[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Proposed Rules]
[Pages 46444-46449]
[FR Doc No: 2018-19865]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 807, 812, and 814

[Docket No. FDA-2018-N-0628]
RIN 0910-AH48

Medical Device Submissions: Amending Premarket Regulations That
Require Multiple Copies and Specify Paper Copies To Be Allowed in
Electronic Format

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
proposing to amend requirements for medical device premarket
submissions to remove paper and multiple copies and replace them with
requirements for a single submission in electronic format. If
finalized, this action would reduce the number of copies in electronic
format required, thus improving and making more efficient the FDA's
premarket submission program for medical devices. This action is part
of FDA's implementation of Executive Orders (EOs) 13771 and 13777.
Under these EOs, FDA is comprehensively reviewing existing regulations
to identify opportunities for repeal, replacement, or modification that
will result in meaningful burden reduction while allowing the Agency to
achieve our public health mission and fulfill statutory obligations.

DATES: Submit either electronic or written comments on this proposed
rule by December 12, 2018.

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 December 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 12, 2018. 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-2018-N-0628 for ``Medical Device Submissions: Amending Premarket
Regulations that Require Multiple Copies and Specify Paper Copies to be
Allowed in Electronic Format.'' 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: Diane Garcia, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
II. Background
III. Legal Authority
IV. Description of the Proposed Rule
V. Proposed Effective Date
VI. Economic Analysis of Impacts
 VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination with Indian Tribal Governments
XI. References

I. Executive Summary

    This proposed rule would amend regulations on medical device
premarket submissions to remove requirements for paper and multiple
copies and replace them with requirements for a single submission in
electronic format to improve the FDA's premarket submission program for
medical devices and to create a more efficient submission program.
Because a medical device premarket submission in electronic format is
easily reproducible,

and the requirement for multiple copies, whether in electronic format
or paper form, is no longer necessary, FDA believes it is beneficial to
the public to limit any burden and expense to submitters caused by
requiring additional copies.

II. Background

    On February 24, 2017, E.O. 13777, ``Enforcing the Regulatory Reform
Agenda'' (https://www.gpo.gov/fdsys/pkg/FR-2017-03-01/pdf/2017-04107.pdf, 82 FR 12285 (March 1, 2017)) was issued. One of the
provisions in the E.O. requires Agencies to evaluate existing
regulations and make recommendations to the Agency head regarding their
repeal, replacement, or modification, consistent with applicable law.
As part of this initiative, FDA is updating regulations as specified in
this proposed rule.
    FDA's current medical device regulations that require multiple
copies and paper submissions predate the authority provided to FDA in
the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require
electronic submissions (see 21 CFR parts 807, 812, and 814 and section
745A of the FD&C Act (21 U.S.C. 379k-1)).
    The FD&C Act was amended by the Food and Drug Administration Safety
and Innovation Act (FDASIA) (Pub. L. 112-144) (see section 745A(b) of
the FD&C Act and section 1136 of FDASIA). The amendments in FDASIA
provided that after FDA issued guidance on the submission of electronic
copies (eCopies), the submission of eCopies will be required for
presubmissions and submissions and any supplements to these
presubmissions and submissions for medical devices. (For sections
requiring submission, see sections 510(k), 513(f)(2)(A), 515(c), (d)
and (f), 520(g) and (m), or 564 of the FD&C Act (21 U.S.C. 360(k),
360c(f)(2)(A), 360e(c), (d) and (f), 360j(g) and (m), and 360bbb-3 or
section 351 of the Public Health Service Act (42 U.S.C. 262).) Congress
granted explicit statutory authorization to FDA to implement eCopy
requirements by providing through guidance the standards and criteria
for waivers and exemptions (section 745(b)(1) and (2) of the FD&C Act).
    On January 2, 2013, FDA published the guidance entitled ``eCopy
Program for Medical Device Submissions'' (eCopy guidance). The issuance
of the eCopy guidance marked the beginning of the eCopy program. The
2013 guidance was superseded by an updated guidance of the same title
issued on December 3, 2015. The eCopy guidance recommends that one
paper copy should be submitted, and that any additional copies required
under the regulations be submitted as eCopies. While the eCopy guidance
does not change the overall number of copies required for any
submission, the guidance states that eCopies should be provided in lieu
of some of the paper copies. The guidance also outlines other
requirements for eCopies. The eCopy guidance provides instructions for
the processing and technical standards for eCopies based on FDA's
experience with the program (Ref. 1).
    In 2017, the FD&C Act was amended by the FDA Reauthorization Act of
2017 (FDARA) (Pub. L. 115-52) (see section 745A(b) of the FD&C Act and
section 207 of FDARA). The amended provisions in the FD&C Act require
presubmissions and submissions, any supplements to such presubmissions
or submissions for devices, and any appeals of action taken with
respect to such presubmissions or submissions, including devices under
the Public Health Service Act to be submitted solely in electronic
format as specified by FDA in guidance (section 745A(b)(3) of the FD&C
Act).

III. Legal Authority

    FDA is issuing this proposed rule from the same authority under
which FDA initially issued these regulations: 21 U.S.C. 321, 331, 351,
352, 353, 355, 360, 360h-360j, 360c-360j, 371, 372, 373, 374, 375, 379,
379e, 381, 382, 393; 42 U.S.C. 216, 241, 262, 263b-263n, 264, 271. In
addition, section 745A of the FD&C Act and section 207 of FDARA provide
FDA authority with respect to electronic format for submissions and any
appeals, and section 701(a) of the FD&C Act (21 U.S.C. 371(a)) grants
FDA general rulemaking authority to issue regulations for the efficient
enforcement of the FD&C Act.

