimated fee using these fully supported FTE hourly rates, and
estimates of the number of hours it would take FDA to perform relevant
activities. These estimates represent FDA's current thinking and differ
from the Preliminary Regulatory Impact Analysis (PRIA) for the
Accreditation of Third-Party Auditors proposed rule (Ref. 1). FDA's
thinking may also continue to evolve as we consider the RIA for the
Accreditation of Third-Party Auditors final rule. We estimate that it
would take, on average, 60 person-hours to review an AB's submitted
application, 48 person-hours for an onsite performance evaluation of
the applicant AB (including travel and other steps necessary for a
fully supported FTE to complete an onsite performance evaluation), and
45 person-hours to prepare a written report documenting the onsite
audit.
    FDA employees are likely to review applications and prepare reports
from their worksites, so we use the fully supported FTE hourly rate
excluding travel, $202/hour, to estimate the portion of the user fee
attributable to those activities: $202/hour x (60 hours + 45 hours) =
$21,210. FDA employees will likely travel to foreign countries for the
onsite performance evaluations because most ABs are located in foreign
countries, so for this estimated fee we use the fully supported FTE
hourly rate for work requiring foreign inspection travel, $305/hour, to
estimate the portion of the user fee attributable to those activities:
$305 x 48 hours (i.e., 2 fully supported FTEs x (2 travel days + 1 day
onsite)) = $14,640. The estimated average cost of the work FDA performs
in total for reviewing an application for recognition for an AB based
on these figures would be $21,210 + $14,640 = $35,850.
    We anticipate that the RIA for the Accreditation of Third-Party
Auditors final rule, which FDA intends to publish in the fall of 2015,
will include updated hourly estimates based on comments received on
that rulemaking. In addition, we expect that all of these estimates
used to calculate the actual user fees will be informed by FDA's
experience with the third-party accreditation program, once that
program begins, and the estimates used to calculate the user fees will
be updated accordingly. For example, if it takes less time, on average
for us to prepare written reports documenting audits, we will use that
information to decrease the fee for the following year. As another
example, if an AB applying for recognition is located in the United
States, domestic travel, not foreign travel will be needed to conduct
onsite audits of such applicant ABs. This, too, would lower the average
cost to FDA of conducting onsite audits, and, in turn, would contribute
to lowering the estimated fee rate.
    Note that in the above calculation, we estimate the average number
of hours it would take for FDA to conduct relevant activities, and
multiply that by the appropriate fully supported FTE hourly rate to
generate one flat fee that would be paid by every applicant AB.
Alternatively, we could track the number of hours it actually takes FDA
staff to conduct relevant activities for each applicant AB, and
multiply that number by the fully supported FTE hourly rate calculated
by the Agency for the applicable fiscal year. We could then bill each
applicant AB separately for the actual application costs attributable
to it. Under this approach, we would likely bill after ABs learn
whether or not they are accepted into the program.
    The proposed approach provides predictability for FDA and for
industry, and allows FDA to collect application fees before beginning
to perform the work of reviewing the application. However, this
alternative approach may create incentives for higher quality
applications. Applications that are faster to review, e.g., because
they are better prepared, could result in lower fees, while
applications that are slower to review, e.g., because they are less
organized or necessitate more back-and-forth with the applicant, could
result in higher fees. Similarly, applicants that facilitate the onsite
audit process and have higher quality operations would likely have
shorter onsite audits than other applicants. Still, because FDA would
bill applicant ABs after completing application review, applicants
whose applications are not accepted may have a lowered incentive to pay
the application fee at all. This alternative approach might also raise
questions regarding differences in

