[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Notices]
[Pages 72145-72147]
[FR Doc No: 2016-25285]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2016-9284]

Applicability of National Environmental Policy Act (NEPA) to
Federal Aviation Administration (FAA) Review of Airport Wildlife Hazard
Management Plans

AGENCY: Federal Aviation Administration (FAA), DOT

ACTION: Notice and request for comments.

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SUMMARY: The Federal Aviation Administration (FAA) Office of Airports
is clarifying a program guidance letter issued in 2006 concerning how
federal environmental laws apply to FAA approval of a new or updated
airport Wildlife Hazard Management Plan (WHMP). Recent issues and
questions have arisen that make it necessary to update and clarify the
guidance. The clarified policy includes circumstances where the FAA
would approve WHMPs, and delineate which individual measures in a plan
the airport may implement based upon a categorical exclusion without
further environmental review or coordination. In contrast, other
measures might be subject to a higher level of review and interagency
coordination prior to approval. The FAA is publishing this for notice
and comment prior to implementation.

DATES: Written comments must be received on or before November 18,
2016.

ADDRESSES: Send comments identified by docket number FAA-2016-9284
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Mr. Elliott Black, Director, Office of
Airport Planning and Programming. Mailing address: Federal Aviation
Administration, 800 Independence Ave. SW., Washington, DC 20591.
Telephone:<PHONE_NUMBER>. Email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Authority. 49 United States Code (U.S.C.) Sec.  44706 (``Airport
operating certificates) and 14 CFR part 139.337 (``Wildlife Hazard
Management''); and 42 United States Code [U.S.C.] Sec. Sec.  4321-4335
National Environmental Policy Act (NEPA).
    Title 14 CFR part 139 Sec.  139.337 (``Wildlife hazard
management'') requires in part that when the FAA determines that a
wildlife hazard management plan is needed, the certificate holder must
formulate and implement a plan using the wildlife hazard assessment as
a basis. The plan must provide measures to reduce or eliminate wildlife
hazards to air carrier operations, and be submitted to (and approved
by) the FAA prior to implementation.
    In 2006, the FAA's Office of Airports issued Program and Policy
Guidance Letter 92 (``Policy 92'') to address questions about the
applicability of the National Environmental Policy Act (NEPA) to FAA
approval of WHMPs, and the certificate holder's implementation of those
plans.\1\ That policy referred in part to Section 209 of FAA Order
5050.4B, ``National Environmental Policy Act (NEPA) Implementing
Instructions for Airport Actions'' (April 28, 2006), which addressed
the applicability of NEPA to

an approval of a WHMP required under 14 CFR part 139.
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    \1\ Available online at http://www.faa.gov/airports/airport_safety/wildlife/.
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    Recent litigation concerning the snowy owl at an airport in New
York and coordination with federal resource agencies on plan updates
has led to closer scrutiny of some of the language contained in Section
209 of FAA Order 5050.4B. The language may have created some confusion,
because it may appear to some readers to focus on NEPA requirements
primarily in the context of Airport Improvement Program (AIP) grants or
Airport Layout Plan (ALP) approvals. The FAA will similarly explain in
an upcoming revision of Order 5050.4B that NEPA applies to the federal
action of approving the WHMP and that this environmental review is
typically sufficient for any related AIP grant or ALP approvals. The
approval of the WHMPs is considered to involve sufficient discretion
that NEPA (and other federal environmental laws) apply.
    In the meantime, the FAA is proposing to revise the 2006 ``Policy
92'' document (``Applicability of National Environmental Policy Act to
Federal Aviation Administration Mandated Wildlife Hazard Management
Plans'') to clarify the process and procedures. The revised policy
would read as follows:
    Proposed Text of Revised Policy 92. When the FAA requires the
holder of an Airport Operating Certificate to prepare a new or updated
\2\ Wildlife Hazard Management Plan (WHMP), the Certificate Holder must
submit the plan to the FAA for approval before implementation [Sec.
139.337(e)].
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    \2\ For purposes of this FRN, every reference to ``WHMP'' should
be read as ``new or updated WHMP,'' because the same provisions
apply to either circumstance.
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    The FAA's approval of a WHMP is a federal action subject to the
National Environmental Policy Act (NEPA). In addition, WHMPs may
include measures that are subject to related federal actions of airport
layout plan approval and/or federal funding. Section 209 of FAA Order
5050.4B, ``National Environmental Policy Act (NEPA) Implementing
Instructions for Airport Actions'' (April 28, 2006), addressed the
applicability of NEPA to a WHMP required under Part 139. However,
insofar as that section may have been read by some to focus primarily
on airport actions implementing WHMPs that involved AIP grant funding
and/or airport layout plan approval, and to suggest that these actions
were handled distinctly from plan approval for purposes of NEPA, it may
have led to some misunderstanding. NEPA applies to the federal action
of approving WHMPs. This environmental review is typically sufficient
for any related AIP grant or ALP approvals. As a matter of federal or
state law, the certificate holder may also be subject to permitting or
licensing requirements for its actions in implementing discrete WHMP
measures. FAA considers whether there is a reasonable assurance of
obtaining these permits and licenses in reviewing approval of the plan
under NEPA.
    The FAA must consider the existence of extraordinary circumstances
when determining whether to categorically exclude approval of any or
all WHMP measures. In our experience, airport certificate holders will
often be able to implement many, if not all, measures under a WHMP
based upon a categorical exclusion. The measures in most plans qualify
for a categorical exclusion because they are not reasonably expected to
significantly change land use management or cause environmental
impacts. Most of the measures in a WHMP also have independent utility
from other measures because they address different safety concerns.
However, under certain circumstances, an EA or EIS may be required
prior to FAA approval of a WHMP, and/or prior to the certificate
holder's implementation of certain measures within an approved WHMP.
    The effect of this clarification will be to set forth in more
detail how and why the FAA and airport sponsor, consistent with
independent utility and requirements to consider extraordinary
circumstances, may delineate certain measures in the Plan for approval
based upon categorical exclusion while identifying others that trigger
special purpose environmental laws like ESA Section 7 for further
environmental review prior to approval. In other words, the measures in
the plan that do not trigger special purpose laws may be approved by
the FAA, provided they have independent utility and otherwise qualify
for categorical exclusion. The FAA may then conditionally approve the
plan as to the remaining measures pending any further required
environmental review.

