[Federal Register Volume 82, Number 105 (Friday, June 2, 2017)]
[Proposed Rules]
[Pages 25556-25559]
[FR Doc No: 2017-11002]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0521; Directorate Identifier 2016-NM-189-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bombardier, Inc., Model CL-600-2B16 (CL-601-3A, CL-601-3R, and
CL-604 Variants) airplanes. This proposed AD was prompted by reports of
fuel leaks in the engine and auxiliary power unit (APU) electrical fuel
pump (EFP) cartridge/canister electrical connectors and conduits. This
proposed AD would require repetitive inspections for fuel leakage at
the engine and APU fuel pumps, and related investigative and corrective
actions if necessary. We are proposing this AD to address the unsafe
condition on these products.

DATES: We must receive comments on this proposed AD by July 17, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:

     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; Widebody Customer Response Center North America toll-
free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may view this referenced service information at
the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0521; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Steven Dzierzynski, Aerospace
Engineer, Avionics and Services Branch, ANE-172, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2017-0521;
Directorate Identifier 2016-NM-189-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2016-32R1, dated October 12, 2016 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for certain Bombardier, Inc., Model CL-600-
2B16 (CL-601-3A, CL-601-3R, and CL-604 variants) airplanes. The MCAI
states:

    Fuel leaks have been reported in the engine and auxiliary power
unit (APU) electrical fuel pump (EFP) cartridge/canister electrical
connectors and conduits on production aeroplanes. Initially,
Bombardier had determined that the subject discrepancy was limited
to the new pump canister installations on 24 production aeroplanes.
Bombardier also reported the possibility of cut insulation on the
electric harness wires of the newly installed canister housing
assemblies.
    Emergency [Canadian] AD CF-2014-17 [which corresponds to FAA AD
2014-15-17, Amendment 39-17919 (79 FR 44268, July 31, 2014)] was
issued to limit landing light operation on-ground in order to
address a potential fire hazard as result of possible fuel leak from
APU, EFP electrical conduit in the landing light compartment. In
addition, [Canadian] AD CF-2014-21 [which corresponds to FAA AD
2014-20-01, Amendment 39-17974 (79 FR 59640, October 3, 2014),
superseded by FAA AD 2016-10-10, Amendment 39-18521 (81 FR 31497,
May 19, 2016)(``AD 2016-10-10'')] was issued to mandate removal of
then identified 24 discrepant EFP canister assemblies from service.
    Bombardier has recently determined that the subject fuel leaks
may not be limited to the 24 units affected by [Canadian] AD CF-
2014-21 [(AD 2016-10-10)], but may potentially affect other in-
service [Bombardier Model] CL-600-2B16 aeroplanes. Until such time
that a final fix for the fuel leak problem is realized, Bombardier
as an interim mitigating action, has issued [Service Bulletins] SB
604-28-022 and SB 605-28-010 that introduces [a] repeat [general
visual] inspection and if required, rectification [related
investigative and corrective actions] of subject fuel leaks on
affected aeroplanes. [Canadian] AD CF-2016-32 was issued on 29
September 2016 to mandate compliance with applicable Bombardier SBs,
to mitigate any potential safety hazard resulting from fuel leaks.
    Revision 1 of this [Canadian] AD is being issued to correct a
typographic error in paragraph B.1. of the [Canadian AD] Corrective
Actions.

    Related investigative actions involve, for certain airplanes,
further inspections for fuel leakage. Corrective actions involve
repair, and for certain other airplanes, those actions could include
replacing O-rings, and replacing the fuel cartridge. You may examine
the MCAI in the AD docket on the Internet at http://www.regulations.gov
by searching for and locating Docket No. FAA-2017-0521.

Related Service Information Under 1 CFR Part 51

    Bombardier, Inc., has issued the following service bulletins:
     Bombardier Service Bulletin 604-28-022, dated October 19,
2015; and
     Bombardier Service Bulletin 605-28-010, dated October 19,
2015.
    The service information describes procedures for repetitive general
visual inspections, and related investigative and corrective actions if
necessary. These documents are distinct since they apply to airplanes
in different configurations. This service information is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    We estimate that this proposed AD affects 121 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
General Visual Inspection.............  1 work-hour x $85 per                 $0             $85         $10,285
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

    For Model CL-600-2B16 airplanes, having serial numbers 5701 through
5955 inclusive, 5957, 5960 through 5966 inclusive, 5968 through 5971
inclusive, and 5981, we estimate the following costs to do any
necessary replacements that would be required based on the results of
the proposed inspection. We have no way of determining the number of
aircraft that might need these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace O-Ring in Affected Pump...............  3 work-hours x $85 per hour =                $17            $272
                                                 $255.
Replace Cartridge in Affected Pump............  2 work-hours x $85 per hour =              8,618           8,788
                                                 $170.
----------------------------------------------------------------------------------------------------------------

    For Model CL-600-2B16 airplanes having serial numbers 5301 through
5665 inclusive, we have received no definitive data that would enable
us to provide cost estimates for the on-condition actions specified in
this proposed AD.
    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect 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.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Bombardier, Inc.: Docket No. FAA-2017-0521; Directorate Identifier
2016-NM-189-AD.