application review costs that in turn could take additional FDA
resources to resolve.
    We request comment on the proposed and alternative approaches,
particularly whether one approach would create more favorable
incentives for quality of the application. For the alternative
approach, we also request comment on possible consequences we should
impose on ABs for not paying the fee on time. We also request comment
on whether we should adopt the alternative approach for a portion of
the application review process, e.g., the onsite audit portion, while
maintaining a flat fee for other portions, e.g., the paper application
review. Such a hybrid approach may be most consistent with how ABs
currently charge CBs and provide a balance of predictability and
incentives.
2. Application Fee for Recognized ABs Submitting Renewal Applications
    Under proposed Sec.  1.705(a)(2), recognized ABs submitting renewal
applications would be subject to a renewal application fee for the
estimated average cost of the work FDA performs in reviewing and
evaluating renewal applications for recognition of ABs. The average
cost of the work FDA performs in reviewing and evaluating renewal
applications for recognized ABs would be estimated by: (1) Estimating
the number of hours it would take an FTE to review and evaluate a
renewal application, on average and (2) multiplying that estimate by
the fully supported FTE hourly rates calculated by the Agency for the
applicable fiscal year.
    The review and evaluation of renewal applications submitted by
recognized ABs, including the onsite assessments, is expected to be
less burdensome than the review and evaluation required for initial
applications for recognition submitted by ABs. As above, to provide a
sense of the fee we are proposing, we calculate an estimated fee here
using estimates that represent FDA's current thinking of the number of
hours it would take FDA to perform relevant activities and the fully
supported FTE hourly rates described above. We estimate that it would
take, on average, 40 person-hours to review an AB's renewal
application, including review of reports prepared by FDA detailing the
FDA performance evaluations, which include FDA's onsite assessments of
the AB, review of the AB's annual self-assessment reports submitted to
FDA, and review of relevant records maintained by the AB. We estimate
that for AB's seeking renewal of recognition, approximately 25 percent
of such FDA performance evaluations will be conducted onsite and we
expect that it will take 1 fully supported FTE 2 travel days and 2
onsite days to conduct an onsite assessment for a total of 32 hours.
Therefore, on average, 8 person-hours (i.e., 25 percent x 1 fully
supported FTE x (2 travel days + 2 onsite days)) would be spent on an
onsite evaluation of an AB as part of FDA's review of an AB's renewal
of recognition application. In addition, 41.25 person-hours would be
spent on report preparation. For activities FDA employees are likely to
perform at their worksites (i.e., the application review and report
preparation), we use the fully supported FTE hourly rate excluding
travel, of $202/hour, while for activities FDA employees are likely to
need to travel to foreign countries to perform (i.e., the onsite
audit), we use the fully supported FTE hourly rate for work requiring
inspection travel, of $305/hour. The estimated average cost of the work
FDA performs in reviewing and evaluating an application for renewal of
recognition for an AB would be $16,413 ($202/hour x (40 hours + 41.25
hours)) plus $2,440 ($305/hour x 8 hours), which is $18,853 total. As
previously mentioned, the hourly rate used would be adjusted each year
for changes in FDA's costs using an inflation adjustment factor, and we
expect the estimates of the number of hours each activity takes will be
revised in the RIA of the Accreditation of Third-Party Auditors final
rule. More generally, we expect that these estimates will be informed
by FDA's experience with the third-party accreditation program, once
that program begins.
    Similar to the alternative approach we discussed for initial
application fees, we are considering billing each applicant for the
actual amount of time FDA takes to review and evaluate the particular
applicant's renewal application, using the fully supported FTE hourly
rates calculated by the Agency for the applicable fiscal year. We see
the same policy considerations as discussed for the analogous
alternative approach for the initial application fees discussed above.
We request comment on the proposal and alternative approach for renewal
application fees. We also request comment on whether we should adopt
the alternative approach for a portion of the renewal application
review process, e.g., the onsite audit portion, while maintaining a
flat fee for other portions, e.g., the paper application review.
3. Application Fee for CBs Applying for Direct Accreditation
    Under proposed Sec.  1.705(a)(3), CBs applying for direct
accreditation would be subject to an application fee for the estimated
average cost of the work FDA performs in reviewing and evaluating
applications for direct accreditation. As with the two proposed
application fees for ABs, the average cost of the work FDA performs in
reviewing and evaluating applications for direct accreditation of CBs
would be estimated by: (1) Estimating the number of hours, on average,
it would take an FTE to review and evaluate an application for direct
accreditation and (2) multiplying that estimate by the fully supported
FTE hourly rates calculated by the Agency for the applicable fiscal
year.
    Again, to provide a sense of the fee we are proposing, we calculate
an estimated fee here using estimates that represent FDA's current
thinking of the number of hours it would take FDA to perform relevant
activities and the fully supported FTE hourly rates described above.
For activities FDA employees are likely to perform at their worksites,
we use the fully supported FTE hourly rate excluding travel, of $202/
hour, while for activities FDA employees are likely to need to travel
to foreign countries to perform, we use the fully supported FTE hourly
rate for work requiring inspection travel, of $305/hour. We tentatively
estimate that it would take, on average, 60 person-hours to review a
CB's application for direct accreditation, 48 person-hours to conduct
an onsite performance evaluation of the applicant CB, including travel
and other steps necessary for a fully supported FTE to complete an
onsite performance evaluation, and 45 person-hours to prepare a written
report documenting the onsite performance evaluation. Given that FDA
employees are likely to conduct application review and report
preparation at their worksites, the estimated average cost of the work
FDA performs for those activities would be $202/hour x (60 hours + 45
hours) = $21,210. FDA employees will likely travel to foreign countries
for the onsite performance evaluations, so the estimated average cost
of the work FDA performs for those activities would be $305 x 48 hours
(i.e., 2 fully supported FTEs x (2 travel days + 1 day onsite)) =
$14,640. Therefore, the estimated average cost of the work FDA performs
in reviewing and evaluating an application for direct accreditation for
a CB would be $21,210 + $14,640 = $35,850. As previously mentioned, the
hourly rate used would be adjusted each year for changes in FDA's costs
using an inflation adjustment factor, we expect the estimates of the
number of hours each activity takes will be revised in the RIA for the
Accreditation of Third-Party