Responsibilities and Procedures

     Certificate Holders. The Certificate Holder is responsible
for monitoring wildlife hazards and initiating required coordination
with the FAA early enough to mitigate risks while complying with all
applicable environmental laws and regulations. The Certificate Holder
is responsible for identifying any protected environmental resources
(e.g., threatened and endangered species, wetlands, archeological
sites) on or near the airport. It is the Certificate Holder's
responsibility to contact the appropriate FAA Airports Regional Office
or Airports District Office to provide any information required in
support of the environmental review process for all measures within the
WHMP. The Certificate Holder is responsible for implementing measures
of the WHMP only after they have received the required environmental
approvals, unless an emergency condition compels the Certificate Holder
to take immediate steps in order to protect the safety of air
transportation. In such circumstances, the Certificate Holder must
immediately alert the FAA of the emergency circumstances so that FAA
may follow emergency provisions in applicable environmental laws such
as NEPA and the ESA.\3\ The Certificate Holder is responsible for
compliance with 14 CFR part 139.337 (``Wildlife Hazard Management'') as
well as all applicable Federal, state and local environmental laws and
regulations. For plan components/measures not covered by categorical
exclusions, certain findings and determinations required under special
purpose laws, requirements, regulations, or orders may need to be
completed before FAA can approve them.\4\
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    \3\ FAA's emergency procedures are outlined in section 807 of
FAA Order 1050.1F.
    \4\ FAA Order 1050.1F Desk Reference describes laws,
regulations, and orders in addition to NEPA that must be complied
with before approving a proposed Federal action.
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     Safety Inspectors. The FAA's designated Airport
Certification Safety Inspector (ACSI) must review all WHMPs that are
required for compliance with Sec.  139.337(f). The ACSI must coordinate
approval of the WHMP with the FAA Environmental Protection Specialist
(EPS), and should involve the EPS as early as possible in the process
in order to help identify and address potential environmental issues as
expeditiously as possible. The FAA's approval of new WHMPs and updates
to WHMPs is normally categorically excluded under FAA Order 1050.1F,\5\
paragraph 5-6.2(e),\6\ provided there are no extraordinary
circumstances. If there is evidence of protected environmental
resources (e.g., threatened and endangered species, wetlands,
archeological sites) on or near the airport, an environmental review
associated with the WHMP must address how the implementation of
wildlife control measures might impact these resources, and clearly
identify any

