[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Notices]
[Pages 57222-57231]
[FR Doc No: 2015-24107]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0031]

Nationally Recognized Testing Laboratories; Proposed Revised Fee
Schedule and Proposed Adoption of New Application Acceptance and Review
Procedures

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: In this notice, OSHA proposes to revise the schedule of fees
that the Agency charges to Nationally Recognized Testing Laboratories
(NRTLs) and NRTL applicants. In addition, OSHA proposes to adopt new
streamlined procedures for accepting and reviewing applications of
organizations seeking to obtain, renew, or expand NRTL recognition.

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission, on
or before October 22, 2015.

ADDRESSES: Submit comments by any of the following methods:
    1. Electronically: Submit comments and attachments electronically
at http://www.regulations.gov, which is the Federal eRulemaking Portal.
Follow the instructions online for making electronic submissions.
    2. Facsimile: If submissions, including attachments, are not longer
than 10 pages, commenters may fax them to the OSHA Docket Office at
(202) 693-1648.
    3. Regular or express mail, hand delivery, or messenger (courier)
service: Submit comments, requests, and any attachments to the OSHA
Docket Office, Docket No. OSHA-2007-0031, Technical Data Center, U.S.
Department of Labor, 200 Constitution Avenue NW., Room N-2625,
Washington, DC 20210; telephone:<PHONE_NUMBER> (TTY number: (877) 889-
5627). Note that security procedures may result in significant delays
in receiving comments and other written materials by regular mail.
Contact the OSHA Docket Office for information about security
procedures concerning delivery of materials by express mail, hand
delivery, or messenger service. The hours of operation for the OSHA
Docket Office are 8:15 a.m.-4:45 p.m., e.t.
    4. Instructions: All submissions must include the Agency name and
the OSHA docket number (OSHA-2007-0031). OSHA places comments and other
materials, including any personal information, in the public docket
without revision, and these materials may be available online at http://www.regulations.gov. Therefore, the Agency cautions commenters about
submitting statements they do not want made available to the public, or
submitting comments that contain personal information (either about
themselves or others) such as Social Security numbers, birth dates, and
medical data.
    5. Docket: To read or download submissions or other material in the
docket, go to http://www.regulations.gov or to the OSHA Docket Office
at the address above. All documents in the docket are listed in the
http://www.regulations.gov index; however, some information (e.g.,
copyrighted material) is not publicly available to read or download
through the Web site. All submissions, including copyrighted material,
are available for inspection at the OSHA Docket Office. Contact the
OSHA Docket Office for assistance in locating docket submissions.
    6. Extension of comment period: Submit requests for an extension of
the comment period on or before October 7, 2015 to the Office of
Technical Programs and Coordination Activities, Directorate of
Technical Support and Emergency Management, Occupational

Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue NW., Room N-3655, Washington, DC 20210, or by fax
to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Press inquiries: Contact Mr. Frank
Meilinger, Director, OSHA Office of Communications, U.S. Department of
Labor, 200 Constitution Avenue NW., Room N-3647, Washington, DC 20210;
telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue NW., Room N-3655, Washington, DC 20210; phone:
(202) 693-2110 or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Introduction

    OSHA proposes to adopt new streamlined procedures for accepting and
reviewing applications of organizations seeking to obtain, renew, or
expand NRTL recognition, and to revise the existing NRTL Program fee
schedule pursuant to the NRTL Program regulation, 29 CFR 1910.7(f).
Section III of this notice covers the proposed adoption of new
application acceptance and review procedures, and Section IV covers the
proposed revision of the fee schedule.

II. Background on the NRTL Program

    Many of OSHA's safety standards (e.g., 29 CFR 1910, Subpart S)
require that equipment and products be tested and certified to help
ensure their safe use in the workplace. To implement these
requirements, OSHA established the NRTL Program and the Agency
generally requires NRTLs to perform this testing and certification.
    The NRTL Program regulation, 29 CFR 1910.7, requires that, to
obtain and retain OSHA recognition as an NRTL, an organization must:
(1) Have the appropriate capability to test, evaluate, and approve
products to assure their safe use in the workplace; (2) be completely
independent of employers subject to the tested equipment requirements
and manufacturers and vendors of products for which OSHA requires
certification; (3) have internal programs that ensure proper control of
the testing and certification process; and (4) have effective reporting
and complaint handling procedures (29 CFR 1910.7(b)). OSHA requires
organizations applying for NRTL recognition to provide, in their
applications, detailed and comprehensive information about their
programs, processes, and procedures, in writing. When an organization
makes an initial application to be recognized as an NRTL, OSHA reviews
the written information contained in the organization's application and
conducts an on-site assessment to determine whether the organization
meets the requirements of 29 CFR 1910.7. OSHA uses a similar process
when an NRTL applies for expansion or renewal of its recognition,
although the type and amount of information in some areas can differ
significantly from those of initial applications. In addition, the
Agency conducts annual assessments \1\ of NRTLs to ensure that the
recognized laboratories adequately maintain their programs and continue
to meet the recognition requirements.
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    \1\ OSHA uses the term ``assessments'' to mean those activities
described by the term ``audits'' under 29 CFR 1910.7(f). OSHA uses
the term ``assessments,'' rather than ``audits'' because it better
reflects the overall purpose of the program's activities, i.e.,
conformity assessments.
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    To support these core functions, OSHA also performs a number of
ancillary activities. For example, OSHA: Investigates complaints filed
against NRTLs to ensure that the laboratories are performing their
testing and certification functions adequately; represents the NRTL
Program in a variety of forums related to conformity assessment
products used in the workplace; and maintains a detailed Web site that
both explains the program and, more importantly for the NRTLs, lists
all the laboratories currently recognized under the NRTL Program, the
products each laboratory can test, and registered certification marks
used by each laboratory.

III. Proposed Revision of Existing Application Acceptance and Review
Procedures

    OSHA currently has a number of initiatives underway to improve the
operations of the NRTL Program. This section of the notice discusses
one such initiative, under which OSHA proposes new streamlined
procedures for accepting and reviewing applications of organizations
seeking to obtain, renew, or expand NRTL recognition. OSHA would follow
these new procedures in lieu of those contained in the Agency's
existing NRTL Program Directive (CPL 1-0.3, NRTL Program Policies,
Procedures, and Guidelines, December 2, 1999) (``Directive'' or ``NRTL
Program Directive'') and the additional practices OSHA has routinely
followed in accepting applications.
    OSHA proposes the adoption of the new streamlined procedures to
eliminate delays caused by multiple revisions by an applicant during
the application-acceptance and -review process. In addition, OSHA seeks
to simplify the application process to make it clearer when the
application acceptance process ends and the substantive application
review process begins. This streamlined application process would also
reduce NRTL Program fees, as OSHA will discuss later in this notice.
    The existing procedures for application acceptance and review are
contained in both Appendix A to the NRTL Program regulations
(``Appendix A'') and the NRTL Program Directive. OSHA does not propose,
in this notice, to revise Appendix A; instead, as stated, OSHA proposes
to follow new streamlined procedures in lieu of the existing procedures
in the Directive. The new streamlined procedures would be consistent
with, and would clarify, the procedures contained in Appendix A.

A. Existing Procedures in Appendix A That Are Not Subject to Revision
in This Notice

    Per Appendix A, the burden is generally ``on the applicant to
establish by a preponderance of the evidence that it is entitled to
recognition as an NRTL'' (App. A. Introduction). Thus, in its
application, an applicant must ``provide sufficient information and
detail demonstrating that it meets the requirements set forth in Sec.
1910.7, in order for an informed decision concerning recognition to be
made'' by the Assistant Secretary for Occupational Safety and Health
(``Assistant Secretary''), and must also ``identify the scope of the
NRTL-related activity for which the applicant wishes to be recognized''
(i.e., the test standards the applicant will use for testing products)
(App. A.I.A.2.b). To meet its burden, the applicant may include any
documentation (i.e., enclosures, attachments, or exhibits) it deems
appropriate (App. A.I.A.2.c).
    Also under Appendix A, ``[a]pplications submitted by eligible
testing agencies will be accepted by OSHA, and their receipt
acknowledged in writing'' (App. A.I.B.1.a). Moreover, ``[a]fter receipt
of an application, OSHA may request additional information if it
believes information relevant to the requirements for recognition has
been omitted'' (Id.). In addition, ``OSHA shall, as necessary, conduct
an on-site review of the testing facilities of the