(a) Comments Due Date

    We must receive comments by July 17, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model CL-600-2B16 (CL-601-
3A, CL-601-3R, and CL-604 variants) airplanes, certificated in any
category, having serial numbers 5301 through 5665 inclusive, 5701
through 5955 inclusive, 5957, 5960 Through 5966 inclusive, 5968
through 5971 inclusive, and 5981.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Reason

    This proposed AD was prompted by reports of fuel leaks in the
engine and auxiliary power unit (APU) electrical fuel pump (EFP)
cartridge/canister electrical connectors and conduits. We are
issuing this AD to detect and correct fuel leaks in certain fuel
pumps to remove a potential fuel ignition hazard.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) General Visual Inspection and Corrective Action--Model CL-600-2B16
Airplanes, Serial Numbers 5301 Through 5665 Inclusive

    For Model CL-600-2B16 airplanes, having serial numbers 5301
through 5665 inclusive:
    Within 600 flight hours or 12 months, whichever occurs first,
after the effective date of this AD, do general visual inspections
of the locations specified in paragraphs (g)(1), (g)(2), and (g)(3)
of this AD, and do all applicable corrective actions, in accordance
with the Accomplishment Instructions of Bombardier Service Bulletin
604-28-022, dated October 19, 2015; except where the Bombardier
Service Bulletin 604-28-022, dated October 19, 2015 specifies to
contact the manufacturer, before further flight accomplish
corrective action in accordance with the procedures specified in
paragraph (i)(2) of this AD. Do all applicable corrective

actions before further flight. Repeat the general visual inspections
at intervals not exceeding 600 flight hours or 12 months, whichever
occurs first.
    (1) Do a general visual inspection for traces of fuel coming
from the right-hand side engine boost pump at the location of the
belly fairing screw (FS412, BL 0.0).
    (2) Do a general visual inspection for traces of fuel coming
from the left-hand side engine boost pump at the location of the
belly fairing screw (FS412, BL 0.0).
    (3) Do a general visual inspection for traces of fuel coming
from the EFP electrical wiring conduit outlet at the lower body
fairing area for engine EFPs and at the right-hand landing light
compartment for the APU EFP.

(h) General Visual Inspection and Corrective Action--Model CL-600-2B16
Airplanes, Having Serial Numbers 5701 Through 5955 Inclusive, 5957,
5960 Through 5966 Inclusive, 5968 Through 5971 Inclusive, and 5981

    For Model CL-600-2B16 airplanes, having serial numbers 5701
through 5955 inclusive, 5957, 5960 through 5966 inclusive, 5968
through 5971 inclusive, and 5981: Within 600 flight hours or 12
months, whichever occurs first, after the effective date of this AD,
do general visual inspections of the locations specified in
paragraphs (h)(1), (h)(2), and (h)(3) of this AD, and do all
applicable related investigative and corrective actions, in
accordance with the Accomplishment Instructions in Bombardier
Service Bulletin 605-28-010, dated October 19, 2015; except where
Bombardier Service Bulletin 605-28-010, dated October 19, 2015
specifies to contact the manufacturer, before further flight
accomplish corrective actions in accordance with the procedures
specified in paragraph (i)(2) of this AD. Do all applicable related
investigative and corrective actions before further flight. Repeat
the general visual inspections at intervals not exceeding 600 flight
hours or 12 months, whichever occurs first.
    (1) Do a general visual inspection for traces of fuel coming
from the right-hand side engine boost pump at the location of the
belly fairing screw (FS412, BL 0.0).
    (2) Do a general visual inspection for traces of fuel coming
from the left-hand side engine boost pump at the location of the
belly fairing screw (FS412, BL 0.0).
    (3) Do a general visual inspection of the right-hand side
landing light compartment for traces of fuel coming from the APU
EFP.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO, ANE-170, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the ACO, send it
to ATTN: Program Manager, Continuing Operational Safety, FAA, New
York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO,
ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2016-32R1, dated October
12, 2016, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2017-0521.
    (2) For more information about this AD, contact Steven
Dzierzynski, Aerospace Engineer, Avionics and Services Branch, ANE-
172, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax
516-794-5531; email<EMAIL_ADDRESS>    (3) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; Widebody Customer Response Center
North America toll-free telephone 1-866-538-1247 or direct-dial
telephone 1-514-855-2999; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may view this service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on May 19, 2017.
Victor Wicklund,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-11002 Filed 6-1-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Notices]
[Pages 46571-46572]
[FR Doc No: 2015-19202]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER15-1919-000; ER15-1919-001]

