[Federal Register Volume 84, Number 223 (Tuesday, November 19, 2019)]
[Proposed Rules]
[Pages 63822-63825]
[FR Doc No: 2019-24993]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0872; Product Identifier 2019-NM-156-AD]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Dassault Aviation Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5,
and 20-F5 airplanes. This proposed AD was prompted by a determination
that new or more restrictive airworthiness limitations are necessary.
This proposed AD would require revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations. The FAA is proposing this AD to
address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by January 3,
2020.

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 https://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 Dassault
Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South
Hackensack, NJ 07606; telephone<PHONE_NUMBER>; internet https://www.dassaultfalcon.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0872; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2019-0872;
Product Identifier 2019-NM-156-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM because of those comments.
    The FAA will post all comments the agency receives, without change,
to https://www.regulations.gov, including any personal information you
provide. The FAA will also post a report summarizing each substantive
verbal contact the agency receives about this NPRM.

Discussion

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2019-0201, dated August 20, 2019 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for Dassault Aviation Model MYSTERE-FALCON
20-C5, 20-D5, 20-E5, and 20-F5 airplanes, on which the Supplemental
Structural Inspection Program (SSIP) (Dassault Service Bulletin 730)
has been embodied into the airplane's maintenance program. You may
examine the MCAI in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0872.
    This proposed AD was prompted by a determination that new or more
restrictive airworthiness limitations relating to safe life limits and
certification maintenance requirements are necessary. The FAA is
proposing this AD to address fatigue cracking, damage, and corrosion in
principal structural elements, which could result in reduced structural
integrity of the airplane. See the MCAI for additional background
information.

Relationship Between Proposed AD and AD 2010-26-05

    This NPRM does not propose to supersede AD 2010-26-05, (Amendment
39-16544 (75 FR 79952, December 21, 2010)) (``AD 2010-26-05''). Rather,
the FAA has determined that a stand-alone AD is more appropriate to
address the changes in the MCAI. This proposed AD would require
revising the existing maintenance or inspection program, as applicable,
to incorporate new or more restrictive airworthiness limitations.
Accomplishment of the proposed actions would then terminate paragraph
(g)(1) of AD 2010-26-05 only for Model MYSTERE FALCON 20-C5, 20-D5, 20-
E5, and 20-F5 airplanes on which the SSIP has been embodied into the
airplane's existing maintenance or inspection program.

Related Service Information Under 1 CFR Part 51

    Dassault Aviation has issued Chapter 5-40-01, Airworthiness
Limitations, of the Dassault Falcon 20 Retrofit 731 Maintenance Manual,
Revision 10, dated January 1, 2019. This service information describes
airworthiness limitations for safe life limits and certification
maintenance requirements. 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

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
and service information referenced above. The FAA is proposing this AD
because the FAA evaluated all the relevant information and determined
the unsafe condition described previously is likely to exist or develop
on other products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would require revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance according to paragraph
(j)(1) of this proposed AD.

Costs of Compliance

    The FAA estimates that this proposed AD affects 57 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD.
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the FAA recognizes that this number may vary from operator to
operator. In the past, the FAA has estimated that this action takes 1
work-hour per airplane. Since operators incorporate maintenance or
inspection program changes for their affected fleet(s), the FAA has
determined that a per-operator estimate is more accurate than a per-
airplane estimate. Therefore, the FAA estimates the total cost per
operator to be $7,650 (90 work-hours x $85 per work-hour).

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.
    The FAA is 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.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes and associated appliances to the
Director of the System Oversight Division.

Regulatory Findings

    The FAA 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) Will not affect intrastate aviation in Alaska, and
    (3) 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):

Dassault Aviation: Docket No. FAA-2019-0872; Product Identifier
2019-NM-156-AD.

(a) Comments Due Date

    The FAA must receive comments by January 3, 2020.

(b) Affected ADs

    This AD affects AD 2010-26-05, Amendment 39-16544 (75 FR 79952,
December 21, 2010) (``AD 2010-26-05'').

(c) Applicability

    This AD applies to Dassault Aviation Model MYSTERE-FALCON 20-C5,
20-D5, 20-E5, and 20-F5 airplanes, certificated in any category, on
which the Supplemental Structural Inspection Program (SSIP)
(Dassault Service Bulletin 730) has been embodied into the
airplane's existing maintenance or inspection program.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address fatigue cracking, damage, and corrosion
in principal structural elements, which could result in reduced
structural integrity of the airplane.