Auditors final rule based on comments to that proposed rulemaking, and
we expect our estimates used to calculate actual user fees will be
informed by FDA's experience with the third-party accreditation
program, once that program begins.
    Similar to the alternative approach we discussed for initial
application fees for AB recognition, we considered an alternative
approach for direct accreditation applications where FDA would bill
each applicant for the actual amount of time FDA takes to review and/or
evaluate the particular applicant's application, using the fully
supported FTE hourly rate calculated by the Agency for the applicable
fiscal year. This would likely have the same policy considerations as
discussed for the analogous alternative approach discussed in section
III.B.1. We request comment on this alternative. We also request
comment on whether we should adopt the alternative approach for a
portion of the application review process, e.g., the onsite audit
portion, while maintaining a flat fee for other portions, e.g., the
paper application review.
4. Application Fee for CBs Applying for Renewal of Direct Accreditation
    Under proposed Sec.  1.705(a)(4), CBs applying for renewal of
direct accreditation would be subject to an application fee for the
estimated average cost of the work FDA performs in reviewing and
evaluating renewal applications for direct accreditation. The average
cost of the work FDA performs in reviewing and evaluating renewal
applications for directly accredited CBs would be estimated by: (1)
Estimating the number of hours it would take an FTE to review and
evaluate a renewal application, on average and (2) multiplying that
estimate by the fully supported FTE hourly rates calculated by the
Agency for the applicable fiscal year.
    The review and evaluation of renewal applications submitted by
directly accredited CBs, including the onsite assessments, is expected
to be less burdensome than the review and evaluation required for
initial applications for direct accreditation. As above, to provide a
sense of the fee we are proposing, we calculate an estimated fee here
using estimates that represent FDA's current thinking of the number of
hours it would take FDA to perform relevant activities and the fully
supported FTE hourly rates described above. We estimate that it would
take, on average, 40 person-hours to review a CB's renewal application,
including review of reports prepared by FDA detailing the records
review from the FDA performance evaluations, which include FDA's onsite
assessments of the CB, review of the CB's annual self-assessment
reports submitted to FDA, and review of relevant records maintained by
the CB. In addition, we estimate that 32 person-hours (i.e., 1 fully
supported FTE x (2 travel days + 2 onsite days)) would be spent on
onsite audits and 45 person-hours would be spent on report preparation.
For activities FDA employees are likely to perform at their worksites
(i.e., the application review and report preparation), we use the fully
supported FTE hourly rate excluding travel, of $202/hour, while for
activities FDA employees are likely to need to travel to foreign
countries to perform (i.e., the onsite audit), we use the fully
supported FTE hourly rate for work requiring inspection travel, of
$305/hour. The estimated average cost of the work FDA performs in
reviewing and evaluating a renewal application for direct accreditation
for a CB would be $17,170 ($202/hour x (40 hours + 45 hours)) plus
$9,760 ($305/hour x 32 hours), which is $26,930 total.
    As previously mentioned, the hourly rate used would be adjusted
each year for changes in FDA's costs using an inflation adjustment
factor, and we expect the estimates of the number of hours each
activity takes will be revised in the RIA for the Accreditation of
Third-Party Auditors final rule. More generally, we expect that these
estimates will be informed by FDA's experience with the third-party
accreditation program, once that program begins.
    Similar to the approach we discussed for renewal application fees
for AB recognition, we considered an alternative approach to renewal
applications for direct accreditation of CBs where FDA would bill each
applicant for the actual amount of time FDA takes to review and
evaluate the particular applicant's renewal application, using the
fully supported FTE hourly rates calculated by the Agency for the
applicable fiscal year. We see the same policy considerations as
discussed for the analogous alternative approach for renewal
application fees for ABs discussed above. We request comment on the
proposal and alternative approach for these renewal application fees.
We also request comment on whether we should adopt the alternative
approach for a portion of the renewal application process, e.g., the
onsite audit portion, while maintaining a flat fee for other portions,
e.g., the paper application review.
5. Annual Fees for Recognized ABs
    Proposed Sec.  1.633(a) of the Accreditation of Third-Party
Auditors proposed rule states that FDA would periodically evaluate the
performance of each recognized AB to determine its compliance with the
applicable requirements of that proposed rule. Such evaluation would
occur by at least 4 years after the date of recognition for a 5-year
term of recognition, or by no later than the mid-term point for
recognition granted for less than 5 years. FDA may conduct additional
performance evaluations of a recognized AB at any time.
    Proposed Sec.  1.705(b)(1) would require recognized ABs to pay an
annual fee for the estimated average cost of the work FDA performs to
monitor performance of recognized ABs under proposed Sec.  1.633. The
average cost of the work FDA performs to monitor performance of a
recognized AB would be estimated by: (1) Estimating the number of
hours, on average, it would take an FTE to monitor the performance of a
recognized AB and (2) multiplying that estimate by the fully supported
FTE hourly rates calculated by the Agency for the applicable fiscal
year.
    To calculate the annual fee for each recognized AB, FDA would take
the estimated average cost of work FDA performs to monitor performance
of a single recognized AB and annualize that over the average term of
recognition. For the calculations in this document, we assume an
average term of recognition of 5 years. We also assume that FDA would
monitor 10 percent of recognized ABs onsite. Terms of recognition may
initially be shorter than 5 years during the first few years of the
program, but we anticipate that 5 years is likely to be the most common
term of recognition as the program continues. We estimate that for one
performance evaluation of a recognized AB, it would take, on average
(taking into account that not all recognized ABs would be monitored
onsite), 24 hours for FDA to conduct records review, 4.8 hours of
onsite performance evaluation (i.e., 10 percent x 2 fully supported
FTEs x (2 travel days + 1 day onsite)), and 8 hours to prepare a report
detailing the records review and onsite performance evaluation. Using
the fully supported FTE hourly rates described above, the estimated
average cost of the work FDA performs to monitor performance of a
single recognized AB would be $6,464 ($202/hour x (24 hours + 8 hours))
plus $1,464 ($305/hour x 4.8 hours), which is $7,928. Annualizing this
amount over 5 years would lead to an annual fee of