required mitigation measures and associated regulatory/permit
requirements.
    The ACSI will coordinate with the FAA's EPS to determine whether
any measures of the WHMP may require NEPA review beyond a categorical
exclusion, and to ensure compliance with any other applicable
environmental law. Approval letters will indicate which measures are
not yet approved for implementation due to a need for additional FAA
NEPA or special purpose law compliance, which measures are approved
with conditions that the Certificate Holder must satisfy prior to
implementation of the measure, and which measures are approved outright
and ready for implementation.
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    \5\ ``Environmental Impacts: Policies and Procedures'' (dated
July 16, 2015).
    \6\ Previously paragraph 308e in FAA Order 1050.1E.
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     Environmental Protection Specialists (EPS's). The EPS will
coordinate with the ACSI to review all available information to
determine whether FAA may categorically exclude the approval of any or
all of the WHMP measures comprising the WHMP in accordance with
paragraph 5-6.2(e) of FAA Order 1050.1F, or whether any may require
preparation of an Environmental Assessment (EA) or Environmental Impact
Statement (EIS). To avoid segmentation, the FAA's EPS will, as part of
the review of extraordinary circumstances, consider whether any
measures considered for approval under a categorical exclusion are
connected to other measures that may require further environmental
review or interagency coordination. The EPS will provide the ACSI with
language (for inclusion in the letter to the Certificate Holder)
explaining which measures and aspects of the Plan are approved,
approved with conditions (like obtaining a 404 permit) but without
requiring further FAA action, or disapproved or requiring further
environmental analysis or consultation by FAA. The EPS will also advise
the Certificate Holder regarding which agency is responsible for
coordination with the applicable resource agencies.\7\ If there are
additional environmental reviews needed before the Certificate Holder
can implement a specific action, the EPS will help draft conditions
requiring such coordination and completion of the environmental review
before implementation of the action is undertaken by the Certificate
Holder.
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    \7\ The FAA is also reviewing its Policy and Guidance Letter 78
(dated June 21, 2004), which addresses Section 7 consultation with
the U.S. Fish & Wildlife Service (USFWS) under the Endangered
Species Act (ESA). The FAA will either update, revise or rescind
that policy as appropriate after coordination with the USFWS.
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    Certification Status: Certificate Holders should note that,
pursuant to Section 139.337(e), FAA's approval of a WHMP satisfies
their requirements as long as the Certificate Holder implements the
approved provisions and works to obtain approval of the remaining
measures. To the extent there are measures that require additional NEPA
review and/or other interagency coordination, the Certificate Holder
may not implement those measures unless and until the FAA and/or the
appropriate resource agency have reached a favorable environmental
determination. The Certificate Holder must then carry out the approved
measures to remain in compliance with Part 139 certification
requirements. This does not relieve the Certificate Holder of their
responsibility to continue to monitor wildlife hazards and take
relevant and appropriate measures to minimize the risks, to the extent
permissible under the WHMP and all applicable environmental laws and
regulations.
    If the WHMP has no measures that can be implemented immediately,
the Certificate Holder must consider and document interim mitigation
measures, in consultation with the FAA's ACSI and EPS. For example, if
the WHMP calls for certain depredation measures which require approval
by the U.S. Fish & Wildlife Service, then the Certificate Holder may
commit to monitoring wildlife numbers and activities, and seek under
any available emergency provisions to conduct the least invasive
measure in the interim. In extraordinarily rare circumstances, it may
be possible for a Certificate Holder to demonstrate that wildlife
hazards represent such an immediate threat to the safety of the
traveling public that the emergency provisions of NEPA and the
Endangered Species Act offer some latitude for interim action. This
would be rare, however, because the FAA expects Certificate Holders to
monitor wildlife hazards and initiate required coordination early
enough to mitigate risks while complying with all applicable
environmental laws and regulations.
    Applicability to non-139 airports: The FAA encourages all airport
operators to actively monitor and manage wildlife hazards on and near
the airport environs. Other airports (such as those that are
certificated under 14 CFR part 139 but that have not had a triggering
event that would mandate a WHMP, or for airports not certificated under
Part 139) are still encouraged to undertake Wildlife Hazard Assessments
or Wildlife Hazard Site Visits, and to establish and implement WHMPs
when justified.\8\ However, the FAA would not approve such plans, so
unless implementation of the WHMP required a change to the ALP, or
involved federal funding, there would most likely be no Federal action
from the FAA's perspective. Airport owners and operators would have to
comply with all applicable Federal environmental laws and regulations
related to any measures contained within such WHMPs if they have the
potential to impact threatened and endangered species, wetlands,
archeological sites or other protected environmental resources. The FAA
would make its expert wildlife and environmental resources available to
the airport in such circumstances, and may support interagency
coordination if necessary depending upon the proposed measures.
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    \8\ The FAA previously issued a Federal Register notice for
public comment on December 10, 2012 (77 FR 73511). The FRN presented
a clarification of Grant Assurance #19 (Operation and Maintenance),
which would have clarified the expectation for all federally-
obligated airports to conduct Wildlife Hazard Site Visits (WHSVs) or
Wildlife Hazard Assessments (WHAs). Based in part on comments
received in response to that Federal Register notice, the FAA has
decided not to proceed with this clarification at this time.
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    Effective date: Once the FAA has received and reviewed any comments
submitted in response to this Federal Register notice, the FAA will
publish a final revision of Policy 92, which will be effective as of
the date of its publication for any new or updated WHMP that has not
yet been submitted to the FAA for review and approval as of that date.
However, this does not relieve airport Certificate Holders of their
responsibilities for additional permitting and interagency coordination
that may already be required under applicable federal environmental
laws for implementation of certain measures, even if those measures
were submitted as part of a WHMP that was previously approved by the
FAA but not yet implemented.