applicant, as well as the applicant's administrative and technical
practices, and, if necessary, review any additional documentation
underlying the application'' (App. A.I.B.1.b).
    Appendix A provides the responsible OSHA staff with two options
following review of the application, and any additional information and
on-site review report. On the one hand, if ``the applicant appears to
have met the requirements for recognition,'' responsible OSHA staff
must make a ``positive finding'' to the Assistant Secretary, which
consists of ``a written recommendation . . . that the application be
approved, accompanied by a supporting explanation'' (App. A.I.B.2).
Once this recommendation is made, OSHA follows the procedures in the
Appendix for making preliminary and final findings on the application
(App. A.I.B.4, A.I.B.5, A.I.B.6).
    On the other hand, if ``the applicant does not appear to have met
the requirements for recognition,'' responsible OSHA staff must make a
``negative finding'' to the ``applicant in writing, listing the
specific requirements of Sec.  1910.7 and [Appendix A] which the
applicant has not met, and allow[ing] a reasonable period for
response'' (App. A.I.B.3.a). After the applicant receives ``a
notification of negative finding (i.e., for intended disapproval of the
application), and within the response period provided,'' the applicant
may either (1) ``[s]ubmit a revised application for further review,
which could result in a positive finding'' (the procedures for which
are explained in the previous paragraph), or (2) ``[r]equest that the
original application be submitted to the Assistant Secretary with an
attached statement of reasons, supplied by the applicant of why the
application should be approved'' (App. A.I.B.3.b.i). In either case
(i.e., if a positive finding is made on a revised application or if the
applicant requests that the original application be submitted to the
Assistant Secretary), OSHA would follow the procedures in the Appendix
for making preliminary and final findings on the application (App.
A.I.B.4, A.I.B.5, A.I.B.6). The ``procedure for applicant notification
and potential revision shall be used only once during each recognition
process'' (App. A.I.B.3.b.ii).

B. OSHA Proposes That It Will No Longer Follow Existing NRTL Program
Directive Procedures for Accepting and Reviewing Applications

    Existing policies contained in the NRTL Program Directive expand on
the application procedures contained in Appendix A, as follows. Per the
Directive, OSHA staff ``formally accept or reject the application''
based on a review of the application for ``completeness and for
adequacy'' (Directive Ch.2.V.B, Ch. 3.II.B.1). The procedures for this
review are contained in Appendix D to the Directive (Directive Ch.
3.II.B.1). An application is considered complete ``if it contains all
necessary documents, and sufficient information for all relevant
items,'' and is considered adequate ``if the information submitted
sufficiently demonstrates that the requirements for recognition can be
met, and where relevant, if at least one test standard requested can be
approved'' (Directive App. D) (emphasis in original).
    In reviewing the application, OSHA staff will return and ``take[]
no further action'' on an application ``[i]f [the] application is
frivolous or grossly incomplete or inadequate.'' In such circumstances,
``any future application from the applicant'' will be processed ``as a
new application'' (Directive Ch. 3.II.A).
    If the application is not ``frivolous or grossly incomplete or
inadequate,'' OSHA staff discusses its review with the applicant,
``noting any deficiencies found or clarifications needed'' (Directive
Ch. 3.II.B.2). If the ``application is determined to be complete and
adequate,'' OSHA ``sends a letter to the applicant to accept the
application'' (Directive Ch. 3.II.C).
    If the application is determined to be incomplete or inadequate,
the Directive provides two opportunities for applicants to correct
deficiencies before rejection of an application (Directive Ch. 3.II.C).
In practice, however, OSHA has given applicants three such
opportunities. Per the Directive, OSHA ``sends a letter to the
applicant, detailing the deficiencies and the additional information
needed and requesting a response by an appropriate deadline,'' and if
``the response does not adequately resolve the deficiencies,'' OSHA
``provides the applicant a [second] opportunity to respond within a
given period.'' (Directive Ch. 3.II.C.) If deficiencies remain after
the second opportunity, OSHA, in practice, gives applicants a third,
but relatively limited, opportunity to make corrections before the
effective date of the rejection. This limited duration is sufficient
for applicants to correct deficiencies if only a few critical
deficiencies remain.
    If an applicant's timely response cures the deficiencies in its
application, OSHA ``sends an acceptance letter to the applicant''
(Directive Ch. 3.II.C). However, ``[i]f the applicant does not respond
adequately or fails to reply by any deadline(s) provided or an approved
extension of these deadline(s),'' OSHA ``sends a letter notifying the
applicant that the application is not accepted and the Case File is
closed'' (Directive Ch. 3.II.C.2).
    Finally, the Directive provides that, after an application is
accepted, ``the assigned staff determines whether an on-site review is
necessary'' (Directive Ch.3.II.D). However, the Directive also provides
for non-acceptance during the on-site review process, if an applicant
fails to respond adequately to the findings of an on-site review
(Directive Ch.4.IV.C).
    Under OSHA's proposal, it would no longer follow the existing
procedures, described above, to afford applicants three opportunities
to modify their applications before acceptance or non-acceptance. This
existing procedure is inefficient and causes delays because, in some
cases, these multiple opportunities cause the process to take years.
OSHA would also not follow its existing procedure for accepting an
application only when it is found to be complete and adequate. This
existing procedure has caused confusion as to when the application
acceptance process ends and the substantive application review process
begins.

C. OSHA Proposes new Streamlined Procedures for Accepting and Reviewing
Applications

    In lieu of the existing NRTL Program Directive procedures,
described above, OSHA proposes to follow streamlined procedures for
accepting and reviewing applications. These streamlined procedures
would reduce delays, fees, and confusion associated with application
processing. Under these streamlined procedures, OSHA would review an
application for completeness, but not adequacy, in deciding whether to
accept the application. OSHA's review for adequacy, and any on-site
review, would occur only after OSHA accepted the application.
Furthermore, OSHA would permit the applicant one opportunity only,
rather than three, to resolve deficiencies in the completeness of its
application before deciding whether to accept it. OSHA describes these
proposed streamlined procedures in more detail, below.
1. Initial Review and Acceptance
    When it receives an application, OSHA would acknowledge its
receipt, establish (for initial applications) or update (for expansion
and renewal applications) the docket for the organization, and upload
the

application materials to the docket.\2\ OSHA would perform an
administrative review of the application to determine whether it is
complete (i.e., has sufficient information to determine whether the
applicant meets the requirements for recognition). If not complete,
OSHA would notify the applicant, in writing, that it has 30 days from
the date of the notice to provide the missing or additional
information. OSHA would also inform the applicant, in the notice, that
it is unable to review the merits of the application because the
application itself does not contain sufficient information to show that
the requirements for recognition can be met. Finally, OSHA would inform
the applicant, in the notice, that this review involved no technical
determination, only an administrative one of whether the application
has all of the necessary documentation. If the applicant does not
respond by the 30-day deadline, or does not adequately respond, and the
application remains incomplete, OSHA would inform the applicant that
OSHA cannot accept the application, and the applicant must reapply. If
the applicant provides a complete application within the 30 days, or
provided a complete application when it was first received, OSHA would
accept the application.
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    \2\ As currently used by OSHA, the term ``docket'' means an
electronic file folder containing documents that pertain to an
official action taken by the Agency. OSHA generally makes these
documents available to the public.
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2. Determination of Adequacy
    After accepting the application, OSHA would review the merits of
the application to determine whether the application is adequate. OSHA
would first conduct a technical review of the application (i.e., a
detailed review of all of the application's administrative and
technical procedures and content). Following this technical review,
OSHA would determine whether to conduct an on-site assessment as part
of evaluating the management system and technical capabilities of the
organization. OSHA would generally conduct an on-site review for
initial applications and for expansion applications that involve new
areas of testing for the NRTL or areas of concern to OSHA. If OSHA
finds deficiencies during the technical review or during the on-site
assessment, OSHA would provide the applicant with an explanation of
deficiencies and needed corrections, and a 90-day opportunity to
respond. Failure to respond by the 90-day deadline would constitute a
withdrawal of the application, and OSHA would take no further action on
it. If the applicant or NRTL responds, it would need to demonstrate it
corrected all deficiencies found in its application and/or during the
assessment, and provide evidence to OSHA that the corrections have been
implemented into the applicant's or NRTL's management systems. In that
case, OSHA would conclude the application is adequate. On the other
hand, if OSHA finds that deficiencies remain, OSHA would conclude the
application is not adequate.
    If OSHA staff determines an application is adequate, OSHA would
follow existing procedures, and recommend a positive finding, per
Appendix A.I.B.2. Otherwise, OSHA staff would notify the applicant in
writing that they intend to recommend a negative finding. In that case,
the applicant has two options under Appendix A.I.B.3. First, the
applicant has one additional chance to revise its application within 30
days of receipt of OSHA's written notice. Second, the applicant may
request that its original application (as supplemented in response
during the review for adequacy) be submitted to the Assistant Secretary
(also within 30 days of receipt of OSHA's written notice). In this
case, the applicant must attach a statement of reasons to the
application explaining why the application should be approved. OSHA
would consider the failure to submit a revised application or a request
that the original application be submitted to the Assistant Secretary
within the 30-day deadline to be a withdrawal of the application.
    If the applicant opts to revise its application, OSHA would invoice
the applicant for the fee to review its revised submission. This fee
would equal the estimated hours for the review multiplied by the hourly
rate for the applicable Miscellaneous Fee in the NRTL Program's fee
schedule. Like other application fees, this review fee would not be
refundable. The applicant would need to pay this fee before OSHA
performs the review of the revised application. OSHA would consider a
failure to pay the fee within 30 days of receipt of the invoice as a
withdrawal of the application. When OSHA receives the fee, OSHA would
review the revised application to determine whether to sustain the
negative finding or change it to a positive one. If OSHA staff decides
to sustain the recommendation for a negative finding, they would first
afford the applicant the opportunity to withdraw the application. If
the applicant does not withdraw it, OSHA would proceed with the
preliminary finding.
    Once OSHA staff recommends a positive finding on either an original
or revised application, sustains its recommendation for a negative
finding after a review of a revised application, or the applicant
requests that the original application be submitted to the Assistant
Secretary, OSHA would follow the procedures in Appendix A for making
preliminary and final findings on the application (App. A.I.B.4,
A.I.B.5, A.I.B.6).