California Independent System Operator Corporation; Notice of
Conference

    Take notice that a staff-led conference will be convened in this
proceeding

commencing at 10 a.m. (EST) on Tuesday, August 11, 2015, at the offices
of the Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The purpose of the conference is to further
explore the questions raised in the concurrently issued deficiency
letter in these proceedings, and the discussion at this informal
conference will be limited to the issues raised in the deficiency
letter.
    Any party, as defined by 18 CFR 385.102(c), or any participant as
defined by 18 CFR 385.102(b), is invited to attend. Persons wishing to
become a party must move to intervene and receive intervenor status
pursuant to the Commission's regulations (18 CFR 385.214).
    This conference will not be webcasted or transcribed. However, an
audio listen-only line will be provided. If you need a listen-only
line, please email Sarah McKinley<EMAIL_ADDRESS>by 5:00
p.m. (EST) on Thursday, August 6, with your name, email, and phone
number, in order to receive the call-in information the day before the
conference. Please use the following text for the subject line, ``ER15-
1919 listen-only line registration.''
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free 1 (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER>
with the required accommodations.
    For additional information, please contact Laura Switzer at (202)
502-6231<EMAIL_ADDRESS>or Jennifer Shipley at<PHONE_NUMBER>,
<EMAIL_ADDRESS>
    Dated: July 30, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-19202 Filed 8-4-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Pages 4828-4830]
[FR Doc No: 2023-01467]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0169]

Compounding Certain Ibuprofen Oral Suspension Products Under
Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Compounding Certain Ibuprofen Oral Suspension Products Under Section
503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance
describes FDA's regulatory and enforcement priorities regarding
compounding certain ibuprofen oral suspension products in outsourcing
facilities for administration in hospitals and health systems.

DATES: The announcement of the guidance is published in the Federal
Register on January 25, 2023.

ADDRESSES: You may submit either electronic or written comments on

Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-0169 for ``Compounding Certain Ibuprofen Oral Suspension
Products Under Section 503B of the Federal Food, Drug, and Cosmetic
Act.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Ian Reynolds, Office of Compounding
Quality and Compliance, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Compounding Certain Ibuprofen Oral Suspension Products Under
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This
guidance is being implemented without prior public comment because FDA
has determined that prior public participation for this guidance is not
feasible or appropriate (see section 701(h)(1)(C) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR
10.115(g)(2)). This guidance document is being implemented immediately
to bolster access to ibuprofen oral suspension products in hospitals
and health systems during the current surge in respiratory infections,
but it remains subject to comment in accordance with the Agency's good
guidance practices.
    This guidance describes the Agency's regulatory and enforcement
priorities regarding the compounding of certain ibuprofen oral
suspension products in outsourcing facilities for administration in
hospitals and health systems. The United States is currently
experiencing a surge in three viruses: Coronavirus Disease 2019 (COVID-
19), respiratory syncytial virus (RSV), and influenza. Each of these
viruses may produce fever in young children. FDA has received reports
related to increased demand for pediatric fever-reducing medications,
including ibuprofen oral suspension products. Further, FDA has received
a number of reports related to hospitals and health systems
experiencing challenges with obtaining these medications to use in the
treatment of pediatric patients with fevers as well as for adults who
are unable to swallow solid oral dosage forms (e.g. persons with
feeding tubes). FDA is continually assessing the needs and
circumstances related to the temporary policy set forth in this
guidance, and as relevant needs and circumstances evolve, FDA intends
to update, modify, or withdraw this policy as appropriate.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Compounding Certain Ibuprofen Oral
Suspension Products Under Section 503B of the FD&C Act.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget

(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collection of information for current good manufacturing practice
requirements has been approved under OMB control number 0910-0139. The
collections of information for adverse event reporting and human drug
compounding under sections 503A and 503B of the FD&C Act have been
approved under OMB control number 0910-0800. The collections of
information for adverse event and product experience reporting under
the MedWatch System has been approved under OMB control number 0910-
0291.