roughly $1,585 to $1,878, depending on inflation.
    The proposed approach is relatively simple and consistent with
industry models. However, if a recognized AB leaves the program, either
voluntarily or because FDA revokes such AB's recognition, before FDA
conducts its monitoring activities, such AB will have paid an annual
fee for monitoring that never occurs. If a recognized AB leaves the
program after FDA conducts its monitoring activities, but before the
term of recognition ends, such AB's annual fees will not fully
compensate FDA for monitoring. In addition, if an AB completes its term
of recognition in the program but its term of recognition is less than
the average term of recognition used to calculate the annual fee, the
proposed approach will not fully reimburse FDA for monitoring of that
AB.
    We request comment on the proposed approach and whether another
approach would resolve some of these issues. For example, each AB could
pay in full for monitoring in the year that FDA conducts it. FDA could
calculate the fee using the same method applied under the proposed
approach (i.e., by estimating the number of hours, on average, it would
take an FTE to monitor the performance of a recognized AB and
multiplying that estimate by the fully supported FTE hourly rates
calculated by the Agency for the applicable fiscal year). Or, FDA could
track the number of hours spent monitoring that particular AB and
multiply the fully supported FTE hourly rate by that number of hours.
Either way, in general, FDA would receive the money as costs are
incurred. However, a large fee for each instance that FDA conducts a
performance evaluation that may or may not be charged in any given year
may be financially impractical for ABs who would otherwise participate
in the program. They may prefer a smaller fee collected annually,
rather than a much larger fee due at one time.
    Under another alternative, FDA would calculate the annual
monitoring fee using the same method applied by the proposed approach,
adjusted for inflation, but the fee would be annualized based on the
term of recognition for each recognized AB. So if an AB is only
recognized for a term of 3 years, the fee would be annualized over 3
years, while an AB that is recognized for a 5-year term would have its
fee annualized over 5 years. As a result, an AB with a shorter term of
recognition would have a higher annual fee than an AB with a longer
term of recognition. Under this alternative, FDA would need to
calculate a different annual fee for each possible term length, and FDA
would have to ensure that ABs are billed an annual fee consistent with
their particular term lengths.
6. Annual Fees for CBs Directly Accredited by FDA
    Similarly, proposed Sec.  1.662 of the Accreditation of Third-Party
Auditors proposed rule states that FDA would periodically evaluate the
performance of each accredited CB to determine whether the accredited
CB continues to comply with the requirements and whether there are
deficiencies in the performance of the accredited CB that, if not
corrected, would warrant withdrawal of its accreditation. FDA would
evaluate each directly accredited CB annually. FDA may conduct
additional performance evaluations of an accredited CB at any time.
    Proposed Sec.  1.705(b)(2) would require directly accredited CBs to
pay an annual fee for the estimated average cost of the work FDA
performs to monitor directly accredited CBs under proposed Sec.  1.662.
The average cost of the work FDA performs to monitor directly
accredited CBs would be estimated by: (1) Estimating the number of
hours, on average, it would take an FTE to monitor the performance of a
directly accredited CB and (2) multiplying that estimate by the fully
supported FTE hourly rates calculated by the Agency for the applicable
fiscal year. We estimate that it would take FDA about the same amount
of time to conduct records review (24 hours) and to prepare a report
detailing the records review and onsite performance evaluation (8
hours) as it would for FDA to perform these activities for a recognized
AB. However, we expect to conduct onsite performance evaluations for
100 percent of directly accredited CBs (48 hours per directly
accredited CB, including travel and other steps necessary for a fully
supported FTE to complete an onsite performance evaluation). In
addition, because FDA would be conducting these activities annually for
each directly accredited CB, the annual fee for a directly accredited
CB would cover the full cost of performance evaluation, approximately
$21,104. We request comment on this proposal.
7. Annual Fees for CBs That Are Accredited by a Recognized AB
    Proposed Sec.  1.662(a) of the Accreditation of Third-Party
Auditors proposed rule states that FDA would evaluate an accredited CB
annually evaluated by a recognized accreditation body by not later than
3 years after the date of accreditation for a 4-year term of
accreditation, or by no later than the mid-term point for accreditation
granted for less than 4 years. FDA may conduct additional performance
evaluations of an accredited CB at any time.
    Under proposed Sec.  1.705(b)(3), CBs accredited by recognized ABs
would be subject to an annual fee for the estimated average cost of the
work FDA performs to monitor CBs under proposed Sec.  1.662 that are
accredited by a recognized AB. The average cost of the work FDA
performs to monitor performance of a CB accredited by a recognized AB
would be estimated by: (1) Estimating the number of hours, on average,
it would take an FTE to monitor the performance of a CB accredited by a
recognized AB and (2) multiplying that estimate by the fully supported
FTE hourly rates calculated by the Agency for the applicable fiscal
year.
    To calculate the annual fee for each CB accredited by a recognized
AB, FDA would take the estimated average cost of work FDA performs to
monitor performance of a single CB accredited by a recognized AB and
annualize that over 4 years, assuming that 4 years would be the most
common term of accreditation. We estimate that FDA would conduct, on
average, the same activities for the same amount of time to monitor CBs
accredited by a recognized AB as we would to monitor an AB recognized
by FDA, costing approximately $7,928. Annualizing this over 4 years
would generate an annual fee of approximately $1,982 to $2,250,
depending on inflation.
    The proposed provision is analogous to proposed Sec.  1.705(b)(1),
which would establish the annual fee for recognized accreditation
bodies. As discussed for that provision, the proposed approach is
relatively simple and consistent with industry models. But if an
accredited CB leaves the program, either voluntarily or because of a
decision from its AB or FDA, before FDA conducts its monitoring
activities, such CB will have paid an annual fee for monitoring that
never occurs. If the CB leaves the program after FDA conducts its
monitoring activities, but before the term ends, the CB's annual fees
will not fully compensate FDA for monitoring. In addition, if a CB
completes its term of accreditation in the program but its term is less
than 4 years, the proposed approach will not fully reimburse FDA for
monitoring of that CB. We request comment on the proposed approach and
any possible alternatives. For example, each CB could pay in full for
monitoring in the year that FDA conducts it. FDA could calculate the
fee using the same method applied under the proposed approach (i.e.,
estimating the number of