IV. Proposed Revision of the NRTL Program Fee Schedule

A. Background

    OSHA proposes to revise the existing NRTL Program fee schedule
pursuant to the NRTL Program regulation, 29 CFR 1910.7(f). That
regulation requires NRTLs and applicants to ``pay fees for services
provided by OSHA in advance of the provision of those services'' (29
CFR 1910.7(f)(1)). OSHA assesses fees for core service activities, that
is, for ``[p]rocessing of applications for initial recognition,
expansion of recognition, or renewal of recognition, including on-site
reviews; review and evaluation of the applications; and preparation of
reports, evaluations and Federal Register notices;'' and ``[a]udits of
sites'' (Id.). OSHA's fee schedule ``reflects the full cost of
performing the activities'' for these services (29 CFR 1910.7(f)(2)).
    OSHA calculates fees ``based on either the average or actual time
required to perform the work necessary; the staff costs per hour (which
include wages, fringe benefits, and expenses other than travel for
personnel that perform or administer the activities covered by the
fees); and the average or actual costs for travel when on-site reviews
are involved'' (Id.). Thus, the formula for calculating a fee for an
activity is the ``[Average (or Actual) Hours to Complete the Activity x
Staff Costs per Hour] + Average (or Actual) Travel Costs'' (Id.).
    OSHA periodically reviews the full costs of performing core
services and, if warranted, will propose a revised fee schedule in the
Federal Register (29 CFR 1910.7(f)(3), (f)(4)). If OSHA approves the
proposed fee schedule (after giving the public an opportunity to
comment), it ``publish[es] the final fee schedule in the Federal
Register, making the fee schedule effective on a specific date'' (29
CFR 1910.7(f)(3), (f)(4)).
    To ensure that its fees for core services reflect the full cost of
those services, OSHA's existing fee schedule (which OSHA adopted in
2011) takes into account both the direct and indirect costs it incurs
in performing those services (76 FR 10501-10504). Direct costs include
staff costs (i.e. the applicable portion of the salaries and

fringe benefits of the applicable staff) incurred for application
processing and assessment (Id.). Ancillary (or indirect) costs include
staff costs incurred for the administration and support of the program,
including legal support, budgeting, policy matters, intragency and
international coordination, responses to requests for information
related to the program, handling complaints, Web site development and
maintenance, and participation in meetings with stakeholders and
outside interest groups (Id.). OSHA refers to the sum of its direct
costs and ancillary costs as the total program costs (TPC) for the
purpose of this notice. TPC does not include travel expenses, which are
assessed separately (29 CFR 1910.7(f)(2), 76 FR 10504 n.5).
    In the existing fee schedule, OSHA calculates the fee for each core
service activity by multiplying an equivalent average cost per hour
rate (ECR) by the time it takes to perform that activity: Fee for
Activity = ECR x Time for Activity (76 FR 10504). In 2000, when OSHA
began assessing fees for services, OSHA explained that it derived that
fee schedule's ECR by dividing TPC by the total available annual work
hours of the NRTL Program and legal staff that perform the services
(TAW) (Id.). Accordingly, ECR2000 = TPC2000/TAW2000. The approach used
in 2000 resulted in fees that recouped the costs only of the time spent
actually performing individualized audits and application processing,
which is only a portion of TAW, and did not recoup the costs of the
time associated with running the program and providing other benefits
shared among all NRTLs (Id.).
    To account for the costs associated with these shared benefits,
OSHA adopted a new approach for calculating ECR (ECR2011) in the
existing fee schedule (Id.). Under the new approach, OSHA divides the
estimated total cost of the NRTL Program (TPC2011) by the total annual
service hours (TAS2011) (Id.). This latter term equals the total
estimated work hours that the NRTL Program staff spend on the core
service activities for which OSHA would bill NRTLs; accordingly,
ECR2011 = TPC2011/TAS2011 (Id.). By way of comparison with the 2000 fee
schedule, TAS equals TAW minus estimated hours spent on ancillary
activities (AH) and leave (LH) (i.e., TAS = TAW - AH - LH) (Id.). By
continuing to include the full program costs in the numerator
(TPC2011), but including in the denominator (TAS2011) only the amount
of time spent on providing ``billable'' core services, OSHA believed
the revised ECR would more accurately represent the total work hours
spent on those core activities than the 2000 equation \3\ (Id.).
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    \3\ The existing fee schedule was supposed to have been phased
in over a three-year phase-in period. (76 FR 10508). OSHA
implemented the first phase on March 28, 2011. However, due to other
priorities and factors, OSHA was unable to implement the second and
third phases of the increase, as planned. The revised fee schedule
OSHA proposes in the current notice would render moot the
implementation of the second and third phases.
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B. Explanation of Proposed Revision of Fee Schedule

    OSHA has reviewed its existing fee schedule and, based on that
review, proposes to revise its fee schedule. This proposed fee schedule
would more accurately reflect the full cost of performing the
activities for which OSHA charges fees.
    OSHA proposes the following:
    1. OSHA proposes a new grouping of fees for each of the core
activities for which OSHA charges fees to NRTLs (i.e., ``[p]rocessing
of applications for initial recognition, expansion of recognition, or
renewal of recognition, including on-site reviews; review and
evaluation of the applications; and preparation of reports, evaluations
and Federal Register notices;'' and ``[a]udits of sites'' (29 CFR
1910.7(f)(1)). Under the existing fee schedule, OSHA groups these
activities under the terms Application Processing, Audits, and
Miscellaneous (76 FR 10508). Under OSHA's proposed fee schedule, shown
below in Table A, OSHA would group these activities under the terms:
Administrative Evaluation, Technical Evaluation, Assessments, Federal
Register Notices, and Miscellaneous (which includes late fees and other
activities not specifically described). OSHA proposes these new
groupings to align its fee schedule with the proposed streamlined
procedures for accepting and reviewing applications, described above.
OSHA also believes that the times it proposes estimating for completion
of these activities (see Tables 2 thru 5, below) more accurately
represent the actual time it takes to complete the core activities for
which OSHA charges fees. Therefore, adoption of the proposed groupings
would more accurately reflect the full cost of the services for which
fees are assessed.
    2. OSHA proposes to revise the approach it uses to calculate ECR.
Again, under the existing approach, OSHA calculates ECR by dividing TPC
by the total estimated work hours that the NRTL Program staff and legal
staff spend on the core service activities for which OSHA bills NRTLs
(or TAS) (76 FR 10504).
    The existing approach depends, in large measure, on OSHA estimating
an accurate TAS (i.e., number of ``billable'' core hours). If this
estimate is accurate, the ECR (i.e., the hourly rate OSHA charges for
services) will accurately reflect the full cost of services (because
ECR = TPC/TAS). But OSHA's estimate has not been accurate in practice.
Due in part to insufficient program staffing and other uncontrollable
factors, the staff has been unable to work the number of estimated
billable hours. This has resulted in an hourly rate charged by OSHA
that results in fees that are far lower than the fees OSHA would be
charging if its estimate had been accurate.
    OSHA could reassess TAS on a regular basis to achieve a more
accurate estimate. However, due to the changing nature of the staff's
workload, OSHA likely would need to make such calculation adjustments,
and thus publish fee schedules, more than once within a given year to
ensure an accurate estimate. OSHA likely could not make such
adjustments in a timely manner, largely due to the length of the
process for issuing fee schedules.
    OSHA proposes to simplify the existing calculation; for the purpose
of the fees proposed in this notice, OSHA would assume that certain
NRTL Program staff (which OSHA calls ``direct staff'' in this notice)
work exclusively on core billable activities, and that other NRTL
Program staff (which OSHA calls ``indirect staff'' in this notice) work
exclusively on ancillary activities. Under the proposal, OSHA would
calculate the ECR (ECR2015) by dividing TPC by total direct staff
annual paid (i.e., compensable) hours, or simply, direct staff annual
hours (DSH).
    Because of the difficulties of implementing the existing approach,
OSHA believes the proposed change in approach (replacing TAS with DSH)
would, on average and in practice, more accurately reflect the full
cost of services for which OSHA charges fees than the existing
approach. The accuracy of the DSH approach also does not depend on the
variable workload of staff, and would therefore be simpler to implement
than the existing approach.
    OSHA estimates for the proposal that four full-time NRTL Program
staff members are direct staff and the other full-time NRTL Program
staff member is indirect staff. OSHA believes the estimate of four
full-time direct staff is reasonable because OSHA projects a
significant increase in the number of applications the NRTL Program
will process and audits the NRTL Program will perform (i.e., a
significant increase

in the time NRTL Program staff will spend on core activities).
    For the purposes of the proposed fee calculation, DSH would equal
8,352 hours. This is derived by multiplying 2,088, the regular annual
paid hours for one full-time staff, by the number of full-time direct
staff \4\ (again, currently four).
---------------------------------------------------------------------------