    Issued in Washington, DC, on October 14, 2016.
Elliott Black,
Director, Office of Airport Planning and Programming.
[FR Doc. 2016-25285 Filed 10-18-16; 8:45 am]
 BILLING CODE 4910-13-P


Table 6. Risk Estimates and Cost of Control Options for Area Sources 1993 NESHAP Option I  LDAR Option II  LDAR + Secondary Controls Estimated Lifetime Cancer Risk 1 220 in 1 million 175 in 1 million 110 in 1 million Non Cancer HQ 1 0.1 0.1 0.1 Capital Cost ($ 1,000,000)  $ 12.4 $ 85.7 Annualized Cost ($ 1,000,000)  ($ 3.5) $ 7.9 Emission Reduction ( tons per year ( tpy))  3,236 5,749 1993 NESHAP No New Co residential Sources Estimated Lifetime Cancer Risk 1 31,000 in 1 million 0 Non Cancer HQ 20 0 Capital Cost ($ 1,000,000)  $ 14.3 Annualized Cost ($ 1,000,000)  $ 1.6 Emission Reduction ( tons per year ( tpy))  97 1 Assumes a facility using a dry to dry machine with a refrigerated condenser emitting 8 tons of PCE per year ( highest known emitting dry to dry machine)

Table 7. Risk Estimates and Cost of Control Options for Co residential Sources 1 Assuming continuous exposure for 70 years at the maximum concentration monitored by New York Department of Health.


[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1747-1749]
[FR Doc No: 2019-01022]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6702]

The Least Burdensome Provisions: Concept and Principles; Guidance
for Industry 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 a final guidance entitled ``The Least Burdensome
Provisions: Concept and Principles.'' FDA utilizes a least burdensome
approach to medical device regulation to eliminate unnecessary burdens
that may delay the marketing of beneficial new products, while
maintaining the statutory requirements for clearance and approval. This
document describes the guiding principles and recommended approach for
FDA staff and industry to facilitate consistent application of least
burdensome principles to the activities pertaining to products meeting
the statutory definition of a device regulated under the Federal Food,
Drug, and Cosmetic Act (FD&C Act).

DATES: The announcement of the guidance is published in the Federal
Register on February 5, 2019.

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-2017-D-6702 for ``The Least Burdensome Provisions: Concept and
Principles; Guidance for Industry 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 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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    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 ``The
Least Burdensome Provisions: Concept and Principles'' 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.
Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Joshua Silverstein, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-
796-5155; 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