hours, on average, it would take an FTE to monitor the performance of a
CB accredited by a recognized AB and multiplying that estimate by the
fully supported FTE hourly rates calculated by the Agency for the
applicable fiscal year). Or, FDA could track the number of hours spent
monitoring that particular CB and multiply the fully supported FTE
hourly rate by that number of hours. Either way, in general, FDA would
receive the money as we incur the costs. However, a large fee for each
instance that FDA conducts a performance evaluation that may or may not
be charged in any given year may be impractical for CBs who would
otherwise participate in the program.
    Under another alternative, FDA would calculate the annual
monitoring fee using the same method applied under the proposed
approach, adjusted for inflation, but the fee would be annualized based
on the term of accreditation for each CB. So if a CB is only accredited
for a term of 2 years, the fee would be annualized over 2 years, while
a CB that is accredited for a 4-year term would have its fee annualized
over 4 years. As a result, a CB with a shorter term of accreditation
would have a higher annual fee than a CB with a longer term of
accreditation. FDA would need to calculate a different annual fee for
each possible term length, and FDA would have to ensure that CBs are
billed an annual fee consistent with their particular term lengths.
8. General Fee Structure and Alternatives
    Having an application fee that is separate from the annual
monitoring fee would allow FDA to recover costs of work performed to
review applications that are ultimately denied because the applicants
do not meet the eligibility criteria for the program. In addition, we
understand that it is common for ABs to charge an application fee to
CBs that apply for accreditation and an annual fee to accredited CBs;
our proposed fee structure is consistent with this industry model.
    The application fee would likely be significantly higher than the
annual monitoring fee, as can be seen by the examples above. We are
wary that a high application fee could deter participation in the
program. We considered alternative fee structures to address this
potential issue. For example, we considered annualizing the cost of
application review over the length of the term of recognition (e.g., 5
years) or accreditation (e.g., 4 years), adjusting for inflation. The
annualized application fee could be added to the annual fee funding
FDA's monitoring costs to generate a single annual fee. Under this
alternative, the total fee paid each year by participants in the
program would be consistent, adjusting for inflation, over the term of
the recognition or accreditation. In an application year, the total fee
charged for that year would be lower under this alternative than under
the proposed fee structure, but the total fee charged in each
subsequent year of the term of recognition or accreditation would be
higher than under the proposed fee structure.
    We decided against this alternative approach for several reasons.
First, if an application is not accepted into the program or an
applicant leaves the program before the end of the term of recognition
or accreditation, e.g., because FDA revokes an AB's recognition under
proposed Sec.  1.634, FDA would not recover the total cost of reviewing
the application. Second, while an excessively large application fee
could deter participation in a way that would negatively affect program
participation, an application fee that is appropriately high, and not
annualized over the length of the term of recognition or accreditation,
could serve as a barrier for lower quality applicants that may not have
sufficient resources to meet the program criteria and carry out the
duties of program participants as prescribed in proposed 21 CFR part 1,
subpart M.
    Third, as described above, the cost to FDA of reviewing a renewal
application is expected to be less than the cost to FDA of reviewing an
initial application. Therefore, to avoid overcharging ABs and directly
accredited CBs in their second or third terms of recognition or direct
accreditation, we would need to establish two different annual fees for
ABs and two different annual fees for directly accredited CBs; one for
those in their first term and one for those who are in a subsequent
term, with the latter reduced to account for the lower annualized cost
to FDA of reviewing renewal applications. For proper billing, FDA would
need to keep track of which term each participant was in as well as the
length of the term, adding another layer of complexity. Moreover, FDA
would continue to need to establish a separate annual fee that does not
include an application surcharge for those CBs that are accredited by
ABs. For these reasons, FDA tentatively concludes that the alternative
fee structure could potentially reimburse FDA less for work performed
and could lead to more lower-quality applications.
    We request comment on the proposed fee structure, the alternative
discussed here, and any other alternative fee structures that may be
simpler or more consistent with industry practice.

C. How will FDA notify the public about the fee schedule?

    In general, FDA publishes notices in the Federal Register in late
summer announcing the fee rates of its user fee programs for the
upcoming fiscal year (e.g., Generic Drug User Fee Rates for Fiscal Year
2015 (79 FR 44797, August 1, 2014) and Medical Device User Fee Rates
for Fiscal Year 2015 (79 FR 44178, July 30, 2014)). Therefore, under
proposed Sec.  1.710, FDA would notify the public of the fee schedule
annually prior to the beginning of the fiscal year for which the fees
apply. Each new fee schedule would be calculated based on the
parameters in this proposed rulemaking, adjusting for improvements in
the estimates of the cost to FDA of performing relevant work for the
upcoming year and inflation. For example, after experience with the
program, FDA is likely to have more accurate estimates of the costs of
performing certain activities to carry out the program than it does
now. FDA would use these revised estimates to calculate the fee.

D. When must the user fee be submitted?

    Under proposed Sec.  1.715(a), ABs applying for recognition and CBs
applying for direct accreditation would be required to submit a fee
concurrently with submitting their applications or renewal
applications. FDA would not review an application until the fee has
been submitted (see proposed Sec.  1.725(a)). This approach would
require applicants to pay the user fee in a timely manner and would
maximize the extent to which work FDA performs to review applications
is user fee funded.
    Under proposed Sec.  1.715(b), ABs and CBs subject to an annual fee
must submit payment within 30 days of receiving billing for the fee. We
understand 30 days to be a generally accepted norm in financial
transactions and consistent with FDA's practice for its other user fee
programs. We request comment on these proposed timeframes.

E. Are user fees refundable?

    Under proposed Sec.  1.720, user fees submitted under this subpart
would not be refundable. We tentatively conclude that this is the
simplest approach and is most likely to encourage higher quality
applications and to encourage ABs and CBs to make thoughtful decisions
about whether to remain in the program for subsequent years. In
addition, we are wary of creating additional costs to administer the
program--which would then need to be paid for either through

raising user fees or through appropriated funds--as a result of
disagreements between FDA and industry about whether a particular
refund would be granted. However, we note that FDA may refund other
user fees in a few very limited specific circumstances (see, e.g., User
Fees and Refunds for Premarket Approval Applications and Device
Biologics License Applications; Guidance for Industry and FDA Staff).
    We request comment on whether we should consider refund requests
under this program and, if so, under what circumstances.