III. Electronic Access

    Persons with access to the internet may obtain the document at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: January 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01467 Filed 1-23-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Pages 63662-63663]
[FR Doc No: 2019-24917]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2649]

Advisory Committee; Nonprescription Drugs Advisory Committee,
Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Nonprescription Drugs Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the
Nonprescription Drugs Advisory Committee for an additional 2 years
beyond the charter expiration date. The new charter will be in effect
until August 27, 2021.

DATES: Authority for the Nonprescription Drugs Advisory Committee will
expire on August 27, 2021, unless the Commissioner formally determines
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3, FDA is announcing
the renewal of the Nonprescription Drugs Advisory Committee (the
Committee). The committee is a discretionary Federal advisory committee
established to provide advice to the Commissioner.
    The Committee advises the Commissioner or designee in discharging
responsibilities as they relate to helping to ensure safe and effective
drugs for human use and, as required, any other product for which FDA
has regulatory responsibility.
    The Committee reviews and evaluates data concerning the safety and
effectiveness of over-the-counter (nonprescription) human drug
products, or any other FDA-regulated product, for use in the treatment
of a broad spectrum of human symptoms and diseases and advises the
Commissioner either on the promulgation of monographs establishing
conditions under which these drugs are generally recognized as safe and
effective and not misbranded or on the approval of new drug
applications for such drugs. The Committee serves as a forum for the
exchange of views regarding the prescription and nonprescription
status, including switches from one status to another, of these various
drug products and combinations thereof. The Committee may also conduct
peer review of agency sponsored intramural and extramural scientific
biomedical programs in support of FDA's mission and regulatory
responsibilities.
    Pursuant to its charter, the Committee consists of a core of 10
voting members, including the Chair. Members and the Chair are selected
by the Commissioner or designee from among authorities knowledgeable in
the fields of internal medicine, family practice, clinical toxicology,
clinical pharmacology, pharmacy, dentistry, and related specialties.
Members are invited to serve for overlapping terms of up to 4 years.
Almost all non-Federal members of this committee serve as Special
Government Employees. The core of voting members may include one
technically qualified member, selected by the Commissioner or designee,
who is identified with consumer interests and is recommended by either
a consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
one non-voting member who is identified with industry interests.
    Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/nonprescription-drugs-advisory-committee/nonprescription-drugs-advisory-committee-charter or by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact
that no change has been made to the committee name or description of
duties, no amendment will be made to 21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: November 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24917 Filed 11-15-19; 8:45 am]
 BILLING CODE 4164-01-P


Memorandum

To: Tom Mockler, OSHA

From: Chet Fenton and Carlie McCullough, ERG

Date: March 6, 2012

Subject: Analyses for Subpart V FEA

1.	ERG reviewed a set of electric utility burn accidents obtained from
OSHA’s IMIS database of fatality/catastrophe reports to assess the
potential preventability of fatalities and injuries as the result of
compliance with the flame-resistant clothing requirements of the final
Subpart V rule. This data set contained accident reports for 99
accidents involving arc-related burns associated with electrical utility
type work and covering the period 5/15/1991 to 9/8/1998. These accidents
resulted in 21 fatalities and 94 hospitalized injuries. This time period
is subsumed with the 1984 to 2001 time period encompassed by CONSAD’s
IMIS review that formed the basis for benefits assessment for the
proposed rule. At issue are arc-related burn injuries that result from
equipment failures (e.g., electrical faults resulting from a transformer
failure) or other events that are not otherwise preventable by the
clearance requirements of the final rule.

ERG used preventability criteria supplied by OSHA to judge the
preventability of each fatal or nonfatal injury. These criteria are
summarized in the table below.

Accident characteristics	Reduction of injuries	Rationale

Clothing ignition	Eliminate all burns due to clothing ignition	Rule
requires FR clothing under conditions when clothing can be ignited.

Hydraulic oil	None, except to the extent that clothing ignited	FR
clothing will not substantially reduce burns from hydraulic oil, except
to the extent that clothing ignition is prevented.

Contact	Reduce due to clothing ignition and for parts of body > arc
distance	FR clothing prevents ignition and will reduce injury
substantially, with reduction to first-degree burns at the arc distance.

Burns to face	Eliminate if burns to other parts of body, except the
hands	If parts of the body other than the hands are burned, the energy
is likely sufficient to require face protection.

Burns to hands	Eliminate	Hand protection is required.

Third-degree burns	Reduce to 10-percent second-degree burn, except for
contact	Third-degree burns will be reduced to first-degree, except to
the extent that the employee is closer than the arc distance.

Second-degree burns	Eliminate	FR clothing will prevent nearly all
second-degree burn.

First-degree burn	None	FR clothing will likely reduce first-degree burns
substantially, but no reduction is taken.