    \4\ This figure is the number of compensable hours in a fiscal
year, which is used to determine full-time equivalents (FTE) (i.e.,
full-time staffing levels) for purposes of the Federal Budget. See
Office and Management and Budget (OMB) Circular A-11, Preparation,
Submission, and Execution of the Budget, Section 85--Estimating
Employment Levels and the Employment Summary (Schedule Q), 2015
(available at http://www.whitehouse.gov/sites/default/files/omb/assets/a11_current_year/s85.pdf).
---------------------------------------------------------------------------

    3. OSHA proposes to break out the fees for the legal review of
Federal Register notices associated with initial, renewal, and
expansion applications from the general fees it charges for preparation
of these Federal Register notices by NRTL Program staff. Under the
existing fee structure, OSHA charges one general fee that covers both
preparation and legal review of a Final Report and Federal Register
notice (76 FR 10505-10511).\5\
---------------------------------------------------------------------------

    \5\ Although OSHA did not state explicitly in the 2011 notice
that the Final Report and Federal Register notice fee included legal
review, the hours used for calculating this fee did in fact include
the legal staff's time for this review.
---------------------------------------------------------------------------

    OSHA proposes this revision to more accurately reflect the portion
of the fees attributed to legal review. Under the existing fee
structure, OSHA charges a single hourly rate for core activities,
regardless of whether the time charged is attorney time or NRTL Program
staff time (76 FR 10505). Under the proposed fee structure, OSHA
calculates a separate hourly rate for core activities performed by
legal staff to reflect that certain ancillary costs, such as Web site
development and maintenance, which are properly incorporated into the
hourly rate for NRTL Program staff, should not be incorporated into the
hourly rate for legal services. OSHA would continue to incorporate in
the hourly rate for legal costs those indirect costs that tie directly
into the salary of legal staff, such as fringe benefits. As a result of
the proposed change, the hourly rate for legal fees, shown in Table 5,
would be less than the rate for NRTL Program staff fees, shown in Table
1.
    OSHA notes that the Department of Labor incurs legal costs in
connection with the NRTL Program other than costs associated with the
legal review of Federal Register notices associated with initial,
renewal, and expansion applications. These other legal costs are
included in the existing fee schedule (See 76 FR 10504 n.5), and would
continue to be included in the proposed fee schedule, as elements in
TPC, and therefore, as elements of the calculation of the hourly rate
for NRTL Program staff.
    4. OSHA proposes to revise the manner it calculates the salaries of
NRTL Program staff and Solicitor of Labor staff for the purpose of
calculating TPC. For the existing fee schedule, OSHA calculates staff
costs using actual staff salaries, which can vary, sometimes
significantly, over time due to changes in personnel and positions.
OSHA proposes to calculate salaries using midpoint salaries. These
midpoint salaries are the Step 5 amounts shown for a particular grade
(e.g., grade 13) in the Office of Personnel Management (OPM) General
Schedule (GS) salary table for 2015, called the ``Salary Table 2015-
DCB,'' which pertains to federal workers who have duty stations located
mostly in Washington, D.C, Maryland, and Virginia. (See Office of
Personnel Management 2015 General Schedule (GS) Locality Pay Tables at
www.opm.gov.) These midpoint salaries may differ from actual staff
salaries, which depend on the actual grade and step for each staff.
However, using these midpoint figures would simplify the calculation of
the staff costs and provide a consistent fee that OSHA expects will
reflect, on average, actual staff salaries over time. Because OPM
adjusts its salary tables annually, OSHA would monitor the adjustments
to determine if their magnitude requires modification of the fee
schedule.
    Also, to include an amount for regular fringe benefits, OSHA would
multiply the midpoint salaries by a fringe benefit rate. OSHA proposes
to use a 29% rate, and bases this rate on the one the Agency uses to
estimate fringe costs of other OSHA activities.
    5. OSHA proposes to revise the manner in which it calculates
ancillary (or indirect) costs. Under the existing fee schedule, OSHA
includes, in its calculation of ancillary (or indirect) costs,
equipment, training, and space of the staff. Under the proposed fee
schedule, OSHA would not include these items in its calculation of
ancillary costs because NRTLs do not derive a special benefit from
these cost items. For example, training costs for the program staff
currently consist of general training available to all employees. OSHA
would include such costs in future fee schedules if it determines that
NRTLs do derive special benefits from the items. OSHA believes the
proposed revision to the fee schedule would more accurately reflect the
full costs of performing the activities for which OSHA charges fees.
    6. OSHA proposes to not charge fees for determining whether
proposed test standards are appropriate test standards under the NRTL
Program. OSHA charges such fees under the existing fee schedule.
However, OSHA recently updated its process whereby it incorporates new
test standards into the NRTL Program's list of appropriate test
standards (the scope of an appropriate test standard must cover
products for which OSHA requires NRTL approval and must meet the
requirements of 29 CFR 1910.7(c)(1)). Under the updated policy, OSHA
adds new test standards when it is made aware of new test standards and
determines them appropriate (79 FR 17188). It is therefore no longer
necessary to charge NRTLs specific fees in connection with the
incorporation of standards into the list of appropriate test standards.
OSHA notes, however, that the costs associated with the incorporation
of test standards would be ancillary costs under the proposed fee
schedule, and would therefore be an element in the calculation of the
fees OSHA proposes to assess.

C. Basis and Derivation of Proposed Fee Amounts

    Table 1, below, shows the direct and indirect program costs (TPC),
direct staff annual hours (DSH), and hourly rate OSHA proposes to use
to calculate the revised fees.

          Table 1--NRTL Program Staff--Hourly Rate Calculation
------------------------------------------------------------------------
                     Description
------------------------------------------------------------------------
OSHA Direct Costs....................................           $579,383
OSHA Ancillary Costs.................................            287,541
                                                      ------------------
    OSHA Total Costs of NRTL Program, excluding                  866,924
     travel (TPC)....................................
OSHA Direct Staff Annual Hours (DSH).................              8,352

OSHA Hourly rate (TPC divided by DSH)................                104
------------------------------------------------------------------------

    Tables 2 to 5, below, describe the fees OSHA proposes to adopt in
conjunction with the core services for which OSHA charges fees. OSHA
would calculate each fee (with the exception of fees for legal review
of Federal Register notices) by multiplying the NRTL Program staff
hourly rate of $104 (see Table 1, above) by the time OSHA estimates it
takes NRTL Program staff to perform the activity at issue, on average
(i.e., fee for activity = NRTL Program staff hourly rate ($104) X
estimated time for activity). OSHA would calculate the fees for legal
review of Federal Register notices by multiplying the hourly rate for
legal services of $89 (see Table 5, below) by the time OSHA estimates
its takes legal staff to perform the activity at issue, on average
(i.e., fee for activity = legal staff hourly rate ($89) X estimated
time for activity). OSHA notes that it rounds the proposed fees down to
the lower multiple of ten.
    OSHA's proposed (and existing) fee for travel related to
assessments is based on actual travel expenses, and thus OSHA does not
derive a fee to charge for travel.