F. What are the consequences of not paying a user fee on time?

    Under proposed Sec.  1.725(a), applications would not be considered
complete until FDA receives the application fee. In practice, this
means that FDA would not review an application until it is informed by
the receiving bank that the application fee payment is received. This
is consistent with FDA's practices for its other user fee programs with
application fees. In addition, this approach would require applicants
to pay the user fee in a timely manner and would maximize the extent to
which work FDA performs to review applications is user fee funded.
    As of the date of this publication, the two receiving banks that
FDA uses for user fee payment are the Federal Reserve Bank of New York,
for wire transfer, and U.S. Bank, for check payment. For FDA's user fee
programs currently in place, these banks generally notify FDA within 24
hours of the receipt of fee payments. We expect the same for the user
fee proposed here. FDA intends to publish payment instructions with the
addresses for sending payments (by mail, courier, or wire) at the time
that the fee payment schedules are published, before the start of the
fiscal year. Again, this is consistent with FDA's practice for its
other user fee programs.
    Under proposed Sec.  1.725(b), a recognized AB that fails to submit
its annual user fee within 30 days of the due date would have its
recognition suspended. FDA would notify the AB that its recognition is
suspended electronically, in English. FDA would notify the public of
the suspension on the Web site that lists the recognized ABs (described
in previously proposed Sec.  1.690 of the Accreditation of Third-Party
Auditors proposed rule). During the period that an AB's recognition is
suspended, the AB would not be permitted to accredit additional CBs for
participation in FDA's program. However, any CB accredited by such AB
prior to the suspension would be unaffected by the suspension, as would
any food or facility certification issued by such CB.
    Unlike the grounds for revocation listed in proposed Sec.  1.634 of
the Accreditation of Third-Party Auditors proposed rule, failure to pay
a user fee within 30 days does not necessarily indicate that the AB no
longer meets the substantive standards of the program. We tentatively
conclude that there should be some significant consequence to the AB
for not paying the user fee in a timely manner, but the consequence
should be easily reversible once the fee is paid. Therefore, we decided
to propose a middle ground, suspension, during which an AB suffers some
consequences for not paying the fee, but those consequences are not as
significant as the consequences of revocation.
    Our proposal to notify the AB electronically in English of
suspension is consistent with the provision in proposed Sec.
1.634(c)(1) that FDA would notify the AB electronically in English of
revocation. Our proposal to notify the public of the suspension on our
Web site is consistent with the provision in proposed Sec.  1.634(f) of
the Accreditation of Third-Party Auditors proposed rule that FDA would
provide notice on its Web site of the revocation of recognition of an
AB. We tentatively conclude that there is no reason for the process of
notifying the AB and the public of suspension to differ from the
process of notifying the AB and the public of revocation in these
respects. We request comment on these tentative conclusions. We also
request comment on whether FDA should notify a CB if the recognition of
its AB has been suspended.
    At some point, an AB that does not pay its annual fee should not be
allowed to continue to participate in the program. Therefore, under
proposed Sec.  1.725(b)(3), if payment is not received within 90 days
of the payment due date, FDA would revoke the AB's recognition under
proposed Sec.  1.634(a)(4), and provide notice of such revocation in
accordance with the procedures in proposed Sec.  1.634. We are
proposing to amend proposed Sec.  1.634(a)(4) by adding a new proposed
Sec.  1.634(a)(4)(iii), which would explicitly include failure to pay
the annual user fee within 90 days of the payment due date, as
specified in Sec.  1.725(b)(3), as a basis for revoking an AB's
recognition. We request comment on whether 90 days is an appropriate
timeframe and whether all of the consequences of revocation (see
proposed Sec.  1.634(d) and (e)) should apply here. Please note that we
are no longer soliciting comment on the consequences of revocation
generally proposed in Sec.  1.634; we are only requesting comment on
the appropriate consequences in the narrow circumstance of failure to
pay a user fee.
    Under proposed Sec.  1.725(c), an accredited CB that fails to
submit its annual user fee within 30 days of the due date would have
its accreditation suspended. FDA would notify the CB that its
accreditation is suspended electronically, in English. FDA would notify
a recognized AB as well, electronically and in English, if the
accreditation of one of its CBs is suspended. FDA would notify the
public of the suspension on the Web site that lists the recognized ABs
and accredited CBs (described in proposed Sec.  1.690). While a CB's
accreditation is suspended, it would not be allowed to issue food or
facility certifications as part of FDA's third-party accreditation
program. However, food or facility certifications issued by a CB prior
to the suspension of the CB's accreditation would remain in effect. If
payment is not received within 90 days of the payment due date, FDA
would withdraw the CB's accreditation under proposed Sec.  1.664(a),
and provide notice of such withdrawal in accordance with the procedures
in proposed Sec.  1.664. We propose this process to be analogous to the
process for suspending recognition of a recognized AB that is
delinquent on its fee payment. We are also proposing to amend proposed
Sec.  1.664(a) of the Accreditation of Third-Party Auditors proposed
rule to add a new proposed Sec.  1.664(a)(4), which would explicitly
include failure to pay the annual user fee within 90 days of the
payment due date, as specified in Sec.  1.725(c)(3), as a basis for
withdrawing a CB's accreditation. We request comment on whether the
consequences of a CB failing to pay a user fee by the due date are
appropriate. Please note that we are no longer soliciting comment on
the consequences of withdrawal of accreditation generally proposed in
Sec.  1.664(a); we are only requesting comment on the appropriate
consequences in the narrow circumstance of failure to pay a user fee.