    The FD&C Act, as amended by the Food and Drug Administration
Modernization Act of 1997, the FDA Safety and Innovation Act (FDASIA),
and the 21st Century Cures Act (Cures Act), includes least burdensome
provisions that direct FDA to take a least burdensome approach to
medical device evaluation in a manner that eliminates unnecessary
burdens that may delay the marketing of beneficial new products, while
maintaining the statutory requirements for clearance and approval. The
updates to the least burdensome provisions in FDASIA and the Cures Act
clarified the original least burdensome provisions and further
recognized the role of postmarket activities as they relate to
premarket decisions. FDA believes, as a matter of policy, that least
burdensome principles should be consistently and widely applied to all
activities in the premarket and postmarket settings to remove or reduce
unnecessary burdens so that patients can have earlier and continued
access to high quality, safe, and effective devices. This guidance,
therefore, reflects FDA's belief that least burdensome principles
should be applied throughout the medical device total product
lifecycle.
    For the purposes of this guidance, FDA defines ``least burdensome''
as the minimum amount of information necessary to adequately address a
relevant regulatory question or issue through the most efficient manner
at the right time. This guidance describes the least burdensome guiding
principles and recommended approach for FDA staff and industry to
ensure consistent application of least burdensome principles to the
activities pertaining to products meeting the statutory definition of a
device regulated under the FD&C Act.
    FDA considered comments received on the draft guidance that
appeared in the Federal Register of December 15, 2017 (82 FR 59623).
FDA revised the guidance as appropriate in response to the comments.
Among the comments that FDA received were those regarding metrics
assessing the application of least burdensome principles and internal
training on least burdensome principles. FDA issued a Report to
Congress entitled ``Least Burdensome Training Audit'' pursuant to
section 513(j) of the FD&C Act (21 U.S.C. 360c(j)), as added by the
Cures Act.\1\ This report summarizes the mandatory training on least
burdensome requirements for device review staff and supervisors and
outcome of an audit of such training.
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    \1\ FDA Report to Congress, ``Least Burdensome Training Audit,''
June 8, 2018, available at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM610577.pdf.
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    This guidance document replaces the 2002 Least Burdensome Guidance

entitled ``The Least Burdensome Provisions of the FDA Modernization Act
of 1997: Concept and Principles'' (October 4, 2002).

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 ``The Least Burdensome Provisions: Concept
and Principles.'' 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 Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``The Least Burdensome Provisions:
Concept and Principles; Guidance for Industry and Food and Drug
Administration Staff'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1332 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. 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
the following FDA regulations, guidance, form, and statutory provision
have been approved by OMB as listed in the following table:

------------------------------------------------------------------------
    21 CFR part or section;                                 OMB control
 guidance; FDA form; or statute           Topic                 No.
------------------------------------------------------------------------
820............................  Quality System                0910-0073
                                  Regulation.
812............................  Investigational Device        0910-0078
                                  Exemption.
807, subpart E.................  Premarket Notification.       0910-0120
860.123........................  Reclassification              0910-0138
                                  Petition.
814, subparts A through E......  Premarket Approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
806............................  Medical Devices;              0910-0359
                                  Reports of Corrections
                                  and Removals.
803............................  Medical Device                0910-0437
                                  Reporting.
822............................  Postmarket Surveillance       0910-0449
Form FDA 3670..................  Adverse Event Reports/        0910-0471
                                  MedSun Program.
801 and 809....................  Labeling...............       0910-0485
``Recommendations for Clinical   CLIA Waiver............       0910-0598
 Laboratory Improvement
 Amendments of 1988 (CLIA)
 Waiver Applications for
 Manufacturers of In Vitro
 Diagnostic Devices''.
807, subparts A through D......  Registration and              0910-0625
                                  Listing.
807, 812, and 814..............  Human Subject                 0910-0741
                                  Protection; Acceptance
                                  of Data from Clinical
                                  Studies for Medical
                                  Devices.
``Requests for Feedback on       Q-Submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
42 U.S.C. 241..................  Electronic Submission         0910-0769
                                  of Allegations of
                                  Regulatory Misconduct
                                  Associated with
                                  Medical Devices.
830............................  Unique Device                 0910-0720
                                  Identification System.
``De Novo Classification         De Novo Classification        0910-0844
 Process (Evaluation of           Process.
 Automatic Class III
 Designation)''.
------------------------------------------------------------------------

    Dated: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-01022 Filed 2-4-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 202 (Friday, October 18, 2013)]
[Notices]
[Pages 62346-62347]
[FR Doc No: 2013-24484]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER13-1352-000.
    Applicants: Massachusetts Electric Company.
    Description: Refund Report Regarding Interconnection Agreement with
Ameresco Northampton to be effective N/A.
    Filed Date: 10/8/13.
    Accession Number: 20131008-5125.
    Comments Due: 5 p.m. ET 10/29/13.

    Docket Numbers: ER13-2169-000.
    Applicants: Goal Line L.P.
    Description: Supplement to Application for Market-Based Rate
Authorization of Goal Line L.P.
    Filed Date: 10/1/13.

    Accession Number: 20131001-5164.
    Comments Due: 5 p.m. ET 10/22/13.