IV. Description of the Proposed Rule

    We are proposing to revise FDA's regulations for devices to remove
the requirements for multiple copies of submissions and to instead
require one electronic version. The affected submissions include
premarket notification submissions (510(k) submissions) (21 CFR
807.90), including confidentiality of information certification (21 CFR
807.95); investigational device exemption applications (21 CFR 812.20);
premarket approval applications (PMA) (21 CFR 814.20), including PMA
supplements (21 CFR 814.39); and humanitarian device exemption
applications (21 CFR 814.104). This proposed rule also affects
submissions for Center for Biologics Evaluation and Research (CBER)
regulated devices.
    Another amendment that the proposed rule will make, if finalized,
is to the sections of the regulations that identify FDA's mailing
addresses for submissions. Current regulations include specific mailing
addresses for submissions. If a mailing address needs to be updated,
this necessitates an amendment to the regulations to update that
address. A simpler and more efficient means of providing current
mailing addresses is to create a website that can list current mailing
addresses. Any changes to mailing addresses can be added to the website
without the need for an amendment to the regulations. This proposed
rule will amend the regulations to remove the mailing addresses for
submissions and replace those addresses with a website address for the
Center for Devices and Radiological Health (CDRH) and CBER.
    The submission of an eCopy is separate and distinct from FDA's
electronic submission programs (eSubmitter), which include the
Electronic Submission Gateway (ESG) and CDRH's 510(k) eSubmissions
Pilot Program (79 FR 24732, May 1, 2014). Nevertheless, FDA considers
both to be submissions in electronic format. While eCopy provides for
submissions to be in electronic format, the eCopy submissions must
still be mailed to FDA. By contrast, eSubmitter allows for electronic
submissions to be transmitted over the internet. FDA has been moving
toward transforming all regulatory submissions from mailed copies to
electronic means via the internet. Since January 1999, FDA has accepted
voluntary electronic submissions through eSubmitter. FDA presently
utilizes the ESG for the receipt and processing of many types of
electronic regulatory submissions (Ref. 2). FDA considers eCopies,
submissions copied to a CD, DVD, or flash drive and mailed to FDA, and
eSubmissions, to be submissions in electronic format.
    These changes are intended to improve the efficiency of the review
process by allowing immediate availability of an electronic version for
review, rather than relying solely on the paper version. Because a
submission in electronic format is easily reproducible, the requirement
for multiple copies (whether in electronic format or paper form) is no
longer necessary. Furthermore, FDA believes it is beneficial to the
public to limit any burdens and expenses to submitters caused by
requiring additional copies.
    FDA is proposing to amend current medical device regulations that
require multiple copies and paper submissions

(21 CFR parts 807, 812, and 814). FDA is taking this action because the
requirement for multiple copies (whether in electronic format or paper
form) listed in the regulation is no longer necessary, and it is
beneficial to the public to limit any burden and expense to submitters
caused by requiring additional copies.

V. Proposed Effective Date

    FDA is proposing that any final rule based on this proposal become
effective 30 days after the date of publication of a final rule in the
Federal Register.

VI. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under E.O. 12866,
E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
E.O.s 12866 and 13563 direct us to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). E.O. 13771 requires that
the costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations.'' We believe that this
proposed rule is not a significant regulatory action as defined by E.O.
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the proposed rule amends the existing premarket
regulations requiring multiple copies and paper submissions to
electronic format submissions without imposing any new requirements, we
propose to certify that the proposed rule will not have a significant
economic impact on a substantial number of small entities.
    The Unfunded Mandate's Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $150 million, using the most current (2017) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
    The purpose of this proposed rule is to amend device regulations
requiring that firms submit a specific number of copies with a
premarket presubmission or submission to a single submission in
electronic form. The proposed rule also amends all device regulations
containing references to submission media (i.e., paper copies) to a
submission in electronic form. The amendment will produce cost savings
for firms without imposing any additional regulatory burdens for
submissions. Firms will incur minimal administrative costs to read and
understand the rule. We expect the economic impact of this regulation
to be a total net costs savings yielding positive net benefits.
    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
analysis of economic impacts is available in the docket for this
proposed rule (Ref. 3) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

Summary of Costs and Benefits

    The proposed rule, if finalized, would amend device regulations
requiring the number of copies firms must submit with a premarket
presubmission or submission. The proposed rule would also amend all
device regulations containing a reference to the specific form of a
submission to require an electronic submission. The amendment would
produce cost savings for firms without imposing any additional
regulatory burdens for submissions or affecting the Agency's ability to
review submissions. Firms would incur minimal administrative costs to
read and understand the rule. We expect the economic impact of this
regulation to be a total net costs savings yielding positive net
benefits.
    Table 1 summarizes the benefits, costs, and distributional effects
of the proposed rule. We find that the proposed rule would result in
annualized net benefits in the form of cost savings of around $2.80
million with a 3 percent discount rate and $2.71 million with a 7
percent discount rate.

                                    Table 1--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
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                                                                                Units
             Category                   Primary      Low estimate    High estimate ------------------------------------------------         Notes
                                       estimate                                      Year dollars    Discount rate  Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized....................           $3.37           $1.31           $5.47            2016              7%        10 years  Benefits are cost
                                                                                savings.
    Monetized $millions/year......           $3.37           $1.31           $5.47            2016              3%        10 years  Benefits are cost
                                                                                savings.
    Annualized....................  ..............  ..............  ..............  ..............              7%  ..............  ....................
    Quantified....................  ..............  ..............  ..............  ..............              3%  ..............  ....................
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  ....................
Costs:
    Annualized....................           $0.67           $0.67           $0.67            2016              7%        10 years  ....................
    Monetized $millions/year......           $0.57           $0.57           $0.57            2016              3%        10 years  ....................
    Annualized....................  ..............  ..............  ..............  ..............              7%  ..............  ....................
    Quantified....................  ..............  ..............  ..............  ..............              3%  ..............  ....................
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  ....................
Transfers:
    Federal Annualized............  ..............  ..............  ..............  ..............              7%  ..............  ....................
    Monetized $millions/year......  ..............  ..............  ..............  ..............              3%  ..............  ....................
                                   ---------------------------------------------------------------------------------------------------------------------

    From/To.......................  From:
                                    To:
                                   ---------------------------------------------------------------------------------------------------------------------
    Other Annualized..............  ..............  ..............  ..............  ..............              7%  ..............  ....................
                                   ---------------------------------------------------------------------------------------------------------------------
    Monetized $millions/year......  ..............  ..............  ..............  ..............              3%  ..............  ....................
    From/To.......................  From:
                                    To:
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    Table 2 summarizes the E.O. 13771 impacts of the proposed rule.
Over an infinite time horizon, the present value of the total net costs
would range from $40.01 million to $182.94 million at a 3 percent
discount rate and from $15.04 million to $78.67 million at a 7 percent
discount rate. Over an infinite time horizon, the total annualized net
costs would range from $1.17 million to $5.33 million at a 3 percent
discount rate, and range from $0.98 million to $5.15 million at a 7
percent discount rate. This proposed rule, if finalized, is considered
an Executive Order 13771 deregulatory action.