          Table 2--Proposed Fees for Administrative Evaluation
------------------------------------------------------------------------
            Program component              Average hours        Fee
------------------------------------------------------------------------
Initial Application--Limited review (per              40          $4,160
 application)...........................
Expansion Application--Limited review                 24           2,490
 (per application)......................
Renewal request review..................              16           1,660
------------------------------------------------------------------------

             Table 3--Proposed Fees for Technical Evaluation
------------------------------------------------------------------------
            Program Component              Average Hours        Fee
------------------------------------------------------------------------
Initial Application--Management                       80          $8,320
 Procedures review (per application)....
Initial or Expansion Application--                    24           2,490
 Testing capability review (per
 standard)..............................
Initial or Expansion Application--Site                24           2,490
 capability review (per site)...........
------------------------------------------------------------------------

                 Table 4--Proposed Fees for Assessments
------------------------------------------------------------------------
            Program component              Average hours        Fee
------------------------------------------------------------------------
Assessment preparation and close out                  54          $5,610
 (per lead auditor).....................
Assessment preparation and close out                  32           3,320
 (per assistant auditor)................
Each day on-site or at office (per                     8             830
 auditor)...............................
------------------------------------------------------------------------

           Table 5. Proposed Fees for Federal Register Notices
------------------------------------------------------------------------
            Program component              Average hours        Fee
------------------------------------------------------------------------
Initial Application Federal Register                  20          $4,080
 notice preparation (per application)**.
Initial Application Federal Register                  16           1,420
 notice legal review (per application)..
Total for Initial Application Federal                 36           5,500
 Register notices.......................
Renewal or Expansion Application Federal              16           2,470
 Register notice preparation (per
 application) **........................
Renewal or Expansion Application Federal               8             710
 Register notice legal review (per
 application)...........................
Total for Renewal or Expansion                        24           3,180
 Application Federal Register notices...
------------------------------------------------------------------------

    Includes estimated Office of Federal Register (OFR) processing
fees: $2,000 per initial application notice, or $810 per expansion and
renewal notice, as applicable.\6\
---------------------------------------------------------------------------

    \6\ The OFR charges Federal agencies a per column rate for
publishing Federal Register notices. See http://www.archives.gov/federal-register/write/conference/publishing-billing.pdf. OSHA
derived an estimated average processing fee based on the number of
columns in typical Federal Register notices published for the NRTL
Program.
---------------------------------------------------------------------------

D. Proposed Fee Schedule and Description of Fees

    OSHA proposes the adjusted fee schedule shown below in Table A.

               Table A--Proposed NRTL Program Fee Schedule
------------------------------------------------------------------------
        Fee category              Fee activity              Fee *
------------------------------------------------------------------------
Administrative Evaluation...  Initial application-- $4,160.
                               Limited review.
                              Expansion             2,490.
                               application--Limite
                               d review.

                              Renewal request       1,660.
                               review.
Technical Evaluation........  Initial application-- 8,300.
                               Detailed management
                               procedures review.
                              Initial or Expansion  2,490.
                               application--Testin
                               g capability review
                               (per standard).
                              Initial or Expansion  2,490.
                               application--Site
                               capability review
                               (per site).
Assessment..................  Assessment            5,610.
                               preparation and
                               close out (per lead
                               auditor, per site).
                              Assessment            3,320.
                               preparation and
                               close out (per
                               assistant auditor,
                               per site).
                              Assessment--per day   830 plus travel
                               at office, on-site,   expenses.
                               or on travel (per
                               auditor, per site).
Federal Register Notices....  Federal Register      5,500.
                               notices--initial
                               application.
                              Federal Register      3,180.
                               notices--renewal or
                               expansion
                               application.
Miscellaneous...............  Late Fees...........  210.
                              Other activities or   104.
                               services not
                               specifically
                               described (per
                               hour).
------------------------------------------------------------------------
* All fees must be paid in advance of activity or service.

General Information Regarding the Fees
1. Explanation of Fees
     The Administrative Evaluation fee covers an administrative
review of the application packet to ensure completeness. It also covers
creating the docket and addition of the application to the docket. An
applicant must submit this fee with the application.
     The Technical Evaluation fee covers a detailed examination
of the application packet to determine the applicant's ability to meet
the requirements of the requested recognition/expansion. An applicant
must submit this fee with the application.
     On-site or office assessment fees are calculated based on
estimated staff time and, if applicable, actual travel expenses. Travel
expenses include expenses for hotel, air transportation, ground
transportation, and per diem. The assessment preparation and close-out
fees (per lead and assistant auditor, as applicable) include staff time
to make travel arrangements and file travel reimbursement claims. At
the conclusion of the assessment, actual travel expenses are calculated
based on the government per diem and other travel rules. OSHA will bill
or refund the difference between the prepaid and the actual travel
amounts.
     The fees for ``Other activities or services not
specifically described'' cover application- or assessment-related
activities that are not specifically covered by the other fee
categories. One example would be the technical review of a revised
application that an applicant submits to OSHA in response to OSHA's
negative finding on an applicant's original application.
2. Refunds
     If an application is withdrawn before OSHA commences the
Technical Evaluation, or the application is rejected after OSHA
completes the Administrative Evaluation, OSHA will refund the Technical
Evaluation fee.
     If an application is withdrawn before OSHA commences
travel to a site to perform an on-site assessment, the Agency will
refund any prepaid assessment fees.
    3. Late Fees/Failure to Pay. If an invoice is not paid in full by
the due date, the Late Payment fee will be assessed. If payment for an
application is not received within 30 days of the invoice's original
due date, the application will be rejected. If payment for an
assessment is not received within 30 days of the invoice's original due
date, OSHA will commence the process to revoke the NRTL's recognition
(see 29 CFR 1910.7, App. A.II.E). OSHA notes that NRTLs or applicants
may be subject to collection procedures under U.S. Federal law for
unpaid fees.
    4. Changes to Fee Schedule. The effective date of this fee schedule
is thirty days after the publication of the Assistant Secretary's final
decision in the Federal Register. An NRTL or applicant pays fees
according to the fee schedule in effect on the date the Agency receives
an application or commences an on-site assessment.

E. Comparison of Current and Proposed Fees

    The following table shows the differences between the existing fee
schedule and the proposed fee schedule shown in Table A, above.

                   Table 6--Differences Between Planned 2013 Fees and the Proposed Fee Amounts
----------------------------------------------------------------------------------------------------------------
                                                                Proposed activity or
   Current activity or category    Planned 2013 fee amount *          category            Proposed fee amount.
----------------------------------------------------------------------------------------------------------------
Initial application review.......  $17,750..................  Initial application--     $4,160.
                                                               Limited review.
                                                              Initial application--     8,300.
                                                               Detailed management
                                                               procedures review.
                                                              Initial or Expansion      2,490.
                                                               application--Site
                                                               capability review
                                                               (assuming one site--add
                                                               $2,490 for each
                                                               additional site).
                                                              Subtotal Initial........  14,950.
Expansion-application review (per  8,280....................  Expansion application--   2,490.
 additional site).                                             Limited review.
                                                              Initial or Expansion      2,490.
                                                               application--Site
                                                               capability review
                                                               (assuming one site--add
                                                               $2,490 for each
                                                               additional site).
                                                              Subtotal Expansion......  4,980.
Renewal or expansion (other)       300......................  Renewal request review..  1,660.
 application review.
                                                              Expansion application--   2,490.
                                                               Limited review.
Renewal information review fee...  2,370....................  None....................  0.

Additional review--initial         2,370....................  None....................  0.
 application (if the application
 requires substantial revision,
 submit one-half of initial-
 application review fee).
Additional review--renewal or      730......................  None....................  0.
 expansion application.
Limited review--initial            3,550....................  Initial application--     4,160.
 application.                                                  Limited review.
Assessment--initial application    4,440 plus travel          Assessment preparation    5,610.
 (per person, per site--first       expenses.                  and close out (per lead
 day).                                                         auditor, per site).
Assessment--renewal application    4,140 plus travel
 (per person, per site--first       expenses..
 day).
Assessment--expansion application  3,550 plus travel
 (additional site) (per person,     expenses..
 per site--first day).
Assessment--expansion application  2,960 plus travel
 (other) (per person, per site--    expenses..
 first day).
None.............................  NA.......................  Assessment preparation    3,320.
                                                               and close out (per
                                                               assistant auditor, per
                                                               site).
Assessment--each additional day    1,180 plus travel          Assessment--per day at    830 plus travel
 or each day on travel (per         expenses.                  office, on-site, or on    expenses.
 person, per site).                                            travel (per auditor,
                                                               per site).
Review and evaluation ($30 per     30 per standard OR 296     Initial or Expansion      2,490.
 standard if already recognized     per standard.              application--Testing
 for NRTLs and requires minimal                                capability review (per
 review; otherwise, $296 per                                   standard).
 standard).
Final report and Federal Register  19,520...................  Federal Register          5,500.
 notice--initial application.                                  notices--initial
                                                               application.
Final report and Federal Register  7,390....................  Federal Register          3,180.
 notice--renewal or expansion                                  notices--renewal or
 application (if OSHA performs on-                             expansion application.
 site assessment).
Final report and Federal Register  4,440....................
 notice--renewal or expansion
 application (if OSHA performs no
 on-site assessment).
On-site audit (per person, per     7,400 plus travel          Assessment preparation    5,610.
 site, first day)                   expenses.                  and close out (per lead
 nonconformances).                                             auditor, per site).
On-site audit (per person, per     7,400 plus travel          Assessment preparation    3,320.
 site, first day).                  expenses.                  and close out (per
                                                               assistant auditor, per
                                                               site).
On-site audit--each additional     1,180 plus travel          Assessment--per day at    830 plus travel
 day (on-site or on travel) (per    expenses.                  office, on-site, or on    Expenses.
 person, per site); or review of                               travel (per auditor,
 revised audit response--per on-                               per site).
 site or office audit.
Office audit (per person, per      1,180 or 2,370...........  Assessment preparation    5,610.
 site, per day) (lower fee                                     and close out (per lead
 applies if no nonconformances).                               auditor, per site).
Supplemental travel (per site--    1,000....................  None....................  0.
 for sites located outside the 48
 contiguous U.S. states or the
 District of Columbia).
Supplemental program review (per   590......................  None....................  0.
 program requested).
Invoice processing fee (per        300......................  Included in Assessment    0.
 application or audit).                                        preparation and close
                                                               out (per lead auditor,
                                                               per site).
Travel document processing (4      590......................  Included in Assessment    0.
 hours, per application or audit).                             preparation and close
                                                               out.
Late payment.....................  150......................  Late payment............  210.
Compensatory time for travel (per  56.40....................  Included in Assessment--  None.
 hour).                                                        per day at office, on
                                                               site, or on travel (per
                                                               auditor, per hour).
----------------------------------------------------------------------------------------------------------------
* These fee amounts represent fees that were to have been associated with phase 3 of the fee increase authorized
  by OSHA's February 2011 final rule pertaining to NRTL Program fees (see footnote 3, above).