Based on these criteria, ERG found that compliance with the final
Subpart V rule would have potentially prevented 11 of the 21 fatalities,
either by preventing the injury entirely (two cases) or by reducing the
burn severity to a nonfatal level (nine cases). This same review found
that compliance with the final rule would have potentially prevented 34
of the 94 hospitalized injuries and resulted in reduced severity for 29
others. On an annual basis, this review of the IMIS data suggests that
the final rule might potentially prevent an average of 1.14 arc-related
burn fatalities per year and 3.52 arc-related nonfatal hospitalized burn
injuries. Under the proposed rule, only 0.93 of these fatal and 1.66 of
these nonfatal burn injuries would be prevented annually.

An earlier review of IMIS electric utility accident data by CONSAD found
that in comparison to fatality data collected BLS in the Census of Fatal
Occupational Injuries (CFOI) the IMIS fatality incidence underestimated
the incidence of fatalities as reported by BLS by about 41%.  Using this
adjustment factor, ERG estimated that compliance with the final rule
would potentially prevent 1.92 fatal arc-related burn fatalities
annually. This compares to an estimate of 1.57 fatalities prevented
annually under the proposed rule.

ERG’s review also found that 23 of the 99 accidents were associated
with inadvertent direct contact with energized equipment. These
accidents would have been avoided through strict adherence to
requirements of the existing standard. According to the preventability
guidelines shown in the above table, use of FR clothing, however, would
reduce the severity of injury if the fire resulted in ignition of
clothing or burns to parts of the body within the maximum distance of
the arc. Of the injuries in the 23 contact cases, ERG judged only one
would have been would have been prevented (burns to the hand only),
while four more would have resulted in less severe burns had FR clothing
been used. None of the fatalities judged preventable were among these
direct contact-related incidents. The remaining cases involved burns
from equipment failure-related fires and other similar causes. Neither
the existing nor the final standard would prevent these accidents, but
the proper use of FR clothing might prevent or mitigate any resultant
injuries. Of the 76 accidents in this category, ERG judged that the
associated injuries were preventable in 32 cases and would be less
severe in 23 cases if FR clothing had been worn.

2.	ERG also assessed the preventability of alternative versions of the
flame-resistant clothing requirements, including a more stringent
requirement where workers would be required to wear head protection and
face shields whenever working around energized equipment and a less
stringent requirement where only clothing rated at 4 calories would be
required. The review of the same set of IMIS reports indicated that the
more stringent requirement would also prevent 1.92 fatalities (after
adjustment for undercounting), while the less stringent option would
prevent 1.40 fatalities per year.  A summary of the IMIS accident review
is shown below.

Preventability Review of Arc-Related Burn Cases

 – IMIS Accident Reports

	Final Rule	Proposed Rule	Less Stringent Alternative	More Stringent
Alternative

Fatal Injuries

	Prevented	2	0	0	2

Less Severe	9	9	8	9

Not Prevented	9	11	12	9

Insufficient Information	1	1	1	1

Total	21	21	21	21

Nonfatal Injures

Prevented	34	16	9	43

Less Severe	29	29	32	29

Not Prevented	31	49	53	22

Insufficient Information	0	0	0	0

Total	94	94	94	94

3.	ERG also investigated whether the existence of trends in the
incidence of the types of injuries and fatalities potentially prevented
by the final rule might indicate that a revision in the baseline
estimate of the annual number of fatalities and injuries might be
appropriate. Fatality data published by the BLS in the CFOI for 2003
through 2007 fail to show, however, that any such trend exists. The
table below shows the results for the two private sector industries
segments most directly affected by the rule. While these fatality totals
do not encompass all the affected industries, any trends should be
apparent from a review of these industries. Although the fatality totals
vary year to year, no trend is apparent in these data.

Number of Fatal Injuries by Accident Type and Year

 (Private Sector Only)

Industry	2003	2004	2005	2006	2007

Electric Power Generation, Transmission and Distribution (2211)

22	40	22	39	25

Power and Communication Line and Related Structures Construction (23713)

49	30	33	29	36

Source: BLS, Census of Fatal Occupational Injuries, 2003-2007.

4.	ERG received input on several aspects of the cost model from Charlie
Grose, a Licensed Professional Engineer who has served as a consultant
on the construction and operation of high voltage power systems since
retiring from the New York Power Authority in 1991.

ERG first consulted Mr. Grose on September 27, 2010 about minimum
approach distances (MAD). MAD becomes relevant for work done on lines
with a line-to-line voltage above 72.5kV. Mr. Grose reported that if a
utility has a digital transient analysis program of their system
available, it can be programmed to develop data at a specific work site
location. The primary cost item is the initial programming to add a line
location. Once the programming is completed, runs for a programmed work
site location take very little time. A typical run would take less than
5 minutes.