                        Table 2--Summary of the Executive Order 13771 Impacts of the Proposed Rule Over an Infinite Time Horizon
                                                                    [2016 $ millions]
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                                                              Primary       Lower bound     Upper bound       Primary       Lower bound     Upper bound
                                                           estimate (3%)       (3%)            (3%)        estimate (7%)       (7%)            (7%)
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Present Value of Costs..................................           $5.01           $5.01           $5.01           $5.01           $5.01           $5.01
Present Value of Cost Savings...........................          115.79           45.02          187.95           51.55           20.04           83.68
Present Value of Net Costs..............................        (110.78)         (40.01)        (182.94)         (46.54)         (15.04)         (78.67)
Annualized Costs........................................            0.15            0.15            0.15            0.33            0.33            0.33
Annualized Cost Savings.................................            3.37            1.31            5.47            3.37            1.31            5.47
Annualized Net Costs....................................          (3.23)          (1.17)          (5.33)          (3.04)          (0.98)          (5.15)
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Note: Values in parentheses denote net negative costs (i.e. cost-savings).

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) and 25.34(a) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VIII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information subject to review by the Office of Management
and Budget under the Paperwork Reduction Act of 1995. Rather, it
proposes to remove requirements to submit multiple paper copies of
certain medical device presubmissions and submissions and to replace
them with one copy in an electronic format.

IX. Federalism

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

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in E.O. 13175. We have determined that the rule
does not contain policies that would have a substantial direct effect
on one or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes. The
Agency solicits comments from tribal officials on any potential impact
on Indian Tribes from this proposed action.

XI. References

    The following references are on display at Dockets Management Staff
(see ADDRESSES) and are available for viewing by interested persons
between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. ``eCopy Program for Medical Device Submissions; Guidance for
Industry and Food and Drug Administration Staff'' available at:
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM313794.pdf.
2. Electronic Submission Gateway procedure for electronic regulatory
submission is available at: https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm.
3. Preliminary economic impacts analysis for this proposed rule
available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 807

    Confidential business information, Imports, Medical devices,
Reporting and recordkeeping requirements.

21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, 21 CFR
parts 807, 812, and 814 are proposed to be amended as follows:

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

0
1. The authority citation for part 807 is revised to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.

0
2. In Sec.  807.90, revise paragraph (a), remove and reserve paragraph
(b), and revise paragraph (c).
    The revisions read as follows:

Sec.  807.90   Format of a premarket notification submission.

* * * * *
    (a)(1) For devices regulated by the Center for Devices and
Radiological Health, be addressed to the current address displayed on
the website https://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation
and Research, be addressed to the current address displayed on the
website https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm; or for devices
regulated by the Center for Drug Evaluation and Research, be addressed
to the Central Document Room, Center for Drug Evaluation and Research,
Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD
20705-1266. Information about devices regulated by the Center for
Biologics Evaluation and Research is available at https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/default.htm.
    (3) All inquiries regarding a premarket notification submission
should be sent the address in this section or one of the current
addresses displayed on the Food and Drug Administration's website.
* * * * *
    (c) Be submitted as a single version in electronic format.
* * * * *
0
3. Amend Sec.  807.95 by revising paragraph (b)(1) introductory text to
read as follows:

Sec.  807.95  Confidentiality of information.

* * * * *
    (b) * * *
    (1) The person submitting the premarket notification submission
requests in the submission that the Food and Drug Administration hold
as confidential commercial information the intent to market the device
and submits a certification to the Commissioner:
* * * * *

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

0
4. The authority citation for part 812 is revised to read as follows:

    Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42 U.S.C.
216, 241, 262, 263b-263n.

0
5. Amend Sec.  812.19 by revising paragraphs (a)(1) and (2) to read as
follows:

Sec.  812.19  Addresses for IDE correspondence.

    (a) * * *
    (1) For devices regulated by the Center for Devices and
Radiological Health, send it to the current address displayed on the
website https://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation
and Research, send it to the current address displayed on the website
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
* * * * *
0
6. Amend Sec.  812.20 by revising paragraph (a)(3) to read as follows:

Sec.  812.20  Application.

    (a) * * *
    (3) A sponsor shall submit a signed ``Application for an
Investigational Device Exemption'' (IDE application), together with
accompanying materials in electronic format, to one of the addresses in
Sec.  812.19, and if eCopy by registered mail or by hand. Subsequent
correspondence concerning an application or a supplemental application
shall be submitted in electronic format and if eCopy by registered mail
or by hand.
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
7. The authority citation for part 814 is revised to read as follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360bbb-8b, 360c-360j,
371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.

0
8. Amend Sec.  814.20 by:
0
a. Revising paragraph (b) introductory text and paragraph (b)(2);
0
b. Removing the phrase ``of the act'' and adding in its place ``of the
Federal Food, Drug, and Cosmetic Act'' in paragraphs (b)(5)
introductory text, (b)(5)(i), and (b)(10);
0
c. Revising paragraph (c);
0
d. Revising paragraph (e) introductory text; and
0
e. Revising paragraphs (f) and (h)(1) and (2).
    The revisions read as follows:

Sec.  814.20  Application.

* * * * *
    (b) Unless the applicant justifies an omission in accordance with
paragraph (d) of this section, a PMA shall include in electronic
format:
* * * * *
    (2) A table of contents that specifies the volume and page number
for each item referred to in the table. A PMA shall include separate
sections on nonclinical laboratory studies and on clinical
investigations involving human subjects. A PMA shall be submitted as a
single version. The applicant shall include information that it
believes to be trade secret or confidential commercial or financial
information in the PMA and identify the information that it believes to
be trade secret or confidential commercial or financial information.
* * * * *
    (c) Pertinent information in FDA files specifically referred to by
an applicant may be incorporated into a PMA by reference. Information
in a master file or other information submitted to FDA by a person
other than the applicant will not be considered part of a PMA unless
such reference is authorized in a record submitted to FDA by the person
who submitted the information or the master file. If a master file is
not referenced within 5 years after the date that it is submitted to
FDA, FDA will return the master file to the person who submitted it.
* * * * *
    (e) The applicant shall periodically update its pending application
with