(f) Compliance

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

(g) Maintenance or Inspection Program Revision

    Within 90 days after the effective date of this AD, revise the
existing maintenance or inspection program, as applicable, to
incorporate the information specified in Chapter 5-40-01,
Airworthiness Limitations, of the Dassault Falcon 20 Retrofit 731
Maintenance Manual, Revision 10, dated January 1, 2019. The initial
compliance time for doing the tasks is at the time specified in
Chapter 5-40-01, Airworthiness Limitations, of the Dassault Falcon
20 Retrofit 731 Maintenance Manual, Revision 10, dated January 1,
2019, or within 90 days after the effective date of this AD,
whichever occurs later.

(h) No Alternative Actions or Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) or intervals may be used unless the
actions or intervals are approved as an alternative method of
compliance (AMOC) in accordance with the procedures specified in
paragraph (j)(1) of this AD.

(i) Terminating Action for AD 2010-26-05

    Accomplishing the actions required by this AD terminates the
requirements of paragraph (g)(1) of AD 2010-26-05 only for Model
MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes on which the
SSIP has been embodied into the airplane's existing maintenance or
inspection program.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, 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 International Section, send it to the attention of
the person identified in paragraph (k)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>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 instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Union
Aviation Safety Agency (EASA); or Dassault Aviation's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2019-0201, dated August 20, 2019, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2019-0872.
    (2) For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000,
South Hackensack, NJ 07606; telephone<PHONE_NUMBER>; internet https://www.dassaultfalcon.com. You may view this service information at
the FAA, Transport Standards Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on November 12, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-24993 Filed 11-18-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 68 (Monday, April 9, 2012)]
[Notices]
[Pages 21152-21153]
[FR Doc No: 2012-8460]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2012-0008; Notice 1]

OSRAM SYLVANIA Products Inc., Receipt of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Receipt of Petition.

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SUMMARY: OSRAM SYLVANIA Products, Inc.\1\ (OSRAM) has determined that
certain Type HB2 replaceable light sources, manufactured between
September 25, 2011, and October 8, 2011, do not fully comply with
paragraph S7.7 of Federal Motor Vehicle Safety Standard (FMVSS) No.
108, Lamp, Reflective Devices, and Associated Equipment. OSRAM has
filed an appropriate report dated November 23, 2011 \2\, pursuant to 49
CFR part 573, Defect and Noncompliance Responsibility and Reports.
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    \1\ OSRAM SYLVANIA Products Inc., is a manufacturer of motor
vehicle replacement equipment and is registered under the laws of
the state of Delaware.
    \2\ OSRAM submitted an amended version of the report on January
6, 2012.
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    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule
at 49 CFR part 556), OSRAM submitted a petition for an exemption from
the notification and remedy requirements of 49 U.S.C. Chapter 301 on
the basis that this noncompliance is inconsequential to motor vehicle
safety.
    This notice of receipt of OSRAM's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    Equipment involved: Affected are approximately 40,544 Type HB2
replaceable light sources that were manufactured by OSRAM Sylvania
Products, Inc., between September 25, 2011, and October 8, 2011.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, these provisions
only apply to the subject Type HB2 replaceable light sources that OSRAM
no longer controlled at the time it determined that the noncompliance
existed.
    Noncompliance: OSRAM explains that the noncompliance is due to an
error in the production facility. Certain Type HB2 replaceable light
sources were produced with an incorrect upper beam filament wire which
results in an upper beam luminous flux outside (below) the
specifications as required in paragraph S7.7 of FMVSS No. 108.
    Rule text: Paragraph S7.7 of FMVSS No. 108 requires in pertinent
part:

    S7.7 Each replaceable light source shall be designed to conform
to the dimensions and electrical specifications furnished with
respect to it pursuant to part 564 of this chapter, and shall
conform to the following requirements:* * *

    Summary of OSRAM's Analysis and Arguments:
    OSRAM stated its belief that although the subject Type HB2
replaceable light source may not meet the required luminous flux
specifications the noncompliance is inconsequential to motor vehicle
safety. OSRAM came to this conclusion based on the following results of
testing that it conducted on a large sample of lamps using the subject
noncompliant Type HB2 replaceable light sources:

    (1) In half of the vehicle/lamp applications, the upper beam
photometry specified for HB2 lamps will continue to be met,
    (2) in the remaining applications, the photometry performance falls
just below the specified minimums for HB2 lamps (and in no more than
three, but typically just one or two, test points on a per-measured
headlamp basis), and
    (3) all lamps using the noncompliant bulbs perform at or above the
upper beam photometry requirements of other lamp types, such as HB1 and
HB5, that are currently permitted by FMVSS 108 and in prevalent use on
U.S. roads.
    OSRAM also stated that the issue that caused the subject
noncompliance has been corrected at the production facility and all
products currently being shipped meet the applicable requirements.
    In summation, OSRAM believes that the described noncompliance of
its Type HB2 replaceable light sources to meet the requirements of
FMVSS No. 108 is inconsequential to motor vehicle safety, and that its
petition, to exempt from providing recall notification of noncompliance
as required by 49 U.S.C. 30118 and remedying the recall noncompliance
as required by 49 U.S.C. 30120 should be granted.
    Comments: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited at the beginning of this notice and be
submitted by any of the following methods:
    a. By mail addressed to: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
    b. By hand delivery to U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590. The Docket Section is open on
weekdays from 10 a.m. to 5 p.m. except Federal Holidays.
    c. Electronically: by logging onto the Federal Docket Management
System (FDMS) Web site at http://www.regulations.gov/. Follow the
online instructions for submitting comments. Comments may also be faxed
to 1-202-493-2251.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.

DATES: Comment closing date: May 9, 2012.

    Authority: (49 U.S.C. 30118, 30120: delegations of authority at
CFR 1.50 and 501.8)

    Issued on: April 2, 2012.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2012-8460 Filed 4-6-12; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Notices]
[Pages 67298-67299]
[FR Doc No: 2018-28235]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0197]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Shortages Data Collection System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed reinstatement of an existing collection of information,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on the Shortages Data Collection System for
certain medical devices.

DATES: Submit either electronic or written comments on the collection
of information by February 26, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 26, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2012-N-0197 for ``Shortages Data Collection System.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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.
     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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed reinstatement of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Shortages Data Collection System
OMB Control Number 0910-0491--Reinstatement
    Under section 1003(d)(2) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 393(d)(2)), the Commissioner of Food and
Drugs is authorized to implement general powers (including conducting
research) to carry out effectively the mission of FDA.
    After the events of September 11, 2001, and as part of broader
counterterrorism and emergency preparedness activities, FDA's Center
for Devices and Radiological Health (CDRH) began developing operational
plans and interventions that would enable CDRH to anticipate and
respond to medical device shortages that might arise in the context of
federally declared disasters/emergencies or regulatory actions. In
particular, CDRH identified the need to acquire and maintain detailed
data on domestic inventory, manufacturing capabilities, distribution
plans, and raw material constraints for medical devices that would be
in high demand, and/or would be vulnerable to shortages in specific
disaster/emergency situations or following specific regulatory actions.
Such data could support prospective risk assessment, help inform risk
mitigation strategies, support real-time decision making by the
Department of Health and Human Services during actual emergencies or
emergency preparedness exercises, and mitigate or prevent harm to the
public health.
    The data collection process will consist of an initial telephone
call to firms who have been identified as producing an essential
medical device. In this initial call, the intent and goals of the data
collection effort will be described, and the specific data request
made. Data will be collected, using least burdensome methods, in a
structured manner to answer specific questions. After the initial
outreach, we will request updates to the information on a quarterly
basis to keep the data current and accurate. Additional followup
correspondence may occasionally be needed to verify/validate data,
confirm receipt of followup correspondence(s), and/or request
additional details to further inform FDA's public health response.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Shortages Data Collection.....             500               4           2,000  0.5 (30 minutes)           1,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA based the burden estimates in table 1 on past experience with
direct contact with the medical device manufacturers and anticipated
changes in the medical device manufacturing patterns for the specific
devices being monitored. FDA estimates that approximately 500
manufacturers would be contacted by telephone and/or electronic mail 4
times per year either to obtain primary data or to verify/validate
data. Because the requested data represent data elements that are
monitored or tracked by manufacturers as part of routine inventory
management activities, it is anticipated that for most manufacturers,
the estimated time required of manufacturers to complete the data
request will not exceed 30 minutes per request cycle.
    We adjusted our estimated burden for the information collection to
reflect an increase in the number of submissions over the last few
years. This adjustment results in an increase of 750 hours to the total
burden estimate.

    Dated: December 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-28235 Filed 12-27-18; 8:45 am]
 BILLING CODE 4164-01-P