    As the Table shows, the proposed fees for individual core service
activities are often significantly less than the analogous existing
fees for such services. These changes arise from the change in the way
that OSHA is proposing to calculate the ECR (which excludes some
previously included indirect costs but increases the number of direct
staff hours) and streamlined review procedures (which decrease the
amount of staff hours needed for some tasks in the process). OSHA
nonetheless estimates that fees collected under the proposed fee
schedule will, in toto, approximate the full costs of administering the
NRTL Program because, as stated above, OSHA estimates a significant
increase in the number of applications the NRTL Program will process
and audits the NRTL Program will perform (i.e., a significant increase
in the time NRTL Program staff will spend on core service activities).

V. Proposed Decision

    OSHA performed its periodic review of the fees it currently charges
to NRTLs, as provided under 29 CFR 1910.7(f). Based on this review,
OSHA preliminarily determined that the existing fee schedule warrants
adjustment, as detailed in this notice. As a result, OSHA proposes to
replace the existing fee schedule with the proposed fee schedule shown
in Table A, above. OSHA also proposes to adopt new streamlined
procedures for accepting and reviewing applications of organizations
seeking to obtain, renew, or expand NRTL recognition, as described
above.
    OSHA welcomes public comments on this notice. Comments should
consist of

pertinent written documents and exhibits. Commenters needing more time
to comment must submit a request in writing, stating the reasons for
the request. Commenters must submit comments or requests for extensions
by the due dates, and follow all instructions for submitting comments
and requests for extensions, specified in the DATES and ADDRESSES
sections of this notice. OSHA will limit any extension to 10 days
unless the requester justifies a longer period. OSHA may deny a request
for an extension if the request is not adequately justified.
    OSHA staff will review all timely-submitted comments to the docket
and, after addressing the issues raised by timely-submitted comments,
will recommend to the Assistant Secretary for Occupational Safety and
Health whether to adopt the proposed NRTL Program fee schedule and new
streamlined procedures for accepting and reviewing applications. The
Agency will publish a final fee schedule in the Federal Register, as
provided under 29 CFR 1910.7, as well as a final decision on whether to
adopt the new streamlined procedures for accepting and reviewing
applications. The final fee schedule would become effective 30 days
after the date of publication of the schedule in the Federal Register,
and the final streamlined procedures for accepting and reviewing
applications would become effective on the date of publication of the
procedures in the Federal Register.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on September 16, 2015.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2015-24107 Filed 9-21-15; 8:45 am]
BILLING CODE 4510-26-P


Under the proposed rule, the notification would be required to be
submitted to FDA electronically at least 6 months prior to the date of
the permanent discontinuance or interruption in manufacturing. If 6
months' advance notice is not possible because the permanent
discontinuance or interruption in manufacturing was unanticipated 6
months in advance, the applicant would be required to notify FDA as
soon as practicable, but in no case later than 5 business days after
the permanent discontinuance or interruption in manufacturing occurs.
    If an applicant fails to submit the required notification, the
proposed rule would require FDA to issue a letter informing the
applicant or manufacturer of its noncompliance. The applicant would be
required to submit to FDA, not later than 30 calendar days after FDA
issues the letter, a written response setting forth the basis for
noncompliance and providing the required notification.
    Description of Respondents: Applicants of prescription drugs and
biological products subject to an approved NDA, ANDA, or BLA, and
manufacturers of prescription drug products marketed without an
approved ANDA or NDA, if the product is life supporting, life
sustaining, or intended for use in the prevention or treatment of a
debilitating disease or condition, including use in emergency medical
care or during surgery, and is not a radiopharmaceutical product. If
the BLA applicant is a manufacturer of blood or blood components, it is
only subject to this rule if it manufactures a significant percentage
of the nation's blood supply.
    Burden Estimates: Based on the number of drug and biological
product shortage related notifications we have seen during the past 12
months, we estimate that annually a total of approximately 75
respondents (``number of respondents'' in table 3) would notify us of a
permanent discontinuance of the manufacture of a drug or biological
product or an interruption in manufacturing of a drug or biological
product that is likely to lead to a meaningful disruption in the
respondent's supply of that product under the proposed rule. We
estimate that these respondents would submit annually a total of
approximately 305 notifications as required under proposed Sec. Sec.
310.306, 314.81(b)(3)(iii), and 600.82. Approximately 80 of these
notifications are notifications that we currently receive under OMB
control number 0910-0699 for the IFR, thus we expect to receive
approximately 225 new notifications under the proposed rule (``total
annual responses'' in table 3).\10\ We estimate three notifications per
respondent, because a respondent may experience multiple
discontinuances or interruptions in manufacturing in a year that
require notification (``no. of responses per respondent'' in table 3).
We also estimate that preparing and submitting these notifications to
FDA would take approximately 2 hours per respondent (``hours per
response'' in table 3).
---------------------------------------------------------------------------

    \10\ This estimate is based on the number of new notifications
we would receive under the proposed rule as compared to
notifications we currently receive under the IFR. The IFR is our
baseline for comparison for purposes of estimating the burden under
the PRA, because additional notifications that we may currently
receive, but that are not required under the IFR (e.g., as requested
in the draft guidance for industry on Notification to the Food and
Drug Administration of Issues That May Result in a Prescription Drug
Shortage) are not covered under any existing OMB control number, and
thus must be captured in this PRA estimate. In contrast, the
preliminary analysis of impacts of the proposed rule estimates the
costs and benefits of the proposed rule as compared to current
practice. As a result of the use of different baselines for
comparison, the estimate of new notifications under the PRA does not
match the estimate of new notifications included in the preliminary
analysis of impacts (see Table 2B of Ref. 3, which estimates the
number of new notifications we would receive under the proposed
rule, as compared to the number of notifications the Agency receives
currently, including all voluntary notifications not specifically
required by the IFR).
---------------------------------------------------------------------------

    We base these estimates on our experience with the reporting of
similar information to FDA since the issuance of the President's
Executive Order 13588 of October 31, 2011 (Ref. 1 of this proposed
rule), and under the interim final rule entitled ``Applications for
Food and Drug Administration Approval To Market a New Drug; Revision of
Postmarketing Reporting Requirements--Permanent'' (76 FR 78530;
December 19, 2011), and the draft guidance entitled ``Draft Guidance
for Industry on Notification to Food and Drug Administration of Issues
That May Result in a Prescription Drug Shortage'' (77 FR 11550;
February 27, 2012).
    FDA estimates the burden of this collection of information as
follows:

                                                         Table 3--Estimated Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                                                                        Number of      responses per     Total annual      Hours per       Total hours
                                                                       respondents       respondent       responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notifications required under proposed Sec.  Sec.   310.306                       75                3              225                2              450
 (unapproved drugs), 314.81(b)(3)(iii) (products approved under an
 NDA or ANDA), and 600.82 (products approved under a BLA)..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

    The information collection provisions of this proposed rule have
been submitted to OMB for review. Interested persons are requested to
fax comments regarding the information collection by December 4, 2013,
to the Office of Information and Regulatory Affairs, OMB. To ensure
that comments on the information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>,
or emailed to<EMAIL_ADDRESS>All comments should be
identified with the title of this information collection and should
include the FDA docket number found in brackets in the heading of this
document.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, 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, the Agency tentatively concludes 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. Environmental Impact

    The Agency has determined 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.