new safety and effectiveness information learned about the device from
ongoing or completed studies that may reasonably affect an evaluation
of the safety or effectiveness of the device or that may reasonably
affect the statement of contraindications, warnings, precautions, and
adverse reactions in the draft labeling. The update report shall be
consistent with the data reporting provisions of the protocol. The
applicant shall submit any update report in electronic format and shall
include in the report the number assigned by FDA to the PMA. These
updates are considered to be amendments to the PMA. The time frame for
review of a PMA will not be extended due to the submission of an update
report unless the update is a major amendment under Sec.  814.37(c)(1).
The applicant shall submit these reports--
* * * * *
    (f) If a color additive subject to section 721 of the Federal Food,
Drug, and Cosmetic Act is used in or on the device and has not
previously been listed for such use, then, in lieu of submitting a
color additive petition under part 71 of this chapter, at the option of
the applicant, the information required to be submitted under part 71
may be submitted as part of the PMA. When submitted as part of the PMA,
the information shall be submitted in electronic format. A PMA for a
device that contains a color additive that is subject to section 721 of
the Federal Food, Drug, and Cosmetic Act will not be approved until the
color additive is listed for use in or on the device.
* * * * *
    (h) * * *
    (1) For devices regulated by the Center for Devices and
Radiological Health, send it to the current address displayed on the
website http://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation
and Research, send it to the current address displayed on the website
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
* * * * *
0
9. Amend Sec.  814.39 by revising paragraph (c)(1) to read as follows:

Sec.  814.39  PMA supplements.

* * * * *
    (c)(1) All procedures and actions that apply to an application
under Sec.  814.20 also apply to PMA supplements except that the
information required in a supplement is limited to that needed to
support the change. A summary under Sec.  814.20(b)(3) is required for
only a supplement submitted for new indications for use of the device,
significant changes in the performance or design specifications,
circuits, components, ingredients, principles of operation, or physical
layout of the device, or when otherwise required by FDA. The applicant
shall submit a PMA supplement in electronic format and shall include
information relevant to the proposed changes in the device. A PMA
supplement shall include a separate section that identifies each change
for which approval is being requested and explains the reason for each
such change. The applicant shall submit additional information, if
requested by FDA, in electronic format. The time frames for review of,
and FDA action on, a PMA supplement are the same as those provided in
Sec.  814.40 for a PMA.
* * * * *
0
10. Amend Sec.  814.104 by revising paragraphs (d) introductory text
and (d)(1) and (2) to read as follows:

Sec.  814.104  Original applications.

* * * * *
    (d) Address for submissions and correspondence. All original HDEs,
amendments and supplements, as well as any correspondence relating to
an HDE, must be provided in electronic format. These materials must be
sent or delivered to one of the following:
    (1) For devices regulated by the Center for Devices and
Radiological Health, send it to the current address found on the
website https://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation
and Research, send it to the current address displayed on the website
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
* * * * *

    Dated: September 7, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2018-19865 Filed 9-12-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Notices]
[Pages 34858-34859]
[FR Doc No: 2018-15710]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4357-DR; Docket ID FEMA-2017-0001]

American Samoa; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster for the
territory of American Samoa (FEMA-4357-DR),

dated March 2, 2018, and related determinations.

DATES: This amendment was issued June 28, 2018.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated June 28, 2018, the President amended the cost-sharing
arrangements regarding Federal funds provided under the authority of
the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (the ``Stafford Act''), in a letter to Brock Long,
Administrator, Federal Emergency Management Agency, Department of
Homeland Security, under Executive Order 12148, as follows:

    I have determined that the damage in the territory of American
Samoa resulting from Tropical Storm Gita during the period of
February 7 to 12, 2018, is of sufficient severity and magnitude that
special cost-sharing arrangements are warranted regarding Federal
funds provided under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act'').
    Therefore, I amend my declaration of March 2, 2018, to authorize
Federal funds for all categories of Public Assistance, Hazard
Mitigation, and Other Needs Assistance under Section 408 of the
Stafford Act at 90 percent of total eligible costs.

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

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-15710 Filed 7-20-18; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Rules and Regulations]
[Pages 4149-4151]
[FR Doc No: 2017-00287]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-8557; Airspace Docket No. 16-AGL-17]

Amendment of Class E Airspace for the Following Wisconsin Towns;
Antigo, WI; Ashland, WI; Black River Falls, WI; Cable Union, WI;
Cumberland, WI; Eagle River, WI; Hayward, WI; and Wausau, WI; and
Revocation of Class E Airspace; Wausau, WI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies Class E airspace extending upward from
700 feet above the surface at Langlade County Airport, Antigo, WI; John
F. Kennedy Memorial Airport, Ashland, WI; Black River Falls Area
Airport, Black River Falls, WI; Cable Union Airport, Cable Union, WI;
Cumberland Municipal Airport, Cumberland, WI; Eagle River Union
Airport, Eagle River, WI; Sawyer County Airport, Hayward, WI; and
Wausau Downtown Airport, Wausau, WI. Decommissioning of non-directional
radio beacon (NDB), cancellation of NDB approaches, and implementation
of area navigation (RNAV) procedures have made this action necessary
for the safety and management of Instrument Flight Rules (IFR)
operations at the above airports. This action also removes Class E
surface area airspace at Wausau Municipal Airport (Wausau Downtown
Airport), Wausau, WI, as a review has determined that the airport no
longer meets the requirements for this airspace. Additionally, the
geographic coordinates at Langlade County Airport, John F. Kennedy
Memorial Airport, Cumberland Municipal Airport, Eagle River Union
Airport, and Wausau Downtown Airport (formerly Wausau Municipal
Airport) are adjusted to coincide with the FAA's aeronautical database.

DATES: Effective 0901 UTC, April 27, 2017. The Director of the Federal
Register approves this incorporation by reference action under Title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11A, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone:<PHONE_NUMBER>.
The Order is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E airspace extending upward from 700 feet above the
surface at Langlade County Airport, Antigo, WI; John F. Kennedy
Memorial Airport, Ashland, WI; Black River Falls Area Airport, Black
River Falls, WI; Cable Union Airport, Cable Union, WI; Cumberland
Municipal Airport, Cumberland, WI; Eagle River Union Airport, Eagle
River, WI; Sawyer County Airport, Hayward, WI; and Wausau Downtown
Airport, Wausau, WI; and removes Class E surface area airspace at
Wausau Downtown Airport (formerly Wausau Municipal Airport), Wausau,
WI.