G. Possible Exemptions

    Under the proposed rule, there would be no exemption or reduced fee
for small businesses or entities. Under other (non-food) FDA user fee
programs, some exemptions or reductions for small businesses are
specified by the authorizing legislation (Refs. 2 and 3). For the user
fees proposed here, no such statutory exemption, reduction, or
requirement for consideration exists in

section 808 of the FD&C Act. While we are not proposing a small
business exemption or reduction here, we believe that some of the
proposed approaches and alternative approaches we discussed above could
be more amenable to small businesses than others. For example, an
annualized fee may be more affordable for a small business than a
larger lump sum payment. We seek comment on whether we should account
for small businesses in other ways, including whether an exemption or
fee reduction would be appropriate. We request that comments that state
that FDA should provide an exemption or fee reduction for small
businesses state who should be eligible for an exemption or fee
reduction; if recommending a fee reduction, how much of a reduction
should be granted; and why.
    Under the proposed rule, FDA would charge user fees to government
entities that are applying to and participating in the program as
either an AB or a CB. FDA is requesting comment on the impact of
charging a user fee to foreign governments applying to and
participating in the program, and whether, for trade or other reasons,
we should consider a different approach.

IV. Preliminary Regulatory Impact Analysis

A. Introduction

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a
significant regulatory action as defined by Executive Order 12866.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The proposed rule demonstrates how user fees will be
calculated for different activities FDA conducts under FDA's third-
party accreditation program. The proposed rule does not require action
by entities affected by the forthcoming Accreditation of Third-Party
Auditors final rule; it merely provides additional information so that
affected entities can make an informed decision on whether to
participate in FDA's third-party accreditation program. FDA plans to
analyze the costs and benefits of FDA's third-party accreditation
program including imposition of user fees resulting from participating
in the third-party accreditation program in the regulatory impact
analysis of the Accreditation of Third-Party Auditors final rule.
Hence, for the purpose of this rule, the Agency proposes to certify
that the resulting final rule will not have a significant economic
impact on a substantial number of small entities.

C. Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

D. Need for This Regulation

    The need for the proposed regulation is under the authority of
section 808(c)(8) of the FD&C Act, established by FSMA, which requires
FDA to establish by regulation a reimbursement (user fee) program by
which we assess fees and require reimbursement for the work we perform
to establish and administer the third-party accreditation program under
section 808 of the FD&C Act.

V. Paperwork Reduction Act of 1995

    This proposed rule contains no collection of information.
Therefore, clearance by OMB under the Paperwork Reduction Act of 1995
is not required.

VI. Analysis of Environmental Impact

    We have carefully considered the potential environmental effects of
this action. We have concluded, under 21 CFR 25.30(h), that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required (Ref. 4).

VII. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we have tentatively concluded that the proposed rule does not contain
policies that have federalism implications as defined in the Executive
order and, consequently, a federalism summary impact statement is not
required.

VIII. Comments

    Interested persons may submit either electronic comments regarding
this document to http://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 http://www.regulations.gov.

IX. References

    The following references have been placed on display in FDA's
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

1. FDA, ``Preliminary Regulatory Impact Analysis for the proposed
rules on Foreign Supplier Verification Programs (Docket No. FDA-
2011-N-0143) and Accreditation of Third-Party Auditors/Certification
Bodies to Conduct Food Safety Audits and to Issue Certifications
(Docket No. FDA-2011-N-0146) under Executive Order 13563, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Unfunded Mandates
Reform Act of 1995 (Public Law 104-4), and the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520),'' (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM363286.pdf), 2013. Accessed and printed on June 23, 2015.
2. FDA, ``FY 2015 Medical Device User Fee Small Business
Qualification and

Certification: Guidance for Industry, Food and Drug Administration
Staff and Foreign Governments,'' (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM314389.pdf), August 1, 2014. Accessed and printed on June 23,
2015.
3. FDA, ``Guidance for Industry: User Fee Waivers, Reductions, and
Refunds for Drug and Biological Products,'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079298.pdf), September 2011. Accessed and printed on June 23,
2015.
4. FDA, ``Memorandum: Proposed Rule: User Fees for FDA's Third Party
Accreditation Program for Food and Feed,'' March 3, 2015.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 1, as proposed to be amended on July 29, 2013
(78 FR 45782), be further amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 350k, 352,
355, 360b, 362, 371, 374, 381, 382, 384a, 384b, 384d, 393; 42 U.S.C.
216, 241, 243, 262, 264.

0
2. In Sec.  1.634, add paragraph (a)(4)(iii) to read as follows:

Sec.  1.634  When will FDA revoke recognition?

* * * * *
    (iii) Failure to pay the annual user fee within 90 days of the
payment due date, as specified in Sec.  1.725(b)(3).
* * * * *
0
3. In Sec.  1.664, add paragraph (a)(4) to read as follows:

Sec.  1.664  When can FDA withdraw accreditation?

* * * * *
0
(4) If payment of the auditor/certification body's annual fee is not
received within 90 days of the payment due date, as specified in Sec.
1.725(c)(3).
* * * * *
0
4. In subpart M, add Sec. Sec.  1.700 through 1.725 to read as follows:

Sec.
1.700 Who is subject to a user fee under this subpart?
1.705 What user fees are established under this subpart?
1.710 How will FDA notify the public about the fee schedule?
1.715 When must a user fee required by this subpart be submitted?
1.720 Are user fees under this subpart refundable?
1.725 What are the consequences of not paying a user fee under this
subpart on time?

Sec.  1.700  Who is subject to a user fee under this subpart?

    (a) Accreditation bodies submitting applications or renewal
applications for recognition in the third-party accreditation program;
    (b) Recognized accreditation bodies participating in the third-
party accreditation program;
    (c) Auditors/certification bodies submitting applications or
renewal applications for direct accreditation; and
    (d) Accredited auditors/certification bodies (whether accredited by
recognized accreditation bodies or by FDA through direct accreditation)
participating in the third-party accreditation program.

Sec.  1.705  What user fees are established under this subpart?