IX. 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.

X. References

    The following references have been placed on display in the
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 all the Web site addresses in this reference section, but
we are not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register).

1. Executive Order 13588, Reducing Prescription Drug Shortages,
October 31, 2011, available at http://www.gpo.gov/fdsys/pkg/FR-2011-11-03/pdf/2011-28728.pdf, accessed November 2012.
2. Center for Drug Evaluation and Research, Manual of Policies and
Procedures 6003.1, Drug Shortage Management, September 26, 2006,
available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm079936.pdf, accessed November
2012.
3. Preliminary Regulatory Impact Analysis, Initial Regulatory
Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for
Permanent Discontinuance or Interruption in Manufacturing of Certain
Drug or Biological Products; Proposed Rule, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 20

    Confidential business information, Courts, Freedom of information,
Government employees.

21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.

21 CFR Part 314

    Administrative practice and procedure, Confidential business
information, Drugs, Reporting and recordkeeping requirements.

21 CFR Part 600

    Biologics, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR parts 20,
310, 314, and 600 be amended as follows:

PART 20--PUBLIC INFORMATION

0
1. The authority citation for 21 CFR part 20 continues to read as
follows:

    Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21
U.S.C. 321-393; 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n,
243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.

0
2. Revise Sec.  20.100 by adding paragraph (c)(45) to read as follows:

Sec.  20.100  Applicability; cross-reference to other regulations.

* * * * *
    (c) * * *
    (45) Postmarket notifications of a permanent discontinuance or an
interruption in manufacturing of certain drugs or biological products,
in Sec. Sec.  310.306, 314.81(b)(3)(iii), and 600.82 of this chapter.

PART 310--NEW DRUGS

0
3. The authority citation for 21 CFR part 310 is revised to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356c, 356e,
360b-360f, 360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241,
242(a), 262, 263b-263n.

0
4. Add Sec.  310.306 to subpart D to read as follows:

Sec.  310.306  Notification of a permanent discontinuance or an
interruption in manufacturing of marketed prescription drugs for human
use without approved new drug applications.

    (a) Applicability. Marketed prescription drug products that are not
the subject of an approved new drug or abbreviated new drug application
are subject to this section.
    (b) Notification of a permanent discontinuance or an interruption
in manufacturing. The manufacturer of each product subject to this
section must make the notifications required under Sec.
314.81(b)(3)(iii) of this chapter and otherwise comply with Sec.
314.81(b)(3)(iii) of this chapter. If the manufacturer of a product
subject to this section fails to provide notification as required under
Sec.  314.81(b)(3)(iii), FDA will send a letter to the manufacturer and
otherwise follow the procedures set forth under Sec.
314.81(b)(3)(iii)(e).
    (c) Drug Shortages List. FDA will include on the drug shortages
list required by Sec.  314.81(b)(3)(iii)(d) drug products that are
subject to this section that it determines to be in shortage. For such
drug products, FDA will provide the names of each manufacturer rather
than the names of each applicant. With respect to information collected
under this paragraph FDA will observe the confidentiality and
disclosure provisions set forth in Sec.  314.81(b)(3)(iii)(d)(2).

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

0
5. The authority citation for 21 CFR part 314 is revised to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a,
356b, 356c, 356e, 371, 374, 379e.

0
6. Revise Sec.  314.81 paragraph (b)(3)(iii) to read as follows:

Sec.  314.81  Other postmarketing reports.

* * * * *
    (b) * * *
    (3) * * *
    (iii) Notification of a permanent discontinuance or an interruption
in manufacturing.
    (a) An applicant of a prescription drug product must notify FDA in
writing of a permanent discontinuance of manufacture of the drug
product or an interruption in manufacturing of the drug product that is
likely to lead to a meaningful disruption in supply of that drug in the
United States if:
    (1) The drug product is life supporting, life sustaining, or
intended for use in the prevention or treatment of a debilitating
disease or condition, including any such drug used in emergency medical
care or during surgery; and
    (2) The drug product is not a radiopharmaceutical drug product.
    (b) Notifications required by paragraph (b)(3)(iii)(a) of this
section must be submitted to FDA electronically in a format that FDA
can process, review, and archive:
    (1) At least 6 months prior to the date of the permanent
discontinuance or interruption in manufacturing; or
    (2) If 6 months' advance notice is not possible because the
permanent discontinuance or interruption in manufacturing was not
reasonably anticipated 6 months in advance, as soon as practicable
thereafter, but in no case later than 5 business days after the
permanent discontinuance or interruption in manufacturing occurs.
    (c) Notifications required by paragraph (b)(3)(iii)(a) of this
section must include the following information:
    (1) The name of the drug subject to the notification, including the
NDC for such drug;
    (2) The name of the applicant;
    (3) Whether the notification relates to a permanent discontinuance
of the drug or an interruption in manufacturing of the drug;
    (4) A description of the reason for the permanent discontinuance or
interruption in manufacturing; and
    (5) The estimated duration of the interruption in manufacturing.
    (d)(1) FDA will maintain a publicly available list of drugs that
are determined by FDA to be in shortage. This drug shortages list will
include the following information:
    (i) The names and NDC(s) for such drugs;
    (ii) The name of each applicant for such drugs;
    (iii) The reason for the shortage, as determined by FDA from the
following categories: Requirements related to complying with good
manufacturing practices; regulatory delay; shortage of an active
ingredient; shortage of an inactive ingredient component;
discontinuation of the manufacture of the drug; delay in shipping of
the drug; demand increase for the drug; or other reason; and
    (iv) The estimated duration of the shortage.
    (2) FDA may choose not to make information collected to implement
this paragraph available on the drug shortages list or available under
section 506C(c) of the FD&C Act if FDA determines that disclosure of
such information would adversely affect the public health (such as by
increasing the possibility of hoarding or other disruption of the
availability of drug to patients). FDA will also not provide
information on the public drug shortages list or under section 506C(c)
of the FD&C Act that is protected by 18 U.S.C. 1905 or 5 U.S.C.
552(b)(4), including trade secrets and commercial or financial
information that is considered confidential or privileged under Sec.
20.61.
    (e) If an applicant fails to submit a notification as required
under paragraph (b)(3)(iii)(a) of this section and in accordance with
paragraph (b)(3)(iii)(b) of this section, FDA will issue a letter to
the applicant informing it of such failure.
    (1) Not later than 30 calendar days after the issuance of such a
letter, the applicant must submit to FDA a written response setting
forth the basis for noncompliance and providing the required
notification under paragraph (b)(3)(iii)(a) of this section and
including the information required under paragraph (b)(3)(iii)(c) of
this section; and
    (2) Not later than 45 calendar days after the issuance of a letter
under paragraph (b)(3)(iii)(e) of this section, FDA will make the
letter and the applicant's response to the letter public, unless, after
review of the applicant's response, FDA determines that the applicant
had a reasonable basis for not notifying FDA as required under
paragraph (b)(3)(iii)(a) of this section.
    (f) The following definitions of terms apply to paragraph
(b)(3)(iii) of this section:
    Drug shortage or shortage means a period of time when the demand or
projected demand for the drug within the United States exceeds the
supply of the drug.
    Intended for use in the prevention or treatment of a debilitating
disease or condition means a drug product intended for use in the
prevention or treatment of a disease or condition associated with
mortality or morbidity that has a substantial impact on day-to-day
functioning.
    Life supporting or life sustaining means a drug product that is
essential to, or that yields information that is essential to, the
restoration or continuation of a bodily function important to the
continuation of human life.
    Meaningful disruption means a change in production that is
reasonably likely to lead to a reduction in the supply of a drug by a
manufacturer that is more than negligible and affects the ability of
the manufacturer to fill orders or meet expected demand for its
product, and does not include interruptions in manufacturing due to
matters such as routine maintenance or

insignificant changes in manufacturing so long as the manufacturer
expects to resume operations in a short period of time.
* * * * *

Sec.  314.91  [Removed]

0
7. Remove Sec.  314.91.

PART 600--BIOLOGICAL PRODUCTS: GENERAL

0
8. The authority citation for 21 CFR part 600 is revised to read as
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 356c, 356e, 360,
360i, 371, 374; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-25.

0
9. Add Sec.  600.82 to subpart D to read as follows:

Sec.  600.82  Notification of a permanent discontinuance or an
interruption in manufacturing.