History

    On August 11, 2016, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM), (81 FR 53093) Docket No. FAA-
2016-8557, to modify Class E airspace extending upward from 700 feet
above the surface at Langlade County Airport, Antigo, WI; John F.
Kennedy Memorial Airport, Ashland, WI; Black River Falls Area Airport,
Black River Falls, WI; Cable Union Airport, Cable Union, WI; Cumberland
Municipal Airport, Cumberland, WI; Eagle River Union Airport, Eagle
River, WI; Sawyer County Airport, Hayward, WI; and Wausau Downtown
Airport, Wausau, WI, and to remove Class E surface area airspace at
Wausau Municipal Airport (Wausau Downtown Airport), Wausau, WI.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class E airspace designations are published in paragraph 6002 and
6005, respectively, of FAA Order 7400.11A, dated August 3, 2016, and
effective September 15, 2016, which is incorporated by reference in 14
CFR part 71.1. The Class E airspace designation listed in this document
will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11A, Airspace Designations and
Reporting Points, dated August 3, 2016, and effective September 15,
2016. FAA Order 7400.11A is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11A lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 modifies Class E airspace extending upward from 700 feet above
the surface at the following airports:
    Within a 6.5-mile radius (increasing from the previous 6.4-mile
radius) of Langlade County Airport, Antigo, WI, removing the extension
to the north of the airport, and updating the geographic coordinates of
the airport to coincide with the FAA's aeronautical database;
    Within a 7.0-mile radius (increasing from the previous 6.5-mile
radius) of John F. Kennedy Memorial Airport, Ashland, WI, with an
extension southwest of the airport from the 7.0-mile radius to 8.2
miles, removing extensions to the southwest and southeast of the
airport, and updating the geographic coordinates of the airport to
coincide with the FAA's aeronautical database;
    Within a 7.1-mile radius (increasing from the previous 6.4-mile
radius) of Black River Falls Area Airport, Black River Falls, WI, with
an extension southwest of the airport from the 7.1-mile radius to 11.7
miles, with an extension northeast of the airport from the 7.1-mile
radius to 11.4 miles;
    Within a 6.9-mile radius (increasing from the previous 6.4-mile
radius) of Cable Union Airport, Cable Union, WI, and removing the
extension to the southwest of the airport;
    Within a 6.4-mile radius of Cumberland Municipal Airport,
Cumberland, WI, with extensions from the 6.4-mile radius to 10.2 miles
west and east; and updating the geographic coordinates of the airport
to coincide with the FAA's aeronautical database;
    Within a 6.5-mile radius (reducing from the previous 6.6-mile
radius) of Eagle River Union Airport, Eagle River, WI, with an
extension southwest of the airport from the 6.5-mile radius to 9.2
miles, and updating the geographic coordinates of the airport to
coincide with the FAA's aeronautical database;
    Within a 6.6-mile radius (increasing from the previous 6.5-mile
radius) of Sawyer County Airport, Hayward, WI, with an extension
northeast of the airport from the 6.6-mile radius to 8.5 miles;
    And within a 6.8-mile radius (increasing from the previous 6.5-mile
radius) of Wausau Downtown Airport, Wausau, WI, and updating the name
and geographic coordinates of the airport to coincide with the FAA's
aeronautical database.
    The Class E airspace designated as a surface area at Wausau
Municipal Airport, Wausau, WI, is removed as the airport no longer
meets the requirements for this airspace.
    These airspace reconfigurations are necessary due to the
decommissioning of NDBs, cancellation of NDB approaches, or
implementation of RNAV standard instrument procedures at these
airports. Controlled airspace is necessary for the safety and
management of standard instrument approach procedures for IFR
operations at these airports.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 6002 Class E Airspace Designated as Surface Areas.

* * * * *

AGL WI E2 Wausau, WI [Removed]

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL WI E5 Antigo, WI [Amended]

Langlade County Airport, WI
    (Lat. 45[deg]09'14'' N., long. 89[deg]06'38'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Langlade County Airport.

AGL WI E5 Ashland, WI [Amended]

John F. Kennedy Memorial Airport, WI
    (Lat. 46[deg]32'55'' N., long. 90[deg]55'08'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.0-mile radius of John F. Kennedy Memorial Airport, and
within 2.9 miles each side of the 201[deg] bearing from the airport
extending from the 7.0-mile radius to 8.2 miles southwest of the
airport.
* * * * *

AGL WI E5 Black River Falls, WI [Amended]

Black River Falls Area Airport, WI
    (Lat. 44[deg]15'03'' N., long. 90[deg]51'19'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.1-mile radius of Black River Falls Area Airport, and
within 2 miles each side of the 081[deg] bearing from the airport
extending from the 7.1-mile radius to 11.4 miles east of the
airport, and within 2 miles each side of the 260[deg] bearing from
the airport extending from the 7.1-mile radius to 11.7 miles west of
the airport.
* * * * *

AGL WI E5 Cable Union, WI [Amended]

Cable Union Airport, WI
    (Lat. 46[deg]11'42'' N., long. 91[deg]14'54'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.9-mile radius of Cable Union Airport.
* * * * *

AGL WI E5 Cumberland, WI [Amended]

Cumberland Municipal Airport, WI
    (Lat. 45[deg]30'22'' N., long. 91[deg]58'51'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Cumberland Municipal Airport, and within
2 miles each side of the 091[deg] bearing from the airport extending
from the 6.4-mile radius to 10.2 miles east of the airport, and

within 2 miles each side of the 270[deg] bearing from the airport
extending from the 6.4-mile radius to 10.2 miles west of the
airport.
* * * * *

AGL WI E5 Eagle River, WI [Amended]

Eagle River Union Airport, WI
    (Lat. 45[deg]55'56'' N., long. 89[deg]16'06'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Eagle River Union Airport, and within 2
miles each side of the 225[deg] bearing from the airport extending
from the 6.5-mile radius to 9.2 miles southwest of the airport.
* * * * *

AGL WI E5 Hayward, WI [Amended]

Sawyer County Airport, WI
    (Lat. 46[deg]01'31'' N., long. 91[deg]26'39'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Sawyer County Airport, and within 2
miles each side of the 025[deg] bearing from the airport extending
from the 6.6-mile radius to 8.5 miles northeast of the airport.
* * * * *

AGL WI E5 Wausau, WI [Amended]

Wausau Downtown Airport, WI
    (Lat. 44[deg]55'35'' N., long. 89[deg]37'37'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.8-mile radius of Wausau Downtown Airport.