After consulting with Mr. Grose, and OSHA, ERG concluded that the
relevant high voltage work is performed almost entirely by the utilities
themselves. Some utilities may need to use portable protective gaps
(PPGs) to ensure that the required MAD can be accommodated. Current
rates of PPG use are low, as they are typically used on compact design
lines which are found in the major population areas. At the present
time, Mr. Grose knows of only 15 utilities using PPGs on a regular
basis. The cost of a PPG varies, as each must be designed and tested to
suit a particular utility’s line configuration. A single PPG and its
grounding equipment might cost $4,000 for use on line-to-line voltage up
to and including 242 kV, or $6,500 for use on line-to-line voltage above
242 kV. If the live work only involves one phase, two PPGs are normally
used one on each side of the work site. If the live work only involves
all phases, six PPGs are normally used, with three on each side of the
work site. For lines at or below 242kV, installing or removing a single
PPG takes about 15 minutes, while installing or removing three PPGs on
each side of the work site takes about 25 minutes. For lines at and
above 262 kV, it could take up to 60 minutes to install or remove a PPG.
Installing or removing PPGs requires a two man crew and an aerial lift.
Mr. Grose also estimated that utilities in dense urban areas use PPGs
about ten percent of the time and that PPGs are normally used on compact
design lines which are found in the major population areas. Since PPGs
are less likely to be used in non-urban areas, the ten percent statistic
is a conservative measure of the extent of PPG use among all utilities
with high voltage transmission lines.

For the purposes of assisting the Agency with the estimation of
compliance costs for the Final Economic Analysis, ERG simplified the
information provided by Mr. Grose and assumed that PPG capital costs
would average $5,000 per unit. ERG also estimated that a typical
affected utility would require 24 PPG units. This would allow the
utility to work simultaneously at four sites, based on the requirement
that six PPGs per site are required for 3-phase work.

In consultation with OSHA, ERG estimated that large utilities would
require, on average, eight hours of engineering time to calculate the
maximum anticipated transient overvoltage (T) on their system, while
small utilities would require, on average, four hours of engineering
time to perform this calculation.

ERG also consulted with Mr. Grose regarding arc hazard assessment on
December 21 and 22, 2010. Mr. Grose felt that most large utilities are
already using software mentioned in the rule, such as ARCPRO, and that
conducting an in-house arc hazard assessment would take an engineer
approximately 20 hours. Smaller utilities would be more likely to use a
consultant who has ARCPRO. It would take a consultant longer to perform
the analysis than an in-house engineer, at a rate of $250 to $300 per
hour.

5.	The PRIA was based in part on a report prepared by CONSAD, which was
based on 1997 NAICS and SIC codes. The Final Economic Analysis was
updated with the assistance of ERG, using data from the U.S. Census
Bureau’s 2007 Statistics of U.S. Businesses (SUSB). The numbers CONSAD
developed for small, large, and total establishments were based on the
1997 U.S. Economic Census, which used some NAICS classifications which
are now obsolete. In order to be analytically consistent, however, ERG
maintained the older NAICS categories, but updated them using the U.S.
Census Bureau’s 1997 NAICS and 1987 SIC Correspondence Tables, 1997
NAICS to 2002 NAICS Correspondence Tables, and 2002 NAICS to 2007 NAICS
Correspondence Tables to match CONSAD’s NAICS and SIC categories to
2007 NAICS. In many cases a single 1997 NAICS code maps to multiple 2007
NAICS codes.  In these cases ERG averaged the wages, number of
employees, number of establishments, profit rates, or other data for the
2007 NAICS categories to produce a single updated estimate for the 1997
NAICS category. Data for Industrial Power Generators, Major Publicly
Owned Utilities, and Line-Clearance Tree Trimmers are not included in
the SUSB data, and ERG estimated data for these sectors from other
sources (as detailed in the FEA).

6.	Following the algorithm developed by CONSAD, ERG projected the number
of projects per year for a given industry as equal to the number of
crews (i.e., the number of power workers divided by the crew size)
multiplied by the number of projects per crew day (1) multiplied by the
number of work days per year (250). For most industries a crew consists
of 3 power workers at small establishments and 6 power workers at large
establishments. For Ornamental Shrub and Tree Services (SIC 0783),
however a crew consists of 2 power workers at a small establishment and
4 power workers at a large establishment. The following table shows the
estimated number of projects per year for each of the affected
industries.