    (a) The following application fees:
    (1) Accreditation bodies applying for recognition are subject to an
application fee for the estimated average cost of the work FDA performs
in reviewing and evaluating applications for recognition of
accreditation bodies.
    (2) Recognized accreditation bodies submitting renewal applications
are subject to a renewal application fee for the estimated average cost
of the work FDA performs in reviewing and evaluating renewal
applications for recognition of accreditation bodies.
    (3) Auditors/certification bodies applying for direct accreditation
are subject to an application fee for the estimated average cost of the
work FDA performs in reviewing and evaluating applications for direct
accreditation.
    (4) Accredited auditors/certification bodies applying for renewal
of direct accreditation are subject to an application fee for the
estimated average cost of the work FDA performs in reviewing and
evaluating renewal applications for direct accreditation.
    (b) The following annual fees:
    (1) Recognized accreditation bodies are subject to an annual fee
for the estimated average cost of the work FDA performs to monitor
performance of recognized accreditation bodies under Sec.  1.633.
    (2) Auditors/certification bodies directly accredited by FDA are
subject to an annual fee for the estimated average cost of the work FDA
performs to monitor directly accredited auditors/certification bodies
under Sec.  1.662.
    (3) Auditors/certification bodies accredited by recognized
accreditation bodies are subject to an annual fee for the estimated
average cost of the work FDA performs to monitor auditors/certification
bodies that are accredited by a recognized accreditation body under
Sec.  1.662.

Sec.  1.710  How will FDA notify the public about the fee schedule?

    FDA will notify the public of the fee schedule annually prior to
the beginning of the fiscal year for which the fees apply. Each new fee
schedule will be adjusted for inflation and improvements in the
estimates of the cost to FDA of performing relevant work for the
upcoming year.

Sec.  1.715  When must a user fee required by this subpart be
submitted?

    (a) Accreditation bodies applying for recognition and auditors/
certification bodies applying for direct accreditation must submit a
fee concurrently with submitting an application or a renewal
application.
    (b) Accreditation bodies and auditors/certification bodies subject
to an annual fee must submit payment within 30 days of receiving
billing for the fee.

Sec.  1.720  Are user fees under this subpart refundable?

    No. User fees submitted under this subpart are not refundable.

Sec.  1.725  What are the consequences of not paying a user fee under
this subpart on time?

    (a) An application for recognition or renewal of recognition will
not be considered complete for the purposes of Sec.  1.631(a) until the
date that FDA receives the application fee. An application for direct
accreditation or for renewal of direct accreditation will not be
considered complete for the purposes of Sec.  1.671(a) until FDA
receives the application fee.
    (b) A recognized accreditation body that fails to submit its annual
user fee within 30 days of the due date will have its recognition
suspended.
    (1) FDA will notify the accreditation body electronically that its
recognition is suspended. FDA will notify the public of the suspension
on the Web site described in Sec.  1.690.
    (2) While an accreditation body's recognition is suspended, the
accreditation body will not be able to accredit additional auditors/
certification bodies. The accreditation of auditors/certification
bodies that occurred prior to an accreditation body's suspension, as
well as food or facility certifications

issued by such auditors/certification bodies, would remain in effect.
    (3) If payment is not received within 90 days of the payment due
date, FDA will revoke the accreditation body's recognition under Sec.
1.634(a)(4)(iii), and provide notice of such revocation in accordance
with Sec.  1.634.
    (c) An accredited auditor/certification body that fails to submit
its annual fee within 30 days of the due date will have its
accreditation suspended.
    (1) FDA will notify the auditor/certification body that its
accreditation is suspended, electronically and in English. FDA will
notify a recognized accreditation body, electronically and in English,
if the accreditation of one if its auditors/certification bodies is
suspended. FDA will notify the public of the suspension on the Web site
described in Sec.  1.690.
    (2) While an auditor/certification body's accreditation is
suspended, the auditor/certification body will not be able to issue
food or facility certifications. A food or facility certification
issued by an auditor/certification body prior to the suspension of the
auditor/certification body accreditation will remain in effect.
    (3) If payment is not received within 90 days of the payment due
date, FDA will withdraw the auditor/certification body's accreditation
under Sec.  1.664(a)(4), and provide notice of such withdrawal in
accordance with Sec.  1.664.

    Dated: July 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18141 Filed 7-23-15; 8:45 am]
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[Federal Register Volume 78, Number 55 (Thursday, March 21, 2013)]
[Notices]
[Page 17393]
[FR Doc No: 2013-06512]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER13-1081-000]

Just Energy New York Corp.; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding,
of Just Energy New York Corp.'s application for market-based rate
authority, with an accompanying rate schedule, noting that such
application includes a request for blanket authorization, under 18 CFR
Part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is April 4, 2013.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 15, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-06512 Filed 3-20-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 20 (Tuesday, January 31, 2023)]
[Notices]
[Page 6295]
[FR Doc No: 2023-01907]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4611-DR; Docket ID FEMA-2022-0001]

Louisiana; Amendment No. 7 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Louisiana (FEMA-4611-DR), dated August 29, 2021, and
related determinations.

DATES: This change occurred on December 16, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Benjamin
Abbott, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of John E. Long as Federal
Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-01907 Filed 1-30-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: October 21, 2005 (Volume 70, Number 203)]
[Notices]
[Page 61274]
[DOCID:fr21oc05-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-20-000]

MIGC, Inc.; Notice of Proposed Changes in FERC Gas Tariff

October 14, 2005.
    Take notice that on October 11, 2005, MIGC, Inc. (MIGC) tendered
for filing as part of its FERC Gas Tariff, First Revised Volume No. 1,
Fifth Revised Sheet No. 70, to become effective December 1, 2005.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E5-5824 Filed 10-20-05; 8:45 am]

BILLING CODE 6717-01-P