    Issued in Fort Worth, Texas, on December 28, 2016.
Thomas L. Lattimer,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-00287 Filed 1-12-17; 8:45 am]
 BILLING CODE 4910-13-P


EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 1 EPA National Community Recognition Program Validation of Beta Application Thank you very much for contributing your expertise and time to assist the EPA in creating this national recognition program for communities who are creating smart growth initiatives that also specifically enhance the health and well being of older Americans.

The purpose of the beta testing process is to establish content validity of the project questions and gather feedback for question revision through rankings by content area experts in smart growth and active aging, local/ county/ state officials, and others representing potential applicants to the recognition program. We also want to assess the ease of completing the on line instrument.

Instructions:

Please read the introductory section containing the definitions of the smart growth and active aging/ physical activity programming of interest, and the descriptions of the process and program levels. Applicants will also be asked to acknowledge their review of accompanying documents regarding specific components of smart growth policy, and the participation of a local aging services official in completion of the recognition program application.

Read each statement beginning on page 3 for items 1A through 5D and rate each on a scale of 1  10 as to how well it reflects the content described in the process and program definitions provided below. YOU DO NOT HAVE TO COMPLETE THE INFORMATION ABOUT THE PROGRAM ITSELF, ONLY THE SECTION REGARDING HOW WELL THE ITEM ASSESSES THE CONTENT REGARDING SMART GROWTH ( SG) and/ or PHYSICAL ACTIVITY ( PA). WE WANT TO DETERMINE IF THE ITEM IS CLEAR AND UNDERSTANDABLE TO YOU. Questions for you to complete are in red and bold type. Regardless of your rating, we encourage you to suggest any revision that would clarify the content of the item.

Introduction Definitions:

* Smart Growth ( SG): Smart Growth is defined as community development that serves the environment, community, economy, and public health. The principles of smart growth include: 1) Mixed use zoning; 2) Take advantage of compact building design; 3) Create a range of housing opportunities and choices; 4) Create walkable neighborhoods with access to healthy choices; 5) Foster distinctive, attractive neighborhoods with a sense of place; 6) Preserve open space, farmland, natural beauty, and critical resources; 7) Strengthen and direct development towards existing communities; 8) Provide connectivity through a variety of transportation choices; 9) Make development decisions predictable, fair, and cost effective; 10) Encourage community stakeholders collaboration in development decisions.

To be completed by applicant:

I have reviewed the accompanying policy and activity components that are integral to the smart growth principles above, and understand that they should form the basis for our community's responses to the application items for the Smart Growth and Active. Aging National Recognition Program. EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 2 * Active Aging/ Physical Activity ( PA): includes planning and implementing a variety of widely accessible programs and/ or self directed opportunities for those 60+ and which emphasize activities that increase endurance, strength, flexibility, balance, and the principles of injury prevention. These types of activities include walking, biking, fitness trails and similar activities/ programs at various levels of intensity to fit the capacities of participants in an location that is safe from injuries from humans and the environment. * This section will include additional resource links * Community assessment or survey: can include formal needs assessment or community survey or discussion of community needs with service providers with smart growth or active aging/ physical activity programming or opportunities in the community. It is important for this survey to include a diverse group of individuals, including racial/ ethnic diversity as well as economic diversity. * This section will include additional resource links * Denotes information link to definitions, examples, weblinks, etc Description of process and program levels:

Process I: Awareness of and general commitment to basic smart growth principles and active aging/ physical activity programs and opportunities.

Process II: Awareness of smart growth and active aging/ physical activity principles, applications and implementation strategies formulated with attention to linking smart growth and active aging/ physical activity programs and opportunities in the community.

Process III: Well established processes combining smart growth and active aging with coherent framework and broad smart growth and aging network community participation. Well conceived and funded strategic attention to smart growth principles and active aging programs and opportunities; ability to mentor or serve as model for other communities. Processes are scalable, sustainable, and sharable. Should measurable be added here as well?

Program I: Actively engaged in formulating pilot programs and activities combining smart growth and active aging.

Program II: Established/ expanding programs combining smart growth and active aging; engagement of broader segments of the community in program activity; active promotion of the program on a community basis. Strong focus on community education/ awareness?

Program III: EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 3 Ongoing/ expanding programs on a wide community basis that are effectively applying principles of smart growth and active aging; wide community involvement of multiple sectors within the community; program funding sources established; ability to mentor or serve as a model program for other communities. Programs are scalable, sustainable, measurable and sharable.

BETA Items Level1 1 A: SG Process I: Our community has defined goals or a mission for advancing or applying * smart growth principles in relation to the aging population.

Not at all

Just starting

Partially completed

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Process I:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: ___ 5___ Suggestions for revision: See edits in question   this question only addresses smart growth, not in relation to aging; however the process seems to be targeting aging as well  not sure if this is where you are going?

1 B: SG Process I: Our community has conducted a * community assessment, survey or other planning activity for applying * smart growth principles.

Not at all

Just starting

Partially completed

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Process I:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 4 Your Score: __ 5____ Suggestions for revision: Once again, is this supposed to focus on aging as well as smart growth ( there is no reference to aging in the smart growth definition).

1 C: PA Process I: Our community has defined goals or a mission for increasing older adult participation in * active aging/ physical activity.

Not at all

Just starting

Partially completed

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Process I:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: __ 10____ Suggestions for revision: This addresses aging   good.

1 D: PA: Process I: Our community has conducted a * community assessment or survey, or reviewed information/ data for increasing older adult participation in active aging/ physical activity.

Not at all

Just starting

Partially completed

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Process I:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: _ 10_____ EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 5 Suggestions for revision:

Level 2 2 A: SG: Process II: Our community's strategic development plan includes aspects of feasibility, cost, impact, time frame and leadership for applying smart growth principles.

Not at all

Just starting

Partially completed

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Process II:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: __ 5____ Suggestions for revision: Not sure if this needs to have aging in here?