Estimated Number of Power Projects

Industry	Power Projects per Year

Water, Sewer, and Pipeline Construction (NAICS 234910)	65,078

Power and Communication Transmission Line Construction (NAICS 234920)
1,701,656

Industrial Nonbuilding Structure Construction (NAICS 234930)	78,017

All Other Heavy Construction (NAICS 234990)	410,541

Electrical Contractors (NAICS 235310)	1,247,104

Structural Steel Erection Contractors (NAICS 235910)	21,066

Building Equipment and Other Machine Installation Contractors (NAICS
235950)	19,739

All Other Special Trade Contractors (NAICS 235990)	62,701

Electric Power Generation (NAICS 221110)	1,582,025

Electric Power Transmission, Control, and Distribution (NAICS 221120)
2,689,805

Major Publicly Owned Utilities (NAICS 2211)	360,869

Industrial Power Generators	723,820

Ornamental Shrub and Tree Services (SIC 0783)	990,830

 Some arc-related burn injuries are caused by equipment failures in
which heated fluids are released, burning nearby workers. Burn injuries
from these types of accidents are not prevented by use of the
flame-resistance clothing required by the Subpart V rule. Six of the 99
accidents in the dataset reviewed were of this type.

 CONSAD’s review of fatality data from the BLS Census of Fatal
Occupational Injuries and from the OSHA’s IMIS database concluded that
“656 fatalities occurred due to accidents between 1992 and 2000
involving power generation, transmission, and distribution work
(including line-clearance tree trimming work) that would be covered by
the proposed, revised 1926 and 1910 standards” or 72.9 fatalities per
year [CONSAD, p. 4.23]. A review of comparable fatal accidents contained
in the IMIS database for the period from March 1984 through October 2001
found 759 fatal cases or 43.2 fatalities per year [CONSAD, p. 4.12].
Thus, CONSAD concluded that the IMIS fatalities undercount the true
number of fatalities by 40.7% (43.2 = (1 - 0.407)*72.9).

 ERG again relied on preventability criteria for different types of burn
accidents under the alternative regulatory options as supplied by OSHA
for this analysis.

 The 4-digit NAICS code 2211 encompasses the entire electric utility
industry including generation, transmission, and distribution.

 NAICS 23713is the 2007 (and 2002) NAICS equivalent of the 1997 NAICS
234920 used in the FEA.

 U.S. Census Bureau. 2009a. 1997 NAICS and 1987 SIC Correspondence
Tables. Available at    HYPERLINK
"http://www.census.gov/epcd/www/naicstab.htm"
http://www.census.gov/epcd/www/naicstab.htm . U.S. Census
Bureau. 2009b. 1997 NAICS to 2002 NAICS Correspondence Tables.
Available at    HYPERLINK
"http://www.census.gov/eos/www/naics/concordances/"
http://www.census.gov/eos/www/naics/concordances/
1997_NAICS_to_2002_NAICS.xls. U.S. Census Bureau. 2009c. 2002 NAICS to
2007 NAICS Correspondence Tables. Available at
http://www.census.gov/eos/www/naics/concordances/2002_to_2007_NAICS.xls.

  PAGE   \* MERGEFORMAT  1


[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)]
[Notices]
[Pages 57460-57462]
[FR Doc No: 2017-26195]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1159]

Food and Drug Administration Categorization of Investigational
Device Exemption Devices To Assist the Centers for Medicare and
Medicaid Services With Coverage Decisions; Guidance for Sponsors,
Clinical Investigators, Industry, Institutional Review Boards, and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``FDA Categorization of
Investigational Device Exemption (IDE) Devices to Assist the Centers
for Medicare and Medicaid Services (CMS) with Coverage Decisions;
Guidance for Sponsors, Clinical Investigators, Industry, Institutional
Review Boards, and Food and Drug Administration Staff.'' This guidance
modifies the FDA's current policy on categorization of investigational
device exemption (IDE) devices, which assists the CMS in determining
whether or not an IDE device should be covered (reimbursed) by CMS. On
December 2, 2015, FDA's Center for Devices and Radiological Health
(CDRH) and CMS's Coverage and Analysis Group (CAG) executed a
Memorandum of Understanding (MOU) to streamline and facilitate the
efficient categorization of investigational medical devices in order to
support CMS's ability to make Medicare coverage (reimbursement)
determinations for those devices. This guidance document further
explains the framework that FDA intends to follow for such
categorization decisions.

DATES: The announcement of the guidance is published in the Federal
Register on December 5, 2017.