    (a) Notification of a permanent discontinuance or an interruption
in manufacturing.
    (1) An applicant of a biological product, other than blood or blood
components for transfusion, which is licensed under section 351 of the
Public Health Service Act, and which may be dispensed only under
prescription under section 503(b)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353(b)(1)), must notify FDA in writing of a
permanent discontinuance of manufacture of the biological product or an
interruption in manufacturing of the biological product that is likely
to lead to a meaningful disruption in supply of that biological product
in the United States if:
    (i) The biological product is life supporting, life sustaining, or
intended for use in the prevention or treatment of a debilitating
disease or condition, including any such biological product used in
emergency medical care or during surgery; and
    (ii) The biological product is not a radiopharmaceutical biological
product.
    (2) An applicant of blood or blood components for transfusion,
which is licensed under section 351 of the Public Health Service Act,
and which may be dispensed only under prescription under section 503(b)
of the Federal Food, Drug, and Cosmetic Act, must notify FDA in writing
of a permanent discontinuance of manufacture of any product listed in
its license or an interruption in manufacturing of any such product
that is likely to lead to a significant disruption in supply of that
product in the United States if:
    (i) The product is life supporting, life sustaining, or intended
for use in the prevention or treatment of a debilitating disease or
condition, including any such product used in emergency medical care or
during surgery; and
    (ii) The applicant is a manufacturer of a significant percentage of
the U.S. blood supply.
    (b) Submission and timing of notification. Notifications required
by paragraph (a) of this section must be submitted to FDA
electronically in a format that FDA can process, review, and archive:
    (1) At least 6 months prior to the date of the permanent
discontinuance or interruption in manufacturing; or
    (2) If 6 months' advance notice is not possible because the
permanent discontinuance or interruption in manufacturing was not
reasonably anticipated 6 months in advance, as soon as practicable
thereafter, but in no case later than 5 business days after such a
permanent discontinuance or interruption in manufacturing occurs.
    (c) Information included in notification. Notifications required by
paragraph (a) of this section must include the following information:
    (1) The name of the biological product subject to the notification,
including the National Drug Code for such biological product, or an
alternative standard for identification and labeling that has been
recognized as acceptable by the Center Director;
    (2) The name of the applicant of the biological product;
    (3) Whether the notification relates to a permanent discontinuance
of the biological product or an interruption in manufacturing of the
biological product;
    (4) A description of the reason for the permanent discontinuance or
interruption in manufacturing; and
    (5) The estimated duration of the interruption in manufacturing.
    (d)(1) Public list of biological product shortages. FDA will
maintain a publicly available list of biological products that are
determined by FDA to be in shortage. This biological product shortages
list will include the following information:
    (i) The names and National Drug Codes for such biological products,
or the alternative standards for identification and labeling that have
been recognized as acceptable by the Center Director;
    (ii) The name of each applicant for such biological products;
    (iii) The reason for the shortage, as determined by FDA, selecting
from the following categories: Requirements related to complying with
good manufacturing practices; regulatory delay; shortage of an active
ingredient; shortage of an inactive ingredient component;
discontinuation of the manufacture of the biological product; delay in
shipping of the biological product; demand increase for the biological
product; or other reason; and
    (iv) The estimated duration of the shortage.
    (2) Confidentiality. FDA may choose not to make information
collected to implement this paragraph available on the biological
product shortages list or available under section 506C(c) of the FD&C
Act if FDA determines that disclosure of such information would
adversely affect the public health (such as by increasing the
possibility of hoarding or other disruption of the availability of the
biological product to patients). FDA will also not provide information
on the public shortages list or under section 506C(c) of the FD&C Act
that is protected by 18 U.S.C. 1905 or 5 U.S.C. 552(b)(4), including
trade secrets and commercial or financial information that is
considered confidential or privileged under Sec.  20.61 of this
chapter.
    (e) Noncompliance letters. If an applicant fails to submit a
notification as required under paragraph (a) of this section and in
accordance with paragraph (b) of this section, FDA will issue a letter
to the applicant informing it of such failure.
    (1) Not later than 30 calendar days after the issuance of such a
letter, the applicant must submit to FDA a written response setting
forth the basis for noncompliance and providing the required
notification under paragraph (a) of this section and including the
information required under paragraph (c) of this section; and
    (2) Not later than 45 calendar days after the issuance of a letter
under this paragraph, FDA will make the letter and the applicant's
response to the letter public, unless, after review of the applicant's
response, FDA determines that the applicant had a reasonable basis for
not notifying FDA as required under paragraph (a) of this section.
    (f) Definitions. The following definitions of terms apply to this
section:
    Biological product shortage or shortage means a period of time when
the demand or projected demand for the biological product within the
United States exceeds the supply of the biological product.
    Intended for use in the prevention or treatment of a debilitating
disease or condition means a biological product intended for use in the
prevention or treatment of a disease or condition associated with
mortality or morbidity that has a substantial impact on day-to-day
functioning.
    Life supporting or life sustaining means a biological product that
is

essential to, or that yields information that is essential to, the
restoration or continuation of a bodily function important to the
continuation of human life.
    Meaningful disruption means a change in production that is
reasonably likely to lead to a reduction in the supply of a biological
product by a manufacturer that is more than negligible and affects the
ability of the manufacturer to fill orders or meet expected demand for
its product, and does not include interruptions in manufacturing due to
matters such as routine maintenance or insignificant changes in
manufacturing so long as the manufacturer expects to resume operations
in a short period of time.
    Significant disruption means a change in production that is
reasonably likely to lead to a reduction in the supply of blood or
blood components by a manufacturer that substantially affects the
ability of the manufacturer to fill orders or meet expected demand for
its product, and does not include interruptions in manufacturing due to
matters such as routine maintenance or insignificant changes in
manufacturing so long as the manufacturer expects to resume operations
in a short period of time.

    Dated: October 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25956 Filed 10-31-13; 11:15 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Proposed Rules]
[Pages 6111-6112]
[FR Doc No: 2014-02111]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16, 225, 500, 507, and 579

[Docket No. FDA-2011-N-0922]
RIN 0910-AG10

Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals; Extension of Comment
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the notice of proposed rulemaking that appeared in
the Federal Register of October 29, 2013 (78 FR 64736), entitled
``Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals '' and its information
collection

provisions. We are taking this action in response to requests for an
extension to allow interested persons more time to comment given that
in addition to the proposed preventive control requirements, the
proposed current good manufacturing practice (CGMP) requirements are
also new to the animal food industry, unlike the human food industry.
    We also are taking this action to keep the comment period for the
information collection provisions associated with the rule consistent
with the comment period for the proposed rule.

DATES: FDA is extending the comment period on the proposed rule and its
information collection provisions. Submit either electronic or written
comments on the proposed rule and the information collection by March
31, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0922 and/or Regulatory Information Number (RIN) 0910-AG10, by any of
the following methods, except that comments on information collection
issues under the PRA must be submitted to the Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB) (see the
``Paperwork Reduction Act of 1995'' section of this document).

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 Agency
name, Docket No. FDA-2011-N-0922, and RIN 0910-AG10 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
``Request for 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, 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: With regard to the proposed rule: Kim
Young, Center for Veterinary Medicine, Food and Drug Administration,
7519 Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.
    With regard to the information collection: Domini Bean, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400T, Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 29, 2013, we published a
proposed rule entitled ``Current Good Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive Controls for Food for Animals'' with
a 120-day comment period on the provisions of the proposed rule and on
the information collection provisions that are subject to review by OMB
under the PRA (44 U.S.C. 3501-3520).
    FDA has received requests for an extension of the comment period on
the proposed rule. The requests conveyed concern that the current 120-
day comment period does not allow time to develop a meaningful response
to the proposed rule because, unlike the human food industry, in
addition to the proposed preventive controls, the proposed CGMPs are
new to the animal food industry. The requests also stated an extended
comment period would allow interested persons an opportunity to
consider the interrelationship between this proposed rule and the
proposed rules entitled ``Foreign Supplier Verification Programs for
Importers of Food for Humans and Animals'' (78 FR 45729, July 29, 2013)
and ``Accreditation of Third-Party Auditors/Certification Bodies to
Conduct Food Safety Audits and to Issue Certifications'' (78 FR 45782,
July 29, 2013). FDA has considered the requests and is granting an
extension of the comment period to March 31, 2014, for the ``Current
Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Food for Animals'' proposed rule to allow
interested persons additional time to submit comments. We also are
extending the comment period for the information collection provisions
to March 31, 2014, to make the comment period for the information
collection provisions the same as the comment period for the provisions
of the proposed rule. To clarify, FDA is requesting comment on all
issues raised by the proposed rule.

II. Paperwork Reduction Act of 1995

    Interested persons may either submit electronic comments regarding
the information collection to<EMAIL_ADDRESS>or fax
written comments to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>. All comments should be
identified with the title ``Current Good Manufacturing Practice and
Hazard Analysis and Risk-Based Preventive Controls for Food for
Animals.''

III. Request for Comments

    Interested persons may submit either electronic comments regarding
the proposed rule 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.

    Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02111 Filed 1-31-14; 8:45 am]
BILLING CODE 4160-01-P