2 B: SG: Process II: Our community is actively engaged in formulating plans and strategies for specifically linking smart growth initiatives with programs, amenities or opportunities that include active aging/ physical activity for older adults

Not at all

Just starting

Partially completed

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Process II:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: _ 10_____ Suggestions for revision: EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 6 2 C: PA: Process II: Our community has a broad based planning process that includes feasibility, cost, impact, time frame and leadership for creating/ promoting active aging/ physical activity for aging adults.

Not at all

Just starting

Partially complete

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Process II:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: __ 10____ Suggestions for revision: Only other suggestion would be that the planning process is mandated   this would truly evaluate the consistency of the consideration of these principles.

2 D: PA: Process II: Our community has established interagency committees, task forces, or other community partnerships with local aging organizations, service providers, and agencies as a means of coordinating activities and programs with smart growth and active aging/ physical activity components.

Not at all

Just starting

Partially complete

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Process II:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: _ 10_____ Suggestions for revision: EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 7 Level 3 3 A: SG & PA: Process III: Our community's comprehensive planning integrates smart growth principles and promotes application of these to encompass active aging/ physical activity programs and opportunities for older adults.

Not at all

Just starting

Partially complete

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Process III:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: __ 10____ Suggestions for revision:

3 B: SG: Program I: Our community has legislative, zoning, comprehensive plan initiatives and other policies in place or in consideration that include provision for both smart growth and active aging/ physical activity programs or opportunities for older adults.

Not at all

Just starting

Partially complete

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Program I:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: ____ 10__ Suggestions for revision: This is a critical question   good! EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 8 3 C: PA: Program I: Our community has created pilot programs, or has existing programs for active aging/ physical activity for older adults which take advantage of the resources and environments created by local smart growth activities such as safe walking area, biking amenities, age sensitive exercise trails, safe parks, etc. * This section will include additional resource links

Not at all

Just starting

Partially complete

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Program I:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: _ 10_____ Suggestions for revision:

Level 4 4 A: SG: Program II: Our community is increasing its capacity through budget allocation, staff resources, infrastructure improvement, etc. for systematically expanding existing initiatives that combine smart growth principles and planning and active aging/ physical activity programs and opportunities.

Not at all

Just starting

Partially complete

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Program II:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: _ 10_____ Suggestions for revision: EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 9 4 B: SG: Program II: Our community is reaching out to local/ county/ state officials and departments, land developers, community organizations, and public health experts to expand the integration of smart growth and active aging/ physical activity programs.

Not at all

Just starting

Partially complete

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Program II:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: ___ 9___ Suggestions for revision: I added public health experts, as they can provide valuable feedback regarding this process w. r. t. death/ injury statistics, health needs of aging population.

4 C: PA: Program II: Our community includes gathering evidence about and evaluating the effectiveness of and level of participation in our active aging/ physical activity programs and opportunities for older adults.

Not at all

Just starting

Partially complete

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Program II:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: __ 10____ Suggestions for revision: EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 10 4 D: PA: Program II: Our community has an initiative that includes promotion, advertising, recruitment, and widely available programs and opportunities to engage more older adults in active aging/ physical activity.

Not at all

Just starting

Partially completed

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Program II:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: _ 10_____ Suggestions for revision: GOOD!!!

Level 5 5 A: SG: Program/ Process III: Our community has already implemented, or has the capacity to implement a model program combining smart growth principles with programs emphasizing active aging/ physical activity for older adults.

Not at all

Just starting

Partially completed

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Program/ Process III:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: _ 10_____ Suggestions for revision:

5 B: SG: Program/ Process III: EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 11 Our community has a well established smart growth initiative and active aging/ physical activity programs and opportunities and is planning to expand these to a wider segment of our population as well as the partnerships that will support these programs.

Not at all

Just starting

Partially completed

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Program/ Process III:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: ___ 10___

Suggestions for revision:

5 C: PA: Program/ Process III: Our community has an established coalition of service providers, advocacy organizations, businesses and governmental agencies who are cooperating to create more innovative and widely available programs that integrate smart growth principles and active aging/ physical activity programs and opportunities.

Not at all

Just starting

Partially completed

Fully Completed

Ongoing Describe Activity:

> How well does this item assess the content for Program/ Process III:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: 10______ Suggestions for revision:

5 D: PA: Program/ Process III: EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 12 Our community has an existing model program integrating active aging/ physical activity and smart growth for older adults and we can provide technical assistance and a contact person to share information with other communities.

Not at all

Just starting

Partially completed

Fully Completed

Ongoing Please describe your program/ initiative below or attach additional information:

Contact Person for program/ initiative described above: Name:_____________________________________________ Title:______________________________________________ Organization:_______________________________________ Address:___________________________________________ ____________________________________________ City:________________________________ State:_____ Zip:__________ Phone:___________________ Fax:_________________ Email:__________________________________________

> How well does this item assess the content for Program/ Process III:

1 2 3 4 5 6 7 8 9 10 Not at all Adequately Very Well Your Score: __ 7___ Suggestions for revision: I recommend asking how they know that it is effective/ a model so that it can encourage other communities to use it. It can be difficult to encourage others to use a program without measurables.

BETA TEST RESPONDENTS: PLEASE COMPLETE THE QUESTIONS BELOW:

> How was the process of completing this document for you and/ or your staff? EPA Smart Growth & Active Aging National Recognition Program DCTM_ ARP. doc 13 1 2 3 4 5 6 7 8 9 10 Easy Somewhat Difficult Difficult If you rated this process with a score of 6   10, please suggest how we might make this questionnaire easier to complete:

> Approximately how long did it take to complete this? _____ hrs. __ 30___ min.

> Would you recommend applying for this recognition program to other communities? X ___ Yes ___ No Applicant completing this beta test form:

Name: _____ Monica Buhlig___________________________________

Title: ______ Program Administrator__________________________________

Organization: _________ Denver Environmental Health ______________________________

Address: ________ 201 West Colfax Ave, Dept 1009 ___________________________________ ___________________________________________

City: _____________ Denver____________ State:__ CO_ Zip:__ 802020____

Phone: _ 702 865 5407____ Fax:_________________

Email: __ monica. buhlig@ ci. denver. co. us__________________________

Thank you for you assistance. Please return the completed MSWord document to Dr. John Migliaccio at drjohnmig@ aol. com or hardcopy by mail to Maturity Mark Services Co., 55 Springdale Ave., White Plains, NY 10604 2309 ( 914) 684 9112.