ADDRESSES: You may submit either electronic or written comments on this
guidance at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-1159 for ``FDA Categorization of Investigational Device
Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid
Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical
Investigators, Industry, Institutional Review Boards, and Food and Drug
Administration Staff.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff office between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the

electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled ``FDA
Categorization of Investigational Device Exemption (IDE) Devices to
Assist the Centers for Medicare and Medicaid Services (CMS) with
Coverage Decisions; Guidance for Sponsors, Clinical Investigators,
Industry, Institutional Review Boards, and Food and Drug Administration
Staff'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Owen Faris, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1682, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for sponsors,
clinical investigators, industry, institutional review boards, and FDA
staff entitled, ``FDA Categorization of Investigational Device
Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid
Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical
Investigators, Industry, Institutional Review Boards, and Food and Drug
Administration Staff.'' This guidance modifies the FDA's current policy
on categorization of IDE devices. In September 1995, FDA entered into
an Interagency Agreement (IA) regarding reimbursement categorization of
investigational devices with the Health Care Financing Administration
(now known as CMS). FDA would assign a device with an approved IDE
based on the level of risk the device presented to patients. The
categorization would then be used by CMS as part of its determination
of whether or not items and services met the requirements for Medicare
coverage under section 1862(a)(1)(A) of the Social Security Act. In
following with the IA, FDA categorized devices as either Category A
(``Experimental'') or Category B (``Nonexperimental/Investigational'').
In the more than 20 years since the IA was signed, FDA has received a
number of IDEs which do not easily fit into any of the eight sub-
categories identified in the IA. There have also been several
developments which prompted FDA and CMS to revise their shared
understanding regarding the categorization of IDE devices. These
include the publication of the guidance document entitled,
``Investigational Device Exemptions (IDEs) for Early Feasibility
Medical Device Clinical Studies, Including Certain First in Human (FIH)
Studies; Guidance for Industry and Food and Drug Administration
Staff,'' (Ref. 1) and a subsequent increase in submission of early
feasibility studies to FDA, as well as modifications to CMS's
regulation regarding IDEs (42 CFR 405 Subpart B).
    On December 2, 2015, FDA's CDRH and CMS's Coverage and Analysis
Group (CAG) executed a Memorandum of Understanding (MOU) to streamline
and facilitate the efficient categorization of investigational medical
devices. The MOU became effective as of June 2, 2016. This guidance
document describes the process and information that will be used to
help determine the appropriate category for a device to be studied.
Importantly, the categorization paradigm has shifted from a more rigid
approach to one which allows more flexibility and could be of great
benefit specifically to manufacturers of, and patients receiving,
innovative medical devices. The previous categorization paradigm
included several specific criteria upon which a categorization would be
based. These criteria were tied to information known about other
similar, legally marketed products. The policy has been revised in
order to allow FDA to consider information known about investigational
devices as well, and provide FDA the flexibility to change
categorization as more information regarding a device has been
obtained. Therefore, while an innovative medical device may not be
reimbursable during early-stage clinical trials, information gained
during such studies now can be utilized to potentially help support a
category change, and thus full reimbursement, for the device during
subsequent studies.
    FDA considered comments received on the draft guidance that
appeared in the June 1, 2016, Federal Register notice (81 FR 35032).
FDA revised the guidance as appropriate in response to the comments.
This document supersedes IDE Guidance Memorandum #95-2 ``Implementation
of the FDA/HCFA Interagency Agreement Regarding Reimbursement
Categorization of Investigational Devices'' issued on September 15,
1995.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``FDA Categorization of Investigational
Device Exemption (IDE) Devices to Assist the Centers for Medicare and
Medicaid Services (CMS) with Coverage Decisions.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. A search capability for all CBER guidance documents is
available at: https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Guidance documents
are also available at https://www.regulations.gov. Persons unable to
download an electronic copy of ``FDA Categorization of Investigational
Device Exemption (IDE) Devices to Assist the Centers for Medicare and
Medicaid Services (CMS) with Coverage Decisions; Guidance for Sponsors,
Clinical Investigators, Industry, Institutional Review Boards, and Food
and Drug Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document.
Please

use the document number 1500074 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA and CMS regulations. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 812 have been
approved under OMB control number 0910-0078. The collections of
information in 42 CFR part 405, subpart B have been approved under OMB
control number 0938-1250.

V. Reference

    The following reference is on display in the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
    1. Investigational Device Exemptions (IDEs) for Early Feasibility
Medical Device Clinical Studies, Including Certain First in Human (FIH)
Studies; Guidance for Industry and Food and Drug Administration Staff,
available at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103.

    Dated: November 29, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26195 Filed 12-4-17; 8:45 am]
 BILLING CODE 4164-01-P