    Docket Numbers: ER13-2308-000.
    Applicants: Sapphire Power Marketing LLC.
    Description: Supplement to September 3, 2013 Sapphire Power
Marketing LLC tariff filing.
    Filed Date: 10/8/13.
    Accession Number: 20131008-5126.
    Comments Due: 5 p.m. ET 10/22/13.

    Docket Numbers: ER14-55-000.
    Applicants: Arizona Public Service Company.
    Description: Cancellation of Service Agreement No. 315--Boquillas
LGIA to be effective 12/8/2013.
    Filed Date: 10/8/13.
    Accession Number: 20131008-5068.
    Comments Due: 5 p.m. ET 10/29/13.

    Docket Numbers: ER14-56-000.
    Applicants: California Independent System Operator Corporation.
    Description: 2013-10-08--NextEraDesertCenter to be effective 11/1/
2013.
    Filed Date: 10/8/13.
    Accession Number: 20131008-5075.
    Comments Due: 5 p.m. ET 10/29/13.

    Docket Numbers: ER14-57-000.
    Applicants: CES Placerita, Incorporated.
    Description: Amended Change in Status Filing to be effective 9/30/
2013.
    Filed Date: 10/8/13.
    Accession Number: 20131008-5087.
    Comments Due: 5 p.m. ET 10/29/13.

    Docket Numbers: ER14-58-000.
    Applicants: The Potomac Edison Company, PJM Interconnection, L.L.C.
    Description: FirstEnergy and Potomac Edison Co submit PJM Service
Agreement No. 3649 to be effective 10/4/2013.
    Filed Date: 10/8/13.
    Accession Number: 20131008-5098.
    Comments Due: 5 p.m. ET 10/29/13.

    Docket Numbers: ER14-59-000.
    Applicants: The Potomac Edison Company, PJM Interconnection, L.L.C.
    Description: FirstEnergy and Potomac Edison Co submit Service
Agreement No. 3650 to be effective 10/4/2013.
    Filed Date: 10/8/13.
    Accession Number: 20131008-5099.
    Comments Due: 5 p.m. ET 10/29/13.

    Docket Numbers: ER14-60-000.
    Applicants: Southwest Power Pool, Inc.
    Description: 2299R2 Rattlesnake Creek Wind Project, LLC GIA to be
effective 9/26/2013.
    Filed Date: 10/8/13.
    Accession Number: 20131008-5100.
    Comments Due: 5 p.m. ET 10/29/13.

    Docket Numbers: ER14-61-000.
    Applicants: Chestnut Flats Wind, LLC.
    Description: Notice of Cancellation of Market-Based Rate Tariff for
Chestnut Flats Wind to be effective 10/9/2013.
    Filed Date: 10/8/13.
    Accession Number: 20131008-5122.
    Comments Due: 5 p.m. ET 10/29/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 9, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-24484 Filed 10-17-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 18, 2008 (Volume 73, Number 244)]
[Notices]
[Page 77101]
[DOCID:fr18de08-134]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Third Meeting--RTCA Special Committee 217/EUROCAE WG 44--Airport
Mapping Databases

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 217 meeting: Airport Mapping
Databases.

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 217 meeting: Airport Mapping
Databases

DATES: The meeting will be held on January 26-30, 2009, from 9 a.m. to
5 p.m.

ADDRESSES: The meeting will be held at Honeywell, 21111 N. 19th Avenue,
Phoenix, AZ 85036-1111, Contact: Allan Hart, Telephone: Office: 602-
436-1098, Cell:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 805, Washington, DC 20036-5133; telephone<PHONE_NUMBER>; fax
(202) 833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a Special Committee 217 meeting. The agenda will
include:

26 January

     Opening Plenary (Chairmen's remarks and introductions)
     Review and approve meeting agenda
     Review and approval of meeting minutes of previous meeting
     Discussion
     Schedule for this week
     Schedule for next meetings
     Action Items
     Presentations
     Final Review and Comments (FRAC) process

27 January

     Final Review and Comments (FRAC) process

28 January

     Final Review and Comments (FRAC) process
     Begin work on revisions to DO-272, DO-276 and DO-291
     Review new Terms of Reference for application to new work
     Determine need for subgroups
     Presentations as appropriate

29 January

     Work on revisions to DO-272, DO-276, and DO-291

30 January

     Work on revisions to DO-272, DO-276, and DO-291
     Plenary Session
     Summarize action items
     Determine and agree on action plan
     Closing Plenary (Meeting Plans and Dates, Other Business)
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on December 11, 2008.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. E8-30034 Filed 12-17-08; 8:45 am]

BILLING CODE 4910-13-P