[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Rules and Regulations]
[Pages 10650-10651]
[FR Doc No: 2012-4146]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 381

[Docket No. RM12-5-000]

Annual Update of Filing Fees

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Final rule; annual update of Commission filing fees.

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

SUMMARY: In accordance with its regulations, the Commission issues this
update of its filing fees. This notice provides the yearly update using
data in the Commission's Management, Administrative, and Payroll System
to calculate the new fees. The purpose of updating is to adjust the
fees on the basis of the Commission's costs for Fiscal Year 2011.

DATES: Effective Date: March 26, 2012.

FOR FURTHER INFORMATION CONTACT: Raymond D. Johnson Jr., Office of the
Executive Director, Federal Energy Regulatory Commission, 888 First
Street NE., Room 42-66, Washington, DC 20426,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Document Availability: In addition to publishing the full text of
this document in the Federal Register, the Commission provides all
interested persons an opportunity to view and/or print the contents of
this document via the Internet through FERC's Home Page (http://www.ferc.gov) and in FERC's Public Reference Room during normal
business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street
NE., Room 2A, Washington, DC 20426.
    From FERC's Web site on the Internet, this information is available
in the eLibrary (formerly FERRIS). The full text of this document is
available on eLibrary in PDF and Microsoft Word format for viewing,
printing, and/or downloading. To access this document in eLibrary, type
the docket number excluding the last three digits of this document in
the docket number field and follow other directions on the search page.
    User assistance is available for eLibrary and other aspects of
FERC's Web site during normal business hours. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll free at (866)
208-3676, or for TTY, contact<PHONE_NUMBER>.

Annual Update of Filing Fees

    The Federal Energy Regulatory Commission (Commission) is issuing
this notice to update filing fees that the Commission assesses for
specific services and benefits provided to identifiable beneficiaries.
Pursuant to 18 CFR 381.104, the Commission is establishing updated fees
on the basis of the Commission's Fiscal Year 2011 costs. The adjusted
fees announced in this notice are effective March 26, 2012. The
Commission has determined, with the concurrence of the Administrator of
the Office of Information and Regulatory Affairs of the Office of
Management and Budget, that this final rule is not a major rule within
the meaning of section 251 of Subtitle E of Small Business Regulatory
Enforcement Fairness Act, 5 U.S.C. 804(2). The Commission is submitting
this final rule to both houses of the United States Congress and to the
Comptroller General of the United States.
    The new fee schedule is as follows:

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

------------------------------------------------------------------------
              Fees Applicable to the Natural Gas Policy Act
------------------------------------------------------------------------
1. Petitions for rate approval pursuant to 18 CFR                $12,370
 284.123(b)(2). (18 CFR 381.403)........................
------------------------------------------------------------------------
                  Fees Applicable to General Activities
------------------------------------------------------------------------
1. Petition for issuance of a declaratory order (except           24,860
 under Part I of the Federal Power Act). (18 CFR
 381.302(a))............................................
2. Review of a Department of Energy remedial order:

                  Amount in controversy

$0-9,999. (18 CFR 381.303(b))...........................             100
$10,000-29,999. (18 CFR 381.303(b)).....................             600
$30,000 or more. (18 CFR 381.303(a))....................          36,290
3. Review of a Department of Energy denial of
 adjustment:

                  Amount in controversy

$0-9,999. (18 CFR 381.304(b))...........................             100
$10,000-29,999. (18 CFR 381.304(b)).....................             600
$30,000 or more. (18 CFR 381.304(a))....................          19,030
4. Written legal interpretations by the Office of                  7,130
 General Counsel. (18 CFR 381.305(a))...................
------------------------------------------------------------------------

                Fees Applicable to Natural Gas Pipelines
------------------------------------------------------------------------
1. Pipeline certificate applications pursuant to 18 CFR           *1,000
 284.224. (18 CFR 381.207(b))...........................
------------------------------------------------------------------------
        Fees Applicable to Cogenerators and Small Power Producers
------------------------------------------------------------------------
1. Certification of qualifying status as a small power            21,380
 production facility. (18 CFR 381.505(a))...............
2. Certification of qualifying status as a cogeneration           24,200
 facility. (18 CFR 381.505(a))..........................
------------------------------------------------------------------------
* This fee has not been changed.

List of Subjects in 18 CFR Part 381

    Electric power plants, Electric utilities, Natural gas, Reporting
and recordkeeping requirements.

    Dated: February 16, 2012.
Charles H. Schneider,
Executive Director.

    In consideration of the foregoing, the Commission amends Part 381,
Chapter I, Title 18, Code of Federal Regulations, as set forth below.

PART 381--FEES

0
1. The authority citation for Part 381 continues to read as follows:

    Authority:  15 U.S.C. 717-717w; 16 U.S.C. 791-828c, 2601-2645;
31 U.S.C. 9701; 42 U.S.C. 7101-7352; 49 U.S.C. 60502; 49 App. U.S.C.
1-85.

Sec.  381.302  [Amended]

    2. In Sec.  381.302, paragraph (a) is amended by removing
``$23,540'' and adding ``$24,860'' in its place.

Sec.  381.303  [Amended]

    3. In Sec.  381.303, paragraph (a) is amended by removing
``$34,370'' and adding ``$36,290'' in its place.

Sec.  381.304  [Amended]

    4. In Sec.  381.304, paragraph (a) is amended by removing
``$18,020'' and adding ``$19,030'' in its place.

Sec.  381.305  [Amended]

    5. In Sec.  381.305, paragraph (a) is amended by removing ``$
6,750'' and adding ``$7,130'' in its place.

Sec.  381.403  [Amended]

    6. Section 381.403 is amended by removing ``$11,720'' and adding
``$12,370'' in its place.

Sec.  381.505  [Amended]

    7. In Sec.  381.505, paragraph (a) is amended by removing
``$20,240'' and adding ``$21,380'' in its place and by removing
``$22,920'' and adding ``$24,200'' in its place.

[FR Doc. 2012-4146 Filed 2-22-12; 8:45 am]
BILLING CODE 6717-01-P